COVID-19 Frequently Asked Questions | FDA

COVID-19 Frequently Asked Questions | FDA

The FDA is working to address the coronavirus disease (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. Vaccines approved for marketing may also be required to undergo additional studies after approval 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 vaccines available for the prevention of COVID-19. The FDA is expediting 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. Vaccine developers can find more info about the review process here. For more information on vaccines, see: Vaccines Protect Children From Harmful Infectious Diseases Prepare for Flu Season With the Flu Vaccine Vaccines for Children - A Guide for Parents and Caregivers Q: Are there any vaccines or other medical products to prevent COVID-19? A: At this time there is no vaccine to prevent coronavirus disease 2019 (COVID-19). The FDA is working with vaccine developers and other researchers and manufacturers to help expedite the development and availability of medical products such as vaccines, antibodies that come from the blood of people who recovered from COVID-19, and drugs to prevent COVID-19. Read more about what the FDA is doing to mitigate the effects of COVID-19.