Sanofi-Aventis Recalls ActHIB vaccine
The Health Ministry of Japan has suspended the use of vaccines made by Pfizer Inc and Sanofi-Aventis SA after five children were found dead. There was no clear link between the use of vaccines and deaths but the company officials are investigating further.
Following the suspension of the vaccine the manufacturer of ActHIB vaccine, Sanofi-Aventis SA has recalled the 200,000 doses of the vaccine distributed in Japan. The vaccine is distributed in Japan by Daiichi Sankyo Co which has recalled 13 lots of the ActHIB vaccine.
The spokeswoman of Sanofi-Aventis SA, told that the vaccine was recalled following the detection of undetermined foreign matter in two syringes of the vaccine. She has also said that the contamination of the syringes had not affected the sterility of the vaccine so there is no need to take any action.
The company is investigating into the matter but has said that the syringes must have got contaminated during the manufacturing process. The vaccine is injected with the use of syringes in Japan but not in US.
On March 8, a panel of experts at Japan's health ministry (the MHLW Safety Countermeasure Committee and Vaccines Adverse Event Committee) said they had found no clear, direct causal relationship between vaccination and the cases reported.
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