In a unanimous decision, all 21 voting members of the U.S. Food and Drug Administration’s vaccine committee recommended that the U.S. start using the same COVID-19 virus strain in all of the COVID-19 vaccines, including primary and booster doses
This data, plus the appeal of a simpler immunization regimen, persuaded the panel. “Simpler is better, and we saw evidence today that closer is better,” said committee member Dr. Michael Nelson, professor of medicine at University of Virginia, referring to the fact that the BA.4/5 in the bivalent vaccine is a closer match to the currently circulating Omicron variants than the virus in the original vaccine.
Dr. Ofer Levy, director of the precision vaccines program at Boston Children’s Hospital and member of the committee, agreed. “As we turn the corner from the pandemic to endemic phase, today’s vote marks a big practical win for the American people,” he said. “It’s going to really simplify things and benefit public health.”The experts noted that there are still gaps in what health officials know about how the bivalent vaccine is providing immunity.
The committee discussed, but was not tasked to resolve, other issues. The most notable were about whether to move to an annual COVID-19 booster schedule and conduct yearly reviews each June to better match vaccines to whatever version of the coronavirus will likely be circulating the following winter. The committee members were in favor of these strategies and will make more concrete decisions about them at a meeting in June.
Novavax, which makes a COVID-19 vaccine authorized for use as both primary immunization and a booster in the U.S., also presented data at the meeting. Its shot uses a different technology based on a recombinant form of the spike protein on the SARS-CoV-2 virus, along with an adjuvant to wake up the immune system. Novavax reported that its vaccine generated similar protection as that of the mRNA bivalent boosters.
The experts also raised questions about some cases of stroke that CDC scientists are continuing to investigate to determine if the bivalent vaccine raises risk of these events. “The evidence is not sufficient to conclude a safety problem with respect to stroke,” said Dr. Tom Shimabukuro, deputy director of the H1N1 vaccine task force in the immunization safety office at the CDC. “The CDC recommendations are that everyone who is eligible should get a bivalent booster.
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