Bangalore, Mar 17, 2010: The World Health Organization (WHO) has suspended procurement and use of Shan5 vaccine made by India's Shantha Biotechnics, owned by France's Sanofi Aventis. The recommendation by WHO came March 12.

WHO, which is the biggest buyer of Shantha's vaccines, said procurement and use of all lots of the Shan5 vaccine supplied to countries are being suspended pending ongoing investigations over quality issues.

The decision came after officials in Colombia, Nepal and Comoros Islands complained of presence 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).

WHO has advised these countries to put any remaining vaccine in quarantine until further notice. If it is confirmed that the country has received shipments of any lot of Shan5 vaccine, the vaccine should not be used until further direction is provided by WHO.

Shantha was awarded a two year $340 million contract by WHO in September 2009 for the supply of Pentavalent vaccine. It is believed the sediment was found in batches supplied as part of this contract.

The Geneva-based organization has asked countries to continue vaccination using pentavalent vaccine from an alternative manufacturer or an alternate DTP-containing vaccine until further notice.

Shan5 is India’s first locally developed liquid pentavalent vaccine (DTP-Hep B-Hib) to protect infants from five major childhood diseases—Diphtheria, Pertussis (Whooping cough), Tetanus, Hepatitis-B, Infections fromHemophilus influenzae type-B. It is used for vaccination of infants aged more than 6 weeks and given in three doses.

Sanofi Aventis officials in France said the suspension is a “precautionary measure pending outcome of an investigation of vaccine quality.”