An expert panel of the FDA on vaccines voted to recommend that anyone who receives a primary COVID vaccine in the future receive a bivalent shot instead of the original formula, indicating the beginning of the FDA’s transition to a more long-term immunization strategy. This is a crucial initial step in a process that may result in millions of Americans receiving an annual COVID booster, similar to the flu vaccine. However, further discussion and decisions are necessary before any changes are implemented, and the FDA seems to be moving away from addressing the immediate phase of the pandemic to a more prolonged approach.
he Vaccine and Related Biological Products committee of the agency voted unanimously to recommend the replacement of the authorized Covid-19 vaccine with the bivalent version. This version was reformulated by Pfizer-BioNTech and Moderna to provide protection against the BA.4/BA.5 Omicron subvariants, which were prevalent at the time and could infect those who had received the initial vaccine series and booster.
Recent studies indicate that the current bivalent vaccine offers protection against severe illness and death caused by the XBB.1 variant, which is prevalent in the U.S. at present.
“As we’ve turned the corner from a pandemic phase to an endemic phase,” said Ofer Levy, a staff physician at Boston Children’s Hospital, professor at Harvard Medical School and a member of the FDA panel. “Today’s vote marks a big practical win for the American people.”
According to the CDC, approximately 69 percent of adults in the U.S. have completed their primary vaccination series. Over 80 percent have received at least one dose, but 20 percent remain unvaccinated. Only around 15 percent of Americans, or 50 million people, have received bivalent boosters so far.
Advisers emphasized that this update would make vaccinations simpler going forward, potentially resulting in increased vaccination rates.
“I think anything that results in better public communication, to get more of the unvaccinated vaccinated would be extremely valuable,” said Henry Bernstein, a professor of pediatrics at Hofstra University and a member of the advisory committee.
The proposal for updating all vaccines must first be accepted by both the FDA and the CDC. While the FDA is not obligated to follow the suggestions of its advisory committee, it usually does.
“We think that simplification of the vaccination regimen would contribute to easier vaccine deployment and better communication and improved vaccine coverage,” said Jerry Weir, director of the division of viral products in the office of vaccines research and review at FDA.
The proposed update will affect pediatric vaccines, including those for children aged 5 and under. Vaccination rates among the youngest age group are the lowest among all demographics; only 5.3% of children aged 2 to 4 and 3.5% of children between 6 months and 2 years have completed a full vaccine series.
Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, stated that for children under 2, the agency wishes to gather more data on the bivalent vaccine. “The reassuring aspect is that the safety profile that we have observed with the bivalent boosters is very similar to the original vaccine in this age range,” he said.
In addition to the panel’s recommendation, advisers also focused their discussion on Thursday on finding the best ways to continue with Covid immunization strategies. One possible strategy could be updating the vaccine every year based on the most prevalent variants and distributing it annually, similar to the flu shot. Given that the majority of people in the U.S. have already been exposed to Covid-19, it’s possible that healthy adults and teens who have been previously vaccinated would only need a single shot annually, while the youngest children, oldest adults, or those with compromised immune systems would require two shots.
Advisers warned that simply replicating flu vaccination schedules may not be effective for Covid-19. Despite this, they acknowledged the appeal of implementing a familiar endemic schedule. Bruce Gellin, the chief of global public health strategy at the Rockefeller Foundation and a member of the advisory committee, stated, “We need to … make sure that we don’t just follow the dogma.”
The group determined that more information would be required before determining a definite vaccination plan. Hayley Gans, a professor of pediatrics at Stanford University Medical Center, explained, “In order to answer this question of how often, along with the immunogenicity and efficacy data, [we need] safety data.”
Despite this, the FDA emphasized their aim to make the vaccination process more efficient in order to persuade those who have yet to receive a vaccine to do so. Marks stated, “We heard loud and clear that we need to use a data-driven approach to get to the simplest possible scheme that we can for vaccination. It should be as simple as possible, but not over-simplified, a little bit like they say about Mozart’s music.”
Furthermore, advisers discussed the possibility of manufacturers coordinating updates for Covid-19 shots to target the same variant. Currently, only the Pfizer-BioNTech and Moderna shots have been adapted to target the BA.4 and BA.5 Omicron subvariants. Data indicates that these shots also provide immunity against the XBB.1 strain of the virus, which is currently the most prevalent. The Novavax vaccine, which has been authorized for use as a primary series and booster for adults, has not yet been updated.
According to Filip Dubovsky, Novavax’s executive vice president and chief medical officer, the company considers itself to be a valuable resource for increasing immunity. Dubovsky stated that Novavax will seek the guidance of the agency in terms of selecting variants for future vaccinations.
Novavax presented data demonstrating that their primary vaccine effectively protected against the BA.4/5 variants, unlike mRNA shots that required updates. However, Dubovsky also highlighted that immunity against variants such as XBB.1 had decreased, indicating the need for a new version of the vaccine.
Pamela McInnes, a retired deputy director of the National Center for Advancing Translational Sciences at the National Institutes of Health and voting member, praised mRNA vaccines but acknowledged that they may not provide enough coverage.
Advisers had differing opinions on the need for annual vaccinations in the future. Cody Meissner, a pediatrician at Tufts Children’s Hospital, stated that it is currently too early to make a decision on this matter. Gellin added that while the current plan is a positive step, adjustments may be necessary as the situation evolves.
(With inputs from Politico)
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