Edda West from VRAN (Canada) on 5 in 1 vaccine (Pentacel)
Good for the folks in the UK who are protesting the
new 5 in 1 vaccine being foisted on them. Here in Canada, we
didn't hear a peep in the media when Aventis Pasteur's 5 in 1 vaccine
(Pentacel) was introduced across the board and injected into most
Canadian babies starting in 1997.
Although we can be grateful that thimerosal is no longer in the vaccine (except perhaps for trace amounts used in the manufacturing process which apparently they don't have to disclose), it has been replaced with 2-phenoxyethanol, a main ingredient in anti-freeze. You'd need to check the ingredients list to determine whether this is also being used in the U.K.version of the 5 in 1 vaccine. We've not been able to find any data showing that it is safe to inject infants with 2-phenoxyethanol or anti-freeze for that matter. Our understanding is that they were unable to continue using thimerosal, not because of safety concerns to babies, but because the inactivated polio viruses in Pentacel vaccine are altered by thimerosal, hence the need to switch to another preservative. Some sources state that 2-phenoxyethanol is a 'protoplasmic poison'. No matter how many vaccines your David Salisbury and Paul Offit in the U.S. think babies can handle, the bottom line is they are still being injected with toxic substances.
Canadian infants have been the main test market for this vaccine these past 7 years, and based on this large experiment, Aventis is aiming to have it licensed for use in the U.S. either in 2004 or 05. Undoubtedly licensing in other countries is pending as well.
Canada is the perfect test market for pharmaceutical companies testing new vaccines because:
a) There is no mandatory reporting of vaccine reactions in this country, with the result that only a small fraction (between 1-10%) of adverse reactions are reported.
b) Reporting of adverse reactions hinges solely on the individual doctor's 'opinion' as to whether a reaction is vaccine related. Most physicians refuse to entertain the possibility of vaccine involvement when a child presents with any range of collapse, seizures, neurological injurty post vaccination. Hence, the vast majority of vaccine reactions are discounted as 'coincidental' and reports are not filed.
c) to the best of our knowledge the original trials did not monitor reactions in chilren beyond 72 hours (see attached pdf medscape report), and prelicensure testing was only done in healthy children.
d) Testing on children with existing or evolving neurological or other health problems was not undertaken until after the vaccine was already in widespread use. (we have not seen the results of this additional post licensure evaluation) We suspect that parents whose children suffered existing health problems and who were vaccinated with Pentacel were not informed their children were included in a test group. (see Marina's story, attached)
e) Although reporting of adverse reactions
in the first 72 hours are substantially less than with
the old whole cell vaccine that contained thimerosal,
the pattern we have observed from parents who have contacted
us, is that serious reactions to this 5 in 1 vaccine are delayed often by
10 or 12 days, way beyond a time frame that any physician will consider
the seizures or collapse to be vaccine related. See
f) No public access to govenment or pharmaceutical data bases for independent inquiries into reactions that are being reported. Without independent evaluation of reactions and in the absence of mandatory reporting of vaccine reactions, sweeping statements claiming that the 5 in 1 vaccine has been proven safe after 7 years of injection into Canadian children are fraudulent.
Following is backgrounder from Scott Hunter, (parent of vaccine injured child) who has been investigating Pentacel:
"I have not been able to unearth any clinical trials used to license the product in 1996 that used the products exact ingredients. To the contrary I've been able to find several references pointing in the opposite direction. The accellular component was added in 1997 post-licensure and the preservative Thimerosal was replaced with 2-phenoxyethanol seemingly without the product being retrialed. Most clinical trials references in the monograph utilize component trials not the DTaPP -ActHib all in one combination with the one mention of Quadracel trials in Canada not dated. Any change in the product ingredients should have constituted a reason for retrial given the potential immunologic sensitivities to the new elements."
Additional writes Scott "VAESS (canadian reporting system) requires that physicians and health professionals NOT make causal assessments prior to reporting. Kirk's neurologist refused to entertain vaccine injury to such an extent, he informed us after 6 months of intensive testing which confirmed a diagnosis of idiopathic seizures, he would "never" reconsider vaccine as a possible trigger. This, I presume, contributed to the reason it took us over a year of constant parental shoving to get this "possible" injury recorded. As a matter of fact Kirk's only official documenting of the our suspicions was recorded at the MAYO Clinic in Rochester, despite repeated attempts with several health professionals here." (see attached letter to minister of health - saskatchewan)
The attached is a significant piece of the puzzle I've been trying to put together. The other pieces regarding my sons injury and the lack of reporting is apart from this. But suffice to say, even if they had performed these trials properly - the way in which they report/monitor injury is flawed. ie:
1. it's a completely volunteer system - health professionals are left to decide what constitutes injury even though the guidelines clearly state causal determinations are not to be made.
2. the manufacturer (Aventis) says Health Canada isn't legally bound to report injury claims to them therefore what piecemeal data do the trials represent.
3. Aventis said they encourage reporting through their monograph - which no one in this province recieves. Just the one pager Sask Health gives to parents which says the benefit outweighs risk.
4. It took almost two years for my sons possible injury (intractable siezures) to be reported when it should have taken 15 days.
5. By their own admission trial data is so small (as few as 250 kids)
they rely on post-market data tracking to reveal
anomolies and trends in injury (See above)
Beginning with the attached, the following observations/questions come to mind.
1. Vaccine approved for use in Canada in 1996 (I need to reconfirm this)
2. Vaccine changed in 1997 (whole cell to accellular) (and at some point thimerosal changed to phenoxethanol2)
3. appears only data used to trial done on heathy children
4. data required on children with underlying heath issues
5. What were the parents told when their children with health problems were vaccinated/offered vaccination ie: was info given that related to healthy childrens trial only?
6. There are additional questions on reporting - Is 0-72 hours really sufficient? How is the data collected shared with the maker?
BTW - Aventis is seeking FDA approval this year for the product.
There has been a HUGE increase in anaphylaxis disorders following the widespread use of the 5 in 1 vaccine and its precursor Penta (4 in one plus Hib). Attached is a letter from a parent whose child developed anaphylaxis following injection with Penta, the precursor to Pentacel - it took her over a year to get a list of reactions to the lot numbers of vaccine her boy was injected with. Of course we have no idea how many lot numbers were issued in all, or how many children overall were vaccinated during the course of this experiment before they created its progeny, the 5 in 1 vaccine trademarked Pentacel in Canada.
.............I'm sending you a separate email on the legal perspective of vaccine injury cases in Canada - that's another huge topic.
VRAN - Vaccination Risk Awareness Network Inc.