Good news for Gardasil as UK backs HPV innoculation plan

by | 20th Jun 2007 | News

As expected, the UK has provisionally agreed to begin a programme of human papillomavirus vaccination to prevent cervical cancer for girls starting secondary school.

As expected, the UK has provisionally agreed to begin a programme of human papillomavirus vaccination to prevent cervical cancer for girls starting secondary school.

The Department of Health says it has agreed, in principle, to accept advice from the UK Joint Committee on Vaccination and Immunisation that HPV jabs should be introduced routinely for girls aged around 12-13 years, “subject to independent peer review of the cost-benefit analysis”. The news comes two days after Swiss authorities backed a similar scheme and the UK is now likely to become the ninth European country to introduce a national inoculation programme.

The announcement is great news for Merck & Co, whose Gardasil, which targets HPV types 6, 11, 16, or 18, is the only licensed jab in Europe for the prevention of cervical cancer. GlaxoSmithKline’s vaccine, Cervarix, is currently under review by EU regulators.

The DoH said that routine vaccination of girls could start as early as autumn 2008, though details of the programme will be finalised over the next few months, following further advice from JCVI and discussions with the National Health Service. Public Health Minister Caroline Flint said that it is “great news that vaccines have been developed that protect women

against this form of cancer” and the benefits “will be felt by women and their families for generations to come”.

She went on to say that in England, 2,221 new cases of invasive

cervical cancer were diagnosed in 2004 alone and around 200,000 women are identified through smear tests as having a pre-cancerous change. “This vaccine will prevent many women from catching the HPV virus in the first place, potentially saving hundreds of lives,” Ms Flint claimed, before adding that “a significant amount of planning is required before we can introduce the immunisation into our programme”.

The DoH concluded that cases of cervical cancer will be reduced by up to 70% with the introduction of a national immunisation programme and this view was echoed by Pamela Morton, director of the Jo’s Trust Fighting Cervical Cancer charity. She said she was delighted that the JCVI “has, at last made a recommendation on HPV vaccine and pleased that the Government has agreed in principle with its recommendation, so progress has been made”.

No mention of catch-up programme

However, she added: “I am disappointed that there is still prevarication about funding and clarity about when this commitment will be made but more importantly that there is no ‘catch up’ programme for the 14 year-olds and upwards within the JCVI recommendation so thousands of young women will continue to be a risk from a cancer that is now avoidable.”

Ms Morton went on to say that HPV vaccines “represent a major scientific breakthrough in the prevention of a cancer and we owe a huge debt of thanks to the British scientists, researchers and pharmaceutical companies who developed them as they will save literally, hundreds of thousands of women’s lives around the world”. Nevertheless, she added, “it is important to reiterate that adult women continue to attend for regular cervical screening as it offers the best protection against cervical cancer.”

Not everybody shares Ms Morton’s and the government’s enthusiasm, however and religious groups have expressed concern that a programme which targets girls in their early teens may create more problems than it solves and send out the message that underage sex and general promiscuity is normal and acceptable. Also, much of the media reporting about the vaccination contains the phrase ‘sex jab’ in the headline.

Aside from any moral issue, the claim that there is little evidence of any side effects from Gardasil is also under fire. Recently, Judicial Watch, a US public interest group set up to investigate government corruption, released documents obtained from the Food and Drug Administration under the Freedom of Information Act spotlighting 1,637 reports of adverse reactions to Gardasil since its approval in June last year. More seriously, three deaths were also associated with the vaccine.

A Sanofi Pasteur MSD spokesman (the joint venture which markets Gardasil in Europe) responded to that report by telling PharmaTimes World News that such spontaneous adverse event reports show a temporal rather than causal relationship and he added that the data need to be systematically evaluated before the company and the regulators can make an accurate judgement.

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