HPV Vaccine for Clinicians

female doctorsGardasil® was approved by The Food and Drug Administration (FDA) in June 2006 to help prevent cervical cancer, genital warts, and certain neoplasias of the vulva and vagina caused by types 6, 11, 16, and 18 of the Human Papillomavirus (HPV). As of October 2009, the vaccine is indicated for all males and females between the ages of 9-26 as a preventive intervention and it is given in a series of three injections over a 6 month period.

In December 2014, Gardasil 9® was approved by the FDA. This vaccine helps prevent cervical, vaginal, vulvar and anal cancers and genital warts caused by five additional HPV types – 31, 33, 45, 52, and 58 – which case approximately 20% of cervical cancers that were not previously covered by the previously-approved Gardasil® vaccine. Gardasil 9® could thus potentially help prevent up to 90% of these cancers. Similar to quadrivalent Gardasil®, Gardasil 9® is given in a series of three injections over a six month period.

Cervarix® was approved by the FDA in October 2009 to prevent cervical cancer caused by HPV types 16 and 18. The vaccine is indicated for girls and young women between the ages of 10-25 and it is also given in a series of three injections over a 6 months period.

In October 2016, the CDC updated dosing recommendations for the HPV vaccine. Scientific studies have shown that “2 doses of HPV vaccine given to 9-14 year olds at least 6 months apart were as good as or better than 3 doses given to adolescents and young adults.”

We hope this guide will answer your questions so you will feel comfortable and confident while offering guidance to young women.

What is HPV?

There are more than 150 different types of Human Papillomavirus (HPV) and more than 40 are sexually transmitted. Types 6, 11, 16, and 18 are common kinds of HPV.

Types 6 & 11 cause genital warts (condyloma acuminata) around the vagina and/or anus, and types 16, 18, 31, 33, 45, 52, and 58 cause pre-cancerous changes. HPV can also cause other types of neoplasias of the vulva, vagina, and anus in females, and the anus and penis in males and the oropharynx (back of throat, tongue and/or tonsils) in both.

Who is at risk of getting HPV?

Any young woman who plans to have sexual contact in her lifetime is at risk for getting HPV. According to the latest statistics, at least 1 in every 2 sexually active young women has had a genital HPV infection.

About 6 million new cases of genital HPV are diagnosed in the United States each year. Of this number, it is estimated that 74% of them occur in 15-24 year olds.

What are the symptoms of HPV?

Some people who have been infected with the HPV virus know they have it because they have genital warts or an abnormal Pap test. However, most people do not know they have HPV because they have no symptoms. If a young woman has a type of HPV that causes cervical dysplasia, she may have changes on her Pap test. Otherwise, it is unlikely that she will be aware that she has HPV. For young women who have the type of HPV type that causes condyloma acuminata (genital warts), she may have one or more soft, moist, flesh or pink colored bumps somewhere on her genital area. She may have one wart or she could have a cluster of warts that resemble a cauliflower. The warts may be itchy but they are usually painless unless they are located in a location that becomes irritated.

How is HPV Spread?

HPV and genital warts are usually spread by direct skin-to-skin contact during vaginal, anal, or oral sex with someone who is infected with HPV. Condoms and dental dams (used as a barrier during oral sex) can help protect against HPV, but they aren’t 100% effective because warts can be found on skin that isn’t covered by a condom. The only 100% effective way to prevent exposure to HPV is to avoid sexual activity that involves any genital contact.

What is the HPV Vaccine?

Gardasil® protects young women and men against four different types of HPV. The vaccine works to prevent two types of HPV—16 and 18, which cause 70% of cervical cancer, and two other types—6 and 11, which cause 90% of genital warts. It can also prevent some vulvar, vaginal, and anal cancers. Gardasil® has also been approved by the FDA for young men and is effective in protecting against genital warts.

Gardasil 9® protects young women and men against nine different types of HPV, including the four previously covered by Gardasil® (6, 11, 16, 18) and five additional types (31, 33, 45, 52, and 58). Overall, Gardasil 9® is expected to prevent 90% of genital warts and 90% of cervical cancers. It can also prevent some vulvar, vaginal and anal cancers.

Cervarix® protects young women against two types of HPV. This vaccine works to prevent HPV-16 and 18, which cause 70% of cervical cancer. It does not protect against HPV-6 and 11.

The vaccine works best in girls/young women who have not yet come in contact with these viruses. It is recommended for all 11 and 12 year old boys and girls as a routine vaccination and for all young women 13-26 years of age who have not yet received the vaccine. It is also recommended for all young men 13-21 years of age who have not yet received the vaccine, but young men ages 22-26 years may also receive Gardasil®. Cervarix® is not approved for young men because it doesn’t prevent genital warts (6, 11).

How does the HPV vaccine work?

The vaccine is a fluid that has very small particles in it that look like HPV. After the vaccine is administered, the body starts making antibodies against certain types of HPV. Antibodies are necessary to fight HPV. The virus is not a live virus, and therefore a vaccine recipient can’t get HPV from the injection.

