Recall and destruction recommended for Shan5 vaccines

A recall and destruction for all of the lots of Shantha Biotechnics pentavalent Shan5 vaccines has been recommended by the World Health Organization as a precautionary measure following the discovery of undissolved white sediments in the vaccine.

“The recommendation is based on the advice of an ad hoc committee of experts convened on April 8, following incidents of white sediments sticking to Shan5 vaccine vials that were difficult or impossible to re-suspend," the WHO said in a statement. "There have been no reports of any side effects from the use of Shan5."

French drug maker Sanofi-Aventis, which owns Shantha Biotechnics, plans to present the WHO with an action plan to resolve the issue within two months.

Twenty four million doses of the vaccine were supplied by Shantha Biotechnics through Unicef and the Revolving Fund of the Pan-American Health Organization between November 2008 and February 2010.

Shan5 offers protection against diphtheria, pertussis, tetanus, haemophilus influenza B and hepatitis B.

“The WHO decision to suspend the use of Shan5 is based on information that is available to date, regarding its abnormal visual appearance," a Sanofi-Aventis spokesman told "This information is insufficient to make conclusions about the potential cause for the sediment sticking to the sides of the vial."

Multiple investigations have been launched to establish the cause of the sediment, which has not resulted in safety or efficacy issues, the spokesperson said.