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BLOG: September 2007

Pneumococcal vaccine

Those reading health articles this month may have noticed media lamenting over newly developing crack in the efficacy of pneumococcal vaccine Prevnar (Wyeth). It turned out that its limited action - it only protects from the 7 most common, out of over 90 strains of pneumococcus bacteria - opens up room for more virulent strains, such as the antibiotic-resistant superbug named A19, to flourish.

It is such a pity, for Prevnar is saving great many little ones from contracting pneumococcal diseases, suffering or even dying from them. Or is it?

Approved by the FDA in February of 2000 for prevention of pneumococcal infections that can cause both, so called invasive pneumococcal diseases (IPD) - meningitis, blood poisoning (bacteraemia) and pneumonia with bloodstream infection - as well as non-invasive, or local forms, like earache (otitis media), sinusitis, pneumonia and bronchitis, Prevnar vaccine (PCV7) is being recommended for routine vaccination at 2, 4, 6 and 15-18 months of age, as well as catch-up vaccination of older children with medical conditions predisposing them to a higher risk of contracting IPD.

Also, PCV is administered to other age groups on a more random, preventive basis. What are the actual risks and benefits?

According to the manufacturer's study, average incidence of "invasive pneumococcal diseases" for children under 2 years of age is about 1 in 670. Factoring in that health preconditions, such are all genetic and chronic diseases with immune-system suppressing effect, will result in significantly higher incidence - nearly 40 times with sickle cell anemia - the incidence is lower for the majority of generally healthy children.

What really does matter is the risk of serious consequences. Since not all the numbers are available, and those that are amount to estimates, we have to settle with an approximation. Roughly, about 1/3 of the IPD deaths in this age group are caused by meningitis. With its incidence of 7 in 100,000, and the death rate of 8%, it comes to the death risk of nearly 1 in 180,000. Multiplied by 3, it comes to 1 in 60,000 for all three major IPD diseases. And, with about as many children left debilitated, as dying from meningitis, puts the risk of serious consequences from invasive pneumococcal diseases roughly at the level of 1 in 45,000.

Now, those that advocate the vaccine are quick to point out impressive statistical reduction in the incidence of IPD caused by the seven pneumococcal strains it fights off (more than 80% of all IPD), and even some IPD caused by dozens of other pneumococcal strains. Claimed reduction for the former is 94%, while the overall reduction is in the 60%-70% range.

However, for some reason,

no one is mentioning the death rate.

And, chances are, not because it was just overlooked. One condition for the vaccine to work is well functioning immune system.

In other words, it works well in those who need help the least, and does little for those most vulnerable. For those with compromised immune function,

it can be plain dangerous.

The problem is that there is no efficient system in place to identify infants and children at risk.

Data from the Vaccine Adverse Effects Reporting System (VAERS) published in the October 13th 2004 JAMA show that in 4154 reports of events after immunization with PCV there was 608 reports of serious adverse effects, including 117 deaths. That puts the death rate at 1 in 36.

Most of the deaths (90%) is linked to PCV given with other vaccines, and only 10% for PCV given alone. Also, most of deceased (80) were infants younger than 6 months of age. Most of unexplained deaths (73) were classified as Sudden Infant Death Syndrome, while out of 44 deaths with identified cause 22 were caused by infections, 13 by pre- and antenatal conditions, and 8 by seizures. What is particularly disturbing in these numbers is that the

death rate of 1 in 36 is exorbitantly higher than that from IPD alone, without vaccination.

Of course, significant number of these deaths is likely caused by other vaccines, or their combined effect. Children in developed countries - and in particular USA, which has mandatory vaccination for 12 diseases, more to come (in comparison, countries like Belgium or France only have a single mandatory vaccination, for polio) - are routinely subjected to a barrage of vaccines, and no one knows what are the immediate and long term consequences of it. But VAERS numbers raise serious concerns about the efficacy - and dangers - of Prevnar.

 Among the 22 children that died from infections, 7 died from pneumococcal infections. They died from infections they were vaccinated against. In other words, those were possible - and very likely - direct vaccine failures, causing the diseases they were intended to protect from. Even these seven deaths alone still make for 1 in 593 death rate, higher than the statistical death incidence for all invasive pneumococcal diseases combined, without vaccination.

Plainly put, the VAERS numbers suggest that the

number of children dying from IPDs inflicted by the vaccine may be higher than a number of children
that would only get infected by IPD with no vaccination at all.

And that the overall death rate resulting from the vaccine administered in this manner is even higher. Is that why no one is mentioning the death rate? How much of a factor is that, at nearly $60 per injection, PCV7 is among the most expensive vaccines ever, bringing in half a billion dollars, or so, in annual sales. It has been approved despite serious objections in regard to:

documented conflict of interest (i.e. financial ties) between those who were testing, officially promoting and approving it,

low benefit, considering very low statistical risk of serious consequences from IPD in children below 2 years of age (more so considering that PCV protection is limited to the bacterial forms of these diseases, which amount to 45% of all meningitis cases, 97% for blood poisoning and 63% for pneumonia),

insufficient basis for the routine use in prevention of earache (otitis media), which is only about 40% bacterial, and resolves without medical intervention within a couple of days 90% of the time

inadequate research in regard to possible effects when combined with other mandatory vaccines,

unknown toxic, carcinogenic and mutagenic effects; every 0.5ml vial containing 0.125mg of aluminum, and also possible traces of cyanide, lead and mercury (the FDA's safe level for infants is 0.005mg/kg/day)

possibly contributing to development of diabetes - and other chronic diseases - years after administration

increasing seizure rate by fourfold in the manufacturer's own premarket trial, according to Dr. Erdem Cantekin, Professor of Otolaryngology, University of Pittsburgh, one of the nation's leading experts on earache.

No one objects that vaccination did great things in the fight against infectious diseases. And so did antibiotics. But there is a limit to everything, and these two are not exception. After that line is crossed, it starts backfiring. Creating superbugs is only part of the problem. Neither vaccination nor antibiotics can ever replace our immune system; they can only be an aid to it, the less frequently used the better.

The problem is in finding the way to make profit-hungry drug industry accept this wise, minimalistic approach, and spare people - especially the children - from the harm caused by excessive vaccination.

Is this newest vaccine not more than a decoy concealing another money-making scheme of the Big pharma? Only an independent investigation could find it out for sure, but the indications are definitely worrisome. Dr. Cantekin has already made up his mind: "Prevnar ranks as one of the biggest selling hype snow jobs in modern medicine..."