|I need to get this off my chest, before I explode. I have been looking at adjuvants for a few years. The reason why I kept at it was, everytime I wanted to find something to reassure me, I found something worse. But still, I considered myself a veteran, who's (not quite, but almost) seen it all. You know, the misleading/fraudulent references, like this example, and the use of a cosmetics review paper to support the safety of squalene (see here, here, and here). The absence of widely claimed animal safety data (see here, here, and here). The misleading/fraudulent comments by company representatives (example). Attempts by the UK government to downplay AEs for the HPV vaccine by simply telling NHS staff to NOT report certain symptoms (more here). The misleading/fraudulent presentation of data in the FDA Gardasil file, to hide an 44.6% increased risk of getting CIN (carcinoma in situ) AFTER vaccination, for the group that was already seropositive and PCR positive (see here). I can go on.
So, I didn't think I could still get so angry. Last night I started to look through the H1N1 vaccines 'approved' by the EMEA. I went through the file for the GSK vaccine. Tonight I started to read the one for the Novartis vaccine. These files are important because these products are proprietary, therefore NO ONE has any safety (or any) data on them except what the companies put out. And, supposedly, these are the kinds of information the EMEA depended on, to license these products to be given to MILLIONS AND MILLIONS of people, pregnant women and their unborn offsprings included.
There really isn't one thing that made me so mad, but the cumulative effect of reading page after page of, well, to call it mildly, stuff. Like (not in order of importance, I'm too mad to care, sorry):
The EMEA approved the Novartis vaccine based on 4 clinical trials on a grand total of 1018 subjects, of whom - drum rolls please - only 59 were given the nonadjuvanted flu vaccine as control. (see CHMP assessment report for Focetria) All other trials compared MF59 adjuvanted H5N1 vaccine vs MF59 adjuvanted seasonal flu vaccine (or different doses of HA in the H5N1 adjuvanted vaccine). And that included 471 kids. Like, Hello? How on earth are you supposed to evaluate the safety of an ADJUVANTED vaccine, when the ADJUVANT is given to both groups? Do we care to compare the safety difference between H5N1 and seasonal flu? Heck, No!! But obviously, the EMEA scientific committee thinks it's perfectly proper and acceptable. Hence the vaccine is approved.
Now for GSK. (see CHMP assessment report for Pandemrix) This one you may already know about. They did 'reproductive toxicity' tests, tested the offsprings for reflexes, found a whole bunch of them not up to par, and their conclusion on that page? That those tests are appropriate to evaluate reproductive toxicity. How about, since these tests are appropriate, then the test results DEMONSTRATE fetal toxicity?? You know, rats don't go to school. They are pretty primitive, compared to humans. Therefore, any neurodevelopmental test is very CRUDE. But PRECISELY because they are crude, any positive finding is of great concern. The report itself says it's likely to be due to 'treatment'.
BUT, the great men and women of the scientific committee seem to think it's ok, so they concluded that the tests did not show any reproductive or fetal toxicity. Or something to that effect.
And then, he scientific committee expressed concern about the lack of safety data for early pregnancy (ie concerned about possible early abortion) GSK responds that there is no risk because there is no systemic cytokine response DETECTABLE. (Increase in certain cytokines, notably IL6, is associated with risk of abortion).
Well, yeah, if you don't MEASURE it, you can't DETECT it! (Or you measure it and then
hide not disclose the data.) So, where is the data to support that claim? Since Novartis published something on cytokine response a gazillion years ago (not really, in 1994) proudly showing the increase in IL5 and IL6, they have been scrambling to cover their backsides, because we now know that IL6 is a strong proinflammatory cytokine associated with, among many things, autoimmune diseases, adverse outcome in ARDS, trauma, pancreatitis, etc etc. I'm thinking of the 'hypothetical' risk of someone who gets vaccinated when in fact they already just got infected and is brewing a viral pneumonia. I asked this question of 2 WORLD-CLASS scientists whose names are instantly recognizable to most here, and they both said, that's a good question, we don't really know what happens in that case. Meaning, they DIDN'T think I was a wacko thinking up doomsday scenarios. I wish they said I was wacko, but they DIDN'T!! (more on adjuvants and cytokines.)
I guess they all got smart, huh? These companies, I mean. There is ZERO data on serum cytokines for AS03, whether in published journals or in the EMEA file, but they are ALLOWED to make the claim there is no cytokine effect???
BUT, scattered ALL over the clinical trials data, are reports of fever, myalgia, malaise, etc after vaccination. Including a significant % of Grade 3 fever (39 or above) in kids. And how does fever happen? It happens when your body makes some pyrogens (fever-causing molecules). Where do they come from? They come mostly from signals from the hypothalamus, which in turn is induced by, listen up, CYTOKINES!! (more)
And then there's one case of anterior uveitis in a pediatric case for the AS03 vaccine, which they THEMSELVES said is likely to be causally related. And in the very next paragraph, after they describe 2 more cases of autoimmune hepatitis, they go on to say, quite 'logically', that
Therefore, there is currently no evidence to suggest that AS03-adjuvanted vaccines are causally associated with development of AIH or other autoimmune disorders.
Pediatric uveitis is no small matter. It is often associated with or precede the onset of juvenile rheumatoid arthritis. There is also significant risk of long-term visual impairment. (more here) AIH is a very serious LIFE-LONG disease that, especially with childhood onset, often need LIFE-LONG treatment with such nasty drugs as steroids plus (not or) immunosuppressive drugs. Relapse is more common in pediatric cases, and some of them need liver transplant. A very small % develop liver cancer.
You know, I have asked this question so many times that I'm sick and tired of it, and that is, HOW DO THEY SLEEP AT NIGHTS??
We here have been debating on vaccine safety issues (which is great). I come across SO many places on the internet, stuff about thimerosal. Well, guess what? It suits them just FINE, for parents to be fighting trench warfare with GOVERNMENTS over something that no one can prove or disprove (so sue me if you disagree), while the whole time the COMPANIES are laughing all the way to the bank.