Senators Hassan, Braun, Murkowski Introduce Bipartisan Bill to Help Ensure Safety and Efficacy of Potential COVID-19 Vaccine

Statement

U.S. Senators Maggie Hassan (D-NH), Mike Braun (R-IN), and Lisa Murkowski (R-AK) introduced bipartisan legislation to maintain critical safeguards to help assure the public that a potential COVID-19 vaccine that receives emergency use authorization is safe and effective. The Safe Authorization for Vaccines during Emergencies (SAVE) Act also aims to improve public confidence in a potential COVID-19 vaccine by increasing the transparency of the vaccine approval process.

"As we work to get a potential vaccine approved, produced, and distributed as quickly as possible, it's critically important that the public is confident that the federal government followed the necessary protocols to ensure that the vaccine is safe and effective," said Senator Hassan said. "This bipartisan bill would ensure that key oversight mechanisms of the vaccine approval process stay in place, and that recommendations provided during this process are publicly available, even during an expedited vaccine approval process. We will push for this bill's inclusion in the upcoming COVID-19 relief package."

"When a COVID-19 vaccine comes to market, Americans need to be confident it is safe and effective for their families," said Senator Braun. "The SAVE Act makes the vaccine approval process transparent so Americans can see CDC's and FDA's rigorous review process for themselves as a vaccine gets closer to market. We need a vaccine to get us back to business and normal life. Academic institutions, researchers, and industry have all stepped up during this crisis to move towards a successful vaccine--regulators need to as well. This bill makes sure that federal regulators do their part to ensure that a safe and effective vaccine will be deployed to the public in a timely manner. It also ensures that the regulatory approval process for any potential COVID-19 vaccine is efficient--and not slowed down by regulatory hurdles that have nothing to do with safety and effectiveness."

"My focus right now is providing all Americans with the resources and support they need to address the impacts of the COVID-19 pandemic, including supporting efforts to help develop a vaccine. Equally important, is that a vaccine is safe and effective, and that people trust it," said Senator Murkowski. "Our bill works to ensure that the vaccine approval process is clear and transparent, giving Americans the confidence they will need in making decisions once we have a successful vaccine."

This Safe Authorization for Vaccines during Emergencies (SAVE) Act would codify existing processes within the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) for vaccine review. It would codify requirements that the CDC Advisory Committee on Immunization Practices and FDA Vaccine and Related Biological Products Advisory Committee each meet to issue recommendations on the safety and efficacy of vaccine products seeking emergency use authorization, and ensure that public recommendations on safety for specific priority populations are issued by these committees. This bipartisan legislation would not slow down the current vaccine approval process, but rather would ensure that transparent committee meetings take place as they normally would, or alternatively, if such meetings do not take place, the Secretary of Health and Human Services is required to explain the justification for those decisions.

Source