Pharma Times reports that FDA staff like the look of Cervarix, as well as Gardasil for men. The piece says that as GlaxoSmithKline gets ready for a review of Cervarix by advisors to the US Food and Drug Administration, agency staff have said the cervical cancer vaccine has a favourable risk/benefit profile.
Consultant Gynaecologist Adeola Olaitan comments:
Thirty years after the discovery that human papillomavirus (HPV) can cause cervical cancer, fifteen years after the start of vaccine development and two years after the approval of the four-type (6,11,16,18) HPV vaccine Gardasil®, vaccination to prevent cervical cancer and other HPV-related diseases has been widely implemented. Merck, the company that manufactures the vaccine is now seeking approval for the vaccine to be used in boys.
While the vaccine’s efficacy in women has been well established — with data showing up to 100% protection against HPV — studies of the vaccine’s use in men are just starting to appear. Initial data suggests that the vaccine is generally well tolerated in 9- to 26-year-old males.
Genital human papillomavirus is the most common sexually transmitted infection. There are more than 40 HPV types that can infect the genital areas of men and women, including the skin of the penis, vulva, and anus, and the linings of the vagina, cervix, and rectum. The types of HPV that can cause genital warts (6,11 – ‘low risk’) are not the same as the types that can cause cancer (16,18- ‘high risk’) but Gardasil prevents both low risk and high risk viruses.
Genital warts are a very infectious agent and transmission of the virus is very common. If a couple has unprotected sexual activities for years and one happens to be infected with genital warts, there’s a 75 percent chance of transmitting the virus to his/her partner.
Thus, vaccinating both men and women would reduce the prevalence of the virus that can be transmitted with hopes that there will be a benefit not only to men themselves but also their partners. .
While the potential benefits are encouraging, efficacy and safety must be considered in the approval of this vaccine in men.
The external opening of the back passage, the rectum.
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Abnormal, uncontrolled cell division resulting in a malignant tumour that may invade surrounding tissues or spread to distant parts of the body.
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Relating either to the cervix (the neck of the womb) or to the cervical vertebrae in the neck (cervical spine).
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Any neck-like structure; most commonly refers to the neck of the uterus.
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The basic unit of genetic material carried on chromosomes.
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An abbreviation for human papilloma virus, a sexually transmitted virus that can cause genital warts and may also have a role in the development of various cancers.
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Invasion by organisms that may be harmful, for example bacteria or parasites.
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A non-cancerous growth that resembles a wart.
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per vaginam
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The last part of the large intestine, where faeces are stored before being passed.
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The means of producing immunity by stimulating the formation of antibodies.
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The muscula passage, forming part of the femal reproductive system, between the cervix and the external genitalia.
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A microbe that is only able to multiply within living cells.
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Microbes that are only able to multiply within living cells.
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The external part of the female genitalia.
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A common, contagious, harmless growth that occurs on the skin or mucous membranes. Only the topmost layer of skin is affected.
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