“According to an ex-pharmaceutical industry and biotech executive, documents obtained from the U.S. Department of Health and Human Services (HHS) on Moderna’s COVID-19 vaccine suggest the U.S. Food and Drug Administration (FDA) and Moderna colluded to bypass regulatory and scientific standards used to ensure products are safe,” The Defender reported.
Alexandra Latypova spent 25 years in pharmaceutical research and development, working with more than 60 companies worldwide to submit data to the FDA on hundreds of clinical trials.
According to Alexandra Latypova, an ex-pharmaceutical industry executive, documents obtained from HHS on Moderna’s COVID-19 vaccine suggest the FDA + Moderna colluded to bypass regulatory and scientific standards used to ensure products are safe.https://t.co/ZvIjrKrhYx
— Robert F. Kennedy Jr (@RobertKennedyJr) July 13, 2022
Latypova analyzed 699 pages of studies and test results “supposedly used by the FDA to clear Moderna’s mRNA platform-based mRNA-1273, or Spikevax.
She told The Defender she believes U.S. health agencies are lying to the public on behalf of vaccine manufacturers.
“It is evident that the FDA and NIH [National Institutes of Health] colluded with Moderna to subvert the regulatory and scientific standards of drug safety testing,” Latypova said.
“They accepted fraudulent test designs, substitutions of test articles, glaring omissions and whitewashing of serious signs of health damage by the product, then lied to the public on behalf of the manufacturers.”
Latypova disclosed the following findings in an op-ed on Trial Site News:
- Moderna’s nonclinical summary contains mostly irrelevant materials.
- Moderna claims that the active substance mRNAs of Spikevax does not need to be studied for toxicity and can be replaced with any other mRNA without further testing.
- Moderna’s nonclinical program consisted of studies of other unapproved mRNAs, and only one non-GLP toxicology study of mRNA-1273 (active substance of SPIKEVAX).
- There are two separate Investigational New Drug numbers for mRNA-1273: one held by Moderna, the other – by DMID (NIH), representing a serious conflict of interest.
- Vaccine induced antibody-enhanced disease was identified as a serious risk and was not excluded by Moderna due to absence of positive control and unvalidated methods used.
- FDA and Moderna lied about reproductive toxicology studies in public disclosures and product labelling.
“Finally, all documents are poorly and often incompetently written. There are numerous hypothetical statements unsupported by any data, proposed theories, admissions of using unvalidated assays and repetitive paragraphs throughout. Quite shockingly, this represents the entire safety toxicology assessment for an extremely novel product that has gotten injected into millions of arms worldwide,” Latypova wrote.
“Furthermore, the manufacturer’s claim is not supported by any real data, no studies are cited showing that all toxicity of the product resides with the lipid envelope and none with the “payload” of the type and sequence of mRNA delivered to various tissues and organs. In addition, even though some components of the lipid envelope, such as cholesterol and DSPC may not be considered novel chemical entities, they are used in an entirely novel two-part construct,” she added.
The Defender addressed ‘serious conflicts of interest’ between Moderna and the NIH:
According to Latypova, Moderna’s documents contain a letter from the Division of Microbiology and Infectious Diseases authorizing the FDA to refer to IND #19635 to support the review of Moderna’s own IND #19745 provided in “Module 1.4.”
Although Module 1.4 was not included in the documents provided by HHS, the FDA on Jan. 30 revealed the following timeline for Moderna’s Spikevax.
According to the FDA, Spikevax has two sponsors of its IND application package, including the NIH division that reports to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and chief medical advisor to President Biden.
The date of the pre-IND meeting for Spikevax was on Feb. 19, 2020. The IND submission for the NIH’s IND was on Feb. 20, 2020, while Moderna’s own IND was submitted on April 27, 2020.
According to the CDC, as of Jan. 11, 2020, Chinese health authorities had identified more than 40 human infections as part of the COVID-19 outbreak first reported on Dec. 31, 2020.
The World Health Organization on Jan. 9, 2020, announced the preliminary identification of the novel coronavirus. The record of Wuhan-Hu-1 includes sequence data, annotation and metadata from the virus isolated from a patient approximately two weeks prior.
Latypova said this raises several questions warranting further investigation:
- Preparation for a pre-IND meeting is a process that typically takes several months, and is expensive and labor-consuming. How was it possible for the NIH and Moderna to have a pre-IND meeting for a Phase 1 human clinical trial scheduled with the FDA for a vaccine product a month before the COVID-19 pandemic was declared?
- “How was it possible to have all materials prepared and the entire non-clinical testing process completed for this specific product related to a very specific virus which was only isolated and sequenced (so we were told) by Jan. 9, 2020?”
- Ownership of the IND is both a legal and commercial matter, which in the case of a public-private partnership, must be transparently disclosed. “What is the precise commercial and legal arrangement between Moderna and NIH regarding Spikevax?”
- “Does NIH financially benefit from sales of Moderna’s product? Who at NIH specifically?”
- “Does forcing vaccination with the Moderna product via mandates, government-funded media campaigns and perverse government financial incentives to schools, healthcare system and employers represent a significant conflict of interest for the NIH as a financial beneficiary of these actions?”
- “Does concealing important safety information by a financially interested party (NIH and Moderna) represent a conspiracy by the pharma-government cartel to defraud the public?”
Latypova further noted that immediately after the pre-IND meeting with the FDA, an “extremely heavy volume of orders for Moderna stock” began to be placed in the public markets.
This warrants an “additional investigation into the investors that were able to predict the spectacular future of the previously poorly performing stock with such timely precision,” she said.
“The venerable regulators, therefore, concluded that using novel unapproved mRNAs in support of another unapproved novel mRNA was acceptable! The circular logic is astonishing. The regulators that allow (and personally promote) the use of failed experiments in support of another new experiment directly on the unsuspecting public are a dangerous failure themselves. The FDA, pharmas and all other perpetrators of this fraud must be urgently stopped and investigated,” Latypova concluded in her op-ed.