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Cancer vaccine approval urged
Di Caelers
2006-01-27
The Medicines Control Council has been urged to fast-track approval of Gardasil, the first vaccine against cervical cancer.
The appeal came from the head of the South African subsidiary of Merck, the pharmaceutical company which late last year announced research results that pointed to the astonishing efficacy of the vaccine.
Cervical cancer is the deadliest malignancy among South African women,
according to the Cancer Association of South Africa, which puts it top of the
list of the five most common cancers in local women.
It is also curable if detected and treated early, and local prevention efforts
have until now focused on regular pap smears.
Human papillomavirus, or HPV, is a common virus among sexually active women and
men. Types 6 and 11 are associated with genital warts, while 70% of cervical
cancers are due to types 16 and 18 of the same virus.
While 80% of women will become infected with the virus by the age of 50, the
infection is most common in the 18 to 28 age group.
Chirfi Guindo, chief executive of Merck's local pharmaceutical arm Merck Sharpe
and Dohme, hailed Gardasil as offering hope to millions of young women at risk
of cervical cancer.
Gardasil's Phase 3 clinical trials showed 100% prevention of cervical
pre-cancers, and non-invasive cervical cancers caused by the human
papillomavirus.
The vaccine was given in three doses over six months in the study, which
involved more than 12 000 women aged 16 to 23 from 13 different countries. Half
were given Gardasil and half a dummy injection and they were monitored for two
years.
None of the women given the vaccine developed high-grade cell changes that lead
to cancer or pre-cancer, but 22 women given placebos did.
None of the women in the trial had HPV when they were enrolled.
Guindo pointed to the fact that in South Africa, between 1998 and 1999, cervical
cancer was estimated as the most common malignancy among young women aged 15 to
29.
Following news of the dramatic results of the vaccine trial, British doctors
have said it should be given to all boys and girls between the ages of nine and
11, before they start sexual activity.
According to the Cancer Association of South Africa, risk factors for cervical
cancer include having sex before the age of 15, having multiple sexual partners,
or having a partner who has multiple sexual partners.
A licence application for Gardasil was submitted to the US Food and Drug
Administration on December 1 last year, and Merck has also announced plans to
submit similar applications in the European Union and Australia early this year.
Merck is seeking priority review designation for Gardasil, and an answer is
expected in the US around the end of the month.
dic@incape.co.za
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