New COVID vaccine and booster shots for this fall to be available by mid-September
The first new COVID-19 vaccines updated for this fall season should start to be available in mid-September now that both the Food and Drug Administration and the Centers for Disease Control and Prevention have signed off on the new shots. The new shots are designed to target the XBB variants — strains of the virus descended from the original Omicron variant — which are now the most common form in circulation.
Three vaccine manufacturers, Moderna, Pfizer and Novavax, will offer the revised shots for this fall, which virtually all children and adults are eligible for. Pfizer and Moderna's are rolling out now, with Novavax likely to follow later this month.
The CDC recommends a new shot for nearly all Americans to reduce the risk of severe illness, hospitalization or death.
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The rollout of the shots will also mark three major shifts in the U.S. response to the virus: the end of government-bought vaccine supplies, a simplification of who is eligible to get shots and a significant change to the recipe used in the vaccines.
What's different about the new COVID-19 vaccines?
After a meeting of its outside vaccine advisers in June, the FDA said it would ask vaccine makers to switch to using only a single component in their recipes targeted at the XBB.1.5 variant, in hopes of broadening immunity.
This is a change from the "bivalent" composition used in the last round of boosters, which blended two components: one aimed at boosting immunity against the original strain of the virus and another aimed at the Omicron BA.4/5 strain.
While newer XBB descendants have since emerged — including EG.5, a strain that's rapidly gaining ground — experts say these variants so far remain closely related, and the updated vaccine formula should offer protection.
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"There doesn't seem to be any particular advantage to a bivalent vaccine. XBB is the lineage right now, and there is good cross-protection, no matter what antigen is chosen, according to the data that we've been shown," Dr. Eric Rubin, one of the FDA's vaccine advisers, said at the June meeting.
When will new COVID-19 vaccines be available?
While the new vaccines will start to roll out as soon as Wednesday, Sept. 13, it could be late September or October before they're widely available for everyone who wants them.
Two steps were required before the new vaccines could make their debut in the U.S. commercial market: a green light from the FDA and new recommendations from the CDC. Both were granted for Pfizer and Moderna's shots the week of Sept. 11.
Novavax was a bit behind in completing its submission for a new FDA emergency use authorization for its updated vaccine, so it will be considered separately.
"That's going to be concluded this month, with expectation for us to be delivering product by the end of September," Novavax's President of Research and Development Filip Dubovsky told investors on August 8.
The CDC convened a meeting of its Advisory Committee on Immunization Practices on Sept. 12 before issuing updated recommendations for the new shots, and it voted strongly in favor of recommending them for all eligible people ages 6 months and older. This is needed to ensure liability protections for vaccinators as well as to guarantee access to the new shots.
Who will be eligible to get the new COVID-19 vaccines?
Unlike vaccinations earlier in the pandemic, federal officials say they have been working in recent months to simplify eligibility for future rounds of shots, akin to the annual seasonal influenza shot.
Americans ages 12 and older will have their pick of any of the three updated vaccines, once they are all available.
Younger children down to six months old are able to get at least one dose of the updated shots from Moderna or Pfizer, depending on what they have previously received.
Insurers are required to cover vaccinations for all eligible Americans at in-network providers.
"The intent is to harmonize for all doses, all ages, same composition. So in the fall, that would be the 2023-2024 formula, would be an XBB.1.5," the FDA's Dr. David Kaslow said in June at the CDC meeting.
