FDA’s Stance on Covid-19 Vaccines for Children Faces Criticism
The FDA’s recent decision to not authorize Covid-19 vaccines for healthy children has sparked some debate. Many argue that if parents are interested in vaccinating their kids, shouldn’t they be able to? This line of thinking somewhat misses the point about FDA approval and its significance.
The FDA frequently approves medications based on risk assessments or incomplete evidence of effectiveness, which can be an acceptable trade-off for sick individuals. After all, for someone who is unwell, the alternative often means facing an untreated condition. However, vaccines—especially those administered to millions of healthy children—must meet much higher standards regarding safety, immune response, and long-term efficacy. A vaccine’s approval carries considerable weight and reflects institutional endorsement.
A historical case that illustrates the FDA’s approach to vaccine approval involves measles. Before the introduction of the measles vaccine in 1963, around 3-4 million people were infected each year in the U.S., leading to approximately 48,000 hospitalizations, about 1,000 cases of encephalitis, and 400-500 deaths. This tragic backdrop naturally prompted the question of why we wouldn’t vaccinate the most vulnerable, especially infants.
Initially, the vaccine was recommended for infants starting at nine months, but this age was raised to at least one year within a couple of years. This change wasn’t due to a belief that younger babies were not at risk or that the vaccine posed dangers, but rather because the vaccine’s effectiveness in this age group did not warrant a broad campaign.
Research has continued regarding the specific vulnerabilities of young infants in terms of measles vaccination. More recent trials concerning the measles/mumps/rubella (MMR) vaccine have demonstrated safety and antibody production in infants aged 5-7 months, yet the ability to deliver lasting protection against hospitalization remains unclear.
Consequently, the FDA does not approve the MMR vaccine for regular use in healthy children under 12 months. This decision underscores the importance of maintaining herd immunity for measles. Protecting the youngest infants relies heavily on the immunization of the population at large.
Now, concerning Covid-19 vaccinations for infants and children, there’s evidence showing robust antibody responses—often more pronounced than in adults. But the real-world benefits appear to be weaker, with a concerning pattern of short-lived immunity and mixed results in terms of protection. Before Covid-19 vaccines can be broadly administered to healthy children, they lack the robust evidence that U.S. regulators typically require.
Some advocate for parental and pediatrician autonomy in deciding on vaccinations, even where benefits might be marginal. Yet, FDA approval isn’t merely about personal choice. It’s a matter of public health affecting over 70 million healthy children. The safety evaluations must go beyond statistical assessments since even rare side effects can have harmful implications on a large scale. The initial hope surrounding immune responses from the Covid-19 vaccine suggested benefits at the population level, but early signs of optimism have steadily diminished over recent years due to disappointing clinical outcomes.
The takeaways from the measles example are evident: vaccines can be safe yet ineffective enough to preclude their authorization for specific age groups. The same principle should apply to Covid-19 vaccines for healthy children. This isn’t about financial motivations but rather about meeting stringent standards of efficacy seen in other vaccines. Without sufficient evidence to support clinical effectiveness, the FDA is right to decline approval at this time.
