Every media outlet and government institution tells us that the Moderna “vaccine” is “safe and effective.” Since COVID-19 shots are recommended for everyone, mandated for some, and are based on a new technology that doesn’t have a positive track record, it’s important to learn all about their effectiveness and safety. Let’s examine if the Moderna “vaccine” has a favorable safety profile and is efficacious in preventing COVID-19.
Generally, vaccines and other pharmaceutical products have to go through different phases of clinical trials. Manufacturers have to engage in animal testing prior to human testing. This process takes between 8 to 15 years. This is the average time that takes before pharmaceutical products are deemed safe and effective and can be FDA-approved. However, this hasn’t been the case with these COVID shots.
Besides the Pfizer “vaccine,” Moderna is another major manufacturer of COVID-19 shots. Moderna ”vaccine” is the mRNA-1273 / Spikevax, which contains “a nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized spike (S) glycoprotein of SARS-CoV-2 that is encapsulated in a lipid nanoparticle (LNP) composed of four lipids: SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]. The mode of action
is based on the delivery of the mRNA-LNPs into host cells to allow expression of the SARS-CoV-2 S antigen. The vaccine elicits an immune response to the S antigen, which protects against COVID-19.”
Problems with Moderna COVID-19 “Vaccine”
According to Alexandra Latypova, the documents that Moderna sent to the FDA for the approval of its Moderna “vaccine” are not up to standards. She worked for 25 years in the pharmaceutical research and development field with more than 60 companies worldwide and she helped submit hundreds of clinical trials for FDA approval.
🛑 Package without content info
➡️ The package insert for FDA-approved Spikevax does not contain any information regarding the concentration of the product supplied in its vials.
🛑 Different formulations of the mRNA-1273 in the document
➡️ Parts of the document referring to mRNA-1273 (COVID-19 shot) showed three separate versions of the product. Generally, if a company is asking for a product’s approval, it only contains that product – one specific formulation.
- “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.”
“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.”
🛑 Irrelevant content, not related to mRNA-1273
➡️ From the 699-page document sent to the FDA for approval, “approximately 400 pages refer to a single biodistribution study in rats conducted in Canada in 2017 on another product (mRNA-1674). The document contained several copies of the “same irrelevant study,” suggesting that Moderna was probably trying to meet a minimum word count.
The study showed how lipid nanoparticles traveled throughout the body to all major organ systems. The study was in relation to the cytomegalovirus, not SARS-CoV-2. Plus, this mRNA product cited was never approved.
The total lack of disregard for the proper protocol in experimentation can be seen in Moderna’s CEO Stéphane Bancel. In a 2018 presentation at a JP Morgan conference, he stated, “If mRNA works once, it will work many times.” That may be his logic for using other mRNA products in the approval of the SARS-CoV-2 “vaccine.”
🛑 No specific details about mRNA-1273
➡️ mRNA shots have lipid nanoparticles (LNPs – the lipid envelope or delivery platform) and the mRNA “payload” (the biologic activity of the antigens – the mRNA code). Each component constitutes a new chemical entity and both together form a unique entity (product).
Moderna claimed that “the distribution, toxicity, and genotoxicity associated with mRNA vaccines formulated in LNPs are driven primarily by the composition of the LNPs and, to a lesser extent, by the biologic activity of the antigen(s) encoded by the mRNA… the active drug substance of a novel medicine does not need to be tested for toxicity.”
Based on that fraudulent claim, Moderna only cited the 2017 study that was testing another product (mRNA-1674). The documents didn’t have any toxicity results for the mRNA-1273 product.
“This is analogous to claiming that a truck carrying food and a truck carrying explosives are the same thing. Ignore the cargo, and focus on the vehicle… imagine Ford Motor Company claiming that its crash testing program should be contained to the vehicle’s tires and that one test is sufficient for all vehicle models.”
Latypova said that mRNAs and LNPs separately and together are “entirely novel chemical entities” that each requires their own IND application and data dossier filed with regulators. The LNP delivery platform, as well as the mRNA payload, need to undergo standard safety toxicological tests, “All new chemical entities must undergo rigorous safety testing before they are approved as medicinal products.”
🛑 There was only one toxicology study of mRNA-1273 but it was non-GLP (Good Laboratory Practice)
➡️ The studies cited didn’t live up to GLP. There were “10 studies using mRNA-1273, nine were pharmacology (‘efficacy’) studies, and only one was a toxicology (‘safety’) study… the research experiments were conducted without validation standards acceptable for regulatory approval.” Other studies cited were about other “unapproved experimental mRNAs products unrelated to mRNA-1273 or COVID illness.”
