SAVE Act

Safe Authorization for Vaccines during Emergencies Act or the SAVE Act

This bill imposes requirements related to the emergency authorization of a vaccine during a declared public health emergency.

If a sponsor of a product seeks Food and Drug Administration (FDA) authorization to use the product as a vaccine to address the threat causing the declared public health emergency, both the FDA and the product sponsor must meet with, and present product-related data and information to, the Vaccines and Related Biological Products Advisory Committee. The Department of Health and Human Services may make an exception to this requirement if convening a meeting would not be in the public interest.

To receive an emergency authorization, the product sponsor must agree to seek FDA market approval for the vaccine within a certain time period.

After an emergency authorization, the Advisory Committee on Immunization Practices shall report recommendations regarding the vaccine to Congress and the Centers for Disease Control and Prevention.