Flu Shots, Vaccines, Bird Flu and Swine Flu

Early data collected by the Centers for Disease Control and Prevention (CDC) suggeststhat the 2014-2015 flu season could be severe.

“I think it's just getting kicked off but we see already that in several states there's widespread activity so we're expecting it to ramp up rather quickly,” Dr. Michael Martino, medical director at AFC/Doctors Express in South Bend, Ind., told ConsumerAffairs.

AFC/Doctors Express operates urgent care facilities nationwide and sees lots of patients who have come down with the virus. So far Illinois, Maryland, North Carolina, Florida, Puerto Rico, Louisiana and Alaska have seen widespread flu outbreaks but Martino expects other states may quickly join them.

If you haven't gotten a flu shot yet, there's good reason to do it soon. The CDC says so far this year seasonal influenza A H3N2 viruses have been most common. During years when they are predominant resulting illnesses are more severe, increasing the number of hospitalizations.

Vaccine doesn't cover all viruses

Making matters worse, this year's vaccine – which has to be produced well in advance of the flu season – covers only about half of the active H3N2 viruses in the vaccine. But Martino says that's no reason to skip the flu shot.

“In a normal year getting a flu shot might reduce your risk of getting the flu 70% to 80%,” he said. “It's going to be a little less than that this year but there's no question it will help avoid getting sick, and reduce the severity of the flu if you happen to get it.”

At the CDC, director Dr. Tom Frieden says however severe the season turns out to be, Americans need to be prepared.

“We can save lives with a three-pronged effort to fight the flu: vaccination, prompt treatment for people at high risk of complications, and preventive health measures, such as staying home when you’re sick, to reduce flu spread,” Frieden said.

Holidays increase flu risks

Since the vaccine takes about 2 weeks to become effective, getting vaccinated this week is your last window of opportunity to protect yourself before the holidays. And that's important because each year, the holidays seem to produce a multiplier for the flu virus.

“We're traveling, so we're exposed to people from a wider area,” Martino said. “We have increased traffic in public areas so there's increased exposure. And we have close contact with a lot of people, whether it be hand shaking, hugging and kissing relatives – and those are all ways to get exposed to the flu.”

Prevention tips

Even if you get a flu shot, Martino says it's important to take simple precautions during flu season. They include:

• Avoid close contact with people who are sick. When you are sick, keep your distance from others to protect them from getting sick too.
• If possible, stay home from work, school, and errands when you are sick. You will help prevent others from catching your illness.
• Cover your mouth and nose with a tissue when coughing or sneezing. It may prevent those around you from getting sick.
• Washing your hands often will help protect you from germs. If soap and water are not available, use an alcohol-based hand rub.
• Avoid touching your eyes, nose or mouth. Germs are often spread when a person touches something that is contaminated with germs and then touches his or her eyes, nose, or mouth.
• Clean and disinfect frequently touched surfaces at home, work or school, especially when someone is ill. Get plenty of sleep, be physically active, manage your stress, drink plenty of fluids, and eat nutritious food.

If you get sick, get treated

If, despite everything, you do get the flu Martino says you can reduce the effects of the illness if you seek treatment quickly.

“It's very smart to go to your doctor or seek urgent care treatment within 48 hours of developing flu symptoms,” he said. “Drugs like Tamiflu are very effective and can shorten the duration and severity of the flu and helps prevent complications.”

Getting a flu shot is your best chance of avoiding the flu, according to the Mayo Clinic. Each year the vaccine is engineered to counter the expected strains of the flu virus, so getting a shot doesn't make you bullet-proof.

In past years unexpected strains have cropped up and people that got the shot got sick. However, these tend to be the exception, not the rule. Getting the vaccine simply improves your odds.

If you choose not to get a flu shot, your other option is to constantly wash your hands and avoid public places where you might pick up the germ from an infected person.

Serious business

The flu can kill. It's a serious illness – more so for some people – the very old and very young – than others. The Centers for Disease Control and Prevention (CDC) estimates that over 31 flu seasons between 1976 and 2007, as many as 49,000 people in the U.S. died of flu-related complications.

According to the CDC, about 90% of flu deaths during a regular flu season occur in people 65 years old and older.

Getting a flu shot can also make flu season less dangerous for others. People get the flu, after all, from other people. If more people get flu shots and fewer of them get the flu, there are fewer flu germs in circulation.

Reduced risk of heart disease

A final reason for getting a flu shot has nothing to do with the flu. Previous research has suggested that flu vaccines have proved effective against heart disease – even reducing the risk of a heart attack.

A new study this month reveals why. The scientists who conducted it say the information could be used to prevent heart disease directly.

Heart disease is known to be the leading cause of death worldwide. The risk can be reduced by eating healthily, exercising and stopping smoking. However, right now there is no vaccine against heart disease.

Over the years clinical studies have shown that people who receive the seasonal flu vaccine get the added benefit of its protective effect against heart disease. The risk of heart attack in the year following vaccination is 50% lower than people who did not receive the vaccination. Until now, scientists haven't understood why.

The latest study shows that the flu vaccine stimulates the immune system to produce antibodies that activate important processes in cells. These processes, in turn, lead to the production of molecules that protect the heart.

Potential heart vaccine

Because of this discovery, the researchers say it may be possible to develop a new vaccine against heart disease.

"Even though the protective effect of the flu vaccine against heart disease has been known for some time, there is very little research out there looking at what causes it,” said Dr. Veljko Veljkovic, Institute Vinca, Belgrade, the lead author of the study.

Veljkovic and his colleagues propose more research, including ways the components of the flu vaccine might be used to create a vaccine against heart disease.

Last week's grilling of federal health officials at the hands of Congress may say a lot about rising public concern and frustration over the arrival of the deadly Ebola virus on American shores.

While Republican lawmakers might be expected to take political shots at the Obama Administration over its handling of the Ebola outbreak, it's worth noting two prominent Democrats on the ballot next month – Wendy Davis of Texas and Kay Hagan of North Carolina – have broken with the White House and called for a temporary ban on flights from the 3 affected West African countries.

Is the growing fear that Ebola could become a deadly epidemic in the U.S. justified? The medical community, for the most part, continues to insist it is not.

Before the first case turned up in Dallas Ira Longini, professor of biostatistics at the University of Florida, released a study predicting a 20% chance of “isolated cases” of Ebola showing up in the U.S.

Limited outbreak

Now that the first cases have appeared, Longini is sticking to his prediction that there will be a very limited outbreak in the U.S. He also is not in favor of restricting travel.

“Very far down on the list is the control of movement of people, which on the surface looks like it's important, but it's so difficult to carry out,” he said. “I don't think that that's going to have a big impact on the spread of the epidemic.”

So far, Longini is one of the few experts willing to put a number on Americans eventually stricken with the disease. Based on containment methods available in the U.S., he said he believes the U.S. will see fewer than 100 cases of Ebola. The number of U.S. cases, he says, depends largely on the number of African cases.

“Unless the epidemic continues to be completely out of control and more countries are affected and it gets much larger, I wouldn't expect to see more than a handful of cases in the U.S,” he said.

We've been here before

Howard Markel, a doctor and medical historian at the University of Michigan, says there have been epidemics throughout history and most have been accompanied by fear. He cautions Americans against over-reacting.

“You should pay attention, certainly, but, at this point there’s no need to get into the frenzy about Ebola in the United States,” he said.” We all need to take a breath and do a reality check.”

The reality, he says, is that Ebola is hard to catch and easy to kill. It's also a reality, he says, that most of the cases to date have been in people who live or worked in West Africa.

“While there may continue to be transmissions to health care workers here in this country, the risk to most of us is quite small,” he said.

In fact, the two Americans who contracted Ebola without visiting Africa are nurses who were part of the Dallas team that treated Thomas Eric Duncan, who died of Ebola after visiting West Africa. David Weber, professor of medicine, pediatrics, and epidemiology at the University of North Carolina Schools of Medicine and Public Health, warns that health care workers are particularly vulnerable, despite the strictest precautions.

"In Africa, more than 300 healthcare workers have acquired Ebola,” he said. “More than 200 of those have died."

Weber says the emphasis now should be on training health care workers to deal with Ebola, so that more are not infected while treating patients. The training needs to be completed now, he says, before there are patients.

America's health concerns this fall are focused firmly on Ebola, a deadly virus that appears to kill half its victims.

Though largely confined to West Africa, the death in Dallas of a recent visitor to that region – and the subsequent infection of two medical personnel who cared for him – has made Ebola dominate every news cycle, even when there is nothing new to report.

Dr. Daniel Hussar, pharmacy professor at Philadelphia College of Pharmacy, thinks Americans should take a breath and stop worrying about Ebola. It's the flu we should be worrying about, he says.

Flu is the killer

Ebola might kill, if it spreads in the U.S., which Hussar says is unlikely. But flu, he points out, does kill year in and year out. He says there were 131 flu-related deaths in Pennsylvania alone last flu season. Influenza remains a leading cause of death in the U.S, according to the Centers for Disease Control and Prevention (CDC).

“While everyone should get a flu vaccine this season, it’s especially important for infants, children, pregnant women, and seniors because they are most vulnerable to developing serious complications – like pneumonia – if they catch the flu,” he said.

According to its study of the 2012-2013 flu season, the CDC estimates that the flu vaccine prevented 79,000 hospitalizations and 6.6 million illnesses. Still, more than 381,000 Americans were hospitalized because of flu-related illness during that season.

Isolation

Dr. Charlene Chick, a family physician at the Rowan University School of Osteopathic Medicine, is also strongly urging consumers to get a flu vaccine. She points out that to avoid contact with the virus you would also have to avoid going out in public during flu season. You couldn't touch things like elevator buttons, door knobs, ATM keypads and stair railings where the flu can be left behind by someone who is infected.

And that, in short, is what makes flu a bigger threat. Unlike Ebola, it can be transmitted through the air, from person to person. Germs left on objects can live for long periods of time, allowing them to infect multiple people.

The Ebola virus is spread through contact with an infected person's bodily fluid. Scientists believe that until an infected person begins having symptoms they can't spread the virus. Ebola viruses left on an inanimate object die very quickly. In short, Ebola is harder to get than the flu.

“Don't let the recent Ebola news headlines distract you from taking measures to protect yourself and your loved ones from the much greater risk of catching the flu,” Hussar said.

Misinformation

Hussar says there is a lot of misinformation about flu vaccines out there. For example, he says the vaccine is perfectly safe for pregnant women. Also, it's never too late to get a flu shot. Even late in the season the vaccine can provide protection within two weeks of receiving it.

Don't like shots? Hussar says you can still get vaccinated with the nasal spray option. This vaccine, is commonly known by its trade name, FluMist, and offers protection to healthy adults from 2 to 49 years old who are not pregnant. FluMist contains a live but weakened flu virus that cannot cause flu illness.

A prestigious group of German scientists is warning that the Ebola virus is spreading rapidly and to an unexpected extent and they say the current outbreak is not following the patterns seen in the past and is showing "a new disease dynamic in regions where it has never been recorded before."

"The Ebola virus epidemic on this scale presents completely new challenges, both to the countries that are directly affected and the international community," the scientists said. "Germany, together with other industrialized countries, has an important role to play here."

In a statement issued today, the German National Academy of Sciences, the German Academy of Science and Engineering, and the Union of the German Academies of Sciences and Humanities, among others, said new vaccines and antivirals are urgently needed.

"Even if the pathogen should temporarily disappear again, research must continue as a precautionary measure because another outbreak is highly probable," they said. "Such precautionary measures must also include ensuring that sufficient quantities of available vaccines and antivirals are stockpiled in case of a new outbreak."

They noted that while the vast majority of cases in the current outbreak have been in Western Africa, the "possible consequences of further international spread are particularly serious in view of the virulence of the virus, the intensive community and health facility transmission patterns, and the weak health systems in the currently affected and most at-risk countries."

"Entirely different"

Since its discovery in 1976, there have been repeated outbreaks of the Ebola virus, which were generally contained to remote regions of Central Africa and never amounted to more than 500 cases, the German scientists noted but said the current outbreak of the virus is entirely different from past outbreaks.

"Over 8,000 cases were registered by 5 October 2014. About half of the people infected have died. The death toll includes many doctors and nursing staff and an end to the outbreak is not in sight," they noted.

Doctors Without Borders and the European Mobile Laboratory Project were the first to come to the region in March 2014. From very early on, these organizations have repeatedly said that the outbreak will not be contained without a massive increase in medical and epidemiological aid, they said.

The Ebola virus

Ebola viruses are transmitted from animals to humans. Fruit bats are presumed to be the natural reservoir of the virus. The Zaire species of Ebola virus, responsible for the current outbreak in West Africa, causes a particularly severe form. The disease progresses primarily with massive virus proliferation and immune dysfunction. The main symptoms are fever, diarrhea, vomiting and impaired coagulation, leading to multiple organ failure and shock.

Initial examinations of the genetic material have shown that the virus is different from past strains with numerous genetic mutations, but the significance of this is not known, the scientists said.

Only about half of all pregnant women in the U.S. get a flu shot each season, leaving thousands of moms-to-be and their babies at increased risk of serious illness.

“Getting a flu shot should be a routine part of prenatal care,” said Edward McCabe, MD, March of Dimes chief medical officer. “Health care providers should offer their pregnant patients a flu shot each year and if they don’t, then women should ask for it.”

A report by the U.S. Centers for Disease Control and Prevention, presented today by the National Foundation for Infectious Disease, found that among those pregnant women whose health care provider offered them a flu shot had the highest vaccination rates.

All pregnant women and those planning to become pregnant should receive a flu shot because the normal changes to a pregnant woman’s immune system, heart and lungs put moms-to-be at increased risk of the harmful effects of flu infection.

Also, babies born to mothers who got their flu shot while pregnant were protected from serious illness from influenza during their first six months of life. They also had a lower risk of flu-related hospitalizations for chronic asthma, heart conditions, diabetes, a weakened immune system, and other health-related problems.

Studies that looked at thousands of pregnant women who received the seasonal flu vaccine, found that immunized moms did not have a higher risk of babies being born too soon or developing a birth defect when compared with babies born to women who did not get a vaccine. Also, researchers found that women who were vaccinated were less likely to experience a stillbirth.

If you're the parent of a preteens or teen, a major goal is keeping the kids healthy and safe during all the fun stuff they have planned for the summer.

But eventually, they'll be going back to school and that usually means vaccinations, which most states require before school starts again.

There are 4 vaccines recommended to help protect your preteens and teen-aged children, their friends and their family members. While your kids should get a flu vaccine every year, the 3 other preteen vaccines should be given when kids are 11- 12 years old. Teens may also need a booster of a vaccine that requires more than one dose to be protected completely.

What they need

The following vaccines are recommended by the American Academy of Pediatrics, the American Academy of Family Physicians, other medical societies and Centers for Disease Control and Prevention (CDC):

• HPV vaccine: Human papillomavirus (HPV) vaccines help protect both girls and boys from HPV infection and cancers caused by HPV. HPV vaccine protects girls from the types of HPV that cause most cervical cancer. HPV vaccine also helps protect both girls and boys from anal cancer and genital warts. Girls and boys should start and finish the HPV vaccine series when they are 11 or 12 years old. Preteens and teens who have not gotten all HPV shots should ask their doctor or nurse about getting them now.
• Meningococcal conjugate vaccine: Meningococcal conjugate vaccine (MenACWY) protects against some of the bacteria that can cause meningitis (swelling of the lining around the brain and spinal cord) and sepsis (an infection in the blood). Meningitis can be very serious, even fatal. Preteens need the meningococcal shot when they are 11 or 12 years old and then a booster shot at age 16. Teens who got the meningococcal shot when they were 13, 14, or 15 years old should still get a booster at 16 years. Older teens who haven't gotten any meningococcal shots should get one as soon as possible.
• Tdap vaccine: Tdap vaccine protects against 3 serious diseases: tetanus, diphtheria and pertussis (also called whooping cough). The Tdap vaccine takes the place of what used to be called the tetanus booster. Preteens should get Tdap at age 11 or 12. If your teen didn't get a Tdap shot as a preteen, ask their doctor or nurse about getting the shot now.
• Flu vaccine: Flu vaccine protects against flu and the other health problems flu can cause, like dehydration (loss of body fluids), making asthma or diabetes worse, or even pneumonia. Preteens and teens should get the flu vaccine every year as soon as it's available, usually in the fall. It is very important for preteens and teens with chronic health conditions like asthma or diabetes to get the flu shot, but the flu can be serious for even healthy preteens and teens.

Safe and effective

The vaccines for preteens are very safe. Some kids might have some mild side effects from shots, such as redness and soreness in the arm. Some preteens and teens may faint after getting a shot or any other medical procedure. Sitting or lying down for about 15 minutes after getting shots can help prevent fainting. Most side effects from vaccines are very minor, especially compared with the serious diseases that these vaccines prevent.

Be sure to check with the doctor to make sure that your teen has received all of the vaccines recommended for them. They may need to "catch up" on vaccines they might have missed when they were younger.

Paying a problem?

Most health insurance plans cover the cost of vaccines. If you don't have insurance, or if it does not cover vaccines, the Vaccines for Children (VFC) program may be able to help.

The VFC program provides vaccines for children ages 18 years and younger, who are not insured or under-insured, Medicaid-eligible, American Indian or Alaska Native.

The measles, a once-common childhood disease, is back. According to the Centers for Disease Control and Prevention (CDC), the U.S. is seeing the biggest measles outbreak in decades.

