[continued from post above]
Regarding reproductive toxicology, the only assessment was conducted on rats.
Pharmacokinetics — or the biodistribution, absorption, metabolism and excretion of a compound — were not studied with Moderna’s Spikevax mRNA-1273.
“Instead, Moderna included a set of studies with another, unrelated mRNA-1647 — a construct of six different mRNAs which was in development for
cytomegalovirus in 2017 in a non-GLP compliant study,” Latypova said. “This product has not been approved for market and its current development status is unknown.”
Moderna claimed the LNP formulation of mRNA-1647 was the same as in Spikevax, so the study using this particle was “supportive of” the development of Spikevax.
“This claim is dishonest,” Latypova said. “While the kinetics of the product may be studied this way, the toxicities may not!”
She explained:
“We do not know what happens with the organs and tissues when the delivered mRNA starts expressing spike proteins in those cells. This is a crucial safety-related issue, and both the manufacturer and the regulator were aware of it, yet chose to ignore it.
“The study demonstrated that the LNPs did not remain in the vaccination site exclusively, but were
distributed in all organs analyzed, except the kidney. High concentrations were observed in lymph nodes and spleen and persisted in those organs at three days after the injection.
“The study was stopped before full clearance could be observed, therefore no knowledge exists on the full time-course of the biodistribution. Other organs where vaccine product was detected included bone marrow, brain, eye, heart, small intestine, liver, lung, stomach and testes.”
Given that LNPs of the mRNA-1647 were
detected in these tissues, it’s reasonable to assume the same occurs with mRNA-1273 and “likewise would distribute in the same way,” Latypova said. “Therefore the spike protein would be expressed by the cells in those critical organ systems with unpredictable and possibly catastrophic effects.”
“Neither Moderna nor FDA wanted to evaluate this matter any further,” she added. “No metabolism, excretion, pharmacokinetic drug interactions or any other pharmacokinetic studies for mRNA-1273 were conducted,” nor were safety pharmacology assessments for any organ classes.
Finding 4: ‘Serious conflict of interest’ exists between Moderna and 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.
Finding 5: FDA failed to question Moderna’s ‘scientifically dishonest studies’ dismissing an ‘extremely significant risk’ of vaccine-induced antibody-enhanced disease.
Moderna, prior to 2020, had never
brought an approved drug to market.
“Its entire product development history was marked by
numerous failures despite millions of dollars and lengthy time spent in development,”
Latypova said. “Notably, its mRNA-based vaccines were associated with the
antibody-dependent-enhancement phenomenon.”
For example, Moderna’s
preclinical study of its mRNA-based Zika vaccine in mice showed all mice “uniformly [suffered from] lethal infection and severe disease due to antibody enhancement.”
The scientists were able to develop a type of vaccine that generated protection against Zika that “resulted in significantly less morbidity and mortality,” but all versions of the vaccine unequivocally led to some level of antibody-dependent-enhancement.
The Primary Pharmacology section for Spikevax includes nine studies evaluating immunogenicity, protection from viral replication and potential for vaccine-associated enhanced respiratory disease.
“These studies included the correct test article (mRNA-1273), however, all were non-GLP compliant,” Latypova said. The results of these studies are briefly summarized in the text of the document package, yet the study reports are not provided.
In the disclosed documents, Moderna claims “there were no established animal models” for SARS-CoV-2 virus due to its extreme novelty.
Yet, in the next sentence, “despite the extreme novelty of the virus,”
Ralph Baric, Ph.D., at the University of North Carolina possessed an already mouse-adapted SARS-CoV-2 virus strain and provided it for some of Moderna’s studies, Latypova said.
According to
Latypova’s assessment, there were other numerous contradictions in Moderna’s documents, and when enhanced disease risk was revealed in assays, the company waived off its own results with a statement regarding the invalidity of the assays and methods they used.
“As SARS-CoV-2 neutralization assays are, to this point, still highly variable and in the process of being further developed, optimized and validated, study measurements should not be considered a strong predictor of clinical outcomes, especially in the absence of results from a positive control that has demonstrated disease enhancement,” Moderna said.
