Both the Moderna and Pfizer vaccines have been approved through the FDA’s Emergency Use Authorization (EUA) program. An EUA is granted during a public health emergency and is different than an FDA approval (licensure) of a vaccine.
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 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 because the EUA standard may permit authorization based on significantly less data than would be required for approval, clearance, or licensing by the FDA. This enables 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.
Learn more about EUAs in this video
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 December 11, 2020, the FDA issued an Emergency Use Authorization (EUA) for the use of the Pfizer-BioNTech COVID-19 Vaccine. On December 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.
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.
Source: US Food and Drug Administration: Updated 2/11/21 https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-frequently-asked-questions
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