WASHINGTON, June 8 (Xinhua) -- The Food and Drug
Administration(FDA) of the United States on Thursday announced the approval of
Gardasil, the first vaccine developed to prevent cervical cancer.
The vaccine, which also prevents precancerous genital
lesions as well as genital warts due to human papilloma virus (HPV) types 6,11,
16 and 18, has also been approved for use in females aged between nine and 26.
Gardasil was evaluated and approved within six months
under FDA's priority review process -- a process for products with potential to
provide significant health benefits.
"Today is an important day for public health and for
women's health, and for our continued fight against serious life-threatening
diseases like cervical cancer," said Alex Azar, Deputy Secretary of U.S.
Department of Health and Human Services (HHS).
The HPV is the most common sexually-transmitted
infection in the United States. The Centers for Disease Control and Prevention
estimates that about 6.2 million Americans become infected with genital HPV each
year and that over half of all sexually active men and women become infected at
some time in their lives.
On average, there are 9,710 new cases of cervical
cancer and 3,700 deaths attributed to the disease in the United States each
year.
Cervical cancer, the second most common cancer in
women worldwide, is estimated to have more than 470,000 new cases and cause
233,000 deaths each year.
For most women, the body's own defense system will
clear the virus, and infected women do not develop HPV-related health problems.
However, some HPV types can cause abnormal cells on
the lining of the cervix that years later can turn into cancer. And other HPV
types can cause genital warts.
The vaccine is effective to prevent the infection of
HPV types 16 and 18, which cause approximately 70 percent of cervical cancers,
and to prevent that of HPV types 6 and 11, which cause approximately 90 percent
of genital warts.
Gardasil, manufactured by Merck and Co.,Inc., is a
recombinant vaccine (contains no live virus), which is given as three injections
over a six-month period.
The safety of the vaccine was evaluated in about
11,000 individuals. Most adverse experiences reported by the study participants
who received Gardasil are mild or moderate local reactions, such as pain or
tenderness at the site of injection. Enditem