 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 emergency use authorizations (EUA), and vaccines for adolescents.
Q: What is an emergency use authorization, and how is it being used to respond to COVID-19?
A: In certain types of emergencies, the FDA can issue an emergency use authorization, or EUA, to provide more timely access to critical medical products – including medicines, vaccines, and tests – that may help during the emergency when there are no adequate, approved, and available alternative options.
The EUA process is different than FDA approval, clearance, or licensing. The EUA standard may permit authorization based on significantly less data than would be required for approval, clearance, or licensing by the FDA. This allows the FDA to authorize the emergency use of medical products that meet the criteria within weeks, rather than months to years.
EUAs are in effect until the emergency declaration ends but can be revised or revoked as we evaluate the needs during the emergency and new data on the product’s safety and effectiveness, or as products meet the criteria to become approved, cleared, or licensed by the FDA.
Q: Are there any vaccines available to prevent COVID-19?
A: Yes. The FDA issued emergency use authorizations for three COVID-19 vaccines. On May 10, 2021, the FDA expanded the EUA of the Pfizer-BioNTech COVID-19 vaccine to include adolescents ages 12 to 15.
The FDA regulates vaccines. Vaccines undergo a rigorous review of laboratory, clinical and manufacturing data to ensure the safety, effectiveness, and quality 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.
The FDA is working with other vaccine developers, researchers, and manufacturers to help expedite the development and availability of medical products such as additional vaccines, monoclonal antibodies, and other drugs to prevent or treat COVID-19.
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.
For the latest information about COVID-19, visit:
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