Is the HPV vaccine effective?

Based on research that found the HPV vaccine lowered the chances of young women getting HPV, the Food and Drug Administration (FDA) approved its use.

When tested in young women, Gardasil® was 100% effective in preventing pre-cancerous changes in the cervix caused by HPV types 16 and 18. Gardasil® was also shown to be nearly 100% effective in preventing vulvar and vaginal pre-cancers and genital warts caused by HPV types 6 and 11.

Gardasil 9® was 97% effective in preventing cervical, vaginal, vulvar and anal cancers caused by the five additional HPV types (31, 33, 45, 52, and 58). From measurements of antibody titers, Gardasil 9® appears to be just as effective as Gardasil® in preventing genital warts and cancers caused by the previously covered HPV types 6, 11, 16, and 18.

When Cervarix® was tested in girls not yet exposed to HPV types 16 and 18, it was 93% effective in preventing pre-cancerous changes in the cervix caused by HPV types 16 and 18.

Both vaccines are less effective in young women who have already come in contact with the HPV types in the vaccines. For example, if a young woman has already been infected with HPV 18, the vaccine will not protect her from this virus or treat any Pap test abnormalities. However, if a young woman has been exposed to only one type, the vaccine still gives protection against the other types.

When is the best time for a young woman to get vaccinated?

The best time for a young individual to get vaccinated is before he or she comes in contact with the HPV virus. The Advisory Committee on Immunization Practices (ACIP) recommends that all 11 and 12 year old girls and boys receive it. Health care providers can actually offer the vaccine to younger girls and boys (9 and 10 year olds) since the Food and Drug Administration (FDA) has approved and licensed Gardasil® for individuals between the ages of 9-26 and Cervarix® for girls and young women between the ages of 10-25.

How is the HPV vaccine given?

The CDC now recommends that girls and boys under the age of 15 require only 2 single doses. The first dose before the age of 15 and the second one within 6-12 months later. All others who are 15 or older should continue to receive a series of 3 single dose IM injections over a 6 month period. The first vaccine injection can be given at any time. The second injection should be given two months after the first one, and the third injection should be given six months after the initial one. It is preferred that the same HPV vaccine be used for the entire 3 shot series. If a patient is late to receive the next vaccine in the series, the vaccine doses should not be repeated.

Both vaccines come in two preparations: a single dose vial and a pre-filled syringe.

Single dose vial method: Using a 3cc sterile syringe and 1”, 22 gauge needle, withdraw 0.5ml of the vaccine. Once the syringe is prepared, use it promptly and then discard the vial. The contents of the vial should not be diluted or reconstituted. Withdraw the entire contents of the vial. It will be slightly more than 0.5ml. Expel any extra fluid as 0.5ml is the recommended dose. Administer 0.5ml of the vaccine injection in the deltoid area of the arm or in the higher antereolateral area of the thigh. Remember to discard the used syringe and needle in a sharps container.

Pre-filled Syringe method: Use the needle that comes with the kit to ensure proper fitting on the pre-filled syringe. If you must change needles, be sure to use a 1”, 22 gauge needle. See kit insert for proper assembly of the pre-filled syringe. Before administering, roll the syringe between your hands until the solution is completely mixed. It should appear white and cloudy. Administer the vaccine injection in the deltoid area of the arm or in the higher antereolateral area of the thigh. Of note – once the needle is withdrawn from the skin, and a certain amount of pressure is reached, the needle will enclose itself inside the syringe. Remember to discard the syringe in a sharps container.

Tips for Administering the HPV vaccine (Gardasil®)

  • Shake vaccine vial well – be sure that the suspension is completely mixed.
  • The HPV vaccine is always given as an intramuscular (IM) injection.
  • Never inject the vaccine intravascularly.
  • Other injection routes such as subcutaneous or intradermal administration have not been studied and thus these routes should not be used.
  • Administer the vaccine in the deltoid area of the arm or in the higher anterolateral area of the thigh.
For more information about administration of the Gardasil® vaccine, visit the Merck website to view a video or access printer-friendly directions. For more information about administration of the Cervarix® vaccine, read the pdf on the GlaxoSmithKline website.

Are there any side effects with the HPV vaccine?

More than 20,000 young women between the ages of 16-26 years of age were enrolled in five clinical studies to evaluate the efficacy of Gardasil®. Serious side effects were rare.

The most common side effects reported were

  • Pain at the injection site
  • Swelling at the injection site
  • Erythema
  • Pruritis

These discomforts are usually temporary but may last a couple of days. In very few cases, side effects may include: fever, dizziness, and/or nausea. In very few cases, side effects may include: fever, dizziness, and/or nausea. Syncope can also occur after injections, and the chance of a serious injury after falling can be lessened by having the vaccinated person sit quietly (or lie down if dizzy) for 15 minutes after vaccination.

The U.S. Department of Health and Human Services has set up a Vaccine Adverse Event Reporting System (VAERS). For more information, visit vaers.hhs.gov.

Do young people have a choice about getting the HPV vaccine?

