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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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