The Scoop on Pediarix: the New 5-in-1 Vaccine for DTaP Hep B IPV

PEDIARIX, the new 5-in-1 vaccine will be showing up in syringes in front of unsuspecting parents in pediatrician offices around the country now that it is FDA approved. Dr. Sheri Tenpenny did this great write up of information on PEDIARIX that all parents should have to consider before going taking their child in to the pediatrician. This was published in Dr. Mercola's recent issue of his awesome Wellness newsletter and appears on his website at http://www.mercola.com/2003/jan/25/pediarix.htm. If you know a mom whose baby may be due for shots soon, please pass this on.

From www.mercola.com January 25, 2003 Commentary on PEDIARIX by Dr. Sherri Tenpenny, D.O and nationally renowned and respected vaccine expert.

The pharmaceutical industry has shown its true colors on this one.

The goal of creating Pediarix, a new 5-in-one combination vaccine for diphtheria, tetanus, pertussis, hepatitis B and polio, is clearly stated in the GlaxoSmithKline (GSK) press release: "combination vaccines will allow more vaccines to be added to the 'crowded' pediatric vaccination schedule." With more than 200 vaccines currently under development, it is certain that many more will be added to the childhood and adolescent vaccination schedules. To accommodate the new additions, many combination vaccines are in the pipeline, including:

MMR and Varivax DTaP and IPV DTaP and Hepatitis B (HepB) DTaP, IPV and HiB (Pentavac) DTaP, HepB and HiB DTaP, IPV, HepB and HiB (Hexavac) DTaP, IPV, HepB, HiB and Hepatitis A[1]

Scientifically, the D-T-aP is composed of three separate vaccines, and the polio vaccine contains three viruses, so it is actually three vaccines. After adding the projected number of antigens in the "combination vaccines," the fictional vaccine Omnivax portrayed in Michael Palmer's book "Fatal," which combined 30 vaccines into one shot, does not seem so "fictional."

It is certainly disturbing for parents to see their babies receive five to seven separate vaccinations at the 2-, 4- and 6-month "well-baby visits." However, reducing the total number of shots by combining them, rather than eliminating unnecessary shots from the schedule, is nothing more than a deceptive "placebo" for concerned parents.

Even when familiar vaccines are combined, the mixture is considered to be a new product. The vaccine must be subjected to "safety and efficacy" clinical trials as though it were brand-new.[2] After reviewing several of the studies that allowed this vaccine to come to market, similar investigational flaws were discovered for this vaccine trial as in all others: safety is not "proven" through the studies, and "effectiveness" is defined only as the presence of antibodies.

The design of all vaccine safety studies is seriously flawed. A scientifically sound safety study would compare the new vaccine to an inert substance, such as sterile water or saline. In addition, current vaccine safety studies compare a new vaccine to a vaccine with a "known side effect profile." These flaws are bad enough, but the design of the Pediarix study coordinated by the UCLA Center for Vaccine Research, Research and Education Institute, was even more bizarre.

Various combinations of vaccines were given to 400 children who had been divided into four groups:

Group A received 3 doses of Pediarix + the HiB (H.flu) vaccine

Group B received 2 doses of Pediarix + HiB;

The third vaccine was [DTaP + HepB] + oral polio

Group C received 3 doses each of [DTaP + HepB], IPV (injectable polio), and HiB

Group D received 3 doses each of DTaP, HepB, HiB and oral polio

The conclusion? The researchers found that the antibody levels of each of the vaccines were nearly the same in all groups, therefore, "the use of the pentavalent combination vaccine will greatly reduce the number of required injections during the first 2 years of life, thereby simplifying the immunization schedule, enhancing compliance and facilitating acceptance of additional injections engendered by introduction of newer vaccines."[3]

That sounds like proving convenience, but not proving safety.

