Japan Continues Vaccine Suspension
Two shots for children halted after four deaths; no causal relationship found.
March 8, 2011— -- After a preliminary review, Japanese health officials decided on Tuesday to continue the suspension of two pediatric vaccines following the deaths of four young children shortly after immunization.
An expert panel convened by Japan's Ministry of Health, Labor, and Welfare did not find evidence of a causal relationship between the deaths and Pfizer's Prevnar (Prevenar outside the United States) and Sanofi Pasteur's ActHIB, but called for further studies, according to Reuters, which cited the Kyodo news agency based in Tokyo.
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The ministry suspended the use of the two vaccines on Monday following the deaths, which occurred last week.
All four of the children are reported to have received Prevnar, and three also received ActHIB and a combination vaccine against diphtheria, pertussis, and tetanus at the same time.
The makers of both of the vaccines have said that they are cooperating with the investigation.
A spokesperson for Sanofi said in a statement that ActHIB, which has been available in Europe since 1992, in the U.S. since 1993, and in Japan since 2007, "is a safe and efficacious vaccine against Hib infections, and over 200 million doses have been administered to children in well over 100 countries with an excellent safety profile."
A spokesperson for Pfizer said in a statement that Prevnar, which has been available in the U.S. since 2000, "has a well-documented safety profile and is associated with significant public health benefits where the vaccine is routinely used."
In an e-mailed statement to MedPage Today, an FDA spokesperson said that the agency is aware of the situation in Japan but has not detected any new safety concerns or unusual reporting patterns in the agency's Vaccine Adverse Event Reporting System.
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