HPV Vaccination is Cancer Prevention - EverThrive Illinois

HPV Vaccination is Cancer Prevention

Resource Toolkit for School Based Health Centers

HPV Vaccination is Cancer Prevention Resource Toolkit for School Based Health Centers

Created by:

Publications, journal articles, etc. produced under a CDC grant support project must bear an acknowledgment and disclaimer, and appropriate, such as: “This publication was supported by Grant Number 3H23IP000722-02S1 from the Centers for Disease Control and Prevention (CDC). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of CDC.”

HPV Facts & Highlights

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HPV Talking Points

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Vaccine Specific Recommendations

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Vaccines for Children (VFC)

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Vaccine Information for Parents

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Standing Orders for Vaccines

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HPV CANCER PREVENTION 20

min.

That’s 1 person every 20 minutes of every day, all year long.

HPV VACCINE IS RECOMMENDED AT THE SAME TIME AS OTHER TEEN VACCINES

Preteens need three vaccines at 11 or 12. They protect against whooping cough, cancers caused by HPV, and meningitis.

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Tdap Vaccine

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Meningococcal Vaccine

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Flu Vaccine

63 - 64

Immunization Schedule for Children 7 - 18 Years Old

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Page(s) Posters (11” x 17”)

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Most of these cancers can be prevented by HPV vaccine.

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Understanding How Vaccines Work

HPV is Cancer Prevention - Boy Swimming Vaccine Awareness Calendar l HPV is Cancer Prevention - Girl l HPV is Cancer Prevention - Boy Playing Soccer l Meningitis - Dad and Son (English) l Meningitis - Dad and Son (Spanish) l HPV is Cancer Prevention Infographic

HPV vaccine protects against HPV types that most commonly cause anal, cervical, oropharyngeal, penile, vaginal, and vulvar cancers. Every year in the U.S., 27,000 people get cancer caused by HPV.

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HPV VACCINE IS CANCER PREVENTION

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HPV Preteen & Teen Factsheets

Provider Background & Additional Resources

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Vaccine Information for Parents

Provider-Parent Sample Discussion

Posters & HANDOUTS

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your es for Vaccin year old: 2 11-1 ap Td   HPV gococcal in  Men

HPV VACCINE IS BEST AT 11-12 YEARS 10 11 12 13 14 15 16 17 18 19

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While there is very little risk of exposure to HPV before age 13, the risk of exposure increases thereafter.

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Parents and healthcare professionals are the key to protecting adolescents from HPV cancers.

VACCINATE YOUR 11-12 YEAR OLDS. www.cdc.gov/vaccines/teens Distributed by:

U.S. Department of Health and Human Services Centers for Disease Control and Prevention NCIRDig406 | 07.23.2014

HPV Vaccine - A Guide for Young Adults

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Protect yourself from HPV...

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Online Resources

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resources for adolescents

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Preteens have a higher immune response to HPV vaccine than older teens. 9

Provider Background and Additional Resources

PROVIDER SAMPLES:

#1

Your child needs three shots today: meningococcal vaccine, HPV vaccine* and Tdap vaccine.

You child will get three shots today that will protect him/her from many cancers caused by HPV, as well as to prevent tetanus, diphtheria, pertussis (whooping cough), and meningitis.


HPV Vaccination is Cancer Prevention Provider-Parent Sample Discussion

#2

*Note: Parents tend to question the HPV vaccine less often if it is mentioned in the middle of other vaccines.

PROVIDER FOLLOW-UP SAMPLES:

#1

The HPV vaccine is given in three shots over a 6-month period. It is important to receive all three shots for the best protection. Please make your next appointments on your way out.

The HPV vaccine is a three-dose series given over a 6 month period. Your next shot is due in two months. Let’s put a reminder in your phone right now.

#2

The information in the following section of this toolkit provides further information related to the provider recommendation and talking with parents about the HPV vaccine. Additionally, you may want to listen to “Recommending the HPV Vaccine Successfully,” a 6:36 minute video of Anne Schuchat, MD, Assistant Surgeon General, United States Public Health Service, Director National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention. The video can be found online at www.medscape.com, and is also included on the flash drive of this toolkit.