Most older Americans probably remember getting the measles. It usually meant missing a couple of weeks of school.

Measles, also known as rubeola, is a highly contagious respiratory disease caused by a virus, which meant if a kid in your class got it, sooner or later you probably would too. Besides the fever, runny nose, cough, people with measles also had a rash all over their body.

Once you had it, you usually didn't get it again. While it might not sound all that serious, it could be. For every 1,000 kids who got the disease, one or two would die, according to the CDC.

Measles all but died out after the 1960s. The first measles vaccine was licensed in 1963 and nearly 19 million people were vaccinated over the next 12 years.

The end of measles

Over the years other vaccines followed and the disease started to disappear. In 2000 the CDC declared endemic measles had been eradicated but U.S. residents remained at risk for infection from imported cases.

“We are seeing a rise in children in the U.S. with measles because international travel has become so common. People bring it back from endemic areas and because it’s highly contagious,” said Nadia Qureshi, MD, pediatric infectious disease specialist at Loyola University Health System. “If your child is not vaccinated they are at-risk.”

But vaccination rates in the U.S. have fallen, which may be another reason for the measles resurgence. The dramatic rise in autism coincided with the use of many childhood vaccines, leading many worried parents to suspect a connection.

Lancet article

In 1998 the British medical journal Lancet published – and later retracted – a study that seemed to imply a connection between the MMR (measles-mumps-rubella) vaccine and the development of autism in children.

Because it's a disease that many of today's parents' parents had as children, some think skipping the vaccine is the lesser of the risks. The CDC begs to differ.

No treatment

It points out that measles is caused by a virus and there is no specific treatment for the infection. It simply has to run its course and the child's immune system has to be strong enough to recover. Most are but a few aren't.

“We don’t have a specific treatment and can only address the symptoms of the infection. But, we do have a very effective vaccine that can prevent the virus. Children in the U.S. usually get two doses of the vaccine. After the first dose 95 percent are protected and 98 percent protected after the second. It is a safe vaccine that can protect children from a potentially deadly disease,” said Qureshi.

Even with a vaccinated population Qureshi says there will be 1-2% who are still at-risk. Since the virus was considered eliminated from the U.S. for nearly a decade there are many doctors who have never seen an actual case.

“Vaccine rates were so good in this country that many physicians have seen it in books or photos, but no live cases. This can make it difficult to diagnose and people can be walking around with the contagious virus not even knowing it. The best way to keep your family safe is to vaccinate,” said Qureshi.

Kids who get flu shots are 74% less likely to end up in a hospital's intensive care unit than those who don't, according to a study by the Centers for Disease Control and Prevention (CDC), published in the Journal of Infectious Diseases.

The study is the first to estimate vaccine effectiveness (VE) against flu admissions to pediatric intensive care units (PICU). It illustrates, according to CDC, the important protection flu vaccine can provide to children against more serious flu outcomes. The agency recommends annual flu shots for everyone 6 months and older -- especially for children at high risk of serious flu-related complications.

“These study results underscore the importance of an annual flu vaccination, which can keep your child from ending up in the intensive care unit,” said Dr. Alicia Fry, a medical officer in CDC’s Influenza Division. “It is extremely important that all children -- especially children at high risk of flu complications -- are protected from what can be a life-threatening illness."

Children younger than 5 years and children of any age with certain chronic medical conditions like asthma, diabetes or developmental delays, are at high risk of serious flu complications.

Reducing the risk

Fry’s team analyzed the medical records of 216 children age 6 months through 17 years admitted to 21 PICUs in the United States during the 2010-2011 and 2011-2012 flu seasons. They found that flu vaccination reduced a child's risk of ending up in the pediatric intensive care unit for flu by an estimated 74%. These findings show that while vaccination may not always prevent flu illness, it protects against more serious outcomes.

Though flu vaccination was associated with a significant reduction in risk of PICU admission, flu vaccine coverage was relatively low among the children in this study: only 18% of flu cases admitted to the ICU had been fully vaccinated.

More than half (55%) of cases had at least one underlying chronic medical condition that placed them at higher risk of serious flu-related complications.

How much protection?

CDC usually measures flu VE against “medically attended flu illness” -- that is, how well it protects against having to go to the doctor for flu symptoms. During the 2010-2011 and 2011-2012 seasons, the midpoint VE estimates against medically attended illness were 60% and 47% respectively.

"Because some people who get vaccinated may still get sick, it's important to remember to use our second line of defense against flu: antiviral drugs to treat flu illness,” Fry said. “People at high risk of complications should seek treatment if they get a flu-like illness. Their doctors may prescribe antiviral drugs if it looks like they have influenza."

Symptoms of flu may include fever, cough, sore throat, runny or stuffy nose, body aches, headache, chills, and sometimes diarrhea and vomiting.

Flu causes hospitalizations in children each season, but how many children are affected varies, depending on the severity of the season. CDC estimates that 20,000 children younger than 5 years are hospitalized on average each year.

For children younger than 18 years, published studies suggest an annual range of flu-related hospitalization rates of between one child and seven children per 10,000 children. Between 4% and 24% of hospitalized children require PICU admission.

Younger- and middle-age adults took a particularly hard hit from the flu season, according to the Centers for Disease Control and Prevention’sMorbidity and Mortality Weekly Report (MMWR ).

People age 18-64 represented 61 percent of all hospitalizations from influenza compared with the previous three seasons when this age group represented only about 35% of all such hospitalizations. Flu deaths followed the same pattern with more deaths than usual occurring in this younger age group.

A second MMWR report showed that influenza vaccination offered substantial protection this season, reducing a vaccinated person’s risk of having to go to the doctor for flu illness by about 60% across all ages.

“Flu hospitalizations and deaths in people younger- and middle-aged adults is a sad and difficult reminder that flu can be serious for anyone, not just the very young and old; and that everyone should be vaccinated,” said CDC Director Tom Frieden, M.D., M.P.H. “The good news is that this season's vaccine is doing its job, protecting people across all age groups."

Ain't over til it's over

U.S. flu surveillance data suggest flu activity is likely to continue for several weeks, especially in places where activity started later in the season. Some states that saw earlier increases in flu are now seeing decreases. Other states are still seeing high levels of flu activity or continued increases.

While flu is responsible for serious illness and death every season, the people who are most affected can vary by season and by the predominant influenza virus. The currently circulating H1N1 virus triggered a pandemic in 2009, in which there were high rates of hospitalization and death in younger- and middle-aged people. While H1N1 viruses have continued to circulate since the pandemic, this is the first season since then that they have been predominant in the U.S. Once again, the virus is causing severe illness in younger- and middle-aged people.

High hospitalization rates

Approximately 61% of flu hospitalizations so far this season have occurred among persons aged 18-64 years. Last season, when influenza A (H3N2) viruses were the predominant circulating viruses, people 18 to 64 years accounted for only 35% of hospitalizations. During the pandemic season of 2009-2010, people 18 to 64 years old accounted for about 56% of hospitalizations.

Hospitalization rates have also been affected. While rates are still highest among people 65 and older (50.9 per 100,000), people 50 to 64 years now have the second-highest hospitalization rate (38.7 per 100,000), followed by children 0-4 years old (35.9 per 100,000). During the pandemic, people 50 to 64 years also had the second-highest hospitalization rate. Note that hospitalization rates are cumulative and thus will continue to increase this season.

Flu deaths this season are following a pattern a similar to the pandemic. People 25 years to 64 years of age have accounted for about 60% of flu deaths this season compared with 18%, 30%, and 47% for the three previous seasons, respectively. During 2009-2010, people 25 years to 64 years accounted for an estimated 63% of deaths.

Not invincible

"Younger people may feel that influenza is not a threat to them, but this season underscores that flu can be a serious disease for anyone," said Dr. Frieden. "It's important that everyone get vaccinated. It's also important to remember that some people who get vaccinated may still get sick, and we need to use our second line of defense against flu: antiviral drugs to treat flu illness. People at high risk of complications should seek treatment if they get a flu-like illness. Their doctors may prescribe antiviral drugs if it looks like they have influenza."

People at high risk for flu complications include pregnant women, people with asthma, diabetes or heart disease, people who are morbidly obese and people older than 65 or children younger than 5 years, but especially those younger than 2 years.

The value of flu shots

In the flu vaccine effectiveness (VE) study, CDC looked at data from 2,319 children and adults enrolled in the U.S. Influenza Vaccine Effectiveness (Flu VE) Network from December 2, 2013, to January 23, 2014. They found that flu vaccine reduced the risk of having to go to the doctor for flu illness by an estimated 61% across all ages. The study also looked at VE by age group and found that the vaccine provided similar levels of protection against influenza infection across all ages.

VE point estimates against influenza A and B viruses by age group ranged from 52% for people 65 and older to 67% for children 6 months to 17 years. Protection against the predominant H1N1 virus was even slightly better for older people; VE against H1N1 was estimated to be 56% in people 65 and older and 62% in people 50 to 64 years of age. All findings were statistically significant.

The interim VE estimates this season are comparable to results from studies during other seasons when the viruses in the vaccine have been well-matched with circulating influenza viruses and are similar to interim estimates from Canada for 2013-14 published recently.

While flu vaccine can vary in how well it works, vaccination offers the best protection currently available against influenza infection. CDC recommends that everyone 6 months and older get an annual flu vaccine.

“We are committed to the development of better flu vaccines, but existing flu vaccines are the best preventive tool available now,” said Dr. Frieden. “This season vaccinated people were substantially better off than people who did not get vaccinated. The season is still ongoing. If you haven’t yet, you should still get vaccinated."  

The winter of 2013-14 has been particularly tough. Not only have people in wide areas of the country been blasted with deep snows and frigid temperatures, the flu season has been particularly nasty.

The first week of 2014 brought Winter Storm Hercules, with at least 16 deaths in the Midwest and Northeast blamed on either extreme temperatures or treacherous conditions.

While the weather has gotten a lot of attention, the flu has been quietly killing people. In late December the U.S. Centers for Disease Control and Prevention (CDC) reported a resurgence of the H1N1 strain, also known as swine flu, which claimed over more than 1,000 lives in 2009.

Flu deaths occur each year, usually affecting the very old and very young and, in particular, those in fragile health to begin with. In the 2012-13 influenza season, CDC estimates that there were approximately 380,000 influenza-associated hospitalizations . In a marked difference this season, the young and healthy appear to be falling victim in greater numbers.

Picking up momentum

Since the beginning of the year officials say the flu – and swine flu in particular – has picked up frightening momentum. As a result, health officials have seen what they describe as a dramatic rise in flu deaths among young and middle-aged adults. The CDC describes the flu death rate as epidemic levels, with most of the mortality occurring in the last five weeks.

Some states are getting hit harder than others. California has recorded more than 240 death of people under age 65, well ahead of last year's rate. In San Diego County, eight people died from the flu in a single week. 

Nationwide, infections appear to be subsiding a bit. In its latest flu report, covering the first week of February, the CDC said influenza activity decreased from the previous week but remains high.

Rough week

For that week 7,562 specimens were tested with 1,268 – 16.8% – testing positive for influenza. Of those positives, 61% were of the swine flu variety. That's made worse by the fact the CDC found high levels of resistance to primary anti-viral medications among that strain. Deaths from flu for the week were above the “epidemic threshold” for the first time during the season.

Another troubling statistic comes from the hospitalization rate. More than 6,600 people were admitted to hospitals for treatment of the flu and 60% of them were between the ages of 18 and 64. This pattern of more hospitalizations among younger people was also seen during the 2009 swine flu pandemic.

The fact that cold weather and flu season overlap does not mean the two are related. The flu season normally begins in October and runs through May. Being exposed to the wet and cold may lower your resistance and make you more vulnerable to flu germs but the best way to avoid the flu is avoid the germs in the first place – and get a flu shot.

What to do

Is it too late to get a flu shot this season? Probably not, though it takes two weeks for the vaccine to kick in and provide protection against infection. With eight or more weeks remaining in flu season, a vaccination at this point is still a good idea.

After all, you can't do anything about the winter weather. At least you can improve your odds against winter's other scourge, the flu.

Okay it's February and you still haven't got around to getting your flu shot. That doesn't mean you're cooked.

The Food and Drug Administration (FDA) says vaccinations can be protective as long as flu viruses are circulating. And while seasonal flu outbreaks can happen as early as October, flu activity usually peaks in January or February, and can last well into May. So -- get with it.

Why a new vaccine

Marion Gruber, Ph.D., director of FDA’s Office of Vaccine Research and Review points out that there are several reasons that new vaccines must be manufactured each year. “Influenza viruses can change from year to year, due to different subtypes and strains that circulate each year,” she explains. “A vaccine is needed that includes virus strains that most closely match those in circulation, and the protection provided by the previous year’s vaccine will diminish over time.

Each February, before that year’s flu season ends, FDA, the World Health Organization, the Centers for Disease Control and Prevention (CDC) and other public health experts collaborate on collecting and reviewing data from around the world to identify the flu viruses likely to cause the most illnesses in the next flu season. Based on that information and the recommendations of an FDA advisory committee, the agency selects the virus strains for FDA-licensed manufacturers to include in their vaccines for use in the United States.

“The closer the match between the circulating strains causing disease and the virus strains in the vaccine, the better the protection against influenza,” Gruber says.

The most affected

CDC tracks flu activity year round in the U.S. and typically children and seniors are most at risk for influenza, but occasionally a flu virus will circulate that disproportionately affects young and middle-aged adults. So far, data reported by CDC suggest that 2013-2014 could be such a flu season.

CDC received an unusually high number of reports of severe respiratory illness among young and middle-aged adults in the last two months of 2013. Many of the cases were associated with the H1N1 strain of influenza that affected children and young adults compared to older adults during the 2009 influenza pandemic.

The 2009 H1N1 virus has circulated each year since the pandemic. It is not known if those most severely affected received a vaccine, but this particular strain is included in this year’s vaccine and will help provide protection.

“Influenza seasons and severity are often unpredictable. Annual influenza vaccination is the best way to prevent influenza among people 6 months of age and older,” says Gruber. “However, taking such practical measures as washing hands, covering coughs and sneezes and staying home when sick can also help to decrease the spread and minimize the effects of flu.”

In addition, while antiviral drugs are not a substitute for vaccine, they can help to treat influenza. Tamiflu (oseltamivir phosphate) and Relenza (zanamivir) are the two FDA-approved influenza antiviral drugs recommended by CDC for use against recently circulating influenza viruses.

The flu virus is widespread in at least 35 states, according to the Centers for Disease Control and Prevention (CDC), which says the illness is hitting the young and healthy particularly hard.

In flu cases severe enough to admit the patient to the hospital, 61.5% of the patients are between 18 and 64, ages considered young enough to withstand the worst of the flu's symptoms. That's nearly double the number from last year, the agency said.

The CDC reports that, in a typical year, more than 200,000 people are hospitalized due to flu-related complications. While younger patients appear to be bearing the brunt of this flu season, the young and old are at special risk. For people who are especially susceptible to developing complications, such as children under the age of five, adults age 65 or older and women who are pregnant, coming down with the flu can result in serious complications that may even be fatal.

A lot of swine flu this year

Doctors at Northwestern Medicine, at Northwestern University, report a spike in flu cases in the last weeks of 2013 and the first weeks of this year. The hospital recorded a total of 101 confirmed cases as of January 4. At least 75% of those cases were caused by the H1N1, or “swine flu” strain, which first surfaced in humans in 2009.

"Vaccination is the most important way to keep yourself from getting sick with influenza" said Dr. Gary A. Noskin, senior vice president and chief medical officer at Northwestern Memorial Hospital. "Patients who are reluctant to get the flu shot often believe that it is unnecessary for them. We know that between five to 20% of the population contracts the flu each year, and the majority of them have not been vaccinated."

Flu myths

It turns out there is a lot of misinformation about the flu. For example, many people believe that risk of coming down with the virus is greatest when it's cold in the winter. Staying warm and bundled up when they venture outside, they reason, will keep them safe.

Actually, you can get sick with the flu during any time of the year. The CDC says that the peak of flu season can occur anywhere from late November through March. It isn't too late to get a flu shot in January, but it is usually best to get it earlier in the season.

Some people who are healthy see no reason to get a flu shot. Again, that's something of a mistaken assumption. Being healthy, with a strong immune system, can help prevent someone from getting the flu, but no one is immune. As this year's large number of cases among the young and healthy shows, anyone can get sick if exposed to the virus.

Another myth that Noskin said he would like to shoot down is the idea you can get the flu by getting the flu shot. You can't, he says.

"The vaccination cannot give someone the flu,” Noskin said. “Every flu shot contains a form of the virus that is inactive and no longer infectious."

Keep it clean

While getting a seasonal flu shot can help prevent the flu, there are other things you should be doing to stay healthy. The simplest step is to wash your hands regularly with soap and water. Germs most often travel between people by way of their hands.

"Everyday interactions and routines cause us to come in contact with surfaces that are frequently used by others, such as keyboards, phones and doorknobs,” Noskin said. “Because soap and water isn't always easily available, using an alcohol-based hand sanitizer can offer a quick and simple solution that is just as effective."

Supermarkets and department stores often have hand sanitizer wipes available at entrances and exits. Making a habit of using them may reduce the chances of picking up flu germs from the handle of your shopping cart.

This is National Influenza Vaccination Week and the Centers for Disease Control and Prevention (CDC) is using the occasion to urge estimated 60% of Americans 6 months and older had who have been vaccinated yet to do so.

