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The World Health Organisation has suspended the procurement of the hepatitis B vaccine – Revac B – from the Hyderabad-based vaccine-maker Bharat Biotech International Ltd. According to an alert released by the WHO, the decision was taken after a site audit of Bharat Biotech facility here conducted in September showed deficiencies in good manufacturing practices quality management systems.
The arm of the United Nations had also terminated the on-going pre-qualification process of all other vaccines of the company which were under consideration for the United Nations procurement, the alert said. Launched in 1998, Revac B was the world's first caesium chloride-free recombinant vaccine to combat hepatitis B. It was being supplied to the United Nations since 2008 for distribution in various countries.
When contacted, company official said: “WHO does not recommend recall of Revac-B+ already distributed, since the suspension is a precautionary and interim measure. It is not based on reported complaints from the field regarding the Revac-B+ product.” –
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