Tromethamine: Ingredient Added to Pfizer-BioNTech’s Comirnaty for Children Aged 5 - 11
Tromethamine: Ingredient Added to Pfizer-BioNTech’s Comirnaty for Children Aged 5 - 11
Should a potentially toxic chemical used inside coronavirus injections, be mandated for children aged five to eleven?
On October 29th, 2021 the U.S. Food and Drug Administration’s (FDA) ‘vaccine advisory panel’ passed a unanimous vote (17-0), recommending the FDA officially authorize the “emergency” use of Pfizer-BioNTech’s coronavirus concoctions for use in children aged 5 - 11 years.
Pfizer’s safety data comes not only from their experimental trials which tested potential harmful vaccine effects on 2,268 “volunteered” children, but from more than 4,600 participants, monitored for safety at least two months after receiving the concoction.
According to FDA.gov, “The available safety data to support the EUA [Emergency Use Authorization] include more than 4,600 participants (3,100 vaccine, 1,538 placebo) ages 5 through 11 years enrolled in the ongoing study. In this trial, a total of 1,444 vaccine recipients were followed for safety for at least 2 months after the second dose.”
What was not publicized by the unveiling of this new vaccine approval for America’s youth, was the quiet adjustment to the vaccine’s “formula” by Pfizer.
Comirnaty Ingredients -
Taking a closer look at the ingredients of the Comirnaty coronavirus vaccine now injected into children, the pharmaceutical companies Pfizer-BioNTech have altered the vaccine ingredients, for greater efficacy in children aged 5 - 11.
Both vaccines use predominantly identical ingredients. The striking difference between the two Comirnaty injections (adult vs child) is that Pfizer-BioNTech has added a new inactive ingredient to their concoction. The new vaccine formula uses a small dose of a volatile and toxic chemical known as “tromethamine”. Clinical studies show larger amounts of tromethamine is known to cause organ damage, as well as numerous other drug induced injuries with only a single exposure.
Has this vaccine been used before?
“Millions of individuals 12 years of ages and older have received the Pfizer-BioNtech COVID-19 Vaccine under EUA since December 11, 2020. In a clinical trial, approximately 3,100 individuals 5 through 11 years of age have received at least 1 dose of Pfizer-BioNtech Vaccine. In other clinical trials, approximately 23,000 individuals 12 years of age and older have received at least 1 dose of the vaccine. The vaccine the is authorized for use in children 5 through 11 years of age includes the same mRNA and lipids but different inactive ingredients compared to the vaccine that has been used under EUA in individuals 12 years of age and older and that has been studied in clinical trials. The use of different inactive ingredients helps stabilize the vaccine under refrigerated temperatures and the formulation can be readily prepared to deliver appropriate doses to the 5 through 11 year-old population.” - revised on October 29th, 2021
Ingredients in Comirnaty
Each 0.3 mL dose of the COMIRNATY includes the following ingredients:
Each vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine.
30 mcg of a nucleoside-modified messenger RNA (mRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2.
lipids
0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate),
0.05 mg 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide
0.09 mg 1,2-distearoyl-sn-glycero-3-phosphocholine
0.2 mg cholesterol)
0.01 mg potassium chloride,
0.01 mg monobasic potassium phosphate
0.36 mg sodium chloride,
0.07 mg dibasic sodium phosphate dihydrate
6 mg sucrose.
The diluent (0.9% Sodium Chloride Injection, USP) contributes an additional 2.16 mg sodium chloride per dose.
COMIRNATY does not contain preservative.
The vial stoppers are not made with natural rubber latex.
Vaccine Formulation
The inactive ingredient tromethamine acts as a buffer, instead of phosphate-potassium chloride (PBS), also excluding sodium chloride and potassium chloride.
0.01 mg potassium chloride
0.36 mg sodium chloride
Why was this ingredient altered?
The ingredient was altered in order to allow greater stability of the mRNA. Arriving frozen between -130°F/-90°C to -76°F/-60°C the vials are then thawed and refrigerated for up to 10 weeks.
Vaccine formulation
“Authorization is being requested for a modified formulation of the Pfizer-BioNTech COVID-19 Vaccine. Each dose of this formulation contains 10 micrograms of a nucleoside-modified messenger RNA (mRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 that is formulated in lipid particles and supplied as a frozen suspension in multiple dose vials.”
“To provide a vaccine with an improved stability profile, the Pfizer-BioNTech COVID -19 Vaccine for use in children 5-11 years of age uses tromethamine (Tris) suffer instead of the phosphate-buffered saline (PBS) as used in the previous formulation and excludes sodium chloride and potassium chloride. The packaged vials for the new formulation are stored frozen at -90˚C to -60˚C. The frozen vials may be thawed and stored at refrigerator at 2˚C to 8˚C for up to 10 weeks.”
“The Pfizer-BioNTech COVID-19 Vaccine does not contain preservative. The vial stoppers are not made with natural rubber latex. For the 10 microgram RNA dose, each 1.3-ml filled via vial must be diluted with 1.3ml 0.9% sodium chloride for injection to provide 10 doses at 10 micrograms RNA / 0.2mL injection volume. After dilution, the vials should be stored at 2˚C to 25˚C and should be used within 12 hours.”
National Institutes of Health
According to the National Institutes of Health, Tromethamine is a toxic and unstable compound that poses significant health risks with just a single exposure.
Although the substance exists in other vaccinations by the FDA, what are the potential risks associated with Tromethamine?
