GARDASIL- THE CERVICAL CANCER VACCINE zhion JUNE 10, 2006
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NEWS UPDATE ON JUNE 8, 2006 The FDA announced the
approval of Gardasil to prevent cervical cancer, precancerous
genital lesions and genital warts due to human papillomavirus
(HPV) types 6, 11, 16 and 18. The vaccine is approved for use
in females 9-26 years of age. Gardasil was evaluated and
approved in six months under FDA's priority review process.
According to the news, the side effects or the adverse
experiences of Gardasil include mild or moderate local
reactions, such as pain or tenderness at the site of injection.
Anyway, the manufacturer has agreed to conduct several
studies to evaluate general safety and long-term effectiveness.
[s]
Human Papillomaviruses (HPV) infection is transmitted
predominately through sexual contact. However, the fact that
more than 80% of women followed over time will acquire at
least one Human Papillomaviruses infection reflects the ease of
transmission. [2] Currently, the cervical cancer victimizes
about 470,000 women a year. [3]
Human Papillomaviruses can lead to the development of
various cutaneous and mucosal lesions. Some genotypes play
a role in the cervical cancer, which is the second most common
cancer in women. Human Papillomaviruses types 16 and 18
account for 60 to 72% of all Human
Papillomaviruses-associated cervical cancers, while types 6 and
11 cause genital warts. [1] The real promise held in this area is
the availability of an apparently highly effective prophylactic
Human Papillomaviruses vaccine, targeting at least HPV 16, 18,
6, and 11. This vaccine cocktail, if it achieved 100% coverage,
could theoretically prevent 50% to 70% of invasive cervical
cancers and most genital warts. [2]
The Human Papillomaviruses major capsid protein L1
self-assembles into virus-like particles. Immunization after
parenteral vaccination with it provided very good protection
against experimental infection in different animal models. [1]
Vaccination will be required among women before initiation of
sexual contact, presumably among girls 10 to 13 years of age.
Vaccine trials have proven high short-term efficacy. It is
unclear whether the protection will remain over an individual's
lifetime without vaccine booster. [2]
HPV is also the most common sexually-transmitted infection in
the United States. The CDC estimates that about 6.2 million
Americans become infected with genital HPV each year. On
average, there are 9710 new cases of cervical cancer and 3700
deaths attributed to it in the United States each year.
NEWS
Merck said that its experimental vaccine Gardasil was 100
percent effective at preventing cervical pre-cancers and
non-invasive cervical cancers in a final-stage clinical trial. The
new vaccine may reach the market in 2006 to compete with
GlaxoSmithKline's Cervarix. Cervarix, is designed to protect
against two strains of the human papilloma virus (HPV).
These strains, called HPV-16 and HPV-18, make up just a
small proportion of the 15 forms of the virus linked to cervical
cancer. However, they are thought to account for 70 percent
of disease cases.
Merck is partnering with Sanofi-Aventis to seek first regulatory
approvals for its vaccine in Europe. [3]
THIS ARTICLE IS FOR YOUR REFERENCE ONLY. AUTHOR CANNOT GUARANTEE
ITS ACCURACY. IF YOU HAVE ANY QUESTION, PLEASE, CONSULT WITH YOUR
DOCTOR. ALL RIGHT RESERVED 2008 zhion.
REFERENCE
[1] Hantz S et al, Anti-papillomavirus vaccines and prevention of cervical
cancer: progress and prospects Presse Med. 2005 Jun 4;34(10):745-53. [2]
Gravitt PE and Jamshidi R Diagnosis and management of oncogenic cervical
human papillomavirus infection. Infect Dis Clin North Am. 2005
Jun;19(2):439-58. [3] A vaccine for cervical cancer found, Earthtimes.org, April
5, 2006 [s] FDA Licenses New Vaccine for Prevnetion of Cervical Cancer and
Other Diseases in Females Caused by Human Papillomavirus, FDA NEWS, June
8, 1996
