Japan Stops Using Pfizer and Sanofi Vaccines after Four Deaths Occur

The use of some pediatric vaccines manufactured by Pfizer Inc. and Sanofi-Aventis SA was suspended by Japan’s health ministry after four infants died following their immunizations.  A day after they were immunized, three out of the four children died, between March 2^nd and March 4^th.

It is still not known whether there is a connection between their deaths and the vaccines, but an investigation will try and determine if there is any link. ActHIB, which is designed to fight Haemophilus influenzae type b, made by Sanofi, and Prevenar, designed to protect children from pneumonia and meningitis, made by Pfizer, have been suspended until tomorrow.  A safety panel will then meet to determine the cause of these four deaths, according to a website post on March 4^th by the health ministry.

Victor Carey, the medical director in Sydney for the Asia Pacific branch of Sanofi’s vaccines, said “No causal relationship has been established between immunization and these fatalities, but an investigation is under way, which we’re fully cooperating with.”

In the year 2000, Hib, or Haemophilus influezae type b, was the cause of serious disease in 2 to 3 million people, in some cases causing pneumonia and meningitis, as well as causing 386,000 young children to die in the same year, according to the World Health Organization.

Around 1.5 million children in Japan have been vaccinated with ActHIB since its approval by Japan in 2007.  It has been used in various countries in Europe for over 10 years and no major safety concerns have been identified.  Children in more than 120 countries have received more than 200 million immunizations with ActHIB, according to Sanofi.

Prevenar, manufactured by Pfizer, is a pneumococcal conjugate vaccine which works to stop disease caused by closely related variants (called serotypes) of the Streptococcus pneumoniae bacterium.

Prevenar has been used for a decade or more in Europe and North America, and no major safety concerns have been identified, according to a 2007 report by the World Health Organization.  On the contrary, the same health agency says that evidence shows that pneumococcal conjugate vaccines will make a “considerable impact on pneumococcal disease and overall infant mortality.”

A spokeswoman for Pfizer, Victoria Davis, said by email, “The company thoroughly evaluates all reported cases and works closely with health authorities to determine if there is any association with the use of our medicines and vaccines.”