On December 10 FDA (Food and Drug Administration) holds an advisory committee meeting to discuss authorization of COVID-19 vaccine candidate (vaccine from Pfizer and Biontech) as part of the agency’s review of safety and effectiveness data.
“Today, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), made up of independent scientific and public health experts from around the country, is meeting to discuss the first request for emergency use authorization (EUA) for a vaccine for COVID-19 prevention, submitted by Pfizer Inc. in partnership with BioNTech Manufacturing GmbH.
The FDA’s career staff—made up of physicians, biologists, chemists, epidemiologists, statisticians and other professionals—have been working around the clock to thoroughly evaluate the data and information in the EUA request, for this potential COVID-19 vaccine, in a comprehensive and science-based manner. I can assure you that no vaccine will be authorized for use in the United States until FDA career officials feel confident in allowing their own families to receive it,” – said FDA Commissioner Stephen M. Hahn, M.D.
The day before Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting was reported about cyber-attack on the EMA (European Medicines Agency), which contain Pfizer and BioNTech’s COVID-19 vaccine candidate, BNT162b2, inside information.
“Today, we were informed by the EMA that the agency has been subject to a cyber-attack and that some documents relating to the regulatory submission for Pfizer and BioNTech’s COVID-19 vaccine candidate, BNT162b2, which has been stored on an EMA server, had been unlawfully accessed.
It is important to note that no BioNTech or Pfizer systems have been breached in connection with this incident and we are unaware that any study participants have been identified through the data being accessed. At this time, we await further information about EMA’s investigation and will respond appropriately and in accordance with EU law. EMA has assured us that the cyber-attack will have no impact on the timeline for its review,” – BioNTech said.
The EUA Granting For Pfizer And Biontech
On November 10, was announced that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17 to 4 in support of the FDA granting Emergency Use Authorization (EUA) for the companies’ COVID-19 mRNA vaccine (BNT162b2). There is one member of the Committee whose vote is not included in the 17 to 4 vote decision.
VRBPAC based its recommendation on the totality of scientific evidence shared by the companies, including data from a pivotal Phase 3 clinical study announced last month and published today in The New England Journal of Medicine.
The Phase 3 data demonstrated a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose.
“We have been looking forward to presenting our robust data package to the committee of vaccine experts for the U.S. government since we began our efforts to develop a novel COVID-19 vaccine earlier this year,” said Dr. Albert Bourla, Pfizer Chairman and CEO.
“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 U.S. in an effort to help combat this devastating pandemic.”