Dr. Jeffrey Barke – Breaking Down the Package Insert for Vaxelis – (The 6-in-1 Vaccine)


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 Dr. Jeffrey Barke – Breaking Down the Package Insert for Vaxelis – (The 6-in-1 Vaccine)


Parents: Are you being Informed of the potential Risks for each vaccine and the vaccine Ingredients that are being injected in your child?


We need to be informed on what is in the Vaccine Inserts for EVERY Vaccine. That is called Informed Consent and that is the right that EVERYONE has.


That is in the Geneva Convention in which we have the right to be informed of what is being injected into our body. The exception is if you voluntarily accept which is what 99% of people do, especially during COVID.


Let’s take a look at the Package Insert for the 6-in1 Vaccine called VAXELES.


VAXELIS:


  • Manufactured by Sanofi Pasteur Limited

  • Approved by FDA on December 21, 2018.

  • The Advisory Committee on Immunization Practices (ACIP) voted to include Vaxelis in the federal Vaccines for Children (VFC) program on June 26, 2019. 


Package Insert: VAXELIS (Indications & Use)

VAXELIS is a vaccine indicated for active immunization to prevent:


  • Diphtheria

  • Tetanus

  • Pertussis

  • Poliomyelitis

  • Hepatitis

  • Invasive Disease due to Haemophilus Influenzae type b


Yes, this is a 6-in-1 shot, meaning that there are 6 different vaccines in one shot.


How often do you hear of children dying of these?


How many babies do you know that have died of Tetanus or Hepatitis B or Polio?



Package Insert: VAXELIS (Section 5 – 5.1)

WARNINGS AND PRECAUTIONS:


Epinephrine hydrochloride solution (1:1,000) and other appropriate agents and equipment must be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs.


So, Epinephrine MUST be available for immediate use in case of Anaphylactic Shock occurs.


That is a RED Flag, isn’t it?


That should be the sign that there is something in this 6-in-1 vaccine that just might be harmful to your baby.


Package Insert: VAXELIS (Section 5.3)

Guillain-Barré Syndrome and Brachial Neuritis:


A review by the Institute of Medicine (IOM) found evidence for a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome.


OKAY – the keyword here is CAUSAL Relation. That means that studies have indicated the ingredients have caused both Brachial Neuritis (muscle weakness & pain in shoulder, arm and hand) and Guillain-Barré syndrome.


Guillain-Barré syndrome – can lead to paralysis similar to Polio, making it difficult to eat or breathe.


This is a SERIOUS Condition.


Is it even worth it to take the chance when it says on the insert that this vaccine could CAUSE Guillain-Barré syndrome?



Package Insert: VAXELIS (Section 5.6)

Limitations of Vaccine Effectiveness:


Vaccination with VAXELIS may not protect all individuals.


This is their way of saying that this vaccine may not work.


Don’t we deserve to know more?


Why would they say this?


Because VAXCELIS as all vaccines are NOT studied with an INERT Placebo.


The controls are other treatments (vaccines).


What’s this mean?


It wasn’t tested properly and they have no idea if this is better than an inert placebo.


There are NO Vaccinated vs Unvaccinated Studies.


This may seem very hard to believe, but this is true for ALL Vaccines.


You have to ask yourselves – WHY??


Why would they not want to know if this vaccine was better than an inert placebo?


Why would they not want to know if children who received this vaccine were healthier in 2, 5, 10 and 15 years down the road compared to children who were not vaccinated at all??


WHY?????

Do we really know anything about Safety and Effectiveness if they do not do comparison and multiple multi-year follow-up studies between the Vaccinated and the Unvaccinated?


And no inert placebo?


Isn’t that CRAZY??



Package Insert: VAXELIS

How is VAXELIS given?


Vaxelis is given to children from 6 weeks through 4 years of age (up to 5th birthday).


  • Your child will need 3 shots: one shot at 2 months old, one shot at 4 months old, and one shot at 6 months old


So, this vaccine is indicated for babies 6 weeks to 4 years and your child will “NEED” 3 jabs.