Please visit http://everthriveil.org/resources/hpv-toolkit-school-health-centers for updates on this toolkit. | PAGE 5


HPV Vaccination is Cancer Prevention Facts and Highlights Remember, the health care provider’s recommendation to vaccinate is the single most influential factor in determining whether a parent gets their child vaccinated.

HPV Facts and Highlights HPV strains 6 and 11 account for 90% of genital warts HPV strains 16, 18, 31, 33, 45, 52 and 58 account for 90% of cervical cancer HPV strains 16 ,18, 31, 33, 45, 52 and 58 cause 90%-95% anal cancers HPV-associated oropharyngeal cancers in males are a growing problem. Prevalence of this cancer increased from 16.3% (1984-89) to 71.7% (2000-04) in boys In addition to the personal and emotional stress it causes, HPV-associated disease and screening costs over $8 billion annually in the United States

HPV Vaccination HPV vaccine has been available since 2006. No safety concerns have been found in female or male vaccine recipients HPV vaccination is MOST effective when given at ages 11 to 12 The highest antibody level response from HPV vaccination occur in preteens 11 to 12 year-olds, as compared to 16 year-olds HPV vaccine should be administered as 3 doses given over 6 months (0, 1-2, 6 months) Missed opportunities to vaccinate are sadly common – 78% of teen girls vaccinated for Tdap and MCV4 who were eligible to receive HPV vaccination were not vaccinated Several studies have shown that HPV vaccination does NOT increase sexual activity or lower the age of sexual debut HPV vaccination does not eliminate the necessity for girls to continue to undergo recommended cervical cancer screening later in life

Impact of HPV Vaccination 77% reduction in HPV strains 6, 11, 16 and 18 in adolescent girls in Australia within 3 years of vaccine introduction (3-dose vaccination rate of 70%)

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Tips and Time-savers for Talking with Parents about HPV Vaccine Recommend the HPV vaccine series the same way you recommend the other adolescent vaccines. For example, you can say “Your child needs these shots today,” and name all of the vaccines recommended for the child’s age. Parents may be interested in vaccinating, yet still have questions. Taking the time to listen to parents’ questions helps you save time and give an effective response. CDC research shows these straightforward messages work with parents when discussing HPV vaccine—and are easy for you or your staff to deliver.

CDC RESEARCH SHoWS:

The “HPV vaccine is cancer prevention” message resonates strongly with parents. In addition, studies show that a strong recommendation from you is the single best predictor of vaccination.

Try saying:

HPV vaccine is very important because it prevents cancer. I want your child to be protected from cancer. That’s why I’m recommending that your daughter/son receive the first dose of HPV vaccine today.

CDC RESEARCH SHoWS: Try saying:

Disease prevalence is not understood, and parents are unclear about what the vaccine actually protects against.

Parents want a concrete reason to understand the recommendation that 11–12 year olds receive HPV vaccine. We’re vaccinating today so your child will have the best protection possible long before the start of any kind of sexual activity. We vaccinate people well before they are exposed to an infection, as is the case with measles and the other recommended childhood vaccines. Similarly, we want to vaccinate children well before they get exposed to HPV.


Parents may be concerned that vaccinating may be perceived by the child as permission to have sex.


Parents might believe their child won’t be exposed to HPV because they aren’t sexually active or may not be for a long time.

Research has shown that getting the HPV vaccine does not make kids more likely to be sexually active or start having sex at a younger age.

HPV is so common that almost everyone will be infected at some point. It is estimated that 79 million Americans are currently infected with 14 million new HPV infections each year. Most people infected will never know. So even if your son/daughter waits until marriage to have sex, or only has one partner in the future, he/she could still be exposed if their partner has been exposed.


Emphasizing your personal belief in the importance of HPV vaccine helps parents feel secure in their decision.


Understanding that the side effects are minor and emphasizing the extensive research that vaccines must undergo can help parents feel reassured.


Parents want to know that HPV vaccine is effective.


I strongly believe in the importance of this cancer-preventing vaccine, and I have given HPV vaccine to my son/daughter/grandchild/ niece/nephew/friend’s children. Experts (like the American Academy of Pediatrics, cancer doctors, and the CDC) also agree that this vaccine is very important for your child.

