Covid Jab Contains Substance Medical Documents Say Not to be Used on Humans – FULL SHOW 5/21/21

Owen goes full technician as he exposes the vaccine fraud.

SM-102 (heptadecan-9-yl 8-((2-hydroxyethyl) (6-oxo-6-(undecyloxy) hexyl) amino) octanoate) is an ionizable amino lipid that has been used in combination with other lipids in the formation of lipid nanoparticles. Administration of luciferase mRNA in SM-102-containing lipid nanoparticles induces hepatic luciferase expression in mice. Formulations containing SM-102 have been used in the development of lipid nanoparticles for delivery of mRNA-based vaccines.[1][2][3]

Ingredients*included in mRNA COVID19 vaccines
Ingredients*included in mRNA COVID19 vaccines*As reported in the prescribing information20DescriptionPfizerBioNTechModernamRNAnucleosidemodified mRNA encoding the viral spike (S) glycoprotein of SARSCoV2nucleosidemodified mRNA encoding the viral spike (S) glycoprotein of SARSCoV2Lipids2[(polyethylene glycol)2000]N,NditetradecylacetamidePEG2000DMG:1,2dimyristoylracglycerol, methoxypolyethylene glycol1,2distearoylsnglycero3phosphocholine1,2distearoylsnglycero3phosphocholinecholesterolcholesterol(4hydroxybutyl)azanediyl)bis(hexane6,1diyl)bis(2hexyldecanoate)SM102:heptadecan9yl 8((2hydroxyethyl) (6oxo6(undecyloxy) hexyl) amino) octanoateSalts, sugars, bufferspotassium chlorideTromethaminemonobasic potassium phosphateTromethamine hydrochloridesodium chlorideAcetic aciddibasic sodium phosphate dihydrateSodium acetatesucrosesucrose

Ingredients*included in mRNA COVID19 vaccines*As reported in the prescribing information21DescriptionPfizerBioNTechModernamRNAnucleosidemodified mRNA encoding the viral spike (S) glycoprotein of SARSCoV2nucleosidemodified mRNA encoding the viral spike (S) glycoprotein of SARSCoV2Lipids2[(polyethylene glycol)2000]N,NditetradecylacetamidePEG2000DMG:1,2dimyristoylracglycerol, methoxypolyethylene glycol1,2distearoylsnglycero3phosphocholine1,2distearoylsnglycero3phosphocholinecholesterolcholesterol(4hydroxybutyl)azanediyl)bis(hexane6,1diyl)bis(2hexyldecanoate)SM102:heptadecan9yl 8((2hydroxyethyl) (6oxo6(undecyloxy) hexyl) amino) octanoateSalts, sugars, bufferspotassium chlorideTromethaminemonobasic potassium phosphateTromethamine hydrochloridesodium chlorideAcetic aciddibasic sodium phosphate dihydrateSodium acetatesucrosesucrose

Primary ingredient in osmotic laxatives and oral bowel preparations for colonoscopy proceduresInactive ingredient or excipient in medicationsUsed in a process called pegylation to improve therapeutic activity of some medicationsCrossreactive hypersensitivity between PEG and polysorbates can occurPolysorbates are included as an excipient in some vaccines and other therapeutic agentsPolyethylene glycol (PEG)Information on whether a medication contains PEG, a PEG derivative, or polysorbates can be found in the package insert. The NIH DailyMed databasemay also be used as a resourceMedications that contain PEG and/or polysorbate are described in the supplemental materials of Stone CA, et al. “Immediate hypersensitivity to polyethylene glycols and polysorbates: more common than we have recognized.” The Journal of Allergy and Clinical Immunology: In Practice7.5 (2019): 15331540.

This is a phase I, open-label, dose-ranging clinical trial in males and non-pregnant females, starting at 18 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of mRNA-1273 manufactured by ModernaTX, Inc. mRNA-1273 is a novel lipid nanoparticle (LNP)-encapsulated mRNA-based vaccine that encodes for a full-length, prefusion stabilized spike (S) protein of SARS-CoV-2. Enrollment will occur at up to 3 domestic clinical research sites. Up to one hundred and fifty-five subjects will be enrolled into one of thirteen cohorts (10 micrograms [mcg], 25 mcg, 50 mcg, 100 mcg, and 250 mcg). Subjects will receive an intramuscular (IM) injection (0.5 milliliters [mL]) of mRNA-1273 on Days 1 and 29 in the deltoid muscle and will be followed through 12 months post second vaccination (Day 394). Follow-up visits will occur 1, 2, and 4 weeks post each vaccination (Days 8, 15, 29, 36, 43, and 57), as well as 3, 6, and 12 months post second vaccination (Days 119, 209, and 394). The primary objective is to evaluate the safety and reactogenicity of a 2-dose vaccination schedule of mRNA-1273, given 28 days apart, across 5 dosages in healthy adults.

Optional Substudy:

This is an optional third mRNA-1273 vaccination substudy, in subjects 18 years of age and older, who received both the first and second mRNA-1273 vaccinations in the main study and meet all other substudy eligibility criteria. This optional third mRNA-1273 vaccination substudy is designed to assess safety, reactogenicity, and immunogenicity through 12 months post third vaccination (Day 731). Subjects who receive the third mRNA-1273 vaccination will exit the Schedule of Activities for the main study and will enter the Schedule of Activities for the optional substudy. Up to one hundred and twenty subject will be enrolled into two cohorts (consisting of participating subjects who received 2 doses of 25 or 50 mcg and participating subjects who received 2 doses of 100 and 250 mcg). Subjects will receive an IM injection (0.5 mL) at a dosage of 100 mcg/0.5 mL. The primary objective is to evaluate the safety and reactogenicity of a third mRNA-1273 vaccination, at a dosage of 100 mcg.

