FDA Approves Updated COVID Vaccines for Some: When Can We Expect the Shots?

Updating the vaccine means it will more closely match the variants of the coronavirus currently circulating and causing infections. Last year’s COVID vaccine was updated to target the KP.2 strain (also from the JN.1 lineage), which is no longer in circulation in the U.S.

William Schaffner, M.D., a professor of preventive medicine and infectious diseases at Nashville, Tennessee’s Vanderbilt University School of Medicine, says the newly reformulated vaccines for 2025-2026 are expected to provide good protection against the virus for the upcoming respiratory illness season.

A key reason: “All the currently circulating variants are children, if you will, of the omicron strain,” he says. The updated vaccines “should cover the strains that are circulating now and that we anticipate will be circulating this winter.”

Keep in mind that the vaccines are best at preventing severe disease that leads to hospitalizations, but not necessarily infections, Schaffner adds.

“So we can still get milder illnesses, but particularly for people in high-risk groups, it’s very important to be vaccinated, because high-risk people are those who are at risk of getting more severe disease and requiring hospitalization, and that’s exactly what it is that the vaccines are designed to prevent,” he explains.

Who will be able to get an updated COVID vaccine?

In previous years, the COVID-19 vaccine has been available to most people ages 6 months and older. This year's vaccines, however, have been approved for a narrower population.

On Aug. 27, Secretary Kennedy said that the FDA has issued vaccine marketing authorization “for those at higher risk,” aligning with proposed changes outlined by health officials in a May article published in The New England Journal of Medicine.

Many factors can increase a person’s risk for severe COVID-19, including age — more than 81 percent of COVID-19 deaths occur in people over age 65, according to the CDC — and a number of health issues, such as:

• Cancer
• Cerebrovascular disease
• Chronic kidney disease
• Chronic liver disease
• Chronic lung disease
• Cystic fibrosis
• Dementia or other neurological conditions
• Diabetes
• Disabilities
• Heart conditions
• Hemoglobin blood disorders
• HIV infection
• Immunocompromised condition or weakened immune system
• Mental health conditions
• Overweight and obesity
• Physical inactivity
• Pregnancy
• Smoking, current or former
• Solid organ or blood stem cell transplant
• Substance use disorders
• Tuberculosis (TB)

In an Aug. 27 news release, Pfizer said its shot was approved by the FDA for adults 65 years and older and individuals ages 5 through 64 with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. Moderna said its updated vaccine is approved for individuals 6 months through 64 years of age with at least one high-risk condition and all adults 65 years of age and older.

Kennedy said Novavax’s vaccine was approved for higher-risk individuals age 12 and older. His announcement also said the vaccines “are available for all patients who choose them after consulting with their doctors.”

When will the COVID-19 vaccines be available?

Both Pfizer and Moderna said they plan to ship their vaccines immediately.

However, a panel that advises the CDC on vaccine policy typically meets to recommend the shots before they can be administered. As of Aug. 27, the August/September committee meeting date has yet to be posted on the CDC’s website.

It’s possible that professional medical groups will develop their own vaccine recommendations that cast a wider net than government recommendations. For example, the American Academy of Pediatrics (AAP) released its immunization guidance for routine vaccines in mid-August, including the COVID-19 vaccine.

The group is recommending the 2025-2026 COVID-19 vaccine for children ages 6 months to 2 years and older children whose parents want them vaccinated. A recent AAP analysis found that children ages 0 to 4 accounted for 58 percent of the confirmed COVID-19 hospital admissions from January 2022 to April 2024.

It is not yet known how any new or differing recommendations will affect insurance coverage. It’s also possible that new changes will make it more difficult for people to get vaccinated at pharmacies.

What can I do to protect myself from COVID-19?

Even if you received a spring or summer dose of the COVID vaccine — which the CDC recommended for adults 65 and older and immunocompromised individuals — consider wearing a mask when participating in indoor activities or events where there are lots of other people, in light of the rising cases, Schaffner says.

(Wondering if you should get that second dose now, ahead of the launch of the new vaccines? Talk to your doctor for guidance. Some vaccine administrators are no longer stocking the 2024-2025 vaccine. If you can’t find one at your local pharmacy, a spokesperson from the American Academy of Family Physicians suggests calling your doctor’s office to see if they are still available.)

“And if you’re really in a high-risk group, you might think about streaming a movie rather than going to the movie,” Schaffner adds.

Another tip: While you’re thinking about scheduling your updated COVID vaccine, make plans to get your updated flu shot too. Annual influenza vaccines should be in doctors’ offices and pharmacies soon, and the CDC says the best time to get vaccinated against the flu is in September or October.

Editor’s note: This story, first published Aug. 20, 2025, has been updated to include new information.