22-05-2025
Concerned about losing access to COVID boosters? Here's how to make your voice heard.
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The FDA says the change reflects a more targeted and evidence-driven approach to vaccination. In their jointly published article, Makary and Prasad wrote that 'the benefit of repeat dosing — particularly among low-risk persons who may have previously received multiple doses of Covid-19 vaccines, had multiple Covid-19 infections, or both — is uncertain.' The goal, they added, is to produce 'gold-standard data on persons at low risk.'
Some public health experts warn that if boosters are no longer authorized for healthy people under 65, insurers could stop covering them — making the shots more expensive or entirely out of reach, especially for low-income families, essential workers, and communities already facing barriers to care — and further eroding public trust in vaccines.
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'I don't think anything that they're proposing is going to make these vaccines safer. I don't think anything that they're proposing is going to make these vaccines more effective,' said Dr. Paul Offit, a virology and immunology expert at the Children's Hospital of Philadelphia. 'I think their basic premise, that they will once again regain lost public trust in vaccines by setting it up the way they're doing, is also wrong.'
He added: 'It's a false solution for a false premise. The reason people don't get vaccinated is because they don't fear the disease anymore. They think COVID is not a problem, they read a lot of misinformation about the vaccine — including from our current Secretary of Health and Human Services.'
COVID vaccines, including boosters for healthy people under 65, have been authorized each year based on safety and efficacy data reviewed by FDA and CDC advisory panels. Offit and other critics argue that the agency's new approach disregards this
Dr. Robyn Riseberg, founder of Boston Community Pediatrics, said her primary concern is how the policy change was proposed.
'The biggest issue for me is that the process that we created is not being followed,' she said.
Riseberg noted that the decision was published in a journal without review by two longstanding external advisory panels — the FDA's
Vaccines and Related Biological Products Advisory Committee (VRBPAC) and the Advisory Committee on Immunization Practices (ACIP), which advises the Centers for Disease Control and Prevention. 'When you take out those panels of experts and just let, in this case, two people make a decision, I think you're setting a precedent for not using scientific evidence to guide national policy,' she said.
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'The people who will be harmed the most are the people who are the most vulnerable,' Riseberg added. 'Kids and people living in poor housing conditions, with asthma, or other risk factors,' she said.
Some public health advocates worry that this approach — limiting access to a widely used product based on narrower evidentiary standards — could be used to justify restrictions on other vaccines or medications in the future.
Offit shared that concern. 'We have a head of Health and Human Services who has for 20 years been anti-vaccine because he believes that vaccines cause far more harm than good,' he said. 'He believes vaccines have replaced infectious diseases with chronic ones. I think he will do everything he can in his power to make [vaccines] less available, less affordable.'
The public has the opportunity to weigh in. As part of the federal rulemaking process, the FDA is accepting public comments through an online portal until 11:59 p.m. EST on Friday, May 23. Anyone can submit feedback — supportive or critical — by visiting
Nathan Metcalf can be reached at