Wednesday, March 9, 2011

Japan Halts Prevenar, ActHIB Vaccines After Four Children Die

From Reuters Health Information > Alerts, Approvals and Safety Changes > Alerts

By James Topham

TOKYO (Reuters) Mar 07 - Japan's health ministry has halted the use of vaccines made by Pfizer Inc and Sanofi-Aventis SA to 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 (called Prevnar in some countries) and Sanofi's ActHIB (an Haemophilus b conjugate vaccine) 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.

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 who died in Japan received 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. A spokesman for Pfizer said the firm has distributed more than 2 million doses of Prevenar in Japan since last year.

Prevenar is active against 13 strains of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F).

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