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Human Papillomavirus (HPV)                                                                   

Overview of Gardasil

Gardasil Vaccine Effectiveness

Gardasil on the Market

Gardasil and Cervical Cancer 

Revised: 11/03/09.  Copyright © 2006 Clinical Research Associates of Tidewater.  All rights reserved.

 

 

 

 

Human Papillomavirus (HPV) is an infectious virus that is often spread by sexual activity.  It's one of the most common sexually transmitted diseases (STD) in the country, according to the Center for Disease Control, with more than 20 million men and women currently infected and another 6.2 million contracting the virus each year. About half of those with HPV are aged 15 to 24.

In the United States, about 9,710 new cases of cervical cancer are expected this year, according to the American Cancer Society, and about 3,700 women will die of the disease this year. Worldwide, cervical cancer is expected to claim 233,000 lives this year, with 470,000 new cases.

Except in very serve cases (cancer), there are usually no signs or symptoms of HPV.  A person may have the virus for several years even after the last time they have had sexual contact. Maintaining a healthy immune system can sometimes fight the infection naturally.  Although there are no treatments for the virus itself, there are treatments for the diseases HPV can cause (i.e. genital warts, cervical cancer). New vaccine called Gardasil® to prevent the virus is now available. 

 

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Overview of Gardasil

Gardasil, the new vaccine designed to help prevent cervical cancer and human papillomavirus (HPV) infection -- which causes both cervical cancer and genital warts -- is now available nationwide.

 

What is Gardasil?
Gardasil is a vaccine, licensed for use in June, 2006, by the FDA. It targets four strains of human papillomavirus (HPV) -- HPV-6, 11, 16, and 18. HPV-16 and 18 account for about 70% of all cervical cancers; HPV-6 and 11 cause about 90% of genital warts. Cervical cancer attacks the cervix, which connects the vagina to the uterus. The new vaccine is also OK'd to help prevent vaginal and vulvar pre-cancers, and genital warts, which are also associated with HPV.

Who should get the vaccine?
Gardasil is approved by the FDA for girls and women ages 9 to 26. Formal recommendations from the CDC and the American Academy of Pediatrics are in the process of being finalized. In June, the CDC's Advisory Committee on Immunization Practices (ACIP) voted to recommend that the vaccine be given routinely to girls 11 or 12 years old. The recommendation also allows for vaccination of girls beginning at age 9, as well as the vaccination of girls and women aged 13 to 26. That recommendation is being reviewed by the CDC; a final decision is expected by November. The American Academy of Pediatrics is also discussing issuing recommendations and hopes to do so by the end of November.

The vaccine is also being studied in women up to age 45, although that group may be targeted for the vaccine later. The vaccine is being studied in males, too. They can become infected with HPV, getting genital warts or passing the virus on to partners. HPV in men is associated with rare cases of penile or anal cancers.

 

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Gardasil Vaccine Effectiveness

 

How effective is the new vaccine?
Studies have shown it is 100% effective in the prevention of cervical pre-cancers and noninvasive cervical cancers caused by HPV-16 and 18 in those not already exposed to those strains, according to Merck & Co. Inc., which makes Gardasil. Merck is a WebMD sponsor.

If someone is already sexually active, will this vaccine still work?
If a person has been infected with any of the four strains the vaccine protects against, the vaccine won't provide protection against that type. But it will prevent infection from the other three.

How long is Gardasil effective?
Research suggests the vaccine lasts at least four years. Long-term results are not yet certain. The protection might last longer.

Does the vaccine actually contain the virus, or any live virus?
No. It has a virus-like particle but not the actual virus.  Clinical trial data have found it is safe.

 

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Gardasil on the Market


What does the vaccine cost, and will insurance cover it?
The "list" price is about $120 per dose, and three doses are needed. But that is the price your doctor pays to the manufacturer and does not include the cost of an office visit or other charges, so the cost to individuals could be higher. The federal Vaccines for Children Program will provide free vaccines to those under age 19 who qualify. More information on that program is on the CDC web site, www.cdc.gov. A number of insurers say they plan to cover the costs.

Is it available everywhere in the U.S.?
Supplies have been shipped nationwide, according to Merck, although your individual doctor's office or clinic may not have ordered it.

 

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Gardasil and Cervical Cancer

 

Does Gardasil protect against all cervical cancers?
No. The vaccine does protect against the leading causes of cervical cancer, but not all. However, recent reports suggest that the vaccine may give wider protection than originally thought. It may protect against other HPV strains, which cause 8% or 9% of cervical cancers, according to a report at the International Papilloma Conference in Prague in early September.

Will the new vaccine make cervical cancer screens such as the Pap test passé?
No. Screening with a Pap test is still needed, since the vaccine does not protect against all cervical cancer.

Is this the only vaccine for cervical cancer?
It is the first, although another is under study.

 

With additional reporting from Miranda Hitti.

Published Sept. 5, 2006.

SOURCES: John Bradley, MD, director, division of infectious diseases, Rady Children's Hospital San Diego; committee member, American Academy of Pediatrics Committee on Infectious Diseases. Mary Elizabeth Blake, spokeswoman, Merck & Co., Inc., Whitehouse Station, N.J. Joseph Bocchini, MD, professor of pediatrics, Louisiana State University Health Sciences Center, Shreveport; committee member, AAP Committee on Infectious Diseases. Curtis Allen, spokesman, CDC, Atlanta, Ga. News release, CDC, June 29, 2006. CDC ACIP Provisional Recommendations for the Use of Quadrivalent HPV Vaccine, June 29, 2006. HPV and HPV Vaccine, Information for Healthcare Providers, August 2006. WebMD Medical News: "Cervical Cancer Vaccine Q&A." www.webMD.com

 

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