Reactions to Glaxo Flu Vaccine Under Investigation in Canada

Trista Kelley and Alexandre Deslongchamps
Bloomberg
Thursday, Nov 26th, 2009

Canada is still investigating an unusually high rate of a side effect known as anaphylaxis from a batch of GlaxoSmithKline Plc’s swine flu vaccine, health officials said today.

Anaphylaxis occurred at a rate of about 4 per 100,000 shots in one lot of 172,000 doses of the vaccine, David Butler-Jones, Canada’s chief public health officer, said at an Ottawa news conference. Typically, about 1 person in 100,000 will suffer such a reaction. Anaphylaxis is an acute allergic reaction that includes swollen tongues, throats and respiratory distress.

Glaxo, the sole supplier of swine flu shots to Canada, has shipped 7.5 million doses of the Arepanrix vaccine to the country, the company said this week. For all batches, the rate of side effects is 0.32 per 100,000, health officials said today.

The higher rate from one batch may be a statistical anomaly, Butler-Jones said. About 15,000 shots from the batch that still haven’t been used are being held back while investigators look into the matter, officials said. There were no obvious glitches in the manufacturing process, Butler-Jones said.

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