Going anti-Viral

How Vaccines Get Approved in the US: The RSV Story and the Role of the ACIP – Dr Yvonne Maldonado


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In episode 50 of Going anti-Viral, Dr Yvonne Maldonado joins host Dr Michael Saag to discuss the respiratory syncytial virus (RSV) vaccine and the vaccine approval process in the United States. Dr Maldonado is a Professor in the Stanford University School of Medicine where she has achieved national and international recognition for her scholarship in the epidemiology and control of infectious diseases. She has served on several national and international committees including, until recently, the CDC Advisory Committee on Immunization Practices (ACIP). Dr Maldonado and Dr Saag provide an overview of RSV including the history of RSV vaccine research and development and provide an update on the availability of RSV vaccine in adults but not in children. They also discuss the risk of severe disease in children and the limited treatments available. Dr Maldonado and Dr Saag also discuss the process for vaccine approvals in the United States. Specifically, they review the role of the ACIP committee in vaccine approvals and provide an update on the recent dismissal of all of the prior members of the committee, which included Dr Maldonado. They discuss the potential impact that this will have on the review of all vaccines and the overall impact on public health.
 
0:00 – Introduction
 
1:30 – Overview of RSV including the history of RSV vaccine research and development
 
5:08 – Status of RSV vaccine availability in adults and children
 
8:15 – Discussion of the length of RSV vaccine protection and the differences in RSV respiratory disease between children and adults
 
10:17 – Risk of severe disease from RSV in children
 
12:22 – Overview of the vaccine approval process in the United States and how the CDC ACIP committee operates
 
19:27 – Discussion of the recent dismissal of all members of the ACIP including Dr Maldonado and her concern for the process of vaccine approval moving forward
 
23:54 – The vetting process for new members of the ACIP and assessment of newly appointed members
 
27:20 – How the recent personnel changes at the ACIP and other federal agencies impact public health
 
32:08 – Discussion of the public commitment and support for vaccination moving forward

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Produced by IAS-USA, Going anti–Viral is a podcast for clinicians involved in research and care in HIV, its complications, and other viral infections. This podcast is intended as a technical source of information for specialists in this field, but anyone listening will enjoy learning more about the state of modern medicine around viral infections.

Going anti-Viral’s host is Dr Michael Saag, a physician, prominent HIV researcher at the University of Alabama at Birmingham, and volunteer IAS–USA board member. In most episodes, Dr Saag interviews an expert in infectious diseases or emerging pandemics about their area of specialty and current developments in the field. Other episodes are drawn from the IAS–USA vast catalogue of panel discussions, Dialogues, and other audio from various meetings and conferences.

Email [email protected] to send feedback, show suggestions, or questions to be answered on a later episode.

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