To shore up its pro-flu shot argument, the CDC cites a Morbidity and Mortality Weekly Report that says flu vaccination prevented an estimated 6.6 million influenza-associated illnesses, 3.2 million medically attended illnesses, and 79,000 hospitalizations during the 2012-2013 flu season.

The agency says the estimated benefits of vaccination for the 2012-2013 season are higher than any other season for which it has produced similar estimates. According to the report, there were a total of 31.8 million influenza-associated illnesses in the U.SD., last season, along with 14.4 million medically attended illnesses, and 381,000 hospitalizations.

“The estimated number of hospitalizations reinforces what we have always known about flu: that it is highly variable and can be very serious,” said CDC Director Tom Frieden, M.D., M.P.H.

Difference of opinion

Not everyone agrees, though

Dr. Donald Miller, a cardiac surgeon and Professor of Surgery at the University of Washington, recommends avoiding the flu shot. He recommends taking vitamin D instead. Writing on the website Mercola.com, Miller claims “Seventy percent of doctors do not get a flu shot.”

While the CDC says children aged 6 months through four years accounted for an estimated 69% of prevented hospitalizations last year, Miller maintains that there is a lack of evidence that young kids benefit from flu shots.”

In fact,” he writes, “a systematic review of 51 studies involving 260,000 children age 6 to 23 months found no evidence that the flu vaccine is any more effective than a placebo. But there is also a risk of harm from the flu vaccine itself, particularly from the mercury, aluminum, and formaldehyde it contains.”

The push is on

Despite the continuing controversy, the CDC maintains that getting an annual flu vaccination is becoming a habit for many people. But says Dr. Anne Schuchat, director of CDC's Center for Global Health, “there is still much room for improvement. The bottom-line is that influenza can cause a tremendous amount of illness and can be severe. Even when our flu vaccines are not as effective as we want them to be, they can reduce flu illnesses, doctors' visits, and flu-related hospitalizations and deaths.”

With further increases in influenza activity across the U.S. expected in the coming weeks, she says, “If you have not gotten your flu vaccine yet this season, you should get one now.”   

As another cold and flu season gets underway, one thing is a given. There's going to be a lot of coughing and sneezing around school or the office. That just increases the chances you, and others, will get sick too.

Getting a flu shot might help but there are other steps you can take to improve your odds of staying healthy this fall and winter. The first is to avoid others who are already sick.

That isn't always easy to do. Invariably a co-worker or two will drag themselves into the office, even through they are obviously ill. A survey by Kimberly-Clark Professional found that 59% of people reported going to work when they're sick.

Three in 10 said it was because they were too important to the business operation or had too much work to do and couldn't lose the time. But that may be a short-sighted view. Health experts say a contagious person in the office can wreak health havoc in a place of business.

Germ hot spots

Think about all the places germs may show up: an elevator button, a stair railing, the handle to the coffee urn and your stapler that everyone borrows. Viruses on surfaces like sink faucets and door handles quickly move from surface to hands, especially in public places.

Public places outside the office are also crawling with germs this time of year. If you take public transportation, for example, you are almost certainly picking up germs. You can be sure germs reside on the handles of grocery carts.

Since most germs travel from hands to mouth your first line of defense is to keep your hands clean. It will pay to keep sanitary moist wipes, or liquid, alcohol-based hand cleaner, in handy locations. While these hand sanitizers are often effective shields, the Centers for Disease Control and Prevention says old-fashioned hand washing is even more effective.

“Washing hands with soap and water is the best way to reduce the number of germs on them,” the CDC says. “If soap and water are not available, use an alcohol-based hand sanitizer that contains at least 60% alcohol. Alcohol-based hand sanitizers can quickly reduce the number of germs on hands in some situations, but sanitizers do not eliminate all types of germs.”

Not as easy as it sounds

And washing your hands means washing them thoroughly. The CDC says there is a prescribed manner of doing it:

• Wet your hands with clean, running water (warm or cold) and apply soap.
• Rub your hands together to make a lather and scrub them well; be sure to scrub the backs of your hands, between your fingers, and under your nails.
• Continue rubbing your hands for at least 20 seconds. Need a timer? Hum the "Happy Birthday" song from beginning to end twice.
• Rinse your hands well under running water.
• Dry your hands using a clean towel or air-dry them.

Even if you are exposed to cold and flu germs you may avoid getting sick if your immune system remains strong. You can promote a robust immune system by eating a diet rich in nutrients – especially vitamin C – and getting enough sleep at night.

A healthy lifestyle can also be important, especially in warding off the flu. The CDC cites studies that suggest smokers are more likely to get the flu than non-smokers.

Getting the message

The Kimberly Clark survey suggests consumers have become more sensitive to germ-transmission issues over the years. Seventy-nine percent said they wash their hands after coming in contact with a sick colleage and 81% said they use a hand sanitizer or disinfectant wipes.

"Germs can be spread throughout the workplace and elsewhere when people touch hot spots that have been contaminated by people who are ill," said Dr. Charles Gerba, Professor of Microbiology at the University of Arizona. "That's why individual efforts can make such a big difference.”

Here's something else you can do. Ask your boss or human resources manager to take the lead, providing hand-cleaning tools and encouraging frequent hand-washing. And though they may not want to encourage absenteeism, workplaces really should encourage employees to stay home when they feel they are contagious with the cold or flu.

If you do become sick with a flu-like illness, the CDC recommends that you stay home for at least 24 hours after your fever is gone. Yes, you are important and you have work to do but call in sick and don't feel guilty about it.  

This might not be the best time to plan a trip to China. The new bird flu virus is a growing threat there and health officials say it is killing a fifth of all those it infects.

The virus, known as H7N9, is so far only being transmitted to humans from chickens but the fear is that it will mutate into a form that could be passed from person to person, enabling it to spread worldwide.

Scientists say five separate mutations would be needed for that to happen, and that two of them have already occurred.

The World Health Organization (WHO) says there have been 126 cases of H7N9 bird flu so far, all but one in China. The other involved a man who had traveled to Taiwan from China. Of those infected, 24 have died.

Chickens don't get sick

Adding to the difficulty of containing the virus is the fact that it doesn't cause illness in chickens, making it impossible to know which specific chickens are infected.  The virus is, however, known to be present in all 31 provinces of China.

Unlike other viruses that have surfaced in the past, this virus has not been in the human population before. That means older generations don't have immunity to it, enabling the virus to strike everyone from the youngest to the oldest.

"The cases are going up daily – about 20% have died, 20% have recovered and the rest are still sick," said Prof. John McCauley, director of the WHO Collaborating Centre for Influenza at the MRC National Institute for Medical Research in London. "The WHO considers this a serious threat."

Public health officials are worried not only about the virus itself but also about the politics of the situation. After the 2009 swine flu outbreak, there was widespread criticism suggesting that health officials had pressed the panic button unnecessarily.

In fact, health officials say humanity dodged a bullet in 2009 and the precautions that were taken were the bare minimum needed to protect the population as much as possible.

"The longer the virus is unchecked in circulation, the higher the probability that this virus will start transmitting from person to person," Colin Butte, an expert in avian viruses at Britain's Pirbright Institute, said at a media briefing in London yesterday.

While previous outbreaks of bird flu haven't lived up to some fears about it, this latest strain of the virus that has shown up in China is causing growing concern.

The virus, known as H7N9, has infected 108 people and killed 22 in China since early March, when it was first reported. The World Health Organization (WHO) says the virus normally circulates among birds. It's only been recently that it has shown up in people.

“As yet, there is limited information about the scope of the disease the virus causes and about the source of exposure,” the WHO said in a statement. “The disease is of concern because most patients have been severely ill. There is no indication thus far that it can be transmitted between people, but both animal-to-human and human-to-human routes of transmission are being actively investigated.

Worst-cast scenario

A human-to-human transmission would be a worst-case scenario. As long as the spread is limited to bird-to-human, a person would have to come in contact with a diseased bird in order to come down with the virus.

However, if it is found that a person can catch the virus from a bird and then spread it to another human, health officials fear that would lead to a pandemic. Seasonal flu germs are easily spread among humans and the H7N9 is a particularly nasty virus for people.

The good news, so far, is that health officials do not believe any of the human cases so far have been transmitted from another human. The bad news is that when humans do come down with the disease, it can be life-threatening.

"This is definitely one of the most lethal influenza viruses that we've seen so far," said the WHO's Keiji Fukuda.

Not yet widespread

From the animal side, WHO said only a handful of the tens of thousands of chicken and birds tested have been positive for H7N9. There have been no positive results in pigs and virtually none of those animals were sick, in contrast to H5N1, which is the bird flu that emerged 15 years ago.

“With this different situation in animals, the presumed source of infection, we are still uncertain about the source of illness in people,” said Dr. Michael O'Leary, a WHO representative in China.

Until this week the outbreak had been confined to the Chinese mainland. This week there was a case of H7N9 reported in Taiwan. According to news reports a 53-year old man was stricken days after returning to Taiwan from Shanghai. He is reported hospitalized and in critical condition.

China is especially vulnerable to bird flu because birds play a prominent role as a source of food and livelihoods. WHO said it and its health sector partners are working at the level where humans and animal come in contact to identify and reduce animal health and public health risks within China and other countries where poultry is a major industry.

CDC monitoring

In the U.S. the Centers for Disease Control and Prevention (CDC) is monitoring H7N9 in China. The agency notes that not all the people infected had documented contact with poultry.

“Close contacts of confirmed H7N9 patients are being followed to determine whether any human-to-human spread of H7N9 is occurring,” the CDC said in a statement. “No sustained person-to-person spread of the H7N9 virus has been found at this time.”

The agency also reports that some limited person-to-person spread of a milder strain of bird flu may have occurred in the past. It says some limited human-to-human spread of this more “lethal” strain wouldn't be surprising.

It's almost over.

According to the Centers for Disease Control and Prevention, influenza-like-illness is below baseline for the first time since early December. Other indicators are declining as well, signaling that the flu season is drawing to a close.

The 2012-2013 flu season kicked off about 4 weeks early, with flu-like illnesses elevated for 15 consecutive weeks, making for a longer-than-average season. For the past 10 seasons, the flu has remained above baseline an average of 12 consecutive weeks with a range of one week to 16 weeks.

Hospitalizations among people 65 years and older with flu-like symptoms were the highest for that age group since record-keeping began during the 2005-2006 season. Seniors accounted for half of all reported hospitalizations. The cumulative influenza-related hospitalization rate across all age groups is

More information about the recent flu season -- and influenza in general -- is available at Flu.gov.

Bird flu is back in the headlines, with a new strain showing up in China. Should you be concerned? At this point, probably not. But as always, that could be subject to change.

In 2006 the media was full of scary scenarios about bird flu. For example, there were fears of panic and chaos if a strain of avian, or bird, flu spread around the world, creating a pandemic.

Bird flu did kill some people who were infected with it but the disease was fairly isolated and never got close to the pandemic proportions some health officials feared. The virus spreads easily among birds, such as ducks and chickens, and from birds to humans. But to date it has been unable to spread from human to human. Those who were infected with the virus got it from exposure to sick birds.

H7N9

Now there is a new strain of bird flu, called H7N9. For the first time it has shown up in humans, infecting 16 people and killing six of them in China. All of the victims had direct exposure to birds before getting sick.

Health officials in China have carefully monitored more than 100 family members of the victims and so far, not one has gotten sick. That's very good news, since it suggests that like the previous strain of bird flu, H7N9 cannot be spread from human to human.

International health officials are hoping it stays that way. The danger is the possibility that the virus mutates to a form that can be spread among humans. Since other family members of someone with ordinary seasonal flu get sick as much as 30% of the time, a virus that was transmitted from human to human could be very dangerous.

The H7N9 virus is a lot like regular flu, affecting the respiratory system, only it's more severe. Not everyone who gets it dies, but if you are in advanced years or poor health generally, the risks are greater.

All flu can kill

People die from seasonal flu all the time, it just doesn't make news. For example, in the week ending March 23, 2013 the U.S. Centers for Disease Control and Prevention (CDC) reported five children in the U.S. died from the flu. The agency said the proportion of U.S. deaths attributed to pneumonia and influenza was “at the epidemic threshold” that week.

While H7N9 bears watching, it isn't considered a danger at the moment, except for people in China involved in the poultry industry in one form or another. The Chinese government notified the World Health Organization (WHO) last week of the steps it is taking to monitor the situation.

In the U.S. the CDC said it is following the situation in China closely and is coordinating with U.S. and international partners to gather more information for development of a vaccine. CDC said that among the steps it is taking, it is studying the genetic sequencing of the new H7N9 virus and assessing the possible risk in terms of its spread.

Chances are, the next seasonal flu vaccine will contain protections against H7N9. The CDC calls these steps “routine.”

“This is an evolving situation and there is still much to learn,” the agency said in a statement over the weekend. “It is too soon to speculate regarding the significance of these cases/viruses, however, CDC will provide updated information as it becomes available.”

It's also too early to know how similar H7N9 is to previous avian flu strains. The uncertainly is what makes health officials nervous.

What you should do

At the moment, you should worry more about ordinary, seasonal flu than the new strain of bird flu. To date, no cases of H7N9 have shown up outside China. People who work in the poultry industry, however, should probably exercise even greater caution.

H7N9 symptoms are a lot like seasonal flu symptoms, only more severe. They include high fever, cough and respiratory tract infection at the early stage. About a week after the disease begins, patients develop pneumonia and have trouble breathing.

To avoid getting sick with any kind of flu, practice good hand hygiene.

Remember how your mother would warn you that going out in chilly or rainy weather without a coat would make you sick? Turns out that -- as was usually the case -- mom was on to something.

An epidemiological study led by researchers at the National Institutes of Health’s Fogarty International Center found that two types of environmental conditions -- cold-dry and humid-rainy -- are associated with seasonal influenza epidemics.

The paper, published in PLoS Pathogens, presents a simple climate-based model that maps flu activity globally and accounts for the diverse range of seasonal patterns observed across temperate, subtropical and tropical regions.

Tracking the spread of flu

The findings could be used to improve existing current influenza transmission models, and could help target surveillance efforts and optimize the timing of seasonal vaccine delivery, according to Fogarty researcher Cecile Viboud, Ph.D., who headed the study.

“The model could have a broader application, encouraging researchers to analyze the association between climatic patterns and infectious disease across a wide range of diseases and latitudes,” said Viboud.

Human influenza infections exhibit a strong seasonal cycle in temperate regions, and laboratory experiments suggest that low specific humidity facilitates the airborne survival and transmission of the virus in temperate regions. Specific humidity is the ratio of water vapor to dry air in a particular body of air while relative humidity -- commonly used in weather forecasts -- the amount of water vapor in the air relative to its capacity to hold water vapor, and is primarily a function of temperature.

Data from animal studies indicate low temperature and humidity increase the duration of the virus’s reproduction and expulsion in infected organisms and virus stability in the environment, increasing the probability of transmission through coughing, sneezing or breathing. In contrast, high temperature seems to block airborne transmission.

According to James Tamerius, Ph.D., a geographer at Columbia University, New York City, and the first author of the study, the effect of low specific humidity on influenza could cause annual winter epidemics in temperate areas. “However, this relationship is unlikely to account for the epidemiology of influenza in tropical and subtropical regions where epidemics often occur during the rainy season or transmit year-round without a well-defined season,” he said.

Predicting flu outbreaks

After assessing the role of local climatic variables on virus seasonality in a global sample of study sites, Viboud and her colleagues found that temperature and specific humidity were the best individual predictors of the months of maximum influenza activity, known as influenza peaks.

The team discovered that in temperate regions, influenza was more common one month after periods of minimum specific humidity. These periods happen to coincide with months of lowest temperature. In contrast, sites that maintained high levels of specific humidity and temperature were generally characterized by influenza epidemics during the most humid and rainy months of the year. “The models we used predicted the timing of peak influenza activity with 75 to 87 percent accuracy,” said Viboud.

More to be done

"Anecdotal evidence suggests that colder climates have winter flu while warmer climates that experience major fluctuations in precipitation have flu epidemics during the rainy season, and the current study fits that pattern,” said Viboud. “In contrast, the seasonality of influenza is less well-defined in locations with little variation in temperature and precipitation, and is a pattern that remains poorly understood. One hypothesis that is often used to explain tropical influenza activity is that people congregate indoors more frequently during the rainy season, increasing contact rates and disease transmission. There is little data to confirm this, however, and it’s an interesting area for future research."

Though the study offers researchers a new tool in the global effort to track the spread of influenza, climate is only one of several potential drivers of influenza seasonality. “Further work should focus on examining the role of population travel and other factors in influenza transmission,” notes Mark Miller, M.D., director of Fogarty’s Division of International Epidemiology and Population Studies. ”

More broadly, additional analysis of the link between climate and infectious diseases is needed -- particularly for respiratory and intestinal pathogens that display marked seasonality. The authors conclude, “A better understanding of the environmental, demographic and social drivers of infectious disease seasonality is crucial for improving transmission models and optimizing interventions.”

Personally, I’ve never gotten a flu shot and never gotten the flu, but it’s easy to see why so many people get them, since there has been a lot of documentation about their effectiveness.

According to the Centers for Disease Control and Prevention (CDC), people over six months of age should receive their flu vaccinations each year, and annually the government health agency as well as other entities put out strong publicity campaigns that encourage people to get their shots.

But not everyone believes the flu shot is the all-protecting serum that it’s advertised as, and although many health experts agree that getting a flu shot is better than not getting one, a lot of experts say people may be putting too much faith in a vaccine that might not be all that preventive.

