The Food and Drug Administration is rewriting America’s Covid vaccine playbook — and not for the better. Its new guidance would trade the clarity and reach of our current vaccination strategy for a confusing age-based and risk-based framework that simply doesn’t fit the realities of Americans’ health. As a primary care physician who has spent years on the front lines of pandemic response, I see this as a step backward that ignores both the lessons of our past and the needs of our most vulnerable patients.
The FDA’s proposed framework eerily mirrors the segmentation we attempted in fall 2021 with Covid boosters. When boosters initially rolled out in September 2021, the FDA authorized them only for specific groups: adults 65 and older, those 18-64 with high-risk conditions, and those with occupational exposure risks.
The timeline for completing such studies would make timely vaccine updates nearly impossible.
The approach failed. As someone who had to explain these complex eligibility requirements to confused patients, I can attest to the chaos it created. This limited approach created tremendous confusion among health care providers and patients alike. Pharmacies and clinics struggled to verify eligibility, people misunderstood their risk category and, ultimately, many high-risk individuals who genuinely needed boosters never received them.
By December 2021, less than 30% of fully vaccinated Americans had received a booster, including just 54% of those 65 and older. These disappointing numbers reflect the practical failure of risk-stratified approaches in real-world settings.
Not only does the FDA ignore past failures, it makes new impractical demands. The agency’s commissioner, Dr. Marty Makary, and its vaccine chief, Dr. Vinay Prasad, demand any updated vaccines undergo randomized, placebo-controlled trials (RCT) for healthy adults under 65.
But the timeline for completing such studies would make timely vaccine updates nearly impossible. Respiratory viruses evolve rapidly, and waiting for completed RCTs before authorizing new vaccines means we’ll perpetually be playing catch-up with viral evolution. In addition, the cost and complexity of conducting these trials will likely result in manufacturers simply not pursuing approval for younger populations. That will artificially restrict access, based not on medical needs but on regulatory hurdles.
Then there are the ethical concerns of asking 50 to 64 year olds — many of whom may have undiagnosed conditions that increase their risk — to potentially receive saline instead of protection against a circulating pathogen. Most frustratingly, such risks are entirely unnecessary. We already have robust real-world evidence systems that could provide the same safety and effectiveness data without these drawbacks. The Centers for Disease Control and Prevention’s existing surveillance networks, health care database analyses, and test-negative design studies have repeatedly demonstrated their value for vaccine evaluation.
Clear, simple public health messaging works better than complex eligibility criteria.
In making their case, Makary and Prasad argue that the United States should be consistent with Europe’s approach to vaccines policies. But America’s vaccine policy is different for good reasons. While nations like France restrict flu vaccine recommendations to those 80+ and high-risk individuals, and Germany focuses on those 60+ and high-risk groups, the U.S. has successfully adopted a universal flu vaccination recommendation for everyone 6 months and older since 2010.
This universal approach makes sense for the U.S. because Americans have higher rates of chronic conditions, which increase vulnerability to respiratory viruses. According to CDC data, approximately 90% of people hospitalized with influenza have at least one chronic medical condition. The 47% of adults aged 50 to 64 with one or more chronic conditions account for 68% of influenza-related hospitalizations in their age group — and 69% of deaths. Even among younger adults aged 18 to 49, the 14% with chronic conditions represent nearly 30% of hospitalizations and deaths in their age bracket. When we combine these statistics with America’s obesity rates and the practical challenges of identifying at-risk individuals, the universal approach becomes not just reasonable but necessary. The FDA’s proposal ignores this success and the public health infrastructure built around it. Instead of this misguided approach, the FDA should bolster real-world evidence-collection systems while maintaining a universal Covid vaccination recommendation. A recommendation is not a requirement: people can still choose not to be vaccinated. But we need policies that reflect the reality of health care, and clear, simple public health messaging works better than complex eligibility criteria. The universal influenza vaccination approach has served us well for over a decade. Creating artificial barriers to Covid vaccines based on age and narrowly defined risk factors will cause unnecessary confusion and ultimately harm public health. As a primary care physician, I want what’s best for my patients — straightforward guidance based on real-world practicality, not regulatory frameworks that ignore the lessons we’ve already learned. Those lessons came at great costs — costs we risk suffering again.
Dr. Kavita Patel
Dr. Kavita Patel is a teaching professor of medicine, Division of Hospital Medicine, at Stanford University and a board-certified internal medicine physician. She served in the Obama administration as director of policy for the Office of Intergovernmental Affairs and Public Engagement in the White House. Her area of expertise is around the intersection of health policy, clinical medicine and innovation. She also spends time advising venture capital and is a medical contributor for NBC News. 
