FDA approves updated COVID-19 vaccines for upcoming fall and winter season

(SILVER SPRING, Md.) — The U.S. Food and Drug Administration approved and granted emergency use authorization Thursday for updated COVID-19 vaccines for the upcoming fall and winter season.

The FDA said the vaccines will target the KP.2 strain, which is an offshoot of the omicron variant.

The federal health agency said the decision applies to the vaccines manufactured by Pfizer-BioNTech and Moderna. No decision has been made on the vaccines from Novavax.

“Vaccination continues to be the cornerstone of COVID-19 prevention,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a statement. “These updated vaccines meet the agency’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality.”

“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 variant,” the statement continued.

The CDC previously recommended that everyone ages 6 months and older receive an updated vaccine. The updated vaccines from Pfizer-BioNTech and Moderna will be available for those 6 months old and older

Vaccine manufacturers told ABC News the vaccines are expected to be available in the coming week.

Winter months tend to see an increase of respiratory illness spread, including COVID, flu and RSV. COVID, particularly, typically spikes in the winter and summer months.

“These updated COVID-19 vaccines come at a crucial time as we head into the fall and winter months, when respiratory viruses tend to surge,” said Dr. John Brownstein, an epidemiologist and chief innovation officer at Boston Children’s Hosptial and an ABC News contributor. “By targeting the most currently circulating variants, these vaccines offer us a better chance at reducing severe illness and keeping communities safe.”

The CDC has said that it is safe to receive a COVID-19 vaccine at the same time as a flu shot or an RSV vaccine, for those who are being eligible.

Anyone who has recently had COVID, may want to consider delaying getting vaccinated by three months, according to the CDC.

Those who are covered by Medicare, Medicaid or private insurance will receive coverage for the updated vaccines.

In previous years, the CDC had a Bridge Access Program that provided free COVID-19 vaccines to adults without health insurance and adults whose insurance does not cover all COVID-19 vaccine costs. The program is ending in August 2024. It remains unclear what might be available to provide access to this population.

Unvaccinated children from ages 6 months through 4 years are eligible to receive three doses of the Pfizer vaccine or two doses of the Moderna vaccine. Children in this age group who are vaccinated are eligible to receive one or two doses of either vaccine.

Those who are 5 and older, regardless of vaccination status, are eligible to receive a single dose of the updated vaccine. If they have been previously vaccinated, it should be at least two months after the last dose.

The FDA said additional doses are authorized for certain immunocompromised individuals aged 6 months through 11 years.

“It’s important for everyone aged six months and older to consider getting this updated shot. We know that that immunity wanes over time, and staying up to date with vaccinations is the best way to maintain strong protection against COVID-19, especially with new variants emerging,” Brownstein said.

ABC News’ Youri Benadjaoud contributed to this report.

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