FDA signs off on updated protein-based Covid-19 vaccine from Novavax

By Amanda Sealy and Brenda Goodman, CNN

(CNN) — The US Food and Drug Administration on Tuesday authorized Novavax’s updated protein-based Covid-19 vaccine for people 12 and older.

This vaccine is effective against EG.5, the currently dominant coronavirus strain in the United States, and like Pfizer and Moderna’s mRNA vaccines, it has been updated to target the XBB Omicron subvariant.

Novavax’s protein-based approach is a more traditional one for vaccine development than the mRNA vaccines.

Protein-based vaccines work by getting the body’s immune system to recognize small modified pieces of the virus it’s targeting. In this case, that means pieces of the coronavirus spike protein.

Novavax makes up 0.01% of all Covid-19 vaccines delivered in the country, but during the US Centers for Disease Control’s Advisory Committee on Immunization Practices last month, there was an acknowledgement for the need of alternatives to mRNA-based vaccines.

Although Novavax’s vaccine did not have FDA signoff at the time of the CDC advisory meeting, the company presented its data, and the committee determined broadly to vaccines as authorized by the FDA for the 2023-24 season.

CDC Director Dr. Mandy Cohen’s recommendation of the updated Covid-19 vaccines last month also covers the newly authorized Novavax shot, so it does not need separate CDC endorsement.

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