GSK puts hold on Canadian batch of H1N1 vacc
Late last week, Canada’s Public Health Agency said it had received reports of six patients who had suffered allergic reactions after receiving the shot, telling Reuters that the usual rate is around 1 per 100,000 vaccinations.
The PHA spokesperson added that all six patients have since recovered and stressed that people who have already received the vaccination should not be concerned if they did not suffer an anaphylactic reaction immediately after administration.
A GlaxoSmithKline (GSK) spokesperson told in-PharmaTechnologist that the firm has placed a voluntary hold on a single batch of its AS03 adjuvanted H1N1 vaccine Arepanrix in Canada as a precautionary measure.
The spokesperson declined to provide the number of the batch in question but said that it comprises 172,000 doses of the vaccine.
She added that GSK and Health Canada are conducting pharmacovigilance assessments to further examine any potential problems, but could not say how long the process will take to complete.
Various media reports suggest that the affected batch has been shipped to health authorities in Manitoba, British Columbia, Alberta, Saskatchewan, Ontario and Prince Edward Island.
Japan to investigate
Understandably, given the level of public interest in H1N1, GSK’s move has aroused considerable attention among media organisations and drug regulators around the world.
For example, earlier today it emerged that Japan, which ordered significant quantities of Arepanrix earlier this year as part of efforts to build a vaccine stockpile in response to the H1N1 pandemic, is to investigate the Canadian reports.
According to a Bloomberg report, Japan’s Asahi newspaper reported that government officials will travel to Canada sometime in the next two weeks to further examine the issue but that as yet the country’s import plan has not changed.
