A white sediment reported last week on the inside walls of Shan5 vaccine vials has prompted the World Health Organization to suspended purchase and distribution of the India-made product. No safety issues are suspected, but the WHO has decided to wait for quality-check results before resuming distribution of the prophylactic for diphtheria, pertussis, tetanus, Haemophilus influenza B, and hepatitis B.
The vaccine has been quarantined in countries where supplies contain the sediment. Manufacturer Shantha Biotechnics, a subsidiary of Sanofi-Aventis, has initiated no recall. Shantha was working under a $340 million UNICEF contract that it won last fall.
The vaccine supply chain is fraught with challenges. The sediment is not likely a contaminant because the vaccine passed QA tests prior to shipment, the company says. A more likely scenario is that part of the vaccine contents condensed in transit, perhaps the result of improper cold storage.
Separately, a vaccine cold-storage incident remains in the news in China. Reports state that vaccines were removed from cold storage so that monitoring stickers could be affixed; the stickers were unable to stick in the air conditioned environment. The cold chain breach is suspected in the deaths of four children and the sickening of dozens more.