FDA Gives Full Approval to Moderna’s COVID-19 Vaccine
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The US Food and Drug Administration (FDA) has granted full licensure to Moderna’s COVD-19 vaccine, Spikevax, in individuals 18 years of age and older. The vaccine has been authorized for emergency use for this indication since December 2020.

Moderna’s COVID-19 vaccine is the second COVID-19 vaccine to be granted full licensure by the FDA. In August 2021, Pfizer’s/BioNTech’s COVID-19 vaccine, Comirnaty, was the first COVID-19 vaccine to be fully approved.

Spikevax has the same formulation as the Moderna COVID-19 vaccine authorized for emergency use and is administered as a primary series of two doses, one month apart.

Moderna COVID-19 Vaccine remains available under emergency use authorization 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 five months after completing a primary series of the vaccine. It is also authorized for use as a heterologous (or “mix and match”) single booster dose for individuals 18 years of age and older following completion of primary vaccination with a different available COVID-19 vaccine.

Source: US Food and Drug Administration and Moderna