COVID-19 vaccine candidates regulatory process update with Professor Norman Baylor

https://is1-ssl.mzstatic.com/image/thumb/Podcasts211/v4/b5/51/e7/b551e72b-bc7a-a10a-b90a-95f919c6b41a/mza_10872013384498953585.jpg/600x600bb.jpg

COVID19 Road to a vaccine

MVEC

18 episodes

8 months ago

The year 2020 has seen the emergence of the SARS-CoV-2 virus (COVID19), a unique and potentially devastating virus, with no known prevention or treatment. This new SARS-CoV-2 virus has shown to not only have significant international health implications, but also immense psychological and economic impacts. Associate Professor Nigel Crawford, a vaccinologist and consultant paediatrician at the Murdoch Children’s Research Institute (MCRI) & Royal Children’s Hospital (RCH), Melbourne, will delve into the global pursuit of a safe and effective vaccine to prevent COVID19. This is all occurring at ‘pandemic speed’ and MVEC’s new podcast will explore this complicated and multi-faceted process through interviews with a variety of national and international vaccine experts.

Medicine

Health & Fitness

RSS

All content for COVID19 Road to a vaccine is the property of MVEC and is served directly from their servers with no modification, redirects, or rehosting. The podcast is not affiliated with or endorsed by Podjoint in any way.

Medicine

Health & Fitness

https://d3wo5wojvuv7l.cloudfront.net/t_rss_itunes_square_1400/images.spreaker.com/original/89a7f3d037c7a3c66e8b53401be97e50.jpg

COVID-19 vaccine candidates regulatory process update with Professor Norman Baylor

COVID19 Road to a vaccine

27 minutes

5 years ago

COVID-19 vaccine candidates regulatory process update with Professor Norman Baylor

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