An up and a down for GSK vaccine

Japanese drug officials are visiting Canada following GlaxoSmithKline's advice to the Great White North to hold the remaining 15,000 doses of a batch of swine flu vaccine. GSK wants to investigate reported cases of anaphylaxis associated with the drug, Arepanrix. Japan's interest is in a yet-to-be-delivered stockpile shipment.

Meanwhile, the World Health Organization signed off this week on a prequalification for global use of the adjuvenated vaccine.

In Canada, more cases than expected have been reported of acute allergic reactions, including swollen tongues, throats and respiratory distress, reports Bloomberg. Canada's Public Health Agency says it has received reports of six patients who had reactions after receiving their shots, which came from a 172,000-dose batch. The usual reaction rate is about 1 per 100,000 vaccinations, the agency says.

The pharma giant has placed a voluntary hold on the one batch of the vaccine involved while pharmacovigilance assessments are underway. Officials have ruled out the adjuvant as the culprit. Statistical anomaly and shipping mishap are current targets of the investigation. Officials report "no obvious glitches" during manufacturing.

The drug maker has shipped some 7.5 million doses to Canada. About 80 million have been shipped worldwide. Japan reportedly has no plans now to back away from its order for vaccine to inoculate 37 million people.

- here's the GSK "hold" announcement (.pdf)
- here's the Bloomberg report
- see the in-PharmaTechnologist article