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Omicron-based covid booster shots will roll out this fall

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Omicron-based covid booster shots will roll out this fall

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This fall, vaccine makers will begin rolling out booster vaccines for the coronavirus that are better suited to the current stage of the pandemic.

Two days after outside experts voted for a new vaccine suitable for preventing omicron, the U.S. Food and Drug Administration announced that the fall vaccine would include components of BA.4 and BA.5, the omicron sub-variants making progress in the United States.

The change shows the FDA trying to be more flexible in its efforts to keep up with the changing virus. The precise formulation has not been tested in humans, but studies have shown that the vaccine tweaked for previous versions of omicron modestly increased people’s short-term immune responses compared to more vaccines from the original version. The agency will rely in part on the data when reviewing new vaccines.

The FDA recommended Thursday that companies develop a two-part vaccine for the fall booster campaign. Part of the vaccine will be the original formula, based on a version of the virus that circulated around the world in early 2020. Another portion will be sequenced in the United States based on the BA.4 and BA.5 micron variants that currently constitute half the strain.

BA.4 and BA.5 are likely to be replaced by new variants in the fall, but hopefully the new vaccine will help expand immunity as they are closer to where the virus is today. In mice, vaccines based on these versions of omicron appeared to generate stronger immune responses, a Pfizer scientist presented data to FDA advisers on Tuesday.

Tracking the Coronavirus Vaccine

For a year and a half, a coronavirus vaccine based on a version of the original virus has provided strong protection, especially against severe disease. But immunity wanes over time, and the virus has proven cunning, spawning more and more new variants that are more contagious and more nimble at evading people’s immune defenses.

“As we head into the fall and winter, we must have safe and effective vaccine boosters that provide protection against circulating and emerging variants to prevent the worst consequences of covid-19,” the FDA statement said. .”

Experts are distressed that such an important decision must be made on the basis of very limited data. Such a change could significantly improve people’s protection against serious illness and infection, but it’s uncertain.

“I think the FDA is taking their best guesses about what they think is the right thing to do, and the results may or may not be good,” said John Moore, a professor of microbiology and immunology. Weill Cornell Medicine. “We don’t know, and there’s no real way of knowing.”

The improved vaccine will be used as a booster. People who are still getting their first shot will continue to receive the original version of the vaccine.

An FDA official who requested anonymity because he was not authorized to speak said unvaccinated or unvaccinated people should not delay getting vaccinated in the hope of getting a new vaccine, especially given the high level of transmission. People may still be eligible for a booster dose in the fall, all vaccines that best protect against serious illness and hospitalization.

The federal government announced Thursday that it had agreed to buy 105 million doses of Pfizer’s restarted vaccine for $3.2 billion. The $30.50 per dose is a premium over the government’s initial contract for the original vaccine in 2020, when the vaccine was priced at $19.50 per dose.

Pfizer has said the price of its vaccines could rise post-pandemic, and that may not be the cap.

“We expect this to be just the second pricing boost between pandemic pricing and future commercial pricing,” SVB Securities Research analysts wrote in a note analyzing the announcement.

Moderna President Stephen Hoge told the FDA advisory committee that his company will have a vaccine based on versions BA.4 and BA.5 of omicron by late October or early November. The timeline for the company to deliver the modified dose to the U.S. was unclear on Thursday.

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