COVID-19 vaccine candidates regulatory process update with Professor Norman Baylor
Sign up for free
Listen to this episode and many more. Enjoy the best podcasts on Spreaker!
Download and listen anywhere
Download your favorite episodes and enjoy them, wherever you are! Sign up or log in now to access offline listening.
Description
In episode 16 of our COVID19 Road to a vaccine series, our host, Associate Professor Nigel Crawford speaks once again with Professor Norman Baylor. Professor Baylor is the former Director...
show moreIn this episode they discuss:
•The recent FDA Vaccines and related biological products advisory committee meeting which was, as is customary, open to the public
•The huge amount countries like Australia can learn from the transparency of these open forums
•What vaccine efficacy thresholds are and what they have been set at for COVID-19 vaccine candidates in the USA
•Including children and special risk groups such as pregnant women in clinical trials
•Potential for confusion when more than one COVID-19 vaccine becomes available with varying levels of efficacy
•The ongoing collection of data to monitor vaccine safety and effectiveness
•Pauses or clinical holds being a normal part of clinical trials
•The importance of communication from regulatory bodies as COVID-19 vaccines become available
Links:
Biologics Consulting
https://www.biologicsconsulting.com/
FDA: Expanded access
https://www.fda.gov/news-events/public-health-focus/expanded-access
FDA: Emergency Use Authorisation
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
FDA: Vaccines and related biological products advisory committee October 22 2020
https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-october-22-2020-meeting-announcement#event-materials
MVEC: Covid19 Road to a vaccine episode 7: The importance of regulatory bodies in the development of vaccines with Professor Norman Baylor
https://mvec.mcri.edu.au/covid19-road-to-a-vaccine-episode-7-professor-norman-baylor/
The Conversation: Halting the Oxford vaccine trial doesn’t mean it’s not safe, it shows they’re following the right process
https://theconversation.com/halting-the-oxford-vaccine-trial-doesnt-mean-its-not-safe-it-shows-theyre-following-the-right-process-145837
Information
Author | MVEC |
Organization | MVEC |
Website | - |
Tags |
-
|
Copyright 2024 - Spreaker Inc. an iHeartMedia Company