The FDA has determined that the Moderna COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that the Moderna 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 18 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 Moderna COVID-19 Vaccine EUA Letter of Authorization here.
In addition to the EUA letter, below are links to fact sheets from the FDA:
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.
For more information on COVID-19 vaccines, the EUA process, and guidance to industry for developing a COVID-19 vaccine please visit: