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Prevnar vaccine dangers

Search the Internet for Prevnar vaccine SAFETY and, surprise, surprise, you will get plenty of results about its dangers instead.

I did such a search just out of curiosity. I had already learned that three babies in the Netherlands had died recently, at end-Oct / early-Nov 2009, after they were given this pneumococcal conjugate vaccine (PCV),

Also, I am familiar with data from Vaccine Adverse Events Reporting System (VAERS) - which include "coincidental" events as well as those truly caused by vaccines - that showed 28,317 adverse reactions since the Prevnar vaccine was approved in 2000. These included:

  • 558 deaths
  • 555 life threatening conditions
  • 238 permanent disabilities
  • 2,584 hospitalisations
  • 101 prolonged hospitalisations
  • 8,166 emergency room cases and
  • 16,155 "not serious".

In addition, I had written in an earlier article about pneumonia vaccine side effects that the introduction of Prevnar and other pneumonia vaccines has led to:

  • an increase in the incidence of pneumonia caused by bacteria NOT covered by these vaccines
  • an increase in middle-ear infections due to bacteria not linked to pneumonia
  • the emergence of "superbugs" that are resistant to vaccines.

So I was already quite familiar with the dangers and side effects of PCV vaccines like Prevnar. I was curious what was being claimed about the safety of Prevnar vaccine. So I did a search on Google. I found...

  • Prevnar vaccine insert

    The Prevnar vaccine insert for doctors contains instructions, warnings, information about side effects etc.

    The insert warns, in big bold letters, that Prevnar® SHOULD UNDER NO CIRCUMSTANCES BE ADMINISTERED INTRAVENOUSLY.

    This means the vaccine should be injected into the muscles, and special care is needed to avoid injecting into, or near, a blood vessel or nerve. But with infants, whose blood vessels are fine and close together, and who might move about as they are being injected, it can be difficult to ensure this. So apart from the usual vaccine dangers, there is also the danger of human error.

    Adverse reactions listed in the insert are:
    --
    Fever
    -- Febrile seizures
    -- Erythema
    -- Induration
    -- Tenderness
    -- Repressed limb movement
    -- Irritability
    -- Drowsiness
    -- Restless sleep
    -- Decreased appetite
    -- Diarrhea
    -- Vomiting
    -- Urticaria (hives)
    -- Injection site dermatitis
    -- Pruritis
    -- Lymphadenopathy
    -- Anaphylactic reaction/shock
    -- Bronchospasm
    -- Dyspnea
    -- Apnea

    As for the efficacy of the Prevnar vaccine, the insert reveals that it reduces the rate of Otitis Media (ear infection) by only 7 percent. Yet Prevnar is widely touted as a "vaccine for ear infections".

    Prevnar IS Safe - Have a look at the studies... It tells about a new PCV-13 Prevnar vaccine trial in India that was stopped after a baby died. Looks like the title was just being sarcastic

  • VaccineRiskAwareness.com... This is pretty straightforward, no sarcasm or anything of the sort. But I learn here that, oh, by the way, Prevnar has not been evaluated for any carcinogenic or mutagenic potential, or impairment of fertility (ie they don’t know if it causes cancer, mutates into other illnesses or impairs people’s ability to have children).

    By law, vaccines are not required to be tested for any links to cancer. This itself is not necessarily a danger, just a (very) possible danger of the unknown.

  • A petition against the Prevnar vaccine. The petition cites research by Dr. J. Bart Classen, an immunologist at Classen Immunotherapies, on a similarly structured vaccine, the Hemophilus vaccine for meningitis. Data published by Dr. Classen in the British Medical Journal (1999; 319:1133) support a causal relationship between the Hemophilus vaccine and the development of insulin dependent diabetes.

    Dr. Classen had told the US FDA that the Prevnar PCV-7 may be seven times as toxic as the Hemophilus vaccine, possibly causing an estimated 400 to 700 children to develop insulin dependent diabetes per 100,000 children vaccinated. These cases of diabetes may not occur until 3.5 to 10 years following vaccination.

