On May 20, 2025, Marty Makary, the new FDA Commissioner, and Vinay Prasad, the new head of the Center for Biologics Evaluation and Research (CBER), which regulates vaccines, published their framework for yearly COVID vaccines in an op-ed (Prasad V and Makary M. An Evidence-Based Approach to Covid-19 Vaccination. N Engl J Med. 2025 May 20. DOI: 10.1056/NEJMsb2506929). The authors suggested that decisions by the FDA during this pandemic hadn’t been based on “gold-standard evidence.” Consequently, the American public had lost trust not only in COVID-19 vaccines, but in all vaccines. This new framework, they argued, would restore that trust, in part by 1) licensing the COVID-19 vaccine for only those less than 65 years of age who are in high-risk groups, and 2) requiring a prospective, placebo-controlled trial every year in otherwise healthy people 50-64 years of age.
Makary and Prasad were right to claim that “public trust in vaccination has declined.” But they are wrong about what caused it or how it can be restored. Loss of trust in vaccines occurred early in the COVID pandemic. In 2020, when the virus was killing hundreds of people a day — and vaccines, monoclonal antibodies and antiviral drugs weren’t available — the U.S. government closed businesses, shuttered schools, restricted travel, and insisted on testing, masking and social distancing. Many Americans perceived these measures as massive government overreach. The following year, 2021, when vaccines were available, people couldn’t visit their favorite bars or restaurants or sporting events or places of worship without proof of vaccination. Many who refused vaccines were fired from work. Again, this was seen as a heavy-handed government impinging on our freedoms. Makary and Prasad are now arguing that requiring placebo-controlled studies for yearly COVID vaccines will restore lost trust. But retrospective studies done by the CDC have already shown that the COVID-19 vaccines have remained safe and effective during the past few years.
Retrospective studies of people who did or did not receive yearly COVID vaccines were performed in 2022-2023, 2023-2024, and 2024-2025. While retrospective studies aren’t perfect, these studies consistently showed that mRNA COVID vaccines remained effective in preventing COVID in all age groups, independent of risk factors, for at least several months. Regarding safety, the mRNA COVID vaccines have been administered to hundreds of millions of people. Arguably, no vaccine has been better studied. A study of more than 100 million people found that the vaccine is remarkably safe. The small studies of healthy adults aged 50-64 years proposed by Makary and Prasad will likely add little to nothing to what we already know about yearly COVID vaccines.
Contributed by: Paul A. Offit, MD
On May 20, 2025, Marty Makary, the new FDA Commissioner, and Vinay Prasad, the new head of the Center for Biologics Evaluation and Research (CBER), which regulates vaccines, published their framework for yearly COVID vaccines in an op-ed (Prasad V and Makary M. An Evidence-Based Approach to Covid-19 Vaccination. N Engl J Med. 2025 May 20. DOI: 10.1056/NEJMsb2506929). The authors suggested that decisions by the FDA during this pandemic hadn’t been based on “gold-standard evidence.” Consequently, the American public had lost trust not only in COVID-19 vaccines, but in all vaccines. This new framework, they argued, would restore that trust, in part by 1) licensing the COVID-19 vaccine for only those less than 65 years of age who are in high-risk groups, and 2) requiring a prospective, placebo-controlled trial every year in otherwise healthy people 50-64 years of age.
Makary and Prasad were right to claim that “public trust in vaccination has declined.” But they are wrong about what caused it or how it can be restored. Loss of trust in vaccines occurred early in the COVID pandemic. In 2020, when the virus was killing hundreds of people a day — and vaccines, monoclonal antibodies and antiviral drugs weren’t available — the U.S. government closed businesses, shuttered schools, restricted travel, and insisted on testing, masking and social distancing. Many Americans perceived these measures as massive government overreach. The following year, 2021, when vaccines were available, people couldn’t visit their favorite bars or restaurants or sporting events or places of worship without proof of vaccination. Many who refused vaccines were fired from work. Again, this was seen as a heavy-handed government impinging on our freedoms. Makary and Prasad are now arguing that requiring placebo-controlled studies for yearly COVID vaccines will restore lost trust. But retrospective studies done by the CDC have already shown that the COVID-19 vaccines have remained safe and effective during the past few years.
Retrospective studies of people who did or did not receive yearly COVID vaccines were performed in 2022-2023, 2023-2024, and 2024-2025. While retrospective studies aren’t perfect, these studies consistently showed that mRNA COVID vaccines remained effective in preventing COVID in all age groups, independent of risk factors, for at least several months. Regarding safety, the mRNA COVID vaccines have been administered to hundreds of millions of people. Arguably, no vaccine has been better studied. A study of more than 100 million people found that the vaccine is remarkably safe. The small studies of healthy adults aged 50-64 years proposed by Makary and Prasad will likely add little to nothing to what we already know about yearly COVID vaccines.
Contributed by: Paul A. Offit, MD