Batch of H1N1 Vaccine Pulled Due to Severe Allergic Reactions
December 10 2009
Health officials across Canada are being asked to hold back a batch of swine flu vaccine that appears to be causing higher rates of severe allergic reactions.
The vaccine's manufacturer, GlaxoSmithKline, is asking governments to stop using vaccine doses from one particular lot shipment issued in late October.
Bloomberg reports that Glaxo advised Canadian doctors to hold off on using a batch of the vaccine while the company probes reports of higher-than-expected occurrences of a side effect known as anaphylaxis.
The batch of 172,000 doses of Arepanrix was linked to more cases of acute allergic reactions, including swollen tongues, throats and respiratory distress, than is expected, spokeswoman Gwenan White said.
According to Manitoba health officials, severe allergic reactions from the batch in question was seen in one of 20,000, which is far higher than the typical rate of one in 100,000.
It is no surprise that this vaccine is producing an increasing number of unexpected adverse reactions, as more and more people are injected with ingredients that have not been thoroughly tested in a clinical setting.
The truth is, the package insert for Arepanrix, the H1N1 vaccine GSK is distributing in Canada, states that the clinical experience with Arepanrix is so limited that GSK had to use data from other vaccines for its dosage and administration guidelines. That’s right – the information that Canada is using as “proof” that this vaccine is safe and effective doesn’t even come from the vaccine itself.
Instead, GSK, with the blessing of Health Canada, is making a big leap of faith by asserting that flu vaccines are so much alike that it’s safe to assume that a new one is no different than existing ones.
One vaccine they used for comparison in approving Arepanrix was Pandemrix, an H1N1 vaccine currently being marketed in Europe. Another one contains H5N1 – bird flu – as the antigen. Both the comparables and Arepanrix contain an investigational formulation of ASO3, an adjuvant commonly known as squalene.
Separately, each of these substances can cause a variety of autoimmune diseases as well as anaphylactic reactions, even before you mix them all up together in a single vaccine!
No Data for Dlderly, Children or Pregnant Women
It doesn’t stop there. GSK prefaces its Arepanrix guidelines with the statement that there is no clinical experience at all for this vaccine or its comparison, H5N1, in the elderly, children or adolescents. The trials they do have data on, the insert says, are only for healthy adults aged 18-60!
It goes on to say that NO data have been generated in pregnant or breastfeeding women, either! Yet, governments around the world have been pushing for children and pregnant women to line up first for this vaccine.
Unfortunately, the trials to collect the data for this vaccine are happening as the current injections are being given. In other words, every person who gets this vaccine is actually part of the experiment. It’s called “post-marketing surveillance,” in which the manufacturer is allowed to submit data on safety and effectiveness of the vaccine as it is rolled out, rather than in advance.
Fetal Malformations in the ‘Comparable’ H5N1 Lab Rats
Let’s assume for a moment that the vaccines that are being used as examples are perfectly acceptable as safety comparisons. That means we should pay special attention to page 18 of the package insert, where it talks about Pre-Clinical Safety Data and two reproductive studies that were conducted with the ASO3-adjuvanated H5N1 vaccine.
What these studies found was an increased incidence of fetal malformations, including dilated ureter and delayed neurobehavioral maturation in the offspring of lab rats injected with this vaccine. A second study listed on the insert also found an increased incidence of post-implantation loss – miscarriage of their pregnancies – in the lab rats that received this vaccine.
GSK was required to report these unfortunate lab rat events as part of its comparable data. But the requirements didn’t keep GSK from dismissing the results by calling them “uncertain” in the package insert, with “no definite conclusion” as to whether fetal malformations and miscarriages were connected to the vaccine.
Because “not all findings were observed in both studies,” the insert says. In other words, since they didn’t see all the adverse events in both of the lab rat studies, rather than acknowledging that it’s possible that fetal malformations and miscarriages can occur with this vaccine, they decided to say the “significance was uncertain.”
Thinking along that line, then it also must be okay to dismiss any possibility of fetal malformations or miscarriages in humans that get this vaccine, or one just like it, such as Arepanrix.
