Canada Sets Aside 170,000 Doses of
the Arepanrix H1N1 Vaccine After Reactions
More than 100,000 doses of the H1N1 vaccine are being withdrawn
across Canada, after Manitoba health officials announced Thursday
they'd noticed a higher-than-usual number of allergic reactions
from one batch.
Vaccine manufacturer GlaxoSmithKline (GSK) has asked several
provinces to set aside the 170,000 doses from the questionable
GSK say the batch recall is a precaution an they will investigate
to see whether there is something wrong with the batch.
Health Canada and the Public Health Agency of Canada (PHAC) have
been criticized by the decision
to approve the Arepanrix
vaccine without any safety
or efficacy testing on a single Canadian. The vaccine was
was rushed through regulatory processes to ensure it would be
British Columbia Centre for Disease Control has recently probed
residents have suffered anaphylaxis at a higher rate compared
with the previous five seasonal-flu-vaccination programs, suggesting
it could be because some people received H1N1 and the seasonal
flu shot simultaneously.
"GSK is taking this cautionary action because the Public
Health Agency of Canada has received a higher than expected number
of reports of anaphylaxis in this lot number compared to other
lots," the company said in a written statement Thursday.
One or two allergic reactions are expected in a batch that size.
But health officials recorded six severe allergic reactions and
"We've been asked by the manufacturer GlaxoSmithKline not
to use this vaccine at this time, pending further investigation,"
said Kettner at a press conference Thursday.
"We are being cautious and following the advice... to hold
onto the remaining stock until we get further information."
About 1,500 doses of the vaccine were sent to Ontario, but officials
say none were administered. Officials are now shelving them until
the investigation is complete.
The Alberta government has stopped giving out doses from the
same batch, although it says it has not seen a jump in allergic
Most involved allergic reactions began within minutes of vaccination.
All were treated promptly by medical people at the vaccination
One person is believed to have died from an anaphylactic reaction
following vaccination, but Butler-Jones stressed the death hasn't
been conclusively linked to the flu shot.
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November 20, 2009