Skip to main content

Breaking: FDA Issues EUA for Pfizer-BioNTech COVID-19 Vaccine

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.


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.



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.”


Julie Gould


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]. December 11, 2020.


Your Name
8 + 12 =
Back to Top