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Committee recommends Emergency Use Authorization of first mRNA-based COVID-19 vaccine; FDA approval is pending.
FDA’s Vaccines and Related Biological Products Advisory Committee voted on Dec. 10, 2020 to recommend that the agency issue an Emergency Use Authorization (EUA) to BNT162B2, an mRNA-based COVID-19 vaccine developed by Pfizer and BioNTech, for people ages 16 years and older.
The recommendation was expected following the release of clinical trial data reporting the vaccine had an efficacy rate of 95%. The New England Journal of Medicine published safety and final efficacy results from a Phase III trial of the vaccine on December 10, confirming the data.
In the day-long hearing, some committee members expressed concern about the limited number of trial participants ages 16 or 17 years. Others questioned reported severe allergic reactions to the vaccine that occurred in two recipients of the vaccine in the United Kingdom.
The independent advisory committee’s recommendation that the benefits of the vaccine outweigh the risks—by a vote of 17–4 with one member abstaining—passes the final EUA approval decision to FDA. The agency has indicated support for the EUA; a decision is expected in the next few days.
“We have been looking forward to presenting our robust data package to the committee of vaccine experts for the US government since we began our efforts to develop a novel COVID-19 vaccine earlier this year,” said Dr. Albert Bourla, Pfizer Chairman and CEO, in a press statement. “We are pleased with the committee’s strong majority vote, and if the FDA issues an authorization, stand at the ready to bring this vaccine to people in the US in an effort to help combat this devastating pandemic.”
The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is scheduled to meet on December 11 to weigh a recommendation that the vaccine be deployed for use; a vote is scheduled for December 13.
Sources: News reports and Pfizer