The change indicates that the FDA is trying to be more flexible in its efforts to keep up with a changing virus. The exact formula has not yet been tested in humans, but studies have shown that vaccines designed to combat the previous version of omicron modestly boosted the short-term immune response in humans compared to more shots of the original. The agency will be partially dependent on this information when reviewing new vaccines.
The FDA on Thursday advised companies to create a two-part vaccine for the fall booster campaign. Part of the vaccine will be an original formula based on the version of the virus that spread worldwide in early 2020. The other part will be based on BA.4 and BA.5 omicron variants, which currently make up half of the strains. Sequentially in the United States.
It is quite possible to catch BA.4 and BA.5 with new variants by the fall, but the hope is that the new vaccine will help boost immunity, as they are closer to where the virus is today. A scientist from Pfizer told FDA advisers on Tuesday that a vaccine based on these versions of the omicron in mice had a stronger immune response.
For a year and a half, coronavirus vaccines based on the original version of the virus have provided strong protection against particularly serious diseases. However, over time, immunity declined, and the virus proved to be cunning, giving rise to a growing Greek alphabet of new variants that were more contagious and capable of slipping into people’s immune defenses.
“As we move through the fall and winter, it is critical that we have safe and effective vaccine boosters that are in circulation and can protect against emerging variants to prevent the most serious consequences of covid-19,” he said. FDA statement he said.
Experts are concerned about such a costly decision based on very limited information. It is possible that the change could provide a noticeable increase in people’s protection against serious diseases and possibly infections, but this is not clear.
John Moore, a professor of microbiology and immunology, said, “I think the FDA here makes the best estimates of what needs to be done, and it may or may not be a good thing.” Weill Cornell Medicine. “We don’t know and we don’t have a real way to know.”
The modified vaccine will be used as a booster. People who are vaccinated first will continue to receive the original version of the vaccine.
people who are unvaccinated or unvaccinated An FDA official, who asked for anonymity because he did not have the authority to speak, said he should not delay vaccination in the hope of getting a new shot, especially given the high transmission rate. People will still be eligible for a booster in the fall, and all vaccines are best at protecting against serious illness and hospitalization.
The federal government announced on Thursday that it had agreed to take 105 million doses Pfizer’s reactivated vaccine $ 3.2 billion. At $ 30.50 per dose, this is a reward for the government’s first contracts for the original vaccine in 2020, when each dose of the vaccine was $ 19.50.
Pfizer said the price of the vaccine would rise after the pandemic and that it could not reach the ceiling.
“We expect this to be the second price step between pandemic prices and future commercial prices,” SVB Securities Research analysts said in a note analyzing the announcement.
Moderna president Stephen Hogg told the FDA advisory committee that his company would take until late October or early November to develop a vaccine based on omicro’s BA.4 and BA.5 versions. It was not immediately clear on Thursday what time the company would deliver the recycled doses to the United States.