December 11, 2020
In a late Friday evening announcement, the US Food and Drug Administration (FDA) said it has issued emergency use authorization (EUA) for the first COVID-19 vaccine. The vaccine, created by Pfizer and BioNTech, will be distributed throughout the United States for adults and teenagers 16 years of age and older.
“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,” said FDA Commissioner Stephen M. Hahn, MD, in a press statement.
According to the agency, the vaccine met criteria for issuance of an EUA, and the available data shows that the vaccine may be an effective option in preventing COVID-19. Further, the known and potential benefits outweigh the known and potential risks, according to the data.
“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,” the agency explained in a press release.
The vaccine specifically contains the genetic material, messenger RNA (mRNA). Additionally, the vaccine contains “a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein.” The FDA explained when a person receives this vaccine, copies of the spike protein will be produced by the human body that triggers the immune system to learn to react defensively and will not cause the disease itself. This will then produce an immune response against SARS-CoV-2.
“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,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.
“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.”
The FDA based their decision off of data that included 36,523 participants in the ongoing randomized, placebo-controlled international study. Of those patients, the majority are US participants who did not have evidence of SARS-CoV-2 infection through seven days after the second dose. More specifically, 18,198 participants received the vaccine and 18,325 were in the placebo arm of the trial. According to the data, the vaccine showed a 95% efficacy rate in preventing COVID-19 among the clinical participants. Of important note, the trial results in eight COVID-19 cases in the vaccine group and 162 in the placebo group. The FDA did note, however, that “data are not available to make a determination about how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.”
“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,” Dr Hahn stressed.
US Food and Drug Administration. FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine [press release]. https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19. December 11, 2020.