Questions & Answers

When were the HPV vaccines licensed?
On June 8, 2006, the Food and Drug Administration (FDA) licensed the first vaccine developed to prevent cervical cancer and other diseases in females caused by certain types of genital human papillomavirus (HPV). The vaccine, Gardasil (by Merck), protects against four HPV types—6, 11, 16, 18. On October 16, 2009, a second HPV vaccine was licensed (Cervarix by GlaxoSmithKline) that protects against two types of HPV viruses—types 16 and 18. About 70% of cervical cancers are caused by HPV types 16 and 18; 90% of anogenital warts are associated with HPV types 6 and 11.

What kind of vaccine is it?
HPV vaccine is an inactivated (not live) vaccine.

How is this vaccine given?
This vaccine is given as a shot in the muscle.

Who should get this vaccine?
In June 2006, the CDC's Advisory Committee on Immunization Practices (ACIP) voted to recommend routine vaccination of girls age 11–12 years, and that the vaccine may be given to girls as young as age 9 years. The vaccine was also recommended for females age 13–26 years who have not yet received or completed the vaccine series. In October of 2009, FDA licensed Merck's Gardasil vaccine for use in males ages 9 through 26 years for the prevention of genital warts caused by HPV types 6 and 11. CDC then recommended that Gardasil vaccine could be given to males to reduce their likelihood of acquiring genital warts.

How many doses are needed and on what schedule?
The schedule for both Gardasil and Cervarix consists of three injections over a six-month period. The second dose should be given one to two months after the first dose and the third dose should be given six months after the first dose. The vaccine can be administered at the same visit as other needed vaccines.

It is best if the vaccine is given before onset of sexual activity. However, people who are sexually active also may benefit from vaccination. People who have not been infected with any vaccine HPV type would receive the full benefit of vaccination and those who already have been infected with one or more HPV types would still get protection from the vaccine types they have not acquired. HPV vaccine can be given to females who have had an abnormal Pap test or genital warts. However, the vaccine will not have any helpful effect on existing Pap test abnormalities, HPV infection, or genital warts.

Why is HPV vaccine licensed for use in people as young as 9 years of age?
This is because the vaccine is most effective in young people who have not yet acquired any of the HPV types covered by the vaccine so that they will receive the full benefits of the vaccine.

Why are HPV vaccines not licensed for adults older than 26 years?
HPV vaccines have been widely tested in people age 9 through 26 years. Research on the vaccine's safety and efficacy began later in older people. The FDA will consider licensing the vaccines for older people when there is research to show that it is safe and effective for them.

Should individuals be screened before getting vaccinated?
No. Girls/women do not need to get an HPV test or Pap test to find out if they should get the vaccine. An HPV test or a Pap test can tell that a woman may have HPV, but these tests cannot tell the specific HPV type(s) that a woman has. Even individuals with one HPV type could get protection from the other vaccine HPV types they have not yet acquired.

How effective are the HPV vaccines?
Gardasil and Cervarix are highly effective in preventing infection with types of HPV they target. Studies have shown that both Gardasil and Cervarix prevent nearly 100 percent of the precancerous cervical cell changes caused by the types of HPV targeted by the vaccine for up to 4 years after vaccination among women who were not infected at the time of vaccination.

How long does vaccine protection last? Will a booster shot be needed?
The length of immunity is usually not known when a vaccine is first introduced. So far, studies have shown people to still be protected after five years. More research is being done to find out how long protection will last, and if a booster dose will eventually be needed.

Who recommends HPV vaccine?
The Centers for Disease Control and Prevention (CDC), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP) all recommend HPV vaccination in females. The vaccine is also recommended by the American Cancer Society for use in females ages 9 through 18 years. The CDC has recommended that Gardasil vaccine could be given to males to reduce their likelihood of acquiring genital warts.

