The US is poised to make the COVID-19 vaccination more like an annual flu shot, a major shift in strategy despite a litany of questions about how best to protect against the still rapidly mutating virus.
The Food and Drug Administration asked scientific advisers on Thursday to help lay the groundwork for switching to once-a-year boosters for most Americans — and how and when to update the shot’s prescriptions.
“This is an important meeting to determine if we have reached a point in the pandemic that allows us to simplify the use of the current COVID-19 vaccine,” said Dr. David Kaslow of the FDA.
The advisory panel mostly agreed with the FDA’s approach.
The COVID-19 vaccine has saved millions of lives and booster doses continue to help the most vulnerable even as more contagious variants emerge. But the protection is not reduced and the shot does not prevent milder infections for long.
And people are tired of getting vaccinated. While more than 80% of the US population has had at least one COVID-19 shot, only 16% eligible for the latest boosters — called bivalent doses that are updated to match newer strains of the virus — have gotten one.
That makes difficult decisions about how to move forward: Who needs another shot, how often and what type?
“We are still protected from severe disease, thank goodness,” even as the latest mutated omicron strain emerges, said FDA advisor Dr. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia.
The first step: An FDA advisory panel voted unanimously that people should get the same vaccine formula, whether they’re receiving an initial vaccination or a booster. Today, Americans get one formula based on the original coronavirus strain that appeared in 2020 for the first two or three doses – and the latest booster is a combination made by Pfizer or Moderna that increases omicron protection.
The FDA must decide how to phase in these changes.
But “this is not just convenience” to reduce confusion about different types of shots, said Dr. Archana Chatterjee, dean of the Chicago School of Medicine. Since the original coronavirus strain has disappeared, “moving to the circulating strain is very important.”
Who needs another shot and when to create another debate.
Going forward, the FDA says most Americans should do just fine if they get a once-a-year booster targeted for the newest variant in the fall. The agency is questioning whether some people need two doses — adults with weakened immune systems and young children who have never been vaccinated before. It’s similar to how young people get their first flu vaccination.
But more data is needed to show exactly who needs two doses a year — such as carefully counting who is still hospitalized with COVID-19 despite being up-to-date with current vaccinations, Offit said.
“Only then can we make the best decisions about who to vaccinate with what and when,” he said.
It’s also not clear whether younger, healthier people need annual COVID-19 boosters.
“It’s hard to say it will be annual at this point,” said Harvard Dr. Eric Rubin.
Fall may not be the best time to boost, which will depend on when infections start to increase and how long the booster’s protection lasts, said FDA adviser Dr. Arthur Reingold of the University of California, Berkeley.
Unlike the flu, which generally spreads in the US during late fall and winter, waves of COVID-19 occur year-round.
For the prescription, the FDA’s plan is to call the advisory panel for another meeting in late May or early June to decide whether the vaccine prescription should be changed – including the virus strain to be targeted and whether it should be single-strain or multi-strain. Pfizer and Moderna said they would give themselves enough time to produce the necessary doses in the fall when a third manufacturer, Novavax, requested the start of a prescription change.
Also, on Thursday, US officials updated how they are tracking whether the latest COVID-19 boosters are safe. The Centers for Disease Control and Prevention found a warning signal that older people who got Pfizer’s updated boosters may have a higher risk of stroke. But FDA safety expert Richard Forshee said data from Medicare and various other health systems — including those in other countries — found no signs of a problem, leading the government to conclude there were no red flags.
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