FDA approves updated COVID-19 vaccines targeting XFG strain
The FDA has authorized updated mRNA and protein-based COVID-19 shots from Moderna, Pfizer and Sanofi that target the XFG omicron subvariant, with eligibility extending to children, adults with underlying conditions and seniors.
The U.S. Food and Drug Administration this week granted approval for updated COVID-19 vaccines from Moderna, Pfizer and Sanofi aimed at the XFG recombinant omicron strain, which accounts for roughly 40% of recent cases, according to CDC data.
Moderna’s vaccine is authorized for individuals six months to 64 years old who have an underlying health condition and for all adults 65 and older. Pfizer’s product covers children five years and older with a condition and all adults over 65, while Sanofi’s protein-based shot received similar clearance.
"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," said Dr. William Schaffner, a preventive-medicine professor at Vanderbilt University Medical Center.
Schaffner added that the vaccines are most effective at preventing severe disease and hospitalisation.
The shots are expected to be distributed through pharmacies, hospitals and clinics nationwide in the coming days. Health officials say they can be administered alongside flu or RSV vaccines, either in separate arms or the same arm with a spacing interval.
"Both of those means of getting the vaccine and getting them simultaneously work just fine," Schaffner said.
Insurance coverage is anticipated to follow CDC recommendations, with most plans, Medicare Part B and Medicaid expected to pay for the doses. The previous Bridge Access Program that offered free vaccines to uninsured adults ended in August 2024, leaving the cost for uninsured individuals uncertain.
Infectious-disease specialist Dr. Peter Chin-Hong noted that immunity can wane and highlighted four groups at highest risk – adults 65 and older, the severely immunocompromised, pregnant women and children six months to 23 months – as priorities for vaccination.
"I'm hopeful [insurers] will cover the vaccine because it makes sense for insurance companies to pay for it to prevent as many people from getting seriously ill," Chin-Hong told ABC News.