FDA approves updated COVID-19 vaccines
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Key takeaways:
- The FDA approved updated COVID-19 vaccines aimed at omicron XBB subvariants of SARS-CoV-2.
- A CDC panel will meet Tuesday to discuss and vote on recommendations for the monovalent vaccines.
The FDA on Monday approved and authorized updated COVID-19 vaccines from Moderna and Pfizer-BioNTech that target omicron XBB subvariants of SARS-CoV-2.
The agency fully approved the monovalent messenger RNA vaccines for people aged 12 years or older and authorized them for emergency use among people aged 6 months to 11 years.
The vaccines are now given in one dose instead of two, but the FDA authorized additional doses for certain immunocompromised groups of people.
The CDC’s Advisory Committee on Immunization Practices (ACIP) will meet Tuesday to discuss and vote on recommendations for the new monovalent shots.
“The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness and manufacturing quality,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “We very much encourage those who are eligible to consider getting vaccinated.”
There was a 15.7% increase in COVID-19-linked hospitalizations in the United States in the most recent week of reporting and a 10.5% increase in the percentage of U.S. deaths linked to COVID-19, according to CDC tracking of the two primary surveillance metrics still in use for the disease.
Omicron XBB viruses have emerged to become the predominant SARS-CoV-2 viruses globally and in the U.S. and currently make up all circulating lineages in the U.S.
Moderna and Pfizer-BioNTech in August announced that their updated shots are effective against EG.5 and FL.1.5.1, among other XBB viruses.
FDA advisors recommended in June that all COVID-19 vaccines in the U.S. be updated to remove the original, wild strain of SARS-CoV-2 and focus on omicron and XBB sub-lineages.
Ahead of the ACIP meeting on Tuesday, executives for both Moderna and Pfizer said in press releases that they expect the updated vaccines to be available “in the coming days.”
References:
- CDC. COVID data tracker: Monitoring variant proportions. https://covid.cdc.gov/covid-data-tracker/#variant-proportions. Accessed Sept. 11, 2023.
- FDA takes action on updated mRNA COVID-19 vaccines to better protect against currently circulating variants. https://www.fda.gov/news-events/press-announcements/fda-takes-action-updated-mrna-covid-19-vaccines-better-protect-against-currently-circulating. Published Sept. 11, 2023. Accessed Sept. 11, 2023.
- Moderna receives U.S. FDA approval for updated COVID-19 vaccine. https://investors.modernatx.com/news/news-details/2023/Moderna-Receives-U.S.-FDA-Approval-for-Updated-COVID-19-Vaccine/default.aspx. Published Sept. 11, 2023. Accessed Sept. 11, 2023.
- Pfizer and BioNTech receive U.S. fda approval for 2023-2024 COVID-19 vaccine. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-us-fda-approval-2023-2024-covid. Published Sept. 11, 2023. Accessed Sept, 11, 2023.
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