In 1938 the FDA was given regulatory authority over experimental drugs. But it wasn't until 1961 that it regulated clinical trials and their methods. In 1954, a foundation performed a methodologically controversial trial with 1.6 million children, ages 6 to 8. It was called the National Foundation for Infantile Paralysis's Salk Vaccine Trial. As we hurdle at "warp speed" to a COVID-19 vaccine, perhaps we can reflect on how much has changed, or not, in our search for safe, effective vaccines.
