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Published on 1 March 2007

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Gardasil trials halted due to high level of success

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Two major trials on the efficacy of Merck’s quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant cervical cancer vaccine Gardasil®, which is also marketed by Sanofi-Aventis, have been halted because of the success of the product.

According to Sanofi Pasteur MSD – a joint venture of the two companies – in light of the high efficacy of Gardasil observed in the large clinical trials FUTURE I and II, the independent data and safety monitoring board for these studies has recommended that women in the placebo group should be vaccinated with the treatment, so the studies “should be terminated as soon as feasible”.

The vaccine, which has been approved both in Europe and the US, has shown in clinical trials that it can prevent up to 100% of cervical cancer and precancerous lesions linked to four high-risk types of human papillomavirus, which is sexually transmitted.

In Europe, vaccination of women in the placebo groups of the FUTURE I and II studies has already begun in Germany, Sweden, Denmark, Austria and the UK. In total, 4,300 women are anticipated to be vaccinated in European study centres, “with the objective of completing before the end of 2007″, Sanofi Pasteur MSD noted, adding that vaccination of almost 4,500 women in other countries around the world will start soon.

News of the suspension of the trials has gone down well. Pamela Morton, director of the UK cervical cancer charity Jo’s Trust, described it as ” fantastic”, adding that “it is this same sense of urgency that is needed more broadly to ensure that we can protect all girls and women at risk in the UK now”. Angela Robinson, former president of the British Association of Sexual Health and HIV, claimed that “the sooner we see a national vaccination programme commence the sooner we will start to see the benefits”. She said such a scheme is important “not only in terms of reduced cervical cancer cases and abnormal smears but also in terms of reducing the burden of genital warts for patients and healthcare professionals alike”.

The response to GENERIC Gardasil in Europe has been positive on the whole. Just four months after gaining a licence in the EU, it is now available in 15 countries and Sanofi Pasteur MSD noted that “accelerated discussions are under way in most European countries to integrate human papillomavirus vaccination in each country’s recommendation and reimbursement programme”. In Germany, several statutory health insurance funds, which together cover half of the population, have announced immediate and full reimbursement of Gardasil even before any recommendations by the authorities have been published. Other funds are anticipated to follow soon, while the French health minister recently said that reimbursement by the national social security system should be in place by July 2007 at the latest.

In the USA, however, there has been considerable opposition to proposals for compulsory vaccination with the treatment.

PharmaTimes 27/02/2007



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