Sanofi/Shantha vax fix will require WHO requalification

Sanofi-Aventis ($SNY) expects its Shantha Shan5 vaccine for five childhood diseases to be off the market until 2013 while it rebounds from manufacturing issues that yielded white sediment in some vials. The sediment was enough for the World Health Organization to cancel its Unicef order with the drug giant through 2012.

Bloomberg reports that Sanofi has provided the WHO with a corrective action plan. But the extent of the measures to be taken requires the company to reapply for prequalification. The vaccine with sediment was manufactured before Sanofi bought Shantha in 2009.

Meanwhile, the WHO has traced the sediment to Shan5's whooping-cough component and, in domino fashion, the global health authority has suspended the prequalification of a Shantha four-in-one vaccine that includes the same component and halted the approval process for a three-in-one shot.

Sanofi mentioned when it acquired Shantha in 2009 that the Indian drugmaker's manufacturing facilities provided the drug giant with high-quality capacity for making affordable vaccines available globally. Likewise, Johnson & Johnson ($JNJ) last month heralded excellence in manufacturing and supply chain in announcing its acquisition of vaccine maker Crucell. That announcement was quickly followed by Crucell suspending operations at a South Korean facility and halting shipments of two products--the pentavalent Quinvaxem and Hepavax-Gene for hepatitis B--due to contamination concerns. Crucell said it expects to resume shipping this month and that it anticipates full availability of the vaccines in February.

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