“Clearly, both Moderna and FDA knew about disease enhancement and were aware of numerous examples of this dangerous phenomenon, including Moderna’s own Zika vaccine product of the same type,” Latypova said. “Yet, the FDA did not question Moderna’s scientifically dishonest ‘studies’ that dismissed this extremely significant risk without a proper study design.”
Finding 6: FDA and Moderna lied about reproductive toxicology studies in public disclosures and product labeling.
Although the FDA recommends Moderna’s COVID-19 vaccine for
pregnant and lactating women, Moderna conducted only one reproductive toxicology study in pregnant and lactating rats using a human dose of 100 mcg of mRNA-1273.
Although the full study was excluded, a narrative summary of Moderna’s findings state, “high IgG antibodies to SARS-CoV-2 S-2P were also observed in GD 21 F1 fetuses and LD 21 F1 pups, indicating strong transfer of antibodies from dam to fetus and from dam to pup.”
Latypova said safety assessments in the study are very limited, but the following findings are described by Moderna:
“The mothers lost fur after vaccine administration, and it persisted for several days. No information on when it was fully resolved since the study was terminated before this could be assessed.”
In the rat pups, the following skeletal malformations were observed:
“In the F1 generation [rat pups], there were no mRNA-1273-related effects or changes in the following parameters: mortality, body weight, clinical observations, macroscopic observations, gross pathology, external or visceral malformations or variations, skeletal malformations, and mean number of ossification sites per fetus per litter.
“mRNA-1273-related variations in skeletal examination included statistically significant increases in the number of F1 rats with 1 or more wavy ribs and 1 or more rib nodules.
“Wavy ribs appeared in 6 fetuses and 4 litters with a fetal prevalence of 4.03% and a litter prevalence of 18.2%. Rib nodules appeared in 5 of those 6 fetuses.”
Moderna related the skeletal malformations to days when toxicity was observed in the mothers but waived away the finding as “unrelated to the vaccine,” Latypova said.
The FDA then “lied on Moderna’s behalf” in its
Basis for Regulatory Action Summary document (p.14) stating “no skeletal malformations” occurred in the non-clinical study in rat pups despite the opposite reported by Moderna.
“No vaccine-related fetal malformations or variations and no adverse effect on postnatal development were observed in the study. Immunoglobulin G (IgG) responses to the pre-fusion stabilized spike protein antigen following immunization were observed in maternal samples and F1 generation rats indicating transfer of antibodies from mother to fetus and from mother to nursing pups.”
“In summary, the vaccine-derived antibodies transfer from mother to child,” Latypova said. “It was never assessed by Moderna whether the LNPs, mRNA and spike proteins transfer as well, but it is reasonable to assume that they do due to the mechanism of action of these products.”
Latypova said studies should have been done to assess the risks to the child by vaccinating pregnant or lactating women before
recommending these groups receive a COVID-19 vaccine.
“We should ask the question why are they concealing the critical safety-related information from public, and making the product look better than the manufacturer has admitted,” Latypova said.
“The FDA did not have any objective scientific evidence excluding the skeletal malformations being related to the vaccine,” she added. “Thus, the information should have been disclosed fully in the label of this experimental and poorly tested product — not hidden from the public for over a year and then disclosed only under a court order.”
Latypova said FDA reviewers should have “easily seen through the blatant fraud, omissions, use of inadequate study designs and general lack of scientific rigor.”
The fact that more than half of the document package contains non-GLP studies for irrelevant, unapproved and previously failed chemical entities alone should have been sufficient reason to not approve this product, she added.
It would appear the FDA based its decision that the product is safe to administer to thousands of otherwise healthy humans on two studies in rats, Latypova said. The rest of the 700-page package was deemed to consist of “other supportive studies.”
The FDA noted studies were conducted in “five vaccines formulated in SM-102 lipid particles containing mRNAs encoding various viral glycoprotein antigens” but “failed to mention that these were five unapproved and previously failed products,” she said.
The regulators then concluded that using novel unapproved mRNAs in support of another unapproved novel mRNA was acceptable.
“The circular logic is astonishing,”
Latypova said. Regulators allowed and personally promoted the use of failed experiments in support of a different and new experiment directly on the unsuspecting public.
Latypova called for the FDA, pharmaceutical manufacturers and “all other perpetrators of this fraud to be urgently stopped and investigated.”
