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Pentacel/Pediacel® 5-in-1 Vaccine
Ingredients  |   Side Effects  |   News_Alert_May2006

HTML document "Package Insert" European Licensed.

Note: Pediacel is the name of this 5-in-1 vaccine licensed in the UK by Aventis Pasteur®.

This vaccine will be licensed as Pentacel® in the USA by Sanofi pasteur

This vaccine contains: D P T P H: Diphtheria Pertussis Tetanus Polio and Hemophilus Influenza B (HIB) components.
One reference called it: cPDT Polio + Hib.

Additional information on Pentacel & Pediacel
Pediacel 5-in-1 vaccine: News alert
[Sunday Express is a UK newspaper.]

EXCLUSIVE By Lucy Johnston
Brain damage fears after trial results show that two-thirds of patients experience bad reaction
Babies given the new five-in-one jab face a risk of convulsions, brain damage or even death.

Results of medical trials by the firm which makes the vaccine have revealed that the "superdose" vaccination, which was introduced 18 months ago, can have serious side-effects.

The five-in-one is designed to protect children against diphtheria, tetanus, whooping cough, Hib influenza and polio in a single shot.

Evidence from the vaccine's manufacturers, Sanofi Pasteur, shows that in clinical trials 64 per cent of 451 babies given the Pediacel jab experienced bad reactions. Ten per cent of these were "moderate to severe".

These included convulsions, loss of consciousness and high-pitched or persistent inconsolable crying.

Other studies showed that components of the vaccine can cause breathing difficulties, blue discolouration of the skin due to lack of oxygen, swelling of the brain, low blood pressure and extreme allergic shock.

The document prepared for the Medicines Healthcare Regulatory Authority and publicised by What Doctors Don't Tell You, a monthly newsletter that questions conventional medicine, has angered doctors and MPs. Professor Steve Webb, Liberal Democrat health spokesman, criticised the Government saying: "I am very concerned that these apparently wide spread side-effects have not been disclosed. The Government should investigate these concerns urgently".

Dr Richard Halvorsen, a London GP who specialises in innoculations said: "I'm concerned that this five-in-one is overloading a child's immune system.

"The risks of vaccinations have been played down by the Government and parents have been fobbed off with bland reassurances".

And Dr Peter Mansfield, who won a case against the doctor's governing body, the General Medical Council, for refusing to give the combined controversial measles, mumps and rubella to infants, said: "This is scandalous. We're vaccinating babies when their immune systems are not ready".

Jackie Fletcher from the vaccine damage support group JABS, is also concerned. She said: "The Department of Health is failing to acknowledge the dangers of the vaccines and the damage they can cause. It claims the five-in-one is perfectly safe, but clearly it is not.

"The only person taking a risk here is the baby and parents are not being given correct information about it".

Health officials claim it is safer than the four-in-one-jab it replaced which contained the controversial preservative mercury, which has been linked with autism. The new jab is also deemed to be safer because it contains inactivated polio to remove the risk that children could contract polio paralysis from the old oral vaccine that contained a live sample of the virus.

However, the revelations will ignite debate about the over-use of innoculations and could hinder Government plans to bring in an even more intensive vaccination programme that will see children receiving 25 vaccines in 12 injections by the time they are two.

The new proposed schedule contains the controversial MMR jab, the five-in-one jab, a new pneumococcal vaccine and the meningitis C vaccine.

When the five-in-one was launched the Government vaccine chief urged parents: " Please do not delay having your child vaccinated. Our vaccines are extremely safe."

Nicholas Kitchin, medical director of Sanofi Pasteur, insisted: "There are fewer side-effects with the five-in-one than were reported with the older four-in-one vaccine.

"All drugs and vaccines have potential side-effects, which parents should be aware of and these are listed in the information leaflet included with every dose of the vaccine. Severe reactions are rare and the benefits of vaccination far outweigh the risks."

A spokeswoman for the Department of Health added: "The Joint Committee on Vaccination and Immunisation thoroughly assesses the evidence on the safety and efficacy of all new vaccines before they are added to the childhood immunisation programme. Pediacel has an excellent record.

"Every parent is informed about the potential side effects of every vaccine in a guide which is given to parents by health visitors."

