Experts back new COVID vaccine approach
A Food and Drug Administration advisory committee voted unanimously to use the same COVID-19 vaccine — for now, the new bivalent booster — for all future inoculations as part of a broader effort to simplify the nation’s vaccine strategy.
The decision, if the FDA makes it official, spells the end of the original vaccine, which has become less effective against omicron and its subvariants. Research published last week shows the bivalent booster, tailored to two earlier omicron strains, remains effective against the latest version, XBB.1.5, nearly halving the risk of symptomatic infection.
The new approach is a “nobrainer” to Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine and co-director of the Texas Children’s Hospital Center for Vaccine Development.
The broader and more complicated question posed last Thursday by the FDA was whether people should receive updated vaccines once a year, similar to the schedule for flu vaccines. The advisory committee
composed of scientists, physician-researchers, engineers and other science-oriented professionals took up the proposal but did not vote, opting to wait for more data.
In meeting documents, the FDA said the plan could entail huddling with advisers in June to decide which strain to target for a fall vaccine rollout, with exceptions for any aggressive new variants that emerge. The agency noted manufacturing constraints, and some advisers were opposed to the idea of recommending annual shots for
healthy young people.
Experts say it would be a reasonable evolution of a lagging vaccination effort. Only about 15 percent of Americans have taken advantage of the bivalent booster, according to the Centers for Disease Control and Prevention. Establishing a routine could improve uptake, said Dr. Ashley Drews, an epidemiologist and medical director of infection prevention and control at Houston Methodist.
“I think there’s a lot of enthusiasm and appetite for making this annual around the same time that people receive their influenza vaccine, because that’s when they’re thinking about vaccination,” she said. “I feel like, personally, we’re really close.”
Rampant misinformation and pandemic fatigue have contributed to the vaccination gap. Drews, however, said more robust real-world data on the bivalent booster, especially for the pediatric population, could help the public and the FDA feel more confident about routine COVID vaccination.
Dr. Luis Ostrosky, chief of infectious diseases with Mcgovern Medical School at Uthealth Houston, said more data is needed on how COVID interacts with T cells, or immune cells that recognize parts of the virus that do not mutate rapidly. Still, he agreed it is time to simplify vaccinations, despite not having “the perfect information to make every decision.”
Hotez also agrees with the idea of annual vaccinations but said he prefers a twice-a-year routine to account for the anticipated summer and winter surges each year.
“What they’re really doing is balancing the science that says, ideally, semi-annually, with the reality that Americans are not really accepting the boosters barely anyway,” he said.
Money is another factor, he said. Both Pfizer and Moderna are considering raising the price of a single vaccine dose to $130, and the Biden administration has said it no longer has the COVID-19 funding to make additional purchases.
“There’s just not the money from the federal government to pay for more than one dose” per year, Hotez said.
Also last week, the vaccine advisory committee considered whether to recommend one dose of the vaccine for most people, even for initial vaccinations, and reserve the two-dose regimen for people who are immunocompromised and other vulnerable groups.
Overall, experts agree the ongoing conversation around vaccine simplification is a positive step toward establishing more predictability in the COVID response.
“I do think this is a sign that we are moving more into that phase where it is a chronic infection that is here and always prevalent,” Drews said.