FDA OKs second bivalent COVID-19 booster for older adults
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Key takeaways:
- The FDA authorized a second bivalent COVID-19 booster for adults aged 65 years or older and most immunocompromised patients.
- Monovalent Moderna and Pfizer-BioNTech vaccines are no longer authorized in the U.S.
The FDA on Tuesday authorized a second bivalent COVID-19 vaccine booster shot for adults aged 65 years or older and most immunocompromised patients, among other changes the agency said will simplify the U.S. vaccine schedule.
Only the bivalent versions of the Moderna and Pfizer-BioNTech COVID-19 vaccines are authorized now for people as young as age 6 months after the FDA pulled the authorization for the companies’ monovalent vaccines.
This means that even unvaccinated people will now receive a single dose of a bivalent vaccine instead of multiple doses of a monovalent messenger RNA vaccine as a primary series. This follows a unanimous vote in January by the FDA’s Vaccines and Related Biologics Products Advisory Committee (VRBPAC) to harmonize the vaccine schedule by replacing initial, primary doses with the bivalent vaccines being used as boosters, which target both the wild virus and omicron variants.
“At this stage of the pandemic, data support simplifying the use of the authorized mRNA bivalent COVID-19 vaccines and the agency believes that this approach will help encourage future vaccination,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release.
People aged 65 years or older can now get a second booster dose 4 months after their last booster, and immunocompromised people can receive an addition bivalent vaccine dose at least 2 months after their first, the FDA said.
The FDA said the decision to make all COVID-19 vaccines bivalent is based on data submitted to the agency by Moderna and Pfizer-BioNTech, as well as postmarketing data and real-world data on both the monovalent and bivalent vaccines.
The VRBPAC will meet in June to discuss the composition of updated bivalent vaccines for fall 2023, adopting the method used for seasonal influenza vaccines that identifies the viruses that are most likely to circulate in the upcoming year.
Marks said evidence shows that most people in the U.S. who are aged 5 years or older have antibodies against SARS-CoV-2 from vaccination or infection, which can “serve as a foundation for the protection provided by the bivalent vaccines.”
“COVID-19 continues to be a very real risk for many people, and we encourage individuals to consider staying current with vaccination, including with a bivalent COVID-19 vaccine,” he said, adding that “available data continue to demonstrate that vaccines prevent the most serious outcomes of COVID-19, which are severe illness, hospitalization and death.”
The CDC’s Advisory Committee on Immunization Practices (ACIP) will meet on Wednesday to discuss COVID-19 vaccine updates but will not vote on the new FDA authorizations. CDC Director Rochelle P. Walensky, MD, MPH, must endorse the updated FDA authorizations for them to take effect, which she can do without an ACIP vote.
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