An official website of the Biotechnology Innovation Organization
There has been a lot of discussion about whether the FDA should use its authority to grant what is known as “emergency use authorization” for a Covid-19 vaccine and what this might mean for patient safety. The FDA has granted these types of authorizations before, but typically it approves a vaccine through a Biologic License Authorization, which requires years of clinical data for what is considered full FDA approval.
Following multiple public health threats, in 2004, the FDA was given the legal authority to allow the “emergency use” of medical products that had not received full FDA approval. The idea was that during a public health crisis, like the current pandemic, the benefits to families and communities outweighed the known risks of allowing the use of a medical product before it had been approved.
During a public health emergency, the FDA still sets an extremely high bar for emergency use of any vaccine, and that is true in the case of the current pandemic. Also, any emergency use is limited to those at higher risk of infection or serious disease. This ensures we prioritize protecting the most vulnerable populations – like the elderly and our frontline health care workers – while continuing to gather data for broader public use.
If you want to learn more about how emergency use works and what it means for patients, be sure to watch this short, informative video developed by the experts at the FDA.