If the [DTaP + HepB] vaccine looks unfamiliar to you, it is because it is. In this study, five licensed vaccines and two investigational combination vaccines (also manufactured by GSK) were evaluated simultaneously.[4] The FDA appears to be granting permission to compare one experimental vaccine to another. I wonder if the parents knew that their children were being used as truly "experimental subjects"? This type of "research" goes far beyond what can possibly be defended on scientific grounds and borders on being criminal.

The same study further concluded that "there were no vaccine-related serious adverse events in any group after any vaccine dose." But if the study is read carefully, evidence to the contrary exists:

"Two subjects withdrew from the study because of serious adverse events that were determined by the safety monitor to be unrelated to vaccination. One subject in Group A was diagnosed with a seizure disorder 14 days after the first immunization. Another subject in Group B had a neuroblastoma detected 6 weeks after the first immunization. Six other reported serious adverse events involved hospitalizations for bronchiolitis/pneumonia (4), meningitis (1) and apnea (1) and were also determined to be unrelated to vaccination."[5]

Why is it that whenever an adverse event occurs during the course of a vaccine clinical trail, that "event" is never related to vaccination?

Every consumer should ask to read the package insert on every vaccine, but be sure to read this one carefully.[6] Here is a partial list of the additives, adjuvants and contaminants:

VERO (monkey) cells -- potentially containing the SV40 virus incriminated in several different cancers, including leukemia.

Bovine extract, bovine casein and calf (bovine) sera -- It is common knowledge that bovine blood products can be contaminated with viruses, and bovine viral diarrhea virus (BVDV) is the one most often contaminating fetal bovine serum.[7]

Formaldehyde -- a chemical that has caused cancer in laboratory animals and may cause cancer in humans. There is no known threshold level below which cancer risk does not exist. The World Health Organization recommends that exposure should not exceed 0.05 ppm (parts per million).[8]

Glutaraldehyde -- a toxic chemical that is used for cold sterilization of medical and dental equipment. There is no Occupational Safety and Health Administration (OSHA) permissible exposure limit. The National Institute for Occupational Safety and Health (NIOSH) recommends that exposure to glutaraldehyde be under 0.2 ppm.[9] (TOM: reference)

2-Phenoxyethanol -- the chemical name for antifreeze, the vaccine contains 2.5 mg of this compound.

Thimerosal -- this mercury compound is used in the production of Energix, the hepatitis B fraction of the vaccine. It is used during the initial manufacturing process and then removed by a process using cystiene. However, up to 12.5ng (nanograms) remain.

The vaccine also contains these substances: neomycin, polymyxin B, polysorbate 80 and less than five percent yeast protein. The instructions on the package insert caution to "shake well before administering" and describe the vaccine as a "turbid white suspension" consisting of the many particles in the solution.

Is this something that you would want to have injected into your arm? Into your baby's arm? Don't bet on it. The long-term studies on combination vaccines will most likely prove that the biological warfare coming through a needle is just that: war -- on the immune system.

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References:

[1] http://www.keepkidshealthy.com/ newsletters.html

[2] New vaccine supply and financing: a case study of combined vaccines in developing countries. http://www.who.int/ vaccines-access/ vaccines/ Vaccine_Supply/ Vaccine_supply_index_documents/ combination_vaccines.pdf

[3] Sylvia H. Yeh, MD. et.al. Safety and immunogenicity of a pentavalent diphtheria, tetanus, pertussis, hepatitis B and polio combination vaccine in infants. Ped Inf. Dis. J. 2001;20:973-980.

[4] Ibid.

[5] Ibid.

[6] Pediarix package insert: http://us.gsk.com/ products/ assets/ us_pediarix.pdf

[7] European Commission on Health and Consumer Protection Directorate-General. Scientific Committed on Animal Health and Animal Welfare. Adopted 25 October, 2000. http://europa.eu.int/ comm/ food/ fs/ sc/ scah/ out50_en.pdf

[8] IAQ fact sheet: formaldehyde. http://www.nsc.org/ ehc/ indoor/ formald.htm

[9] FMSCME Fact sheet: glutaraldehyde. http://www.afscme.org/ health/ faq-glut.htm

April 5, 2008