FDA OKs Updated COVID Vaccines

The FDA approved and granted emergency use authorization for updated 2024-2025 mRNA COVID-19 vaccines from Moderna (Spikevax) and Pfizer-BioNTech (Comirnaty), the agency announced on Thursday.

The new vaccines, authorized in adults and kids 6 months and up, will target the KP.2 strain of SARS-CoV-2 to more closely align with currently circulating variants, the agency said.

“Vaccination continues to be the cornerstone of COVID-19 prevention,” Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research, said in a statement. “Given waning immunity of the population from previous exposure to the virus and from prior vaccination, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants.”

The news comes amid a summer surge in COVID infections, but dwindling vaccine coverage. As of May, just 23% of adults had received last season’s COVID-19 vaccine. Even among adults ages 75 years and older, a group at high risk of severe outcomes, only 42% had received the 2023-2024 vaccine.

On June 5, the FDA voted that this season’s COVID-19 vaccines should be monovalent JN.1 vaccines. However, “based on further evolution of SARS-CoV-2 virus and a rise in cases of COVID-19,” the agency subsequently advised manufacturers that the preferred JN.1-lineage for the 2024-2025 COVID-19 vaccines should be the KP.2 strain.

The FDA assessed manufacturing and nonclinical data to support the change to include the 2024-2025 formula in the mRNA COVID vaccines. The updated mRNA vaccines are manufactured using a similar process as previous formulas of these vaccines, the agency said.

Both mRNA vaccines are approved for individuals 12 years and older, and are also authorized for emergency use in children ages 6 months through 11 years.

“The mRNA COVID-19 vaccines have been administered to hundreds of millions of people in the U.S., and the benefits of these vaccines continue to outweigh their risks,” the FDA emphasized.

The updated vaccines are expected to provide protection against COVID-19 caused by currently circulating variants, but the FDA reiterated that the composition of COVID-19 vaccines will need to be assessed annually, similar to the seasonal influenza vaccines.

The CDC is expected to recommend the updated vaccines as soon as tomorrow.

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