Studies of cited mRNA products showed that the LNPs did not remain in the vaccination site. The spike protein was distributed throughout different organs, in lymph nodes and spleen in high concentrations, as well as in bone marrow, brain, eye, heart, liver, lung, digestive and reproductive systems. Plus, studies were “stopped before full clearance could be observed, therefore no knowledge exists on the full time-course of the bio-distribution.”
🛑 Despite that Moderna cited studies showed a significant risk of vaccine-induced antibody-dependent enhancement, FDA approved mRNA-1273 for the market
➡️ Previous mRNA products have been associated with the antibody-dependent-enhancement (ADE). ADE is a vaccine-associated phenomenon where induced antibodies from the vaccine enhance infection and inflammatory macrophages and result in more severe pathology compared to the unvaccinated.
ADE was shown in Moderna’s mRNA Zika “vaccine” but Moderna failed to include it as a risk factor. This technology has been failing for years despite millions of dollars in investments. Moderna mentioned previous ADE results in their own studies were invalid due to the methods used, ”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 used a study of one of their product that showed ADE but conveniently dismissed its own results. What’s even worse is that the FDA knew about the risk of disease enhancement, dismissed this dangerous phenomenon, and approved the product.
🛑 Moderna’s claims were contradictory
➡️ In one line Moderna said that “there were no established animal models” for the SARS-CoV-2 virus. However, in the next sentence, they mentioned that Ralph Baric (who has been involved in gain-of-function research and has been funded by the NIH and NIAID) had mouse-adapted SARS-CoV-2 virus strains that he provided for some of Moderna’s studies.
🛑 Clinical trials eliminated the placebo group and unblinded the subjects
➡️ Phase 3 of the clinical trial involved 30,346 participants 18 years of age and older. It started as a randomized, placebo-controlled, double-blind study, where 15,184 participants received the shot and 15,162 were in the placebo (those not receiving the inoculation). However, upon issuance of the Emergency Use Authorization (EUA)
on 12/18/2020, participants were unblinded.
The purpose of clinical trials is to study a treatment/variable (in this case the SARS-CoV-2 shot) by comparing its effect on two groups with a similar number of participants, an experimental group and a control group. Once the effects of the variable on the experimental group are seen, conclusions can be drawn. The control group provides a basis for comparison to assess the effects of the tested treatment.
If the placebo group was eliminated by giving participants the shot too, how can both groups be compared? How can we draw real conclusions about effectiveness if most people received the vaccine?
Besides Moderna’s desire to eliminate controls, Moncref Slaoui, Ph.D., Chief scientific adviser for Operation Warp Speed, said, “it’s very important that we unblind the trial at once and offer the placebo group vaccines” because trial participants “should be rewarded” for their participation. This violates the basics of experimentation.
🛑 This was not a double-blinded study. This is when participants and researchers have no knowledge of which treatment or intervention participants are receiving until the clinical trial is over.
➡️ Researchers knew who belonged in the placebo group and later vaccinated them. Double blindness is necessary to avoid bias in data collection, analysis, or interpretation. Having a double-blinded study avoids any placebo effects as well – this is when participants perceive an effect according to the group that they are assigned to.
🛑 Moderna and the FDA lied about reproductive toxicology issues related to mRNA-1273
➡️ There was only one reproductive toxicology study in pregnant and lactating rats using mRNA-1273. Yet, it was excluded from the summary of findings. The study showed that ”mothers lost fur after vaccine administration, and it persisted for several days.” No further information was included. We don’t know if the issues were resolved since the “study was terminated before this could be assessed.”
Rat pups developed skeletal malformations, ”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.”
Despite these findings, Moderna stated, ”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 a mean number of ossification sites per fetus per litter… 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 the dam to the fetus and from the dam to the pup.”
Furthermore, in its Basis for Regulatory Action Summary document (p.14), FDA lied for 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.”
Claims by Moderna or the FDA that “vaccine-derived antibodies transfer from mother to child” can’t be made since this wasn’t studied by Moderna. Yet, it is “reasonable to assume that LNPs, mRNA and spike proteins are transferred due to the mechanism of action of these products.”
