The change shows that the FDA is trying to be more nimble in its efforts to track the progress of a virus. The precise formula has not yet been tested in humans, but studies have shown that vaccines designed to combat an earlier version of omicron slightly increased the short-term immune response in humans compared to more vaccines of the original. The agency will depend in part on that data when it reviews new vaccines.
The FDA advised companies on Thursday to create a two-part vaccine for a fall recall campaign. Part of the vaccine will be the original formula, based on the version of the virus that spread around the world in early 2020. The other part will be based on the BA.4 and BA.5 omicron subvariants that currently represent half of the stumps. sequenced in the United States.
It is entirely possible that BA.4 and BA.5 will be eclipsed by new variants by fall, but the hope is that a new vaccine will help broaden immunity, as they are closer to where the virus is today. A Pfizer scientist showed FDA advisers data on Tuesday that in mice, a vaccine based on these versions of omicron appeared to generate a stronger immune response.
Coronavirus vaccine tracking
For a year and a half, coronavirus vaccines based on the original version of the virus have provided robust protection, especially against severe disease. But immunity wanes over time, and the virus has proven cunning, spawning a growing Greek alphabet of new variants that are more contagious and adept at bypassing people’s immune defences.
“As we enter fall and winter, it is essential that we have boosters of safe and effective vaccines that can provide protection against circulating and emerging variants to prevent the most serious consequences of covid-19. “, reads the statement of the FDA.
The experts felt anguished that such a consequential decision had to be made on the basis of very limited data. It’s possible that the change could provide a detectable increase in people’s protection against serious illness and possibly infection as well, but that’s not certain.
“I think the FDA here is making a better estimate of what they think is the right thing to do, and it may turn out to be a good thing and it may not be,” said John Moore, professor of microbiology and of Immunology at Weill Cornell Medicine. “We don’t know and have no real way of knowing.”
The modified vaccine will be used as a booster. People who are still receiving their first vaccines will continue to receive the original version of the vaccine.
Unvaccinated or unenhanced people should not put off vaccination in hopes of getting a new vaccine, especially given the high levels of transmission, said an FDA official who requested anonymity because they don’t. were not allowed to speak. People will still potentially be eligible for the fall booster, and all vaccines are best for protecting against serious illness and hospitalization.
The federal government announced Thursday that it had agreed to buy 105 million doses of the restarted vaccine from Pfizer for $3.2 billion. At $30.50 a dose, that’s a premium over the initial contracts the government made for the original vaccine in 2020, when the shots cost $19.50 a dose.
Pfizer said the price of its vaccine will likely rise after the pandemic, and that may not be the cap.
“We expect this to be only the second price increase between pandemic prices and future trade prices,” analysts at SVB Securities Research wrote in a note analyzing the announcement.
Moderna Chairman Stephen Hoge told an FDA advisory panel that his company would take until late October or early November to create a vaccine based on the BA.4 and BA.5 versions of omicron. It was unclear on Thursday what the company’s timeline would be to deliver revamped doses to the United States.
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