Spikevax: Moderna's mRNA-1273 Reborn
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Spikevax: Moderna's mRNA-1273 Reborn
“Get your Spikevax” On January 31, 2022, the U.S. Food & Drug Administration (FDA) announced the approval of a second COVID-19 concoction. The vaccine formerly known as Moderna, and will now be marketed under a different name, Spikevax, and will be marketed to all individuals 18 years of age and older. Spikevax is the exact same ingredients as Moderna, rebranded. According to Moderna, Spikevax has already received approval by regulators in more than 70 countries.
While Spikevax is a name more memorable than its former, “mRNA-1273”, the term “Spikevax” itself feels unsettling. Despite scientists around the world still researching the devasting effects on our species as a result of the infamous Spike protein, Moderna has now capitalized on the term. Although many are willing to submit to mandated injections, few actually understand the ingredients inside of the concoction, despite their public release. Instead, mRNA patients trust their doctors who administer the injections, basing their trust on the scientific and medical community, whose official suggestions come from the pharmaceutical manufacturers themselves.
What’s in Spikevax?
Spikevax contains the same original formulation as the classic Moderna concoction, including SM-102 and tromethamine.
SPIKEVAX (COVID-19 Vaccine, mRNA) is a sterile white to off-white suspension for intramuscular injection.
Each 0.5 mL dose of SPIKEVAX contains 100 mcg of nucleosidemodified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of SARS-CoV-2 virus.
Each 0.5 mL dose of SPIKEVAX also contains the following ingredients: a total lipid content of 1.93 mg, SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.31 mg tromethamine, 1.18 mg tromethamine, hydrochloride, 0.043 mg acetic acid, 0.20 mg sodium acetate trihydrate, 43.5 mg sucrose.
SPIKEVAX does not contain a preservative.
The vial stoppers are not made with natural rubber latex
SM-102
What is SM-102?
SM-102 is a synthetic lipid used in combination with other lipids (fat vesicles) to form a nanoparticle for use with mRNA delivery. This artificial substance is responsible for the effectiveness and the biological delivery of Moderna’s mRNA concoction.
Cayman Chemical Co
.The safety data sheet for the substance, as written by SM-102’s manufacturer and supplier, Cayman Chemical Co. located in Ann Arbor, Michigan. Cayman Chemical’s product safety department, defines SM-102 as “Not for human or veterinary diagnostic or therapeutic use. It is the responsibility of the purchaser to determine suitability for other applications.”
SM-102 is classified and labeled according to the Global Harmonized System, with GHS06 Skull and crossbones (toxic if swallowed, toxic if inhaled), as well as [GHS02] highly flammable. The Safety Data Sheet for the substance SM-102 states it is also label SM-102 with GHS08 citing the substance as a“Health hazard” claiming it “may cause cancer.”
SM-102 is also known to cause the following acute and delayed symptoms: Anemia, Cough, CNS Depression, Drowsiness, Headache, Heart Damage, Lassitude (weakness, exhaustion), Liver Damage, Narcosis, Reproductive “effects”, Teratogenic “effects”
Read the full SM-102 Safety Data Sheet here
Tromethamine
What is tromethamine?
The inactive ingredient tromethamine acts as a buffer for COVID-19 vaccines.
According to the National Institutes of Health, Tromethamine is a toxic and unstable compound that poses significant health risks with just a single exposure.
What are the potential risks associated with Tromethamine?
“FDA Pregnancy Risk Category: C/RISK”
“CANNOT BE RULED OUT. Adequate, well controlled human studies are lacking, and animal studies have shown risk to the fetus or are lacking as well. This is a chance of fetal harm if the drug is given during pregnancy; but the potential benefits may outweigh the potential risk.” - Medical Economics Co; Physicians Desk Reference: Generics 2nd ed p.3033 (1996)
“It is not known whether tromethamine is distributed in human milk. Because many drugs are distributed into milk, the manufacturer recommends the drug be used with caution in nursing women.” - McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Healthy-System Pharmacists, Bethesda, MD. 2007., p. 2647
Tromethamine Toxicity - The National Institutes of Health warns against Tromethamine, citing organ toxicity, drug Induced liver injury, acute toxicity, drowsiness / dizziness, coma, may cause genetic defects, suspected of causing “genetic defects”, may cause cancer, may cause cancer by inhalation, suspected of causing cancer, may damage fertility or the unborn child, may damage fertility, may cause harm to breast-fed children, respiratory depression, local irritation, tissue inflammation, injection site infection, febrile response, chemical phlebitis, venospasm, hypervolemia, IV thrombosis, extravasation (with possible necrosis and sloughing of tissues), transient decreases in blood glucose concentrations, hypoglycemia, hepatocellular necrosis with infusion via low-lying umbilical venous catheters.
