Emergency Use Agreement: What It Is and Why It Matters

In times of public health emergencies, such as the COVID-19 pandemic, it is common for medical products, including vaccines, to be authorized for use under emergency use provisions. But what exactly is an Emergency Use Agreement (EUA) and why is it important?

An EUA is a legal mechanism that allows the Food and Drug Administration (FDA) to authorize the use of medical products that have not yet been fully approved for marketing in the United States. This includes vaccines, therapeutics, and diagnostic tests in response to public health emergencies. The process is intended to allow for expedited access to these critical medical products while the FDA continues to collect and review data on their safety and effectiveness.

Under an EUA, the FDA may issue an authorization if certain criteria are met. The product must be intended to diagnose, treat, or prevent a serious or life-threatening disease, condition, or virus. There must be no adequate, approved, and available alternative to the product for the intended use. The potential benefits of the product must outweigh its potential risks, and the product must be shown to be effective based on the available scientific evidence.

It is important to note that an EUA is not the same as full approval by the FDA. While an EUA allows for expedited access to these critical medical products, it does not mean that the product has undergone the same level of rigorous testing and review required for full approval. However, the FDA still requires ongoing monitoring and evaluation of the product’s safety and effectiveness, and may revoke an EUA if new data suggests that the product is no longer safe or effective.

The authorization of medical products under an EUA has played a critical role in the response to the COVID-19 pandemic. In December 2020, the FDA issued an EUA for the Pfizer-BioNTech COVID-19 vaccine, followed by an EUA for the Moderna COVID-19 vaccine a week later. These authorizations allowed for expedited access to these vaccines, which have since been administered to millions of people across the United States and around the world.

In summary, an Emergency Use Agreement is a legal mechanism that allows for the expedited authorization of medical products in response to public health emergencies. This process enables access to critical medical products, such as vaccines and therapeutics, while the FDA continues to collect and review data on their safety and effectiveness. While an EUA does not mean that a product has undergone the same level of rigorous testing as full approval, ongoing monitoring and evaluation ensure that these products remain safe and effective.