Guest Post by Dr. Robert Malone
There was a World Health Organization (WHO) consultation in April, 2021 (Sept, 2022 online publication ahead of Dec, 2022 print) whereby US government officials laid out strategies for the process of future mRNA vaccine approvals by the FDA. A summary of this meeting has just been published online, ahead of print. So, we no longer have to speculate about what the FDA has decided about considering future mRNA vaccines and using the past pre-clinical data package as the foundation for these vaccines as being a “platform” technology.
The 2021 WHO informal consultation on regulatory considerations discussed these issues. Dr Keith Peden (Center for Biologics Evaluation and Research (CBER), Food and Drug Administration presented the FDA’s experience and position on licensure of new mRNA vaccine products.
WHO informal consultation on regulatory considerations for evaluation of the quality, safety and efficacy of RNA-based prophylactic vaccines for infectious diseases, 20-22 April 2021
Emerg Microbes Infect 2022 Dec;11(1):384-391. doi: 10.1080/22221751.2022.2026742.
From the World Health Organization article:
My comments are in parentheses ( ) within the text below. Continue reading “FDA is using Covid Vaccines as a “Platform Technology””