We hear much these days about the FDA’s decision to provide an Emergency Use Authorization for a COVID-19 vaccine. Emergency Use Authorization, or EUA, is a process by which the FDA authorizes an unapproved product to be used for serious or life-threatening conditions when there are no adequate, approved and available alternatives. This can only occur during a public health emergency. On 11 Dec 2020 the FDA issued an EUA for the first COVID-19 vaccine, one created by a partnership between Pfizer and BioNTech. This will allow the vaccine to be distributed in the US for the length of time that the EUA stays valid. More EUAs are expected; there is a promising COVID-19 vaccine from Moderna that is also currently under review at the FDA for Emergency Use Authorization.
In contrast to the EUA is a separate process which clinicians around the US use frequently and for many years – the Expanded Access process. Expanded Access applies to investigational products that are NOT approved by the FDA, however, under Expanded Access, a clinician can request to use a non-approved therapeutic to treat a patient after receiving permission from the FDA. This is sometimes referred to as Treatment or Compassionate Use. In Expanded Access, the drug, device or biologic is still considered investigational and IRB oversight is required for treatment of the patient. These are two distinct but very useful pathways.
- Expanded Access
- Emergency Use Authorization
University Of Rochester
CTSA Program In Action Goals
Goal 2: Engage Patients and Communities in Every Phase of the Translational Process
Goal 4: Innovate Processes to Increase the Quality and Efficiency of Translational Research, Particularly of Multisite Trials