FDA greenlights updated COVID-19 vaccines for rollout
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Key takeaways:
- Updated COVID-19 vaccines from Moderna and Pfizer-BioNTech target the KP.2 strain of SARS-CoV-2.
- The vaccines should be available within days, the manufacturers said.
The FDA on Thursday announced that it has greenlit the updated COVID-19 vaccines manufactured by Moderna and Pfizer-BioNTech, which the companies said should be available within days.
“Vaccination continues to be the cornerstone of COVID-19 prevention. These updated vaccines meet 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.
“Given waning immunity of the population from previous exposure to the virus and from previous vaccination, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants,” Marks added.
In June, the CDC recommended new formulations of the COVID-19 vaccines that target the JN.1 lineage. The FDA said it later advised the manufacturers to focus on the KP.2 strain of JN.1 to better target circulating SARS-CoV-2 viruses.
According to the CDC, during the week ending Aug. 10, COVID-19 test positivity rose by 18.1%, ED visits diagnosed as COVID-19 rose 2.4% and deaths attributed to COVID-19 rose 1.9%. During the week ending July 20, COVID-19-related hospitalizations were 3.3 per 100,000 people, a 0.1% rise from the week before.
Moderna and Pfizer-BioNTech’s vaccines have both been approved for people aged 12 years or older. They have been authorized for emergency use among individuals aged 6 months to 11 years.
In separate press releases, the companies said they expect their vaccines to be available at pharmacies, hospitals and clinics “in the coming days.”
“This approval is timely, as COVID-19 remains a significant health risk and is the leading cause of respiratory illness-related hospitalization, regardless of age or health condition,” Moderna CEO Stéphane Bancel, MSc, MBA, said in a release. “Staying up to date with COVID-19 vaccines remains one of the best ways to help protect yourself from severe illness.”
Novavax said Thursday that it expects its updated COVID-19 vaccine will be authorized for use “in time for peak vaccination season.” According to a press release, the company filed for an emergency use authorization for the protein-based vaccine in June and has been “working productively with the [FDA] as they complete their review, including providing additional information as needed.”
References:
- CDC. COVID data tracker. https://covid.cdc.gov/covid-data-tracker/#datatracker-home. Updated Aug. 19, 2024. Accessed Aug. 22, 2024.
- Celebrating U.S. FDA approval of our updated COVID-19 vaccine. https://www.modernatx.com/en-US/media-center/all-media/blogs/FDA-approval-updated-COVID-19-vaccine. Published Aug. 22, 2024. Accessed Aug. 22, 2024.
- FDA approves and authorizes updated mRNA COVID-19 vaccines to better protect against currently circulating variants. https://www.fda.gov/news-events/press-announcements/fda-approves-and-authorizes-updated-mrna-covid-19-vaccines-better-protect-against-currently. Published Aug. 22, 2024. Accessed Aug. 22, 2024.
- Novavax continues to work with the U.S. FDA on authorization of 2024-2025 formula COVID-19 vaccine. https://ir.novavax.com/press-releases/Novavax-Continues-to-Work-with-the-US-FDA-on-Authorization-of-2024-2025-Formula-COVID-19-Vaccine. Published Aug. 22, 2024. Accessed Aug. 22, 2024.
- Pfizer and BioNTech receive U.S. FDA approval and authorization for omicron KP.2-adapted COVID-19 vaccine. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-us-fda-approval-authorization. Published Aug. 22, 2024. Accessed Aug. 22, 2024.
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