Japan suspends use of two vaccines after 4 children die

Japan's health ministry on Monday suspended the use of two common vaccines, Prevnar and ActHIB, after four children between the ages of six months and 2 years old died within three days of getting the shots.

A medical panel is investigating the deaths; results are expected tomorrow (March 8), and both sides of the vaccine debate are watching the investigation closely. (Note: Updated below.)

According to the health ministry, some of the children received the vaccines separately; others got them in combination with other inoculations, the ministry said in a statement. Some of the children died the same day the vaccine was administered; the deaths were reported to the ministry between March 2 and March 4.

On Monday, a spokesperson for Pfizer, which manufactures the Prevnar vaccine, said in a statement that 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." According to Pfizer, the four doses of Prevnar came from three separate lots of the vaccine. A spokesman for Sanofi-Aventis said that company is not planning to recall ActHIB for now.

Prevnar protects against seven types of Streptococcus pneumoniae bacteria, including one strain that became resistant to antibiotics about five years ago. A newer version, Prevnar 13 (PCV13) was approved for use by the U.S. Food and Drug Administration just last year and replaces the original Prevnar vaccine, which protected against seven forms of the bacteria. The U.S. Centers for Disease Control and Prevention recommends that children get four doses of PCV13 or the original Prevnar starting at 2 months old; the CDC also recommends that children younger than 4 who have already had four doses of the original Prevnar get one shot of PCV13 before age 5.

ActHIB, which is made by Sanofi-Aventis, protects against Haemophilus influenzae type b, a bacteria that can cause meningitis, pneumonia, and other infections. The CDC recommends that children get two or three doses of Hib vaccine, plus an additional booster shot, by the time they are 15 months old.

The Prevnar and ActHIB vaccinations began in Japan about a year to two years ago, according to their health ministry, and 1 million to 1.5 million children have received the shots. Pfizer suspended distribution and quarantined a batch of Prevnar in the Netherlands in 2009 after three infants were reported to have died soon after being vaccinated. An investigation did not find a link between the Netherlands deaths and the vaccine; a group of medical experts is researching the deaths in Japan, with Pfizer's cooperation, according to news reports. Results are expected March 8 (we'll update with them here).

UPDATE:CBCNews in Canada reports that the Japanese medical experts found no direct link between the vaccines and the deaths of the four children. The Koyodo News agency says that the panel will continue to investigate.


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