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MHRA recalls GSK's Hepatitis B vaccine
07 Apr 2009
Regulatory Affairs
The Medicines and Healthcare Products Regulatory Agency (MHRA) is instructing medical professionals to contact patients who were immunised against Hepatitis B in the last month as the vaccine is thought to be ineffective.
It is advising patients who received the injection, GlaxoSmithKline's (GSK's) Energix B, between March 9th and April 6th, to contact the GP or travel clinic that administered it as the batch was exposed to sub-zero temperatures during transportation.
Professor Kent Woods, chief executive of the MHRA, says: "The safety of the vaccine is not in question, but it is suspected to be ineffective."
The agency has issued a drug alert to recall the batch from the market and it is asking friends and families of people travelling abroad who may have been immunised with the vaccine to contact the clinic where it was dispensed to make sure they have not been affected.
Earlier this month, the MHRA reported that two batches of Novartis' meningitis C vaccine, which were recalled as a precaution in February, have since been found to be safe.
