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New leaflet eases fears over unlicensed BCG vaccine

Global BCG vaccine shortage means the NHS is importing vaccine from Canada

Mark Gould

Tuesday, 28 June 2016

The Department of Health has produced a leaflet for parents and carers explaining why the NHS is offering an unlicensed BCG vaccine. It explains that a global shortage has caused a break in the supply chain to the national BCG immunisation programme meaning that the NHS's supplier in Denmark has not be able to supply the vaccine.

With no other licensed vaccine available in the UK, Public Health England (PHE) is importing the BCG vaccine from InterVax Ltd of Canada. PHE says this vaccine has had the approval of the World Health Organization since 1991 and has been used widely around the world for many years, but a UK licence has never been applied for, as a result this vaccine does not have a UK a licence.

PHE says it does not know when a licensed vaccine will be available again and urges parents not to delay vaccinating their children. "Currently we do not know when a licensed vaccine will become available again. There is a risk, in a very small number of unvaccinated babies, of developing TB, including severe types such as TB meningitis. BCG is less effective in protecting against adult-type disease in older age groups. This means that the greatest benefit of BCG is for small babies and infants at risk of severe TB. Waiting for a licensed vaccine will mean eligible babies lack protection against severe forms of TB such as TB meningitis," the leaflet states.

While vaccines used in the UK are authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) or the European Medicines Agency (EMA), PHE says that in certain areas of healthcare, for example in children’s health, many medicines used are unlicensed, "so, not having a UK licence does not mean the medicine is unsafe or untested."

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