Novavax EUA Justified By US FDA With Claims Of COVID Vaccine Supply Constraints
The agency also includes a myocarditis warning in the fact sheet for the first protein-based COVID-19 vaccine to reach the US market.
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Agency policy now allows several others, along with the FDA chief scientist, to authorize emergency use of products, including CBER Director Peter Marks, who signed the EUA for the modified dosing of the monkeypox vaccine.
One switch raised questions, but by the time the COVID-19 vaccine reached commercial scale, the changes were considered minor.
Providers will have to look up the expiration date for vials of the protein-based vaccine on a website because it is not printed on the carton or packaging; omission sparks ACIP members’ frustrations with FDA and manufacturers about inadequate packaging for some other recently authorized vaccines.