In the document Highlights of Prescribing Information, Moderna recommends mRNA-1273 for everyone and doesn’t report any major adverse events from preliminary data. In relation to pregnant women, they said, “All pregnancies have a risk of birth defect, loss, or other adverse outcomes… the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively… a study performed in female rats administered the equivalent of a single human dose of SPIKEVAX twice prior to mating and twice during gestation. The study revealed no evidence of harm to the fetus due to the vaccine.”
Thorough studies assessing risks to pregnant women and children should take place before recommending this product to children as well as to pregnant and lactating women. The fact that FDA deemed Moderna “vaccine” safe and effective for pregnant and lactating women based on two studies in rats and “five unapproved and previously failed mRNA products” is fraudulent.
The following are the most commonly reported adverse reactions reported by participants following a dose of the Moderna “vaccine:”
- pain at the injection site (93.3% of participants)
- fatigue (71.9%)
- headache (68.7%)
- myalgia (64.8%) – muscle aches and pain involving ligaments, tendons, and muscles
- chills (49.7%)
- arthralgia (48.6%) – joint pain that occurs due to injury or infection
- nausea/vomiting (25.7%)
- axillary swelling/tenderness (22.2%)
Serious adverse events occurring within 28 days following Moderna “vaccine” were reported by 31.3% of participants:
- Lymphadenopathy – a disease of the lymph nodes, in which they are abnormal in size or consistency
- Lymphadenitis – swollen or enlarged lymph nodes
- Urticaria (hives or nettle rash) – is a raised, itchy rash that appears on the skin.
- Angioedema – facial swelling
- Facial paralysis, including Bell’s palsy
- Herpes zoster (shingles) – a painful rash appearing as a stripe of blisters on the trunk of the body. It is caused by the varicella-zoster virus (VZV), the same virus that causes chickenpox.
- Neurologic disorders – affect the brain and nervous systems, such as epilepsy, learning disabilities, neuromuscular disorders, cerebral palsy, and autism. Some neurological conditions affect communication, vision, hearing, movement, and cognition
- Neuroinflammatory disorders – the immune system attacks healthy cells and the central nervous system, such as multiple sclerosis (MS), neuromyelitis optical, anti-myelin oligodendrocyte glycoprotein antibody disorder, autoimmune encephalitis, transverse Myelitis, optic neuritis, neurosarcoidosis
- Nervous System Disorders: syncope – temporary loss of consciousness caused by a fall in blood pressure
- Thrombosis – blood clots that block blood vessels. In venous thrombosis, blood clots block a vein, which carries blood from the body to the heart. In arterial thrombosis, blood clots block an artery, which carries blood to the body.
- Cardiac Conditions: Myocarditis (inflammation of the heart muscle, which can cause irregular heart rhythms, heart failure, and other complications) and pericarditis (swelling and irritation of the thin tissue surrounding the heart – pericardium, causing sharp chest pain). Males under 40 years of age have a higher risk, and the highest risk is in males under 24 years of age
- Anaphylaxis – severe, potentially life-threatening allergic reaction to an antigen
Clinical Trial Participants
Besides all the issues related to the data of the Moderna “vaccine,” we are hearing very concerning feedback from some of the participants from the clinical trials.
- Maddie: She was a healthy twelve-year-old who volunteered for the shot and within 24 hours of the second dose suffered devastating life-altering injuries. She developed problems with her bladder and now requires a tube through her nose that carries her food and medicine, as well as a wheelchair to move around. When her mother reported her side effects to doctors, they were pushed to the side and told that it was all in “her head.”
- Kyle: Professional mountain biker, who developed an extremely elevated heart rate, pericarditis (inflammation of the outer lining of the heart), and reactive arthritis. When he went to doctors for his heart symptoms, he was told that he was having a “psychotic episode;” now his career is over.
- Unfortunately, these are not the only stories from participants. Thousands and thousands of people are experiencing severe adverse events and death. Not only that but their experiences are not being shared with the public. Most social media and mainstream media channels are censoring them. Fortunately, a public roundtable was organized by Senator Ron Johnson showcasing people who experienced adverse reactions to the COVID shot.
Just like some whistleblowers came forward and exposed what they saw during Pfizer’s clinical trials, Moderna “vaccine” whistleblowers reported that the shot is oncogenic and causes fertility problems.
