Americans may be offered a new COVID-19 vaccine annually in the fall, similar to flu shots, according to documents released by FDA on Monday. But the proposed shift in vaccination strategy was met with controversy.
According to FDA, many Americans now have "sufficient preexisting immunity" against the coronavirus thanks to vaccination, infection, or a combination of the two.
As a result, "[m]ost individuals may only need to receive one dose of an approved or authorized COVID-19 vaccine to restore protective immunity for a period of time," FDA said. Very young children who have yet to be infected by the virus, as well as older adults and immunocompromised people, could need two shots.
According to FDA's plan, officials would select the annual COVID-19 vaccine's composition in June based on what variant is dominant. However, if an emergency were to arise—such as the arrival of a more dangerous variant that is able to evade vaccine immunity—FDA would call a meeting of its vaccine advisers and select a new shot.
FDA is also proposing the original COVID-19 vaccines be retired in favor of the bivalent vaccines for primary and secondary doses.
The agency's panel of outside vaccine experts will weigh in on the proposal at a meeting on Thursday.
Some experts praised FDA's plan to make COVID-19 vaccination simpler. Robert Wachter, chair of the department of medicine at the University of California, San Francisco, said the proposed plan "seems reasonable" and could "save a lot of lives" by simplifying the current vaccine regimen.
Eric Rubin, one of FDA's vaccine advisors and editor in chief of the New England Journal of Medicine, said he'd "definitely be in favor of something simpler, as it would make it more likely that people might take [the vaccine]," but added that he'd like "to see some data on the effect of dosing interval, at least observational data."
However, some experts criticized FDA's proposal. Eric Topol, a professor of molecular medicine at Scripps Research, said the idea of an annual shot for COVID-19 is "a flawed approach," adding that no data exists to support the idea that COVID-19 vaccines provide protection beyond four to six months. Topol said people who have never had COVID-19 would especially be at risk since they wouldn't have a reservoir of antibodies generated from fighting the disease.
Similarly, Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security, said FDA was using a "one size fits all" model that needs to be adjusted to reflect that some people need booster shots more frequently than others. Instead, Adalja suggested FDA adopts a risk-based approach based on the specific risks of each individual.
"Precision medicine makes sense," he said. "This needs to be individualized."
FDA's approach would likely work best for younger, healthier people, but not for older people who may need multiple shots, said Lawrence Gostin, a public health professor at Georgetown Law. "I think I would transition only for the young, healthy Americans and continue boosters for the elderly," he said.
Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine said he doesn't believe an annual flu shot model would work for COVID-19, in part because mRNA vaccines don't last for an entire year, and there's still more to learn about the coronavirus variants. "There may be too many unknowns," he said.
Alternatively, some scientists said there was no evidence that Americans at low risk even need an annual shot. Most people are "well protected against severe Covid disease with a primary series and without yearly boosters," said Céline Gounder, an infectious disease physician and senior fellow at the Kaiser Family Foundation.
Some FDA advisors said they'd like to see detailed information about who is most vulnerable to the coronavirus and for the agency to make decisions based on that data.
"How old are they? What are their comorbidities? When was the last dose of the vaccine they got? Did they take antiviral medicines?" Paul Offit, one of FDA's advisors and director of the Vaccine Education Center at Children's Hospital of Philadelphia, said.
Currently, the national strategy appears to be "'OK, well, let's just dose everybody all the time,'" Offit said. "And that's just not a good reason." (Mandavilli, New York Times, 1/23; McGinley, Washington Post, 1/23; Perrone, Associated Press, 1/24)
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