FDA Approves Updated Covid Vaccines From Pfizer and Moderna

US regulators approved updated versions of the Covid-19 vaccines made by Pfizer Inc. and Moderna Inc. Monday as hospitalizations tick up in a late-summer surge of the virus.

(Bloomberg) — US regulators approved updated versions of the Covid-19 vaccines made by Pfizer Inc. and Moderna Inc. Monday as hospitalizations tick up in a late-summer surge of the virus. 

“The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness and manufacturing quality,” said Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research.

The vaccines are approved for those 12 and older, and are authorized under emergency use for those 6 months and up. A different vaccine made by Novavax Inc is currently under review with the FDA for use in ages 12 and up, according to a statement from the company.

On Tuesday, health experts will meet to discuss recommendations for using the new vaccines. The Biden administration has said it intends to make the new vaccines available by mid-September. Pfizer expects its shot to be available in coming days, CEO Albert Bourla said in a statement.

“This decision comes at a time when COVID-19 cases are once again climbing,” Bourla said.

For these shots to reach the public, the US Centers for Disease Control and Prevention has to make an official recommendation, which could come as soon as Tuesday.

In June, US health officials told drugmakers to reformulate shots in time for fall that would protect against the XBB.1.5 subvariant that accounted for about 40% of Covid infections at the time.

Pfizer and Moderna have both said their updated shots protected against EG.5, currently the most widely circulating variant, in early studies. However, a newer variant, called BA.2.86, has more than 30 mutations on its spike protein, raising some initial concerns that the new vaccines would be less effective. Both companies have said their vaccines also increased antibodies to the BA.2.86 strain in studies. 

Those early findings — and others showing that antibodies from prior infection and vaccination still offer protection against BA.2.86 — are reassuring, the CDC said on Sept. 8.

“Preliminary data from laboratory studies from multiple investigators suggest similar antibody activity against BA.2.86 as compared to other currently circulating viruses,” the CDC said on its website, adding that additional studies are ongoing.

Hospitalizations Rising

Covid hospitalizations were up 16% from the week prior, according to data for the week ending Aug. 26. Deaths were up by 11%.

It is too soon to say whether the new variants are causing the uptick in severe cases, experts said. But it’s unlikely that BA.2.86 is to blame. Hospitalizations haven’t increased significantly in regions of the country where the new variant is being detected, said Abraar Karan, an infectious disease expert at Stanford University. The current Covid wave could peak by November, or even earlier, according to research from analysts at Jefferies. That’s because early evidence suggests the BA.2.86 variant isn’t highly transmissible like the original omicron strain.

Still, more people are susceptible to Covid right now because of fading immunity from vaccines and infections, as well as the emergence of new variants with more mutations, said Andy Pekosz, an immunologist at Johns Hopkins University. Deaths and hospitalizations are primarily still concentrated in high-risk populations, such as the elderly and immune-compromised, he said.

Peak hospitalizations are likely to be smaller this season than last winter, when the US had to contend with an RSV, Covid and flu “tripledemic,” according to the data analytics firm Airfinity.

(Updates with new information starting in third paragraph.)

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