(The Defender) 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.
Alexandra Latypova has 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.
After analyzing 699 pages of studies and test results “supposedly used by the FDA to clear Moderna’s mRNA platform-based mRNA-1273, or Spikevax,” Latypova 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.”
In an op-ed on Trial Site News, Latypova disclosed the following findings:
- Moderna’s nonclinical summary contains mostly irrelevant materials.
- Moderna claims the active substance — mRNA in 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 irrelevant studies of unapproved mRNAs and only one non-GLP [Good Laboratory Practice] toxicology study of mRNA-1273 — the active substance in Spikevax.
- There are two separate investigational new drug numbers for mRNA-1273. One is held by Moderna, the other by the Division of Microbiology and Infectious Diseases within the NIH, representing a “serious conflict of interest.”
- The FDA failed to question Moderna’s “scientifically dishonest studies” dismissing an “extremely significant risk” of vaccine-induced antibody-enhanced disease.
- The FDA and Moderna lied about reproductive toxicology studies in public disclosures and product labeling.
“Moderna’s documents are poorly and often incompetently written — with numerous hypothetical statements unsupported by any data, proposed theories, and admission of using unvalidated assays and repetitive paragraphs throughout,” Latypova wrote.
“Quite shockingly, this represents the entire safety toxicology assessment for an extremely novel product that has gotten injected into millions of arms worldwide.”
Finding 1: Moderna’s non-clinical summary contains mostly irrelevant materials.
According to Latypova, about 80% of the materials disclosed by HHS that FDA considered in approving Moderna’s Spikevax pertain to other mRNA products unrelated to SARS-CoV-2 or COVID-19.
“Approximately 400 pages of the materials belong to a single biodistribution study in rats conducted at the Charles River facility in Canada for an irrelevant test article, mRNA-1674,” Latypova said. “This product is a construct of 6 different mRNAs studied for cytomegalovirus in 2017 and never approved for market.”
Latypova said the study showed lipid nanoparticles (LNPs) distribute throughout the entire body to all major organ systems.
Latypova found it odd the study protocol, report and amendments related to the study were copied numerous times throughout the HHS documents, suggesting Moderna may have been trying to meet a minimum word count.
In between the repetitive copies of the “same irrelevant study,” Latypova found “ModernaTX, Inc. 2.4 Nonclinical Overview” for Moderna’s COVID-19 vaccine with the investigational new drug application reference IND #19745.
Module 2.4, she said, is a standard part of the new drug application and is supposed to contain summaries of nonclinical studies.
“There are three separate versions of Module 2.4 included and many sections appear to be missing. It is not clear why multiple versions are included and there is no explanation provided as to which version specifically was used for the approval of Spikevax by the FDA.”
Latypova noted all three copies of Module 2.4 appear to have the same overview but reference a different set of statements and studies.
Latypova said the description of the finished supplied product differs between the two versions:
“Version 1 (p. 0001466) [says] mRNA-1273 is provided as a sterile liquid for injection at a concentration of 5 mg/mL in 20 mM trometamol (Tris) buffer containing 87 mg/mL sucrose and 10.7 mM sodium acetate, at pH 7.5.
“Version 2 (p. 0001499) [says] the mRNA-1273 Drug Product is provided as a sterile suspension for injection at a concentration of 20 mg/mL in 20 mM Tris buffer containing 87 g/L sucrose and 4.3 mM acetate, at pH 7.5.”
“It appears from reading section 2.4.1.2 Test Material (p.0001499) that Version 2 of the drug product had been used for manufacturing the Lot AMPDP-200005 which was used for nonclinical studies,” Latypova said. But “there is no explanation given for why the drug product in version 1 is different, and no comparability testing studies between the two product specifications are provided.”
Latypova pointed out that the package insert for FDA-approved Spikevax does not contain any information regarding the concentration of the product supplied in its vials.
