Robert F. Kennedy Jr. has drawn intense criticism—much of it deserved—for his stance on vaccines. But lost in the uproar is a surprising fact: many of his ideas for improving American health align with mainstream medical thinking.
As a medical school professor and former senior official at the U.S. Department of Health and Human Services, I understand the dangers of vaccine misinformation. Yet I’ve also watched Kennedy be vilified for promoting views long embraced by public health professionals. This raises a legitimate question: are his ideas the real problem—or is it the messenger?
Last week, officials appointed by Kennedy to lead the FDA called for randomized controlled trials (RCTs) to evaluate the safety and effectiveness of new vaccines. Critics were quick to label the proposal unethical, dangerous, or anti-science. But demanding rigorous evidence is the foundation of science, not a betrayal of it.
Take COVID-19 vaccines. Five years into the pandemic, only 23% of U.S. adults have received the latest booster, despite strong government recommendations. One reason may be growing public skepticism about the strength of the supporting evidence. Pew surveys show that 60% of Americans plan to skip the 2024–2025 shot. That skepticism isn’t entirely baseless. Over 83% of healthcare workers declined the 2023-2024 COVID booster.
Many of the updated COVID boosters were authorized based on limited preclinical data, sometimes just small animal studies. When human trials were conducted, they often included fewer than 50 participants. At the same time, boosters have been recommended across all age groups, despite the fact that serious COVID complications are overwhelmingly concentrated among older adults. CDC data show that 95% of Americans over age 50 have already received at least one dose, while children and young adults, who face much lower risk, are still encouraged to receive additional shots. Broad recommendations invite reasonable scrutiny.
Some argue that the science was “settled” by the original Pfizer and Moderna trials in 2021, which reported 95% efficacy. But those results referred only to mild, symptomatic infections. COVID occurred in less than 1% of participants in either group—0.05% in the vaccine group and 0.87% in the placebo group. The claim that the trials demonstrated a mortality benefit is incorrect. Among over 73,000 participants, there was just one COVID-related death, in the placebo group—not enough for meaningful statistical inference. Worse, two months after the data were reported, both trials unblinded participants and offered the vaccine to those in the placebo group, ending any chance to assess long-term outcomes.
Side effects were common. Compared to those receiving a placebo, vaccine recipients were 35 times more likely to experience a fever over 100.4°F, 5.6 times more likely to report injection site pain, and 5.6 times more likely to experience severe fatigue. A controversial reanalysis published in the peer-reviewed journal Vaccine found approximately one serious adverse event for every 800 vaccinated individuals. For context, the 1976 swine flu vaccine was pulled from the market after it was linked to Guillain-Barré syndrome at a rate of about 1 in 100,000.
Yes, observational studies suggest that vaccines reduce hospitalizations and deaths. But these studies are vulnerable to selection bias. People who choose vaccination often differ from those who decline it in many ways—age, education, income, health status, and political beliefs. Only randomized trials can adequately isolate the true effect of a vaccine, free from such confounding factors.
RCTs are the gold standard in medicine. We require them to test treatments for cancer, hypertension, and heart disease. Why should vaccines—especially those developed and authorized in record time—be exempt?
The FDA’s updated policy reflects the current understanding of COVID-19 risk, which is highest among adults over age 65. In response, the agency now recommends annual COVID-19 boosters for older adults, aligning U.S. guidelines with those of other high-income countries, including Australia, Canada, France, Germany, and the United Kingdom. Vaccines will remain available for both older adults and individuals with underlying health conditions that increase the risk of severe illness. For healthy individuals between 6 months and 64 years of age, the potential risks of vaccination may outweigh the benefits; therefore, further clinical trials will be encouraged to better assess vaccine safety and effectiveness in these groups.
Let me be clear: I’m not opposed to COVID boosters. I’ve taken them all, on schedule. People should have access to vaccines and make decisions in consultation with their physicians. But we also owe the public clear, current, and rigorous evidence. Conducting well-designed randomized trials isn’t fringe—it’s standard scientific practice.
Kennedy’s call for more rigorous science shouldn’t be dismissed out of hand simply because of who he is. Martin Makary and Vinay Prasad, the FDA’s newly appointed leaders, are both academic physicians with unusually distinguished research records. While not without controversy, they bring serious scientific credentials to the discussion.
If the latest vaccines and boosters are as effective and safe as claimed, high-quality trials will confirm it. If not, we deserve to know. Either way, public trust depends not on ideology, but on transparent, credible evidence.
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