“The reason for the decision to not give pregnant women in Canada adjuvants is because there is no data on the use of adjuvanted flu vaccine in pregnant women, the report in says.”
“The question, therefore, is: why has WHO ordered its 194 member states around the world to target as a priority group pregnant women and give them the swine flu jab with adjuvants when there is no data on its safety, and when the clinical trials on the “swine flu” vaccine currently underway exclude either pregnant women or adjuvants, so that there are no plans to fill the data gap before the mass vaccination of pregnant women is launched.”
“There is a great deal of data, however, on the dangers of adjuvants, especially squalene, on soldiers.”
“Do WHO Director-General Dr Margaret Chan and Dr Marie-Paule Kieny realise that giving people an injection with an adjuvant when there is no data on its safety under fraudulent misrepresentation is a biological experiment – and biological experiments violate national and international law?”
* * * * * * *
Canada to buy unadjuvanted vaccine for pregnant women, health officer says
By Helen Branswell
Medical Reporter (CP)
Sept 05, 2009
TORONTO – Canada will purchase supplies of unadjuvanted swine flu vaccine to offer to pregnant women who might otherwise choose not to be vaccinated, the country’s chief public health officer has revealed.
Dr. David Butler-Jones told The Canadian Press that Canada will buy 1.2 million doses of unadjuvanted pandemic vaccine which will be reserved for pregnant women, who are at significantly greater risk of becoming severely ill and dying if they contract the virus.
“I’m anticipating for pregnant women we will have an option,” he said in an interview.
The vaccine will be supplied by GlaxoSmithKline, Canada’s pandemic vaccine manufacturer, and is expected to be available at the same time as the country’s other supplies of vaccine.
Adjuvants are compounds that boost the immune system’s response to vaccine, allowing smaller doses to be used per person. Canada is buying adjuvanted pandemic vaccine partly in response to a call from the World Health Organization for affluent countries to use “antigen (vaccine) sparing” techniques so that limited global supplies can be stretched as far as possible.
While some European countries have used adjuvanted flu vaccines for a number of years, none of the currently licensed flu vaccines in Canada contains an adjuvant.
And there are no data on the use of adjuvanted flu vaccine in pregnant women – a fact that may add to the already high degree of reluctance many pregnant women feel about taking any medication or therapy.
“What is absolutely clear is that there is much more of a safety data base in pregnant woman with non-adjuvanted vaccine,” said Dr. Marie-Paule Kieny, head of the WHO’s vaccine research initiative, the division overseeing pandemic vaccine issues.
“Does it mean that it (adjuvanted vaccine) will be unsafe? No. It means that there is no hard evidence that it will be (safe).”
The lack of evidence led a panel of experts that advises the WHO on vaccine issues to recommend unadjuvanted vaccine be offered to pregnant women if that option is available.
Butler-Jones said some pregnant women may prefer an adjuvanted formulation, because it’s likely to protect more broadly against mutated strains of the virus if and when they arise, and because it can be taken in smaller doses.
Another plus, he said, is that one dose of adjuvanted vaccine might suffice, meaning pregnant women could be protected faster than if they had to get two doses of an unadjuvanted vaccine. (Dose requirements for swine flu vaccines are still being determined.)
But the decision to buy unadjuvanted vaccine for pregnant women – something the Public Health Agency of Canada had earlier said it would not do – reflects the very real fear of public health officials that pregnant women may shun this vaccine.
“I think that it is possible that a good chunk of the (pregnant) patients may just say: ‘You know what? No thanks.’ And that’s obviously a problem,” said Dr. Richard Beigi, an academic obstetrician from Pittsburgh who recently published results of a survey suggesting few pregnant women would agree to take a pandemic flu shot.
“I think it is going to be challenging,” Kris Sheedy, head of the H1N1 vaccine communications team at the U.S. Centers for Disease Control, said of the effort to convince pregnant women they should get a pandemic flu shot.
It is well known that in previous pandemics pregnant women were the hardest hit group in terms of deaths. And this time around, there have been many reports already of miscarriages, emergency deliveries and deaths in pregnant women who caught swine flu.
Pregnant women are also at greater risk of complications from catching seasonal flu. Yet their willingness to be vaccinated against it remains low, despite government recommendations that they should get flu shots.
Sheedy said in the U.S., around 15 per cent of pregnant women get vaccinated most years. Dr. Jeff Kwong, a University of Toronto researcher who studies flu shot rates, said he doesn’t know of a corresponding national figure for Canada. But a small study in Toronto during the 2003-04 flu season showed 14 per cent of women got a flu shot during their pregnancy.
[Bird Flu Shot]
Beigi’s survey asked nearly 400 pregnant women if they would agree to be vaccinated with an avian influenza vaccine during a pandemic caused by that virus.
The survey was conducted before swine flu broke out and was done in the context of fears that the H5N1 virus – which kills roughly 60 per cent of the people who catch it – might cause the next pandemic.
Despite the high fatality rate of the H5 virus, only 15.4 per cent of the pregnant women surveyed said they’d take a shot if a bird flu pandemic erupted. And half the office staff of the obstetrical practices where the survey was conducted said they would not recommend the pregnant women in their care get pandemic vaccine.
“I was relatively shocked at the responses,” said Beigi, who teaches in the department of obstetrics, gynecology and reproductive sciences at the University of Pittsburgh Medical Center.
Sheedy said the CDC plans to work with obstetricians, hoping to persuade them to make the case for pandemic vaccination to their patients. Studies have shown, she said, that pregnant women value highly the advice they get from their obstetricians.
“I’m empathetic,” she said, noting she has a two year old and a five year old, and remembers well the concerns of pregnancy.
“I understand that some (pregnant women) are going to choose not to vaccinate, but I do hope that if we’re able to get information out there about what we’re seeing with this virus and its impact on these women, that many of them will at least … consider it.”
Follow Canadian Press Medical Writer Helen Branswell’s flu updates on Twitter at CP-Branswell
Copyright © 2009 The Canadian Press. All rights reserved