Assessing America's Vaccine Safety Systems, Part 1 February 15, 2024

Testimony | In Person

• Testimony of: Peter Marks, M.D., PhD. ; Director - Center for Biologics Evaluation and Research (CBER)

Introduction

Chair Wenstrup, Ranking Member Ruiz, and members of the Subcommittee, thank you for the opportunity to testify before you to discuss the Food and Drug Administration’s (FDA or the Agency) coronavirus disease 2019 (COVID-19) response and vaccine safety and surveillance efforts to date and moving forward.

The American public can be assured of the simple fact that FDA-approved and authorized vaccines are high quality, effective, and safe. Vaccines work and save the lives of millions of children and adults every year by producing immune responses to bacteria or viruses that cause disease.  While they may not always prevent an infection or mild disease, vaccines often can prevent hospitalization and death. The vaccine development process, and FDA’s stringent regulatory and scientific evaluation process, ensure that the health benefits of available approved and authorized vaccines far outweigh any risks.

Vaccines approved or authorized by FDA, including the COVID-19 vaccines, have undergone a rigorous research and development process and have been thoroughly evaluated by FDA prior to authorization for emergency use and prior to approval, in accordance with the Agency’s rigorous policies, procedures, and standards. Furthermore, vaccine safety is closely and continuously monitored through multiple surveillance systems, which alert both FDA and the Centers for Disease Control and Prevention (CDC) should a potential concern arise. 

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