Severe Reactions Spur GlaxoSmithKline to Pull Batch of H1N1 Swine Flu Vaccine in Canada

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Reported by Annette Kreuger, Industrial Info Resources (Sugar Land, Texas)--Following reports from Canada's Public Health Agency that six patients had suffered allergic reactions after receiving the shot, GlaxoSmithKline plc (NYSE:GSK) (GSK) (Middlesex, England) has voluntarily placed a hold on a single batch of the AS03 adjuvanted H1N1 vaccine Arepanrix in Canada as a precautionary measure. The batch comprised 172,000 doses of the drug and had been distributed to health agencies in the provinces of Alberta, British Columbia, Manitoba, Ontario, Prince Edward Island and Saskatchewan.

The move was prompted by the high rate of adverse reactions, as the more typical rate of bad reactions is about 1 per 100,000 vaccinations. Reportedly, the six affected persons, who were struck by anaphylaxis immediately after inoculation, have recovered. Anaphylaxis is life-threatening type of allergic shock.

The 172,000 doses are only a small portion of the estimated 7.5 million doses GSK has distributed throughout Canada. Hoping to head off a widespread refusal of the vaccine by a leery public, the vaccine chief of the World Health Organization, Marie Paule Kieny, has stated that the number of people who went into anaphylactic shock after getting the vaccine in Canada was "a bit higher than normal," but that the numbers were still small. She said the problem has so far been detected in only one lot of the vaccine and that higher rates of side effects have not been seen in other batches.

GSK and Canadian health officials are investigating the suspect batch to determine the problem. Reflecting the global nature of both swine flu and the vaccines to prevent it, there are reports that health officials in Japan are now investigating their own batches of GSK's Arepanrix. Earlier this year, as the threat of the virus began to emerge, Japan began stockpiling the vaccine. To date, no problems have been reported with the Japanese stock and no move has been made to discontinue future orders.

While the number of new cases of H1N1 appears to be easing, health officials across the world are urging continued caution and vigilance in combating the virus. Disturbingly, the number of children and teenagers killed by the flu is continuing to rise. Other groups, including those with underlying chronic health conditions, are also at great risk.

The latest estimates available (from mid-October) show that approximately 22 million Americans have contracted the swine flu, almost 100,000 have been hospitalized and 3,900 have died. Although alarming, these figures are actually less than what is experienced during a typical flu season.

According to the Centers for Disease Control, about 36,000 people in the United States die annually from regular seasonal flu, and 200,000 are hospitalized. The annual flu season typically runs from October through May, with the peak not yet reached for this year. Shortage of the vaccine, for both the swine flu and seasonal strains, remains a problem.

The five companies that have been licensed to make as many as 250 million doses of the H1N1 vaccine (all of which already manufacture the seasonal varieties) for the U.S. market include:

• CSL Limited (ASX:CSL) (Victoria, Australia)
• GlaxoSmithKline
• Novartis Vaccines, a division of Novartis AG (NYSE:NVS) (Basel, Switzerland)
• Sanofi Pasteur, a division of Sanofi Aventis SA (NYSE:SNY) (Paris, France)
• MedImmune, a subsidiary of AstraZeneca plc (NYSE:AZN) (London, England)

Two types of H1N1 vaccines are available, each requiring a different production and delivery process. For the injectable (shot) vaccine, the virus is first introduced into chicken eggs, harvested, killed and segmented. Injected into the arm, it activates the body's immune system to produce antibodies that are supposed to kill the actual flu virus if the recipient is exposed.

A live virus is used in the nasal-spray vaccine. This process also uses eggs to "grow" the virus, but at lower temperatures, thus weakening or "attenuating" it so that the virus can survive only in the nose and not in the greater body heat present in the lungs.

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