SUNDAY EXPRESS MAY 14 2006 OPINION Health chiefs must act now on five-in-one vaccine fears

The Government must move fast to prove that its new super-drug is completely safe for British babies. The five-in-one vaccination, introduced 18 months ago, was claimed to be a major breakthrough in the fight against childhood killer diseases. The drug, which is intended to provide protection against polio, diphtheria, whooping cough, tetanus and meningitis, is given to babies as young as two months and was claimed to be risk-free.

But evidence collected by the drug's manufacturer tells a different story.

The Sunday Express has revealed that the maker's clinical trials showed that nearly two out of three infants given an injection of its super jab experienced significant side effects.

The trials, when linked with other data, revealed a danger that children could suffer convulsions and even run the risk of brain damage.

This is devastating news for parents. Some health campaigners warn that the combination of five powerful vaccines adminstered in this way overwhelms a baby's immune system.

It is vital that the Department of Health intervenes now to restore public confidence. Every parent knows that no threat to a baby's health is ever tolerable.

Discussion forum at


PEDIACEL® - The 5:1 Vaccine
Available from October 2004, for use in babies aged 2/3/4 months.
Abbreviated vaccine composition: DTaP/IPV/Hib (high-dose Diphtheria, Tetanus and Pertussin; inactivated Polio; Haemophylus Influenza type B).
* Purified Diphtheria toxoid (30 I.U.)
* Purified Tetanus toxoid (40 I.U.)
* Purified Pertussis toxoid (PT)
* Inactivated Polio virus
* Haemophylus influenza type B
* Polyribosylribitol phosphate - an artificial sweetener
* Formaldehyde or gluteraldehyde
* Polio virus produced on Vero cells (African green monkey kidney cells)
* Neomycin, streptomycin and polymyxin B - antibiotics
* 2-phenoxyethanol (phenol) - a preservative
* Polysorbate 80 - an emulsifier
* Aluminium phosphate or aluminium hydroxide


4.8 Undesirable effects

In controlled clinical studies performed with PEDIACEL®, 71% of 451 infants immunised at 2, 4 and 6 months experienced a reaction (pain, erythema or oedema) at the injection site within the first 24 hours after vaccination. In 16% of infants the reaction was of moderate to severe intensity. Also, 64% of infants experienced a systemic reaction, which was of moderate to severe intensity in 16%.

There was a trend for an increased frequency of injection site reactions when a fourth dose of PEDIACEL® was given to 401 children in the second year of life. Pain was reported in 33%, erythema in 23% and oedema in 16% compared to rates of 18%, 11% and 11%, respectively, during the primary series. The frequency of systemic reactions was similar whether PEDIACEL® was administered in infancy or in the second year of life.

The reactions observed were as follows:

Nervous system disorders

Rare (0.01-0.1%): Febrile convulsions.

Hypotonic hyporesponsive episodes (HHE) (see section 4.4).

Gastrointestinal disorders

Common (1-10%): Anorexia, diarrhoea and vomiting.

General disorders and administration site conditions

Very common >10%): Pain, erythema and oedema at the injection site.

Irritability, malaise, increased crying and fever.

Very rare (<0.01%): High fever >40.5°C).

Unusual high-pitched or inconsolable crying.

Painless circumferential limb swelling following booster doses which resolve spontaneously.

In a controlled clinical study of PEDIACEL®, administered concomitantly with meningococcal group C conjugate vaccine, 71% of 121 infants immunised at 2, 3 and 4 months experienced a reaction (pain, erythema or oedema) at the PEDIACEL® injection site within the first seven days after vaccination. Also, 92% of infants experienced a systemic reaction within the first seven days after vaccination. The rates of moderate to severe reactions were similar to those described at 2, 4 and 6 months.

Acute allergic reactions have been reported after diphtheria, tetanus and/or pertussis vaccines. Manifestations include dyspnoea, cyanosis, urticaria, angioneurotic oedema, hypotension and, rarely, anaphylaxis.

A persistent nodule at the site of vaccination may occur with all adsorbed vaccines, particularly if administered into the superficial layers of the subcutaneous tissue. Rarely aseptic abscesses have been reported.

Following administration of vaccines containing Haemophilus influenzae type b conjugated to tetanus toxoid, atypical rashes have sometimes been observed and rarely urticarial eruptions, localised oedema, pruritus and oedematous reactions of the lower limbs. The latter consist of oedema with cyanosis or transient purpura that appears soon after immunisation and resolves rapidly and spontaneously.