Column: Dose of credibility

Written by Viveka Roychowdhury | Viveka Roychowdhury | Updated: Mar 23 2010, 01:29am hrs
Last week, WHO suspended the distribution and purchase of the Shan5 vaccine, as complaints of a white sediment in vials came in from agencies like Mdecins Sans Frontires and Unicef. The vaccine lots were manufactured by the Hyderabad-based Shantha Biotechnics, now part of the Sanofi-Aventis group. Though WHO is not anticipating a vaccine safety issue as of now, distributing agencies were advised to quarantine the rest of the batches pending further investigation.

Touted as Indias first indigenously developed liquid pentavalent vaccine, Shan5 protects infants from five major childhood diseasesdiphtheria, whooping cough, tetanus, hepatitis-B and infections from hemophilus influenzae type-B. It is used for the vaccination of infants aged more than six weeks and given in three doses. Shantha Biotech has confirmed that the vaccine lots passed all quality controls and met all specifications required by the WHO and Unicef at the time of shipping.

The vaccine supply chain is fraught with challenges. If the sediment did not exist when it left factory premises and is not foreign matter, then it is part of the contents that condensed during the passage. And when the destination countries include developing countries where cold chain facilities are a luxury, there are bound to be weak links in the vaccine supply chain.

There is no doubt that the manufacture of biological therapeutics, like vaccines, is very complex compared to chemical-based medicines, and requires extreme consistency in operations, with a very small margin for variation in parameters like temperature and relative humidity. So, from an image point of view, this setback is likely to raise doubts on the manufacturing capabilities of Indian vaccine players, even those who are now part of the global vaccine majors, if the weak link is not identified (and fixed) as soon as possible.

Both the parent company as well as the Indian subsidiary need to take swift damage control measures, zero in on the problem, own up if necessary and fix it as soon as possible.