Last week, the American Academy of Pediatrics broke with the Centers for Disease Control and Prevention and declared that COVID-19 vaccination for young children is “evidence-based.” Its case rests on one fact: Children under 2 are still being hospitalized with COVID-19, at rates comparable to adults in their 50s and early 60s.
That fact is real. But it does not justify routine vaccination of healthy infants and toddlers. The burden of proof for vaccinating healthy people appropriately is high: The vaccine must consistently show a clinical benefit. And for COVID-19, it simply does not.
What is the best evidence in favor of COVID-19 vaccination? A trial in infants and toddlers that was designed to measure the prevention of infections, not hospitalizations, found 51% effectiveness. A study in children aged 5-11 found 68% effectiveness against hospitalization, but the confidence interval was so wide that the true number could be as low as 42%. CDC’s own VISION studies showed transient benefits, and similarly wide confidence intervals, not for hospitalization, but for decreases in emergency department utilization that lasted a few months. These are the strongest, most favorable results.
It is not that there is no evidence, but even the most favorable findings do not rise to the level that vaccine advisory bodies use to justify universal vaccination. Put together, the available literature is too thin, too inconsistent, and has not shown the level of durability that would be necessary to justify universal use in healthy children.
These findings were what led to an international consensus that there was insufficient evidence to continue recommending routine vaccination in children, actions that were taken in 2023 by the World Health Organization, Canada’s National Advisory Committee on Immunization, and the United Kingdom’s Joint Committee on Vaccination and Immunisation.
It is telling that the AAP compared children under 2 to adults aged 50-64. In 2023, these same international agencies pulled back on routine vaccinations in most adults. Which healthy adults are still recommended to get the shot? The WHO sets it at age 60 and older, the NACI at 65 and older, and the JCVI at 75 and older. The AAP was right to compare healthy infants and toddlers to healthy adults aged 50-64. The evidence for COVID-19 vaccination is similarly disappointing, whether in a 6-month-old infant or a 60-year-old adult.
How did we get here? In September 2021, the CDC quietly redefined “vaccine.” Before September 2021, a vaccine was “a product that stimulates a person’s immune system to produce immunity to a specific disease, protecting that person from that disease.” After COVID-19, it became “a preparation that is used to stimulate the body’s immune response against diseases.”
That change in language allows agencies such as the AAP to cite safety and antibody studies and say they are taking an evidence-based position, even when the medical literature doesn’t support a benefit to patients. By the new definition, it is fair to say that the COVID-19 vaccine is “effective.” But effective at what? It is a change in definition that conveniently skips what matters: not antibody levels in a lab, but protecting patients.
There are diseases, such as measles, in which the rise in antibodies is a valid surrogate marker, but that’s because in measles, antibody levels correlate tightly with actual disease protection. In contrast, while COVID-19 vaccination causes a rise in antibody levels, the link to preventing infection, let alone hospitalization, in children is weak, short-lived, and inconsistent at best.
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The instinct to do something, anything, when young children are sick is understandable. But it is unethical to recommend universal vaccination of healthy people when we don’t have sufficient evidence that the vaccine provides protection from a disease. Safety is essential, but whether or not the vaccine is safe is irrelevant if it doesn’t demonstrate a clinical benefit.
The AAP isn’t wrong that young children are at risk of being hospitalized. It is wrong to claim that there is meaningful evidence that vaccination prevents those hospitalizations. By leaning on a hollow definition of what makes a successful vaccine, it has put U.S. pediatrics out of step with the rest of the world. Redefining words doesn’t redefine reality: Until a vaccine consistently shows that it protects patients, it has no place in universal recommendations.
Dr. Monique Yohanan has a master’s degree in public health, is a senior fellow at Independent Women, a physician executive and healthcare innovation leader, and chief medical officer at Adia Healthcare.