September 29, 2009 / 2:17 AM / 8 years ago

UK teenager "unlikely" to have died from vaccine

LONDON (Reuters) - GlaxoSmithKline’s cervical cancer vaccine Cervarix probably did not cause the death of a British teenager shortly after she was given the drug, a health official said on Tuesday.

“I think it is unlikely that will be the case ... I think once we get into the investigation ... we may discover there is another cause of her death,” Dr Caron Grainger, joint director of public health in the area where the 14-year-old girl died, said in an interview with the BBC.

GSK said in a statement that it had voluntarily recalled the batch of vaccine that was used, pending the result of an investigation.

“At this stage the cause of this tragic death is unknown,” the company said.

Police are treating the girl’s death as “unexplained” and said a post-mortem was taking place on Tuesday.

The teenager, named by a police source as Natalie Morton, fell ill on Monday after being vaccinated at her school under a national immunization program against the sexually transmitted human papilloma virus (HPV).

A small number of other girls at the Blue Coat Church of England School reported suffering from dizziness and nausea but were not admitted to hospital, health officials said.

“The message for parents at this moment in time and for young girls receiving this vaccine is that you should go ahead with the vaccination,” said Grainger, who works for the National Health Service in the central English city of Coventry.

News of the death came shortly before U.S. health regulators shelved a bid by Glaxo to sell Cervarix in the United States.


Britain’s Department of Health said there were no plans to halt the program 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.

Grainger said only about 2,000 people had suffered any adverse reactions to the immunization program and that these were mostly minor. GlaxoSmithKline said on Monday it was working with regulators to understand the case better.

Sudden teenage deaths, in general, are not unknown. “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 drug is given in three shots over six months.

The program to vaccinate girls aged 12 to 13 began in September 2008. Cervical cancer is the 12th most common women’s cancer in Britain, killing more than 1,000 women each year.

Should Cervarix gain U.S. approval it would compete with Merck & Co’s Gardasil, which has been on the U.S. market since 2006 and had sales of $268 million in the second quarter.

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.

Editing by David Stamp and Matthew Lewis

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