Post-authorization Commitments: Arepanrix^TM H1N1

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Biologics and Genetic Therapies Directorate
Tunney's Pasture
Ottawa, ON K1A 0K9

09-130153-655

November 02, 2009

Manager, Regulatory Affairs
ID Biomedical Corporation of Quebec
525 Cartier Blvd. West
Laval, QC
Canada, H7V 3S8

In keeping with the provisions of the authorization for sale of the Arepanrix H1N1 (AS03-Adjuvanted H1N1 Pandemic Influenza Vaccine) under an Interim Order (Section 30.1 of the Food and Drugs Act), which came into effect October 21, 2009, the following post-authorization commitments are required:

Clinical

• The issuance of a Healthcare Professional Communication (HPC), in collaboration with Health Canada, indicating by which means the vaccine was authorized, including currently known aspects relating to the vaccine's safety and immunogenicity and the types of adverse event requiring prioritized reporting.
• The commitment to perform all activities/studies described in submitted Arepanrix H1N1 vaccine Risk Management Plans (RMP) including the submission of monthly aggregate safety data and the completion of ongoing clinical trials.
• To submit interim and final reports of all clinical trials and post-market studies as soon as they become available.
• To agree to provide patients and healthcare professionals continuous access to updated information regarding Arepanrix H1N1.
  
• To provide Health Canada as well as the Public Health Agency of Canada (PHAC) with information on any signal leading to a change in the balance of the risk-benefit profile.
• To conduct the agreed upon follow-up evaluation for any adverse events noted in pregnant women.
• To provide data concerning safety and immune response in at least one immunocompromised population and assess the feasibility of examining safety in persons with pre-existing auto-immune disease in GSK's ongoing clinical program. GSK is to also pursue collaboration with existing Federal and Provincial systems to support the development of effectiveness estimates for the Arepanrix vaccine. GSK is to continue discussions with PHAC/CIHR Influenza Research Network (PCIRN) and/or other investigators to determine any potential opportunities for collaboration.
• To provide Health Canada with the final results of the ferret challenge studies by the end of November 2009.
  

Chemistry and Manufacturing

• To submit ongoing data on the stability of the antigen component of the vaccine to confirm its approved 18 month shelf life.
• To submit monthly trend analyses on key quality control test results of the final antigen vaccine container.
• To report on a biweekly basis on any issues arising in the production of the antigen.
• To submit, for review and approval, a bridging study report prior to the implementation of new reference preparations used to quantify the level of antigen in the vaccine.
  

Sincerely,

Original signed by:
Dr. Elwyn Griffiths
Director General