The product, which is designed to protect against diphtheria, pertussis, tetanus, haemophilus influenza B, and hepatitis B, was supplied under a $340m contract signed by Shantha with the world health organisation (WHO).
In a statement this week, the WHO said it received several complaint about the vaccines’ quality over the last few months, all of which focused on the detection of “white sediment” which would not re-suspend even after vigorous shaking.”
The organisation added that, while it had not received reports of adverse events linked to the vaccine, it was now asking all governments to return all remaining stocks to a central hub as a precautionary measure.
The WHO action, which is based on the advice of an ad hoc committee of experts convened on 8 April, follows recommendations in February and March that distribution of Shan5 be halted until further notice.
According to a report in India’s Economic Times, Shantha has already initiated the recall which amounts to some 24m doses of the 5-in1 vaccine products supplied between November 2008 and February this year.
A company spokeswoman told the ET that: “Strong-focused investigations are going on with all the speed needed in such circumstances," and added that Shantha plans to file an action plan with the WHO in the next two months.
The paper also reports that Shantha will be asked to cover the cost of replacement vaccines as well as transportation, handling and destruction of the recalled lots
The announcement is also bad news for French drugmaker Sanofi Aventis given that Shantha’s vaccine business was a key motivation for its acquisition of an 80 per cent stake in the Indian firm in July last year.