Merck holds its breath on vaccine acceptance

The cervical cancer vaccine Gardasil may be a step closer to becoming freely available in the UAE, after drug giant Merck confirmed it had approached regional health authorities to pitch inclusion of the agent in national immunisation programmes.

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By  Healthcare Middle East Published  December 6, 2006

The cervical cancer vaccine Gardasil may be a step closer to becoming freely available in the UAE, after drug giant Merck confirmed it had approached regional health authorities to pitch inclusion of the agent in national immunisation programmes. Speaking before Gardasil’s official UAE launch, Dr Wisam Haddadin, franchise manager for Merck Sharpe & Dohme, said discussions had been held with the Dubai Department of Health and Medical Services (DoHMS), the Abu Dhabi General Authority for Health Services (GaHS) and the Health Ministry, but that cost concerns were hampering approval. “The Government are supportive of the vaccine, but the budget is a problem,” Haddadin told Healthcare Middle East. “The authorities are afraid to commit, because the public will then demand free vaccination.” Gardasil has faced repeated cost wrangles since its launch. The Australian national drug advisory committee rejected the proposed inclusion of Gardasil in its subsidised vaccination programme on financial grounds, while the UK-based NHS has also dragged its heels on the issue. All eyes are now on the UAE health authorities to see whether a positive decision will emerge and Haddadin is hopeful that the UAE, as the first Middle Eastern country to receive the vaccine, will follow America’s lead. “The US is the reference country for the UAE and the vaccine is FDA approved,” she said. “Gardasil was approved on the 8th of June, and the CDC (US Centres for Disease Control and Prevention) had it in their vaccination schedule by the 28th. “The vaccine is cost effective, compared to screening and treatment costs,” she added. Gardasil, which is already in use regionally in a number of private clinics, is recommended as a three-dose schedule for girls as young as 9, and young women up to the age of 26. Each dose costs AED 620. Without the benefit of a government-supported vaccination programme, the drug could prove prohibitively costly for those who need it most. A report from the International Agency for Research on Cancer in Lyon, France found that poor access to screening programmes could push deaths from cervical cancer to a huge one million a year by 2050, mainly in developing countries. Certainly, according to Dr Saad Aswad, associate professor of gynecology, at the UAE University and senior consultant gynecologist oncologist at Tawam Hospital, the incidence of cervical cancer in the UAE is on the rise. “What we have suggests the doubling and tripling of cases,” he said. “There are many gaps in the reporting system…(but) we have it, we see it everyday.” Screening programmes are not well established in the Middle East, particularly in rural areas. Widespread availability of the vaccine could slash the number of preventable cases, although Haddadin warns the drug is not intended to substitute screening. “We are not trying to replace screening; this should be carried out alongside screening programmes,” she said, adding that Merck is working closely alongside international charities to try and integrate the vaccine at an affordable costs for developing countries. Gardasil has battled controversy on a second front, amid accusations that vaccinating children may be perceived by young girls as a green light to engage in premarital sex. If added to the UAE’s subsidised vaccination programme, the jab is expected to become mandatory for school-age children. For more conservative families, this raises the thorny issue of parental control, but Haddadin feels physicians can play a key role in negating the problem. “It is most important the way the doctor presents it (Gardasil),” she said. “Here, patients really do trust their physicians. “How much information should you give children? You can simply say “You are getting a vaccine against cancer,” and then give more information when the child is older.” Regional data has shown that, in the case of HIV, the majority of infected women contracted the virus from their husbands, who were likely to have become infected during paid sex. With this in mind, international cancer charities have called for male vaccination against HPV, to minimise the risk of women acquiring the infection. “Yes, we can vaccinate men,” Haddadin admits. “We have data on this, but the vaccine is FDA approved, and in Europe, for women and girls only. "The FDA requires more data to approve it for men, but in Australia it is approved for both genders.” But Haddadin denies that vaccination will become a politically charged issue, suggesting that public support has suggested parents are happy to vaccinate their children. “I don’t think we have that closed a society,” Haddadin adds, pointing to regional healthcare facilities that have already added Gardasil to their schedules. “The Abu Dhabi clinics are already offering the vaccine, the French Medical Centre, the Dubai London and several paediatric centers.” With GlaxoSmithKline’s rival vaccine, Cervarix, in the pipeline, Gardasil has a limited period of time to win subsidisation and establish a dominant role in the UAE market. Cervarix is slated for introduction in 2008; with reports suggesting GSK will begin filing for approval in April next year.

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