Monday, the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech vaccine for the prevention of 2019 coronavirus disease (COVID-19) for individuals 16 years of age and older caused by SARS-CoV-2. This EUA represents the first vaccine authorized for the prevention of COVID-19.
The FDA has determined that the Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that the Pfizer-BioNTech COVID-19 Vaccine may be effective in preventing COVID-19. 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.
A link to the full FDA press release is here. The press release also provides information and discussion on available safety and effectiveness data.
You can review the full Pfizer-BioNTech COVID-19 Vaccine EUA Letter of Authorization here.
In addition to the EUA letter, see below:
Operation Warp Speed and private sector partners now begin distributing the first allocation of doses to sites designated by the public health jurisdictions and five federal agencies with which OWS and CDC have been working to plan distribution. HHS Secretary Alex M Azar II and Acting Secretary of Defense Christopher C. Miller have issued statements on this next step, and they can be viewed here.
Tuesday morning at 9AM EST, FDA Leadership will hold a virtual press conference. As part of the FDA’s commitment to transparency, we invite you to watch our virtual press conference, to be live streamed over the FDA’s YouTube, Facebook and Twitter accounts.
For more information on COVID-19 vaccines, the EUA process, and guidance to industry for developing a COVID-19 vaccine please visit: