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WHO Suspends Vaccine By Sanofi-Aventis Subsidiary Because Of White Sediment Inside Vials

GENEVA -- The U.N. health agency said Wednesday it has suspended its approval of a vaccine against tetanus and four other diseases produced by Sanofi-Aventis SA subsidiary because of a white substance forming inside some vials.

The World Health Organization and the manufacturer of the Shan5 vaccine are investigating the sediment which is ``sticking to the glass inside the vials,’’ said Melinda Henry, a World Health Organization spokeswoman. She said there was no indication of a safety risk.

Shan5 immunizes against diphtheria, pertussis, tetanus, haemophilus influenza B and hepatitis B. It is produced by Sanofi-Aventis’ Indian subsidiary Shantha Biotechnics.

Henry said the WHO made its decision after complaints from regulators in various countries.

She stressed that the suspension was temporary, pending the results of the investigation. The WHO cannot recall or order countries to remove vaccines, but its approval does carry weight among governments and organizations looking to purchase drugs.

Posted: March 2010