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No Surprises in Use of Nasal Spray Flu Vaccine

December 7, 2005

• More Flu Shots for Kids • Record Amount Of Flu Vaccine On Hand • Nasty Flu Year in Store • Nasal Flu Vaccine Approved For Young Children • FDA OKs Relenza for Treatment and Prevention of Flu • Expanded Flu Shot Recommendations for Children • CDC Revises Flu Treatment Guidelines • Flu Outbreak Jams California Emergency Rooms • FDA Approves Tamiflu for Prevention of Flu in Children • Do Flu Shots Really Help Seniors? • No Surprises in Use of Nasal Spray Flu Vaccine • Flu Expert Wants Mandatory Vaccination of Health Care Workers • Like the Flu, Vaccine Shortages Return • Chiron Cleared To Ship Flu Vaccine • Flu Shots' Benefit to Elderly Questioned --- • U.S. Fears Devastating "Bird Flu" Pandemic

A study finds no unexpected risks in the use of nasal spray flu vaccine. Researchers writing in the December 7 issue of JAMA said about 2.5 million people received the nasal vaccine the last two flu seasons in the U.S.

No fatalities were reported about those 2.5 million. There were 7 reports of possible anaphylactic shock, 2 reports of Guillain-Barré syndrome, a temporary inflammation of the nerves, 1 report of Bell palsy, and 8 reports of asthma exacerbation among individuals with a prior asthma history.

Annual flu vaccination is the primary method for protection against the illness. And, until the 2002-2003 influenza season, the only licensed flu vaccine in the United States was the inactivated, trivalent injectable vaccine.

In June 2003, the U.S. Food and Drug Administration (FDA) licensed a trivalent live, attenuated influenza vaccine for use as a nasal spray among healthy persons 5 to 49 years of age.

Each dose contains live attenuated influenza virus of the 3 strains recommended by the U.S. Public Health Service for the corresponding influenza season.

Although the number of vaccinees studied was relatively large, wider use of the vaccine in much larger populations could reveal new safety issues, the researchers cautioned.

"Reports ... did not identify any unexpected serious risk with this vaccine when used according to approved indications. Like many vaccines and other medical products, LAIV-T may rarely cause anaphylaxis," the authors noted.

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