The change shows the FDA is trying to be more agile in its efforts to keep up with a changing virus. The definitive formula has not yet been tested in humans, but studies have shown that vaccines adjusted to combat an earlier version of omicron modestly increase the short-term immune response in humans compared to more shots of the original. The agency will depend in part on this data when reviewing new vaccines.
The FDA recommended on Thursday that companies create a two-part vaccine for its campaign to speed up the fall. Part of the vaccine will be the original formula, based on the version of the virus that spread globally in early 2020. The other part will be based on the BA.4 and BA.5 omicron subvariants, which currently make up half of the strains. Listed in the United States.
It is quite possible that BA.4 and BA.5 will be overshadowed by new variants in the fall, but the hope is that a new vaccine will help expand immunity as they are closer to where the virus is located today. A scientist from Pfizer showed FDA advisors on Tuesday data that a vaccine based on these versions of omicron induced a stronger immune response in mice.
For a year and a half, coronavirus vaccines based on the original version of the virus provided strong protection against particularly severe diseases. But immunity dwindles over time, and the virus has proven its cunning, spawning a growing Greek alphabet of new variants that are more contagious and adept at slipping by humans’ immune defenses.
“As we enter fall and winter, it is critical that we have safe and effective vaccine boosters that can protect against circulating and emerging variants to prevent the most serious consequences of covid-19.” FDA statement aforementioned.
Experts were upset that such an important decision had to be made on the basis of very limited data. It is possible, but not certain, that the change will provide a detectable increase in people’s protection against serious illness and perhaps infection.
“I think the FDA is their best guess at what they think is the right thing to do, and that may and may not be a good thing,” said John Moore, professor of microbiology and immunology. Weill Cornell Medicine. “We don’t know, and there’s no real way to know.”
The modified vaccine will be used as a booster. People who still get their first vaccination will continue to receive the original version of the vaccine.
people with unvaccinated or unvaccinated One FDA official, who requested anonymity because they were not authorized to speak, said you shouldn’t delay vaccination in hopes of a new vaccine, especially given the high levels of transmission. People will remain potentially eligible for supplementation in the fall, and all vaccines offer the best protection against severe illness and hospitalizations.
The federal government announced on Thursday that it has agreed to purchase 105 million doses of the drug. Pfizer’s rebooted vaccine for $3.2 billion. At $30.50 per dose, that’s a premium over the government’s initial contracts for the original vaccine in 2020, when vaccines were $19.50 per dose.
Pfizer said the price of the vaccine will likely increase after the pandemic, and that this may not be the ceiling.
“We expect this to be the second pricing step between pandemic pricing and future commercial pricing,” analysts from SVB Securities Research wrote in a note analyzing the announcement.
Moderna President Stephen Hoge told an FDA advisory committee that his company will take until late October or early November to create a vaccine based on the BA.4 and BA.5 versions of omicron. As of Thursday, it was unclear what the company’s timeline would be for supplying regenerated doses to the US.
