FDA Formally Approves Moderna’s COVID-19 Vaccine

The FDA formally approved the second COVID-19 vaccine, Moderna’s COVID-19 vaccine, which will be marketed as Spikevax. Spikevax is approved for the prevention of COVID-19 in individuals 18 years of age and older. The formal approval process was based on the preclinical and clinical data and information that supported the emergency use authorization (EUA) of Moderna COVID-19 Vaccine as well as details of the manufacturing process and the sites where the vaccine is made.

In addition, the FDA conducted a rigorous evaluation of the postauthorization safety surveillance data pertaining to myocarditis and pericarditis following vaccination with the Moderna COVID-19 vaccine and has determined that the data demonstrate increased risks, particularly within 7 days following the second dose, with the observed risk highest in males 18 to 24 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. The Spikevax prescribing information includes a warning about these risks.

The vaccine has been available under EUA for individuals 18 years of age and older since December 18, 2020. Hundreds of millions of doses of Moderna COVID-19 vaccine have already been administered to individuals under EUA. The formal approval of the vaccine may instill additional confidence in making the decision to get vaccinated, the FDA stated.

Spikevax has the same formulation as the EUA Moderna COVID-19 vaccine and is administered as a primary series of two doses, 1 month apart. Spikevax can be used interchangeably with the EUA Moderna COVID-19 vaccine to provide the COVID-19 vaccination series. The EUA Moderna COVID-19 vaccine remains available under EUA as a two-dose primary series for individuals 18 years of age and older, as a third primary series dose for individuals 18 years of age and older who have been determined to have certain kinds of immunocompromise, and as a single booster dose for individuals 18 years of age and older at least 5 months after completing the primary series of the vaccine. It is also approved for use as a heterologous single booster dose for individuals 18 years of age and older following completion of primary vaccination with a different available COVID-19 vaccine (“mix and match”).

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