NEW CDC/FDA-Approved Six-in-One Hexavalent Vaccine—Vaxelis®—For Infants

By Catherine J. Frompovich

Just when parents, and those concerned about vaccine safety issues, think it can’t get any worse regarding over-vaccination than it is, the U.S. CDC/FDA just approved a new six-active vaccine to be given to infants in three doses starting as early as 6 weeks of age. It’s called Vaxelis®, manufactured by Sanofi and distributed by Merck.It’s approved as a three-dose series before children reach their fifth birthday.”

FiercePharma notes,

The manufacturing scale-up for Vaxelis comes as Sanofi and Merck both count on vaccines for future growth. For Sanofi, it also comes after a letdown for another recent vaccine launch, dengue shot Dengvaxia. Merck, for its part, is hoping its pipeline vaccine V114 can compete with Pfizer in the pneumococcal disease vaccine field, where Pfizer’s Prevnar 13 currently generates billions of dollars in annual sales. [1] [CJF emphasis]

According to the vaccine package insert [2], Vaxelis is

Manufactured by: Sanofi Pasteur Limited Toronto Ontario Canada for: MCM Vaccine Co. Swiftwater PA 18370 USA

Distributed by: Merck Sharp & Dohme Corp. A subsidiary of Merck & Co., Inc. Whitehouse Station NJ 08889 USA and Sanofi Pasteur Inc. Swiftwater PA 18370 USA

VAXELIS is a trademark of MCM Vaccine Company. The trademarks depicted herein are owned by their respective companies.

The Vaxelis packages insert state:

11 DESCRIPTION VAXELIS

(Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine) is a sterile suspension for intramuscular injection. Each 0.5 mL dose is formulated to contain 15 Lf diphtheria toxoid, 5 Lf tetanus toxoid, acellular pertussis antigens [20 mcg detoxified pertussis toxin (PT), 20 mcg filamentous hemagglutinin (FHA), 3 mcg pertactin (PRN), 5 mcg fimbriae types 2 and 3 (FIM)], inactivated polioviruses [29 D-antigen units (DU) Type 1 (Mahoney), 7 DU Type 2 (MEF-1), 26 DU Type 3 (Saukett)], 3 mcg polyribosylribitol phosphate (PRP) of H. influenzae type b covalently bound to 50 mcg of the outer membrane protein complex (OMPC) of Neisseria meningitidis serogroup B, and 10 mcg hepatitis B surface antigen (HBsAg).

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

Other ingredients per 0.5 mL dose includeread the package insert because my computer censor will not permit me to copy and paste the rest!!! [2] [CJF emphasis]

Under 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility, we find this bald-face irresponsibility:

VAXELIS has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility. [2]

Those “legal wiggle room words” and practices are totally outrageous, plus never should be permitted in order to pass the CDC/FDA vaccine licensure approval process!

If a vaccine is not evaluated for carcinogenicity or mutagenic potential or impairment of fertility, that’s in defiance of the long-held health standard of “first do no harm.” Vaccine makers should be mandated by law to publish whether their vaccines can do that, Congress. Wake up and do you job of oversight!

Therefore, CDC/FDA should be prosecuted for not protecting public health, especially vulnerable young children, whose immune systems are not fully developed until about 2 years of age!

Remember, the original polio vaccine contained the SV-40 simian virus, a carcinogen, given to approximately 100 million children!

It is now time to dismantle the CDC/FDA and Big Pharma cartel for fraud and deceit regarding the safety of vaccines, since vaccines are not tested for the ability to cause cancer, mutations or impair fertility, but increasingly are mandated, which contribute to overwhelmingly exponentially-growing, escalating childhood disease statistics [3] while “Approximately 27% of U.S. children live with chronic health conditions that can affect their … According to the Centers for Disease Control and Prevention (CDC] [4].

In Section 6, Adverse Events, we read these disturbing findings during Vaxelis studies:

Deaths In the 2 US studies, death was reported in 6 participants (0.2%) who received VAXELIS and in 1 participant (0.1%) who received Pentacel + RECOMBIVAX HB vaccines; none were assessed as vaccine-related. Causes of death among infants who received VAXELIS were asphyxia, hydrocephalus, unknown cause, sepsis and 2 cases of Sudden Infant Death Syndrome (occurring 1, 2, 10, 42, 44 and 49 days post-vaccination, respectively). Across all 6 clinical studies, there were no deaths assessed as related to VAXELIS. [CJF emphasis]

Bullcrap! How can CDC/FDA and Big Pharma get away with such bald-faced pseudoscience?

It is now time for parents to demand better oversight and legal responsibility from their members of Congress, who in 1986 empowered Big Pharma to harm children’s health with no financial responsibility with The National Childhood Vaccine Injury Act (NCVIA) of1986 (42 U.S.C. §§ 300aa-1 to 300aa-34. That “get out of jail” law empowered vaccine makers to go hog-wild producing hundreds of vaccines which NEVER are tested properly for safety, carcinogenicity, mutagenicity or fertility impairment, or like Big Pharma’s prescription drugs.

The 1986 vaccine law must be repealed now and before any more vaccine mandates for medically-approved child abuse comes forth from Big Pharma-captively-held federal health agencies, i.e., the HHS, CDC and FDA!

References:

[1] https://www.fiercepharma.com/vaccines/sanofi-merck-win-fda-nod-for-6-1-pediatric-vaccine-vaxelis

[2] https://www.merck.com/product/usa/pi_circulars/v/vaxelis/vaxelis_pi.pdf

[3] https://www.usnews.com/news/best-countries/articles/2018-01-11/us-has-highest-child-mortality-rate-of-20-rich-countries

[4] https://www.focusforhealth.org/chronic-illnesses-and-the-state-of-our-childrens-health/

Image credit

Catherine J Frompovich (website) is a retired natural nutritionist who earned advanced degrees in Nutrition and Holistic Health Sciences, Certification in Orthomolecular Theory and Practice plus Paralegal Studies. Her work has been published in national and airline magazines since the early 1980s. Catherine authored numerous books on health issues along with co-authoring papers and monographs with physicians, nurses, and holistic healthcare professionals. She has been a consumer healthcare researcher 35 years and counting.

Catherine’s latest book, published October 4, 2013, is Vaccination Voodoo, What YOU Don’t Know About Vaccines, available on Amazon.com.

Her 2012 book A Cancer Answer, Holistic BREAST Cancer Management, A Guide to Effective & Non-Toxic Treatments, is available on Amazon.com and as a Kindle eBook.

Two of Catherine’s more recent books on Amazon.com are Our Chemical Lives And The Hijacking Of Our DNA, A Probe Into What’s Probably Making Us Sick (2009) and Lord, How Can I Make It Through Grieving My Loss, An Inspirational Guide Through the Grieving Process (2008)

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