Safety of GSK flu vaccine in doubt

Health minister Akira Nagatsuma said Monday he will send a fact-finding team to Canada by early December to "thoroughly investigate" allergic reactions to a new swine flu vaccine that Japan plans to import.

"There are points to make clear, including whether the problem concerns only part of the vaccine or the entire production," Nagatsuma told reporters in Tokyo.

A higher than normal rate of side effects has been reported concerning a batch of H1N1 vaccine produced at a Canadian factory of British pharmaceutical giant GlaxoSmithKline Plc (GSK).

GSK asked Canadian provinces to stop using that vaccine after the rate of anaphylaxis in the province of Manitoba was reportedly one in 20,000 people who received the doses, compared with a normal rate of one in 100,000, according to sources.

Anaphylaxis is an acute, severe allergic reaction that affects the whole body and may cause low blood pressure, breathing difficulty or loss of consciousness. Serious anaphylactic shock can be fatal.

Japan plans to buy vaccine from GSK made in the same Canadian factory for its own inoculation program. Imports of the drug were to start in late December at the earliest.

If other batches are found to have caused severe anaphylaxis side effects, Japan could suspend imports from GSK.

Under the health ministry's plan, most of the 54 million people on a priority inoculation list, including pregnant women and young children, will receive shots of domestically produced vaccines.

But because the domestic supply is limited, imported vaccines will be used starting in January, first for healthy elderly people.

The new flu vaccine imports are to be approved through a simplified procedure because of time constraints. Commenting on applying this procedure, Nagatsuma pledged to "collect all information so there will be no problems."

Canada started using GSK doses in October.

After the problems surfaced in Manitoba, GSK decided to withdraw about 170,000 doses of the vaccine from lot A80CA007A, according to Canadian media reports.

"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 Canadian media quoted the company as saying in its statement.

The severity of the reactions is not known, but those who suffered are said to have soon recovered.

The GSK vaccine is produced with adjuvant, a substance added to improve immune responses. Domestic vaccines are free of adjuvant.

In terms of two-shot vaccinations, the Japanese government has signed contracts to buy new swine flu vaccine from GSK for 37 million people and from Novartis AG of Switzerland for 12.5 million people.

The Ministry of Health, Labor and Welfare started screening the GSK vaccine in October.(IHT/Asahi: November 24,2009)