On Wednesday, the Food and Drug Administration paved the way for a new COVID-19 booster that could be available within days.
The FDA has granted emergency authorization to a “bivalent” vaccine that targets both the original virus and the BA.4 and BA.5 variants that now dominate the world.
An advisory committee from the Centers for Disease Control and Prevention is meeting Thursday to discuss who should get the boosters. The CDC director will also need to approve them before the boosters are available.
At the request of the companies, the Pfizer-BioNTech The booster was authorized for anyone 12 years and older.while modern the vaccine is licensed for adults only. Both were licensed for use at least 2 months after any prior COVID-19 vaccination.
The companies said they are ready to ship the modified boosters in September. Pfizer has said it has the capacity to provide up to 15 million doses by September 9 from its production site in Pleasant Prairie, Wisconsin.
The new injections are not likely to provide much benefit over the original vaccine, according to the scientists. But any increase in protection is worth it, government officials have said.
COVID-19, which still accounts for around 80,000 cases and 400 deaths per day in the US, it is expected to rise again this fall and winter, as it has in the previous two years of the pandemic.
“We see this as the next step in providing broader coverage for a very rapidly mutating virus,” said Annaliesa Anderson, chief scientific officer of vaccine research and development at Pfizer. It should prevent serious infections and illnesses for a while, but it’s not clear for how long.
Both boosters combine the original vaccine, which targeted the spike protein on the surface of the virus, along with a new formulation that targets the mutated spike protein found in the BA.4 and BA.5 versions of the vaccine. omicron variant.
“We’re removing part of the prototype and then adding part of the 4-5. Otherwise, it’s exactly the same as the original vaccine,” Anderson said.
The original vaccine still works well to prevent serious illness, he said, but the new booster should help reduce the number of infections and minimize serious illness. In animal studies, there are “good neutralizing antibody responses” to boosting, Anderson added.
BA.5 now accounts for almost 90% of all infections in the United States, with BA.4 accounting for almost all of the rest. according to CDC reports.
The companies were able to modify the vaccine in less than three months, one of the main advantages of the mRNA technology that forms the basis of the Pfizer-BioNTech and Moderna vaccines. Moderna’s vaccine is called SPIKEVAX, while Pfizer-BioNTech’s is called Comirnaty.
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a prepared statement that the FDA has extensive experience updating vaccines for annual flu shots. “We have worked closely with vaccine manufacturers to ensure that the development of these updated boosters has been done safely and efficiently,” he said. “These bivalent COVID-19 vaccines meet our rigorous safety, efficacy, and manufacturing quality standards for emergency use authorization.”
Andrew Pekosz, a virologist at the Johns Hopkins Bloomberg School of Public Health, said he believes the new boosters will be safe and provide broader protection against omicron variants.
Having a vaccine targeting BA.5 when that’s the most widely circulated variant, he said, “you can’t get better than this.”
Pekosz suggests that people get boosters six months after their last COVID-19 infection or vaccination, although people who are immunocompromised may need more frequent boosters. “The infection should essentially be counted as a booster,” she said.
It’s not clear whether injections will be needed every six months indefinitely, Pekosz said, or whether most people will eventually build up enough immune protection to stave off serious illness and only people at high risk will need to keep boosting.
People can help limit the arrival of new variants by getting vaccinated, he said. Variants are thought to develop within people who are struggling to fight off the virus. “The less replication you have, the less likely a new mutation will arise.”
Getting vaccinated against the original and omicron variants could also help prevent the virus from mutating into earlier variants that were more serious, Pekosz added.
Vaccines, tests and antivirals for infected people “are the tools that are going to allow us to live with this (virus),” he said.
Dr. Richard Besser, president and CEO of the Robert Wood Johnson Foundation, said he is concerned that there is not enough federal funding available to give everyone who wants another chance. Congress hasn’t appropriated money to fight COVID-19 in over a year.
“One’s ability to pay for a vaccine should not determine whether or not someone gets a vaccine,” Besser said.
Contact Weintraub at [email protected].
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