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Before we can discus mRNA vaccines for livestock, pets and wildlife, we must first address the elephant in the room. That is, how come the public is able to access human clinical trial information, but is not able to do the same for clinical trials involving animal health?
(Dr. Malone is narrating this column in this area if you click the read more link below)
During the early days of the AIDS epidemic, the AIDS community demanded public access to clinical trials. In 1988, the U.S. Congress passed the Health Omnibus Programs Extension Act of 1988 (Public Law 100-607) which mandated the development of a database of AIDS Clinical Trials Information Services. This Congressional Act motivated other non-profit disease related groups to demand access also.
The Food and Drug Administration Modernization Act of 1997 amended the Food, Drug and Cosmetic Act and the Public Health Service Act to require that the NIH create a publicly available clinical trials database. This eventually led to the development of the website ClinicalTrials.gov. This allowed tracking of drug efficacy studies resulting from approved Investigational New Drugs (including vaccines).
The law requires (from Wiki):
- Federally and privately funded clinical trials;
- The purpose of each experimental drug;
- Subject eligibility criteria to participate in the clinical trial;
- The location of clinical trial sites being used for a study; and
- A point of contact for patients interested in enrolling in the trial.
- The National Library of Medicine in the National Institutes of Health to host the public website/database
(BTW, one of my former clients held the federal contract to support ClinicalTrials.gov and Pubmed. I have spent time in the back rooms of the NLM and do know a fair amount about these things….)
The searchable ClinicalTrials.gov website was made available to the public via the internet on February 29, 2000.
ClinicalTrials.gov makes searching for human clinical trials easy. For instance, a quick search reveals that there are over 50 clinical trials for mRNA vaccines in progress and over 200 registered.
With animals, there is no such database. mRNA vaccines in the “animal health” or veterinary markets are difficult to track until the company or the USDA is ready to release information on that product’s development or release. The USDA and/or the NIH have no mechanism for tracking potential new vaccines, drugs or biologics for the animal market.
Therefore, one must rely on press releases, the occasional peer reviewed paper, conference notes, USDA grant and contract notifications, university websites and company profiles for discovery of such new products. Not adequate, in my opinion, and most definitely not transparent. By federal law, the public should have open access to the results of this type of federally funded research.
In today’s substack, the state of mRNA “vaccines” for animal “health” is discussed. Citing public sources, I will review what is known and not known about commercial liaisons and partnerships, the corporations involved, ongoing research and products in various states of development.
Bayer Partners with BioNTech to Develop mRNA Vaccines, Drugs for Animal Health
Genetic Engineering and Biotechnology News. May 10, 2016
Bayer will partner with BioNTech to develop novel, first-in-class mRNA vaccines and therapeutics for animal health indications, the companies said today, under a collaboration whose value was not disclosed.
Bayer agreed to secure exclusive rights to BioNTech’s mRNA technology and intellectual property for development of mRNA vaccines for animal health applications…
The companies said their partnership is the first of its kind focused on developing mRNA therapeutics specifically for animal health applications.
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Infectious disease vaccines is the focus of one of the three therapy platforms BioNTech is building through mRNA technologies; the other two are cancer immunotherapies and protein replacement. The three platforms are designed to produce pharmacologically optimized protein coding RNA for targeted in vivo delivery…
2016. This means that Bayer and BioNTech have been working on livestock and companion animal mRNA vaccines for over six years…