WASHINGTON – In a Health, Education, Labor, and Pensions (HELP) Committee hearing today on vaccine development, U.S. Senator Maggie Hassan (D-NH) highlighted the importance of ensuring the safety and efficacy of a potential COVID-19 vaccine, and discussed the need for her bipartisan bill that would help maintain critical safeguards in the vaccine process. The bipartisan Safe Authorization for Vaccines during Emergencies (SAVE) Act, introduced by Senators Hassan, Mike Braun (R-IN), and Lisa Murkowski (R-AK), also aims to improve public confidence in a potential COVID-19 vaccine by helping to ensure transparency in the vaccine review process.
To watch the Senator’s questioning click here.
“We’ve been talking a lot today about public trust in the vaccine approval process, which we all agree is critical to achieving the widespread use of a vaccine,” Senator Hassan said. “But right now people are concerned. A CBS poll released this past weekend found that two thirds of Americans would think the process had been rushed if we got a vaccine this year, and only one in five plan to get vaccinated as soon as possible.”
Senator Hassan discussed her bipartisan SAVE Act with the Surgeon General, Dr. Jerome Adams. The bill would codify existing processes within the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) for vaccine review, including that the CDC Advisory Committee on Immunization Practices and the FDA Vaccine and Related Biological Products Advisory Committee each meet and issue recommendations on vaccine products, and alternatively, if such meetings do not take place, the Secretary of Health and Human Services is required to explain the justification for those decisions.
Senator Hassan asked Dr. Adams about whether the federal government will follow this typical process prior to the FDA approving or authorizing a vaccine product.
Dr. Adams responded, “I think we need to follow the process because the process works. I think we need to be careful about inserting new barriers in the process….”
Senator Hassan pushed back on Dr. Adams’ response, stating, “This isn’t a new barrier or new process. This is the existing process, right?”
Dr. Adams: “I believe we need to follow the existing process.”
Senator Hassan: “So you support that.”
Senator Hassan also pressed Dr. Adams on comments that he made recently on ABC News: “Last week you told ABC News that you have confidence in the COVID-19 vaccine review process because data safety monitoring boards would not allow a product to move forward unless there is, ‘good evidence that these vaccines are efficacious.’ But in addition to ensuring that a vaccine is effective, we also have to ensure that it is safe.”
Senator Hassan specifically asked Dr. Adams what protocols are in place to ensure that clinical trials collect sufficient safety data and what steps are being taken to ensure that these decision will not be subject to political influence from the White House.
“What people are looking for is administratively what are we doing, what systems do we have?” Senator Hassan said. “Because look, if this administration’s vaccine review process is as evidence-based and free from political influence as you both are suggesting, why do you believe that the leading COVID-19 vaccine manufacturers took the unprecedented step of jointly releasing a public pledge yesterday committing to an evidence-based vaccine review process focused solely on safety and efficacy?”