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Novavax COVID-19 vaccine gets emergency use authorization to be booster

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FDA, CDC grant approve use for adults at least six months after first two-dose series, but with no booster.

Federal health authorities have granted emergency use authorization for the Novavax COVID-19 vaccine to be used as a booster shot for adults.

The U.S. Food and Drug Administration and the U.S. Centers for Disease Control announced the rulings Oct. 19. Pharmaceutical maker Novavax also announced the approvals for its COVID-19 vaccine, adjuvanted (NVX-CoV2373).

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The shot now has emergency use authorization for use as a first booster in adults aged 18 years and older; as a two-dose primary series in adults aged 18 years and older; and as a two-dose primary series in adolescents aged 12 through 17 years, according to Novavax.

The federal actions give adults age 18 years and older an option to receive the Novavax COVID-19 vaccine, adjuvanted, as a booster instead of an updated (bivalent) Pfizer-BioNTech or Moderna if they have completed primary series vaccination but have not previously received a COVID-19 booster, and if they cannot or will not receive mRNA vaccines, according to Novavax. The 0.5 mL booster dose may be administered at least six months after completion of the primary vaccination with an authorized or approved COVID-19 vaccine, according to FDA.

"The U.S. now has access to the Novavax COVID-19 Vaccine, Adjuvanted, the first protein-based option, as a booster," Novavax President and CEO Stanley C. Erck said in a news release. "According to CDC data, almost 50 percent 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."


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