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FDA, CDC sign off on Novavax COVID-19 booster shots

The booster shot is authorized for people 18 and older who, for medical or accessibility reasons, cannot take one of the bivalent messenger RNA COVID-19 boosters.

The Novavax COVID-19 vaccine, adjuvanted (NVX-CoV2373) has received emergency use authorization from the Food and Drug Administration, and the Centers for Disease Control and Prevention has recommended its use to provide a first booster dose at least six months after completion of primary vaccination with an authorized or approved COVID-19 vaccine to individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Novavax COVID-19 vaccine, adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.

[Read more: FDA, CDC clear Pfizer, BioNTech's bivalent COVID-19 booster shots for ages 5 to 11 years old]

"The United States now has access to the Novavax COVID-19 vaccine, adjuvanted, the first protein-based option, as a booster," said Stanley Erck, president and CEO of Novavax. "According to CDC data, almost 50% of adults who received their primary series have yet to receive their first booster dose. Offering another vaccine choice may help increase COVID-19 booster vaccination rates for these adults."

In announcing that CDC’s director Rochelle Walensky signed a decision memo allowing Novavax monovalent COVID-19 boosters for adults, the CDC issued a statement that said, "FDA’s authorization of monovalent COVID-19 boosters and CDC’s recommendation for use, are important steps forward in our country’s comprehensive vaccination program — a program that has helped provide increased protection for all Americans COVID-19 disease and death."

[Read more: Retailers begin offering bivalent COVID-19 booster vaccines]

The CDC also stated, "Some may be unable to receive an mRNA vaccine as a result of an allergy to a component of an mRNA COVID-19 vaccine, or as a result of a history of a severe allergic reaction (such as anaphylaxis) after a previous dose of an mRNA COVID-19 vaccine, or a lack of availability of an mRNA vaccine. People ages 18 and older may also choose to receive a Novavax monovalent booster if they are unwilling to receive mRNA vaccines, and would otherwise not receive a booster dose."

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