The agency authorized use of the first coronavirus disease 2019 vaccine to prevent the disease caused by severe acute respiratory syndrome coronavirus 2 in individuals 16 years of age and older.
The FDA issued the first emergency use authorization (EUA) to BNT162b2, a vaccine developed by Pfizer and BioNTech to prevent the coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older, according to a release issued by the agency.
EUA allows the vaccine to be distributed in the U.S. and to be used in an emergency to diagnose, treat, or prevent COVID-19 when there are no adequate, approved, and available alternatives.
“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” FDA Commissioner Stephen M. Hahn, MD, said in the release “Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization. The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide.”
The FDA determined that BNT162b2 has met the statutory criteria for issuance of an EUA. It based its decision on data from an ongoing, randomized, placebo-controlled, international phase 3 trial of the vaccine in 36,523 participants who did not have evidence of SARS-CoV-2 infection through 7 days after the second dose.
In total, 18,198 participants received the vaccine and 18,325 received placebo.
The vaccine was reported to be 95% effective in preventing COVID-19 in trial participants, with 8 COVID-19 cases in the vaccine group and 162 in the placebo group. Among participants with COVID-19, 1 in the vaccine group and 3 in the placebo group were classified as severe.
The FDA noted that, at this time, data are not available to determine how long the vaccine will provide protection. In addition, there is no evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.
“The totality of the available data provides clear evidence that Pfizer-BioNTech COVID-19 Vaccine may be effective in preventing COVID-19,” the FDA stated in the release. “The data also support that the known and potential benefits outweigh the known and potential risks, supporting the vaccine’s use in millions of people 16 years of age and older, including healthy individuals. In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.”
BNT162b2 is targeted at the SARS-CoV-2 – the virus that causes COVID-19 – spike glycoprotein (S) antigen that is encoded by RNA and formulated in lipid nanoparticles (LNPs). The vaccine contains a small piece of the SARS-CoV-2 virus’s messenger RNA that instructs cells in the body to make the virus’s distinctive “spike” protein. “When a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2,” the agency explained.
The vaccine is given in 2 doses, 30 µg each, administered 21 days apart.
The development and testing of BNT162b2 happened under the public-private partnership, Operation Warp Speed, which was created with the goal of bringing a safe and effective vaccine to the market in an expedited manner.
On December 10, a group of federal advisors recommended the approval of BNT162b2 at a Vaccines and Related Biological Products Advisory Committee Meeting.
In issuing an EUA, the FDA evaluated the available evidence and assessed any known or potential risks and any known or potential benefits. Because the benefit-risk assessment was favorable, the vaccine was able to be made available during the pandemic. Under the EUA, it is fact sheets that provide important information, including dosing instructions, and information about the benefits and risks of the Pfizer-BioNTech COVID-19 Vaccine, are required to be made available to vaccination providers and vaccine recipients.
“While not an FDA approval, today’s emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine holds the promise to alter the course of this pandemic in the United States,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research said in the release.
“With science guiding our decision-making, the available safety and effectiveness data support the authorization of the Pfizer-BioNTech COVID-19 Vaccine because the vaccine’s known and potential benefits clearly outweigh its known and potential risks,” he added. “The data provided by the sponsor have met the FDA’s expectations as conveyed in our June and October guidance documents. Efforts to speed vaccine development have not sacrificed scientific standards or the integrity of our vaccine evaluation process. The FDA’s review process also included public and independent review from members of the agency’s Vaccines and Related Biological Products Advisory Committee. Today’s achievement is ultimately a testament to the commitment of our career scientists and physicians, who worked tirelessly to thoroughly evaluate the data and information for this vaccine.”
FDA News Release. FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine. Published: December 11, 2020. https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19. Accessed: December 11, 2020.