Covid vaccine formulation change marks beginning of FDA pivot on immunization strategy

Recent evidence indicates that current bivalents provide protection against serious illness and death from the XBB.1 variant that is currently prevalent in the United States.

“We’ve gone from a pandemic 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 Food and Drug Administration committee. “Today’s vote marks a great practical victory for the American people.”

According to the CDC, approximately 69% of adults living in the United States have completed their primary vaccination series. More than 80% have received at least one injection, but 20% are still not fully immunized. Only about 15% of Americans, or 50 million people, have received bivalent boosters to date.

Advisers emphasized that this modernization would streamline vaccination operations in the future, which could lead to more vaccinations.

“I think anything that results in better public communication to get more unvaccinated vaccines will be very valuable,” said Henry Bernstein, MD, professor of pediatrics at Hofstra University and member of the advisory committee.

The recommendation still needs to be approved by the Food and Drug Administration and the CDC before all vaccines are updated. While the FDA doesn’t have to agree with its advisory committee, it often does.

“We believe that simplifying the vaccination system will contribute to easier vaccine deployment, better communication, and better vaccine coverage,” said Jerry Ware, director of the division of viral products in the FDA’s Office of Vaccine Research and Review.

The update will affect childhood vaccines, including those for children 5 years of age and younger. Vaccination rates among younger children are the lowest of all demographics. Only 5.3% of children aged 2 to 4 years and 3.5% of children aged 6 months to 2 years completed the full series of vaccinations.

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

In addition to the committee’s recommendation, the advisors focused their discussion on Thursday on the best way forward for COVID immunization strategies.

One such strategy is to update the vaccine annually based on the most prevalent variants and distributed annually, similar to the influenza vaccine. Given the fact that the vast majority of people in the United States have already been exposed to Covid-19, it is possible that previously vaccinated healthy adults and teens may only need one dose per year, while younger children, the elderly, or those with disease immune systems may need one. Weak for two servings.

Advisers cautioned that a straight reversal of influenza vaccination schedules may not work for Covid, although they understand the desire to implement an easy-to-implement schedule. “We need to … make sure we don’t just follow dogma,” said Bruce Gillen, chairman of the Rockefeller Foundation’s global public health strategy and an advisory committee member.

They concluded that more data are needed before a decision can be made about a concrete vaccination strategy going forward. To answer this question of how often, combined with data on immunogenicity and efficacy, [we need] disse Hayley Gans, MD, professor de pediatria no Stanford University Medical Center.

However, the US Food and Drug Administration has emphasized its desire to simplify the vaccination process to encourage those who have not been vaccinated to get vaccinated. “We heard loud and clear that we need to use a data-driven approach to create the simplest vaccination schedule possible,” said Marks. “It should be as simple as possible, but not oversimplified, as they say about Mozart’s music.”

The consultants also looked at how manufacturers could align any updates to their Covid-19 vaccines so that they are based on the same variant. Currently, only Pfizer-BioNTech and Moderna injections have been updated to induce immunity against Omicron subtype BA.4 and BA.5 variants. Data indicate that these injections also produce immunity against the XBB.1 strain of the virus, which is currently the most common virus. The Novavax vaccine, licensed as a primary series and booster for adults, has not yet been updated.

“We believe that we are an important publicity tool, and [for] said Philip Dubovsky, executive vice president and chief medical officer at Novavax. Dubovsky said the company will follow the agency’s recommendation on selecting variants for future shots.

Novavax provided data showing that its baseline vaccine provided adequate protection against BA.4/5 variants, as opposed to mRNA injections that required an earlier upgrade. But he noted that immunity has waned against variants like XBB.1, which indicates it’s time for an upgrade.

“The mRNA was amazing,” said Pamela McInnes, deputy director of the National Center for the Development of Translational Science at the National Institutes of Health and a voting member. “But it might not give us that breadth of coverage, which is really what I think is our problem right now.”

Some advisers felt it was too early to say whether managing Covid-19 in the future would require annual visits. “We may or may not need an annual vaccine,” said Cody Meisner, MD, a pediatrician at Tufts Children’s Hospital. “It seems to me that it is too early in the process.”

“I don’t think we’re imposing anything and we’ll see how it goes. Maybe we need to adapt along the way. But overall, I think it’s a good way to go.