FDA Shifts COVID-19 Vaccine Policy to Focus on High-Risk Groups

The U.S. Food and Drug Administration (FDA) announced Tuesday, May 20 that it will limit routine approval of annual COVID-19 vaccines to individuals aged 65 and older and those at risk for severe illness. This move marks a significant departure from the previous strategy of universal vaccination and multiple boosters.

The new guidelines, released in an editorial by FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad in The New England Journal of Medicine, emphasize a more targeted approach to vaccination. The authors argue that the benefits of repeated COVID-19 vaccinations for healthy individuals under 65 are “uncertain” and that a "one-size-fits-all" strategy is no longer appropriate.

Key Changes in Policy:

• Targeted Vaccination: Routine annual COVID-19 vaccinations will now be recommended primarily for adults aged 65 and older and individuals with high-risk conditions, such as asthma, diabetes, cancer, obesity, and pregnancy
• Clinical Trials for Low-Risk Groups: Vaccine manufacturers will be required to conduct randomized, placebo-controlled trials to demonstrate the benefits of COVID-19 vaccines for healthy individuals under 65 before approval is granted
• Consideration of Natural Immunity: The FDA acknowledges that many Americans have acquired immunity through previous infections and vaccinations, reducing the necessity for universal annual boosters

Drs. Makary and Prasad highlight the need for evidence-based policies, stating, "We simply don’t know whether a healthy 52-year-old woman with a normal BMI who has had Covid-19 three times and has received six previous doses of a Covid-19 vaccine will benefit from the seventh dose.”

The policy shift is expected to affect access to COVID-19 vaccines for healthy individuals under 65, raising questions about insurance coverage and eligibility determinations at the pharmacy level.

Vaccine manufacturers, including Moderna and Pfizer, have indicated their willingness to cooperate with the FDA's new guidelines but have also defended the efficacy and broad utility of their vaccines.

The change in recommendations were first hinted at on May 15 by the Wall Street Journal and other outlets, as ALPolitics.com has previously reported.

Notably absent from the editorial and new guidelines was any mention of the mounting evidence of the significant toxicity, morbidity and mortality associated with the COVID-19 vaccines.

The FDA's advisory committee is scheduled to meet on May 22 to discuss updates to COVID-19 vaccine recommendations, including which virus variants to target for upcoming vaccines. The Centers for Disease Control and Prevention (CDC) is expected to finalize related recommendations on June 25.