Health Canada

Health Canada

April 09, 2010 12:10 ET

New Expiry Date for Unused Adjuvanted H1N1 Vaccine (Arepanrix)

OTTAWA, ONTARIO--(Marketwire - April 9, 2010) - Health Canada, in consultation with GlaxoSmithKline, has revised the provisional expiry date of the adjuvanted H1N1 vaccine (Arepanrix). This revision is not safety–related but is due to a decline in strength of the H1N1 antigen in specific lots.

Based on the best scientific evidence available at the time of authorization in October 2009, a provisional expiry date of 18 months was set for Arepanrix. As a condition of the vaccine authorization, subsequent potency testing carried out by Health Canada and GlaxoSmithKline has determined that the expiry date for unused lots of Arepanrix should be revised to six months. 

Canadians can be confident that all vaccinations performed to date using Arepanrix have provided them with a sufficient immune response against H1N1 infection. Health Canada's rigorous standards for vaccine safety, quality and effectiveness prohibit the release of any lot of a vaccine without evidence that it meets specifications.

Health Canada has informed the provincial and territorial governments about the decline in strength of unused Arepanrix. Guidance on appropriate re-labelling for unused vaccine that has not yet expired will shortly be provided to public health officials. 

Health Canada will re-initiate release of Arepanrix lots for domestic or international use that show the revised expiry date.

This revision does not affect the GlaxoSmithKline's unadjuvanted H1N1 vaccine "Influenza A (H1N1) 2009 Pandemic Monovalent Vaccine (Without Adjuvant)." The expiry date for Canada's unadjuvanted H1N1 vaccine remains at 18 months. Health Canada and GlaxoSmithKline are continuing to monitor the situation.

Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

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