FDA approves updated COVID-19 vaccines

WASHINGTON — The U.S. Food and Drug Administration has signed off on updated COVID-19 vaccines for many Americans.

Pfizer and BioNTech said Thursday that the agency had approved their mRNA-based COVID shot for all adults 65 and older, as well as anyone ages 5 through 64 who has a condition that raises their risk of severe illness. It targets the XFG variant and generated immune responses against other currently circulating variants, the companies said.

Moderna said Thursday that it had received approval for its two mRNA-based vaccines: Spikevax for people ages 6 months through 64 who have an underlying condition and anyone 65 or older; and mNexspike for people ages 12 through 64 who have an underlying condition and anyone 65 or older. Both formulations target the XFG subvariant of the JN.1 coronavirus strain.

Nuvaxovid, the only protein-based COVID vaccine available in the US, also received approval for everyone 65 and older and for those 12 through 64 who have an underlying condition, drugmakers Novavax and Sanofi said. It targets the XFG subvariant.

Health conditions that may raise the risk of severe illness include asthma; heart, kidney, liver or lung disease; diabetes; obesity; and pregnancy, according to the U.S. Centers for Disease Control and Prevention.

Under the Trump administration, the federal government has shifted from a universal COVID vaccine recommendation to a more restricted one in which it's recommended that everyone 6 months and older consult with a healthcare provider before getting the shot.

In May, the FDA's independent vaccine advisory committee voted to recommend that XFG be the targeted variant in this year's shots.

The CDC has yet to make an official recommendation for this year's vaccines, but most medical organizations recommend getting one, and insurance companies have indicated that they will continue to cover the shot. Experts say the vaccines should begin hitting pharmacies and doctors offices in September.

Covid case numbers aren't especially high right now, and the United States isn't recording many hospitalizations or deaths. But data from the CDC puts the test positivity rate for the week ending August 15 approaching 5% for the first time since early February, with numbers climbing in every state.

The CDC says it's currently getting low numbers of viral sequences, but as of early July, XFG.1.1 was the predominant coronavirus strain causing illness in the U.S.

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