An outside advisory panel to the U.S. Food and Drug Administration (FDA) voted Thursday (Dec. 10) on the emergency use of Pfizer’s coronavirus vaccine, resulting in an overwhelming majority vote in favor of emergency use of the Pfizer vaccine, paving the way for the drug regulatory agency to authorize its use in the United States.
The FDA is widely expected to authorize emergency use within a few days. Thereafter, distribution and vaccination in the U.S. is expected to begin immediately.
The advisory panel voted 17 to 4, with one abstention, in favor of the determination that the known benefits of the vaccine for people 16 years of age and older outweigh the risks of receiving the vaccine.
Eric Dickson, CEO of the University of Massachusetts Memorial Health Care, was not a member of the advisory panel. He told Reuters after learning the results of the vote, “It’s a historic moment.”
Dickson said the vaccine developed by Pfizer and German partner BioNTech “is the best solution to get us out of the current situation and help us save lives.”
Pfizer requested approval for two doses of the vaccine for people between the ages of 16 and 85. Several members of the panel questioned whether 16- and 17-year-olds should be included in the recommendation. Ultimately, they voted on the question posed by the FDA, which resulted in including the 16- and 17-year-olds.
According to Reuters, it was unclear why the four members voted against the proposal, but several mentioned that they had a view on including 16- and 17-year-olds in the proposal, arguing that the risk to these individuals was low and that there was little relevant evidence from the trial.
In a statement, the FDA said, “The final decision on whether to authorize emergency use of the vaccine will be made by career FDA officials.”
The panel also discussed concerns raised by two reports of severe allergic reactions among U.K. vaccine recipients, as well as recommendations for pregnant women. The study excluded pregnant women, who make up a large percentage of health care workers of childbearing age. They were among the first to receive the vaccine.
The FDA said during the panel’s meeting that there was not enough data to support or oppose the use of the vaccine in pregnant women. The agency advised them to make their own decisions with the advice of their doctors.
Dr. Gregory Poland, a virologist at the Mayo Clinic in Rochester, Minnesota, served two terms on the FDA advisory panel. He was surprised that the advisors did not make more recommendations for pregnant women.
The advisers also spent a lot of time discussing Pfizer’s plan. The plan is to give volunteers in placebo trials the option of getting the vaccine after it is approved for use, based on recommendations made by state and local health officials.
Much of this discussion focused on whether the emergency authorization would affect the scientific integrity of Pfizer’s ongoing studies and how other vaccines would be studied in the future.
Pfizer believes that the vaccine should be made available to the comfort group of volunteers participating in the trial after it is approved for use.
Both the FDA and the panel were concerned that telling trial participants who was using the placebo or the vaccine would amount to removing the blinding that trials should have, i.e., participants should not know whether they were using a placebo or not, or it would be more difficult to obtain the vaccine safety and efficacy data needed for full FDA approval.
The FDA document prepared ahead of the expert meeting did not point to any new safety and efficacy issues, making it appear more optimistic that the U.S. will soon follow the U.K. and Canada in approving the use of the vaccine.
British health regulators on Wednesday advised certain people with a history of allergies to avoid the vaccine. The allergy is an overreaction of the body’s immune system related to drugs and foods.
Dr. William Gruber, Pfizer’s senior vice president of clinical research and development for the vaccine, told the panel that they had “seen no serious allergic reactions to the vaccine among the 44,000 volunteers who participated in the trial.”
But an FDA official said the agency asked Pfizer to add serious allergic reactions to its plan to study safety issues related to the vaccine after it is approved for use.
Pfizer and BioNTech said last month that the vaccine’s two-dose regimen had 95 percent effectiveness in preventing New Crown pneumonia. The agency released detailed data showing that the vaccine had begun to show some protection in volunteers before they received the second dose.
The document also disclosed data on safety, including cases of Bell’s palsy in the placebo and vaccine groups, although the document stated that the incidence was the same in the trial and in the general population. Other reactions mentioned in the paper include fever, fatigue and chills.
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