GSK Issues Hold for One Lot of H1N1 Vaccine Following Adverse Events

November 25, 2009

GlaxoSmithKline (London, UK) has put on hold one lot of its Arepanrix adjuvanted H1N1 flu vaccine in Canada, following reports of a higher than usual number of adverse events.

Yesterday, GlaxoSmithKline (London, UK) put on hold one lot of its Arepanrix adjuvanted H1N1 flu vaccine in Canada, following reports of a higher than usual number of adverse events.

The company took this action as a higher than expected rate of serious allergic reactions (anaphylaxis) related to lot number A80CA007A. These observations have not been reported with vaccines from any other lots.

To date, approximately 15 million doses of Arepanrix have been distributed in Canada, and overall, the frequency of severe allergic reactions following immunization is less than 1 event per 100,000 doses, which is similar to the rate typically reported for vaccines.