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National regulatory authorities have granted full or emergency use authorizations for 40 COVID-19 vaccines.. Ten vaccines have been approved for emergency or full use by at least one stringent regulatory authority recognized by the World Health Organization (WHO): Pfizer–BioNTech, Oxford–AstraZeneca, Sinopharm BIBP, Moderna, Janssen, CoronaVac, Covaxin, Novavax, Convidecia, and Sanofi ...
The vaccine consists of a version of the receptor binding domain (RBD) of the SARS‑CoV‑2 spike protein, together with the adjuvants aluminium hydroxide gel and CpG 1018. [2] As the RBD protein is poorly immunogenic alone, adjuvantation is essential for a RBD-based vaccine immunogenicity. [ 9 ]
The Food and Drug Administration (FDA) granted Pfizer full approval for the vaccine on Aug. 2021 for people ages 16 and older and granted Moderna full approval for people 18 years and older in ...
An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by 21 U.S.C. § 360bbb-3, to allow the use of a ...
Earlier this month, the health regulator approved updated COVID-19 vaccines made by Pfizer and Moderna targeting the KP.2 variant. JN.1 was the dominant strain in the United States earlier this year.
On 16 April 2021, the FDA revoked the emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. [69]
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