MONIQUE YOHANAN: Why FDA Was Right To Say No To COVID-19 Vaccines For Healthy Kids

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