FDA’s narrow COVID-19 vaccine label ignores science and puts millions of lives at risk

COVID-19 vaccines remain our best tool to prevent severe disease, hospitalization and death due to COVID-19 — for healthy adults, children, pregnant patients and others at higher risk. The scientific evidence continues to strongly support broad vaccination far beyond the limited populations outlined in the Food and Drug Administration’s new label. By narrowing its approval, FDA has made a decision that completely contradicts the evidence base, severely undermines trust in science-driven policy and dangerously limits vaccine access, removing millions of Americans’ choice to be protected and increasing the risk of severe outcomes from COVID. 

The American Academy of Pediatrics recently reaffirmed its recommendation for vaccination in children, and IDSA is working with other medical societies to finalize updated guidelines for COVID vaccination in both healthy and immunocompromised adults as part of our comprehensive respiratory virus guidance for this fall and winter. IDSA’s recommendations are expected to be released in September. 

Physicians can still provide COVID vaccines off-label, and IDSA strongly urges doctors to continue recommending and administering vaccination to their patients based on the best available science. However, pharmacists’ ability to provide off-label vaccines may be severely constrained, underscoring the vital role of physicians and other clinicians in maintaining access. 

IDSA calls on insurers to continue covering COVID vaccines consistent with multiple medical society recommendations and scientific evidence, and we urge Congress to conduct strong oversight of the Administration’s decision to restrict Americans’ freedom to choose vaccination as we approach the upcoming respiratory virus season. 

— Tina Tan, MD, FIDSA, FPIDS, FAAP — President, IDSA 

About IDSA 

The Infectious Diseases Society of America is a global community of 13,000 clinicians, scientists and public health experts working together to solve humanity’s smallest and greatest challenges, from tiny microbes to global outbreaks. Rooted in science, committed to health equity and driven by curiosity, our compassionate and knowledgeable members safeguard the health of individuals, our communities and the world by advancing the treatment and prevention of infectious diseases. Visit idsociety.org to learn more.