GlaxoSmithKline recalls a lot of H1N1 vaccine Pandemrix from Canada due to side-effects

GlaxoSmithKline has recalled a lot of its H1N1 swine flu vaccine Pandemrix in Canada following complaints of adverse reactions from the vaccine, reports said.

GlaxoSmithKline has asked that the October batch of H1N1 swine flu Pandemrix be taken out of circulation because it produced serious and immediate anaphylactic reactions in one out of 20,000 vaccinations, compared with one out of 100,000 in other shipments. Update 1: No change in plan to import H1N1 swine flu vaccine Pandemrix Update 2: South Korea drops plan to buy 3 million doses Glaxo’s H1N1 swine flu vaccine: Report

Following this, Canada’s H1N1 flu vaccine manufacturer has asked the provinces to temporarily discontinue vaccinating Canadians from a lot of vaccine shipped in October due to a higher risk of adverse reactions, according to Dr. Joel Kettner, Manitoba’s chief public health officer.

“We’ve been asked by the manufacturer GSK to not use this vaccine at this time pending further investigation,” he said.

GlaxoSmithKline has asked several provinces to set aside the 170,000 doses from the questionable batch.

More than 100,000 doses of the H1N1 vaccine are being withdrawn across the country.

GSK said 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.

One or two allergic reactions are expected in a batch that size. But health officials recorded six severe allergic reactions and alerted GSK, reports said.

However, the anaphylaxis reactions were short-lived and all the patients recovered.

Most of the vaccine Manitoba received from the suspect lot had already been used by the time the province received the alert. Of the 63,000 doses shipped, only 630 remained unused by the four regional health authorities in Manitoba that received them.

About 1,500 doses of the vaccine were sent to Ontario, but officials said 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 has  it had not seen any allergic reactions.

GSK’a H1N1 swine flu vaccine Pandemrix batch is being investigated.

Of the 6.6 million doses of H1N1 vaccine given so far to Canadians, there have been 36 serious adverse reactions reported, according to Canada’s chief public health officer, Dr. David Butler-Jones.

Most of the allergic reactions began within minutes of vaccination. Milder side effects, such as nausea, soreness, headaches and fever, have also been seen. Seasonal flu vaccines have been known to cause such reactions every year. All were treated promptly by medical people at the vaccination site.

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.

What is Pandemrix?
Pandemrix contains parts of influenza (flu) viruses that have been inactivated (killed). Pandemrix contains a flu strain called A/California/7/2009 (H1N1) v-like strain (X-179A).

Pandemrix is given as one dose, injected into the shoulder muscle. A second dose may be given after an interval of at least three weeks. This second dose must be given in children aged from 6 months to 9 years of age.

Pandemrix contains small amounts of haemagglutinins (proteins from the surface) of a virus called A(H1N1)v that is causing the current pandemic. The virus has first been inactivated so that it does not cause any disease.

The most common side effects with Pandemrix (seen with more than 1 in 10 doses of the vaccine) are headache, arthralgia (joint pain), myalgia (muscle pain), reactions at the site of the injection (hardening, swelling, pain and redness), fever and fatigue (tiredness).
The European Commission granted a marketing authorisation valid throughout the EU for the H5N1 mock?up vaccine for Pandemrix to GlaxoSmithKline Biologicals s.a. on 20 May 2008. The marketing authorisation for the H1N1 vaccine was granted on 29 September 2009.