A healthcare worker prepares a dose of the Pfizer-BioNTech Covid-19 vaccine at a vaccination clinic at the Peabody Institute Library in Peabody, Massachusetts, January 26, 2022.
Vanessa Leroy | Bloomberg | Getty Images
The Food and Drug Administration on Monday approved updated Covid vaccines from Pfizer It is Modernputting vaccines on track to reach Americans within days as hospitalizations for the virus rise in the US.
The new vaccines, which target the omicron XBB.1.5 variant, are approved for people ages 12 and older and authorized for emergency use in children ages 6 months to 11 years old, according to an FDA statement.
The updated vaccines from Pfizer and Moderna will not yet be available to Americans.
A CDC advisory panel is scheduled to meet Tuesday to vote on a recommendation on the use of these vaccines. Once the CDC director approves these recommendations, shots can be administered at pharmacies, health clinics and other vaccine distribution sites.
The Biden administration said in August that it expects new single-strain vaccines from Pfizer, Moderna and Novavax targeting XBB.1.5 to be available to the public by mid-September.
The FDA did not announce a decision Monday on an updated Covid vaccine from Novavax, but the company said in a statement that the agency is still reviewing its vaccine. Novavax shares closed nearly 13% lower on Monday following approval of the other updated jabs.
Novavax’s vaccine uses protein-based technology, a method used for decades in routine vaccinations against hepatitis B and shingles. Meanwhile, the Pfizer and Moderna shots use messenger RNA, which teaches cells how to make proteins that trigger an immune response against Covid.
The upcoming arrival of updated vaccines offers some reassurance to Americans as the country sees a rise in Covid cases and hospitalizations.
While the shots won’t target the currently dominant variants, vaccine makers have said the shots will still offer protection against those strains as children return to school and the weather cools.
“We expect this season’s vaccine to be available in the coming days, pending the recommendation of public health authorities,” Pfizer CEO Albert Bourla said in a statement following the approval.
Bourla and Moderna CEO Stphane Bancel, in a separate statement, urged Americans to receive their updated Covid vaccine during the same appointment as their annual flu shot.
Hospitalizations have risen for seven consecutive weeks and rose more than 15% in the week ending Aug. 26, to 17,418, according to the latest CDC data. But that number remains below the increase recorded in the country in the summer of 2022, when hospitalizations rose to more than 40,000.
The increase is fueled by newer but closely related virus strains to XBB.1.5, such as EG.5 or Eris. This omicron strain accounted for 21.5% of all cases as of September 2, according to the CDC.
Meanwhile, XBB.1.5 is declining in the US, the CDC said.
A resident receives Covid-19 booster shots at a vaccine clinic inside Trinity Evangelical Lutheran Church in Lansdale, Pennsylvania, USA, on Tuesday, April 5, 2022.
Hannah Beier | Bloomberg | Getty Images
Pfizer, Moderna and Novavax have released early trial data indicating their new shots provide protection against Eris.
Both Pfizer and Moderna also said their updated shots produced a strong immune response against BA.2.86, a highly mutated omicron subvariant that health officials are watching closely.
“The updated vaccines are expected to provide good protection against COVID-19 against the currently circulating variants,” the FDA said in Monday’s statement.
The agency noted that last year’s Covid boosters from Pfizer and Moderna are no longer authorized in the U.S.
The upcoming vaccine rollout will be the first since the end of the Covid public health emergency in the US, which expired in May.
The end of that declaration means the federal government will shift vaccine distribution to the private market, where manufacturers will sell their updated vaccines directly to health care providers at higher prices. Previously, the government purchased vaccines directly from manufacturers at a discount to distribute free to all Americans.
Private insurers and government payers like Medicare, which cover the vast majority of Americans, are expected to provide vaccines to people for free. Federal efforts like the Biden administration’s Bridge Access Program aim to provide free Covid shots to uninsured people.
The Biden administration will urge Americans to receive an updated Covid vaccine this fall, White House press secretary Karine Jean-Pierre said last week.
“Vaccination against Covid-19 remains the safest protection to prevent hospitalization, long-term health outcomes and death,” Jean-Pierre said during a briefing.
But it’s unclear how many Americans will actually roll up their sleeves for another chance in the coming months.
Only about 17% of the U.S. population (about 56 million people) has received the latest boosters from Pfizer and Moderna since they were approved in September 2022, according to the CDC.
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