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CHMP backs shorter Cervarix schedule

Revised dosing could make running immunisation programmes with GSK's vaccine easier

GSKGlaxoSmithKline's human papillomavirus (HPV) vaccine Cervarix can be administered in two rather than three doses and still be effective in younger girls, according to EU advisors.

The simplified dosing regimen means that it may be easier to implement national immunisation programmes against HPV infection, which raises the risk of cervical cancer.

GSK recently reported results of a phase III trial (HPV-070) which showed that two doses of the vaccine in girls aged nine to 14 years provide an immunogenicity matching the currently licensed three-dose schedule in 15 to 25 year olds. The safety profile was also very similar when compared to the three-dose group.

Meanwhile, Merck & Co reported data in April suggesting its own HPV vaccine Gardasil could also be effective when given in a two-dose regimen in younger females.

If approved, the two-dose regimen for Cervarix will only apply to vaccination of girls aged 9-14, and the three-dose schedule will still be recommended for girls and women aged 15 years and above. Currently, the first and second doses are given one month apart, followed by a third dose at six months later, but the new schedule would skip the middle dose.

Thomas Breuer, senior vice president and lead physician at GSK's vaccines unit, said the endorsement by the Committee for Medicinal Products for Human Use (CHMP) is "another major milestone in our commitment to reducing the global burden of cervical cancer, which remains high".

Many countries are unable to implement national immunisation programmes in young adults with high coverage, he added, so having access to a simpler regimen could help expand the population that will benefit from protection.

A study of HPV vaccination in the US showed that just 30 per cent of women had received the full vaccination schedule by the age of 26, with the low uptake attributed to parent's misconceptions about HPV and reluctance by doctors to push vaccination.

Meanwhile, a study in Europe last year found wide variations between EU member states in take-up rates. Along with the three-dose regimen, parental acceptance and the high cost of Cervarix and Gardasil were also suggested as reasons for lacklustre vaccination rates in some countries.

Cervarix is indicated for the prevention of premalignant genital (cervical, vulvar and vaginal) lesions and cervical cancer causally related to certain oncogenic HPV strains. The two-dose is already approved in several countries including Guatemala, Honduras, El Salvador, Haiti, Suriname, Chile, Guyana, Nigeria and Ghana.

GSK is also looking at the possibility of simplifying the schedule even further, and earlier this month reported preliminary data showing that a single dose of the vaccine could still lead to stable anti-HPV antibody levels in the blood four years later.

Sales of Cervarix declined 44 per cent in the first nine months of the year to £127m ($207m), although the drop is skewed by comparison with the prior year which benefited from a major government vaccination programme in Japan. Gardasil sales were $1.44bn in the same period.

29th November 2013

From: Sales

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