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Japan Stops Use of Pfizer, Sanofi Vaccines on Four Deaths

Japan’s health ministry suspended the use of pediatric vaccines made by Pfizer Inc. (PFE) and Sanofi- Aventis SA after reports of four deaths following immunizations.

The use of Pfizer’s Prevenar, to protect children against meningitis and pneumonia, and Sanofi’s ActHIB, to fight Haemophilus influenzae type b, will be suspended until at least tomorrow, when a safety panel will meet to discuss the cause of the deaths, the ministry said in a March 4 website posting.

The temporary suspension is a precautionary measure following the deaths of four children who had previously been immunized simultaneously with several pediatric vaccines, said Victor Carey, the Sydney-based Asia Pacific medical director for Sanofi’s vaccines unit. About 1.5 million Japanese children have received ActHIB since it was approved in Japan in 2007, 15 years after it was first licensed in Europe, he said.

“No causal relationship has been established between immunization and these fatalities, but an investigation is under way, which we’re fully cooperating with,” Carey said in a telephone interview.

Haemophilus influenzae type b, or Hib, caused 2 million to 3 million cases of serious disease, notably pneumonia and meningitis, and 386,000 deaths in young children in 2000, according to the Geneva-based World Health Organization.

More than 200 million doses of ActHIB have been given to children in more than 120 countries, according to Paris-based Sanofi.

Multiple Vaccines

The deaths of the children in Japan occurred from March 2 to March 4, the ministry said. ActHIB was given to three of the four children, who were simultaneously vaccinated with at least one other vaccine from a different manufacturer, Carey said.

Pfizer’s Prevenar is a so-called pneumococcal conjugate vaccine that aims to prevent invasive disease caused by serotypes of the Streptococcus pneumoniae bacterium. The vaccine that protects against 13 serotypes generated $2.42 billion last year and a shot that fights seven serotypes had $1.25 billion in 2010 sales, according to data compiled by Bloomberg.

Surveillance in North America and Europe, where Prevenar has been used for at least a decade, hasn’t identified any major safety concerns, the WHO said in a 2007 report. Evidence suggests pneumococcal conjugate vaccines will have a “considerable impact on pneumococcal disease and overall infant mortality,” the United Nations health agency said.

Victoria Davis, a Pfizer spokeswoman, declined to comment specifically on the deaths in Japan.

“Pfizer thoroughly reviews and continually monitors all of its medicines and vaccines as safety is our top priority,” the New York-based drugmaker said in an e-mailed statement. “The company thoroughly evaluates all reported cases and works closely with health authorities to determine if there is any association with use of our medicines and vaccines.”

To contact the reporters on this story: Jason Clenfield in Tokyo at jclenfield@bloomberg.net; Junko Hayashi in Tokyo at juhayashi@bloomberg.net

To contact the editor responsible for this story: Jason Gale in Singapore at j.gale@bloomberg.net.

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