HPV vaccine has been carefully studied by medical and scientific experts. HPV vaccine has been shown to be very effective and very safe. Like other shots, most side effects are mild, primarily pain or redness in the arm. This should go away quickly, and HPV vaccine has not been associated with any long-term side effects. Since 2006, about 57 million doses of HPV vaccine have been distributed in the U.S., and in the years of HPV vaccine safety studies and monitoring, no serious safety concerns have been identified.

In clinical trials of boys and girls, the vaccine was shown to be extremely effective. In addition, studies in the U.S. and other countries that have introduced HPV vaccine have shown a significant reduction in infections caused by the HPV types targeted by the vaccine. Many parents do not know that the full vaccine series requires 3 shots. Your reminder will help them to complete the series. I want to make sure that your son/daughter receives all 3 shots of HPV vaccine to give them the best possible protection from cancer caused by HPV. Please make sure to make appointments on the way out, and put those appointments on your calendar before you leave the office today!

www.cdc.gov/vaccines/teens | [email protected]

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HPV can cause cancers of the cervix, vagina, and vulva in women, cancer of the penis in men, and cancers of the anus and the mouth or throat in both women and men. There are about 26,000 of these cancers each year—and most could be prevented with HPV vaccine. There are also many more precancerous conditions requiring treatment that can have lasting effects.

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Strongly recommend all routinely recommended adolescent vaccines. Many parents and adolescents are not aware that vaccine preventable diseases affect adolescents Parents and patients are more likely to accept vaccines when healthcare providers strongly recommend them CDC, AAP, AAFP and ACOG recommend MCV, Tdap, and HPV vaccines routinely HPV vaccine is equally as important as the MCV and Tdap vaccines Emphasize vaccine safety and efficacy


Human Papillomavirus Vaccine (HPV) Recommendations and Talking Points

Use every encounter to evaluate immunization status and administer missing immunizations Adolescents seek healthcare infrequently Use pictures of vaccine preventable diseases and their effects to communicate the importance with adolescents

Establish reminder systems and after-hour/weekend vaccination-only visits to make it easier for adolescent patients to complete multi-dose vaccine series Paper, phone and electronic messages (text messages) can be effective in reminding patients for needed vaccines Increasing access to vaccines can improve coverage levels

We would like you to introduce all recommended adolescent vaccines as a single straightforward vaccination recommendation, similar to how you might recommend infant vaccines to a parent. At the end of an 11 year old clinic visit, “Today Miraya is due for three routine vaccines which include meningitis vaccine; Tdap which is tetanus, diphtheria and whooping cough; and HPV which is Human Papillomavirus vaccine. The nurse will be right in to administer those vaccines and I look forward to seeing you next year.”

This brief statement is modeled after how infant vaccines are presented to parents and avoids the parent sensing that adolescent vaccines recommendations are different (less important, questionable, etc) because the doctors talks about them differently than infant vaccines. We are not encouraging you to avoid discussing adolescent vaccines, rather we are encouraging providers to allow parents who desire more information to initiate the discussion. If parents are undecided about the HPV vaccine the following HPV-focused talking points may be helpful.

Talking points, if needed, for providers about HPV vaccine: Has anyone you care about had cancer? HPV can cause a number of cancers in men and women including cervical and throat cancer. HPV vaccine can reduce the chance of your son/daughter having a cancer experience. HPV vaccine has been shown to be very effective in preventing HPV-related disease and IS as safe as all the other vaccines we give to children. I recommend (stress “I”) HPV vaccination for all girls and boys starting at age 11 years. Girls and boys should begin the series at 11 -12 years of age so they get all 3 doses (shots) long before any sexual activity begins. HPV infection can occur in the first sexual contact with another person and the vaccine produces a stronger immune response when given at a younger age.

Source: Chicago Department of Public Health | PAGE 11


HPV Vaccination is Cancer Prevention Vaccine Specific Recommendations Human Papillomavirus (HPV) Vaccine HPV can cause cervical cancer in women. HPV is also associated with several less common cancers, such as vaginal and vulvar cancers in women, and anal and oropharyngeal (back of the throat, including base of tongue and tonsils) cancers in both men and women. HPV can also cause genital warts and warts in the throat. Some of the health problems caused by HPV can be treated, but there is no cure for HPV infection.

