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Health
Information
FDA Licenses
New Vaccine for Prevention of Cervical Cancer
and
Other Diseases in Females Caused by Human Papillomavirus
Rapid
Approval Marks Major Advancement in Public Health
The Food
and Drug Administration (FDA) today announced the approval
of Gardasil, the first vaccine developed 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-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,
U.S. Department of Health and Human Services (HHS).
"HHS is committed to advancing critical health measures such
as the development of new and promising vaccines to protect
and advance the health of all Americans."
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 it in the United States each year.
Worldwide, cervical cancer is the second most common cancer
in women; and is estimated to cause over 470,000 new cases
and 233,000 deaths each year.
For most women, the
body's own defense system will clear the virus and infected
women do not develop related health problems. However,
some HPV types can cause abnormal cells on the lining of the
cervix that years later can turn into cancer. Other
HPV types can cause genital warts. The vaccine is effective
against HPV types 16 and 18, which cause approximately 70
percent of cervical cancers and against HPV types 6 and 11,
which cause approximately 90 percent of genital warts.
"This vaccine is a
significant advance in the protection of women's health in
that it strikes at the infections that are the root cause
of many cervical cancers," said Andrew C. von Eschenbach,
MD, Acting Commissioner of Food and Drugs. "The development
of this vaccine is a product of extraordinary work by scientists
as well as by FDA's review teams to help facilitate the development
of very novel vaccines to address unmet medical needs.
This work has resulted in the approval of a number of new
products recently, including Gardasil, which address significant
public health needs."
Continued
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A
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 ol.
Every
woman has the right to decide if and when to become pregnant
and whether to continue a pregnancy.
- Many safe and
effective birth control methods are available today.
- Planning pregnancy
helps ensure a healthy pregnancy and a healthy baby. It
is important that a woman (and her partner) be as healthy
as possible before she becomes pregnant.
- Early and regular
prenatal care can prevent, detect, and treat many problems.
- Income should
not be an obstacle! Many options are available to cover
birth control, prenatal care, and abortion services - regardless
of income or immigration status. For information, call 311.
- The consent
of a spouse, partner, or parent is NOT required for reproductive
health services, even for teenagers under 18.
Click
here for the Women's Health Bulletin
"HIV Health Literacy and Treatment Access: Women of Color in New York City"
Read about factors that influence the health outcomes of women of color at www.acria.org |