Source: PubChem [Internet]. Bethesda (MD): National Library of Medicine (US), National Center for Biotechnology Information; 2004-. PubChem Compound Summary for CID 6503, Tromethamine; [cited 2022 Feb. 7]. Available from: https://pubchem.ncbi.nlm.nih.gov/compound/Tromethamine
Animal Trials
In Animal trials, rats injected with the substance experienced weakness, collapse, and coma, “even after neutralization”. Injections of high doses [in animals] produced hypoglycemia. Could these reactions be similarly seen in human subjects? It is unknown how long term regular exposure to the substance could effect children aged five to eleven.
The National Institutes of Health states,
Animal Toxicity Studies, Non-Human Toxicity
"LABORATORY ANIMALS: Acute Exposure/Even after neutralization, large oral doses in lab animals cause weakness, collapse, & coma (without convulsions). Injections of high doses in animals produce hypoglycemia, but concurrent administration of glucose does not prevent death.” - Gosselin, R.E., H.C. Hodge, R.P. Smith, and M.N. Gleason. Clinical Toxicology of Commercial Products. 4th ed. Baltimore: Williams and Willkins, 1976., p. II-74
The study to test tromethamine toxicity used rats, which have an ~85% genomic similarity as humans. This enables clinical researchers to better predict what will happen upon injection into human beings. Yet many of these side effects were overlooked upon addition of tromethamine to Modernas coronavirus concoction.
In addition, Tromethamine is known to cause increased blood coagulation time in dogs. As stated by the National Institutes of Health,
“Tromethamine has caused increased blood coagulation time in dogs and the possibility of such an occurrence in humans should be considered.” - McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American MD. 2007., p. 2647
“A developmental toxicity study was conducted in female rats that received a vaccine formulation containing nucleoside-modified messenger ribonucleic acid (mRNA) (100 mcg) and other ingredients included in a single human dose of SPIKEVAX.”
“No impact on female fertility was reported.”
“SPIKEVAX has not been evaluated for carcinogenic, mutagenic potential, or impairment of male fertility in animals.”
Contamination
The Moderna vaccine does not contain preservatives. Vaccines containing tromethamine have been recalled numerous times in the past—as reported by the FDA—due to “particulate matter”, “potential presence of small particulates”, and “lack of sterility assurance”.
“Administration of products containing particulate matter could obstruct blood vessels and result in local irritation of blood vessels, swelling at the site of injection, a mass of tissue that could become inflamed and infected, blood clots traveling to the lung, scarring of the lung tissues, and allergic reactions that could lead to life-threatening consequences.”
Historically, there have been many instances of contamination in Chinese manufactured tromethamine:
Beyond the tromethamine’s potential toxicity, should Americans be concerned with the sanitary conditions of Moderna’s international manufacturing facilities, and the quality of the ingredient tromethamine, which is used in Spikevax?
Additional Warnings:
Spikevax was denied approval for use in children, due to a lack of studies that have been completed. Spikevax is the same ingredients as Moderna, yet the unapproved version of Moderna is approved for use in children and even pregnant individuals.
“We are deferring submission of your pediatric studies because the product is ready for approval for use in adults and the pediatric studies have not been completed”
Beyond the original warning and side-effects, extensively reported in past articles describing SM-102 and lipid nanoparticles, a new warning has
“There are no data available on the interchangeability of SPIKEVAX with COVID-19 vaccines from other manufacturers to complete the vaccination series. Individuals who have received one dose of SPIKEVAX should receive a second dose of SPIKEVAX to complete the vaccination series.”
Side effects to Spikevax also include
Difficulty breathing
Swelling of your face and throat
A fast heartbeat
A rash all over your body
Dizziness and weakness
Chest pain
Shortness of breath
Feelings of having a fast-beating, fluttering, or pounding heart
Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm of the injection, swelling (hardness), and redness
General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea and vomiting, and fever
Heart Inflammation. “Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The observed risk is higher among males under 40 years of age than among females and older males. The observed risk is highest in males 18 through 24 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html).”
Fainting.“Syncope (fainting) may occur in association with administration of injectable vaccines including SPIKEVAX. Procedures should be in place to avoid injury from fainting.”
Spikevax Efficacy
During Spikevax’s clinical trials, 14,287 patients received the vaccine, where 14,164 received the placebo. Overall the Spikevax provided protection to ~45% more patients than who received the placebo. However less than three percent of the patients in the medical experiments became infected with the coronavirus
Vaccinated. Spikevax is a leaky vaccine. Out of 14,287 patients who received the Spikevax concoction, 180 hosted an asymptomatic infection. This would indicate less than 1.5% [1.259%] infection rate for unvaccinated.
