An FDA Committee Votes To Roll Out A New COVID Vaccination Strategy
A committee of advisers to the Food and Drug Administration voted unanimously on a proposal to simplify the nation's strategy for vaccinating people against COVID-19.
The recommendation is that future COVID-19 vaccines should be interchangeable: no matter whether you're getting your first dose or a booster, the vaccines would all have the same formulation targeting the same viral strain or strains, regardless of the manufacturer. The vote was unanimous: 21-0.
In addition, the committee considered (but didn't vote on) proposals to have an annual COVID vaccination schedule, much like the U.S. has for the flu. If this happens, most people would be advised to get just one shot every fall with a new vaccine that's probably been re-jiggered to try to match whatever variant is predicted to be spreading each winter. This would mean Americans would no longer need to keep track of how many shots they've already gotten or when.
The idea behind the revamp is to make vaccination less complicated and confusing. The ultimate goal would be to get more people vaccinated.
"Because of [the coronavirus'] rapid evolution we've needed to adjust our approach over time, and we're now in a reasonable place to reflect on the development of the COVID-19 vaccines to date to see if we can simplify the approach to vaccination," said Dr. Peter Marks, FDA's top vaccine official, in remarks at the beginning of the all-day meeting.
He added that the goals is "to facilitate the process of optimally vaccinating and protecting the entire population moving forward."
Only 15% of people in the U.S. have received the latest bivalent COVID booster, which targets the original strain of the virus and omicron BA.5, according to data from the Centers for Disease Control and Prevention. Only 40% of people 65 and older, who are at higher risk for serious COVID, have received the booster.
"We can't keep doing what we're doing. We have to move on," said Dr. Bruce Gellin, a temporary voting member on the panel who is the chief of global public health strategy at the Rockefeller Foundation. "I think this is a reasonable approach."
During the discussion the FDA's Marks acknowledge the "lackluster" results in rollout of the booster.
The committee was in agreement that it's time to update COVID vaccine administration.
"As we turn the corner from a pandemic phase to an endemic, today's vote marks a big practical win for the American people. This is really going to benefit public health," said Dr. Ofer Levy, a pediatric infectious disease specialist at Harvard Medical School.
In a discussion after the vote, the committee discussed several ways to improve vaccination strategy. The advisers voiced support for a proposal to hold public meetings to guide the selection of strains in the vaccines. After the meetings, the agency would make a formal decision on selection of strains and direct manufacturers to gear up production.
The agency proposed a meeting in late May or early June this year to have shots ready for the fall. The goal would be to match the vaccine to the likely strains of the coronavirus that would be circulating during the winter.
Some panel member said the meetings may need to be held more frequently than once a year, as is the case for the flu vaccine, because of the pace of changes in SARS-CoV-2, the virus that causes COVID-19.
"This isn't flu," FDA's Marks acknowledged, adding however that there are helpful precedents from the way the flu vaccine is adjusted. He said there would likely be at least one advisory committee meeting a year on the selection of viral strains for a vaccine and related issues.
Under the FDA's proposal, most people would be offered a single shot in the fall. Older people, young children and people with compromised immune systems might be offered multiple shots spaced sometime apart instead of a single shot.
"In general principle, the committee was supportive of going forward with this," said Dr. Stanley Perlman, acting chairman of the committee and a coronavirus researcher at University of Iowa.
No votes were taken on either discussion point.
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