Therein lies the danger in mass-immunizing people with an untested vaccine. Because the clinical studies haven’t been done, or because questionable results weren’t pursued or re-studied, the actual human trials are the vaccines themselves.
So What Happened With This Batch?
Nobody knows what caused a higher number of allergic and anaphylactic reactions in Arepanrix’s Lot Number A80CA007A. In a news story from The Canadian Press on November 24, GSK said it hasn’t come up with any answers yet, even though Health Canada and the Public Health Agency of Canada (PHAC) are also working on the investigation.
What they do know, according to an influenza vaccine expert quoted in the article, is that anytime you immunize masses of people, there will be allergic reactions and anaphylaxis. What can cause those events can vary for a number of reasons, from geographical location to the antibiotic used in a particular batch, according to another vaccine expert quoted in the article.
Presumably, investigators are looking at all the possibilities. In the meantime, Japan, which had planned to import GSK’s vaccine, has formed a coalition to fly to Canada to study the situation for itself.
However, according to Dr. Shiv Chopra, the excessive reactions to a certain batch of Glaxo's H1N1 vaccine cannot be ascribed to "anaphylaxis."
For the occurrence of anaphylaxis, which is a serious and potentially deadly hypersensitivity reaction in individuals receiving an antigenic material, there must be a pre-existing hyper-allergenic disposition to the substance, due to one or more previous exposures to the same antigenic material in the individuals concerned.
Chopra believes that in the present situation, that would be virtually impossible, unless the antigens in the present instance are reacting to the antibodies produced by some previously received seasonal flu vaccines.
On the other hand, the excessive reaction could conceivably be due to a greater toxicity, instead of hypersensitivity, of the "N" (neuraminadase), or some such component of the H1N1 viral strain Glaxo employed to manufacture the batch in question.
The Fox Is Guarding the Hen House
What most people don’t realize is that, no matter what the adverse reactions to Arepanrix are or what their causes, the manufacturer is responsible for collecting information on the safety of the vaccine. And if the lab rat studies are to be the example, that’s the same as letting the fox guard the hen house.
The World Health Organization (WHO) says it is watching this vaccine. In a November 19 briefing the WHO reiterated that the H1N1 vaccines around the world “match the excellent safety profile” of seasonal flu vaccines. It cited China’s success of administering 11 million doses of H1N1, with only 15 reported severe side effects, and two deaths that were determined not to be caused by the vaccine.
What the WHO didn’t say was that China’s vaccine does not contain an adjuvant and therefore isn’t really comparable to the adjuvanted vaccine in Canada.
It did say, however that “no differences” in the safety of nonadjuvanted inactivated vaccines, adjuvanted inactivated vaccines, and live attenuated vaccines had been detected.
The WHO also said it was investigating a “small number of deaths” with the pandemic vaccines – but dismissed the deaths in the investigations that had been completed as not being connected to the vaccine.
The question is: Are they dismissing them like GSK did the lab rat studies?
It would certainly appear that way. In the meantime, reports of other possible serious adverse reactions are coming out, such as the confidential letter leaked to The Daily Mail in the United Kingdom in August. This letter from the Health Protection Agency, the official body that oversees public health in the UK, advises neurologists to be alert for an increase in Guillian-Barre syndrome, which could be triggered by the vaccine. But it didn’t call for any withdrawal of the vaccine.
With reports like this, it’s obvious that the WHO and governments around the world are going to keep pushing their H1N1 vaccines through the winter and into spring, even though the swine flu is on the down slide and nowhere near what you would call a true, dangerous pandemic.
Adverse reactions such as miscarriages, allergic reactions, paralysis or even death after vaccination are especially tragic when you consider the fact that the real danger of the swine flu itself is so minimal.
People are still not realizing that the mortality statistics for H1N1 are being deceptively reported and are NOT accurate – the vast majority of those who’ve reportedly died from swine flu most likely did not even have the H1N1 virus, but rather suffered complications from some other viral or bacterial infection.
I urge you to read my previous article, CBS Reveals that Swine Flu Cases Seriously Overestimated, if you have not already done so, to get a more realistic picture of this overhyped threat.
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