Regulatory

WHO, UNICEF suspend use of Shantha Bio's vaccine: report

Last Updated: 2010-03-17 19:47:30 -0400 (Reuters Health)

MUMBAI (Reuters) - The World Health Organization (WHO) and UNICEF have suspended the use and purchase of the Shan5 vaccine from Sanofi Aventis owned Shantha Biotechnics pending a quality investigation.

The combination vaccine is given to prevent diphtheria, pertussis, tetanus, haemophilus influenza B, and hepatitis B.

"Countries are advised to put any remaining vaccine in quarantine until further notice," the joint WHO-UNICEF statement said.

The investigation was launched after reports "of a white sediment which sticks to the glass of the vaccine vial that is difficult or impossible to re-suspend with vigorous shaking (flocculation)," the statement says.

WHO has received no reports of adverse reactions so far in those who have been given the vaccine.

An Economic Times report said the pending investigation threatens a three-year contract worth $350 million.

An official of Shantha Biotechnics could not be reached immediately for a comment by Reuters.

(Reporting by Kaustubh Kulkarni)