Daiichi recalls contaminated paediatric vaccines
pharmafile | March 15, 2011 | News story | Manufacturing and Production |Â Â ActHIB, Daiichi Sankyo, manufacturing compliance, padiatric vaccine recall, recalls, vaccinesÂ
Japanese drugmaker Daiichi Sankyo has recalled around 1.3 million doses of the paediatric vaccine ActHIB, manufactured by Sanofi-Aventis, because of contamination with unidentified particles.
The conjugate vaccine, which protects against the meningitis-related bacteria Haemophilis influenza type B, was recalled “due to a notification of contamination by foreign matter and the resulting investigation which confirmed two cases of contamination inside syringes of diluent which are used to reconstitute ActHIB”, said Daiichi Sankyo in a statement.
The contaminating particles do not appear to be a micro-organism, but in the interests of patient safety Daiichi Sankyo and Sanofi have decided to withdraw all the ActHIB products manufactured in the same production run. The vaccines were made last year and delivered to Japan between September 2010 and January 2011, according to an AFP report.
Last week, Japan’s Ministry of Health, Labour and Welfare temporarily suspended the use of ActHIB and another vaccine – Pfizer’s Prevenar for protection against meningitis and pneumonia – while it carries out an investigation into the deaths of four children who had received the vaccines as part of their routine immunisation schedule.
An advisory committee convened to review the cases found no evidence of a direct link between the vaccines and the deaths, but their use remains suspended as a precaution.
Phil Taylor
Related Content
AAX Biotech and Daiichi Sankyo partner to evaluate antibody therapeutics
AAX Biotech, a Swedish biotechnology company specialising in next-generation antibody therapeutics, has launched a strategic …
Valneva Scotland supports local cancer charity Team Jak FoundationÂ
Valneva Scotland, the country’s largest vaccine producer, has partnered with local West Lothian-headquartered charity, Team …
Pfizer releases results for severe RSV-associated LRTD treatment study
US-based Pfizer have announced results from its substudy B of the ongoing phase 3 clinical …
