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The AAP has serious concerns that children may not have access to COVID-19 vaccines this fall unless they have underlying health conditions.
Food and Drug Administration (FDA) leaders on Tuesday said they would approve updated vaccines based on immunogenicity data for all people ages 65 years and older and people under 65 years with one or more risk factors for severe disease, which are data that manufacturers typically submit each year. However, for healthy people ages 6 months to 64 years, new randomized, controlled trials would be needed before licensing the vaccines.
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.”
Martin A. Makary, M.D., M.P.H., FDA commissioner, and Vinay Prasad, M.D., M.P.H., director of the FDA’s Center for Biologics Evaluation and Research, laid out their plans Tuesday in a New England Journal of Medicine article and a town hall. 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 including children and more than 10,000 people have died this year, according to Centers for Disease Control and Prevention (CDC) data. COVID hospitalization rates for children under 5 years were similar to flu in the 2022-'23 and 2023-'24 seasons.
Still, Dr. Prasad said he does not believe a yearly schedule should be the default without good evidence of the benefit.
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.
“In this particular case, I think we have a really good balance,” he said. … “The people still at high risk will still have a rapid path to access, but people at average risk and low risk, they need evidence.”
Among children ages 6 months to 17 years hospitalized with COVID, 41% did not have an underlying condition, according to CDC data.
The FDA is recommending 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.”
The FDA’s Vaccines and Related Biological Products Advisory Committee is scheduled to meet Thursday to discuss the composition of the 2025-’26 COVID-19 vaccines.
