Pope Francis gives a vaccine to Rodrigo Lopez Miranda, 5, held by Mexico's first lady Angelica Rivera during a visit to the Federico Gomez Children's Hospital of Mexico in Mexico City Feb. 14. (CNS photo/Paul Haring) See POPE-MEXICO-HOSPITAL Feb. 14, 2016.
Vaccines Licensed for Use in the US
The Center for Biologics Evaluation and Research (CBER) regulates vaccine products.
Vaccines to prevent infectious diseases are given to millions of babies, children, adolescents and adults and they must be demonstrated to be safe and effective. FDA requires that vaccines undergo a rigorous and extensive development program in the laboratory, as well as in animal studies and human clinical trials, to determine their safety and effectiveness. Highly trained FDA scientists and physicians thoroughly evaluate the information in a marketing application and decide whether to license (approve) a vaccine before it can be used in the United States. Before approval, as part of the FDA’s evaluation, the FDA takes all of the ingredients of a vaccine into account. After the FDA approves a vaccine, the FDA continuously monitors its safety.
Status: 12/01/2023
Source: FDA
