Government advisers determined that the Pfizer-BioNTech vaccine is safe and effective, clearing the way for final FDA approval of the shot this week.
A Food and Drug Administration panel officially recommended the agency approve the first coronavirus vaccine in the United States for emergency use.
In a 17-4 vote with one abstention, the government advisers concluded that the vaccine from Pfizer and its German partner BioNTech appears safe and effective for emergency use in adults and teenagers 16 and older. The decision arrives as COVID-19 cases surge to ever-higher levels across the U.S., with deaths hitting an all-time, one-day high of more than 3,100 on Wednesday.
Now the official approval decision is up to the FDA. The agency does not have to follow the independent panel’s recommendation, but they often do. A member of the committee, James Hilreth, said approval could come as early as Friday on NBC last weekend.
The vote came despite questions about allergic reactions in two people who received the vaccine earlier this week when the United Kingdom became the first country to begin dispensing the Pfizer-BioNTech shot.
Despite all the remaining unknowns, in an emergency, “the question is whether you know enough,” said panel member Dr. Paul Offit of Children’s Hospital of Philadelphia, who concluded that the shot’s potential potential benefits outweigh its risks.
Bahrain and Canada joined the UK in approving the Pfizer vaccine for public use earlier this month. According to the Wall Street Journal, the United States has ordered 100 million doses of Pfizer’s vaccine, of which 25 million will be available as soon as the vaccine is approved.
Additional reporting was provided by the Associated Press.