UNICEF yanks Sanofi vax, calls in Crucell

Sanofi's loss is Crucell's gain. As pediatricians in Kathmandu work to calm parents unable to have their infants vaccinated against five diseases, Sanofi Aventis' Indian unit Shantha is scrambling to find the cause of a white sediment in some vials of its Shan5 vaccine. Meanwhile, Crucell is ramping up to fill the gap.

Shan5 is a prophylactic for diphtheria, pertussis, tetanus, Haemophilus influenza B, and hepatitis B. Reports of the sediment began in March, followed by a World Health Organization suspension of the vaccine for use in a distribution program. Shan5 represents a $340 million contract that the Indian drugmaker won last fall.

Some Nepalese parents have decided to cough up $14 for another pentavalent vaccine available at some hospitals, despite assurances that shipments are on their way and the free-vaccine program will resume in a matter of weeks.

The white sediment is reportedly difficult to disperse, even when the vial is shaken. It's not likely a contaminant because the vaccine passed QA tests prior to shipment, the company said in March. A more likely scenario is that part of the vaccine contents condensed in transit, perhaps due to improper storage or shipping conditions.

UNICEF and the WHO in late April recommended the recall and destruction of vaccine still in stock--about 24 million doses--due to the mysterious sediment. The move has affected vaccination programs in seven countries, says the WHO. No safety issues or adverse events have been reported.

The WHO and UNICEF want Shantha to find out what went wrong and to develop a corrective plan before the end of June. Shantha will otherwise be disqualified as a supplier. The company says it has put together a team of specialists to find the cause and resume shipments before the end of the year.

Meanwhile, Dutch biotech Crucell has won a $110 million UNICEF order for its pentavalent Quinvaxem, giving the company a much-needed market boost against Shantha and Panacea Biotech, according to Reuters. The news agency cites a Crucell spokeswoman who said that the Quinvaxem order from UNICEF was due to supply problems experienced by "another company."  

- here's the Kathmandu article
- see this Economic Times article
- here's the Reuters report