  • A 2001 report by News 8 Investigates, from Dallas, USA. It tells of Hayley Graves, who was nine months old when she received her second dose of Prevnar. "I had a baby that was perfectly healthy, happy, okay until she got a shot, until she got her vaccine," said her father, Ray Graves. "Thirty, forty hours later, she's in the hospital having seizures that they can't stop. You're not going to tell me it's not related to the vaccine somehow."

    Hayley slipped in and out of a coma for 45 days until she died in September. Tremors shook her little body almost the entire time.

  • A Critique of Prevnar vaccine, starting off with detailed information about the conflicts of interests of the six most outspoken advocates of Prevnar, who study the drug and travel the world to promote it to other doctors. All are financially supported, either directly or indirectly, by Wyeth, the manufacturer of the vaccine.

  • A comment from the American Academy of Pediatrics that: Available data suggest that PCV-7 (the Prevnar vaccine) may prove to be among the most reactogenic vaccine of those currently used.

And so on. There is just so much information about the side effects and dangers of the Prevnar vaccine. Why, then, do governments approve it?


How is vaccine safety determined?

Of course, there have been studies to determine the "safety" of the Prevnar vaccine. The main study was the Northern California Kaiser Permanente (NCKP) Prevnar Efficacy Trial conducted from October 1995 through August 20, 1998. The NCKP trial involved 37,816 infants who received either the Prevnar vaccine or a control vaccine at two, four, six and 12-15 months of age. Smaller scale follow-up studies were also conducted in Finland.

It is important to understand how these studies are conducted and how the "medical experts" decide whether a vaccine is safe. Without any background information, the average lay person would assume that if a vaccine has been declared to be "safe" it means that studies show it does not produce any serious side effects.

No so. In the case of the NCKP study, of the 17,066 subjects who received at least one dose of the Prevnar vaccine, the researchers recorded:

  • 162 visits to the hospital emergency room within 3 days of vaccination, including 20 cases of seizure, 15 cases of otitis media (ear infection), six cases of pneumonia and 1 case of sepsis.

  • 24 hospitalisations, including two cases of pneumonia, one case of otitis media and one case of congestive heart failure. In addition to this there were also 162 visits to the emergency room department including 20 cases of seizure, 15 cases of otitis media, 6 cases of pneumonia and 1 case of sepsis.

  • 12 deaths, including five cases of SIDS (sudden infant death syndrome, meaning sudden, unexplained deaths) and seven cases "with clear alternative cause" meaning there could have been another reason, apart from vaccination, to explain the death.

How can such serious side effects be considered acceptable?

Here's the interesting part. In normal drug trials, the experimental drug is compared to a placebo, a "dummy drug" that is usually made from sugar. In the case of a vaccine trial, however, the experimental vaccine is compared, not to a "dummy" but to another vaccine. As long as the experimental vaccine produces no worse side effects than the other vaccine, it is considered "safe".

There's more... The experimental vaccine does not even have to be compared to one that is already approved and known to be safe. In the NCKP study, the Prevnar vaccine was compared to another experimental vaccine, for meningitis. And it so happened that the other experimental vaccine produced even more deaths - although fewer of the other less serious side effects - than Prevnar. And so Prevnar was pronounced "safe".


Is death an acceptable side effect of vaccination?

Most doctors and government health authorities obviously think so. They look at cold statistics and tell us that a few deaths from vaccination are justified because it prevents even more deaths due to pneumonia. Such an argument ignores two important factors:

  • Deaths from vaccination often affects babies who were healthy to begin with, whereas death from pneumonia normally affects those already ill with other diseases.

  • Pneumonia can be easily - and safely - prevented through other means including breast feeding, improved hygiene and sanitation, proper diet and nutritional supplementation (eg with zinc). Yet little effort is made to promote these safer means of preventing pneumonia.

"Once you assume that a certain number of children are expendable, it is a very slippery slope. How many can you sacrifice? Is it five? Is it 100? Is it 5,000? It's very dangerous to employ that kind of utilitarian rationale,"" said Barbara Fisher, Co-founder & President of the US National Vaccine Information Center, in News 8 Investigates.

Of the Prevnar NCKP trial, Barbara Fisher said: "What's scientific about that? That every time something bad happens after vaccination it's 'coincidence'? That's not science, that's politics."



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