Pfizer and Sanofi-Aventis Vaccines Suspended in Japan


Japan's health ministry announced it has suspended the use of two vaccines, one from Pfizer (PFE) and the other from Sanofi-Aventis (SNY), following the deaths of four children.

Sanofi-Aventis's ActHIB vaccine protects against haemophilus influenzae type b (Hib), one of the most common causes of bacterial meningitis (an infection of the covering of the brain and spinal cord). Pfizer's Prevnar vaccine protects against the streptococcus pneumoniae bacteria, which cause different pneumococcal infections, including otitis media (ear infection) and bacterial meningitis.

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The four children, ranging in age from three months to two years, were administered Prevnar, according to The Japan Times, and all except one received ActHIB as well, according to information Sanofi received from the ministry. In addition, all except one 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. Three of the deaths occurred last week.

So far authorities haven't found a causal relationship between the vaccines and the children's deaths. Some of them had underlying illnesses. A safety panel will meet Tuesday to examine the cases and discuss the cause of the deaths, the ministry said. Sanofi and Pfizer both said they are fully collaborating with the investigation. The two vaccines will be suspended until at least then, but Sanofi added the ministry did not request a recall of the vaccine.

No Link to Prevnar Found in Europe Deaths

In a similar scare in the Netherlands last year, authorities found no relation between Prevnar and the deaths of three infants, according to Reuters.

Japan has been notoriously slow to accept vaccines following a measles, mumps and rubella shot in 1989 that sickened 1,040 people, three of whom died. Since then Japan has certified about half as many vaccines in the past two decades as the U.S., according to Bloomberg. There have been concerns about the safety of vaccinations and lack of public information about vaccines, and the recent scare will likely not help.

The Hib vaccine, which was first approved in 1992 in Europe, and in the U.S. a few years later, wasn't approved in Japan until more than a decade later in 2007. Over 200 million doses of ActHIB have been administered to children in over 120 countries. Prevnar was approved in the U.S. in 2000, but not in Japan until 2009. To date, Pfizer has distributed more than 360 million doses of the vaccine in more than 100 countries.

Without a Hib shot, the rate of meningitis in Japan rose 36% from 1996 to to 11.7 children per 100,000 in 2005, according to a study at Chiba University. In the U.S., cases of meningitis caused by Hib dropped 94% from 1986 to 0.2 per 100,000 in 1995, because of vaccines, according to research published in the New England Journal of Medicine.

Since its launch in 2008, ActHIB has been administered to an estimated 1.55 million people in over 3 million doses in Japan, Sanofi said. Pfizer Japan has distributed more than 2 million doses (as of February 2011), Pfizer said.

While it's critical to ascertain the safety of vaccines, it's also important to remember what diseases they prevent, as the U.S. Centers for Disease Control and Prevention explains.

Sanofi reported sales of €984 million for its Polio/Pertussis/Hib vaccines in 2010. SNY shares traded 0.7% lower Monday in midday trading. Worldwide, Pfizer reported $2.42 billion in sales in 2010 for Prevnar 13, which protects against 13 strains of streptococcus pneumoniae, and $1.25 billion in sales for Prevnar 7, which protects against seven strains of the bacteria. PFE shares were down more than 1%.

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