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This fall, vaccine manufacturers will begin launching coronavirus-enhancing vaccines best suited to combat the current phase of the pandemic.
Two days after outside experts voted in favor of a new vaccine adapted to protect against omicron, the Food and Drug Administration announced that the fall injections would include a component of BA.4 and BA.5, the subvariants of omicron gaining ground in the United States. .
The change shows that the FDA is trying to be more agile 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 adjusted to fight an earlier version of omicron modestly increased people’s short-term immune response compared to more traits than the original. . The agency will rely in part on this data as it reviews new vaccines.
The FDA advised companies Thursday to create a two-part vaccine for a fall reinforcement campaign. 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 omicron BA.4 and BA.5 subvariants that currently make up half of the strains. which are sequenced in the United States.
It is very possible that BA.4 and BA.5 will be overshadowed by new variants in the fall, but the hope is that a new injection will help boost immunity, as they are closer to where the virus is currently. A Pfizer scientist on Tuesday showed data to FDA advisers that in mice, a vaccine based on these versions of omicron appeared to generate a stronger immune response.
Monitoring of the coronavirus vaccine
For a year and a half, coronavirus vaccines based on the original version of the virus have provided solid protection, especially against serious diseases. But immunity is reduced over time and the virus has proven cunning, generating a growing Greek alphabet of new variants that are more contagious and capable of sliding people’s immune defenses.
“As we move into the fall and winter, it is critical that we have safe and effective vaccine reinforcements that can provide protection against circulating and emerging variants to prevent the more serious consequences of covid-19,” Peter Marks, director of the FDA FDA Center. Biological assessment and research said in a statement.
Some experts have felt anxious that such a consistent decision should be made on the basis of very limited data. It is possible that the change will provide a detectable increase in the protection of people against serious diseases and perhaps also infections, but it is not certain.
“I think the FDA here is making a better guess about what they think is the right thing to do, and that may turn out to be good and maybe not,” said John Moore, professor of microbiology and immunology at Weill Cornell Medicine. “We don’t know and we have no real way of knowing.”
The modified vaccine will be used as a booster. People who are still receiving the first vaccinations will continue to receive the original version of the vaccine.
People who are not vaccinated or without reinforcement should not postpone vaccination in hopes of receiving a new vaccine, especially given the high levels of transmission, said an FDA official who asked for anonymity because he did not they were allowed to speak. People will still be eligible for booster in the fall, and all vaccines are best for protecting against serious illness and hospitalization.
Kathrin Jansen, a Pfizer vaccine scientist, said this week that the vaccine could be delivered in early October.
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, this is a premium over the initial contracts the government made for the original vaccine in 2020, when vaccines were $ 19.50 per dose.
Pfizer has said the price of its vaccine is likely to rise after the pandemic, and perhaps this is not the ceiling.
“We expect this to be only the second price increase between pandemic prices and future trading prices,” analysts at SVB Securities Research wrote in a note analyzing the announcement.
Moderna spokeswoman Elise Meyer said the company could deliver the vaccine in October if no data are required to test the injections in people before a regulatory decision. An agreement to supply the United States has not yet been announced.