Nov. 20, 2009
Batch of H1N1 vaccine pulled after bad reactions
CTV.ca News Staff
http://www.ctv.ca/servlet/ArticleNews/story/CTVNews/20091119/Flu_Reaction_091119/20091119?hub=Health
More than 100,000 doses of the H1N1 vaccine are being withdrawn across the
country, after Manitoba health officials announced Thursday they'd noticed a
higher-than-usual number of allergic reactions from one batch.
Vaccine manufacturer GlaxoSmithKline has asked several provinces to set aside
the 170,000 doses from the questionable batch.
GSK say the batch recall is a precaution an they will investigate to see whether
there is something wrong with the batch.
"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 alerted GSK.
Dr. Joel Kettner, Manitoba's Chief Medical Officer of Health, urged people not
to be alarmed, noting the anaphylaxis reactions were short-lived and all the
patients recovered.
"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 reactions.
Health officials say the batch being investigated is fairly small, so it should
not have an impact on the overall supply.
Earlier this week, the country's chief public health officer, Dr. David
Butler-Jones, noted that of the 6.6 million doses of H1N1 vaccine given so far
to Canadians, there have been 36 serious adverse reactions reported.
Most involved allergic reactions that began within minutes of vaccination. All
were treated promptly by medical people at the vaccination site.
Milder side effects, such as nausea, soreness, headaches and fever, have also
been seen, which is not unexpected. Seasonal flu vaccines have been known to
cause such reactions every year.
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.
"It's important to remember that just because a medical event follows
vaccination, it may not have been caused by the vaccination; it may have been
caused by other factors, as unfortunate events continue to occur with or without
vaccine," he told a news conference Tuesday.