New covid vaccines for summer variants slated for FDA approval late this week

By FENIT NIRAPPIL and LENA H. SUN/The Washington Post

Federal authorities are preparing to approve updated coronavirus vaccines targeting the latest virus variants late this week, a move that could make shots available before Labor Day, according to a federal health official and a person familiar with the plans who spoke on the condition of anonymity to discuss a confidential process.

The mRNA shots manufactured by Pfizer-BioNTech and Moderna designed to target the KP.2 variant can hit the market within days of approval by the Food and Drug Administration. A third protein-based vaccine made by Novavax, preferred by people who are cautious about mRNA vaccines or who have had bad reactions to them, will probably take longer to be approved and will be distributed in subsequent weeks, according to the federal health official.

Consumers should be able to start getting shots at pharmacies within a week after approval and at doctor’s offices soon after.

The arrival of new vaccines comes three months after the start of a summer covid wave that is receding in some places.

The timing of the release is too late for Americans who were looking to shore up their immunity before summer travel and the return of the school year, or for those who face heightened risk because of their age or underlying conditions. In recent weeks, some people weighed whether to get an outdated vaccine for partial protection more quickly or to hang on for the updated version. And those who didn’t want to wait discovered existing shots were no longer easy to find.

“That’s simply unfortunate timing, given the high levels of covid-19 circulating now and the large number of vulnerable people due for vaccination who didn’t get it months ago and are now motivated and anxious,” Kelly Moore, president and CEO of Immunize.org, an organization that educates clinicians about vaccines, said in an email.
The complications raised by summer covid waves illustrate the downsides of releasing updated coronavirus vaccines alongside annual flu shots. Because demand for coronavirus vaccines has become low, federal officials regard that approach as a practical way to boost coverage and ensure Americans are protected by setting a predictable and familiar schedule, while making a second dose available in the spring for older and immunocompromised Americans.
But the decision to update the vaccine for the fall leaves Americans with weakened defenses against a virus that has shifted into new forms by summer. The existing vaccine targets XBB variants no longer in circulation and is not as effective against the latest variants, lab studies show. Experts say the older vaccines should still protect people against severe disease and hospitalization.

“The strategy of emptying the refrigerator between seasons works fine for influenza, but not for covid,” Moore said.

As of last year, the federal government no longer covers the costs and distribution of coronavirus vaccines, meaning doctors and pharmacies buy them based on anticipated demand, and free shots are no longer widely accessible. Some locations offering shots may not be covered by insurance plans. A federal program providing free shots to uninsured and underinsured people expires at the end of August.

But he couldn’t find a coronavirus vaccine at Rite Aid, Walgreens or Walmart before giving up.

“I tried all over the place, and I can’t find anything,” Miller said. “It does seem like it would be nice to have it done before the school year started because that seems like a big spreader event when kids come and mix.”

Scott Orshan, a 67-year-old high school teacher in New Jersey, wondered whether the protection he received from his fall shot had faded away as he heard about friends and relatives getting covid this summer. The new school year looms after Labor Day. But Walgreens was out of stock when he checked.

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