Novavax announced Monday that it has formally submitted a request for the US Food and Drug Administration to authorize its coronavirus vaccine for emergency use in the United States.
in a Phase 3 trial conducted across the United States and Mexico; the trial took place before the Omicron variant dominated in the United States.to the FDA for emergency use authorization of the vaccine, called NVX-CoV2373.
The vaccine can be stored at normal refrigeration temperatures, between 2 and 8 degrees Celsius , and has a shelf life of about nine months, according to the company. Erckthat if the FDA gives the green light for the EUA, the first 100 million doses of the protein-based vaccine will be ready to ship.
Novavax’s vaccine — administered as two doses, three weeks apart — is made using small, laboratory-built pieces of the coronavirus to stimulate immunity, a more traditional approach for vaccine development that some people may be more familiar or comfortable with, compared with the mRNA vaccines made by Moderna and Pfizer/BioNTech.
“In the US, the primary market I think in 2022 is going to be to supply a vaccine, our normal two-dose regimen, to a lot of people who have been hesitant to get other vaccines,” Erck said in November. “And to provide a booster.”
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