Support grows for a new approach to COVID vaccine schedule, as proposed by FDA

The FDA outlined an approach to yearly COVID vaccines, like the flu shot.

January 26, 2023, 6:12 PM

A panel of public health experts for the Food and Drug Administration convened for an all-day meeting on Thursday to discuss whether the U.S. is ready to start treating COVID boosters like an annual flu vaccine, a move that would normalize COVID shots as permanent public health upkeep.

Creating a yearly COVID shot schedule would mean updating the shot once a year and hoping that it matches whichever variant is circulating that upcoming winter season, similar to how the flu shot schedule works. No longer would public health agencies and vaccine companies attempt to reactively update the COVID vaccine when variants come on the scene.

It would also eliminate the two-shot primary series for most unvaccinated people, in favor of a mainstreamed program.

"This is a consequential meeting to determine if we've reached a point in the pandemic that allows for simplifying the use of current COVID-19 vaccines," Dr. David Kaslow, director of the FDA's Office of Vaccines Research and Review, told the group of advisors on Thursday.

Dr. Peter Marks, the FDA's vaccine chief, said the virus has evolved so rapidly that the FDA has constantly needed to revise its approach. Now, he said, it was time to determine if they could do that on a schedule rather than at the whim of the virus' evolutions.

"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 in order to facilitate the process of optimally vaccinating and protecting the entire population moving forward," Marks said.

Dr. Peter Marks testifies during a Senate Health, Education, Labor, and Pensions hearing to examine an update from Federal officials on efforts to combat COVID-19, May 11, 2021, in Washington.
Jim Lo Scalzo/AP, FILE

The goal, FDA officials said, would be to deliver simpler messaging in the hope of reaching more Americans.

The way it stands now, people get different numbers of vaccines depending on their age and prior vaccination status. For example, unvaccinated people get their initial series in two shots, a few weeks apart, while vaccinated people have been encouraged to get a booster every few months, depending on how old they are.

The plan proposed by the FDA is to recommend every American get a single shot every year, with a few exceptions.

It's based on the idea that the vast majority of Americans already have some immunity in their system, either because they've been exposed to COVID itself or gotten vaccinated.

"Presumably, at this point in the pandemic, most of the general U.S. population have been sufficiently exposed to spike protein, either to infection, vaccination or both, such that a single dose of a COVID-19 vaccine would induce or restore vaccine effectiveness," Kaslow said.

But older, high-risk and immunocompromised Americans could still be recommended to get two shots a year, as could young children when they reach the age eligible for vaccinations.

A nurse prepares a syringe of a COVID-19 vaccine at an inoculation station in Jackson, Miss., July 19, 2022.
Rogelio V. Solis/AP, FILE

"It could be that more than one dose is needed for high-risk older adults, persons with compromised immunity and young children who have not yet been completely immunized. At this time, those risk based adjustments remain to be determined," Kaslow said.

Responding to the proposal, some experts on the panel emphasized that people who haven't had COVID or been vaccinated might still need to get two shots to shore up their immunity.

But the members were broadly supportive of the move to simplify the COVID vaccine schedule.

"I certainly support this approach. Simpler is better," said Dr. Mark Sawyer, a professor of clinical pediatrics at the University of California, San Diego and a member of the FDA's panel.

"I think this is definitely the way to go as soon as we can figure out how to do it," he said.

More data is necessary to decide exactly who will be protected enough by one dose, experts said.

"My general feeling from the committee is that we need more data to figure out exactly who should get the two-dose schedule, who should get the one," said Dr. Stanley Perlman, an infectious disease expert with the University of Iowa and a member of the panel.

"So all that kind of information will help determine this immunization schedule, but in general principle, the committee was supportive of going forward with this," Perlman said.

The FDA will likely not make any concrete decisions until later in February, after a panel of experts at the Centers for Disease Control and Prevention has a similar public discussion on the newly-proposed schedule.

And just which variants the updated booster would target for next season won't be decided until this summer, likely in early June, for distribution sometime in the fall.

Of course, the reality is that a small percentage of Americans have opted to get the current booster — around 16%, despite recent CDC research showing that it can cut risk of symptomatic infection by around half. And because less and less people have opted for a booster shot each time one has been recommended, the appetite could be lower by next fall.

But Marks, the FDA's vaccine chief, was optimistic that aligning the COVID vaccine on a yearly schedule with the flu shot could encourage more people to make it a routine.

"If we can see the influenza vaccine and the COVID-19 vaccines occurring at the same visit, it facilitates a vaccination program that may lead to more people getting vaccinated and being protected, and reducing the amount of disease we see," Marks said.

"So I think that overall, this seems like a reasonable way to go."

ABC News' Nicole Wetsman and Youri Benadjaoud contributed to this report.

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