The FDA Regulations for Emergency Use Authorizations around COVID-19
On December 14, US healthcare workers began to receive the first doses of the Pfizer-BioNTech COVID-19 vaccine following its approval under an FDA Emergency Use Authorization (EUA) (FDA, 2020).
The rapid speed at which diagnostic tests and vaccine candidates have been developed in order to respond to the COVID-19 pandemic is unprecedented. However, the process through which these tests and vaccines have received approval is well-established; Congress passed the Project Bioshield Act in 2004 (Public Law 108-276), giving the FDA Commissioner the authority to issue EUAs for products that could diagnose, treat, or prevent disease during declared public health emergencies when “there is no adequate, approved, and available alternative” (Congress). Previously, EUAs have been issued for other public health emergencies such as a diagnostic test for the 2009 Swine Flu outbreak (Federal Register). The process outlined in this law requires many checkpoints to ensure the safety and efficacy of the approved products.
What is an Emergency Use Authorization (EUA)?
- A mechanism the Food and Drug Administration (FDA) utilizes to facilitate the availability and use of medical countermeasures during public health emergencies
- It allows the use of unapproved medical products or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions
How is an EUA requested?
When there are no approved options for addressing a pressing, life-threatening public health emergency, such as a virus during a pandemic, the FDA will field EUA requests in order to identify and employ methods that can help control or quell the emergency, such as a diagnostic test, a treatment, or a vaccine. Therefore, Drug manufacturers take FDA input and criteria into consideration when deciding whether and when to submit a request for an EUA, specifically for a COVID-19 vaccine. The FDA provides notice of what specific data is needed and what standards must be met for EUA approval before any manufacturer submits an EUA request (FDA).
EUA requests for vaccines can be submitted based on a final or interim analysis of phase 3 clinical efficacy trial. Additionally, the request should include safety data for phase 1 and phase 2 studies with the vaccine, as well as phase 3 safety data from clinical trials once the full vaccination regimen is completed.
How is an EUA granted?
In order for an EUA to be issued, the FDA must conclude that the following 4 criteria have been met:
- The disease or illness is serious or life-threatening
- Evidence of the effectiveness of the vaccine or medical product
- Risk-benefit analysis undertaken that concludes the risks outweighs the benefits
- No approved alternative exists that treats, diagnoses, or prevents the disease
The U.S. Secretary for Health and Human Services and FDA career scientists conduct a rigorous evaluation of the data and science to determine if these four criteria have been met (FDA, 2020).
Are there plans for continued follow-up of vaccines approved under an EUA to ensure a vaccine is still safe?
Yes. For an EUA authorization, the FDA requires vaccine manufacturers to submit a plan for active follow-up and provide that follow-up data to ensure the continued efficacy and safety of the vaccine. Additionally, vaccine manufacturers are expected to continue their clinical trials to obtain further safety and effectiveness information, which will be needed to one day in order to license and approve a vaccine by the FDA. The federal government, primarily the FDA and the CDC, are also responsible for monitoring the safety of the vaccine after it is issued an EUA (FDA, 2020). The FDA can also revise or retract an EUA at any point if evidence arises that a vaccine poses a larger risk than benefit, or is unsafe or ineffective (FDA, 2020).
How do the CDC and FDA work together regarding a vaccine for COVID-19?
In addition to working with the FDA to monitor the vaccine’s safety, the CDC’s Advisory College of Immunization Practices (ACIP) holds public meetings after a vaccine is approved under an EUA to review the scientific information on the vaccine, vote on whether to recommend the vaccine and issue guidance on who should receive it (CDC, 2020).
Overview of existing EUAs for COVID-19
- December 9: 298 tests and sample collection devices are authorized, including 229 molecular tests and sample collection devices, 61 antibody tests, and 8 antigen tests (FDA, 2020).
- December 11: FDA issued its first approval for a COVID-19 vaccine manufactured by Pfizer-BioNTech (FDA, 2020).
- December 17: The FDA’s virtual meeting for the Vaccines and Related Biological Products Advisory Committee discussed granting an EUA of the Moderna, Inc., COVID-19 vaccine (FDA, 2020).
- December 18: FDA issued its first approval for the COVID-19 vaccine manufactured by Moderna (FDA, 2020).
The FDA will also publicly issue warning letters to companies selling products that fraudulently claim to prevent, treat, mitigate, diagnose or cure COVID-19. An up-to-date list of companies who have been issued warning letters can be found here.
For the timeliest information regarding COVID-19 updates from the FDA, visit https://www.fda.gov/news-events/fda-newsroom/press-announcements.
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