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A Guide for Nurses
Gardasil is the first vaccine approved by The Food and Drug Administration (FDA) 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). The vaccine is indicated for girls and young women 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. We hope this guide will answer your questions so you will feel comfortable offering guidance to young women.
What is HPV?
There are more than 100 different types of Human Papillomavirus (HPV) and more than 30 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 and 18 cause pre-cancerous changes. HPV can also cause other types of neoplasias of the vulva, vagina, anus in females and the anus and penis in males.
Who is at risk of getting HPV?
Any young woman who plans to be sexually active 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 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 is the new HPV vaccine that protects young women 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. 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 girls as a routine vaccination and for all young women 13-26 years of age who have not yet received the vaccine.
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 the four 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 to lower 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. The HPV vaccine 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. The vaccine is less effective in young women who have already come in contact with HPV (6, 11,16, or 18). 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 abnormalities on Pap smear. However, if a young woman has been exposed to only one type, the vaccine still gives protection against the other three types.
When is the best time for a young woman to get vaccinated?
The best time for a young woman to get vaccinated is before she comes in contact with the HPV virus. The Advisory Committee on Immunization Practices (ACIP) recommends that all 11 and 12 year old girls receive it. Health care providers can actually offer the vaccine to younger girls (9 and 10 year olds) since the Food and Drug Administration (FDA) has approved and licensed it for girls and young women between the ages of 9-26.
How is the HPV vaccine given?
The HPV vaccine is given in 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 about six months after the initial one. The vaccine comes 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)
For more information about administration of the Gardasil vaccine, visit the Merck website to view a video or access printer-friendly directions, at merckvaccines.com/vaccines/gardasil/ |
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:
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.
The U.S. Department of Health and Human Services has set up a Vaccine Adverse Event Reporting System (VAERS). For more information contact the 1-800-822-7967 or vaers.hhs.gov. |
Do young women have a choice about getting the HPV vaccine?
Some states are considering to make the HPV vaccine mandatory while other states will leave the choice to each family and teen. Even if the vaccine is mandatory, each state will have “opt-out” provisions. However, now that the vaccine is available, it is a good idea for young women to take advantage of it. Most young women will become sexually active at some point in their lives, and the vaccine is very effective in decreasing the acquisition of HPV.
Is there any reason why a young woman should not get the HPV vaccine?
The vaccine is not recommended if a young women is pregnant, has a hypersensitivity to any of the active substances or components in the vaccine which include: aluminum phosphate, sodium chloride, L-histidine. Additionally, anyone who has experienced an allergic reaction to a previous dose of the vaccine should not receive any more doses.
Should young women get the HPV vaccine if they are already sexually active or if they don’t know if they were exposed to HPV?
Yes. Girls and young women 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 woman already has HPV, will the vaccine help?
It depends on what type of HPV a young woman 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 four types of HPV that the vaccine targets. Since there is no test available to tell for sure if a young woman has had just one or all four types of the HPV virus, it is recommended that a every young women gets vaccinated so they will be protected from the types they may not yet have come in contact with yet.
If a young woman receives the HPV vaccine will she be protected for the rest of her life?
It is not known how long young women will be protected after they receive the HPV vaccine because it hasn’t been available for that long. To date, research studies have followed girls for 5 years after they received the complete series of the HPV vaccine, and they are still protected. The levels of antibodies are very high, so protection is likely to last for a long time.
Is there an HPV vaccine for young men?
The HPV vaccine has only been approved for young women between 9-26 years of age in the United States. Research is currently underway to understand how males might benefit from HPV vaccine. In the future we may be encouraging males to get vaccinated too.
Does insurance cover the HPV vaccine?
The vaccine is covered by most insurance plans but it is best to tell young women to check directly with their or their family’s insurance provider. Since the HPV vaccine is new, it is possible that some insurance companies may not cover the cost. It may be expensive if their insurance company doesn’t cover it. Each dose is about $120 (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, contact: cdc.gov/vaccines/programs/vfc/default.htm. |
What about a vaccine against the other types of HPV?
With advances in scientific research, it is possible that in the future there will be a vaccine that prevents more types of HPV. Currently, another vaccine is being developed which is designed to protect young women against HPV types 16 and 18.
Are there any special nursing considerations?
Yes, there are some points to consider when counseling young women about the HPV vaccine.
Having a vaccine that protects against the four types of HPV that can cause cervical 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 gynecologist or health care provider for regular check-ups and Pap tests. |
Resources
Centers for Disease Control and Prevention (CDC)
1-800-232-4636 (1-800-CDC-INFO)
Centers for Disease Control and Prevention's Vaccines for Children Program
The Vaccine Adverse Event Reporting System (VAERS) Web site
Updated: 7/26/2007
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