If you were wondering if COVID disappeared, it hasn’t, and the US FDA just approved four COVID vaccines targeting the XFG variant.

Moderna, Pfizer and BioNTech, and Novavax, Sanofi, and Takeda announced Thursday that their COVID shots formulated against the XFG variant for the 2026-2027 season had earned FDA approval. According to the CDC, the XFG variant was the dominant COVID strain during the 2025-26 season and will return for the 26-27 season.

Although the FDA approved the four vaccines, the Advisory Committee on Immunization Practices (ACIP) is in disarray, so we don’t know what the recommendations will be. The previous recommendation for the COVID vaccines was “shared clinical decision-making,” which means the healthcare worker and the patient discuss whether to get the vaccine. That leads to a lot of confusion about vaccines.

This post will examine the FDA approvals for the four COVID vaccines for the upcoming season.

FDA approvals for COVID vaccines

Here are the FDA approvals for the vaccines:

• Pfizer and BioNTech’s mRNA vaccine (Comirnaty) is approved for everyone ages 65 or older, and those ages 5 to 64 with at least one underlying condition that increases severe COVID risk.
• Moderna’s mRNA vaccine (Spikevax) is approved for everyone ages 65 or older, as well as people ages 6 months to 64 years who have at least one comorbidity that increases the risk of severe COVID.
• A second Moderna mRNA vaccine (mNexspike) was approved for everyone ages 65 or older, as well as those ages 12 to 64 with at least one underlying condition that increases the risk of severe COVID.
• Novavax and Sanofi’s protein-based vaccine (Nuvaxovid) was approved for everyone ages 65 or older and those ages 12 to 64 with at least one underlying condition that increases their risk of severe COVID.

Moderna stated that its updated vaccines would be available “in the coming days.” Pfizer and BioNTech also stated that they will begin shipping the updated vaccines immediately.

Despite the CDC’s and APIC’s lack of guidance for the COVID vaccines this year, the Infectious Diseases Society of America, the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians have issued recommendations on fall respiratory virus shots, including COVID and flu vaccines.

Last season, the American Academy of Pediatrics (AAP) recommended COVID vaccination for all infants and children ages 6 to 23 months who lack contraindications. The AAP also recommended shots in children ages 2 to 18 years at high risk of COVID. The AAP will probably update its COVID vaccine recommendations in the next few weeks.

Additionally, most insurers have pledged to cover all recommended vaccines without cost-sharing through the end of 2027. If you were wondering if insurance companies were being generous, that’s not their goal. They know that these vaccines prevent hospitalizations, which cost much more than a vaccine. They look at the cost/benefit ratio, and they know vaccines save them money.

Summary

I know many of you are ready to get your flu and COVID vaccines. However, I would wait until mid-September to make sure your healthcare provider has the updated COVID and mRNA-based flu vaccines.

Also, some data suggest you should get these vaccines a little later in the fall (late September or early October) to maintain immunity through the season, but I’m not sure that’s science-based.

COVID is still a dangerous disease, with numerous hospitalizations still happening across the country. Getting protection against it is a good choice.

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