ActHIB, Prevnar Vaccines Suspended in Japan After Child Deaths

Japan has suspended use of the Pfizer vaccine, Prevnar, and the Sanofi-Aventis vaccine, ActHIB, following the deaths of four children.

Today, a safety panel in Japan’s health ministry will discuss the investigations into the two vaccines, which will not be used in Japan until the investigation is concluded. All four infants died shortly after receiving the vaccines, three of them the next day.

Prevnar, a pneumonia vaccine, is widely used in Japan and many other countries, including the United States. ActHIB, used to prevent meningitis, does not have as widespread a use. All four infants received the Prevnar vaccine, while only three of the four got the ActHIB shot.

This is the second time a country has investigated potential Prevnar safety problems in a little more than a year. In February 2010, the Netherlands investigated the vaccine following the deaths of three children who received the shots. Investigators were unable to find a link between the children’s deaths and the vaccine.

In the United States, the FDA and the Centers for Disease Control and Prevention (CDC) say they will continue to monitor the safety of all vaccines, but they have not seen any safety risks in the use of the shots in this country.

Last month, the U.S. Supreme Court affirmed that vaccine manufacturers are immune from product liability lawsuits in the United States as a result of injuries or deaths that may have been caused by their products. The court rejected an appeal filed by the parents of a girl who was permanently disabled after receiving a Pfizer vaccine for diphtheria, tetanus and pertussis in 1992.

A 1986 law known as the National Childhood Vaccine Injury Act shields vaccine manufacturers from product liability lawsuits in this country, according to the U.S. Supreme Court. It also set up a special vaccine court where plaintiffs with claims could be compensated through a tax on drug manufacturers if they could show that a defective vaccine caused their injuries.

There have been more than 2 million Prevnar vaccine shots distributed in Japan over the last year. Sanofi has distributed more than 3 million ActHIB shots there since 2008.