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 of the Office of Vaccines Research and Review Center at the U.S. Food and Drug Administration (FDA) and is the President and CEO of Biologics Consulting and current advisor to the WHO.
In 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