Risks of Tromethamine include -
As described by the National Institutes of HealthM
Organ Toxicity
Drug Induced Liver Injury
Acute Toxicity
H336 - Drowsiness / Dizziness
Coma
H340 - May cause genetic defects
H341 - Suspected of causing “genetic defects”
H350 - May cause cancer
H350i - May cause cancer by inhalation
H351 - Suspected of causing cancer
H360 - May damage fertility or the unborn child
H360F - May damage fertility
H362 - 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.
GHS Classifications indicate that Tromethamine is
H315 (99.9%): Causes skin irritation [Warning skin corrosion/skin irritation]
H319 (100%): Causes serious eye irritation [Warning serious eye damage/eye irritation]
H335 (88.24%): May cause respiratory irritation [Warning specific target organ toxicity; single exposure, Respiratory tract irritation]
Pregnancy Data
Tromethamine is still an under researched chemical substance. it is not known whether tromethamine is distributed in human milk. The National Institutes of Health states
According to the National Institutes of Health,
“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
“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)
Coronavirus vaccines only contain a small amount of the potentially toxic substance tromethamine. While this chemical does not exist in vaccines suggested for adults, the CDC suggests pregnant women should receive the coronavirus vaccine.
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 Institues of Health states,
Animal Toxicity Studies, Non-Human Toxicity Excerps (Complete)
"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 the side effects were overlooked upon addition of tromethamine to Comirnaty’s coronavirus vaccine.
NIH - Non-Human Toxicity Values (Complete)
LD50 Rat iv 2300 mg/kg - Medical Economics Co; Physicians Desk Reference: Generic 2nd ed p.3033 (1996)
LD50 Rat oral 5900 mg/kg - Lewis, R.J. Sr. (ed) Sax’s Dangerous Properties of Industrial Materials. 11th Edition. Wiley-Interscience, Wiley & Sons, Inc. Hoboken, NJ. 2004., p. 3436
LD50 Mouse iv 3500 mg/kg - Medical Economics Co; Physicians Desk Reference: Generic 2nd ed p.3033 (1996)
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
Who manufactures Tromethamine?
Trometamine is manufactured for use in coronavirus vaccines through Pfizer and their suppliers. While the vaccines are manufactured by Pfizer, there are many international manufacturers that deliver cheap alternatives to domestically produced tromethamine. The FDA is financially unable to inspect all international manufacturing facilities. Could the substance be supplied by these facilities?
Is tromethamine supplied to Pfizer by an international supplier, (such as China) and what are the conditions of the facilities that make the substance? Could the accessibility, and low cost of tromethamine be enough to overlook its manufacturering conditions and potential toxicity?
Tromethamine FDA Recalls
The Comirnaty vaccine does not contain preservatives. Vaccines containing tromethamine have been recalled numerous times in the past 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 substance’s potential toxicity, should Americans be concerned with the conditions of Pfizer’s international manufacturing facilities, and the quality of the tromethamine that is used in our children’s COVID-19 vaccines?
Statements
FDA -
“This new formulation is also authorized for use in individuals 12 years of age and older,” FDA spokesperson Abigail Capobiano said in an email to The Associated Press.
Pfizer -
“To enable extended storage time an alternative buffer is being leveraged, known as a ‘tris buffer,’” said Pfizer spokesperson Jerica Pitts. “This allows the mRNA to resist being degraded for a longer period of time before administration.”
Stanford University -
“The Pfizer data are super good with kids,” said Dr. Holden Maecker, professor of microbiology and immunology at Stanford University. “There are essentially no side effects in their study and they enrolled 20-30% of the kids with comorbid conditions, so obesity, diabetes—they had it all covered.”
Reuters released an official “fact check” statement that the newly added ingredient was not added to counter it’s side effects. They did not mention its potential toxicity.
Conclusion
Should even trace amounts of experimental chemicals with known toxicity be used in emergency use authorization issued vaccines? Although there have been many documented accounts of injecting Tromethamine into children during clinical trials, and the substance has been used in medicines, this will be the first time ever that tromethamine is mandated for use on a mass level to be injected into children aged five to eleven years old, no questions asked.
Should the future generations of our nation be subjected to routine tromethamine-laced injections, in accordance with federal and state regulations? Who decided upon the specific additives used and manufactured for COVID-19 vaccines? Could the decision to use tromethamine in COVID-19 vaccines be financially incentivized, regardless of potential chemical toxicity? What other substance could be used as a buffer in Comirnaty, instead of tromethamine?
Sources
https://www.fda.gov/news-events/press-announcements/fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use-children-5-through-11-years-age
https://www.fda.gov/media/153717/download
https://www.fda.gov/media/153447/download
https://pubchem.ncbi.nlm.nih.gov/compound/Tromethamine#section=Safety-and-Hazards
https://pubchem.ncbi.nlm.nih.gov/source/hsdb/3408#section=Non-Human-Toxicity-Excerpts-(Complete)
https://www.drugs.com/sfx/tromethamine-side-effects.html
https://www.genome.gov/10001345/importance-of-mouse-genome
https://apnews.com/article/020421619563
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://www.pfizer.com/sites/default/files/investors/financial_reports/annual_reports/2017/our-business-our-purpose/manufacturing-supply-chain-excellence/index.html
https://www.google.com/amp/s/mobile.reuters.com/article/amp/idUSL1N2S31ML
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https://www.pharmamanufacturing.com/industrynews/2010/052/