FDA advisers back plan to simplify COVID vaccinations

The US is set to make COVID-19 vaccinations more like an annual flu shot, a major shift in strategy despite a long list of questions about how best to protect against a virus that is still mutating rapidly.

The Food and Drug Administration on Thursday asked its scientific advisers to help lay the groundwork for moving to annual boosters for most Americans — and how and when to periodically update the injection recipe.

“This is a back-to-back meeting to determine if we’ve reached the point in the pandemic that makes it possible to simplify the use of current COVID-19 vaccines,” said FDA’s Dr. David Kaslow.

The advisory group mostly agreed with the FDA’s approach.

COVID-19 vaccines have saved millions of lives and booster doses continue to help the most vulnerable even as more contagious variants have emerged. But the protection wanes, and the injections don’t fend off milder infections for long.

And people are tired of getting vaccinated. While more than 80% of the US population has received at least one COVID-19 vaccine, only 16% of people eligible for the latest boosters – so-called bivalent doses updated to better match the newer virus strains – in have received one.

This makes decisions difficult about how to move forward: who really needs another vaccine, how often and what type?

“We are still protected against serious diseases, thank goodness,” even after the last mutant strains of omicron emerged, noted FDA adviser Dr. Paul Offit, a vaccine expert at Children’s Hospital Philadelphia.

The first step: The FDA advisory committee voted unanimously that people should receive the same vaccine formula whether they receive their initial shots or a booster. Today, Americans are getting a formula based on the original strain of coronavirus that emerged in 2020 for their first two or three doses — and their latest booster is a combination shot made by Pfizer or Moderna that adds omicron protection.

The FDA should decide how to phase in this change.

But “it’s not just a matter of convenience” to clear up confusion about different types of vaccines, said Dr. Archana Chatterjee, dean of Chicago Medical School. The original strain of the coronavirus having disappeared, “going towards the strains which circulate is very important”.

Who needs another shot and when has sparked more debate.

Looking ahead, the FDA said most Americans should be fine if they received a once-a-year recall targeted at newer variants in the fall. The agency asked if some people might need two doses – adults with weakened immune systems and very young children who have never been vaccinated before. It’s similar to how young people get their very first flu shot.

But more data is needed to show exactly who might need two annual doses — like a careful tally of those who are still hospitalized with COVID-19 despite being up to date with today’s vaccinations, Offit said.

“Only then can we really make the best decision about who gets vaccinated with what and when,” he said.

It’s also not clear that younger, healthier people would need a COVID-19 booster every year.

“It’s hard to say it will be annual at this point,” said Harvard’s Dr. Eric Rubin.

Fall may not even be the best time to boost, which depends on when infections start to rise and how long a booster protects, said FDA adviser Dr. Arthur Reingold of the University of California at Berkeley.

Unlike influenza, which in the United States circulates primarily in late fall and winter, waves of COVID-19 have occurred year-round.

As for the recipe, the FDA’s plan is to convene its advisory group for another meeting in late May or early June to decide whether the vaccine recipe needs to be changed — including which viral strain to target and whether it should be a single strain or multi-strain strain. Pfizer and Moderna said that would give enough time to produce needed doses in the fall, while a third manufacturer, Novavax, urged starting any recipe changes sooner.

Also on Thursday, US officials updated how they monitor new COVID-19 boosters are safe. The Centers for Disease Control and Prevention has spotted a possible warning sign that seniors receiving Pfizer’s updated booster may have a slightly higher risk of stroke. But FDA safety expert Richard Forshee said data from Medicare and several other health systems — including in other countries — found no signs of a problem, leading the government to conclude that the red flag is unlikely to be real.