This shows shocking idiocy and malfeasance on the part of the FDA, as well as complete regulatory capture.
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.
Regulatory perspectives
Dr Keith Peden (Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA), USA) presented the FDA’s experience with mRNA vaccines, including product and Chemistry, Manufacturing and Controls (CMC) issues, potency determination, pre-clinical studies, efficacy assessment (what to monitor and what assays to use), evaluation of possible vaccine-enhanced disease, and the question of whether or not mRNA can be viewed as a platform technology.
He commented that whether the individual LNP component should be evaluated separately or as the vaccine is an individual NRA’s decision. CBER decided only the product should be tested (this means only the final formulation - for example, with the COVID-19 vaccine, only the final spike protein mRNA formulated as injected would need to be evaluated. No separate testing of the individual components, which is inconsistent with standard regulatory practice. The shocking implications of this are discussed below).
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https://rwmalonemd.substack.com/p/fda-is-using-the-covid-19-vaccines