The Fraught Legality of DIY Covid-19 Vaccines
Experts call on the FDA to regulate DIY vaccines — and on citizen scientists to respect safety protocols
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In the science community, concerns are mounting over the efforts of some researchers to create and distribute do-it-yourself (DIY) Covid-19 vaccines. These are vaccines that have been developed by citizen scientists — nonprofessional scientists and engineers, only some of whom are trained. Importantly, the vaccines haven’t undergone the rigorous clinical testing or government oversight that traditional vaccines are subject to.
People pursuing DIY vaccines contend that extraordinary measures are necessary in an emergency like a global pandemic, and that through self-experimentation, they can avoid the usual time-consuming scientific, legal, and ethical processes for vaccine development. Some test their vaccines on friends and family; one group, the Rapid Deployment Vaccine Collaborative (RaDVaC) has published a white paper on its vaccine design for anyone else to copy.
Leaders in the science community have raised the alarm about the potential impacts of DIY vaccines on personal and public health. DIY vaccine efforts are problematic because if they go awry, they could further damage public trust in vaccines and science, which is already woefully eroded. Furthermore, as my colleague Alexandra Sifferlin wrote at the beginning of September, “they bypass many important aspects of vaccine clinical trials — like testing for safety and effectiveness testing. It’s also an ethical nightmare.”
In a paper published in Science today, health and legal experts point out that doing so is also a legal nightmare. “Some of the interest in these do-it-yourself (DIY) approaches apparently stems from a belief that self-experimentation is never subject to time-consuming ethics board review of regulation,” they write. “This belief is legally and factually incorrect, and misunderstanding has potentially important public health implications.”