Researchers at the University of Minnesota recently said although the flu shot is helpful, there are many improvements the vaccine needs to undergo in order to match its public perception of being completely protective against the flu.

“The current influenza vaccine protection is substantially lower than for most routine recommend vaccines and is sub-optimal,” said Michael Osterholm, the Director of the Center for Infectious Disease Research and Policy (CIDRAP), a research center that’s within the University of Minnesota.

“The perception that current vaccines are already highly effective in preventing influenza is a major barrier to pursuing game-changing alternatives,” he said

The researchers took this particular stance after examining 12,000 pieces of documentation stemming all the way back from 1936. They also interviewed almost 100 experts on the flu vaccine.

Complacency in the system

Others who weren’t part of the University of Minnesota study said these new findings shouldn’t discourage people from getting flu shots; rather they should put pressure on government entities to improve the vaccine and better communicate the flu shots' true level of usefulness.

“What the authors are saying is that they’re fearful that there is complacency in the system and that people think that the efficacy of the vaccine is higher than it is,” said Mayo Clinics’ Dr. Gregory Poland in an interview. “Therefore they’re not motivated to invest, and this will be billions, to invest the billions we need to get the vaccines.”

Other health experts have also been critical of the way the flu shot has been advertised to the public as a completely preventive vaccine.

Tom Jefferson, who is an epidemiologist with Cochrane Collaboration, a non-profit organization that’s involved in medical research, says that after reviewing a number of studies on the flu shot, many of the findings incorrectly indicate that the vaccine protects people from the flu more than it really does, specifically among the elderly.

“We looked at studies on vaccines in the elderly and in health care workers who work with the elderly, and we found an implausible sequence of results,” said Jefferson in a published interview.

 “We have studies that claim up to 90 percent effectiveness against death from all causes. If you were to believe that evidence, you would believe that flu vaccine is effective against death not only from influenza, but also from heart attack, stroke, hypothermia, accidents and all other common causes of death among the elderly. That is quite clearly nonsense,” he said.

More studies needed

Jefferson also says more studies are needed to prove the effects of the flu vaccine and says it’s time for government officials to largely increase their efforts to provide new and updated research about the effectiveness of the flu shot -- because until then, the general public will never be properly informed about how truly preventive flu vaccines are.

“The answer is a question mark,” Jefferson says. “We don’t know what protection, if any, vaccines offer. I don’t think that’s a bad thing. Uncertainty is the motor of science. We need large studies to find out. We’ve known for years that we needed proof one way or the other, and governments have not taken any notice of this. It’s an extraordinary situation.”

Although researchers at the University of Minnesota would most likely agree with Jefferson’s opinion about the government’s need to provide better transparency about flu vaccines, Osterholm says people should still get the shot since it’s still the best preventive measure we know  today.

“It’s clear that influenza vaccination offers substantially more protection for the population then being unvaccinated, that’s why I’ve got my flu shot this year,” he said.

Dr. Poland of the Mayo Clinic says that improvements on vaccines and all medicines is an ongoing effort, and bettering the public’s chance to avoid and beat certain illnesses will never be complete.

“Urging them [government officials] to do what all of us already feel and many of them, myself included have published, and that’s we need better vaccines, he said.

“We need better and better vaccines and soon as we have the next better vaccine, we’ll be calling for the next better one after that.”

The signs are out early this year. Just as retailers tend to promote holiday merchandise earlier and earlier each year, pharmacies, clinics and other health-related businesses are already pushing flu shots.

Flu season generally begins in the early fall and extends into the early spring. Each year pharmaceutical makers project what strains will be a threat and begin preparing the vaccine in the spring.

CVS/pharmacy and MinuteClinic announced today that flu vaccinations are now available at all of their locations nationwide.

"Getting a flu shot is the first and most important step you can take to protect yourself and your family from getting sick with influenza," said Troyen A. Brennan, M.D., Chief Medical Officer, CVS Caremark. "Flu season can be unpredictable and, because it takes about two weeks after being vaccinated to develop full protection, a flu shot is recommended as soon as vaccine is available."

Preparing for swine flu

“It's possible that sporadic infections and even localized outbreaks among people with this virus will continue to occur,” the Centers for Disease Control (CDC) said in a flu advisory. “While there is no evidence at this time that sustained human-to-human transmission is occurring, all influenza viruses have the capacity to change and it's possible that this virus may become widespread. So far, the severity of illnesses associated with this virus in people has been similar to the severity of illnesses associated with seasonal flu virus infections.”

Flu of all strains poses a more significant threat to the very old and very young. The CDC recommends that everyone who is at least 6 months old get a flu vaccine every year to protect against catching the flu.

Consumers can get a flu shot at many pharmacies and other retail locations, as well as from their health care professional. Some clinics and non-profit groups offer flu shots at no charge.

The U.S. Food and Drug Administration (FDA) has signed off on the 2012-2013 influenza (flu) vaccine formulation for all six manufacturers licensed to produce and distribute the vaccines in the U.S.

Each year experts from the FDA, the World Health Organization, the Centers for Disease Control and Prevention (CDC) and other public health experts study influenza virus samples and global disease patterns to identify virus strains likely to cause the most illness during the upcoming flu season.

Based on that information and the recommendations of the FDA’s Vaccines and Related Biological Products Advisory Committee, the strains selected for inclusion in the 2012-2013 flu vaccines are:

• A/California/7/2009 (H1N1)-like virus
• A/Victoria/361/2011 (H3N2)-like virus
• B/Wisconsin/1/2010-like virus.

While the H1N1 virus is the same as what was included in the 2011-2012 influenza vaccines, this year’s influenza H3N2 and B viruses differ from those in the 2011-2012 influenza vaccines.

Cornerstone of prevention

Vaccination remains the cornerstone of preventing influenza, a contagious respiratory disease caused by different influenza viruses infecting the nose, throat and lungs. This year’s seasonal vaccines will provide protection against the three influenza virus strains that global surveillance indicates are likely to be the most common strains circulating during the upcoming season.

There is always a possibility of a less than optimal match between the virus strains predicted to circulate and the virus strains that end up causing the most illness. However, even if the vaccine and the circulating strains are not an exact match, the vaccine may reduce the severity of the illness or may help prevent influenza-related complications.

“The best way to prevent influenza is by getting vaccinated each year,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “It is especially important to get vaccinated this year because two of the three virus strains used in this season’s influenza vaccines differ from the strains included in last year’s vaccines.”

Get your flu shot

According to the CDC, between five percent and 20 percent of the U.S. population develops influenza each year. This leads to more than 200,000 hospitalizations from related complications. Influenza seasons are unpredictable and can be severe, with annual influenza-related deaths ranging from a low of about 3,000 to a high of 49,000 people in the U.S.

The CDC’s Advisory Committee on Immunization Practices, recommends that everyone six months of age and older receive an annual influenza vaccine.

Health care providers play an important role in advising their patients to get vaccinated each year and should also protect themselves, their patients, their family and the community from influenza by getting vaccinated.

The manufacturers licensed to produce the nation’s 2012-2013 flu vaccines and the brand names of the vaccines for the upcoming flu season are:

• Afluria, manufactured by CSL Limited;
• Fluarix, manufactured by GlaxoSmithKline Biologicals;
• FluLaval, manufactured by ID Biomedical Corporation;
• FluMist, manufactured by MedImmune Vaccines Inc.;
• Fluvirin, manufactured by Novartis Vaccines and Diagnostics Limited; and
• Fluzone, Fluzone High-Dose and Fluzone Intradermal, manufactured by Sanofi Pasteur.

At least 12 people in five states have come down with a new strain of swine flu that isn't covered in this year's flu vaccine, the Centers for Disease Control and Prevention said.

The new strain is not the more common H1N1, that killed more than 17,000 people around the world over a two-year period. The new strain has been identified as H3N2v.

"In the second half of 2011, a number of U.S. residents were found to be infected with influenza A variant viruses, primarily H3N2v," the CDC said in a report. "Investigations revealed human infections with these viruses following contact with swine as well as limited human-to-human transmission."

Not known how widespread

While H3N2v viruses have been detected in U.S. swine, the CDC said it's unknown how widespread they are in swine herds. It's possible that sporadic infections and even localized outbreaks among people with this virus will continue to occur, according to the health agency.

So far, the CDC has counted only 12 cases. There are two in Indiana, three in Iowa, two in Maine, three in Pennsylvania and two in West Virginia.

"While there is no evidence that sustained human-to-human transmission is occurring, all influenza viruses have the capacity to change and it's possible that this virus may become widespread," the CDC warns.

Children appear more vulnerable

To date, the severity of illnesses associated with this virus in people has been similar to the severity of illnesses associated with seasonal flu virus infections. the limited studies that have been conducted so far suggest that adults may have some pre-existing immunity to this virus while children do not.

CDC said it is closely monitoring human infections with all novel influenza viruses, including H3N2v viruses, and will provide more information as it becomes available.

Swine influenza is a respiratory disease of pigs caused by type A influenza viruses that regularly cause outbreaks of influenza in pigs. Influenza viruses that commonly circulate in swine are called “swine influenza viruses” or “swine flu viruses.”

Swine flu viruses do not normally infect humans. However, sporadic human infections with swine influenza viruses have occurred.  

Picture this. You're sitting at your desk and a co-worker drops by but before you can say hi, they start coughing all over you.

If you think this scenario seems to be happening more frequently lately, you'd be right. A new survey finds that nearly one out of every two (46%) employees come to work even though they have a cold or fever and should be home in bed. It would be better for them as well as you. Who needs to get sick unnecessarily?

Apparently, it's going to take more than a cold or flu to get between them and their jobs this cold and flu season, according to a new survey conducted by the cough drop company, Halls.

The national telephone survey found that 46% of working Americans refuse to sacrifice a sick day this year for most cold and flu symptoms, including a cough, sore throat, body aches and sinus headache.

In fact, nearly half of Americans (44%) would consider going to work with a fever, and about a third of Americans (32%) said they would show up to work no matter how sick they get. Isn't that great? Someone with a highly contagious disease decides to show up at the office because he or she is afraid of their boss.

That's right. According to the latest U.S. Bureau of Labor Statistics, one in five Americans (19 percent) feel pressure by their boss or supervisor to go to work even when they're sick. One in three (31%) Americans said they wouldn't get paid for taking off on a sick day, and one in 10 (11%) said they would likely fall behind on their bills by taking a sick day. Additionally, more than 10% thought they would not likely receive their next pay raise or promotion, or worse, would even lose their job for calling out sick.

So what should you do to protect yourself from a medically unsafe workplace?

Get your flu shot. The Centers for Disease Control (CDC) recommends a yearly seasonal flu vaccine as the first and most important step in protecting against seasonal influenza.

Wash your hands and wash them often. You should do what doctors do. Wash your hands frequently with soap and warm water for at least 20 seconds. If soap and water are not available, an alcohol-based hand sanitizer is a good alternative.

If you have to cough or sneeze, do it into your elbow. That's if you don't have a tissue. This will help prevent the spread of germs.

Disinfect common surfaces. Germs can live for hours, and in some cases weeks, on common surfaces. Use a disinfectant regularly to wipe and clean doorknobs, phones, remote controls, toys, computer keyboards, and any other items that are shared at home or at the office.

Practice general good health habits. Eat right and exercise. Diets rich in fruits and vegetables provide a loaded source of immune boosting nutrients. Exercising, whether you're walking or playing outdoor games, builds up immune cells in the body and can help you feel more energetic and healthier while increasing your immunity to certain illnesses.

Drink plenty of non-alcoholic fluids. Hydrate your body by drinking 8-10 glasses of water a day to help flush out the system, and to keep your throat moist.

Get as much rest as possible. Try to sleep at least 8 to 9 hours per night to rejuvenate your body. In addition, try using relaxation techniques that are at your disposal, such as massage, yoga, and meditation. Stress and fatigue can lower your immune system.

Get plenty of fresh air. A regular dose of fresh air is important, especially in cold weather when central heating dries you out and makes your body more vulnerable to cold and flu viruses. Also, during cold weather more people stay indoors, which means more germs are circulating in crowded, dry rooms. 

The holiday season is upon us. So, it seems, is the flu season. The Centers for Disease Control says reported cases of flu have jumped in the last week.

The good news? If you've gotten a flu shot, you're much more protected since the virus strains identified so far closely match the ones used in this year's batch of vaccine.

The CDC has set aside this week as National Influenza Vaccination Week (NIVW). The week-long emphasis on flu vaccination was established to highlight the importance of continuing influenza vaccination, as well as fostering greater use of flu vaccine after the holiday season into January and beyond.

With three strains of flu expected to circulate in the 2010-2011 season, the CDC says it is important that everyone six months of age and older get vaccinated if they haven't already done so, to protect themselves and their loved ones from flu.

Three strains identified so far

The three flu strains identified by the CDCs' Advisory Committee on Immunization Practices are an A/H3N2 strain, a B strain and the 2009 H1N1 pandemic strain. This year's flu vaccine provides protection against all three strains and approximately 160 million doses of the vaccine have already been distributed nationwide.

Unlike previous years, when production snafus resulted in fewer-than-expected doses, there seems to be plenty of vaccine to go around. So much so that health officials want everyone to get a flu shot this year. The universal flu vaccine recommendation, which encourages everyone six months of age and older to be vaccinated, took effect this flu season.

Last year, the H1N1 "swine" flu didn't appear until April, after the U.S. flu vaccine formula was already in production, so the flu vaccine provided little, if any, protection from that strain. Health officials say this year, there are no such complications.

"The new vaccination recommendation shows the importance of preventing the flu in everyone," said Dr. Anne Schuchat, Assistant Surgeon General of the U.S. Public Health Service and CDC's Director of the National Center for Immunization and Respiratory Diseases. "People who do not get vaccinated are taking two risks: first, they are placing themselves at risk for the flu, including a potentially long and serious illness, and second, if they get sick, they are also placing their close contacts at risk for influenza."

"The bottom line is, anyone -- even healthy people -- can get sick from the flu," said Assistant Secretary for Health Dr. Howard K. Koh said anyone - even healthy people - can get sick from the flu bug.

"Lead the way to better health for all by getting your flu shot," he urged.

In much of the Northern Hemisphere, this is prime time for colds, flu, and other respiratory illnesses.

While contagious viruses are active year-round, fall and winter are when we're all most vulnerable to them. This is due in large part to people spending more time indoors with others when the weather gets cold.

Most respiratory bugs come and go within a few days, with no lasting effects. However, some cause serious health problems. Although symptoms of colds and flu can be similar, the two are different.

Cold vs. flu

Colds are usually distinguished by a stuffy or runny nose and sneezing. Other symptoms include coughing, a scratchy throat, and watery eyes. No vaccine against colds exists because they can be caused by many types of viruses. Often spread through contact with mucus, colds come on gradually.

Flu comes on suddenly, is more serious, and lasts longer than colds. The good news is that yearly vaccination can help protect you from getting the flu. Flu season in the United States generally runs from November to April.

Flu symptoms include fever, headache, chills, dry cough, body aches, fatigue, and general misery. Like colds, flu can cause a stuffy or runny nose, sneezing, and watery eyes. Young children may also experience nausea and vomiting with flu.

Fighting flu

According to the Centers for Disease Control and Prevention (CDC):

• More than 200,000 people in the United States are hospitalized from flu-related complications each year, including 20,000 children younger than age five.
• Flu-associated deaths number in the thousands each year. Between 1976 and 2006, the estimated number of flu-related deaths every year ranged from about 3,000 to about 49,000.

Flu vaccine, available as a shot or a nasal spray, remains the best way to prevent and control influenza. The best time to get a flu vaccination is from October through November, although getting it in December and January is not too late. A new flu shot is needed every year because the predominant flu viruses may change every year.

All people six months of age and older should be vaccinated. However, you should talk to your health care professional before getting vaccinated if you

• have certain allergies, especially to eggs
• have an illness, such as pneumonia
• have a high fever
• are pregnant

Flu vaccination for health care workers is urged because unvaccinated workers can be a primary cause of outbreaks in health care settings.

Certain people are more at risk for developing complications from flu; they should be immunized as soon as vaccine is available. These groups include:

• people 65 and older
• residents of nursing homes or other places that house people with chronic medical conditions such as diabetes, asthma, and heart disease
• adults and children with heart or lung disorders, including asthma
• adults and children who have required regular medical follow-up or hospitalization during the preceding year because of chronic metabolic diseases (including diabetes), kidney dysfunction, a weakened immune system, or disorders caused by abnormalities of hemoglobin (a protein in red blood cells that carries oxygen)
• Young people ages 6 months to 18 years receiving long-term aspirin therapy, and who as a result might be at risk for developing Reye's syndrome after being infected with influenza

This year's flu shot

Note that only one vaccine is needed for the 2010-2011 influenza season.

During last flu season, two different vaccines were needed; one to prevent seasonal influenza and another to protect against the 2009 H1N1 flu virus. This year's seasonal flu vaccine protects against three strains of influenza, including the 2009 H1N1 flu virus.

Also, a vaccine specifically for people 65 years and older is available this year. Called Fluzone High-Dose, this vaccine induces a stronger immune response and is intended to better protect the elderly against seasonal influenza.

This vaccine -- which was approved by FDA in 2009 -- was developed because the immune system typically becomes weaker with age, leaving people at increased risk of seasonal flu-related complications that may lead to hospitalization and death.

Good sanitation

Wash your hands often. Teach children to do the same. Both colds and flu can be passed through coughing, sneezing, and contaminated surfaces, including the hands. CDC recommends regular washing of your hands with warm, soapy water for about 15 seconds.

