The US Food and Drug Administration is introducing a stricter policy for COVID-19 vaccines, prioritizing immunizations for people at highest risk for serious complications from the disease. This new approach would require vaccine manufacturers to conduct additional large studies to evaluate safety and effectiveness in children and younger healthy adults.
Under the new policy, annual boosters won’t be automatically recommended for everyone; instead, they’ll be aimed at older individuals and those with health risks. For others, additional studies would need to show the benefits of vaccination outweigh risks. This change could limit access to vaccines for up to 100 million Americans who were previously eligible.
Critics argue that this approach bypasses input from independent outside advisers and ignores evidence showing vaccines are safe and effective. Insurers may also no longer pay for some vaccinations, potentially limiting accessibility. Experts disagree on the necessity of these changes, with some arguing it’s unethical to perform clinical studies involving placebos due to the ongoing threat of SARS-CoV2.
The move aims to balance regulatory flexibility and commitment to gold-standard science, according to FDA Director Dr. Vinay Prasad. An independent advisory committee will discuss new COVID booster compositions later this week.
Source: https://www.npr.org/sections/shots-health-news/2025/05/20/nx-s1-5405013/fda-covid-vaccine-limits