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FDA’s Annual COVID-19 Booster Shot Proposal Sparks Questions, Concerns

The agency is proposing an annual COVID-19 booster shot that is matched to circulating strains and offered in the fall for most Americans.

The Food and Drug Administration wants to shift to a simplified COVID-19 booster plan, but responses to the idea are proving that the issue is a complicated one.

In documents published this week, the FDA proposed a booster shot strategy similar to the flu vaccine schedule, with an updated shot matched to circulating strains offered annually in the fall for most Americans. Its committee of outside vaccine experts is set to discuss the topic during a meeting on Thursday.

But some experts are asking whether available data supports such a plan.

“The big question is: How often do we need repeat vaccination? And I don’t think we have a definitive answer,” Joachim Hombach of the World Health Organization said during a press briefing on Tuesday.

Hombach said that it is conceivable that the booster time frame could be annual but raised concern that COVID-19 has has yet to become seasonal, with surges happening in the summer, fall and winter.

“We also have to say that for the time being COVID hasn’t really come down to the usual seasonality that we see for other respiratory viruses,” Hombach said. “The virus is still very unstable. So this is a bit of an anticipation that we end up in a seasonal pattern as we have, for instance, for influenza.”

WHO’s Maria Van Kerkhove agreed that the coronavirus and its many variants still present uncertainties.

“We don’t know the periodicity of this yet. We haven’t seen SARS-CoV-2 settle into a pattern in terms of its virus evolution,” Van Kerkhove said, referring to the virus by its scientific name. “We have not yet seen a seasonal pattern particularly in the temperate regions of the globe. And we may get to that, but we’re not quite there yet.”

Carlos del Rio of the Emory University School of Medicine said he understands the desire to have a policy in place but added that the virus continues to throw curveballs and complicate plans.

“I think that we’d like to see something simple and similar to the flu,” del Rio, who is the president of the Infectious Diseases Society of America, said during a briefing on Tuesday. “But I think we also need to have the science guide this information, and I think the science right now is not necessarily there.”

He added that more research is needed to produce next generation vaccines that do a better job of protecting against infection.

“My plea is that we continue doing research, we follow the science and we make decisions based on science and not what is most convenient to most,” del Rio said.

The vast majority of Americans are currently considered undervaccinated by Centers for Disease Control and Prevention standards. Just 15% of Americans have gotten the updated COVID-19 booster shot, raising questions about vaccine fatigue with any strategy moving forward.

Still, the move by the FDA is not a surprise, given that members of the Biden administration and President Joe Biden himself have pushed for the idea of switching to an annual COVID-19 shot.

“For most Americans, one COVID shot each year will be all they need,” Biden said at the White House in October when he got his updated COVID-19 booster shot. “And if you get it, you’ll be protected. And if you don’t, you’re putting yourself and other people at unnecessary risk.”

But even then his proposal raised eyebrows.

“Unfortunately, there are no data to support this assertion,” Eric Topol, professor of molecular medicine at Scripps Research tweeted at the time. “Likely attainable by second generation vaccines, but that requires priority and resources to be dedicated, which isn’t happening.”