Package Insert: VAXELIS

Who should not get VAXELIS?


  • Your child should not get VAXELIS, if your child is allergic to any of the ingredients.


Does your pediatrician go over the ingredients with you?


Does your doctor, pharmacy or pediatrician ask you if your child has ever had an allergic reaction to any of the ingredients?


If a doctor doesn’t ask you these basic questions, you are NOT being Informed.



Package Insert: VAXELIS

What is in VAXELIS?


  • aluminum salts

  • polysorbate 80

  • glutaraldehyde

  • formaldehyde

  • bovine serum albumin

  • neomycin

  • streptomycin

  • polymyxin B

  • ammonium thiocyanate

  • yeast protein



Does your doctor INFORM you of these ingredients in Vaxelis?


Do you think it’s really healthy for you SIX Week old child to have aluminum and formaldehyde injected into their tiny body?


Or Cow protein?


Or antibiotics?


Or yeast?


Or glutaraldehyde – which is a disinfectant used in Embalming Fluid.


Or Polysorbate 80 – which has immunosuppression characteristic and in animals has caused low blood pressure and increase heart rate, has developmental neurotoxicity, blood toxicity and gastrointestinal disruptions.


How can these be healthy for a six week old child?


Package Insert: VAXELIS (Section 11)

DESCRIPTION


Each 0.5 mL dose contains 319 mcg aluminum from aluminum salts used as adjuvants.


Yes, your child is receiving 316 mcg of Aluminum in each .5mL dose.


Aluminum is used as an Adjuvant – meaning it simulates or wakes up the immune system to respond to the Antigens in the vaccine.


How can injecting a metal be healthy?


Read the Aluminum chapter. It’s NOT!



Package Insert: VAXELIS

What else is in Vaxelis?


  • inactivated bacteria of diphtheria

  • tetanus, pertussis

  • Hib

  • inactivated hepatitis B

  • polio viruses




Package Insert: VAXELIS

Carcinogenesis, Mutagenesis, Impairment of Fertility


VAXELIS has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility.


HELLO?

They are saying that this may or may not cause infertility.


They are saying they don’t know if this causes cancer.


Isn’t that saying that maybe they should do BETTER testing?



Package Insert: VAXELIS (Section 6.1)

DEATHS


In the 2 US studies, death was reported in 6 participants (0.2%) who received VAXELIS.


Causes of death among infants who received VAXELIS:

  • Sepsis

  • 2 cases of Sudden Infant Death Syndrome

  • Asphyxia

  • Hydrocephalus (occurring 2, 10 and 49, 42, 44 days, and 11 months post-vaccination, respectively).


Were you informed that .2% of the children in this study died?


Of course they say “no deaths were assessed to VAXELIS.”


How do they know that.


Just as in the Case of Maddie de Garay, a 13 year old girl who was completely disabled and paralyzed from the Pfizer Covid Vaccine in the Clinical Trial and it was written down as a “Stomach Ache” for the side effect.


Are we being told the truth?




Package Insert: VAXELIS (Section 6.2)

Postmarketing Experience:


The following adverse events have been reported during post-marketing use of VAXELIS.

  • Immune System Disorders Hypersensitivity (such as rash, urticaria, dyspnea, erythema multiforme), anaphylactic reaction (such as urticaria, angioedema, edema, face edema, shock).

  • General Disorders and Administration Site Conditions Extensive swelling of injected limb (including swelling that involves adjacent joints).

  • Nervous System Seizure, febrile seizure, hypotonic-hyporesponsive episode (HHE).





How often do you hear a child dying of Diphtheria, Tetanus, Pertussis, Haemophilus influenzae, Hep B or Polio?


Do we really want to risk putting these weakened or dead pathogens in babies?


IS IT REALLY WORTH THE RISK???



Sources:


1. Jeffrey Barke -- https://www.facebook.com/reel/2131444147369697


2. https://informedDissentMedia.com


3. Food and Drug Administration. “Package Insert - VAXELIS.” FDA.Gov, www.fda.gov/media/119465/download. Accessed 21 Apr. 2025.



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