March 8, 2011

Pfizer, Sanofi Vaccines Suspended In Japan

Two widely-used vaccines made by Pfizer and Sanofi-Aventis have been suspended for use in Japan, as the health ministry investigates whether they are linked to the recent deaths of four infants.

The vaccines, which are used to prevent meningitis and pneumonia, are Prevenar by New York-based Pfizer and ActHIB by Sanofi Pasteur, a subsidiary of Paris-based Sanofi-Aventis.

The infants died shortly after receiving the vaccines. While it is not yet clear if there is a link between the deaths and vaccines, use of the two vaccines will be halted while Japan's health ministry investigates the incident, the ministry told Reuters in a statement.

A ministry safety panel is scheduled to discuss findings Tuesday.

The infants affected, ranged from six months to under two years old. They died over a three-day period this month after receiving the vaccinations. The health ministry said it is not clear if the infants had also been given any drugs along with the vaccines.

Health officials said they knew of the deaths in Japan but have not seen any safety concerns in the United States. The FDA and the CDC "will continue to monitor the safety of all vaccines, including" the two at issue, spokeswoman Shelly Burgess said in a statement.

Three of the children that died were administered Prevenar together with ActHIB. In addition, three of the children were also given a mixed vaccine against diphtheria, pertussis and tetanus on the same day they received the other vaccines. Three of the four infants died a day after being immunized. The deaths occurred between March 2 and 4.

The two vaccines have so far been administered to an estimated 1.5 million children in Japan, according to the ministry. The Ministry of Health, Labor and Welfare said there have been no reports so far from the doctors who treated the children that establish a causal relationship between the vaccines and their deaths.

The suspension will remain in place until at least Tuesday pending the results of the investigation by a group of medical experts.

"Sanofi Pasteur would like to express its sincere condolences to the families affected by these losses," a spokesman told AFP. "An investigation is underway to which Sanofi Pasteur intends to fully cooperate with health authorities by providing all data available regarding HIB."

Pfizer said in a statement that it would fully cooperate with the ministry's suspension and was also in the process of gathering information.

"Our company, taking the safety of patients as its top priority, has studied and assessed accumulated information, including that on causal relationships, with regard to the side effects of all products including Prevenar," Pfizer said.

The suspension follows the deaths of two infants in France in late February who had been given Prevenar. Health authorities on Thursday cleared Prevenar of those deaths.

A batch of Prevenar was suspended in the Netherlands in 2009 following reports of the deaths of three infants after receiving the vaccination. The vaccine was then owned by Wyeth.

Dutch authorities and Wyeth determined in Feb 2010 that there was no link between the deaths and the vaccinations.


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