An advisory panel to the U.S. Food and Drug Administration (FDA) has recommended approval of the coronavirus (COVID-19) vaccine produced by Pfizer and BioNTech.
The FDA is expected to grant emergency use authorization (EAU) within hours, meaning the vaccine could begin to be distributed in the U.S. to people age 16 and older. The panel reached its decision on a 17-4 vote after a day-long meeting.
Three of the panelists voting no told reporters they would have voted yes if the vaccine were strictly for people 18 and older. They said there was insufficient data for people under 18. Other panelists said the benefits outweighed the risks.
“When you have 2,000 to 3,000 people a day—a day—dying of coronavirus, to me this was a clear choice,” Ofer Levy, a panel member and director of the Precision Vaccines Program at Boston Children’s Hospital, told The Wall Street Journal.
The non-profit Children’s Health Defense expressed concern, saying the clinical trials for the vaccine failed to provide adequate data.
“Only 2.1 percent and 1.8 percent of the study cohort included patients 75 years old and over with pre-existing medical conditions, for the vaccinated and the placebo groups, respectively,” the group said in a press release. “There were only 41 total African Americans over age 75 in both arms of the Pfizer vaccine study. These are insufficient samples on which to base broad recommendations for these very important and vulnerable segments of the population.”
Two health care workers who received the vaccine this week in the UK suffered adverse reactions to it. Health officials said both persons had a history of severe allergic reactions, suggesting the vaccine might not be appropriate for people in that category.
Preparing for distribution
Frontline medical personnel and the staff and residents of nursing homes will be the first Americans to receive the vaccine, under guidelines adopted by the Centers for Disease Control and Prevention (CDC).
Pending the FDA’s green light, Pfizer could begin the vaccine distribution process this weekend. The health agency will next turn its attention to the vaccine produced by Moderna. The two vaccines are similar messenger RNA (mRNA) vaccines that contain a tiny bit of genetic material from the virus but not the virus itself.
If both are approved, the government says 40 million doses could be available in the U.S. by the end of December. However, the CDC said it expects between 5 million and 10 million doses to become available each week for the first few months while manufacturers ramp up production.
"We expect a constrained supply environment," the CDC’s Sara Oliver said earlier this month.
Retail pharmacies are being mobilized to distribute the vaccines as more Americans become eligible to be inoculated.
The Department of Health and Human Services (HHS) has begun working with Kroger, Walmart, CVS, Walgreens, and other national chains to become vaccination distribution centers. These firms have begun training staff and securing large refrigeration units to become vaccination centers.