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Issue with Manufacturing of GSK Hepatitis B Vaccine

17 June 2016

Due to issues in the manufacturing of the Hepatitis B antigen, GSK has placed a temporary hold on the manufacture of bulk Hepatitis B antigen and, as an additional precautionary measure, is holding shipments of vaccines which contain the Hepatitis B antigen from its manufacturing sites.

As a result of this situation, UK supply of Engerix B ® (Hepatitis B (rDNA) vaccine (adsorbed) (HBV)) may be impacted over the summer. Given the importance of providing Hepatitis B vaccination to infants born of Hepatitis B positive mothers, GSK is prioritising UK supply for this purpose and working with customers to manage the stocks that are available as effectively as possible. At this time, there is no indication of an impact on the quality of product already on the market and other GSK vaccines which contain the Hepatitis B antigen are not predicted to have any stock issues in the UK.