FDA says that while soap and water are undoubtedly the first choice for hand hygiene, alcohol-based hand rubs may be used if soap and water are not available. However, the agency cautions against using the alcohol-based rubs when hands are visibly dirty. This is because organic material such as dirt or blood can inactivate the alcohol, rendering it unable to kill bacteria.

Try to limit exposure to infected people. Keep infants away from crowds for the first few months of life. This is especially important for premature babies who may have underlying abnormalities such as lung or heart disease.

Practice healthy habits

• Eat a balanced diet.
• Get enough sleep.
• Exercise. It can help the immune system better fight off the germs that cause illness.
• Do your best to keep stress in check.

Also, people who use tobacco or who are exposed to secondhand smoke are more prone to respiratory illnesses and more severe complications than nonsmokers.

Already sick?

Usually, colds and flu simply have to be allowed to run their course. You can try to relieve symptoms without taking medicine. Gargling with salt water may relieve a sore throat. And a cool-mist humidifier may help relieve stuffy noses.

Here are other steps to consider:

• First, call your doctor. This will ensure that the best course of treatment can be started early.
• If you are sick, try not to make others sick too. Limit your exposure to other people. Also, cover your mouth with a tissue when you cough or sneeze, and throw used tissues into the trash immediately.
• Stay hydrated and rested. Fluids can help loosen mucus and make you feel better, especially if you have a fever. Avoid alcohol and caffeinated products. These may dehydrate you.
• Know your medicine options. If you choose to use medicine, there are over-the-counter (OTC) options that can help relieve the symptoms of colds and flu.

If you want to unclog a stuffy nose, then nasal decongestants may help. Cough suppressants quiet coughs; expectorants loosen mucus so you can cough it up; antihistamines help stop a runny nose and sneezing; and pain relievers can ease fever, headaches, and minor aches.

In addition, there are prescription antiviral medications approved by FDA that are indicated for treating the flu. Talk to your health care professional to find out what will work best for you.

OTC products

• Be wary of unproven treatments. It's best to use treatments that have been approved by FDA. Many people believe that products with certain ingredients -- vitamin C or Echinacea, for example -- can treat winter illnesses.
  

Unless FDA has approved a product for treatment of specific symptoms, you cannot assume the product will treat those symptoms. Tell your health care professionals about any supplements or herbal remedies you use.

• Read medicine labels carefully and follow directions. People with certain health conditions, such as high blood pressure, should check with a health care professional or pharmacist before taking a new cough and cold medicine. Some medicines can worsen underlying health problems.

• Choose appropriate OTC medicines. Choose OTC medicines specifically for your symptoms. If all you have is a runny nose, use only a medicine that treats a runny nose. This can keep you from unnecessarily doubling up on ingredients, a practice that can prove harmful.

• Check the medicine's side effects. Certain medications such as antihistamines can cause drowsiness. Medications can interact with food, alcohol, dietary supplements, and each other.

The safest strategy is to make sure your health care professional and pharmacist know about every product you are taking, including nonprescription drugs and any dietary supplements such as vitamins, minerals, and herbals.

• Check with a doctor before giving medicine to children. Get medical advice before treating children suffering from cold and flu symptoms. Do not give children medication that is labeled only for adults.

Don't give aspirin or aspirin-containing medicines to children and teenagers. Children and teenagers suffering from flu-like symptoms, chickenpox, and other viral illnesses shouldn't take aspirin.

Reye's syndrome, a rare and potentially fatal disease found mainly in children, has been associated with using aspirin to treat flu or chickenpox in kids. Reye's syndrome can affect the blood, liver, and brain.

Some medicine labels may refer to aspirin as salicylate or salicylic acid. Be sure to educate teenagers, who may take OTC medicines without their parents' knowledge.

When to See a Doctor

See a health care professional if you aren't getting any better or if your symptoms worsen. Mucus buildup from a viral infection can lead to a bacterial infection.

With children, be alert for high fevers and for abnormal behavior such as unusual drowsiness, refusal to eat, crying a lot, holding the ears or stomach, and wheezing.

Signs of trouble for all people can include:

• a cough that disrupts sleep
• a fever that won't go down
• increased shortness of breath
• face pain caused by a sinus infection
• worsening of symptoms, high fever, chest pain, or a difference in the mucus you're producing, all after feeling better for a short time

Remember: While antibiotics are effective against bacterial infections, they don't help against viral infections such as the cold or flu.

Each year, the seasonal influenza vaccine contains three flu viruses-- one influenza A (H3N2) virus, one influenza A (H1N1) virus, and one influenza B virus. The 2009 H1N1 (swine) flu) virus strain is included in the 2010-2011 seasonal flu vaccine because scientists continue to see this virus strain circulate in the U.S.

This season's vaccine is expected to have a similar safety profile as past seasonal flu vaccines. Over the years, hundreds of millions of Americans have received seasonal flu vaccines.

The most common side effects found from last year's H1N1 flu vaccines were soreness, redness, tenderness or swelling where the flu shot was given and nasal congestion after the flu vaccine nasal spray.

Feds to monitor vaccine

The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) are closely monitoring for any signs the vaccine is causing unexpected adverse events and are working with state and local health officials and other public health partners to investigate any unusual events.

The purpose of vaccine safety monitoring is to provide quick identification of any clinically significant adverse events following immunization. Adverse events -- including apparent side effects -- following immunization may be coincidental to (meaning occurring around the same time but not elated to vaccination) or caused by vaccination.

CDC and its partners use multiple systems to monitor the safety of this season's flu vaccines. Two of the primary systems that are being used to monitor the safety of these vaccines are: the Vaccine Adverse Event Reporting System (VAERS), which is jointly operated with FDA, and the Vaccine Safety Datalink (VSD) Project.

Vaccine Adverse Event Report System

VAERS is a national program managed by both CDC and FDA to monitor the safety of all vaccines licensed in the United States. Healthcare providers are encouraged to report possible adverse events of concern after vaccination, even if they are not certain that the vaccine caused the event. VAERS relies on information included in these reports to monitor for clinically serious adverse events or health problems that follow vaccination.

Generally, VAERS cannot determine if an adverse event was caused by a vaccine but can help determine if further investigations are needed. FDA and CDC use VAERS data to help identify potential clinically serious vaccine adverse events or health outcomes. If concerns are identified in VAERS, usually further investigation is needed. One important system used to further evaluate concerns identified in VAERS is the Vaccine Safety Datalink (VSD) Project.

Vaccine Safety Datalink (VSD) Project

The VSD Project is a vaccine safety system used to both identify and confirm adverse outcomes after immunization. This project is a collaboration between CDC and eight large managed care organizations, in which comprehensive medical information is collected on approximately nine million people.

The VSD project monitors their data weekly for certain adverse events that could be associated with newly licensed vaccines. VSD conducts studies of vaccine safety adverse events and health outcomes that may arise with any vaccine.

Additionally, CDC works with numerous partners, including other federal agencies, state and local health departments, professional organizations, and academic institutions, to actively follow individuals after vaccination to monitor for any potential adverse events.

Vaccine side effects

Both the flu shot and the nasal spray (LAIV or Flu Mist) vaccines have possible side effects. Among them:

The flu shot: The viruses in the flu shot are killed (inactivated), so you cannot get the flu from a flu shot. Some minor side effects that could occur are:

• Soreness, redness, or swelling where the shot was given
• Fever (low grade)
• Aches
• Nausea

If these problems occur, they begin soon after the shot and usually last a day or two. Almost all people who get flu shots have no serious problems. However, on rare occasions, they can cause serious problems, such as severe allergic reactions. A federal program has been created to help pay for the medical care and other specific expenses of certain persons who have a serious reaction to this vaccine. For more information about this program, call 1-888-275-4772 or visit the program's Website.

The nasal spray (also called LAIV): The viruses in the nasal-spray vaccine are weakened and do not cause severe symptoms often associated with influenza illness. (In clinical studies, transmission of vaccine viruses to close contacts has occurred only rarely.)

In children, side effects from LAIV can include:

• runny nose
• wheezing
• headache
• vomiting
• muscle aches
• fever

In adults, side effects from LAIV can include:

• runny nose
• headache
• sore throat
• cough

Mild problems that may be experienced include soreness, redness, or swelling where the shot was given, fainting (mainly adolescents), headache, muscle aches, fever, and nausea. If these problems occur, they usually begin soon after the shot and last 1-2 days. Life-threatening allergic reactions to vaccines are very rare. If they do occur, it is usually within a few minutes to a few hours after the shot is given.

This season's flu vaccine is made the same way as past seasonal flu vaccines. Millions of seasonal flu vaccines have been given safely. Millions of people have also safely received the 2009 H1N1 vaccine.

CDC expects that any side effects following vaccination with the 2010-2011 flu vaccine would be rare. Any side effects that may occur are expected to be similar to those experienced following past seasonal influenza vaccine.

Cause for concern

Signs of a serious allergic reaction can include difficulty breathing, hoarseness or wheezing, swelling around the eyes or lips, hives, paleness, weakness, a fast heartbeat or dizziness. In addition, after vaccination you should look for any unusual condition, such as a high fever or behavior changes.

If any unusual condition occurs following vaccination, seek medical attention right away. Tell your doctor what happened, the date and time it happened, and when the vaccination was given. Ask your doctor, nurse, or health department to report a possible reaction by filing a Vaccine Adverse Event Reporting System (VAERS) form. Or you can file this report yourself through the VAERS Website or by calling 1-800-822-7967 to receive a copy of the VAERS form.

Particularly worrisome is the find that only 40 percent of people in the "work risk" category -- meaning those who care for young children and those who work in residential nursing homes, hospitals, and other health care environments -- said they would definitely get the vaccine this year, which combines the seasonal and the 2009 H1N1 (swine) flus. Twenty-eight percent said they would definitely NOT get the vaccine.

"It's troubling to hear that people caring for young children, including infants, and the elderly are not planning on getting the vaccine" said Orly Avitzur, M.D., medical adviser, Consumer Reports Health.  "These health care workers are among the most likely to catch the disease and spread it to individuals in their care.  And it's no secret that small children and the elderly are at high risk for complications and even death."

Poll highlights and guidance for flu vaccines are available online.

In a bubble

The nationally representative poll, conducted by the Consumer Reports National Research Center, found additional examples of "at risk" populations living in a bubble.

For example, only 45 percent of those considered "at health risk" said they definitely planned on getting the flu vaccine this year.  This category includes people with lung conditions such as asthma, diabetics, people with heart conditions (except hypertension), those with immune system problems, and those with neurological or neuromuscular disease.  All of these conditions are linked to an increased likelihood of flu-related complications.  

"We suspect that part of the problem involves a lack of understanding of one's own health risks -- in fact, only 42 percent of those at health risk for flu complications described themselves as such," said Dr. Avitzur.

Only 51 percent of those in the "age-risk" category (i.e. those who are 65 and older) said they would definitely get the combined vaccine.  About one-third (33 percent) of those 65 and older believed they were at high risk of seasonal flu complications.

Vaccine worries

Reasons for not getting this year's vaccine lead with the belief that the swine flu epidemic was overblown last year (45 percent), followed by concerns about side effects (44 percent) and safety of the vaccine (41 percent).  Nearly one-third (28 percent) said they believed the vaccine doesn't work.

Some other poll highlights:

-- Overall, only 37 percent of those polled said they would definitely get the combined vaccine this year while 31 percent said it depends.  Thirty percent said they will definitely NOT get the vaccine this year.
-- Of those who did not get the seasonal flu vaccine last year, the top reason was the mistaken belief that it's best to build one's own natural immunities.   "We encourage every American to get this year's combined seasonal and 2009 H1N1 (swine) flu vaccine," said Dr. Avitzur.
--  Men were more likely than women (46 percent versus 35 percent) to cite "I do not get the flu" as a reason for not getting the flu vaccine.   Overall, 41 percent cited this excuse, a significant drop from the 54 percent who provided the same rationale in 2008, suggesting that more people are getting the message that they can't count on being immune to the flu.
--  When it comes to confidence in the safety of the combined vaccine, 69 percent said they were very or somewhat confident in the safety of the 2010 flu vaccine. By comparison, 62 percent were confident in the last year's H1N1 vaccine.  But overall, 25 percent were not too confident or not confident at all in the safety of the vaccine.
--  Those on the fence about getting this year's vaccine cited the following factors that might influence their plans this year:

•  Advice from their health-care provider (73 percent)
•  Reports about outbreaks in the community (62 percent)
•  Guidelines or warnings from local or state health departments and/or federal agencies such as the Surgeon General or Centers for Disease Control and Prevention (57 percent).

On a positive note, 58 percent of parents had their children vaccinated for seasonal flu last year, compared to only 41 percent in 2008. 

More good news: the majority of people (66 percent) told Consumer Reports Health that last year the swine shot and/or nasal vaccine was administered at no charge.  

And, in another sign that cost is not an impediment, only a small number (12 percent) cited cost as a reason for not getting the seasonal flu shot last year.

Last summer, as it began to become apparent that the swine flu might not be the pandemic threat some health officials first feared, the World Health Organization continued to sound the alarm.

The WHO continued to warn that H1N1 would kill millions, even as health officials in the U.S. reported that, while wide-spread, H1N1 appeared to be no more severe, and perhaps less so, than seasonal flu.

Since the beginning of this year some bloggers have speculated that WHO hyped the numbers for one simple reason: money. GlaxoSmithKline, Novartis, Baxter, and Sanofi-Aventis are among the big pharmaceutical companies that sold millions of dollars worth of swine flu vaccine.

In fact, Novartis today reported an eight percent jump in 2009 profits, specifically crediting strong sales of swine flu vaccine.

Add to that the fact that the dire forecasts of a killer flu pandemic failed to materialize, and you have the makings of a great conspiracy theory.

The WHO, however, says the theory is nonsense.

"The WHO influenza pandemic policies and response have not been improperly influenced by the pharmaceutical industry," the organization said in a statement.

The WHO said its job necessarily includes cooperating with a wide range of partners, including drug companies. This cooperation, it says, is essential pursuing its public health objectives.

"Numerous safeguards are in place to manage conflicts of interest or perceived conflicts of interest among members of WHO advisory groups and expert committees," the statement said.

The WHO does, however, concede that its response to the H1N1 outbreak might have been better. The organization has begun an internal review while the Council of Europe, a human rights group, has also begun an inquiry.

The Swiss Government, meanwhile, reported that it purchased 13 million doses of H1N1 vaccine for the country's 7.7 million residents. Only one in five residents, the government reports, took advantage of the free vaccine.

Tamiflu, the anti-flu drug being snapped up in record amounts, does not prevent serious complications from the flu and should not be used for routine control of the flu in healthy adults, according to Public Citizen.

The group is calling for an independent review of raw data from clinical trials funded by Tamiflu's maker, Roche. The company has claimed that the drug dramatically reduced hospital admissions as well as bronchitis and pneumonia. But a recent investigation by the British Medical Journal and British TV Channel 4 concluded that such claims were meritless.

In the wake of widespread media coverage of the H1N1, or swine flu, virus, Tamiflu sales have skyrocketed. In October, 2.5 million prescriptions were filled in the U.S. compared with just 35,000 prescriptions in October 2008. For the past 12 months, 6.8 million prescriptions were written, compared with 4.3 million the previous 12 months.

"Tamiflu is being erroneously peddled as a panacea to flu," said Sidney Wolfe, M.D., director of Public Citizen's Health Research Group. "In fact, no research exists to support this in healthy adults. At best, it can modestly reduce some minor flu systems in such people for a day."

FDA spokeswoman Patricia El-Hinnawy tells ConsumerAffairs.com that "controlled clinical trials conducted among outpatients with acute uncomplicated seasonal influenza reported a reduction of approximately 1 day in the duration of illness when antiviral treatment with oseltamivir (Tamiflu) was initiated within 48 hours of illness compared with placebo."

All of the clinical research conducted to determine the effectiveness of Tamiflu on healthy adults has been funded by the drug's manufacturer, Roche, Public Citizen said. The British investigation involved a review of all published studies examining the effects of Tamiflu in preventing serious complications of the flu in otherwise healthy adults.

The authors concluded that we "have no confidence in claims that [Tamiflu] reduces the risk of complications and hospital admission in people with influenza," and they wrote that it should not be used in routine control of seasonal influenza. There was also concern about underreporting of side effects of the drug.

El-Hinnawy responds that "a manufacturer conducts clinical trials according to FDA requirements, as part of the application for approval of a drug. The data from the trials are reviewed as part of the application 'package'." She adds that "if claims are being made by the company that are not substantiated by the data we reviewed, then the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) would become involved, but, nothing at this point in time would lead us to require an independent review of the data./p>

Although the data available were gathered before the H1N1 virus made its appearance, the results can probably be extrapolated to H1N1 because it is another variety of flu, Wolfe said.

El-Hinnawy notes that there are some observational studies in the published literature assessing potential benefits of Tamiflu in reducing complications, including deaths, among hospitalized patients with 2009 H1N1. But, she says, "There are limitations to these studies and therefore they are not generally included in product labeling."

Health officials have confirmed three new cases of the 2009 H1N1 influenza virus in pets, while the Food and Drug Administration (FDA) has approved a fifth vaccine for use against the disease.

The latest cases involve three ferrets in Oregon, according to The American Veterinary Medical Association (AVMA). The new findings bring the total number of confirmed H1N1 cases involving ferrets in that state to four.

