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GSK faces fresh US delays over Cervarix

Published on 30/09/09 at 12:59pm

GSK faces new delays in the US over the approval of its cervical cancer vaccine Cervarix, after the FDA failed to complete its review by the anticipated deadline.

It adds to the company's problems, coming one day after the jab was linked to the death of a 14-year old girl schoolgirl in the UK who died hours after receiving it.

But the FDA did not indicate the death had factored in its extension of the vaccine's review. Furthermore, the NHS has now declared the death was unrelated to the vaccine, following a post-mortem.

GSK says it "remains confident" in Cervarix's submission and expects the FDA to complete their review soon.

Schoolgirl Natalie Morton died in hospital soon after receiving Cervarix at her school in Coventry. But after investigation, the NHS trust has now said the death was unlinked, and the cause was instead an underlying health problem.

Dr Caron Grainger, director of public health for NHS Coventry, said: "The preliminary post mortem results have revealed a rare serious underlying medical condition which was likely to have caused death.

"We are awaiting further test results which will take some time. However indications are that it was most unlikely that the HPV vaccination was the cause of death."

The UK's national immunisation programme was launched in 2008 to immunise all schoolgirls aged 12 and 13 against the two strains of human papilloma virus (HPV) that most commonly cause cervical cancer.

There have been 4,657 suspected reactions to Cervarix from more than 1.4 million doses administered in the UK so far. The UK Medicines and Healthcare Regulatory Agency said it had received 2,137 reports between 14 April 2008 and 23 September this year.

The UK government chose Cervarix for the programme over Merck & Co's rival Gardasil - the option adopted by many other countries for a similar scheme.

But in the US GSK has had trouble with Cervarix from the outset, where in 2007 regulators refused to approve it until the company provided more information.

The FDA has only recently suggested it could give the vaccine a positive opinion, but the agency has missed many review deadlines while trying to implement new post-marketing requirements required for certain products as part of legislation that took full effect last year.

Meanwhile Merck's rival vaccine Gardasil beat it to market, launching in the US and Europe in 2006, leaving GSK playing catch up.


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