Unvaccinated. (placebo) Out of 14,164 participants who received the placebo vaccine 399 cases in the placebo group. This would indicate less than 3% [2.817%] infection rate for unvaccinated.
Total. The total who became infected with COVID-19 is 579 out of 28451 participants. This means two percent [2.035%] of all participants—vaccinated or not—became infected with COVID-19.
Should a vaccine be forcibly mandated for a virus that [in clinical trials] had a two percent chance of SARS-CoV-2 infection?
Severe Cases. There were two cases of severe COVID-19 in Spikevax patients, where as 106 severe COVID-19 cases in unvaccinated placebo. The data from this study is what Moderna carefully selected for in Spikevax as a measurement of efficacy (98.2%) against severe symptoms of COVID-19. The clinical trial data documented in the Spikevax pamphlet does not justify the use of a one-size-fits-all mandate for the concoction, despite its efficacy against severe cases of COVID-19.
Moderna’s Spikevax package insert states
,“In the Per-Protocol Set, 14,287 participants in the SPIKEVAX group and 14,164 participants in the placebo group had N-serology and/or RT-PCR results available from one or more of the pre-specified timepoints listed above. Among these participants, there were 180 cases of asymptomatic SARS-CoV-2 infection in the SPIKEVAX group compared with 399 cases in the placebo group. Limitations of this analysis include the infrequently scheduled assessments for serology and PCR testing, which may not have captured all cases of asymptomatic infections which occurred during the study”
“Among all participants in the Per-Protocol Set analysis, which included COVID-19 cases confirmed by an adjudication committee, 2 cases of severe COVID-19 were reported in the SPIKEVAX group compared with 106 cases reported in the placebo group, with a vaccine efficacy of 98.2% (95% confidence interval of 92.8% to 99.6%)”
Moderna considers “severe cases” as “defined based on confirmed COVID-19 as per the primary efficacy endpoint case definition, plus any of the following: Clinical signs indicative of severe systemic illness, respiratory rate ≥30 per minute, heart rate ≥125 beats per minute, SpO2 ≤93% on room air at sea level or PaO2/FIO2 <300 mm Hg; or respiratory failure or ARDS (defined as needing high-flow oxygen, non-invasive or mechanical ventilation, or ECMO), evidence of shock (systolic blood pressure <90 mmHg, diastolic BP <60 mmHg or requiring vasopressors); or significant acute renal, hepatic, or neurologic dysfunction; or admission to an intensive care unit or death.”
Statements
"Our COVID-19 vaccine has been administered to hundreds of millions of people around the world, protecting people from COVID-19 infection, hospitalization and death. The totality of real-world data and the full BLA for Spikevax in the United States reaffirms the importance of vaccination against this virus. This is a momentous milestone in Moderna's history as it is our first product to achieve licensure in the U.S.," said Stéphane Bancel, Chief Executive Officer of Moderna. "The full licensure of Spikevax in the U.S. now joins that in Canada, Japan, the European Union, the UK, Israel, and other countries, where the adolescent indication is also approved. We are grateful to the U.S. FDA for their thorough review of our application. We are humbled by the role that Spikevax is playing to help end this pandemic."
Conclusion
“Get your Spikevax today”, a family-friendly name to the mRNA technology being touted as the next revolutionary health technology. What are the long terms of Spikevax? A 98.2% efficacy rate against severe COVID-19 is still a leaky vaccine, allowing the virus to grow and mutate at its leisure while living inside of an asymptomatic host. Thankfully, the Omicron variant appears the SARS-CoV-2 virus is naturally adapting to become weaker, not stronger. This progression would indicate evidence supporting the removal of mandated concoctions. Yet, with Moderna’s financial backing from its funders, the promise of rapid mRNA development and deployment, Spikevax soon hopes to be the next household name, raking in the revenue while vaccine mandates are still underway. “Have you gotten your Spikevax?”
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/spikevax-and-moderna-covid-19-vaccine\
https://spikevax.com
https://www.caymanchem.com/product/33474
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-nationwide-recall-13-lots-ketorolac-tromethamine-injection-usp-due
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hikma-pharmaceuticals-usa-inc-extends-voluntary-nationwide-recall-ketorolac-tromethamine-injection
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sagent-pharmaceuticals-issues-voluntary-nationwide-recall-ketorolac-tromethamine-injection-usp
https://assets.ctfassets.net/qjie68e5s6cv/5z3Eh7GEIURixd7wmKA3RW/3b781794281d5ab4893a20077c47f5bf/Spikevax-PI-Final_1.31.22.pdf