FDA Approves New COVID-19 Jabs For Specific Populations

The Food and Drug Administration (FDA) has approved Moderna’s updated COVID-19 jabs, the company announced.

“Today we announced that the U.S. Food and Drug Administration has approved the supplemental Biologics License Applications for the 2026-2027 formulas for Spikevax® (COVID-19 Vaccine, mRNA) and mNEXSPIKE® (COVID-19 Vaccine, mRNA), containing the JN.1-lineage XFG subvariant of SARS-CoV-2 to help prevent COVID-19,” Moderna stated.

Today we announced that the U.S. Food and Drug Administration has approved the supplemental Biologics License Applications for the 2026-2027 formulas for Spikevax® (COVID-19 Vaccine, mRNA) and mNEXSPIKE® (COVID-19 Vaccine, mRNA), containing the JN.1-lineage XFG subvariant of… pic.twitter.com/Ydu7Dmef3P

— Moderna (@moderna_tx) August 27, 2026

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“The updated formula for Spikevax is now approved for individuals 6 months through 64 years of age with at least one underlying condition placing them at high risk for severe outcomes from COVID-19, and all adults 65 years of age and older,” Moderna stated in a press release.

“mNEXSPIKE, Moderna’s latest COVID-19 vaccine, is approved for individuals 12 through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, and all adults 65 years of age and older,” it continued.

ABC News shared further:

Both Moderna and Pfizer received approval for their mRNA vaccines and Sanofi also received approval for a protein-based shot, similar to vaccines that have been around for decades.

“Like the influenza virus, the COVID virus mutates; it changes notably over time, and so we have to update the vaccine in our best attempt to match the strain that we anticipate will be most active during the coming winter,” Dr. William Schaffner, a professor of preventive medicine at Vanderbilt University Medical Center in Nashville, told ABC News. “The better the match we have with what’s in the vaccine and the circulating strain, the more effective the vaccine will be.”

The updated 2026-2027 COVID-19 vaccines target the XFG strain, a recombinant omicron variant, meaning it formed through the combination of two omicron subvariants.

XFG currently accounts for about 40% of cases in the U.S., according to the latest data from the Centers for Disease Control and Prevention (CDC) in July.

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“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,” said Stéphane Bancel, Chief Executive Officer of Moderna.

“Our updated COVID-19 vaccines help protect those at high risk of severe disease, and we are proud to help ensure Americans have access to the latest protection against currently circulating SARS-CoV-2 strains this respiratory virus season,” he added.

The FDA green-lit updated covid vaccines for higher-risk Americans, such as older adults and people with at least one underlying health condition.

The vaccines are expected to be available in the coming days. https://t.co/LBTTKhXAkK

— The Washington Post (@washingtonpost) August 28, 2026

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More from The New York Times:

About 30 percent to 60 percent of Americans have a qualifying condition, F.D.A. officials estimated last year. Aside from age, a long list of factors can increase the risk of severe illness. They include asthma, diabetes, obesity, physical inactivity and pregnancy, as well as cancer, immune deficiency, some mental illnesses and various heart and lung diseases.

People who are not formally eligible may still be able to get vaccinated. Doctors can administer vaccines off label, meaning outside F.D.A. approval criteria.

But there may be logistical hurdles: Because most Americans who get Covid shots do so at pharmacies, not all doctors’ offices stock the vaccine. And pharmacists in some states may be unable, or may decline, to administer shots off label.

Last year, after significant initial confusion, Walgreens and CVS — two of the nation’s largest pharmacy chains — allowed people to self-attest that they met the criteria, without requiring medical documentation. The companies did not immediately respond to requests to confirm what their policies would be this year.

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