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 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.