FDA took action to fully approve Moderna’s Spikevax which had been the subject of an Emergency Use Authorization (EUA) since December 18, 2020. This means that the FDA has finalized its comprehensive review of the safety and efficacy of the Moderna vaccine. This is the second Covid-19 vaccine to gain full BLA approval status, the first being the Pfizer BioN-tech product.
The vaccine subject of the BLA approval is the same formulation as the Moderna product that was marketed under the EUA. In a statement issued by the Agency, Dr. Janet Woodcock, Acting FDA commissioner, said, “While hundreds of millions of doses of Moderna COVID-19 Vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated.” The full text of the announcement (along with links to additional data on the vaccine) can be found here.