Sanofi's Shan5 vaccine to restart in 2013

The year 2013 still appears correct for Sanofi's ($SNY) relaunch of its Shantha Biotech unit's Shan5 pentavalent vaccine, sidelined in 2010 by the World Health Organization because of a white residue in some vials. The Central Drugs Standard Control Organization of India said it no longer expects to begin the inspection process in January because the company is conducting additional stability studies.

Sanofi said in November 2010 that it expected Shan5 to be off the market until 2013 while it rebounded from manufacturing issues. The troubled vaccine was manufactured in 2009, predating Sanofi's acquisition of Shantha.

Hyderabad, India-based Shantha lost its prequalification status with WHO in July 2010, and along with it a three-year, $340 million contract for the vaccine. Shan5 protects children against diphtheria, pertussis, tetanus, influenza B and hepatitis B. The canceled deal affected vaccination programs in 7 countries, according to WHO. The organization traced the white sediment to Shan5's pertussis component.

Apart from implementing corrective measures at the Hyderabad plant, Shantha faces the additional step of reapplying for WHO prequalification to get back on UNICEF's vaccine-maker list. When Shan5 was sidelined in 2010, WHO tapped Crucell to fill the void.

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Related Articles:
Sanofi's Viehbacher sees green lights ahead for Shantha
Sanofi/Shantha vax fix will require WHO requalification
UNICEF yanks Sanofi vax, calls in Crucell
Sediment forces WHO to halt vax program

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