GSK Recalls Batch of Pandemrix as Adverse Effects Emerge in Canada, Plans to Manufacture Relenza in China Announced

Six Cases of Reported Anaphylactic Shock Linked to Pandemrix Reported in Canada

U.K. pharma major GlaxoSmithKline (GSK) and the Public Health Agency of Canada have advised health authorities in some Canadian provinces to stop administering a batch of GSK's A/H1N1 influenza (swine flu) vaccine Pandemrix, following the emergence of adverse effects in six people. Immediately after being injected with the vaccine, the six individuals developed a severe allergic reaction known as anaphylaxis. The batch in question—7A—contained 170,000 doses of the vaccine distributed in the Canadian Provinces of British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, and Prince Edward Island in October. GSK and the Canadian health authorities have declined to comment on the number of doses from this particular batch that were administered before the guidance was issued last Wednesday (18 November). So far, 6.6 million doses of the vaccine have been administered in Canada, and the number of recorded cases of adverse effects stands at 36. One death has been recorded in an elderly man in Quebec following an anaphylaxis reaction, though it remains unconfirmed whether this was linked to use of the vaccine, and further investigations are being conducted. A full investigation is now underway to explain the causes of the latest adverse effects incidents.

GSK to Expand Swine Flu Operations in China

In other news, GSK has announced plans to further expand its presence in China. The company hopes to manufacture is anti-viral drug Relenza (zanamivir) on the mainland. GSK's chief operating officer Andrew Witty has described what he calls a "three-pronged" approach to tackle the A/H1N1 flu virus in China. This approach will see the company engaged not only in the manufacture of Relenza, but also A/H1N1 flu vaccines and face masks. Following the Chinese drug regulator the State Food and Drug Administration's fast-track approval for the drug back in September (see China: 4 September 2009: GSK's Relenza Clinches Fast-Track Approval in China), the company is keen to maximise the accessibility of the product in the Chinese market.

Outlook and Implications

So far, anaphylactic reactions have been observed in fewer than one in 100,000 vaccines; however, in the 7A batch, one in 20,000 reactions were recorded—a five-fold increase. This is a major setback for the company in terms of the public perception of the vaccine, as it could generate public scepticism about the safety profile of the vaccine, thereby affecting its uptake. It could also raise concerns about the suitability of the fast-track regulatory approvals for the vaccine, which have been seen worldwide. Meanwhile, GSK and the Canadian health authorities are trying to downplay the reports, suggesting that the vaccine is both safe and efficacious. They have also insisted that the vaccine batch is being withdrawn as a precautionary step, and that the fact that this issue was identified is testament to the monitoring system for the vaccine. However, it is believed it was the World Health Organization that first raised the alarm. This will be an important issue for GSK, as Pandemrix is expected to be a major revenue earner for the company in the final quarter of the year, going into the first quarter of 2010, with 440 million orders of the vaccine already clocked. It is therefore important that GSK addresses this issue as soon as possible in order to avoid fears about the vaccine. According to reports from Bloomberg, Japan's Asahi newspaper has reported that the Japanese health ministry is planning to send experts to Canada to investigate the issue, as a precautionary step. Japan has ordered enough doses of the Pandemrix to cover 37 million people.