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The DTaP Vaccine: What the Manufacturer’s Insert Tells Us

Dairy Allergy, Guillain Barre Syndrome, Intussusception, Thrombocytopenia

The Diphtheria-Tetanus-Pertussis vaccine, or DTaP, is among the recommended vaccines given to young infants in the United States beginning at 2 months old.

This vaccine is one of the more controversial because, despite a 95% vaccine rate, pertussis (whooping cough) is still very prevalent. The effectiveness of the pertussis vaccine is estimated at anywhere from 94% to as low as 63%, depending on who you ask. It is difficult to determine because most doctors will not diagnose whooping cough as actually being whooping cough, so legitimate cases go unreported. The Centers for Disease Control estimate that whooping cough cases may be 20 times higher than reported.

Changes To The DPT VaccineThe most common form of this vaccine used to be the DPT, but because of so many reported and documented cases of injury resulting from the pertussis portion, the vaccine is now manufactured with an acellular version, hence the “a” in DTaP. A recent study that compares the two versions can be found in the August 2004 issue of Brain Development.

The Package InsertIt is increasingly difficult for parents to make an informed choice regarding vaccinations because of such factors as an inability to determine their true effectiveness, common misconceptions about vaccine-preventable diseases, and the growing list of children who may have been severely injured or even killed by vaccines. One place parents often forget to look is in the package inserts themselves.

Package inserts are documents included by the manufacturer of a vaccine or drug that contains such information as what it is, its intended use, contraindications (circumstances under which the vaccine or drug should not be used) and potential side effects.

INFANRIX by GlaxoSmithKline
One brand of DTaP vaccine is INFANRIX. The package insert provided by GlaxoSmithKline can be viewed by clicking here.

Manufactured with Casein, a Milk Protein
One of the first important things to note on the DTaP package insert is that portions of the vaccine are cultivated with casein, or milk protein. Cow milk protein is a common infant and child allergen. Any child suspected of having or diagnosed with a dairy allergy should NOT receive this vaccine. This critical information is mysteriously missing from the CDC’s DTaP Vaccine Information Statement (VIS), which doctors are required by law to give to parents at the time the vaccine is administered.

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Formaldehyde in the DTaP
Formaldehyde is a common ingredient in vaccines and is specifically listed here as the ingredient used to detoxify the vaccine. It has been argued that the amount is too small to be of an significant risk to recipients of the vaccine. It is used in several different industries as a fungicide, germicide, disinfectant, and preservative.

Formaldehyde is frequently used in construction materials and off-gases over time, making it one of the most common indoor pollutants. According to the National Cancer Institute, “Cancer and as a probable human carcinogen by the U.S. Environmental Protection Agency. Research studies of workers exposed to formaldehyde have suggested an association between formaldehyde exposure and cancers of the nasal sinuses, nasopharynx, and brain, and possibly leukemia.

The NCI also lists the health effects of low level exposure as “watery eyes; burning sensations of the eyes, nose, and throat; coughing; wheezing; nausea; and skin irritation. Some people are very sensitive to formaldehyde, while others have no reaction to the same level of exposure.”

The Manufacturer’s Studies on Efficacy
GlaxoSmithKline lists studies that determine how effective their DTaP vaccine is at preventing pertussis as defined by the World Health Organization. These two studies concluded that the DTaP vaccine is 84% and 78% effective, respectively. Studies on the vaccine’s effectiveness against diphtheria and tetanus are strangely missing from the package insert.

Why The Exclusion of Youth and Adults?
The DTaP package insert specifically states that INFANRIX should not be given to anyone over the age of 7. An explanation is not given. A review of the package inserts of other brands of DTaP, including older DTP vaccines, reveals the same warning, also without explanation.

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DTaP Warnings and Contraindications
The DTaP package insert warns that the vaccine should not be given if the recipient experiences any of the following with a previous dose:

-Encephalopathy such as coma, seizures, or loss of consciousness

-Progressive neurological disorder, such as spasms or epilepsy

-Guillain-Barre syndrome within 6 weeks of the prior dose (The National Institute of Neurological Disorders and Stroke define Guillain-Barre Syndrome as “a disorder in which the body’s immune system attacks part of the peripheral nervous system. The first symptoms of this disorder include varying degrees of weakness or tingling sensations in the legs. In many instances, the weakness and abnormal sensations spread to the arms and upper body. These symptoms can increase in intensity until the muscles cannot be used at all and the patient is almost totally paralyzed. In these cases, the disorder is life-threatening and is considered a medical emergency.”

-Temperature above 105 degrees within 48 hours

-Collapse or a shock-like state within 48 hours

-Persistent, inconsolable crying lasting longer than 3 hours and occurring within 48 hours

Contraindications, or circumstances which mean that an individual should not receive the DTaP vaccine, include the following:

-Latex sensitivity or allergy (parts of the syringe contain latex)

-Moderate to severe illness, with or without a fever

-Bleeding disorders such as hemophilia

Not Evaluated For Cancer-Causing Potential
The DTaP vaccine package insert specifically states that “INFARIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.” This means no one knows if the DTaP vaccine causes cancer or interferes with fertility, and that no study has been conducted to try and find out.

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Additional Side Effects/Adverse Reactions To The DTaP Vaccine
The following conditions are listed as adverse reactions on the DTaP vaccine package insert. The manufacturer includes many qualifiers, including that some of these reactions are voluntarily reported and so they can neither prove nor disprove that the vaccine actually caused them.

Redness
Swelling
Pain
Fever
Fussiness
Drowsiness
Poor Appetite
Vomiting
Persistent crying
Seizures
Hives
Swelling of the Mouth
Difficulty breathing
Hypotension
Shock
Brachial neuritis
Guillain-Barre Syndrome
Sudden Infant Death Syndrome
Cyanosis
Diarrhea
Intussusception
Idiopathic thrombocytopenic purpura
Lymphadenopathy
Thrombocytopenia
Anaphylactic reaction
Hypersensitivity
Cellulitis
Limb swelling
Convulsions
Encephalopathy
Hypotonia
Hypotonic-hyporesponsive episode
Somnolence
Irritability
Respiratory Tract Infection
Erythema
Pruritus
Rash
Urticaria
Ear pain

The Potential Connection To Sudden Infant Death Syndrome (SIDS)
The DTaP package insert includes mention that there is some concern that the DTaP vaccine is a cause of SIDS, since the vaccine is administered beginning at 2 months of age, and the highest rates of SIDS occur between 2 months and 4 months of age. The manufacturer is quick to include astudy disputing this claim. Various reputable research studies disagree on the connection, so further research is needed to determine causality.

For More Information
Interested individuals should consider visiting the government’s Vaccine Adverse Event Reporting System website for more information on the kinds of adverse reactions are being reported about the DTaP vaccine, and how often, keeping in mind that the government estimates that only 10% of reactions are actually reported, so the actual numbers are much higher.

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