[20200324]LSB10427_新冠病毒-19：新疫苗上市的法律考虑.pdf

CRS Legal Sidebar Prepared for Members and Committees of Congress Legal SidebarLegal Sidebari i COVID-19: Legal Considerations for Bringing a New Vaccine to Market March 24, 2020 As the number of confirmed COVID-19 cases increases at an accelerating rate, interest has grown in developing a COVID-19 vaccine as an avenue for addressing the pandemic. Media reports indicate that a number of countries and companies are working on developing a vaccine. The National Institute of Allergy and Infectious Diseases (NIAID) and the biotechnology company Moderna, Inc., recently initiated the first clinical trials of a potential vaccine in the United States at a hospital in Seattle. However, developing a new vaccine and obtaining approval to market it can take a long time. This Sidebar discusses the licensure (i.e., approval) process for vaccines under the Public Health Service Act (PHS Act) and the federal Food, Drug, and Cosmetic Act (FD&C Act), as well as potential legal avenues for expediting that process to bring a new vaccine to market sooner. FDA Approval of New Vaccines Vaccines are intended to prevent diseases and generally work by introducing pathogens to the human body (usually by inje