A group of independent medical experts on Thursday voted 17-4 in favor of the Food and Drug Administration granting an emergency authorization to BioNTech and Pfizer Inc.’s COVID-19 vaccine candidate.
The ball is in now in the FDA’s court. The regulator is not required to follow the recommendation of the members of the Vaccines and Related Biological Products Advisory Committee but often does.
Federal officials have said they expect the regulator to make a decision on the vaccine within days. BioNTech and Pfizer’s vaccine has already received authorization in Bahrain, Canada, and the United Kingdom.
During an all-day meeting held remotely on Thursday, medical experts, FDA officials, Pfizer executives, and members of the public discussed the risks and benefits of the experimental COVID-19 vaccine.
At the end of the day, the committee voted on one question:
- Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 vaccine outweigh its risks for use in individuals 16 years of age or older? (Seventeen members voted ‘yes’ to this question, four voted ‘no,’ and one person abstained.)
Some of the key points of discussion during the meeting included:
- whether there is sufficient data from the Phase 3 clinical to authorize use of the vaccine in 16- and 17-year-olds. (The companies are seeking an indication that would allow teens in this age group to receive the vaccine.)
- whether the vaccine can prevent infection with asymptomatic disease
- whether certain patient populations like pregnant women and people with HIV/AIDS should receive the vaccine
- how the FDA should respond to reports of allergic reactions in two people who received the vaccine in the U.K. this week. (No allergic reactions were reported in the clinical trial, Pfizer executives told the committee.)
So far this year, shares of Pfizer have jumped 13.1%, BioNTech’s stock has soared 269.3%. The S&P 500
has gained 13.7% since the start of the year.