Coronavirus booster targeting Omicron gets FDA approval for fall push

Booster emergency permits — one at a time modern the other one is Pfizer and its German partner BioNTech — Biden to roll out stronger defenses against a virus that has evolved dramatically over the past two and a half years and is still killing an average of 400 to 500 people. It marks the beginning of a high-risk effort by the administration. A day in the US. This change is the first since the mRNA vaccine appeared in December 2020.

“These updated boosters meet the FDA’s stringent standards and are expected to help restore immune protection against covid-19,” FDA Commissioner Robert M. Calif said in a call with reporters. said.

what is still unknown Whether the American public, who have been slow to accept boosters, show more enthusiasm for the latest shots being offered free to the public. Some, including Paul A. Offit, one of the FDA’s most prominent vaccine advisors. experts in criticized The agency for acting too quickly by saying it’s not clear that the new booster is better than the current shot. Some say its heavy reliance on research) can foster skepticism.

Eric Topol, Professor of Molecular Medicine at Scripps Research, said: While applauding the FDA’s desire to act aggressively against the virus, he said the lack of human data for new shots could cause people to be alarmed. I think it’s unfortunate,” he said.

Peter Marks, the FDA’s top vaccine officer, defended the FDA’s approach and said at a press conference that the FDA is “very confident” in the new booster. It has been administered to billions of people, has a strong safety record, and is well understood by scientists.

As for efficacy, officials believe that adapting the booster to the circulating mutant “restores the kind of protection seen when the vaccine was first launched.” nevertheless Coronavirus cases are now on the decline, he said.Some experts say infections could spike around Thanksgiving as people gather indoors and their immune systems continue to weaken. I am concerned that there is

Human data on updated boosters is at least a month or two behind, and delaying deployment of modified boosters until then may be too late to counter potential surges, he said. Mr Marks said. He also said the modified shots could better protect people from “long covid,” an unexplained set of symptoms such as fatigue, memory loss and chest pain.

The new bivalent booster contains components targeting variants and the original virus. It was long gone. Ofer Levy, head of the Precision Vaccines Program, said including the ingredients in the first vaccine was “hedging the bet.” at Boston Children’s Hospital and another FDA vaccine advisor.

The BA.5 variant now accounts for nearly 90% of US cases. According to the CDC. The number of reported cases has averaged below 100,000 per day, but that number does not capture many of the home coronavirus tests in use.

Revised boosters show that mRNA vaccines can be rapidly redesigned to combat new variants, allowing production to scale up quickly. The FDA didn’t decide on the revised formula until late June. Experts say a vaccine that represents a major change in approach, including shots to combat all coronaviruses and their subspecies, possibly by nasal spray, is years away.

The FDA has cleared the new Pfizer-BioNTech booster for people over the age of 12 and Moderna shots for people over the age of 18. CDC will agree that these ages are appropriate. Anyone who has had her 2-dose primary series of mRNA or Novavax vaccine and her 1-dose Johnson & Johnson vaccine is eligible, regardless of whether she received a booster shot. Officials expect to have pediatric data on the new booster within the next month or two, and may approve it for children later this year.

According to the FDA, people who recently received their first vaccination or booster should wait at least two months before getting a new booster. Administering too soon after a previous booster could make it less effective or increase the chance of rare side effects, officials said. Officials say people can get their flu shots and get the latest vaccine at the same time.

The data used by the FDA to approve shots has sparked sharp debate. FDA officials said they had cleared a booster on the “completeness” of the evidence. This included previous bivalent shot human studies, including one that generated virus-fighting antibodies against the first Omicron subvariant, BA.1. Shots from December 2020 onwards.

The FDA also reviewed mouse data on the new booster and concluded that Omicron-targeted shots generated strong antibody responses to the variant. modern said it had begun human trials of the updated shot, Pfizer and BioNTech Recently, they said they were beginning such research.

Officials at the agency said they have relied on animal testing for years when adjusting their flu vaccine each year.

“These are not vastly different protein products and our people, like myself, are very happy with the changes that have been made here,” Marks said in a pre-approval interview.

Anthony S. Fauci, Director of the National Institute of Allergy and Infectious Diseases, agreed. The updated booster will also help if a different “out of left field” variant emerges than the BA.4 and BA.5.

“The increased immunity also creates some degree of cross-reactivity to new variants,” said Fauci.

But some scientists say coronavirus boosters are no match for flu vaccines because the flu has been circulating for decades, while new pathogens have only been around for a few years.

Michael T. Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, said he hopes human data will be available soon.

“Mouse data is useful,” Osterholm said.

“I don’t think there’s an urgency here,” Osterholm said, referring to the declining number of new coronavirus cases. “There are no data to support the superiority of the BA.4/BA.5 vaccine.”

Peter Hotes, professor of pediatrics and molecular virology and microbiology at Baylor College of Medicine, said the lack of human data may also discourage some people from getting the new boosters. I am concerned.

“If we could add an extra layer of reassurance to the very cautious public who stepped in and voted to take the booster, [the shot] It helps that we’ve gone to humans for some level of research,” Hotez said.

Fewer than half of people in the United States receive a single booster injection. According to the CDC.

However, Jeanne Marazzo, director of the infectious disease division at the University of Alabama at Birmingham, supported approval of the new booster.

“FDA is now doing the right thing in the face of winter and evolving variability,” said Marrazzo. “Most people who have cared for patients are worried about what will happen in the fall and say, ‘There’s nothing we can do about it.'”

Dr. Levy of Boston Children’s Hospital agreed.

“When autumn and winter come, perhaps [deaths from covid] It rises to over 1,000 a day, and that’s no small feat,” Levy said.

Federal officials and their advisers have been debating the composition of the new booster for months. In late June, the FDA’s independent vaccine expert said voted 19-2 Include omicron-based components in Fall Booster. After that, the FDA instructed Manufacturers have called for the inclusion of components targeting BA.4 and BA.5, claiming that such shots are best suited for circulating viruses. Old formulations will no longer be available as boosters.

At the same time, the FDA Said We did not mandate a change in the vaccine for the first vaccination series. That’s because the original formula provided a “base of protection against serious consequences” caused by circulating virus strains.

The US government has purchased 170 million doses of the booster, but officials say 10 million to 15 million doses a week will be available initially.

Now that the vaccine is approved, boosters can be shipped to states and vaccination sites. But shots cannot be administered until the CDC recommends their use.

Joel Achenbach and Lena H. Sun contributed to this report.