Saturday, 14 November 2009

Why people should be paid for taking the vaccine

I have previously discussed the fact that the vaccines against H1N1 have been fast-tracked and not properly tested [1]. The Medical Product Agency seem perfectly fine with this though. The situation calls for quick action, which means that skipping a few steps is called for. That the swine flu has turned out to be less deadly than the seasonal flu is a small side note.

Most people probably can't be bothered to consider the dangers with the vaccines. This vaccine is no different from any other, and we have all grown up with propaganda about how vaccines are both necessary and perfectly safe. Those who don't want vaccines are just wimps afraid of a tiny needle that will cause a slight discomfort to the injection area. The side effect of a slight pain in the arm is clearly much better than falling ill and quite possibly dying from some horrific disease.

Well, first of all, risks exist, and this vaccine contains ingredients that are proven to be bad for our health. These risks should not be downplayed. Squalene is an ingredient included in Arepanrix and Pandemrix (same vaccine but the first one is made in Quebec and the second in Germany) that is not approved by the FDA. How come the US won't allow it? Perhaps because it has been shown that it has quite undesirable effects. [2] We have also learned that the vaccine contains mercury. But of course this risk has been downplayed since the level of mercury is so low that it couldn't possibly do any harm. Apparently, two portions of fish contain as much mercury as one dose of vaccine. What they fail to mention, however, is that a substance that is injected into us is not treated in the same way as a substance we digest. Isn't there a reason for Sweden banning mercury in child vaccines?

I wanted to know more about how well Arepanrix and Pandemrix have been tested and if GSK had found any possible risks involved with the vaccines, so I turned to the Product Information Leaflet, which I assume any nurse or doctor is obliged to have read before being allowed to inject patients with the vaccine. I also assume that they would be obliged to inform patients on possible side effects and unknowns.

But now that I have read the leaflet about Arepanrix, I find it strange that any doctor or nurse could feel good about injecting this stuff into their patients or themselves.

Basically, all those who take the vaccine are being used as test subjects since so few studies have been conducted (especially for those under 18 years old and pregnant women).

First of all, we should all be aware of that the mock up vaccine used in the study was a vaccine against avian flu, H5N1. "The avian influenza strain H5N1 strain was initially considered as a possible candidate to cause the next influenza pandemic." So studies with the actual H1N1 strain vaccine are very limited.

Here follows some thought provoking quotes from the Product Information Leaflet for Arepanrix:

  • No data have been generated in pregnant women with Arepanrix™ H1N1 nor with the prototype AS03 adjuvanted H5N1 vaccine. (p. 7)
  • Two reproductive studies were conducted with AS03-adjuvanted H5N1 antigen and evaluated the effect on embryo-fetal and peri-and post-natal development in rats, following intramuscular administration. Although no definite conclusion could be reached, regarding a possible relation to treatment with the H5N1 vaccine and/or the adjuvant AS03, and other findings were considered normal, the following observations deserve to be mentioned: In the first study, there was an increased incidence of fetal malformations with markedly medially thickened/kinked ribs and bent scapula as well as an increased incidence of dilated ureter and delayed neurobehavioral maturation. In the second study, there was an increased incidence of post-implantation
    loss, and the fetal variation of dilated ureter. Not all findings were observed in both studies, and hence the toxicological significance is uncertain. (p. 18)
  • Elderly (>60 years): No clinical data are available for Arepanrix™ H1N1 in this age group. (p. 6)
  • Children and adolescents aged 10-17 years: No clinical data are available for any influenza vaccines with AS03 in this age group. (p. 6)
  • Children aged from 6-35 months: No clinical data are available for influenza vaccines with AS03 in this age group. (p. 6)

Here are some interesting quotes from the CHMP Assessment Report for Pandemrix:

  • [from studies in rats] In neonates, the reflex development was unimpaired, but among offspring from dams treated with AS03 13 offspring from 7 litters did not show the air righting reflect before day 21 of age and this effect may be related to treatment (p. 16)
  • The real benefits of Pandemrix A(H1N1)v can only be assessed by its use during a pandemic. At present the benefit can only be evaluated based on detailed characterisation of immunological responses to vaccination with the mock-up version of Pandemrix (i.e. containing H5N1 strains) plus the limited data available from administration of a single dose of A(H1N1)v vaccine to healthy adults aged 18-60 years. (p. 64)
  • Based on the data with H5N1 vaccine and the available data with A(H1N1)v vaccine the expected benefit of Pandemrix is to provide some protection against clinically-apparent infection due to A(H1N1) (p. 64)
Ain't it swell how well the public has been informed about the vaccine: its possible side effects and how well it has been tested? Every person needs to weigh the benefits and risks for themselves, but before doing so, they need the information. They should consider how benign this influenza is and that they will be test subjects for a vaccine if they decide to take it. They should also be aware that getting the vaccine is no guarantee for immunization as the vaccine has been expected to provide "some protection", which doesn't sound all too convincing to me. Pregnant women should be especially cautious.

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