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New vaccine approved for prevention
of cervical cancer and other diseases
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[JUNE 13, 2006]
ROCKVILLE, Md. -- The U.S. Food and Drug Administration announced
on June 8 the approval of Gardasil, the first vaccine developed to
prevent cervical cancer, precancerous genital lesions and genital
warts due to human papillomavirus 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.
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"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
the U.S. Department of Health and Human Services. "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."
Human papillomavirus, or 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 it 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,
M.D., 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."
Gardasil is a recombinant vaccine (contains no live virus) that
is given as three injections over a six-month period. Immunization
with Gardasil is expected to prevent most cases of cervical cancer
due to HPV types included in the vaccine. However, females are not
protected if they have been infected with any of those HPV types
prior to vaccination, indicating the importance of immunization
before potential exposure to the virus. Also, Gardasil does not
protect against less common HPV types not included in the vaccine;
thus, routine and regular Pap screening remain critically important
to detect precancerous changes in the cervix, to allow treatment
before cervical cancer develops.
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 "This is the first vaccine licensed specifically to prevent
cervical cancer," said Jesse Goodman, M.D., M.P.H., director of
FDA's Center for Biologics Evaluation and Research. "Its rapid
approval underscores FDA's commitment to help make safe and
effective vaccines available as quickly as possible. Not only have
vaccines dramatically reduced the toll of diseases in infants and
children, like polio and measles, but they are playing an increasing
role protecting and improving the lives of adolescents and adults."
Four studies, one in the United States and three multinational,
were conducted in 21,000 women to show how well Gardasil worked in
women between the ages of 16 and 26 by giving them either the
vaccine or placebo. The results showed that in women who had not
already been infected, Gardasil was nearly 100 percent effective in
preventing precancerous cervical lesions, precancerous vaginal and
vulvar lesions, and genital warts caused by infection with the HPV
types against which the vaccine is directed. While the study period
was not long enough for cervical cancer to develop, the prevention
of these cervical precancerous lesions is believed highly likely to
result in the prevention of those cancers.
The studies also evaluated whether the vaccine can protect women
already infected with some HPV types included in the vaccine from
developing diseases related to those viruses. The results show that
the vaccine is only effective when given prior to infection.
Two studies were also performed to measure the immune response to
the vaccine among younger females, ages 9-15 years. Their immune
response was as good as that found in 16- to 26-year-olds,
indicating that the vaccine should have similar effectiveness when
used in the 9-15 age group.
The safety of the vaccine was evaluated in approximately 11,000
individuals. Most adverse experiences in study participants who
received Gardasil included mild or moderate local reactions, such as
pain or tenderness at the site of injection.
The manufacturer has agreed to conduct several studies following
licensure, including additional studies to further evaluate general
safety and long-term effectiveness. The manufacturer will also
monitor the pregnancy outcomes of women who receive Gardasil while
unknowingly pregnant. Also, the manufacturer has an ongoing study to
evaluate the safety and effectiveness of Gardasil in males.
Gardasil is manufactured by Merck & Co. Inc., of Whitehouse
Station, N.J.
For more information:
[U.S. Food and Drug Administration news release]
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