Building Vaccine Confidence: U.S. Regulatory Safety Practices-Webinar Recording

Video Transcription

Video Summary

In this video, Dr. Peter Marks and Dr. Amanda Cohn discuss the vaccine confidence and the procedures involved in vaccine approval. They highlight the importance of transparency and trust in the regulatory process and emphasize the need for healthcare providers to address concerns and answer questions from patients to boost vaccine confidence. They mention the ongoing post-vaccination surveillance programs, such as VSAFE, to monitor vaccine safety and efficacy. Dr. Marks explains the difference between emergency use authorization (EUA) and full licensure for vaccines, stating that Pfizer has already submitted a biologics license application (BLA) for their COVID-19 vaccine. He mentions that the BLA process involves reviewing manufacturing data, ensuring safety, and following individuals for at least six months. Dr. Cohn discusses the evidence-to-recommendations framework used by the Advisory Committee on Immunization Practices (ACIP) to determine vaccine recommendations. She explains the process of grading evidence and the factors considered in making recommendations, including public health importance, benefits and harms, values and acceptability, feasibility, resource use, and equity. They also highlight the importance of ongoing communication and clear messaging to address vaccine hesitancy and ensure equitable access to vaccines. They conclude by discussing the new CDC guidance on mask use for fully vaccinated individuals and the need to continue monitoring the evolving situation.

Keywords

vaccine confidence

transparency

regulatory process

healthcare providers

post-vaccination surveillance

emergency use authorization

biologics license application

evidence-to-recommendations framework

equitable access