Sponsored by Pfizer.
According to the FDA, an Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic.1 An EUA allows the use of medical products, not yet approved, when there are no adequate, approved and available alternatives.2
Since the start of the COVID-19 pandemic, the FDA has issued EUAs for select medical products and drugs it believes may help address the impact of the virus on the American public.3
What are the criteria for a COVID-19 vaccine candidate to receive an EUA?
When the Health and Human Services (HHS) Secretary has issued a public health emergency the FDA may issue an EUA after it has determined that the following requirements are met2:
- Based on available scientific evidence, including data from clinical trials, it is reasonable to believe that the product may be effective to prevent, diagnose or treat serious or life-threatening diseases or conditions that can be caused by SARS-CoV-2 (the virus that causes COVID-19).
- The identified and potential benefits of the product, when used to diagnose, prevent or treat the identified serious or life-threatening disease or condition, outweigh the identified and potential risks of the product.
- There is no adequate, approved and available alternative to the product for diagnosing, preventing or treating the disease or condition.
Who will have access to a vaccine that receives an EUA?
In the U.S., the Centers for Disease Control and Prevention (CDC) will recommend the allocation of vaccine doses and who should receive a vaccine first, if there are not enough doses of the vaccine for everyone. On December 1, the CDC’s Advisory Committee on Immunization Practices (ACIP) made initial recommendations on who should be offered COVID-19 vaccination in the initial phase of the U.S. COVID-19 vaccination program, while there is limited vaccine supply, and recommended that healthcare personnel and residents of long-term care facilities should be prioritized first.4
Will an EUA mean that the vaccine has been tested for safety?
Issuance of an EUA for a COVID-19 vaccine requires a determination by the FDA that the vaccine’s known and potential benefits outweigh its known and potential risks based on data from at least one well-designed Phase 3 clinical trial that demonstrates the vaccine’s safety and efficacy in a clear and compelling manner.2 An EUA for COVID-19 vaccines will be assessed by the FDA on on a case-by-case basis considering all available scientific evidence.2
“The FDA’s Emergency Use Authorization process serves an absolutely critical role during public health emergencies. Throughout the COVID-19 global pandemic, we have welcomed the opportunity to work collaboratively with the FDA, CDC and regulatory agencies around the world to help fight the COVID-19 global pandemic,” noted Donna Boyce, vice president of Global Regulatory Affairs for Vaccines at Pfizer.
PP-CVV-USA-0065 © 2020 Pfizer Inc. All rights reserved. December 2020
1 Emergency Use Authorization for Vaccines Explained. U.S. Food and Drug Administration. Accessed December 10, 2020. https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained. Published 2020.
2 US Food and Drug Administration. Emergency use authorization for vaccines to prevent COVID-19 – Guidance for industry. Accessed October 2020. https://www.fda.gov/media/142749/download.
3 Emergency Use Authorization. U.S. Food and Drug Administration. Accessed December 4, 2020. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. Published 2020.
4 Centers for Disease Control and Prevention. How CDC is making COVID-19 vaccine recommendations. Accessed November 6, 2020. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations-process.html. Published 2020.