The FDA issued an Emergency Use Authorization (EUA) for the COVID-19 vaccine made by Moderna. This is the second COVID-19 for which the FDA has issued an EUA.
The Moderna vaccine is based on mRNA, or Messenger RNA and does not use the actual COVID-19 virus to provoke the body’s immune response.
This means Moderna may now distribute its vaccine, and that it is approved for use in patients 18 and older. The Moderna vaccine, like the Pfizer/BioNTech vaccine — the first COVID-19 vaccine to receive an EUA — requires two doses. The Moderna vaccine doses will be given around 28 days apart.
With the issuance of the EUA, the FDA concurs with the recommendation of the Vaccines and Related Biological Products Advisory Committee. The Committee met yesterday, and determined the Moderna vaccine met safety and efficacy standards and that its benefits outweighed any risk, and recommended approval of the EUA request.
Dr. Peter Marks of the FDA’s Center for Biologics Evaluation and Research said neither the Moderna vaccine nor the Pfizer/BioNTech vaccines should be given to people known to have severe allergic reactions. Dr. Marks said there have been 5 known severe allergic reactions, and the FDA and CDC as well as the manufacturers are meeting daily to review the data.
The EUA is not full approval. The manufacturers of any of the drugs or vaccines or procedures with EUAs must still submit additional safety and efficacy data to receive full approval.
To hear a media press conference by phone about the Moderna EUA with FDA Commissioner Dr. Stephen Hahn and Dr. Peter Marks of the FDA’s Center for Biologics Evaluation and Research, click here. The press conference begins around 17 minutes into the You Tube recording.