The diagnosis comes just days after a cat in Iowa tested positive for the H1NI virus. That cat, diagnosed earlier this month, was the first feline in the country with a confirmed case of the H1N1 strain of influenza.

In the Oregon case, the ferrets that tested positive for the virus are among a group of nine that lived with a family near the city of Roseburg. All nine ferrets had flu-like symptoms, but state health officials said the family only took three of the animals to a veterinarian.

Those three ferrets tested positive for the H1N1 virus, said Dr. Emilio DeBess, the Oregon state public health veterinarian. Family members who owned the ferrets, Dr. DeBess added, were sick with flu-like symptoms the week before the animals became ill.

There are no indications the ferrets passed the virus to other people or animals, Dr. DeBess said.

Oregon health officials in early October confirmed the first case of H1N1 in a ferret. All of the sick ferrets have since recovered, health officials said.

In the Iowa case, health officials suspect the cat caught the H1N1 virus from its owners, who were sick with that strain of the flu.

The cat has recovered and there are no signs it passed the virus to any other humans or animals, officials said. Besides the Iowa cat and the Oregon ferrets, health officials have confirmed cases of the H1N1 virus in pigs and birds.

The AVMA said these cases illustrate that some viruses can spread from people to animals. The organization said pet owners should contact their veterinarians if their animals show any signs of illness.

Oregon's Dr. DeBess also urged pet owners to take simple precautions to reduce the spread of the H1N1 virus from themselves to their animals.

"Wash your hands, cover your cough and your sneeze, and do your best to prevent contaminating objects your pet may come into contact with," he said. "The key message is to protect your animals much like you protect your family."

The AVMA will continue to track cases of the H1N1 virus in animals and post those findings on its Web site, the organization said.

New vaccine details

The new vaccine approved by the FDA against the H1N1 virus is manufactured by ID Biomedical Corp. of Quebec, Canada, owned by GlaxoSmithKline PLC.

As with the four previous 2009 H1N1 influenza vaccines licensed by the FDA on Sept.15, 2009, ID Biomedical Corporation will manufacture its H1N1 vaccine using the established, licensed egg-based manufacturing process used for producing seasonal flu vaccine.

Potential side effects of this H1N1 vaccine are expected to be similar to those of the seasonal and H1N1 flu vaccines. The most common side effect is soreness at the injection site. Others may include mild fever, body aches and fatigue for a few days after the inoculation.

As with any medical product, unexpected or rare serious adverse events may occur. The FDA is collaborating with other government agencies to enhance adverse event safety monitoring during and after the H1N1 2009 vaccination program.

ID Biomedical's H1N1 monovalent vaccine will be produced in multi-dose vials, in a formulation that contains thimerosal.

As more vaccines become available, there is concern that Internet scamsters will try to take advantage of the spreading fears about flu.

ConsumerAffairs.com recently reported warnings from the FDA on Internet sales of purported swine flu drug products.

By Lisa Wade McCormick
ConsumerAffairs.com

November 5, 2009
Iowa health officials have confirmed the first official case of the 2009 H1NI influenza virus in a cat.

The Iowa Department of Public Health (IDPH) on Tuesday said a 13-year-old indoor cat had contracted the virus from someone in its household.

This was a human-to-feline transfer of the virus, thats what we believe happened, IDPH veterinarian, Dr. Ann Garvey, told ConsumerAffairs.com today. There were two people in the household with symptoms of the virus.

It is not common for cats to get the influenza A virus, she added. (But) this is not completely unexpected, as other strains of influenza have been found in cats in the past. There have been cases of cats getting the H5N1 Avian strain. And in those cases, there was no evidence that the cats transferred the virus back to humans. The cats became a dead-end host.

The Iowa cat and its owners have recovered from their illnesses, Dr. Garvey said, and there are no signs the feline passed the virus to other people or animals.

Before this diagnosis, however, health officials had confirmed the 2009 H1N1 influenza virus in ferrets, pigs, and birds.

Dr. Garvey said the Iowa cat had symptoms that are similar to humans with the H1NI virus: malaise, loss of appetite, and respiratory issues. The cat, however, did not have a fever, she said.

The cats owners took the feline to the Lloyd Veterinary Medical Center at Iowa State Universitys College of Veterinary Medicine, where it tested positive for the H1N1 virus.

The test results came back late last week, Garvey said, adding veterinarians gave the feline supportive care and made sure it did not become dehydrated. Those tests were confirmed earlier this week.

To protect your familys pets from contracting the H1N1 virus, Dr. Garvey recommended the same common sense measures used to prevent exposure of the illness in humans:

• Wash your hands frequently;

• Cover your mouth when you cough and your nose when you sneeze;

• Minimize your contact with your dogs, cats, or other household pets if you have any flu-like symptoms

Pet owners who notice any signs of respiratory illness or other influenza-like symptoms in their animals should contact their veterinarians, Dr. Garvey said.

Meanwhile, the American Veterinary Medical Association is now tracking all cases of H1N1 in animals and will post updates on its Web site.

Only 48 percent of black senior citizens get flu shots, largely because of inaccurate and incomplete information about the flu itself, safety of inoculations, and ease and necessity of the shots.

Also contributing is a lingering distrust of public health inoculation programs, because of misinformation about the notorious 1932-72 Tuskegee syphilis studies of black men, says Lance Rintamaki, assistant professor of communications at the University at Buffalo, in a new study published in Health Communications.

Vaccination rates for non-Hispanic white seniors are 65 percent. The low percentage of inoculations for blacks is of concern to the medical community, Rintamaki says, because 44,000 U.S. residents 65 and older die from flu and its complications every year, compared with a total of 7,000 flu-related deaths in all other age groups.

The researchers found several reasons for the reluctance of older blacks to get flu shots. The study subjects did not understand how often they need to be vaccinated, Rintamaki says.

Some thought that, like vaccines against common childhood illnesses, the flu vaccine provided lifelong protection against the flu. Many did not know they needed to be re-vaccinated every year.

"The participants knew there are different strains of influenza," he says, "but they didn't realize they needed to be vaccinated against each strain as it turned up.

"Some also thought -- as do many members of the public -- that the vaccines cause the flu. If they became sick with a virus of one kind or other around the time they had a flu shot," he says, "they drew the erroneous conclusion that the shot made them sick.

"This is a common misperception and one that needs to be corrected," Rintamaki adds. "We often tell people the vaccine doesn't 'cause' flu but in failing to address why they might assume that it does, we leave the door open for them to think they are avoiding illness by avoiding the vaccine."

Better and more targeted messages and interventions are necessary to address concerns specific to older blacks and to emphasize how important it is for those in this age group to be vaccinated, the researchers say.

The study involved six focus groups of black seniors in the Chicago area. Their average age was 75, and 85 percent of them were women. They were asked to identify their current perceptions about influenza and influenza vaccination.

While 77 percent of participants said they had received a flu shot, only 50 percent had been vaccinated the previous year.

Despite the group size and the fact that their responses cannot be projected to the community as a whole, the authors say the results of the study confirm those conducted by the Centers for Disease Control and Prevention and others.

Some disturbing news to emerge from the study, says Rintamaki, is that the Tuskegee syphilis experiments continue to affect levels of trust among blacks about public health programs.

The Tuskegee experiments, whose original goal was to justify treatment programs for blacks, involved 399 black sharecroppers infected with syphilis.

In 1932, when the study began, the available treatments were highly toxic and of limited effectiveness. The study aimed to determine if patients were better off if they were not treated with those remedies. The researchers also wanted to study the efficacy of specific remedies for individual stages of the disease.

By 1947, penicillin was commonly used as an effective cure for the disease. The researchers, however, failed to treat study participants with the medication. As a result, many men died of syphilis, wives contracted it from husbands, and children were born with congenital syphilis. The study was not discontinued until news of this fact emerged, causing a public uproar.

Rintamaki points out that although the some of the seniors interviewed were not familiar with these experiments, those who were thought that the Tuskegee researchers did more than withhold treatment. They thought they actually injected the men with syphilis.

"The Tuskegee experiments have stirred fear and suspicion in the African American community over many health initiatives," he says, "and the suspicion they spawned has a continuing negative effect on the health of that community.

"In fighting the flu by encouraging inoculation, it is imperative that as health communicators we recognize that such fears exist and address such them," he says.

The Food and Drug Administration (FDA) is informing consumers of potential harm associated with unapproved products claiming to diagnose, prevent, or otherwise act against the 2009 H1N1 virus, aka "swine flu."

Within the past two weeks, the FDA has:

• Urged caution regarding promotions and Internet sites offering products for sale that claim to diagnose, prevent, mitigate, treat or cure the virus

• Enhanced efforts to warn about potentially deceptive products, and encourage reporting of suspected criminal activity, with the release of a flu fraud widget.

• In partnership with the Federal Trade Commission (FTC), issued a warning letter to a Web site marketing fraudulent supplements that claim to help prevent the spread of the virus. The letter advises the site's owners to discontinue marketing the products or face legal action

These new measures follow FDA actions earlier this year to protect consumers against Web sites offering unapproved products. These actions included enforcing laws that protect consumers against these sites, and warnings posted through media outreach and a "Fraudulent Products List" posted on FDA's Web site.

Since May 2009, FDA has warned more than 75 Web sites to stop the sale of more than 135 products with fraudulent H1N1 influenza virus claims.

"Products that are offered for sale with claims to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus must be carefully evaluated," says Commissioner of Food and Drugs Margaret A. Hamburg, M.D. "Unless these products and the claims they make are proven to be safe and effective, they will not prevent the transmission of the virus or offer effective remedies against infection. Furthermore, they can make matters worse by providing consumers with a false sense of protection."

Consumers are urged to purchase only FDA-approved products from licensed pharmacies located in the United States, and should contact their health professional if they have any questions or concerns about medical products or personal protective equipment.

Tamiflu (oseltamivir phosphate) and Relenza (zanamivir) are the only two FDA-approved antiviral drugs for treatment and prophylaxis of the 2009 H1N1 influenza virus. In addition to their approved labeling, these drugs have been issued Emergency Use Authorizations by FDA that describe specific authorized uses during the swine flu public health emergency.

Patients who buy prescription drugs from Web sites operating outside the law are at increased risk of suffering life-threatening adverse events such as side effects from inappropriately using prescription medications, dangerous drug interactions, contaminated drugs, and impure or unknown ingredients found in unapproved drugs.

FDA actively monitors the Internet and, where appropriate, purchases and analyzes drug products. It recently announced what it found when it purchased and analyzed several products represented online as Tamiflu.

One of these online orders resulted in delivery to FDA of an unmarked envelope postmarked from India. Inside were unlabeled, white tablets taped between two pieces of paper that were found to contain talc and acetaminophen, an active ingredient found in many medicines to help relieve pain and reduce fever. Not found was oseltamivir, the active ingredient of Tamiflu.

The Web site selling this product disappeared shortly after FDA placed the order.

The agency also bought four other products purported to diagnose, prevent, treat or cure the H1N1 influenza virus from other Web sites. These products contained various levels of oseltamivir but were not approved for use in the United States. Several did not require a prescription from a health professional.

In actions it announced in June 2009, FDA issued warning letters and advised operators of offending sites to immediately ensure that they weren't marketing products intended to act against the swine flu virus that have not been cleared, approved, or authorized by the agency.

Among the unapproved, uncleared, or unauthorized H1N1 flu products it targeted at that time were:

• A shampoo said to protect against the H1N1 flu virus.

• A dietary supplement said to protect infants and young children from contracting the virus.

• A "new" supplement said to cure H1N1 flu infection within four to eight hours.

• A spray that claims to leave a layer of ionic silver on one's hands that kills the flu virus.

• Several diagnostic tests that have not been approved to detect the swine flu virus.

• An electronic instrument whose sellers claim uses "photobiotic energy" and "deeply penetrating mega-frequency life-force energy waves" to strengthen the immune system and prevent symptoms associated with H1N1 viral infection.

Con artists are now preying on consumers' fears about the outbreak of the H1N1 virus — aka "swine flu" — by launching Internet sites to sell products they claim will diagnose, prevent, treat, or even cure this rapidly spreading virus, federal authorities warned today.

The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) cautioned the public to beware of any Web site or promotions for product that makes such claims about the 2009 H1N1 influenza virus.

Federal authorities also warned Web site operators that have deceptive ads for these fraudulent products to quickly correct or remove them — or face enforcement action.

"Consumers who purchase products to treat the novel 2009 H1N1 virus that are not approved, cleared or authorized by the FDA for the treatment or prevention of influenza risk their health and the health of their families," said Michael Chappell, acting FDA Associate Commissioner for Regulatory Affairs. "In conjunction with the Federal Trade Commission, the FDA has developed an aggressive strategy to identify, investigate, and take regulatory or criminal action against individuals or businesses that wrongfully promote purported 2009 H1N1 influenza products in an attempt to take advantage of the current flu public health emergency."

Many deceptive products for the virus are now being sold online through illegitimate web sites, authorities said. These fraudulent "Swine Flu" products come in several varieties, including dietary supplements or other food products, or products purporting to be drugs, devices or vaccines.

These phony products, however, will not prevent the transmission of the virus or treat infections caused by the H1NI virus, federal authorities said.

"The last thing any consumer needs right now is to be conned by someone selling fraudulent flu remedies," said FTC Chairman Jon Leibowitz. "The FTC will act swiftly against companies that resort to deceptive advertising."

The only two antiviral drugs approved by the FDA for treatment of H1N1 flu are Tamiflu and Relenza, authorities said, adding there are currently no licensed vaccines approved for this virus.

More information about this outbreak and which products are approved for treatment of the virus — is available on the FDA's Web site and the Centers for Disease Control and Prevention's (CDC) Web site.

Consumers with questions about personal protective equipment to use during this health emergency can find answers on the FDA's Web site.

The FDA urged consumers to report any fraudulent products for H1N1 flu — and the names of Web sites selling these items — to http://www.fda.gov/oci/flucontact.html federal authorities.

The CDC has, as of 11 a.m. Friday, confirmed 141 cases of H1N1 flu in 19 states — and one death linked to the virus.

Find out everything you need to know about swine flu.

People covered with facemasks are a common sight in news reports from Mexico about the swine flu outbreak. Do people in the U.S. now need to consider wearing masks, and can they really help?

The Mexican government has been handing out face masks to its citizens. In areas where the flu has already reached epidemic proportions, it may be advisable to wear masks in all public places.

In the U.S., where most infections are now clustered in communities, it makes sense to wear a high-grade mask in situations where youre likely to be exposed to the virus. For example, if youre sick with the flu, wearing a mask can help prevent spreading it to others. And if youre caring for someone who is sick, wearing a mask yourself can also help reduce exposure to the droplets from a cough or sneeze that spread infection.

If there is an outbreak in your community, masks can be helpful tools to reduce your exposure to the virus in confined or crowded places, like buses, trains, and airplanes.

But not all masks are created equal. To prevent the inhalation of most virus-bearing droplets from a cough or sneeze masks and respirators should be labeled N-95 or higher, which means they have been cleared by the FDA. They may also bear a label from the National Institute for Occupational Safety.

How a mask fits is a big influence on its effectiveness. The mask should fit tightly over your nose and mouth, with no gaps. To get the full protective effect, youll need to wear it as long as youre in a high risk situation and replace it after each use.

Masks can help, but are no replacement for basic preventative hygiene, which can go a long way in protecting you from the flu. Wash your hands vigorously for 20 seconds under warm running water before eating or preparing meals, after the using the bathroom, after blowing your nose, and after other potential exposures to the flu virus. Alcohol based hand sanitizer, like Purell, with an alcohol content of at least 60 percent, can be effective, when soap and hot water arent an option.

See the Consumer Reports Health Blog for more information.

Find out everything you need to know about swine flu.

The number of known cases of swine flu in the U.S. rose to 40 Monday, with most of them in New York City. The Centers for Disease Control reports 28 cases in New York City, seven in California, two each in Kansas and Texas, and one in Ohio.

With more outbreaks of the new strain of swine flu come outbreaks of misinformation and rumor. Below are 20 questions answered by infectious disease expert Charles Ericsson, M.D., professor of internal medicine and director of Travel Medicine at The University of Texas Medical School at Houston.

Also, Robert Emery, DrPH, vice president for Safety, Health, Environment & Risk Management at UT Health Science Center and associate professor in the UT School of Public Health explains common sense preparedness and prevention of illness.

1. How do symptoms of swine flu differfrom other types of flu?

None, really, although this flu might include gastrointestinal symptoms (diarrhea and vomiting), as well as the usual respiratory symptoms. The basic symptoms for swine flu are similar to the seasonal flu we are vaccinated for each year, which may include:

• Fever (greater than 100F or 37.8C)
• Sore throat
• Cough
• Stuffy nose
• Chills
• Headache and body aches
• Fatigue

2. If I felt flu-like, how would I know if I had swine flu?

You wouldn't really, nor would your physician know for sure without a respiratory specimen taken within the first 4-5 days. The specimen would then be sent to the US Centers for Disease Control and Prevention (CDC).

The cases so far in the US have been relatively mild compared to the illness described in patients in Mexico. We do not yet know why the US cases have been milder.

The important point is to call your doctor if you think you have the flu. Prescription anti-viral drugs such as TamiFlu or Relenza can be called in by your doctor. Unless you are:

• exceptionally ill with flu-like symptoms
• are chronically ill
• immune-suppressed
• quite elderly
• or have a very young child, under age 2.

It is best not to report to the hospital, clinic or doctor's office, where you could risk spreading the disease. Again, call your doctor first to get instructions as to what you need to do next.

3. How long are people contagious?

Adults are potentially contagious for the length of time one has symptoms, up to 7 days following the beginning of illness. The shedding stage of the virus is during the first 4-5 days of illness. Children can be considered contagious longer, up to 10 days. The initial incubation period is 24-48 hours.

4. Is there medication for this?

Yes, Tamiflu or Relenza have shown to be effective against these recently reported strains of swine flu. Altogether, there are four anti-viral drugs that we commonly use to treat various strains of flu.

5. Can I start taking medicine for it now, just in case I get it later?

That is not presently advised. Preventative medication might be advised for very special circumstances where a person had to expose themselves to potentially ill people during an epidemic (which we do not yet have here). Such people might include ER workers. An outbreak in a nursing home, for instance, might lead to protecting all the other residents with a drug like TamiFlu.

For the general public, the current answer is no to prophylactic (preventative) use with anti-viral medications. Its coverage time is limited.

Do not confuse over-the-counter cold and flu preparations for anti-flu medications that require a prescription.

6. Are the symptoms in children different from adult symptons?

Though the basic symptoms are similar, the signs of potentially life-threatening complications differ.

The CDC advises those with these symptoms to seek emergency care immediately: Emergency warning signs in children are:

• Fast breathing or trouble breathing
• Bluish skin color
• Not drinking enough fluids
• Not waking up or interacting
• Being very irritable
• Fever with a rash Emergency warning signs in adults are:
• Difficulty breathing or shortness of breath
• Pain or pressure in the chest or abdomen
• Sudden dizziness
• Confusion
• Severe or persistent vomiting

7. Is there a vaccine?

Not yet, but the CDC has this current strain of virus and will consider whether to add it to next years flu vaccine as time goes on.

8. If I took the swine flu vaccine in the swine flu scare during the 70s, would that cover me? What about this year's flu shot I just took?

We dont know yet. Previous vaccines could be expected to afford only partial, incomplete protection at best.

This new strain of the swine flu virus (H1N1) actually has a mixture of swine and avian components (not to be confused with the deadly avian flu of Southeast Asia).

9. Can I catch it from pigs?

No. This strain is one that is communicable through human-to-human contact. It is a mutated form of a swine virus.

10. Can I catch it from eating pork?

Absolutely not! Swine flu is not transmitted by food. It is not a so-called foodborne illness. Bacon, ham and other pork products are safe to eat, assuming they are prepared properly. An internal temperature of 160 degrees for cooked meat will kill any bacteria or virus.

Swine flu is transmitted by airborne droplets from an infected persons sneeze or cough; or from germs on hands, or germ-laden surfaces. Eating pork will not give you swine flu any more than eating chicken will give you bird flu.

11. How does it cross from a pig to a human?

The swine virus mutates so that it can infect humans and be spread by humans.

12. Can it kill me?

Deaths have been reported from the Mexico City outbreak. So far the cases in the US have been mild and there have been no deaths as of this writing (Monday, April 27) We do not know all the factors geographically and demographically that may contribute to the mildness or severity of this flu. But, like seasonal flu, there is the potential for serious outcomes.

13. Why the big concern if the regular flu kills 35,000 people a year, which is why we are all encouraged to get a flu shot?

This is a new flu strain that our bodies have not been exposed to before. The flu strains that the CDC creates a vaccine for each year all have the potential to cause great harm, especially in elderly, pediatric and chronically ill patients.

This particular flu strain has struck seemingly healthy, young adults, with some resulting in death in Mexico. It also appears to be quite contagious. We will know more about this strain in the coming days.

14. How is it different from avian (bird) flu?

Avian flu so far has had difficulty infecting humans unless they are exposed intensely to birds, because the virus has not mutated in a way that makes it transmissible by humans to other humans. This virus has origins genetically from both pigs and birds, and the big difference from the avian flu is that this swine virus can be transmitted readily from human to human.

15. Is this just another scare that will go away like bird flu?

Bird flu is a theoretical threat and will need a mutation to be able to be transmitted among humans to become a serious threat. The present "swine/avian" virus clearly has already caused a major outbreak in Mexico City and San Luis Potosi, Mexico and has spread to places in the US (California, New York, Texas, Kansas and Ohio).

What is not clear yet is whether this virus will result in a so-called pandemicworldwide spread with major outbreaks — or whether it will fizzle out. But, even if it fizzles out, there is logical concern that it might re-emerge next flu season.

16. Should I cancel my vacation to Mexico?

At this writing, the situation is very fluid, changeable. I suggest checking frequently with the CDC Web site for possible Travel Alerts. I probably would not travel to Mexico City for a vacation that could easily be rescheduled, if for no other reason than the city has tried to limit access to crowded or public places where transmission might be facilitated. That does not sound like a very pleasant vacation to me!

Having said that, there are more than 4,000 flights to Mexico from the US and none have been cancelled as of this writing. However, some international airports in Europe and Asia are stepping up precautions and issuing alerts. Again, check the CDCs Travel Alerts page.

17. What if I'm on a plane? Should I wear a mask?

Not necessary. The air on a plane is filtered. Transmission might occur if someone sitting close to you coughs or sneezes on you. The newer designs of aircraft airflow keep the air in a top-down flow, not forced air from front to back. However, if you do have a respiratory illness, it might be best not to travel.

18. How long does the germ live on surfaces, like on my desk if someone sneezes in my office?

Influenza virus survives only minutes on inanimate objects or hands, so these are very inefficient ways to spread the illness. Influenza is most easily spread by droplets that come into contact with our mucus membranes such as when someone coughs or sneezes in our faces.

If we shake hands with an infected person who has just wiped their nose and then we rather quickly rub our nose or eyes with our own hand, then we could get the flu. So, good hand washing does play a role in diminishing the spread of the disease.

19. Other than hand washing and covering my mouth if I sneeze or cough, what can I do to take care of myself and others?

If you are ill, stay home. Control your sneezes and coughs. If you cough into your hand, remember the virus could be live on your hand at least for a few minutes, so wash your hands before touching anyone else. If you get symptoms suggesting the flu, call your doctor, who can call in a prescription for medication to treat the flu.

Resist going to the doctors office or a hospital ER for influenza symptoms unless you are seriously ill. You do not want to spread the disease to others.

20. What else can I do?

Keep in touch with the most recent CDC messages through the following links:

www.cdc.gov/swineflu/investigation.htm
www.cdc.gov/swineflu/general_info.htm
www.cdc.gov/swineflu/whatsnew.htm

Go to the sources of verifiable information such as WHO (World Health Organization) or the CDC.

Most important, be alert, not panicked.

There is a huge difference between preparedness and paranoia, says Dr. Robert Emery, occupational health expert at the UT School of Public Health at Houston. Although were dealing with a new strain of flu, a set of universally applicable preventive measures exist that can be employed right away by everyone to help stop the spread of this disease

Proper hand hygiene:

Theres a right way and useless way to wash hands — and wash away — micro-organisms. The object is to break down the protective membranes of germs, dislodge them from your hands and let them go down the drain. Plain soap in the right hands is strong stuff.

• Lather well with a bar of soap or squirt a coin size of liquid soap in the palm of your hand.
• Vigorously rub your hands together, soap up between your fingers, AND your wrists, front and back for 15 seconds. Sing the first chorus of any song you know and thatll take you through the 15 seconds.
• Rinse under warm, RUNNING water. Remember, the object is to dislodge germs. The force of water is key.
• Dry thoroughly your hands with a disposable towel or under the blower, again, rubbing your hands together.
• Discard the towel.

If youre using alcohol-based gels as hand cleansers:

• Put a dime-sized amount in one hand:
• Vigorously rub your hands together and in between your fingers until the GEL IS DRYabout 30 seconds.
• DO NOT touch your face!

Once your hands are clean, do not touch your face, nose, eyes or lips. Rubbing your eyes and nose provides a freeway for micro-organisms and good breeding ground once theyve arrived.

Cover your cough

If you must cough or sneeze, cover your mouth with a tissue, your sleeve or your hand.
• Throw the tissue away in a waste basket. Do not leave discarded tissues on your desk or other surfaces.
• Then, wash you hands thoroughly.
• The throw-it-away part is essential. Micro-organisms live a life span from a few seconds to days on inanimate surfaces such as desks, table tops, faucetstissues. If your tissues are scattered on your coffee table, they then are in contact with community surfaces. Both the tissues and the surface it sits on can spread germs to the person who touches the coffee table.

If you begin to feel ill: feverish, achy, have a dry, painful cough, sore throat, go home from school or work and call your health care provider for further instructions.

If you feel sick with flu-like symptoms and you care for the very young or the very elderly or the chronically ill, inform your health care provider when you call their office.

If you have recently traveled to Mexico or to one of the areas worldwide that has reported a swine flu outbreak, inform your health care provider. He or she may prefer to treat you with prescription anti-viral medications from home, or may request that you come in for a visit. Follow instructions from your health care providers.

Despite three years of massive preparation efforts, the world is not ready to deal with a potential Avian, or bird flu pandemic that could kill millions of people world-wide.

Thats the assessment of David Nabarro, a senior United Nations official in charge of bird flu prevention efforts.

Nabarro says most countries have made some progress on a preparedness plan, but that progress is spotty. And while some have actually been able to stockpile anti-viral vaccines, they have yet to plan for the enormous societal and economic impact a pandemic would bring.

"Unfortunately, only a relatively small number are adequately prepared to keep going in the event that the pandemic has massive absenteeism associated with it, Nabarro said. We need hard work for at least two or three years more to make sure that the whole world is properly pandemic ready.

No if, but when

And a bird flu pandemic is coming, says Nabarro.

To date the handful of humans who have contracted the disease have gotten the virus from infected birds. But once the deadly H5N1 virus mutates so that it is easily transmitted from one person to the next, Nabarro and other heath experts say it will spread quickly around the globe.

Thats what happened in 1918, when an animal virus mutated and began to quickly spread from person to person. Before it ran its course in 1919, the Spanish Flu killed an estimated 40 million people more than died in the just completed World War. Health experts call it the most devastating epidemic in recorded history. So far.

Nabarro says no one knows when the H5N1 virus will jump from birds to humans or how severe the resulting outbreak will be. But he says nations should be prepared for the worst, both in terms of human suffering and economic devastation.

The World Health Organization is working with governments to develop rapid response systems, which include assembling stockpiles of Oseltamivir or Tamiflu, anti-viral medications. Nabarro says the agency is also working on trying to ensure that there will be a plan that can be put into place for rapid production of pandemic vaccines once the new virus appears.

Bird flu has been reported in about 60 countries in the last three years, killing millions of birds. To date only about 350 humans have gotten the disease, but of that number, more than 200 have died, increasing fears of what a potential human pandemic could be like.

The state of Virginia has suspended all sales of live poultry after the discovery of suspected avian flu germs in a flock of Virginia turkeys. The ban will remain in effect through the rest of this month.

As scary as it sounds, state health officials say its a danger to the poultry industry but not to humans.

The Virginia Department of Agriculture said the strain of antibodies discovered in the flock of 54,000 turkeys in Shenandoah County, Virginia does not pose a health risk to humans.

The state has also banned the transfer and application of poultry droppings in 17 counties. Droppings, which could carry and spread the antibodies, are often used as fertilizer.

In Indonesia, the death of a six-year-old boy brought that country's world-leading death toll from the H5N1 avian influenza virus to 81.

The Indonesian government, responding to a spike in new cases, declared a ban on backyard poultry farms in residential areas of nine provinces. It also placed tight restrictions on the movement and sale of poultry and poultry products across the nine provinces, and is preparing more hospitals to treat human cases of the virus.

Most bird flu victims have had direct or indirect contact with sick birds, but scientists fear the virus could mutate into a form that would be easily spread among humans, sparking a global pandemic that could kill millions.

Meanwhile, Egypt, the country hardest hit by bird flu outside Asia, has banned all poultry imports from France and Germany after the H5N1 strain was discovered in birds there.

Egypt took the step after positive H5N1 test results last week on three swans in France and 38 birds in Germany.

With health officials expressing concern there wont be enough vaccine available in the event of a flu pandemic, the U.S. Government is counting on technology and innovation to increase supplies.

The Food and Drug Administration has issued final recommendations to increase production and enhance distribution of safe and effective influenza vaccines for both seasonal and pandemic use.

FDA continues its commitment to help increase the supply of influenza vaccines and support the development of new approaches to vaccine production, said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research (CBER).

Having additional manufacturers of licensed influenza vaccines will enhance the capacity to produce more doses of seasonal influenza vaccines, as well as contribute to the nation's pandemic preparedness, one of our top priorities.

In March 2006, FDA issued two draft guidance documents for public comment one for seasonal influenza vaccines and another for pandemic influenza vaccines. The draft documents outline specific approaches for manufacturers to develop new vaccines that are safe, pure, and potent. The final guidances reflect public input, including vaccine companies and public health officials, the agency said.

Both guidances recommend using recent technologies such as cell culture and recombinant manufacturing to enhance the development and evaluation of vaccines. They also recommend adding substances that improve the immune response from the vaccine.

The plans describe conventional and accelerated approval pathways to get vaccines licensed faster. Under the plan, companies selecting the conventional pathway must provide clinical evidence that the vaccine prevents influenza.

Adequate and well-controlled clinical trials are also required for accelerated approval but companies may use a biological indicator such as immune response to the vaccine to predict effectiveness, an approach that may reduce the vaccine's development time. Further clinical studies are then required to verify the vaccine's clinical benefit.

The guidelines tell manufacturers they should submit a new Biologics License Application (BLA) for the initial licensure of a pandemic or seasonal influenza vaccine to ensure that each pandemic and seasonal vaccine has its own trade name and labeling.

For companies with U.S. licensed seasonal influenza vaccines, the pandemic guidance outlines the regulatory pathway for obtaining licensure for a new pandemic vaccine in which the manufacturing process is the same as for the seasonal vaccine.

For manufacturers developing vaccines using a new manufacturing process, both guidance documents explain the process for obtaining licensure using the accelerated approval pathway.

Should Avian flu jump to the human population and create a pandemic, health officials are counting on the antiviral Tamiflu as a major defense.

But increasingly, public health officials are concerned that widespread use of Tamiflu could have a very unwelcome side effect -- development of drug-resistant strains of the virus in wild birds.

British researchers at the Centre for Ecology and Hydrology in Oxford have released findings in the January 2007 issue of Environmental Health Perspectives (EHP) that demonstrate how Tamiflu's persistence in wastewater and river water could affect the waterfowl that drink from those water sources.

Since the World Health Organization's first warning of an avian flu pandemic two years ago, nations worldwide have been stockpiling Tamiflu for treatment and outbreak prevention. The drug, which minimizes flu symptoms and duration, inhibits the movement of the influenza virus from the cells it infects, and also helps uninfected people avoid contracting the flu.

However, Tamiflu's active agent, the metabolite oseltamivir carboxylate (OC) would be excreted into sewers for several weeks during a pandemic and is expected to withstand biodegradation.

According to the researchers in the current study, once birds drink OC-laced water from catchments receiving treated wastewater, they could produce Tamiflu-resistant strains and pass them on to other birds who share the same waters.

The investigators analyzed 11 waterway catchments in the United States and 5 in England using a metabolic pathway prediction system to determine the potential biodegradability of OC. They also measured wastewater discharges into the catchments.

They estimated the number of clinically infected people in each catchment area treated with a full 5-day course of Tamiflu with 100% compliance, assuming that 80% of the ingested Tamiflu was released into sewer systems as OC and that all of the OC entering each catchment was flushed out in one day.

Their estimates showed a maximum concentration well above that required for development of resistance in vitro for 62 consecutive days in the arid Lower Colorado River catchment area.

Overall, the researchers say that because of the lower population density for many of the U.S. catchments, peak concentrations of OC in a pandemic would be approximately 10 times less than the concentrations in British rivers.

All but one of the American catchments studied are larger than those in Britain and, with the exception of the Lower Colorado River flow area, have more available dilution per person in each given population.

There were no specific ecotoxicological risks from Tamiflu identified at the time the drug was submitted for approval to the European Medicines Agency. The authors, however, suggest that the ecotoxicological risk associated with Tamiflu use needs to be reassessed in light of the hundreds of millions of courses that would be consumed globally during a pandemic.

The authors warn that, with the release of the uniquely structured, biochemically resistant OC antiviral into river water, "the range of OC concentrations predicted . . . will have uncharacterized ecotoxicological consequences." They call for more detailed water contamination modeling, especially in high-risk areas of the world such as Southeast Asian countries, where there is more frequent human-to-waterfowl contact and where future use of Tamiflu would be significant.

They also recommend development of methods to minimize the release of OC into wastewater systems, such as biological and chemical pretreatment in the toilet.

Scientists at The Scripps Research Institute, the Centers for Disease Control, and the Armed Forces Institute of Pathology have identified what the researchers described as a possible pathway for a particularly virulent strain of the avian flu virus to "gain a foothold in the human population."

The H5N1 avian influenza virus, commonly known as "bird flu," is a highly contagious and deadly disease in poultry. So far, its spread to humans has been limited, with 177 documented severe infections, and nearly 100 deaths in Indonesia, Vietnam, Thailand, Cambodia, China, Iraq, and Turkey as of March 14, 2006, according to the World Health Organization.

"With continued outbreaks of the H5N1 virus in poultry and wild birds, further human cases are likely," said Ian Wilson, a Scripps Research professor of molecular biology and head of the laboratory that conducted the recent study. "The potential for the emergence of a human-adapted H5 virus, either by re-assortment or mutation, is a clear threat to public health worldwide."

Of the H5N1 strains isolated to date, the researchers looked at A/Vietnam/1203/2004 (Viet04), one of the most pathogenic H5N1 viruses studied so far. The virus was originally isolated from a 10-year-old Vietnamese boy who died from the infection in 2004. The hemagglutinin (HA) structure from the Viet04 virus was found to be closely related to the 1918 virus HA, which caused some 50 million deaths worldwide.

Using a recently developed microarray technology -- hundreds of microscopic assay sites on a single small surface -- the study showed that relatively small mutations can result in switching the binding site preference of the avian virus from receptors in the intestinal tract of birds to the respiratory tract of humans. These mutations, the study noted, were already known in some human influenza viruses to increase binding for these receptors.

The study was published by ScienceXpress, the advance online version of the journal Science.

The study was careful to note that these results reveal only one possible route for virus adaptation. The study concluded that other, as yet "unidentified mutations" could emerge, allowing the avian virus to switch receptor specificity and make the jump to human-to-human transmission.

The work was supported by the National Institute of Allergy and Infectious Disease, the National Institute of General Medical Sciences and the National Institutes of Health.

Emergency rooms and doctors' offices throughout California are jammed by victims of a sudden surge in influenza cases. This "California Flu" epidemic has nothing to do with the "bird flu;" it is a regional outbreak of the yearly flu onslaughts that sweep the country.

"This human flu now invading California and contiguous states is part of the annual flu season and is not a harbinger of pandemics yet to come," said Gilbert Ross, M.D., Executive and Medical Director of the American Council on Science and Health.

Flu activity is also picking up in New York City. Dr. Thomas R. Frieden, Commissioner of the NYC Department of Health and Mental Hygiene, said daily monitoring of emergency department visits showed a growing number of flu cases.

"The growing number of New Yorkers experiencing cough and fever over the past several days - signs typically associated with the spread of community-wide flu - is a reminder for New Yorkers to get vaccinated for influenza," Frieden said.

The best way to avoid coming down with the annual flu is to get a flu shot. Although it takes a few weeks for the vaccine to become effective, that may be enough time for most Americans, depending on how fast the California outbreak spreads.

The vaccine is not foolproof. Some individuals, especially seniors, do not make protective antibodies to the flu virus, even after a shot.

Ross said that while the bird flu is a theoretical threat, the annual flu is very real.

"The yearly flu epidemics kill up to 40,000 Americans. The 'bird flu' has killed about 70 people. No Americans have died of bird flu," Ross noted. "We should get more upset about this real threat and not pay so much attention to that somewhat over-hyped one, for now."

Ross noted that Tamiflu, the most effective antiviral drug, is in short supply this year, thanks to hoaring by those fearing a bird flu outbreak.

"Some people may actually die for want of this drug, which works well within the first 48 hours of flu infection," he said. "There is another effective drug, the inhaled Relenza, which may be available in sufficient quantities to help right here in the U.S. for this flu season."

Ross and other medical authorities noted that it's important to immunize children, as a means of protecting older Americans.

"Children also get the flu -- indeed, they are the main reservoir of influenza virus, and they generally don't get very sick from it. But, they do transmit it to their grandparents, who do get quite ill, and sometimes even die," he said.

The parents of all toddlers are advised by the CDC to get their youngsters vaccinated against the flu.

"I believe vaccinating all schoolchildren as well would help to reduce the toll among the elderly, and this should be considered as an added indication by vaccine specialists at the CDC," Ross said.

Studies of influenza vaccine effectiveness in elderly people substantially overestimate vaccine benefits, according to new research from the US published in the International Journal of Epidemiology (IJE). The study echoes the findings of research published earlier this year in The Archives of Internal Medicine.

Research by Dr. Lisa Jackson and colleagues at Group Health Co-operative, Seattle, found evidence of serious bias in estimates of influenza vaccine effectiveness in seniors.

Their study suggests that the association between vaccination and risk of death is influenced by the fact that relatively healthy seniors (that is, those already less at risk from dying) are more likely to get vaccinated.

However, the research does not indicate that there is no benefit in vaccinating the elderly, just that the differences in health between seniors who receive vaccine and those who do not make it difficult or impossible to tell what benefit is being derived from the vaccine.

A commentary on the papers also published in the IJE argues that there are reasons to seek ways to augment current vaccination strategy, for example, vaccinating health care workers, nursing home personnel and school children, who are the major spreaders of flu within the community.

This would further decrease flu deaths in the elderly by reducing transmission of the virus. It could be done while better vaccines for the elderly are developed along with the use of new technologies to better evaluate effectiveness.

Dr. Jackson and colleagues studied 73,527 people aged 65 and over during an eight year period. They evaluated the association of flu vaccination and risk of death, and the association of flu vaccination and risk of hospitalization for pneumonia, in periods before, during and after flu season.

Since a protective effect of vaccination should be specific to flu season, they would expect to find reductions in risk of death or hospitalization during the season. However, they found the greatest reductions in the period before flu season when there should be no true vaccine effect.

The reductions in risk before flu season suggest the presence of bias -- due to preferential receipt of vaccine by relatively healthy seniors -- on the estimates of flu vaccine effectiveness observed during flu season.

The researchers then looked at 252 people aged over 65 who had died during a flu season and 572 age-matched controls. Using the subjects' medical records, they identified people with "functional limitations," such as requiring assistance to walk or bathe.

They found that functional limitations were associated with both an increased risk of death and a decreased likelihood of influenza vaccination, and so may confound the association of influenza vaccination and risk of death.

In a commentary on the studies, Professor Paul Glezen of Baylor College of Medicine, Houston said: "During the period from 1989 to 1997 the vaccination rate for people aged over 65 in the US increased from 30 to 67 per cent. Despite this increase, mortality and hospitalization rates continued to increase rather than decline as would be expected if the vaccine were optimally effective.

"The study by Dr Jackson and her colleagues concludes that elderly people who choose to take the vaccine are, contrary to the findings of earlier cohort studies, in better health than those who fail to get the vaccine. This suggests that better studies of the benefits of flu vaccine in elderly and other high-risk groups are necessary to guide strategies for flu control.

"In the meantime, other strategies should be considered in addition to vaccinating the elderly. Many studies have shown that school children have the highest rates of flu infection each year and that they are the major spreaders of flu in the community and introducers into the household. Immunization of school children, therefore, would reduce exposure of vulnerable patients to flu.

"One of the problems with current vaccination strategy is that high-risk persons are relatively inaccessible; no improvement in vaccine coverage has occurred since 1997. School children could be accessible through school-based vaccine clinics allowing rapid administration of vaccine to large numbers, representing all socioeconomic groups, within a short period of time."

The Food and Drug Administration has issued warning letters to nine companies marketing bogus flu products behind claims that their products could be effective against preventing the avian flu or other forms of influenza.

FDA said it is not aware of any scientific evidence that demonstrates the safety or effectiveness of these products for treating or preventing avian flu and the agency is concerned that the use of these products could harm consumers or interfere with conventional treatments.

"There are initiatives in place to deter counterfeiters and those who sell fraudulent or phony products to prevent or treat avian flu," said Andrew von Eschenbach, MD, Acting FDA Commissioner.

"The use of unproven flu cures and treatments increases the risk of catching and spreading the flu rather than lessening it because people assume they are protected and safe and they aren't. I consider it a public health hazard when people are lured into using bogus treatments based on deceptive or fraudulent medical claims."

FDA issued warning letters to nine firms marketing products making unproven claims that they treat or prevent avian flu or other forms of influenza.

Eight of the products purported to be dietary supplements. Examples of the unproven claims cited in the warning letters include: "prevents avian flu," "a natural virus shield," "kills the virus," and "treats the avian flu."

These alternative therapies are promoted as "natural" or "safer" treatments that can be used in place of an approved treatment or preventative medical product.

In the warning letters, the FDA advises the firms that it considers their products to be drugs because they claim to treat or prevent disease. The warning letters further state that FDA considers these products to be "new drugs" that require FDA approval before marketing.

The letters also note that the claims regarding avian flu are false and misleading because there is no scientific basis for concluding that the products are effective to treat or prevent avian flu. The companies have 15 days to respond to FDA.

Tamiflu is surpassing oil as the world's most sought-after substance. The prescription drug made by Roche is one of the few drugs currently in production that is known to help fight viral flu-type infections.

Governments worldwide are stockpiling Tamiflu as they brace for the annual flu season and the prospect that the virus responsible for avian flu mutates and jumps to humans. Roche has reported that demand for the drug has jumped sevenfold in the past two months.

Drug stores in the U.S. filled almost 87,000 prescriptions for Tamiflu during the eight weeks ended Oct. 7, up from about 13,000 a year earlier, according to data released today by market researcher Verispan LLC.

Patients take Tamiflu within a day or two of getting flu symptoms to reduce the severity and spread of the virus and to help reduce the chance of getting influenza.

In many cases, patients who know about the drug are asking their physicians for prescriptions now, hoping to have a stockpile on hand if a pandemic breaks out. Most physicians seem willing to write the prescriptions.

Swiss-based Roche says it is working with other manufacturers to begin producing massive quantities of the drug. It is made from an acid produced from the Chinese star anise plant, which is in limited supply because it is grown in only four provinces in China and is harvested between March and May.

However, Roche says that is has recently developed a way to make the acid, called Shikimic acid, without the plant.

The World Health Organization last year recommended governments stockpile the Tamiflu capsule or Relenza, an inhalable antiviral drug made by GlaxoSmithKline.

The U.S. Government is concerned about a possible pandemic flu outbreak and has drafted a report declaring that the country is completely unprepared for a devastating impact, according to a report in the New York Times, which said it has obtained a copy of the unreleased Bush Administration draft.

Specifically, the report cites concerns about Avian, or so called bird flu, which has surfaced in parts of Asia. Bird flu was first identified in South Korea in December 2003. The most recent cases were found in Romania on Saturday.

Bird flu is an infection caused by avian (bird) influenza viruses, according to the U.S. Centers For Disease Control and Prevention. These flu viruses occur naturally among birds, though wild birds usually do not get sick from them. However, bird flu is very contagious among birds and can make some domesticated birds, including chickens, ducks, and turkeys, very sick and often kills them.

Humans normally dont get sick from bird flu, though there have been a few cases of human illness since 1997, according to the CDC. A total of 65 people in Asia have died from bird flu since 2003.

The draft Bush Administration report expresses the worry that if the virus mutates and jumps to the human population in Asia, it could quickly spread to the United States because of international travel. If that happens, the report warns of what could be the worst disaster in the nations history.

According to the Times report, the document suggests hospitals would be overwhelmed, riots would sweep vaccination clinics and more than a million Americans could die.

The plan, which has been years in the making and may be released in the coming weeks, makes no specific mention of government of military responses, according to the newspaper. It mentions the use of quarantines and travel restrictions, but acknowledges they would likely be ineffective in stopping a pandemic.

Serious Business

A flu pandemic is a global outbreak of disease that occurs when a new influenza A virus appears or emerges in the human population, causes serious illness, and then spreads easily from person to person worldwide. Pandemics are different from seasonal outbreaks or epidemics of influenza.

Seasonal outbreaks are caused by subtypes of influenza viruses that are already in existence among people, whereas pandemic outbreaks are caused by new subtypes or by subtypes that have never circulated among people or that have not circulated among people for a long time. Past influenza pandemics have led to high levels of illness, death, social disruption, and economic loss.

Currently, the CDC assesses the risk of a bird flu pandemic as low, pointing out that the strain of virus found in Asia has not been found in the United States. However, the agency says it is working with domestic and international health agencies to develop and refine techniques to identify new viruses develop antiviral stockpiles.

Help is on the way, says Health and Human Services Secretary Tommy G. Thompson, who says that about 60 million doses of influenza vaccine combined with an ample supply of antiviral medicines -- potentially enough for more than 40 million people during the flu season -- puts America in a strong position during the upcoming flu season.

Thompson said the nation's cache of vaccine and medicines includes an additional 2.6 million doses of influenza vaccine that Aventis will make available in January.

The Centers for Disease Control and Prevention (CDC),meanwhile, issued interim guidance on the use of antiviral medicines for preventing and treating the flu. In addition, the formalization of a federal government task force will help ensure an ongoing coordinated effort to manage the supply of medicine and prevent price gouging.

"In addition to the 60 million doses of influenza vaccine, we have healthy supplies of antiviral medicines to help keep you safe from the flu," Thompson said. "While we don't have as much flu vaccine as we planned for, the combination of existing vaccine and antiviral medicines gives us the ability to stave off any harsh effects of the flu."

Thompson said the combined supply of influenza vaccine and antiviral medications precludes the need for seniors and others to stand in long lines waiting for vaccine. In addition, about 24 million doses of this influenza vaccine supply has yet to be distributed and will be steered toward the people and places who need it the most. He advised seniors seeking vaccine to be patient and persistent, keeping in contact with their doctors and public health departments.

"We are still in the early stages of the flu season, and millions more doses of the vaccine will be shipped in coming weeks, so there is still time to get vaccinated," Secretary Thompson said. "We understand the public's concerns about the loss of the Chiron flu vaccine, but they should know we have a healthy supply of vaccines and medicines to cope with flu season."

Thompson said the government is exploring every option to replace some of the lost vaccine from other sources, and said the Bush administration has made unprecedented investments to protect against the flu.

Federal Task Force

Thompson also announced the formalization of a federal task force that will coordinate our nation's efforts to ensure that the flu vaccine and treatment medication goes to those who need it most and without any price gouging.

Thompson said marshalling all the resources of the federal government -- including the health agencies, Department of Justice, Federal Trade Commission, Homeland Security and Veterans Affairs -- will help ensure that all aspects of flu season are being addressed for the American public.

The Flu Action Task Force will also continue ongoing partnerships with the private sector in addressing challenges of the flu season, including the public health community, physicians, law enforcement and prosecutors, trade associations and advocacy groups.

"From the time we learned about our loss of the Chiron vaccine, a strong partnership between federal agencies, the private sector and the public health and law enforcement communities has helped us rapidly and effectively address the challenges before us," Secretary Thompson said. "It's important that we keep these partnerships strong during flu season, this year and beyond."

The problem

In 1994, there were five injectable influenza vaccine manufacturers: Wyeth, Evans (now part of Chiron), Connaught (now part of Aventis), Parke Davis and Lederle; today there are two - Aventis and Chiron.

The high risks of complex vaccine production, unpredictable consumer demand and low profit margins, coupled with the lack of liability protection from costly lawsuits, drove many manufacturers out of the flu vaccine business during the 1990s.

Getting manufacturers back into the marketplace is further complicated by the length of time for a new manufacturing facility to come on-line - five years or more. The FDA has high standards for flu vaccine production, including good manufacturing processes, which ensure the safety and efficacy of vaccines. These high standards helped keep 46 million doses of contaminated vaccine produced by Chiron from making it into the arms of Americans this year.

Stockpiles

This administration is the first to create stockpiles of both influenza vaccine and antiviral medications, Thompson said. The department invested $40 million in 2004, and seeks another $40 million in 2005, to stockpile influenza vaccine through the Vaccines for Children Program. It invested $87.1 million to stockpile 2.3 million doses of Tamiflu. And it invested $34 million on Rimantadine capsules to treat 4.25 million adults and Rimantadine syrup to treat 750,000 kids.

These stockpiles give the government new ability to protect the most vulnerable, and respond effectively when there is a shortage of vaccine.

Pandemic Flu

In August, Thompson unveiled the department's draft Pandemic Influenza Response and Preparedness Plan. This plan outlines a coordinated national strategy to prepare for and respond to a flu pandemic. One of the first internal committees the Secretary created when he came to HHS was on the pandemic flu.

Sufficient supplies of flu vaccine should be available during the coming influenza season. The Centers for Disease Control and Prevention (CDC) predicts that everyone wanting to get a flu shot to avoid influenza, regardless of age or health status, should be able to get vaccinated as soon as vaccine becomes available in October.

CDC estimates that vaccine manufactures will produce approximately 85.5 million doses of influenza vaccine during the 2003 influenza season. This projection represents 9.5 million fewer doses than were produced last year. However, influenza vaccine production is expected to exceed the estimated 79 million doses that were actually sold to providers in 2002.

"Influenza vaccination is the best way to prevent influenza and its severe complications," said Dr. Walter Orenstein, director of the CDC National Immunization Program. "The best time to be vaccinated against influenza continues to be October and November. However, vaccination in December or later can still be beneficial."

Although anyone who wishes to avoid influenza should be vaccinated, CDC strongly recommends influenza vaccination as soon as vaccine is available for any person who is 6-months old or older and is at increased risk for complications from influenza.

Those at highest risk for complications from influenza include people 65-years old and older, those with chronic, long-term health problems such as heart or lung disease, kidney problems, diabetes, asthma, anemia, HIV/AIDS or any other illness that suppress the immune system. CDC also recommends vaccination for people age 50 to 64 years because this group has an increased prevalence among those with high risk conditions. In addition, healthcare workers and others in close contact with those at high risk should be vaccinated in order to reduce the possibility of transmitting influenza to those at high risk.

Because young children also are at increased risk of influenza-related complications, vaccination of children 6 to 23 months old, their household contacts and out-of-home caregivers are encouraged to be vaccinated against influenza.

"Protect yourself and those you love against influenza," Orenstein said. "Get your influenza vaccine."