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HPV vaccine pressure grows as trials halted

Two major European trials of HPV vaccination have been stopped ahead of time after an independent regulatory board ruled women in the placebo groups should be vaccinated too.

The move intensified pressure on Government advisers as they met last week to discuss whether to introduce an HPV vaccination programme – although some experts demanded an end to the 'hype'.

The Data and Safety Monitoring Board recommended the FUTURE I and II trials of Merck's Gardasil vaccine be stopped 'to provide the benefits of vaccination to [unvaccinated] women'. GPs will now vaccinate young women assigned to placebo on the Scottish arm of the trials.

Studies including FUTURE have shown HPV vaccines can prevent up to 100 per cent of cervical cancers, lesions and genital warts caused by the virus. Sexual health experts said the premature closure of the trial lent more urgency to the calls for introduction of a vaccination programme.

Professor Albert Singer, professor of gynaecological research at the Whittington Hospital in London, said: 'I can more than understand that the board felt the responsibility not to leave women unprotected.'

Dr Angela Robinson, consultant in genito-urinary medicine at the Portland Hospital in London, said: 'The sooner we start a national vaccination programme the sooner we will start to see the benefits. Not only in terms of reduced cervical cancer cases and abnormal smears but also in terms of reducing the burden of genital warts.'

But others questioned the haste with which a move towards HPV vaccination was being made. Dr Angela Raffle, a consultant in public health who consults for the National Screening Programme, recently wrote a letter in The Lancet accusing the manufacturers of the vaccine of 'planting press stories to create a smoke screen'.

Commenting on the latest developments, Dr Raffle said: 'There's no rush, we have a highly effective screening programme. The challenge is can we have a programme that is the best of both measures, that doesn't cost more than the system we currently have? But we must stop the hype.'

The HPV sub-group of the Joint Committee on Vaccination and Immunisation met last week to consider whether to recommend introducing an HPV vaccine – most likely to be in girls aged 11 or 12.

lanekwe@cmpmedica.com

Advisers on verge of decision

In September 2006 the JCVI's HPV sub-group decided:

• It tended to favour vaccination of girls at the age of 11 or 12 years

• Modelling studies suggest the additional benefit from herd immunity from vaccination of boys is unlikely to justify the cost

• Insufficient information to decide if a catch-up campaign should be introduced and what age range it should cover

• Further data should be considered with a view to making a recommendation on vaccination programme in March 2007

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