U.S. Sen. Maggie Hassan

WASHINGTON – U.S. Senator Maggie Hassan (D-NH) is leading her colleagues in requesting that the Food and Drug Administration (FDA) outline its process for ensuring that a future COVID-19 vaccine is safe for older adults.

“As manufacturers seek approval or authorization for drugs and vaccines from your agency, the public must have confidence that the review process is comprehensive, evidence-based, and ensures safety for our most vulnerable populations,” the Senators wrote. “Understanding that there are challenges associated with safely enrolling certain high-risk populations in clinical trials related to COVID-19, I ask that FDA provide a clear plan for how your agency will evaluate the safety and efficacy of investigational COVID-19 drugs and vaccines in older adults.”

In their letter to FDA Commissioner Dr. Stephen Hahn, the Senators ask the FDA to provide clear, transparent information about the steps that the agency is taking to ensure that COVID-19 drugs and vaccines are safe and effective for use in older adults. Along with Senator Hassan, the letter is also signed by Senators Jeanne Shaheen (D-NH), Elizabeth Warren (D-MA), Bob Casey (D-PA), Tina Smith (D-MN), Bernie Sanders (I-VT), and Gary Peters (D-MI).

Senator Hassan is pushing to ensure that the COVID-19 vaccine process is free from political interference and that a potential COVID-19 vaccine is safe and effective. During a recent hearing, the Senator secured commitments from FDA Commissioner Hahn and Dr. Robert Redfield, Director of the Centers for Disease Control and Prevention (CDC), that their agencies would conduct key oversight measures during the COVID-19 vaccine review process to help ensure that any potential COVID-19 vaccine is safe and effective and that the American public have confidence in the vaccine. The Senator also introduced a bipartisan bill that would codify these safeguards into law and ensure that these processes are followed.