Japan halts Pfizer, Sanofi vaccines after four die

Japan’s health ministry halted the use of vaccines made by Pfizer Inc and Sanofi-Aventis SA that prevent meningitis and pneumonia following the deaths of four children.

The infants died shortly after receiving the vaccines. While it was unclear if there was link between the deaths and vaccines, use of Pfizer’s Prevenar and Sanofi’s ActHIB will be suspended while the deaths are investigated, the ministry said in a statement.

A ministry safety panel is scheduled to discuss findings in the investigations on Tuesday.

Pfizer shares fell 0.5 percent to $19.56 in New York on Monday. Its vaccine, known as Prevnar in the United States, was one of the most important products it picked up in its $67 billion acquisition of Wyeth in 2009. Sanofi’s U.S.-listed shares were down 0.8 percent at $35.27 after earlier ending 1.2 percent lower in Paris.

Health officials said they were aware of the deaths in Japan but have not seen any such safety concerns in the United States.

The Food and Drug Administration and the Centers for Disease Control and Prevention “will continue to monitor the safety of all vaccines, including” the two at issue from Pfizer and Sanofi, FDA spokeswoman Shelly Burgess said in a statement.

In February last year health authorities in the Netherlands said no relation was found between Prevenar and the deaths of three infants who had received the vaccine.

Three of the children that died in Japan were administered Prevenar together with ActHIB. In addition, three of the children also received a mixed vaccine against diphtheria, whooping cough and tetanus on the same day they received the other vaccines.

Three of the four children died a day after being immunized. The deaths happened between March 2 and March 4.

Representatives for Pfizer and Sanofi in Tokyo said the companies were cooperating with the investigation.

A spokesman for Sanofi said that the company has shipped more than 3 million doses of ActHIB in Japan since 2008 while a spokesman for Pfizer said the firm has distributed more than 2 million doses of Prevenar in Japan since last year.

(Reporting by James Topham, additional reporting by Lewis Krauskopf in New York and Susan Heavey in Washington; Editing by Edwina Gibbs, Derek Caney, Dave Zimmerman)

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By James Topham

TOKYO