On March 13, 2019, Moderna submitted their Form 10-K Annual Report to the Securities & Exchange Commission (SEC) in which they claimed on page 150 that “Currently, mRNA is considered a gene therapy product by the FDA“. [1, 2]
In that same filing they state “because no product in which mRNA is the primary active ingredient has been approved, the regulatory pathway for approval is uncertain. The number and design of the clinical and preclinical studies required for the approval of these types of medicines have not been established…”
Fast forward to early 2020 and suddenly this mRNA product is no longer a “type of medicine” or drug, but is referred to as a “vaccine”, which means they can slip into an established regulatory pathway of a “biologic“. According to the FDA vaccines are meant to “prevent infectious diseases”. The FDA’s Center for Biologics Evaluation and Research (CBER) regulates vaccine products – a separate department within the FDA to medicines/drugs, with their own assessment and licensing process (BLA).
Moderna goes from a company that has “incurred significant losses since our inception”, having never brought a product to market, to $12 billion in profits in 2021 on the back of an mRNA product they called a “vaccine”.
‘We probably would have had a 95% refusal rate’ for these shots two years ago, but the pandemic and marketing of the injections as ‘vaccines’ has made them popular with the public, said Stefan Oelrich, president of Bayer’s Pharmaceuticals Division, speaks at the 2021 Global Health Summit
Moderna in their June 30, 2020 Q2 Report they state (pg 70) that “mRNA is considered a gene therapy product by the FDA…” yet the FDA and CDC told the public it was an mRNA COVID-19 “vaccine,”. In addition Moderna stated “no product in which mRNA is the primary active ingredient has been approved, the regulatory pathway for approval is uncertain. The number and design of the clinical trials and
preclinical studies required for the approval of these types of medicines have not been established,…” They also state “ We have incurred significant losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable future….As of June 30, 2020, we had an accumulated deficit of $1.74 billion.” [3] How convenient the global regulators allowed mRNA to enter a “vaccine” pathway under EMERGENCY USE legislations.