Condition or disease Intervention/treatment Phase
COVID-19COVID-19 Immunisation Biological: mRNA-1273 Phase 1

 

Detailed Description:

This is a phase I, open-label, dose-ranging clinical trial in males and non-pregnant females, starting at 18 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of mRNA-1273 manufactured by ModernaTX, Inc. mRNA-1273 is a novel lipid nanoparticle (LNP)-encapsulated mRNA-based vaccine that encodes for a full-length, prefusion stabilized spike (S) protein of SARS-CoV-2. Enrollment will occur at up to 3 domestic clinical research sites. Up to one hundred and fifty-five subjects will be enrolled into one of thirteen cohorts (10 micrograms [mcg], 25 mcg, 50 mcg, 100 mcg, or 250 mcg). Subjects will receive an intramuscular (IM) injection (0.5 milliliters [mL]) of mRNA-1273 on Days 1 and 29 in the deltoid muscle and will be followed through 12 months post second vaccination (Day 394). Follow-up visits will occur 1, 2, and 4 weeks post each vaccination (Days 8, 15, 29, 36, 43, and 57), as well as 3, 6, and 12 months post second vaccination (Days 119, 209, and 394). The primary objective is to evaluate the safety and reactogenicity of a 2-dose vaccination schedule of mRNA-1273, given 28 days apart, across 5 dosages in healthy adults. The secondary objective is to evaluate the immunogenicity as measured by Immunoglobulin G (IgG) enzyme-linked immunosorbent assay (ELISA) to the SARS-CoV-2 S (spike) protein following a 2-dose vaccination schedule of mRNA-1273 at Day 57.

Optional Substudy:

This is an optional third mRNA-1273 vaccination substudy, in subjects 18 years of age and older, who received both the first and second mRNA-1273 vaccinations in the main study and meet all other substudy eligibility criteria. This optional third mRNA-1273 vaccination substudy is designed to assess safety, reactogenicity, and immunogenicity through 12 months post third vaccination (Day 731). Subjects who receive the third mRNA-1273 vaccination will exit the Schedule of Activities for the main study and will enter the Schedule of Activities for the optional substudy. Up to one hundred and twenty subject will be enrolled into two cohorts (consisting of participating subjects who received 2 doses of 25 or 50 mcg and participating subjects who received 2 doses of 100 and 250 mcg). Subjects will receive an IM injection (0.5 mL) at a dosage of 100 mcg/0.5 mL. The primary objective is to evaluate the safety and reactogenicity of a third mRNA-1273 vaccination, at a dosage of 100 mcg. The secondary objective is to evaluate the immunogenicity as measured by IgG ELISA to the SARS-CoV-2 S protein following a third mRNA-1273 vaccination, at a dosage of 100 mcg, at all timepoints after the third mRNA-1273 vaccination.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase I, Open-Label, Dose-Ranging Study of the Safety and Immunogenicity of 2019-nCoV Vaccine (mRNA-1273) in Healthy Adults
Actual Study Start Date : March 16, 2020
Estimated Primary Completion Date : November 22, 2022
Estimated Study Completion Date : November 22, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1

25 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 18-55 years of age. N=15 (4 sentinel, 11 non-sentinel)
Biological: mRNA-1273

Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
Experimental: Arm 10

50 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 18-55 years of age. N=15.
Biological: mRNA-1273

Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
Experimental: Arm 11

50 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 56-70 years of age. N=10.
Biological: mRNA-1273

Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
Experimental: Arm 12

50 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants 71 years of age or older. N=10.
Biological: mRNA-1273

Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
Experimental: Arm 13

10 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 18-55 years of age. N=15.
Biological: mRNA-1273

Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
Experimental: Arm 14

Optional third mRNA-1273 vaccination sub-study. 100 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle after Day 209 in participants from Arm 1,4,7,10, 11, and 12 from 18 years of age or older. N=70.
Biological: mRNA-1273

Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
Experimental: Arm 15

Optional third mRNA-1273 vaccination sub-study. 100 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle no later than Day 394 in participants from Arm 2,3,5 and 8 from 18 years of age or older. N=50.
Biological: mRNA-1273

Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
Experimental: Arm 2

100 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 18-55 years of age. N=15 (4 sentinel, 11 non-sentinel).
Biological: mRNA-1273

Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
Experimental: Arm 3

250 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 18-55 years of age. N=15 (4 sentinel, 11 non-sentinel).
Biological: mRNA-1273

Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
Experimental: Arm 4

25 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 56-70 years of age. N=10.
Biological: mRNA-1273

Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
Experimental: Arm 5

100 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 56-70 years of age. N=10.
Biological: mRNA-1273

Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
Experimental: Arm 6

250 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants from 56-70 years of age. N=10.
Biological: mRNA-1273

Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
Experimental: Arm 7

25 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants 71 years of age or older. N=10.
Biological: mRNA-1273

Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
Experimental: Arm 8

100 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants 71 years of age or older. N=10.
Biological: mRNA-1273

Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
Experimental: Arm 9

250 mcg of mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in participants 71 years of age or older. N=10.
Biological: mRNA-1273

Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.