FDA approves Pfizer and Moderna's updated Covid vaccines amid rising hospitalizations

The Food and Drug Administration (FDA) has approved updated Covid vaccines from Pfizer and Moderna, paving the way for the shots to be available to Americans within days. The vaccines are approved for individuals aged 12 and older, and emergency use authorization has been granted for children aged 6 months through 11 years. The approval does not include last year's Covid boosters, which are no longer authorized in the U.S.

The Biden administration had previously announced that the new vaccines targeting the omicron variant XBB.1.5 would be available in mid-September. However, the vaccines still need a recommendation from the Centers for Disease Control and Prevention (CDC) to determine who should receive them. A CDC advisory panel is scheduled to meet to vote on a recommendation.

The arrival of the updated vaccines offers some reassurance as the nation experiences an increase in Covid cases and hospitalizations. While the vaccines do not specifically target the dominant variants, the manufacturers have stated that they will still provide protection against those strains.

Pfizer CEO Albert Bourla expressed optimism about the availability of the new vaccine, encouraging individuals to ask their doctors about receiving an updated Covid shot alongside their annual flu shot. The other vaccine manufacturers, Moderna and Novavax, have not yet commented on the approval.

Covid cases and hospitalizations remain below last year's summer peak, but newer strains of the virus, such as EG.5 or Eris, closely related to XBB.1.5, are contributing to the recent uptick. The CDC reports that XBB.1.5 is declining in the U.S.

Pfizer, Moderna, and Novavax have shared early trial data indicating that their updated shots still provide protection against Eris and highly mutated omicron subvariants. The FDA stated that the updated vaccines are expected to provide good protection against currently circulating variants.

The upcoming vaccine rollout will be the first since the end of the U.S. Covid public health emergency. This means that vaccine distribution will shift to the private market, where manufacturers will sell the shots directly to healthcare providers at higher prices. Private insurers and government payers are expected to provide the vaccines to people for no fee, and efforts are underway to provide free shots to uninsured individuals.

The Biden administration will be encouraging Americans to receive an updated Covid shot this fall, emphasizing that vaccination remains the safest way to avoid hospitalization, long-term health complications, and death. However, it remains to be seen how many Americans will choose to get another shot in the coming months, as only around 17% of the population has received the latest boosters since their approval.


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