FDA is using Covid Vaccines as a “Platform Technology”

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).

The issue of whether mRNA vaccines are a platform technology and what the implications would be if so, has been discussed at the FDA (this means the vaccines would be like the flu – VERY limited pre-clinical and clinical would need to be done for full licensure).

This has implications, e.g., what testing would be required for a new mRNA that expresses a new antigen using the same LNP and manufacturing process? What pre-clinical studies would be required, and which could be dispensed with based on data from similar products? Could the vaccine development process be streamlined?

(He goes on)

CBER has determined that this is in flux, and has not required that biodistribution studies be performed on a new vaccine if studies with another vaccine using the same manufacturing process and same LNP have already been done. (WOW. This is over the top malfeasance. With all this new mRNA vaccine and mRNA clinical trials being conducted – CBER DID NOT REQUIRE NEW BIO DISTRIBUTION STUDIES!)

It is expected that modifications to the manufacturing process, and likely the encapsulating lipids will occur in the future. (as future companies will have to face an onslaught of new requirements, such as addressing the stability of the mRNA in these vaccines, it will be almost impossible to now move away from this manufacturing process and LNP. This functionally provides a monopoly for the current companies, and an associated cash cow in perpetuity).

CBER decided that going forward, with new mRNA vaccine trials, ONLY the product (the final formulation) should be tested as long as same manufacturing process and LNP are used. This is despite the fact that CBER did not do complete biodistribution or toxicity studies on these products, as discovered in the FOIA Japanese pre-clinical package and the US court ordered document release.

Essentially, CBER has completely bypassed the issues of these vaccines not having a complete pre-clinical evaluation, and in April 2021 decided that new mRNA vaccines in development will not have to comply with the norms for vaccine development. That is all mRNA vaccines in the future, as long as don’t vary from what has already been done, will be like processed like the the influenza model, with only the “payload” to be tested.

About the Author: Patriotman

Patriotman currently ekes out a survivalist lifestyle in a suburban northeastern state as best as he can. He has varied experience in political science, public policy, biological sciences, and higher education. Proudly Catholic and an Eagle Scout, he has no military experience and thus offers a relatable perspective for the average suburban prepper who is preparing for troubled times on the horizon with less than ideal teams and in less than ideal locations. Brushbeater Store Page: http://bit.ly/BrushbeaterStore