OTTAWA, ONTARIO -- (Marketwire) -- 11/13/09 -- The Government of Canada today announced that Health Canada has approved an unadjuvanted H1N1 flu vaccine for protection against the H1N1 flu virus. The vaccine, Influenza A (H1N1) 2009 Pandemic Monovalent Vaccine (Without Adjuvant), is manufactured by Canada's pandemic vaccine supplier, GlaxoSmithKline.

This means that Health Canada has judged the GSK unadjuvanted vaccine as safe and effective for use in Canada.

The Government of Canada has ordered 1.8 million doses of the GSK unadjuvanted vaccine. Combined with the 200,000 doses of unadjuvanted vaccine from CSL Australia, which the Government of Canada previously distributed, provinces and territories will have 2 million doses of unadjuvanted H1N1 vaccine for use.

"The Government of Canada has already begun shipping hundreds of thousands of doses of the unadjuvanted vaccine, prepositioning it so that the provinces and territories could continue with their immunization programs as soon as authorization was granted," said Canada's Chief Public Health Officer, Dr. David Butler-Jones. "The approval of this vaccine ensures that the Government of Canada will have up to 1.8 million doses of GSK unadjuvanted vaccine available for Canadians."

Health Canada and the Public Health Agency of Canada are currently working with provincial and territorial governments to deliver the Canadian unadjuvanted H1N1 flu vaccine to health care facility sites to continue immunization programs.

"Health Canada's authorization was arrived at independently and on the basis of sound health science. Canadians can be confident that this vaccine is both safe and effective," said Dr. Elwyn Griffiths, Director General of the Biologics and Genetics Therapies Directorate of Health Canada. "We firmly believe citizens should take advantage of the opportunity to protect themselves and members of their families from this virus."

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 the Canadian unadjuvanted H1N1 flu vaccine have been developed based on the latest scientific evidence, including clinical trial results. The recommendations include: http://www.phac-aspc.gc.ca/alert-alerte/h1n1/vacc/recommendation-recommandation-eng.php

For more information on the H1N1 flu vaccine, visit www.fightflu.ca.

Health Canada news releases are available on the Internet at www.healthcanada.gc.ca/media

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