But there are also significant disadvantages to using the emergency use authorization as the legal basis for approving a COVID-19 vaccine for widespread use. Most such authorizations issued for drug and biological products (a category which doesn’t include medical devices such as diagnostic kits and ventilators) have involved post-exposure prophylaxis or treatments. But vaccines have quite different medical purposes compared to treatments for someone exposed to anthrax or to nerve agents. With vaccination, healthy people take a risk to prevent the possibility of future sickness. “Therapeutics are given to people who are sick, maybe even in life-threatening situations,” FDA Commissioner Stephen Hahn said in October. “Vaccines are given to people who are, in general, healthy but may be at risk for life-threatening complications.”
