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 endors