US gives nod to Novavax’s COVID-19 booster as alternative to mRNA shots
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The FDA authorized a booster shot of Novavax’s COVID-19 vaccine, giving the United States an option for people who cannot or will not receive a messenger RNA vaccine.
The agency authorized the booster for emergency use in adults aged 18 years or older who can take it at least 6 months after receiving an initial two-dose series of the Novavax vaccine or one of the two mRNA vaccines made by Pfizer-BioNTech or Moderna but not if they have already received a previous COVID-19 booster shot.
Those other companies have bivalent boosters that also target the omicron variant of SARS-CoV-2, whereas Novavax’s shot targets only the wild strain of the coronavirus.
CDC Director Rochelle P. Walensky, MD, MPH, signed off on allowing adults to receive the Novavax booster.
“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 [against] COVID-19 disease and death,” the CDC said in a statement.
The FDA initially authorized Novavax’s adjuvanted, protein-based shot for emergency use in adults in July, expanding the country’s COVID-19 vaccine options to four. The vaccine is also now available for adolescents as young as aged 12 years.
Some experts hoped that the addition of a more traditional shot might help raise the country’s flagging COVID-19 vaccination rates, but CDC data show that only around 35,000 of the more than 856,000 doses of the Novavax vaccine delivered in the U.S. had been administered as of Oct. 12.
Novavax’s emergency use authorization submission for the booster shot was based on findings from the phase 3 PREVENT trial, in which a third dose of the vaccine given at least 6 months after the primary series induced an antibody response in participants similar to that of the primary series, and results from the phase 2 COV-BOOST trial, which indicated the vaccine was protective
References:
- CDC allows Novavax monovalent COVID-19 boosters for adults ages 18 and older. https://www.cdc.gov/media/releases/2022/s1019-novavax.html. Published Oct. 19, 2022. Accessed Oct. 20, 2022.
- CDC. COVID-19 vaccinations in the United States. https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-people-additional-dose-totalpop. Accessed Oct. 20, 2022.
- U.S. FDA grants emergency use authorization for Novavax COVID-19 vaccine, adjuvanted as a booster for adults. https://ir.novavax.com/2022-10-19-U-S-FDA-Grants-Emergency-Use-Authorization-for-Novavax-COVID-19-Vaccine,-Adjuvanted-as-a-Booster-for-Adults. Published Oct. 19, 2022. Accessed Oct. 20, 2022.
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