Coronavirus Update: FDA Approves Pfizer/BioNTech's Comirnaty
The FDA granted an expected, though long-awaited, approval to the COVID-19 vaccine. Also, Korean regulators have begun a review of Russian vaccine CoviVac, while Bavarian Nordic has initiated a Phase II study of its vaccine booster candidate and received a commitment for up to DKK 800m from the Danish government.
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Gennova Biopharma’s mRNA ambitions are taking wing as its HDT Bio-partnered self-amplifying vaccine moves to Phase II. Notably, the company will have to prove superiority to AstraZeneca/Serum Institute’s Covishield in what appears to be the first comparative study for a COVID-19 vaccine candidate in India, Scrip learns.
Also, Moderna completed the submission of the BLA for mRNA-1273’s FDA approval, Pfizer starts a rolling submission for a booster shot and Brii Biosciences announced data for its two-antibody antiviral cocktail, and Japan withdraws selected lots of Moderna's vaccine over contamination worries.