In episode 7 of our COVID19 Road to a vaccine series, our host, Associate Professor Nigel Crawford speaks 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 important role of regulatory authorities in the development and release of new vaccines
•Emergency Use Authorisations (EUA) and their use
•Compressed timelines in the development of SARS-CoV-2 vaccines
•Requirements of regulatory bodies in the development of vaccines
•Opportunities for collaboration/”work-sharing” between the national regulatory bodies (FDA, EMA and TGA)
•The role of regulatory bodies in vaccine safety
Links:
WHO draft landscape of COVID-19 candidate vaccines
https://www.google.com/search?client=safari&rls=en&q=WHO+draft+landscape+of+COVID-19+candidate+vaccines&ie=UTF-8&oe=UTF-8Biologics Consulting
https://www.biologicsconsulting.comFDA cautions against use of hydroxychloroquine for COVID-19
https://www.fda.gov/drugs/drug-safety-and-availability/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-orFDA: Vaccines
https://www.fda.gov/vaccines-blood-biologics/vaccinesWHO: Vaccine regulation
https://www.who.int/immunization_standards/vaccine_regulation/en/TGA: Vaccines overview
https://www.tga.gov.au/vaccines-overview
