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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 ...
Pemivibart, sold under the brand name Pemgarda, is a monoclonal antibody medication authorized for the pre-exposure prophylaxis (prevention) of COVID‑19. [4] Pemivibart was developed by Invivyd. [3] [5] The US Food and Drug Administration (FDA) issued an emergency use authorization for pemivibart in March 2024. [4] [5]
In November 2023, the FDA revised the EUA for nirmatrelvir/ritonavir to authorize EUA- or NDA-labeled nirmatrelvir/ritonavir for the treatment of mild-to-moderate COVID‑19 in people aged twelve years of age and older weighing at least 40 kilograms (88 lb), who are at high risk for progression to severe COVID‑19, including hospitalization. [18]
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.
Updated COVID-19 vaccines have now been authorized by the U.S. Food and Drug Administration. New versions of the shots made by Pfizer and Moderna are set to hit doctors’ offices, pharmacies and ...
On 21 November 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for casirivimab and imdevimab to be administered together for the treatment of mild to moderate [COVID‑19] in people twelve years of age or older weighing at least 40 kilograms (88 lb) with positive results of direct SARS-CoV-2 viral ...
On Monday, the FDA removed the clinical hold on Novavax Inc.’s (NASDAQ:NVAX) Investigational New Drug (IND) application for its COVID-19-influenza combination (CIC) and stand-alone influenza ...
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 ]