 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, clinical, and manufacturing data to ensure the safety and effectiveness of these products. Vaccines 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. On Dec. 11, 2020, the FDA issued an Emergency Use Authorization (EUA) for the use of the Pfizer-BioNTech COVID-19 Vaccine. On Dec. 18, 2020, the FDA issued an EUA for the use of the Moderna COVID-19 Vaccine. The issuance of an EUA is different than an FDA approval (licensure) of a vaccine. Learn more about EUAs in this video. In determining whether to issue an EUA for a product, the FDA evaluates the available evidence and assesses any known or potential risks and any known or potential benefits. And if the benefit-risk assessment is favorable, the product is made available during the public health emergency. Once a manufacturer submits an EUA request for a COVID-19 vaccine, the FDA then evaluates the request and determines whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to the agency. In addition to supporting product development for high priority COVID-19 vaccines, the FDA continues to expedite clinical trials for additional vaccine candidates, providing timely advice to and interactions with vaccine developers. Q: Can the FDA help me get a COVID-19 vaccine? A: No. The FDA's authority includes authorizing or approving COVID-19 vaccines for use in the United States, but the FDA is not responsible for vaccine distribution. Go to the Centers for Disease Control and Prevention website to find your state and local health departments that are responsible for COVID-19 vaccine distribution. Address all questions and concerns to your state government or local health department. The U.S. government's goal is to have enough COVID-19 vaccine doses for all people in the United States who choose to be vaccinated. If you are contacted directly by someone who says they are from the FDA about a COVID-19 vaccine appointment, it is a scam. The Federal Trade Commission has easy tips on how to avoid COVID-19 vaccine scams. The FDA encourages you to report a potential COVID-19 drug or medical product scam on our website. Learn how to protect yourself and your family from coronavirus fraud in this article. For more information about COVID-19, visit: | 
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