The screenshot shows the explanation given by two Moderna vaccine engineers:
How the shot works from what was uncovered:
1. Make mRNA coding for S protein
2. Make mRNA coding for mutant versions of CYP19A1 and CDKN1B in smaller amounts
3. Make sure that while the delivery system for (1) mostly ends up in the liver, most of (2) ends up in the gonads
4. Make sure that the form and quantity of additive upregulating LINE-1 reverse transcription activity make it hard to detect among adjuvants
5. Effects from (2) integrated by (4) are recessive; mildly oncogenic effects in vaccine recipients to be noticed for many years
6. (5) recessive but since most of the population is vaccinated, in next-generation female offspring have premature ovarian failure
Conflicts of Interest: Moderna, FDA, NIH/Fauci
The timeline of the events in relation to Moderna’s shot development and approval, and interactions between Moderna and government institutions don’t make sense:
- Curiously on March 28, 2019, the patent US10702600 for Moderna “vaccine” with its composition had already been filed.
- Thanks to a FOIA request we know that on 12/12/2019, Fauci agreed that Ralph Baric (who has been involved in gain-of-function research- funded by the NIH and NIAID) would receive the “mRNA coronavirus vaccine candidates developed and jointly owned by NIAID and Moderna.” By then, Fauci was already a co-owner of the mRNA Moderna “vaccine.”
- On 1/10/2020, Chinese health authorities released the identification of the novel coronavirus: Wuhan-Hu-1 including genetic sequence data, annotation, and metadata from the virus isolated from a patient two weeks prior.
- On 1/12/2020, Moderna and the NIH designed the sequence for the Moderna “vaccine.”
- On 1/30/2020, the FDA already had the Summary Basis for Regulatory Action for Moderna’s mRNA-1273 / Spikevax.
- By 2/11/2020, Moderna had already shipped the first batch of its “vaccine,” mRNA-1273, to the NIAID for use in the study, “Safety and Immunogenicity Study of 2019-nCov Vaccine (mRNA-1273) to Treat Novel Coronavirus” (NCT04283461).
- However, 2/19/2020 was the date of the pre-IND (investigational new drug) meeting for mRNA-1273. The IND application for the NIH’s IND (#19635) was submitted on 2/20/2020, while Moderna’s own IND (#19745) was submitted on 4/27/2020. Interestingly enough, mRNA-1273’s IND application package shows two sponsors, Moderna and Fauci from the NIAID – NIH.
In relation to the timeline, Latypova reported that “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 come all materials prepared and the entire non-clinical testing process were completed for the (Moderna “vaccine”) when the virus had been isolated and sequenced only a month before?
She added that curiously enough modern stock fluctuated immediately after the pre-IND meeting with the FDA, there was an “extremely heavy volume of orders for Moderna stock” placed. How were “investors able to predict the spectacular future of the previously poorly performing stock” that didn’t produce a single product before?
Latypova reported that FDA reviewers should have “easily seen through the blatant fraud, omissions, use of inadequate study designs and general lack of scientific rigor” from Moderna… approving this product “describes the deception practiced by the manufacturers, FDA, CDC, NIH, NIAID, and every government health authority or mainstream media” because Moderna didn’t prove that the shot was safe or effective.
Moderna and the FDA claim that the Moderna “vaccine” is safe and effective. However, their own documents fail to live up to those claims and should nullify Moderna’s results. Plus, it’s hard to believe that a company that couldn’t produce a single successful product in 10 years was able to develop the mRNA shot for SARS-CoV-2 in 2 days. It’s interesting to note that Moderna is funded by the Bill & Melinda Gates Foundation, DARPA, and BARDA.
The fact that the NIH/NIAID co-owns the Moderna “vaccine” is extremely troublesome. When the NIH/NIAID financially benefits from sales of Moderna’s product, the conflict of interest with pharma surpasses all levels. Financial incentives for individuals in these institutions explain vaccine mandates, government-funded media campaigns deceiving the public about the real nature of the shots, collaborations with media companies and tech giants that suppress information that goes against the narrative, and censors people who discuss adverse events and vaccines failures to stop transmission or infection of SARS-CoV-2.
FDA’s approvals were not based on scientifically proven data on the Moderna “vaccine”. The FDA is supposed to be an independent organization, not a marketing arm of pharmaceutical companies -it shouldn’t be parroting the claims of the company that is trying to regulate. This leads us to believe that there are nefarious issues at play. After taking into account all the issues related to the Moderna “vaccine,” the only thing “safe” to say is that these gene modification shots are far from being safe or effective.
To a Fitter Healthier You,
The Fitness Wellness Mentor