ByAnthony Stitt
Fact checked byGerard Gallagher
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FDA approves latest round of COVID-19 shots
August 28, 2026
3 min read
ByAnthony Stitt
Fact checked byGerard Gallagher
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Key takeaways:
- The approvals are for four vaccines that target circulating SARS-CoV-2 variants.
- The vaccines together cover high-risk patients aged 6 months through 64 years and everyone aged 65 years or older.
The FDA approved an updated round of COVD-19 vaccines for the 2026-2027 respiratory disease season that target circulating SARS-CoV-2 viruses
Perspective from Amesh A. Adalja, MD
The agency approved two messenger RNA-based vaccines manufactured by Moderna, according to the company:
- Spikevax, for people aged 6 months through 64 years who have at least one underlying health issue that raises their risk for severe disease, and anyone aged 65 years or older; and
- mNexspike, a lower-dose vaccine for people aged 12 years through 64 years with a high-risk condition and anyone aged 65 years or older.
Pfizer-BioNTech’s mRNA-based vaccine was approved for all adults aged 65 years or older, along with anyone aged 5 years through 64 years with a high-risk condition, the companies announced
The FDA also approved Novavax and Sanofi’s updated Nuvaxovid shot — the only protein-based, non-mRNA COVID-19 vaccine available in the U.S. — for everyone aged 65 years or older and for those aged 12 years through 64 years who have a high-risk health condition, according to the drug makers
“COVID-19 remains a serious public health threat, responsible for up to 2.3 million outpatient visits and 250,000 hospitalizations in the U.S. last year alone,” Moderna CEO Stéphane Bancel, MSc, MBA, said in a press release. “Our updated COVID-19 vaccines help protect those at high risk of severe disease.”
In May, the FDA’s Vaccines and Related Biological Products Advisory Committee voted to recommend targeting the XFG variant with this season’s round of shots, which all four vaccines do
For years, COVID-19 vaccines were universally recommended for children and adults in the U.S. But last year, the FDA said it would begin restricting future approvals based on age and risk factors, aligning U.S. policy with most other countries. The CDC’s Advisory Committee on Immunization Practices then voted last September to downgrade recommendations for the shots, even among older adults, saying vaccination should be based on shared clinical decision-making
A federal court has blocked all ACIP votes made last year and essentially disbanded the committee, ruling that HHS Secretary Robert F. Kennedy Jr. had improperly reconstructed it
Which means the ACIP has not met to make official recommendations for this year’s COVID-19 vaccines, as it would have in the past. Shots recommended by the ACIP and CDC are required by law to be covered for free under insurance
In a statement released in May, America’s Health Insurance Plans, a national political advocacy and trade association that represents the nation’s health insurance industry, said its members “will continue covering all ACIP-recommended immunizations with no cost-sharing through the end of 2027.”
Although the ACIP has not met and made recommendations for this season’s vaccines, medical groups such as the American Academy of Pediatrics and Infectious Diseases Society of America have strongly supported getting vaccinated
According to the CDC, COVID-19 cases are “very low” but, as of Aug. 26, the agency estimates that infections “are growing or likely growing” in 48 states
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