Merck’s Gardasil Further Delayed

By Davie Barret
00:09, January 10th 2009
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Merck has developed a vaccine which is supposed to prevent cervical-cancer in women, but the use of the vaccine will be most likely approved for adult women in 2010. The vaccine Gardasil is currently approved to prevent cervical, vulvar and vaginal cancers, as well as genital warts, in females aged 9 to 26. Specialists say that the vaccine is more efficient in younger women mainly because they were not been exposed to HPV, which is transmitted sexually.

The vaccine is expensive at about $360 for the three-dose regimen, and some experts have said it's not cost-effective for older women to get vaccinated.

The FDA is currently waiting for a trial of the vaccine to be completed and the data to be presented in order to decide if the vaccine is indeed efficient in older women. Merck said it expects to submit the results by the end of this year, which means approval won't come before 2010.

Gardasil’s side effects have been described as pretty aggressive, but even so the FDA has approved its use for females aged 9 to 26. Another problem with Gardasil is that it can protect the person from the type of virus only for a limited period of time, meaning that after a certain age the risks of cervical cancer once again become reality.

Financially speaking, Merck hasn’t sold its vaccine in such large numbers as they believed. They observed that fewer than expected 9 to 26 women chose to be injected with the vaccine.
 



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