Regulatory Affairs

Japan suspends Prevnar, ActHIB following deaths

PBR Staff Writer Published 07 March 2011

The Japan health ministry has temporarily suspended the use of Pfizer's Prevnar and Sanofi-Aventis's ActHIB as it investigates if the deaths of four children reported between 2 and 4 March are due to the pediatric vaccines. The ministry said the children between the ages of six months and two years died after receiving the vaccines separately or as a combination.

The health ministry stated the suspension will be effective until the results of an investigation of the four deaths by a group comprising medical experts, expected to be released on 8 March, reports The Wall Street Journal.

Pfizer's Prevnar is a pneumococcal conjugate vaccine that protects against a bacterium that causes meningitis, while ActHIB is a type b Haemophilus influenzae vaccine that protects against a bacterium that causes meningitis and pneumonia.

Pfizer told The Wall Street Journal that the health ministry has raised certain questions and the company is in the process of preparing responses. As per the company's evaluation, the vaccine doses administered in the four cases were from three separate lots.

Sanofi stated that it is awaiting the findings of the expert panel and is not planning to recall ActHIB at present.