FACTBOX-Which COVID-19 vaccines are FDA approved in US?

Reuters
08/28
FACTBOX-Which COVID-19 vaccines are FDA approved in US?

Aug 27 (Reuters) - The U.S. Food and Drug Administration has approved COVID-19 vaccines in the U.S. including mRNA-based shots from Moderna MRNA.O and Pfizer PFE.N with partner BioNTech 22UAy.DE, as well as Novavax's NVAX.O traditional protein-based shot.

Here are the details of the FDA's approvals:

PFIZER/BIONTECH

Pfizer and BioNTech's shot, Comirnaty, is fully approved for all adults 65 and older and individuals aged five through 64 years who are at increased risk of severe COVID-19 infection.

The FDA has pulled the emergency use approval for the shot in children under the age of 5.

MODERNA

Moderna's vaccine, Spikevax, is approved for individuals 65 years of age and older and for those six months through 64 years of age who are at risk for severe disease.

The agency approved Moderna's next-generation shot, mNEXSPIKE, in May for use in those aged 65 and above and for ages 12 to 64 years who are at high risk of severe disease.

NOVAVAX/SANOFI

Novavax's protein-based shot, Nuvaxovid, is indicated for use in adults aged 65 and older, and for those aged 12 through 64 years who have at least one underlying health conditions that increases their risk of developing severe illness from COVID. It is distributed by Sanofi SASY.PA.

(Reporting by Sriparna Roy and Kamal Choudhury in Bengaluru; Editing by Maju Samuel)

((Kamal.Choudhury@thomsonreuters.com;))

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