On May 20, 2025, Marty Makary, the newly appointed FDA Commissioner, and Vinay Prasad, head of the Center for Biologics Evaluation and Research (CBER), released their proposed framework for annual COVID-19 vaccinations. This proposal was detailed in an op-ed titled “An Evidence-Based Approach to Covid-19 Vaccination” published in the New England Journal of Medicine. They argued that previous FDA decisions during the pandemic were not based on “gold-standard evidence,” leading to a decline in public trust not only in COVID-19 vaccines but in all vaccines.
Makary and Prasad’s framework suggests licensing the COVID-19 vaccine only for individuals under 65 who are considered high-risk. Additionally, they propose conducting a yearly prospective placebo-controlled trial involving healthy individuals aged 50 to 64.
The authors claim that “public trust in vaccination has declined.” However, they may be mistaken about the causes of this distrust and how it can be restored. The loss of trust began early in the pandemic when strict government measures were perceived as overreach. These measures included business closures, school shutdowns, travel restrictions, and mandates for testing, masking, and social distancing. In 2021, proof of vaccination became necessary for access to various public spaces. Many viewed these requirements as an infringement on personal freedoms.
Makary and Prasad believe that requiring placebo-controlled studies will help restore lost trust. However, retrospective studies by the CDC have already demonstrated that COVID-19 vaccines have remained safe and effective over recent years.
Retrospective studies conducted from 2022 to 2025 showed consistent effectiveness of mRNA COVID vaccines across all age groups regardless of risk factors. Safety data from these vaccines have been gathered from hundreds of millions of recipients worldwide. A study involving more than 100 million people confirmed the vaccine’s safety profile.
Paul A. Offit, MD contributed his perspective on this matter by stating that small-scale studies proposed by Makary and Prasad might add little value to existing knowledge about yearly COVID vaccinations.
