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On Tuesday, U.S. Food and Drug Administration (FDA) Commissioner Marty Makary and top U.S. vaccines regulator Dr. Vinay Prasad wrote in the New England Journal of Medicine that the FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under age 65, essentially restricting them to older adults and those at risk of developing severe illness. The two FDA administrators said the benefit of repeated annual shots for healthy adults was uncertain during the past five years of the virus circulating and vaccines being available. Makary and Prasad have been critical of U.S. COVID-19 vaccine policies and had previously indicated that they were under review, Reuters reported. In addition to the journal article, the two conducted a town hall during which they questioned the benefit of additional vaccine doses when many people already have had multiple doses and/or infections. They also cited low vaccination rates this year and declining hospitalizations. However, the COVID-19 virus still causes illness in millions of people, and 11,577 people have died from the virus through May 10, according to U.S. Centers for Disease Control and Prevention (CDC) data. COVID-19 hospitalization rates for children under 5 years were similar to flu in the 2022-23 and 2023-24 seasons. Among children ages 6 months to 17 years hospitalized with COVID-19, 41% did not have an underlying condition, according to CDC data. Makary and Prasad said they expect the FDA will be able to approve the boosters for adults over the age of 65 years based on data from tests that measure immune response in patients. The shots would also be available for everyone over the age of six months with one or more issues that put them at high risk for severe COVID-19 outcomes, they said. The people at high risk include those with asthma, cancer, diabetes, pregnancy, heart conditions, immunocompromise, obesity, and mental health conditions, among others. Dr. Prasad estimated 100 million to 200 million people still would be eligible for vaccination. Members of the American Academy of Pediatrics (AAP) expressed serious concerns that children may not have access to COVID-19 vaccines this fall unless they have underlying health conditions. Dr. Sean T. O’Leary, M.D., M.P.H., FAAP, chair of the AAP Committee on Infectious Diseases, said the plan “ignores all the work that’s already been done looking at effectiveness and safety of this (vaccine).” “The COVID-19 vaccine is safe, effective and the best way to protect children,” Dr. O’Leary said. “If the vaccine were no longer available or covered by insurance, it will take the choice away from families who wish to protect their children from COVID-19, especially among families already facing barriers to care.” The FDA is recommending that vaccine manufacturers conduct randomized, placebo-controlled trials for people ages 50-64 years without risk factors and follow them for at least six months. Manufacturers also could choose to perform trials for younger populations. Dr. O’Leary questioned how full clinical trials would be performed in time to be ready for the season and noted the vaccines have been studied thoroughly. The FDA plan also circumvents the usual process whereby the FDA approves vaccines based on reviews of laboratory and clinical data to ensure their safety and efficacy. The CDC’s Advisory Committee on Immunization Practices then decides who to recommend for vaccination. That group already was evaluating whether to make a risk-based recommendation but had indicated it planned to make vaccines available to anyone who wants one. It is due to discuss the issue in June. Dr. O’Leary said the new process could create confusion instead of building the necessary trust and confidence in vaccines. “The way we license and recommend vaccines in the U.S. is really a model for much of the world and to circumvent that process in this manner is deeply concerning,” he said. In addition, the plan does not address protecting people from post-COVID conditions. “Just as we are seeing with the current measles outbreak, lower vaccination uptake means more disease,” Dr. O’Leary said. “When everyone has access to immunizations, our communities and our children are healthier.”

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