1. United States
2. Maine
3. Letter

I am writing to express my strong concern regarding the recent decision by the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) to require placebo-controlled trials for updated COVID-19 vaccines before approval. This policy change represents a radical departure from the well-established and effective process that has been used to update COVID vaccines to address emerging variants.   For years, the current system-relying on immunogenicity data and prior vaccine efficacy-has allowed timely updates to COVID vaccines, similar to the annual flu vaccine model, ensuring rapid protection against new variants without unnecessary delays. This approach has worked well, enabling millions of Americans who want protection against COVID to access vaccines safely and efficiently.   Requiring new placebo-controlled trials for each updated vaccine will significantly slow down the availability of these critical vaccines. It risks depriving people who want to be vaccinated from timely access, not due to medical reasons but because of political ideology influencing regulatory decisions. Those who do not wish to take the vaccine remain free to decline it; however, preventing willing individuals from receiving updated vaccines is neither safe nor fair.   Congress must intervene to ensure that updated COVID vaccines continue to be authorized on the established schedule using the proven regulatory framework. This will protect public health by maintaining vaccine availability and preventing unnecessary barriers that could increase COVID-related illness and death. Thank you for your attention to this urgent matter. I urge you to demand that the FDA maintain its current process for updating COVID vaccines without imposing placebo trial requirements that would hinder timely access.