The FDA’s decision not to authorize COVID-19 vaccines for healthy children has drawn criticism. Some argue: If parents want the shot, why not let them get it for their kids? That argument misunderstands what FDA authorization means — and why it exists.
The FDA often approves drugs that carry risks or have imperfect evidence of effectiveness. This is a tradeoff we sometimes accept for people who are ill: when someone is already sick, the alternative is untreated disease. Vaccines are different. They are given to millions of healthy children. This requires a higher standard, not just evidence for safety and immune response, but clear, durable clinical effectiveness. Approval for optional use isn’t neutral; once the FDA authorizes a vaccine, it carries the full weight of institutional endorsement.
Measles provides an example for how the FDA approaches vaccine approvals. Before the measles vaccine was introduced in 1963, the U.S. saw 3 to 4 million infections, ~48,000 hospitalizations, ~1,000 cases of encephalitis, and 400-500 deaths each year. Infants bore the brunt of the most severe outcomes.
That created a natural instinct: why not vaccinate the youngest and most vulnerable? The initial measles rollout was to 9-month-olds, but within two years that timing was changed to children who were at least 1 year of age. This was not because younger babies were not at risk or that the vaccine was riskier for them, but because it just didn’t work well enough to justify a universal campaign.
The knowledge of the particular risk younger infants face has led to continued research on the effectiveness of measles vaccination in that group. A 2023 trial of the combined measles/mumps/rubella (MMR) vaccine in infants aged 5-7 months, and subsequent safety and immune studies in 2024 and 2025, produced consistent results—safety and the ability to generate antibodies were demonstrated, but a durable response and protection against hospitalization were not.
That is why the FDA does not approve MMR for routine use in healthy children younger than 12 months of age. It is also precisely why getting back to herd immunity for measles is so essential: the youngest infants can only be protected if the rest of us are immunized.
What’s the evidence for COVID-19 vaccination in infants and children? It generates robust antibodies, often higher than in adults. But clinical benefits are modest, short-lived, and inconsistent. It is nowhere near the level of proof U.S. regulators require before making a vaccine universally available to healthy kids.
Some argue that even if benefits are modest, parents and pediatricians should be free to choose. But FDA authorization is not about personal preference; it is a stamp of approval for more than 70 million healthy children. Statistical safety is not enough. At that scale, even rare risks mean real harm to real children. COVID-19 vaccines were originally authorized in the hope that immune responses would translate into population-level benefits. For healthy children, the initial optimism sparked by early encouraging signals has steadily given way to three years of disappointing clinical results.
The lessons from measles are clear: safe but minimally effective isn’t enough. We don’t authorize MMR for 5-month-olds, even to parents who might want their children to get it. COVID-19 vaccines for healthy children should be judged similarly. This is not because there is a lack of any benefit, but because it doesn’t rise to the level we use for other vaccines. Only if and when proof of clinical effectiveness becomes available should authorization be reconsidered. At this time, the FDA is right to say no.
Monique Yohanan, MD, MPH, is a senior fellow at Independent Women, a physician executive and healthcare innovation leader, and Chief Medical Officer at Adia Health.
The views and opinions expressed in this commentary are those of the author and do not reflect the official position of the Daily Caller News Foundation.
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