Transfer signals start of FDA pivot in immunization strategy to Covid vaccine development

Recent evidence suggests that current bipolarity confers protection against severe disease and death from the XBB.1 variant that is currently dominant in the United States.

“We’ve turned the corner from an epidemic phase to an endemic phase,” said Ofer Levy, a staff physician at Boston Children’s Hospital, a professor at Harvard Medical School and a member of the FDA panel. “Today’s vote represents a major practical victory for the American people.”

According to the CDC, about 69 percent of adults living in the United States have completed their primary vaccination series. More than 80 percent have received at least one shot, but 20 percent are not fully vaccinated. Only about 15 percent of Americans, or 50 million people, have ever received bipolar boosters.

Advisers stressed that the update would make it easier to administer vaccines going forward, which could result in more vaccinations.

“I think it’s going to be very valuable to get the non-vaccine vaccines that lead to better public communication,” said Henry Bernstein, a professor of pediatrics at Hofstra University and a member of the advisory board.

Before all vaccines can be updated, the recommendation must be approved by the FDA and CDC. Although the FDA is not required to agree with its advisory committee, it often does.

“We think that simplifying the vaccine system will facilitate easier vaccine deployment and better communication and contribute to improved vaccine safety,” said Jerry Weir, director of the Division of Viral Products in the Office of Vaccine Research and Review at the FDA.

The update affects childhood vaccines, including vaccines for children under 5 years of age. Vaccination rates among young children are the lowest of all statistics; Only 5.3 percent of children aged 2 to 4 years and 3.5 percent of children aged six months to two years completed the entire vaccination course.

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Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said the agency hopes to see more data on the bivalent vaccine for children under 2 years of age. “What’s reassuring is that … the safety profile we’ve seen with bipolar boosters mirrors the original vaccine very well in this age group,” he said.

In addition to the committee’s recommendation, the advisers on Thursday focused their discussion on the best ways to move forward with Covid-19 prevention strategies.

One such strategy is to update the vaccine annually based on the most widely circulating variants and distribute it annually like the flu shot. Given the fact that the majority of people in the United States have already been exposed to Covid-19, healthy adults and previously vaccinated teenagers will need only one vaccine annually, while younger children, adults or those with compromised immune systems will need two shots.

The advisers cautioned that directly replicating the flu vaccine schedule would not work for Covid, although they understood the desire to roll out a local schedule that could be easily implemented. Bruce Gehlin, head of the Rockefeller Foundation’s global public health strategy and a member of the advisory board, said: “We need to make sure we’re not just following theory …

They concluded that more data are needed before a definitive vaccine strategy can be moved forward. “To answer this question of how often, with immunogenicity and efficacy data, [we need] safety data,” said Haley Gans, M.D., professor of pediatrics at Stanford University Medical Center.

However, the FDA emphasized its desire to streamline the vaccination process to encourage the unvaccinated to get vaccinated. “We heard loud and clear that we needed to use a data-driven approach to get the simplest plan we could for a vaccine,” Marks said. “It should be as simple as possible, but not too simplified, just a little bit like they say about Mozart’s music.”

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The consultants also weighed how manufacturers could coordinate any updates to Covid-19 scenarios based on the same variability. Currently, only the Pfizer-BioNTech and Moderna shots have been updated to induce immunity against the BA.4 and BA.5 Omicron subtypes. The data suggest that these shots produce immunity against the XBB.1 virus, which is currently the most commonly transmitted virus. Novavax’s vaccine, approved as a primary series and booster for adults, has not yet been renewed.

“We think that’s an important tool for scaling up, too [for] this upcoming season,” said Philip Dubowski, executive vice president and chief medical officer of Novavax. Dubowski said the agency will seek the agency’s recommendation on variant selection for future displays.

Novavax presented data showing that its primary vaccine provided adequate protection against the BA.4/5 variants, unlike mRNA sequences that required prior optimization. But immunity against variants like XBB.1 is waning, he noted, and it’s time for an update.

“MRNA is fantastic,” said Pamela McInnes, retired deputy director and voting member of the National Center for the Advancement of Translational Sciences at the National Institutes of Health. “But it may not give us the breadth of coverage, which I think is really our problem right now.”

Some consultants think it’s too late to say whether annual visits are necessary to move forward with managing Covid-19. “We may or may not need an annual vaccine,” said Cody Meissner, a pediatrician at Tufts Children’s Hospital. “It’s very early, I think, in the process.”

“I don’t think we’re setting it in stone, and we’ll see how it goes. We may have to adjust along the way. But overall, I think it’s a good path,” Kellin said.

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