* Post-mortem shows girl had serious ”medical condition“
* Results show vaccine ”most unlikely“ to have caused death
* Glaxo (GSK.L) recalls batch of vaccine as precaution
(Recasts after post mortem shows underlying health condition)
LONDON, Sept 29 (Reuters) - A British girl who died shortly after being given GlaxoSmithKline’s (GSK.L) cervical cancer vaccine had an underlying medical condition and the dose was ”most unlikely“ to have caused her death, health officials said on Tuesday.
The British officials said initial indications from a post mortem examination by an independent forensic pathologist had revealed the underlying condition, but gave no further details.
”The preliminary post mortem results have revealed a serious underlying medical condition which was likely to have caused death,“ said Dr. Caron Grainger, joint director of public health in the area where the 14-year-old girl died.
”We are awaiting further test results which will take some time. However indications are that it was most unlikely that the HPV (human papilloma virus) vaccination was the cause of death.
GSK said earlier on Tuesday that it had voluntarily recalled the batch of vaccine used, pending an investigation.
The girl fell ill on Monday after being vaccinated at school under a national immunisation programme against HPV, a sexually transmitted virus. A small number of other girls at the Blue Coat Church of England School also reported suffering from dizziness and nausea but were not admitted to hospital.
News of the death came shortly before U.S. health regulators again delayed a decision on whether to allow Glaxo to sell Cervarix in the United States. The Food and Drug Administration had no further comment. [ID:nN29150932]
Britain’s Department of Health said there were no plans to halt the vaccination programme under which more than 1.4 million doses of Cervarix have been administered.
“The vaccine has a strong safety record so precautionary measures are focused on the batch,” it said in a statement.
“Unfortunately, some young people do die suddenly for a variety of reasons, including cardiac causes. Sometimes they have been entirely well before their death,” said Dr David Elliman of London’s Great Ormond Street Hospital for Children.
The programme to vaccinate girls aged 12 to 13 began in September 2008 in Britain, where cervical cancer kills more than 1,000 women each year.
GlaxoSmithKline won support for its cervical cancer vaccine from an advisory panel to Japan’s Health Ministry on Tuesday, putting it on track to be the first company to offer such a vaccine in the world’s second-biggest drug market. [ID:nT327756]
(Additional reporting by Susan Heavey in Washington and Matthew Jones and Kate Kelland in London; editing by Michael Roddy)