An advisory committee to the Food and Drug Administration voted 17-4 in favor of recommending the Pfizer COVID-19 vaccine for emergency use authorization for people 16 and older, teeing up the FDA to give final approval to the vaccine in the coming days.
According to The Associated Press, the 22-person advisory committee recommended the vaccine in a meeting Thursday. The FDA is now expected “to follow the recommendation issued Thursday by its expert advisors.” The New York Times, citing people familiar with the FDA’s planning, reports an emergency authorization approval for the Pfizer COVID-19 vaccine could now come by Saturday or Sunday this weekend.
“With the high efficacy and good safety profile shown for our vaccine, and the pandemic essentially out of control, vaccine introduction is an urgent need,” Kathrin Jansen, head of vaccine research and development at Pfizer, reportedly said at the advisory committee meeting.
The Times reports that the advisory committee’s recommendation is not binding, but that the FDA usually follows the recommendations given by such panels. According to The Wall Street Journal, some members of the panel expressed skepticism about approving the vaccine for 16- and 17-year-olds based on current data.
David Kim, a member of the advisory panel, told CBNC he voted “no” because of the language allowing 16- and 17-year-olds to receive the COVID-19 Pfizer vaccine, and would have voted “yes” if the language was changed so that it was only recommended for those 18-years-old or older.
The panelists reportedly didn’t receive enough time to explain their votes, and it’s unclear whether the other three panelists who voted “no” did so for similar reasons. One person also abstained from the vote.
“This meeting is an important step in the review process, providing an opportunity for outside experts to provide valuable advice and input for the agency to consider as part of its review,” the FDA said Thursday. “Importantly, the final decision about whether to authorize the vaccine for emergency use will be made by FDA’s career officials.”
Pfizer, an American company, developed the vaccine with the help of the German biotechnology company BioNTech, and made headlines last month when they said that their vaccine had shown to be over 90% effective in ongoing trials. A recent FDA analysis of the vaccine found it to be 95% effective after two doses spaced 3 weeks apart. The FDA also said the vaccine appeared to be 82% effective after a single dose.
Dr. Greg Poland, director of the Mayo Clinic’s Vaccine Research Group in Rochester, Minnesota, who was not involved in the vaccine development, said the second dose serves to “significantly boost the immune response,” and it would be wrong for people to think they’re “home free” after the first inoculation, reports NBC News.
Pfizer has said that the 95% efficacy rate comes 7 days after receiving the second dose.
This article has been updated to include additional information.