The change to the Covid vaccine formulation signals the start of an FDA pivot in immunization strategy

The change to the Covid vaccine formulation signals the start of an FDA pivot in immunization strategy
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Recent evidence suggests that the current bivalent protects against severe disease and death from the XBB.1 variant that is currently dominant in the United States.

“We’ve moved from a pandemic phase to an endemic phase,” said Ofer Levy, MD, an MD at Boston Children’s Hospital, a professor at Harvard Medical School and a member of the FDA panel. “Today’s vote marks a huge practical victory for the American people.”

According to the CDC, about 69 percent of US adults have completed the primary vaccination series. More than 80 percent have received at least one vaccine, but 20 percent remain completely unvaccinated. Only about 15 percent of Americans, or 50 million people, have ever received bivalent enhancers.

Advisers stressed that this update would simplify future vaccinations, which could result in more vaccinations.

“I think it’s going to be extremely valuable to get more vaccinated than unvaccinated, resulting in better public communication,” said Henry Bernstein, professor of pediatrics at Hofstra University and a member of the advisory committee.

The recommendation still needs to be adopted by the FDA and CDC before all vaccines can be updated. Although the FDA does not have to agree with its advisory committee, it often does.

“We think that simplifying the vaccine regimen will facilitate easier vaccine placement and better communication and improve vaccine coverage,” said Jerry Weir, director of the viral products division in the FDA’s office of vaccine research and review.

The update will affect childhood vaccines, including vaccines for children 5 and younger. Vaccination rates among the youngest children are the lowest among all demographics; Only 5.3 percent of children aged 2 to 4 years and 3.5 percent of children aged six months to two years have completed the full vaccination series.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said the agency hopes to see more information about the bivalent vaccine for children younger than 2 years old. “The unfortunate thing is that the safety profile we see with the bivalent boosters mirrors the original vaccine very well in this age range,” he said.

In addition to the panel’s recommendation, advisers focused Thursday’s discussion on the best ways to move forward with Covid immunization strategies.

One such strategy would be to update the vaccine annually based on the most circulating variants and distribute it annually like the flu vaccine. Given that the vast majority of people in the U.S. have already been exposed to Covid-19, previously vaccinated healthy adults and adolescents will need the vaccine once a year, as will the youngest children, the oldest adults, or those who are sick. a weakened immune system will need two shots.

While they understand the desire to roll out an endemic schedule that can be easily implemented, the advisers have warned that straightforward flu vaccination schedules may not work for Covid. “We … have to make sure we’re not just following dogma,” said Bruce Gellin, head of the Rockefeller Foundation’s global public health strategy and advisory committee member.

They concluded that more information would be needed before deciding on a specific vaccination strategy moving forward. “To answer this question, how often, along with immunogenicity and efficacy data, [we need] safety data,” said Hayley Gans, a professor of pediatrics at Stanford University Medical Center.

Still, the FDA has emphasized its desire to streamline the vaccination process to encourage the unvaccinated to get vaccinated. “We heard loud and clear that we need to use a data-driven approach to arrive at the simplest possible vaccine schedule,” Marks said. “It should be as simple as possible, but not oversimplified, a bit like what they say about Mozart’s music.”

The consultants also weighed how manufacturers could adapt any updates to Covid-19 shots based on the same option. Currently, only the Pfizer-BioNTech and Moderna shots have been updated to confer immunity to the BA.4 and BA.5 Omicron subvariants. The data shows that these shots also produce immunity against the XBB.1 strain of the virus, which is currently the most prevalent virus. The Novavax vaccine, which is approved as a main series and booster for adults, has not yet been updated.

“We think we are an important tool to strengthen and [for] This coming season,” said Philip Dubowski, executive vice president and chief medical officer of Novavax. Dubowski said the company will seek the agency’s advice on options for future shots.

Novavax presented data showing that the initial vaccine provides broad protection against the BA.4/5 variants, unlike earlier mRNA shots that required an update. However, I’ve noticed that immunity has weakened against variants like XBB.1, which means it’s time for an update.

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

Some consultants think it’s too early to say whether managing Covid-19 will require annual visits. “We may or may not need annual vaccines,” said Cody Meissner, a pediatrician at Tufts Children’s Hospital. “I think it’s too early in the process.”

“I don’t think we’re taking it lightly and we’ll see how it goes. We may have to adjust along the way. But in general, I think this is a good way,” said Gellin.

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