How government, Moderna bypassed COVID vaccine safety standards- report

Documents obtained from the U.S Department of Health and Human Services (HHS) on Moderna’s COVID-19 vaccine have revealed that 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.

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“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.”

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.

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.

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) distributed throughout the entire body to all major organ systems.

Latypova alleges Moderna, Pfizer and Janssen — manufacturer of the Johnson & Johnson shot — along with the FDA, have been deceptive in their assertions claiming the risks of COVID-19 vaccines are associated with the LNP delivery platform, and therefore, the mRNA “payload” does not need to undergo standard safety toxicological tests.