The FDA has approved updated COVID-19 vaccines from Pfizer, Moderna and Sanofi targeting the XFG strain, with eligibility centered on adults 65 and older and people ages 12 to 64 who have conditions associated with increased risk of severe illness.
By yourNEWS Media Newsroom
The Food and Drug Administration approved three updated COVID-19 vaccines on Aug. 27, authorizing new shots from Pfizer, Moderna and Sanofi primarily for older Americans and people with health conditions that officials say increase their risk of severe disease.
Pfizer and Moderna received approval for updated messenger ribonucleic acid, or mRNA, vaccines targeting XFG, a subvariant of the JN.1 lineage.
The FDA also cleared Sanofi’s updated COVID-19 vaccine targeting XFG. Unlike the Pfizer and Moderna products, the Sanofi shot does not use mRNA technology.
The approvals cover people age 65 and older as well as individuals ages 12 through 64 who have at least one underlying medical condition associated with a greater risk of severe COVID-19.
Obesity is among the conditions officials identify as increasing that risk.
The decision continues the FDA’s practice of periodically authorizing revised COVID-19 formulations intended to more closely correspond with strains circulating at the time.
Previous versions of the vaccines were estimated by the Centers for Disease Control and Prevention to provide 58 percent protection against hospitalization.
Unlike in previous years, the FDA did not issue a press release announcing the Aug. 27 approvals.
The agency and its parent department, the Department of Health and Human Services, did not respond to requests for comment by publication time.
The approvals come amid continued debate within the federal government over COVID-19 vaccination policy and the performance of mRNA technology against respiratory illnesses.
Health Secretary Robert F. Kennedy Jr. has criticized mRNA vaccines for respiratory diseases, arguing that they do not work well.
FDA documents indicate that manufacturers will conduct single-arm human studies to evaluate the newly approved vaccines.
Federal officials had previously planned to require placebo-controlled trials but ultimately waived that requirement because of what the documents described as “operational and feasibility challenges.”
That represents a change from the approach FDA officials outlined in 2025.
At the time, officials said new placebo-controlled trials were essential for determining how effectively COVID-19 vaccines perform because several years had passed since such trials had been conducted.
Pfizer and Moderna agreed to perform placebo-controlled studies, as did Novavax.
Novavax has since licensed its COVID-19 vaccine to Sanofi.
The documents accompanying the latest approvals provided limited detail about the evidence used as the basis for the FDA’s decision.
During an advisory committee meeting in the spring, vaccine manufacturers presented animal-testing results but did not present human-testing data for the updated formulations.
Following that meeting, the FDA’s vaccine advisory committee recommended that the next generation of COVID-19 vaccines be designed to target XFG.
The newly authorized Pfizer, Moderna and Sanofi products follow that recommendation.
The approvals arrive as demand for COVID-19 vaccination has fallen sharply from levels seen earlier in the pandemic.
CDC figures show that 17.5 percent of adults received a COVID-19 shot during late 2025 or early 2026.
Among children, uptake was lower, with approximately 10 percent receiving a dose during the same period.
The decline in vaccination has occurred even as federal health officials continue to track widespread viral activity.
According to CDC modeling estimates released this month, COVID-19 infections are either increasing or likely increasing in 47 states.
The latest FDA action therefore introduces another round of strain-specific vaccines at a time when infections are rising across much of the country but public participation in COVID-19 vaccination programs remains comparatively low.
For the current round, however, eligibility is more narrowly focused than in earlier phases of the vaccination campaign.
The approved population consists principally of adults 65 and older and people between ages 12 and 64 with at least one qualifying underlying condition that places them at elevated risk of severe COVID-19.
Manufacturers will now proceed with human studies of the updated products under the single-arm designs outlined in FDA documents rather than the placebo-controlled trials that officials had previously contemplated.
The three approvals also preserve a choice between vaccine technologies, with Pfizer and Moderna continuing to offer mRNA-based shots while Sanofi provides a non-mRNA alternative targeting the same XFG strain.
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