FDA approves updated COVID-19 vaccines for fall

Millions of newly updated COVID-19 vaccines will soon be available following the approval announced Thursday by the Food and Drug Administration (FDA).

These updated vaccines from Pfizer and Moderna, designed for individuals aged 6 months and older, come in response to a summer surge in COVID-19 cases across the U.S. The new vaccines are formulated to target the most recent dominant strains of the virus, offering protection against severe illness. Receiving the vaccine now will provide crucial protection ahead of the expected winter surge and the increase in other respiratory illnesses as people spend more time indoors.

"Vaccination continues to be the cornerstone of COVID-19 prevention," said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

In June, a federal advisory panel recommended that the new COVID-19 vaccines focus on the JN.1 lineage, with the FDA also advising manufacturers to include the JN.1 sub-variant KP.2.

Pfizer, Moderna, and Novavax had previously informed federal regulators that their vaccines would be ready by August, pending FDA approval. The vaccines from Pfizer and Moderna will specifically target the KP.2 sub-variant using updated messenger RNA technology, while Novavax’s vaccine employs a traditional protein-based approach against the JN.1 lineage, which the company’s data suggests should provide an immune response against circulating sub-variants.

The KP.3.1.1 sub-variant is currently the most prevalent strain of the virus in the U.S. As with other viruses, SARS-CoV-2 continuously mutates to survive. Since KP.3.1.1 is part of the JN.1 sub-variant lineage, the updated vaccines are expected to offer protection against this circulating variant. Both KP.3.1.1 and its related sub-variants trace their origins to the omicron variant, which caused a significant surge in cases and deaths in late 2021.

Last year’s updated vaccines targeted the XBB.1.5 variant, another omicron offshoot. Despite ongoing cases and deaths from COVID-19, vaccination rates in the U.S. have significantly declined. As of May, only 14% of children aged 6 months to 17 years were up-to-date with their COVID-19 vaccines, according to a federal panel, while the percentage of vaccinated adults was 22.5%.

Although current COVID-19 cases, hospitalizations, and deaths are far below the peaks seen earlier in the pandemic, the virus still poses serious risks to many individuals. Last season, over 916,300 people were hospitalized with COVID-19, and 75,500 died from the disease, according to the Centers for Disease Control and Prevention (CDC).