FDA Advisory Committee Recommends Emergency Use Authorization of Pfizer’s/BioNTech’s COVID-19 VaccineBy
An advisory committee of the US Food and Drug Administration (FDA) met this week (December 10, 2020) to review the request by Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, for emergency use authorization for their COVID-19 vaccine candidate, BNT162b2, and recommended to support emergency use authorization.
FDA advisory committees provide non-binding recommendations, with the final decision on approval or authorization to be made by the FDA. The FDA is expected to make a decision on emergency use authorization in the coming days (as reported on December 10, 2020). If authorized by the FDA, BNT162b2 would be the first COVID-19 vaccine available in the US.
The FDA’s Vaccines and Related Biological Products Advisory Committee recommended authorization by a vote of 17 to 4. In advance of the meeting, the FDA posted a briefing document, in which the agency described the vaccine as offering “highly effective protection against COVID-19.” The companies had filed a request for emergency use authorization with the FDA late last month (November 2020).
“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 Albert Bourla, Pfizer Chairman and CEO, in a December 10, 2020 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.”
Following the positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, the FDA says it has informed the companies that it will “rapidly work toward finalization and issuance of an emergency use authorization.” The agency has also notified the US Centers for Disease Control and Prevention and Operation Warp Speed, a US government initiative to speed the development of treatments and vaccines for COVID-19, so they can execute their plans for timely vaccine distribution.
Companies gain emergency use authorization in Canada; proceed with conditional approval in the EU
In a separate development, Pfizer and BioNTech reported that Health Canada, the pharmaceutical regulatory body of Canada, has granted authorization under interim order for the emergency use of BNT162b2. This follows authorization for emergency use by the UK’s Medicines & Healthcare products Regulatory Agency earlier this month (December 2020).
The distribution of the vaccine in Canada will be prioritized according to the populations identified in guidance from the National Advisory Committee on Immunizations, which recommendations for the use of vaccines currently or newly approved for use in humans in Canada. BioNTech will hold the regulatory approval in Canada while Pfizer Canada will have the commercialization rights. Pfizer Canada and BioNTech will supply the Canadian government a minimum of 20 million doses (and up to 76 million doses) of the vaccine through 2021.
Late last month (November 2020), the companies also submitted an application for conditional marketing authorization with the European Medicines Agency (EMA).The EMA says it will assess the data submitted as part of the formal application for conditional marketing authorization. If the data submitted are robust enough to conclude on the quality, safety and effectiveness of the vaccine, EMA’s scientific committee for human medicines will conclude its assessment during an extraordinary meeting scheduled for December 29, 2020 at the latest.
Source: Pfizer (FDA advisory committee recommendation), BioNTech (FDA advisory committee recommendation), US Food and Drug Adminitration (statement on advisory committee recommendation), Pfizer Canada, BioNTech (Canadian emergency use authorization), US Food and Drug Administration (briefing document)
Note: This article was updated to reflect the FDA’s advisory committee’s recommendation to support emergency use authorization of the vaccine.