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Canadians Will Be Inoculated With H1N1 Vaccine Before Trials Are Completed


The clinical trials conducted in Canada for the H1N1 vaccine will only be weeks into testing once the country's mass vaccination campaigns begin in early November.

The federal minister of Health, Leona Aglukkaq, nevertheless reaffirmed that by November 1st, Canadians will have access to a safe and effective vaccine for the H1N1 flu.

Ironically, her website's slogan at www.leonaaglukkaq.ca is "strong leadership, a better canada", which is certainly opposed to the poor leadership and irresponsible nature of her actions and those of the public health agencies she is responsible for.

On October 1st, Ontario Health Minister David Caplan urged the federal government to speed up approval of untested H1N1 vaccines amid fear-hyped concerns of a second wave of swine flu that never materialized.

Ontario, Canada's largest populated province, was recently critized for marketing H1N1 propaganda kits to 10,000 pharmacists to help promote untested vaccines and dangerous antiviral drugs such as Tamiflu.

In reality, vaccine safety and effectiveness will not be known until the end of trials, in six months. Clinical trials over 30 sites across the country will include some babies over six months of age. When that data is in — likely in a couple of months and possibly after vaccination clinics have started delivering shots — a change in policy on giving young children the adjuvanted form of the vaccine could happen, Dr. David Butler-Jones, Canada's chief public health officer, said last month.

The vaccine produced by GlaxoSmithKline (who holds an exclusive contract as the sole manufacturer of the vaccine for Canada) is not approved by Health Canada. It will likely not be approved until early November, at the end of a process of accelerated evaluation, as officials forsee the fight plan against the pandemic, indicated Health Canada to The Press.

Aspects of the manufacturing procedure for the vaccine are known. Similar procedures have been used for a number of years for the seasonal influenza vaccine. But for Canada, the seasonal vaccine does not contain any adjuvants (a dangerous additive that is supposed to stimulate immune response). In contrast the H1N1 vaccine will contain adjuvants such as AS03, as noted in Pandemrix assessment report.

Some doctors and public health officials have pushed the Canadian federal government to make vaccine without adjuvant available to babies aged six to 18 months, at least until there is more research on whether it causes any side-effects in that age group.

"I wouldn't want to rush into using the adjuvanted product without there having been a reasonable number of clinical trials in that age group," said David Scheifele, a pediatric infection specialist and director of the vaccine evaluation centre at British Columbia's Child and Family Research Institute.

"One does not expect surprises," stated the national director of Quebec public health, Dr. Alain Poirier.

Health Canada attempted to explain its position on why vaccinations will begin despite trials being in their infancy: "The vaccine's process of evaluation uses data that originates from international trials that began in September."

GlaxoSmithKline recently initiated 16 clinical trials with 9000 voluntary participants in Europe, the United States and Canada. Trials began in Germany last month and "GSK Canada foresees the initiation of trials in Canadian clinics on October 1st", said spokesperson, Megan Sporre, to The Press.

In the past few days, companies such as Innovaderm in Montreal and Q&T Research in Sherbrooke, have begun recruiting candidates to test the vaccine. The studies will last six months and will compensate close to 600$ for each of the voluntary participant, aged 19 to 40 years.

But if the trials are not finished, how can the public be assured that the vaccine is safe?

"The studies have two objectives in the short term. We will immediately flag undesirable effects that are observed. As early as November 7, this will be finished and we will know immediately if the vaccine is harmlessness," assures Rock Gervais, pharmacist and director of the research of Q&T. "In terms of the effectiveness of immunity, that will take months."

In essence, the safety and effectiveness of the H1N1 vaccine administered in Canada will not be known until well after mass vaccinations begin. Health officials will continue with the scheduled campaigns despite this knowledge.

Among some of the secondary effects stated are rednesses, fever or analphylactic shock.

* A full list of h1n1 vaccine ingredients, alerts and warnings.


Reference Sources: cyberpresse.ca, vran.org, cbc.ca
October 12, 2009

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