Yes. Most health care providers will recommend the vaccine for young women between the ages of 9-26 to reduce the risk of cervical cancer.

Is there any reason why a young woman should not get the HPV vaccine?

The vaccines are not recommended if a young woman is pregnant.

Gardasil® is not recommended if a young woman has a hypersensitivity to any of the active substances or components in the vaccine which include: aluminum phosphate, sodium chloride, L-histidine. Gardasil® is produced in Saccharomyces cerevisiae (baker’s yeast) and is contraindicated in anyone with a history of immediate hypersensitivity to yeast.

Cervarix® is not recommended if a young woman has a hypersensitivity to any of the active substances or components in the vaccine which include: aluminum hydroxide, 3-O-desacyl-4’ monophosphoryl lipid A, sodium chloride, sodium dihydrogen phosphate dehydrate. Prefilled syringes of Cervarix® have latex in the rubber stopper, so should not be used in anyone with a history of an anaphylactic reaction to latex. The Cervarix® single dose vials do not contain latex.

Additionally, anyone who has experienced an allergic reaction to either the Gardasil® or Cervarix® vaccine should not receive any more doses.

Should young people get the HPV vaccine if they are already sexually active or if they don’t know if they were exposed to HPV?

Yes. All individuals should be offered the vaccine even if they have already engaged in sexual activity. It is not recommended for young women to have an HPV test before getting the vaccine.

Is the HPV vaccine safe?

The vaccine is considered safe by Food and Drug Administration (FDA) standards. It does not contain mercury or thimerosal. It is composed of protein from the outer layer of the HPV virus, not living or infectious matter.

If a young person already has HPV, will the vaccine help?

It depends on what type of HPV a young woman or man has been exposed to. The vaccine won’t cure or improve an HPV infection such as genital warts, pre-cancers (changes that happen before a cancer starts to grow), or cervical cancer. However, many people who have HPV are not infected with all types of HPV that the vaccines target. Since there is no test available to tell for sure if a young person has had just one or multiple types of the HPV virus, it is recommended that every young person gets vaccinated so he or she will be protected from the types he or she may not yet have come in contact with yet.

If a young person receives the HPV vaccine will he or she be protected for the rest of his or her life?

The vaccine is effective for at least 8 years but is likely effective even longer. It is unknown but it’s possible that at some point in the future a booster will be recommended.

Is there an HPV vaccine for young men?

In 2009, the FDA approved the use of Gardasil® in boys and young men up to the age of 26. The vaccine is likely to be particularly helpful in prevention of warts and anal neoplasia in men who have sex with men. The CDC recommends the HPV vaccine for all boys ages 11 or 12, and for males through age 21, who have not yet received all three doses of the vaccine. Cervarix® is not recommended for young men.

Gardasil 9® has also been approved for use in boys and young men ages 9 to 26.

Does insurance cover the HPV vaccine?

The vaccine is covered by most insurance plans, but it is best to tell young individuals to check directly with their family’s insurance provider. The HPV vaccine is expensive if the insurance doesn’t cover it. Each dose is about $130, or $390 for all three (3 doses are needed to complete the series and for it to be effective). The Merck Company has established the “Merck Vaccine Patient Assistance Program” to assist adults over 19 years of age who are not covered by insurance. For more information about this confidential program for eligible young adults, contact Merck at: merckhelps.com or contact the information hotline at: 1-800-293-3881.

There is a program called Vaccines for Children (VFC) that will cover the cost of the vaccine for teens under 19 years of age who are either uninsured, on Medicaid or Medicaid eligible, American Indian, or Alaskan Native. There are thousands of sites including hospitals, private and public clinics that provide VFC vaccines. For more information, visit this page on the cdc website.

What about a vaccine against the other types of HPV?

With advances in scientific research, it is likely that in the future there will be a vaccine or booster that prevents more types of HPV.

Are there any special nursing considerations?

Yes, there are some points to consider when counseling young women about the HPV vaccine.

  • Avoid administering the vaccine to pregnant females. If a girl has already had one or two shots before she became pregnant, delay the other shots until she completes her pregnancy.
  • Be sure to emphasize the vaccine will not be completely effective unless all shots are scheduled and administered as directed. (For <15 yrs old 2 doses; for >15, 3 doses with the first one at an elected time, the second one 2 months later, then the third injection 6 months after the first one.)
  • Assist young women to make their follow-up appointments and remind them of upcoming visits when possible.
  • Tell young women that the HPV vaccine does not take the place of routine gynecological care and Pap tests. They should still make their appointments for Pap tests.
  • Similar to other vaccines, not all recipients of the HPV vaccine will be protected.
  • Explain to young women that condoms offer some protection against HPV, but that avoiding sexual contact is the only way to completely protect oneself from HPV.
Having a vaccine that protects against the types of HPV that can cause cervical, vaginal, and anal cancer and warts is huge; however, young women need to be reminded that the vaccine doesn’t protect them from all types of HPV. It is critical that girls continue to see their health care provider for regular check-ups and Pap tests.