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WASHINGTON: A panel of external advisers from the US Food and Drug Administration voted overwhelmingly on Thursday (December 10) to support the emergency use of Pfizer’s coronavirus vaccine, paving the way for the agency authorize the injection for a nation that has lost more than 285,000 lives to COVID-19.
The FDA is expected to clear the vaccine, developed with German partner BioNTech, for emergency use in the United States within days.
The committee voted 17 to 4 that the known benefits of the vaccine outweighed the risks of getting the shot for people 16 and older, and 1 panel member abstained.
Pfizer has requested that the two-dose vaccine be approved for use in people ages 16 to 85. Several members of the advisory panel discussed whether 16- and 17-year-olds should be included in the recommendation because the risk to these people is low and the evidence at trial was scant.
In the end, they voted on the issue raised by the FDA, which included 16-17 year olds. The FDA generally follows the advice of its expert panels, but is not required to do so.
The panel also discussed concerns raised by two reports of severe allergic reactions among vaccine recipients in Britain and devoted much of the discussion to Pfizer’s plan to give volunteers who received a placebo in its trial the option of receive the vaccine when they are eligible to under the recommendations established by state and local health officials.
READ: At COVID-19 milestone for the West, Britain begins mass vaccination
Documents prepared by the FDA before the meeting did not point to any new safety or efficacy issues, raising optimism that the United States would soon follow the United Kingdom and Canada in licensing the vaccine.
Britain’s health regulator on Wednesday advised some people with a history of anaphylaxis, an overreaction of the body’s immune system related to drugs or food, to avoid receiving the vaccine.
FDA Commissioner Steven Hahn, ahead of Thursday’s meeting, said the agency was carefully reviewing all data on Pfizer’s vaccine, including possible allergic reactions following the UK warning.
He said the vaccine’s label would include details about who the vaccine was recommended to, and who should not receive it, if it is ultimately approved.
READ: In Canada, COVID-19 Vaccine Transportation Rules Will Keep First Doses Out Of Most Nursing Homes
Pfizer and BioNTech said last month that a two-dose regimen of the vaccine was 95 percent effective in preventing COVID-19 disease, and detailed data published in agency documents showed that the vaccine began to show some protection. even before the volunteers received a second dose.
The papers also revealed safety data, including cases of Bell’s palsy among volunteers in the placebo and vaccine groups, although they said cases in the trial occurred at the same rate as in the general population. Other reactions included fever, fatigue, and chills.
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