Here is what you need to know now about this new vaccine.
1. 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 HPV-18 account for about 70% of all cervical cancers. HPV-6 and -11 cause about 90% of genital warts. HPV is also linked to anal cancer.
2. How does HPV spread?
Sexual activity spreads the virus, a very common one. It's one of the most common sexually transmitted diseases (STDs) in the country, according to the CDC, with more than 20 million people currently infected and another 6.2 million contracting the virus each year.
About half of those with HPV are aged 15 to 24. Surveys suggest 3.7% of U.S. girls have sex by age 13, and 62.4% have had sex by the 12th grade.
3. Who should get the vaccine?
Gardasil is approved by the FDA for girls and women ages 9 to 26. The CDC and the American Academy of Pediatrics recommend that the vaccine be given routinely to girls at age 11 to 12 years old, although doctors may choose to vaccinate girls as young as 9. The CDC also recommends the vaccine for women age 13 to 26 who did not receive the vaccine at an earlier age.
However, if a girl or woman is already infected with HPV, the vaccine will not prevent that strain of HPV from causing disease. It will protect against new infections with other strains of HPV included in the vaccine.
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. Men can get HPV infections and can pass the virus to their sex partners. HPV causes genital warts and is associated with rare cases of cancer of the penis. Particularly in gay men, HPV is linked to anal cancers. Merck is currently testing Gardasil in men, including gay men.
4. What is the best way to talk to my daughter about this?
Emphasize that the primary goal is to help prevent cervical cancer. If you, as a parent, are worried this will give your child a false sense of security that she can't catch a sexually transmitted infection from sexual activity, you can also emphasize that the vaccine only protects against certain strains of HPV -- not against any of the many other types of sexually transmitted infections.
5. Does Gardasil protect against all cervical cancers?
No. The vaccine does protect against the strains of HPV most likely to cause cancer. But it does not protect against all HPV strains.
However, recent reports suggest that the vaccine may give wider protection than originally thought. There is preliminary evidence it may offer some protection against other HPV strains, which cause 8% or 9% of cervical cancers.
6. How effective is the new vaccine?
Studies have shown it is 100% effective in the prevention of cervical precancers 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.
7. 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.
8. 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.
9. Does the vaccine actually contain HPV or any live virus?
No. It has a virus-like particle, but not the actual virus.
10. Is Gardasil safe?
Clinical trial data have found it is safe.
11. What does the vaccine cost? 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. It 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.
12. 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.
13. 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.
14. Is this the only vaccine for cervical cancer?
There's a second vaccine in the works: Cervarix, from GlaxoSmithKline. Cervarix targets two HPV strains, HPV-16 and HPV-18. GSK says it plans to seek FDA approval for Cervarix by the end of the year. Early studies find that this vaccine, like Gardasil, is extremely safe and effective. GlaxoSmithKline is a WebMD sponsor.
15. How common is cervical cancer and how deadly?
The American Cancer Society predicts that in 2007, there will be about 11,150 new U.S. cases of invasive cervical cancer, and 3,670 cervical-cancer deaths.
Cervical cancer is the second most common cancer in women worldwide. There are about 500,000 new cases, and 250,000 cervical-cancer deaths each year. According to the World Health Organization, nearly 80% of cases occur in low-income countries, where cervical cancer is the most common cancer in women