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.
Referred to the Subcommittee on Economic Opportunity.
Health
Advisory bodiesDrug safety, medical device, and laboratory regulationEmergency medical services and trauma careImmunology and vaccinationLicensing and registrations
SAVE Act
USA116th CongressS-4427| Senate
| Updated: 8/4/2020
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.
Advisory bodiesDrug safety, medical device, and laboratory regulationEmergency medical services and trauma careImmunology and vaccinationLicensing and registrations