Shantha races against time to fix vaccine glitch

Hyderabad-based Shantha Biotechnics has stopped the production of its five-in-one vaccine after the World Health Organization and Unicef, the two agencies that procured the bulk, decided to temporarily suspend its use due to complaints from some recipient countries.

The company, a subsidiary of European company Sanofi Aventis, hopes to rectify the problem and resume production, as well as its international supplies, in two months.

The pentavalent vaccine provides protection against diphtheria, pertussis, tetanus, haemophilus influenza-B and hepatitis-B, all in one vial. Three nations — Columbia, Comoros and Nepal — had in February complained that Shantha’s vaccine, marketed under the brand name Shan5, had white sediments which stuck to the glass vials even after vigorous shaking.

Industry experts say sediment is a normal feature of pentavalent vaccines, though it always dissolves in the solution once thoroughly shaken. “The problem was seen in four batches of Shan5 (550,000 vials) and WHO recommended temporary suspension of the distribution and use of the specific lots on February 19 as a precautionary measure,” said Varaprasad Reddy, managing director.

A WHO-Unicef statement said the suspension was extended to all vaccine lots after more countries raised similar complaints. “The company has stopped the production of Shan5 completely and wants its research team to find the root cause of the problem,” Reddy said.

Between January 2008 and February 2010, Shantha had supplied 23 million doses of this vaccine through Unicef and the Revolving Fund of the Pan-American Health Organisation.

Reddy said the company would lose $4-5 million (Rs 18-22 crore) if it cannot supply Shan5 for another month. It had received contracts worth $340 million (Rs 1,540 crore) from international agencies for supplies till 2012. WHO has not taken out Shan5 from its list of pre-qualified vaccines, as it is yet to have any proven quality problem.

Sanofi had acquired an 80 per cent stake in Shanta for Rs 3,783 crore in July last year.