FDA: Coronavirus Q&As for ConsumersDec 11, 2020
The FDA is working to address the coronavirus disease 2019 (COVID-19) outbreak and keep you and your family informed on the latest developments. Here are answers to some frequently asked questions from consumers about vaccines.
Q: What is the FDA’s role in approving vaccines and what is being done to produce a COVID-19 vaccine?
A: The FDA regulates vaccines. Vaccines undergo a rigorous review of laboratory and clinical data to ensure the safety and effectiveness of these products. A vaccine approved for marketing may also be required to undergo additional studies to further evaluate the vaccine and often to address specific questions about the vaccine's safety, effectiveness, or possible side effects.
There are currently no approved vaccines available for the prevention of COVID-19. The FDA is helping expedite clinical trials for vaccines by providing timely advice to, and interactions with, vaccine developers. The FDA is also supporting product development and scaling up of manufacturing capacity for high priority vaccines for COVID-19.
The FDA held a public meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) at 9 a.m. Thursday, Dec. 10, to discuss a request for Emergency Use Authorization (EUA) of a COVID-19 vaccine.
The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. To watch the web conference meeting, visit:
Although the VRBPAC members provide advice to the agency, which may include advice on the safety and effectiveness data submitted in the EUA request, final decisions on whether to authorize the vaccine for emergency use are made by the FDA.
For information about vaccine clinical trials for COVID-19, visit clinicaltrials.gov and the COVID-19 Prevention Network. Note: The information on clinicaltrials.gov is provided by the sponsor or principal investigator of a clinical trial. The listing of a study on the site does not reflect evaluation or endorsement of the trial by the Federal government.