CRS report via LC – Legal Issues in COVID-19 Vaccine Development and Deployment, Updated November 25, 2020 – “Private companies, universities, and governmental entities are working to develop a vaccine for coronavirus disease 2019 (COVID-19). Vaccines are biological products regulated under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act (FD&C Act). New vaccines must generally be licensed by the U.S. Food & Drug Administration (FDA) before they can be marketed and used in the United States. To obtain licensure, the vaccine must be tested in human subjects through clinical trials. The clinical trials inform the dosing schedule and labeling that will be used for the approved vaccine. Sponsors use the data from clinical trials, along with other information, to prepare a biologics license application (BLA) to submit to FDA. FDA approves the BLA if it determines that the vaccine is safe, potent, and pure…Even if widely available and affordable, a COVID-19 vaccine can only prevent outbreaks if enough members of a community are vaccinated to achieve herd immunity. One legal tool fo rincreasing vaccination rates is for the government to require it. Courts have typically interpreted states’ general police power to promote public health and safety as encompassing the authority to mandate vaccination. Congress’s authority to mandate vaccination, on the other hand,must emanate from its enumerated powers in the Constitution. Two potential sources of such power, the Spending Clause and the Commerce Clause, are subject to certain constraints that can limit the scope of a federal vaccination mandate..”