Blackletter

Today, we're going to talk about legal issues in the COVID-19 vaccine development arena. A big challenge from a legal perspective is how can these companies get the vaccine to us? Typically when you're developing a new vaccine or anything for use inside of a human being, the FDA under the FD and C Act, the Federal Food, Drug and Cosmetics act, and the Public Health Service Act regulates the development of vaccines and anything that gets injected into your body. And there's a good reason for that and typically it takes a long time. These companies have to go through a series of clinical trials and they have to produce results to the FDA and the FDA has to come back, but there is a provision of the FD and C Act called an EUA, Emergency Use Authorization, and let's see if this happens. For the FDA to issue this EUA, which basically allows temporarily the use of an unapproved product, or an approved product for unapproved uses, the FDA has to go through the secretary of Health and Human Services. And the secret