Exclusive: FDA Stops Recommending Covid Vaccine Boosters for Most Americans
‘This is a restoration of trust,’ said vaccine czar Vinay Prasad. ‘It’s bringing us back to evidence.’
In a paper published today in The New England Journal of Medicine, Martin Makary, the commissioner of the Food and Drug Administration, and Vinay Prasad, the newly appointed head of the FDA’s vaccine division, have unveiled a new policy in which the government will no longer recommend Covid booster shots for healthy Americans ages 64 and younger.
In addition, as of today, Covid vaccine manufacturers like Moderna and Pfizer will have to conduct trials to prove that their updated vaccines offer clinical benefits such as fewer symptoms, hospitalizations, or deaths. Previously, pharmaceutical companies only had to show that their updated booster shots produced antibodies. That less rigorous standard will still apply for people 65 and older and the immunocompromised.
It is well established that people 65 and older account for the vast majority of Covid deaths, while most children, in particular, show few effects from the virus.
In an exclusive interview with The Free Press, Prasad said that the previous one-size-fits-all approach—in which the federal government recommended Covid vaccine boosters for everyone, including healthy 6-month-olds—“fatigued” the country.
“The American people were skeptical, and some of them took that skepticism to every single vaccine, which has led to some big problems,” said Prasad, referring to the fact that a growing number of Americans have stopped having their children vaccinated for measles, mumps, and rubella, leading to measles outbreaks in pockets of the country. “This is a restoration of that trust. It’s bringing us back to evidence.”
The move is one part of what is expected to be further changes in federal Covid vaccine policy. According to The Wall Street Journal, Health and Human Services Secretary Robert F. Kennedy Jr. plans to scrap guidelines recommending routine Covid vaccinations for pregnant women, teenagers, and children. Late last month, in an interview with Phil McGraw (popularly known as Dr. Phil), Kennedy advised parents to “do your own research” before vaccinating their newborns. That skepticism is increasingly shared by the public: Less than a quarter of Americans received boosters in recent years, according to Makary and Prasad’s paper. Even healthcare workers have been slow to roll up their sleeves—fewer than one third reported getting a booster in 2023.
Prior to joining the administration earlier this month, Prasad had been critical of the FDA’s guidance about vaccines and booster shots. As he wrote in The Free Press in 2022, “An 88-year-old has 8,700 times the risk of death of an 8-year-old.” But, he added, “Scientists that advocated for a more nuanced approach—do more to protect older people, and put fewer limits on younger people—were demonized.” Prasad himself was one of those scientists. Makary was also a critic of the federal government’s Covid response, including in the pages of The Free Press.
The shift to more rigorous vaccine approval marks a major departure from how Covid boosters have been authorized over the last few years. In 2020, during the height of Covid, Moderna and Pfizer, the first companies to have a vaccine ready for widespread use, both received emergency-use authorization for their vaccines, despite the fact they had only been shown to produce antibodies. The pandemic emergency caused the government to move faster to approve vaccines than it would have under ordinary circumstances.
But even after the emergency passed, the same standard applied when vaccine makers updated their formulas for booster shots: Antibody production was enough to gain FDA approval. In 2022, when the FDA approved updated boosters that had been tested in mice—but not humans—the agency was deluged in criticism. “Frankly, the biggest downside is less the safety aspect and more the efficacy aspect,” Genevieve Kanter, assistant professor of medicine, medical ethics and health policy at the University of Pennsylvania, told Poynter at the time.
Dr. Paul Offit, a well-known pediatrician specializing in infectious diseases and a member of the FDA’s Vaccines and Related Biological Products Advisory Council, even told Time magazine that he was “uncomfortable” with the agency’s decision to green-light the updated vaccines. The agency’s decision to forgo extensive clinical trials was intended to keep pace with the evolution of the disease. But in their paper, which was shared exclusively with The Free Press, Prasad and Makary said that it was time to return to “gold-standard science.”
“We simply don’t know whether a healthy 52-year-old woman with a normal [body mass index] who has had Covid-19 three times and has received six previous doses of a Covid-19 vaccine will benefit from the seventh dose,” they wrote. “This policy will compel much-needed evidence generation.”
To Prasad, the new framework is a “common sense approach” that will put the U.S. “much closer to every country in Europe.” Countries such as France, the UK, and Sweden now limit Covid-booster recommendations to the elderly and immunocompromised. In stark contrast, the Centers for Disease Control and Prevention still urges everyone ages 6 months and older to get the 2024–2025 vaccine—regardless of prior infection, risk profile, or number of previous doses.
“We’re finally falling in line with all the other thoughtful people in the world who think it is ridiculous to give a healthy 12-year-old girl her seventh dose without any evidence,” Prasad said. “And we’re not saying we’re never going to do it—we’re just saying: Prove to me it helps her before we do it.”
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