Health Canada Approves Pandemic H1N1 Flu Vaccine
OTTAWA - Minister of Health Leona Aglukkaq announced that Health Canada has approved AREPANRIX, a vaccine against the pandemic H1N1 flu virus.
This means that the adjuvanted vaccine has been judged safe and effective for use in Canada by both the Canadian manufacturer, GlaxoSmithKline, as well as by the Health Canada regulator.
"This is a milestone in our efforts to fight the pandemic H1N1 flu virus," said Minister Aglukkaq. "Thanks to careful planning we now have a safe and effective vaccine being distributed to provinces and territories that they will be rolling out in a matter of days. I encourage all Canadians to get vaccinated because it is the best way to protect our health and the health of our loved ones."
Health Canada and the Public Health Agency of Canada are currently working with provincial and territorial governments to deliver the H1N1 flu vaccine to health care facility sites to begin immunization programs.
"Canada is in the enviable position to be able to offer vaccine to every citizen who needs and wants it," said Canada's Chief Public Health Officer, Dr. David Butler-Jones. "Getting the vaccine is the most effective way we know of to curb the spread of the pandemic H1N1 flu virus. I too encourage all Canadians to get the pandemic H1N1 flu vaccine when it becomes available in their provinces and territories."
The Chief Public Health Officer also noted that the Public Health Agency of Canada, Health Canada and the regulatory and public health agencies of other countries, are working together to ensure that appropriate control measures are in place to monitor the safety and effectiveness of the vaccine and to ensure the timely communication of any potential adverse events following immunization. There is also a global commitment amongst regulatory authorities to rapidly share clinical and safety data on H1N1 flu vaccines and on any potential adverse events following immunization.
National recommendations on the use of H1N1 flu vaccine have been developed based on the latest scientific evidence, including clinical trial results. The recommendations include:
All Canadians 10 years of age and older should receive one dose of adjuvanted vaccine;
Children from six months and up to 10 years of age should receive the adjuvanted vaccine in two half-doses, administered at least 21 days apart;
Children age 0-6 months – immunization not authorized; and
Pregnant women should receive one dose of the unadjuvanted vaccine, of which Canada has ordered 1.8 million doses. In cases where the unadjuvanted vaccine is unavailable and pandemic H1N1 flu rates are high or increasing in the community, women more than 20 weeks pregnant should be offered one dose of the adjuvanted vaccine.
The Government of Canada has ordered 1.8 million doses of unadjuvanted vaccine for pregnant women which will be available in early November.
For more information on the pandemic H1N1 flu vaccine, visit www.fightflu.ca.
Public Health Agency of Canada
October 21, 2009
Office of the Honourable Leona Aglukkaq
Federal Minister of Health