What side effects have been reported from HPV vaccine?
Mild problems may occur with HPV vaccine, including pain at the injection site, redness or swelling at injection site, mild or moderate fever, and itching at the injection site. These problems do not last long and go away on their own. Fainting has been reported among adolescents who receive HPV vaccine (and other recommended vaccines as well). It's best for the patient to sit during vaccine administration and then wait at the clinic for 15–20 minutes after getting vaccinated. Like all vaccines, HPV vaccine will be monitored for more serious or unusual side effects.

Can HPV vaccine cause HPV?
No. HPV vaccines are inactivated so they cannot cause disease-like symptoms or HPV disease.

We've heard stories in the media lately about severe reactions to HPV vaccine. Is there any substance to these  stories?
No. While serious events, including death and Guillain-Barre syndrome, have been reported among women who had recently received HPV vaccine, CDC follow-up on these reports has not found that the events occurred more frequently among vaccinees than among the general population, and has detected no pattern that would indicate an association with the vaccine. You can find complete information on this and other vaccine safety issues at www.cdc.gov/vaccinesafety.

Do women still need to get a Pap test if they've been vaccinated against HPV?
Yes! Women should continue to receive regular cervical cancer screening for three reasons. First, the vaccine does not provide protection against all types of HPV that cause cervical cancer. Second, women may not receive the full benefits of the vaccine if they do not complete the vaccine series. Third, women may not receive the full benefits of the vaccine if they receive the vaccine after they have already acquired HPV infection from one of the four types for which the vaccine is preventive.

In addition, vaccinated women should continue to practice protective sexual behaviors since the vaccine will not prevent all cases of genital warts or other sexually transmitted infections.

Does the vaccine protect against all types of HPV?
No, although there are more than 100 types of human papillomaviruses, only four (HPV 6, 11, 16, and 18) are covered in the Gardasil vaccine and only two (HPV 16 and 18) are covered in the Cervarix vaccine. HPV 16 and 18, however, are responsible for 70% of cervical cancers; HPV 6 and 11 cause approximately 90% of genital warts. Because there will be 30% of cervical cancers not prevented by the vaccine, it is important for women to continue getting regular Pap tests.

What if a person doesn't get all of the recommended three doses?
It is not yet known how much protection girls/women would get from receiving only one or two doses of the vaccine. For this reason, it is very important that individuals get all three doses of the vaccine. If there is a gap in the schedule longer than the recommended time, the series should just be continued from where it left off—there is no need to start the series over. A woman can and should complete the series even if she is older than age 26 years.

Do women whose sexual preference is women need HPV vaccine?
Yes. Eligibility for HPV vaccine is not determined by sexual preference.

Who should NOT receive HPV vaccine?
Anyone who has ever had a life-threatening allergic reaction to any component of HPV vaccine, or to a previous dose of HPV vaccine, should not get the vaccine.

Pregnant women should not get the vaccine. Although the vaccine appears to be safe for both the mother and developing baby, this issue is still being studied. Inadvertently receiving HPV vaccine during pregnancy is not a reason to consider terminating the pregnancy. Any woman who learns she was pregnant when she got the HPV vaccine is encouraged to call the HPV Vaccine in Pregnancy Registry at either (800) 986-8999 for the Gardasil vaccine or (888) 452-9622 for the Cervarix vaccine. Information gathered from this registry will help experts learn how pregnant women respond to the vaccine.Breast feeding women can safely get the vaccine.

People who are moderately or severely ill should wait until their condition improves to be vaccinated.

Is HPV vaccine covered by insurance plans?
Many health insurance plans cover recommended vaccines for children and adults. The Vaccines for Children (VFC) program provides free vaccines to children and adolescents younger than 19 years of age, who are either Medicaid-eligible, American Indian, or Alaska Native, uninsured, or receiving care in a Federally Qualified Health Clinic or Rural Health Center. This includes boys as well as girls. For adults, if you're not certain about your healthcare coverage, contact your health insurance plan for further information. If you don't have health insurance or if your plan doesn't cover this vaccine, ask your doctor or your local health department how you can obtain this vaccine.

Questions and answers about HPV disease

Technically reviewed by the Centers for Disease Control and Prevention, September 2010