A vaccine advisory panel of The U.S. Food and Drug Administration included independent scientific experts, infectious disease doctors and statisticians, voted in favor of emergency authorization of Pfizer Inc’s coronavirus vaccine.
An FDA decision could come soon after the meeting.
With the green signal from the panel of FDA’s experts, Pfizer’s Covid-19 vaccine passed a critical milestone on Thursday. FDA’s panel of experts formally recommended that the Food and Drug Administration authorize the vaccine.
The committee voted 17-4 that the known benefits of the vaccine outweighed the risks of taking the shot for individuals 16 and older, with 1 member of the panel abstaining.
Pfizer had asked that the two-dose vaccine be approved for use in people aged 16 to 85. Several advisory panel members discussed whether 16 and 17-year olds should be included in the recommendation because the risk to these individuals is low, and the evidence in the trial was scant.
In the end, they voted on the question as put them by the FDA, which included 16 to 17 year olds.
“The final decision about whether to authorize the vaccine for emergency use will be made by FDA’s career officials,” the agency said in a statement.
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