Moderna Vaccine Gets Full FDA Approval

The U.S. Food and Drug Administration has approved the Moderna vaccine, making it the second COVID-19 vaccine to go from emergency use authorization (EUA) to full approval. With this approval, the company will begin to market the vaccine under the name Spikevax. The approval means the vaccine has met FDA standards for “safety, effectiveness, and manufacturing quality,” according to the FDA.

Spikevax has the same formulation as the Moderna COVID-19 vaccine many have already received. It will still be given in two doses, one month apart. For those getting second shots in a series, either Spikevax or the EUA Moderna vaccine can be used. It can also be used as a “mix and match” booster dose after other vaccines. The vaccine is approved for use in people age 18 and older. Spikevax prescribing information is available here. The first FDA-approved vaccine is the Pfizer-BioNTech under the EUA, now being marketed as Comirnaty.

Topics: Vaccine

Written by Argentum

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