Drug company GlaxoSmithKline has told Canadian doctors to stop using one lot of its H1N1 vaccine until an investigation into a higher-than-expected number of severe allergic reactions is completed.
"The voluntary hold has no impact on the United States," company spokeswoman Sarah Alspach said Tuesday. The U.S. Food and Drug Administration approved GSK's H1N1 vaccine this month, Alspach said, and the company expects to begin shipping it out in the USA in December.
The U.S. vaccine will not be identical to Arepanrix, the GSK H1N1 vaccine used in Canada. Arepanrix contains an adjuvant, a substance designed to boost the immune response, but adjuvants have never been approved for use in U.S. flu vaccines.
Almost all of the 172,000 doses in question, distributed the week of Nov. 2 to six Canadian provinces, already have been administered, said Geoffrey Matthews, a spokeswoman for the Public Health Agency of Canada, which, with GSK and Health Canada, is investigating cases of anaphylaxis.
On Nov. 18, Matthews said, his agency asked the company to tell the provinces to stop using vaccine from the lot. Symptoms of anaphylaxis include trouble breathing, chest tightness and swelling of the mouth and throat.
Six cases have been reported, Matthews says, and all patients have fully recovered from what is a treatable but life-threatening event. Fewer than two cases would usually be expected if every dose in the lot had been administered. Canadians who have received the vaccine and not had an allergic reaction have no reason to worry, Matthews said.
In the USA, the Vaccine Adverse Event Reporting System said that as of Nov. 13 it had received 116 reports of serious health events related to the vaccine, including eight deaths -- similar to the number in previous years after a similar number of seasonal flu vaccine doses had been shipped.
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