A Food and Drug Administration (FDA) advisory panel has recommended the approval of the Covid-19 vaccine developed by Pfizer Inc. and BioNTech SE. The FDA can now grant emergency authorization of the vaccine as early as today.
The FDA’s advisory panel is composed of independent scientific experts, infectious disease doctors, and statisticians. The panel voted 17 to 4 to approve the vaccine with one abstention.
“When you have 2,000 to 3,000 people a day—a day—dying of coronavirus, to me this was a clear choice,” said Ofer Levy, a panel member and director of the Precision Vaccines Program at Boston Children’s Hospital, after the vote.
One of the dissenting voters who voted against the vaccine’s authorization, Dr. Archana Chatterjee, made it clear that her opposition was because she did not believe 16 and 17-year-olds should be included right now.
“I want to be very clear that I am fully supportive of the emergency use authorization for the use of this vaccine from Pfizer and BioNTech for adults 18 years and older,” said Chatterjee, a pediatric infectious disease specialist who serves as dean of the Chicago Medical School.
Some members of the advisory committee also expressed concerns over the likelihood for severe allergic reactions, based on the news that regulators in Britain recommended this week that people with a history of anaphylactic allergic reactions to medicines and foods not get the vaccine while they investigate two cases of allergic reactions among health care workers.
Pfizer officials reassured the panel that there were no cases of severe allergic reactions in the trial of 44,000 participants. People with a history of allergic reactions to vaccines were excluded from the study.
With rare exceptions, the FDA follows the advice of the advisory panel for vaccine approvals. According to people close with the agency’s planning, the FDA is expected to grant an emergency use authorization on Saturday.
“Following yesterday’s positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization,” said FDA Commissioner Stephen Hahn and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a joint statement.
Hahn added that the FDA “is finalizing the necessary documents to ensure that patients and providers have the information that they need to make informed decisions and to safely administer the vaccine.”
According to federal officials, the initial shipment of 6.4 million doses of the vaccine will leave warehouses within 24 hours of being cleared by the FDA. Roughly half of those doses will be sent across the country, and the other half will be reserved for the initial recipients to receive their second dose about three weeks later.
The advisory panel’s approval is a major development for Pfizer and its German partner BioNTech, who began working on the vaccine 11 months ago. The companies have developed the coronavirus vaccine at record speed as vaccine development typically takes years.