Routine HPV Vaccine Schedule: HPV vaccine may be given at the same time as other vaccines. Bivalent HPV vaccine is recommended for girls and quadrivalent HPV and 9v HPV vaccine is recommended for girls and boys 11 or 12 years of age. It may be given starting at age 9.

Catch-up Vaccine Schedule: Bivalent HPV vaccine is recommended for females 13-26 years old who have not completed the 3-dose series. Quadrivalent HPV vaccine is recommended for the following people who have not completed the 3-dose series: Females 13 through 26 years of age, Males 13 through 21 years of age. It is recommended for men through age 26 who have sex with men or whose immune system is weakened because of HIV infection, other illness, or medications. The vaccine may be given to men 22 through 26 years of age who have not completed the 3-dose series. 9-valent HPV vaccine is recommended for the following people who have not completed the 3-dose series: females aged 13 through 26 years and males aged 13 through 21 years not vaccinated previously. Vaccination is also recommended through age 26 years for men who have sex with men and for immunocompromised persons (including those with HIV infection) if not vaccinated previously. For more information on 9vHPV, please visit CDC’s website: http://www.cdc.gov/hpv/downloads/9vHPV-guidance.pdf

Meningococcal Conjugate Vaccine (MCV) The vaccine prevents meningococcal infections which are uncommon but very serious infections that affect adolescents and young adults. ACIP recommends the vaccine at 11-12 years of age with a booster at 16-18 years of age. Complications of meningococcal disease can lead to amputation of limbs, brain damage, loss of hearing and even death. Proof of vaccination will be required for school entry in the 2015-16 school year: 1) Students entering sixth grade will be required to show proof of one (1) meningococcal conjugate vaccination (MCV4) given on or after 10 years of age. 2) All twelfth graders will need to show proof of receiving two doses unless the first dose was administered after 16 years of age.

Pertussis Vaccine (Tdap) In 2012, record numbers of pertussis cases were reported nationally, in Illinois and in Chicago. Infants are at greatest risk for hospitalization or death from pertussis and adolescents often spread pertussis to the infants with whom they live and for whom they care. An adolescent infected with pertussis can be sick for a long time and miss many days of school. All 6th through 12th grade students are required to show proof of having received a single dose of Tdap. There is no minimum interval between Td and Tdap.

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HPV Vaccination is Cancer Prevention Vaccine Specific Recommendations Chickenpox Vaccine (Varicella) Adolescents are at increased risk for severe disease and complications from Varicella (chickenpox) infections. Adolescents who have not had chickenpox disease need 2 doses of the vaccine separated by 3 months (if given before 13 years of age) or by 1 month (if given at 13 years or older) to be protected. Documentation of a second dose of varicella vaccine is required for entry into Kindergarten, 6th and 9th grade.

Measles, Mumps, Rubella Vaccine (MMR) The first dose must be administered on or after the 1st birthday. The second dose must be administered at least 28 days after the first dose. Providers should re-administer invalid doses. Two doses of MMR vaccine are required for entry into kindergarten through 12th grades.

Hepatitis B Vaccine (HBV) Review the immunization record’s intervals between HBV doses to assure that all doses are valid. The Interval between dose 1 and 2 is 4 weeks, dose 2 and 3 is 8 weeks and dose 1 and 3 is 16 weeks. The minimum age for the 3rd dose is 24 weeks. Three doses of hepatitis B vaccine are required for entry to kindergarten through 12th grades.

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What is VFC? It is a federal government program that grants children access to vaccines who may otherwise not have such access. The HPV vaccine is one of many vaccines covered by this program. Who can be part of the program? Children through 18 years of age are eligible for VFC if they meet one of


Vaccines for Children (VFC)

the following criteria:

Medicaid eligible: A child who is eligible for the Medicaid program. (For the purposes of the VFC program, the terms “Medicaid-eligible” and “Medicaidenrolled” are equivalent and refer to children who have health insurance covered by a state Medicaid program) Uninsured: A child who has no health insurance coverage American Indian or Alaska Native: As defined by the Indian Health Care Improvement Act (25 U.S.C. 1603)

Underinsured: Their providers do not cover the vaccine or the insurance has a fixed dollar limit for the vaccine which has been reached. (Note: Children whose health insurance covers the cost of vaccinations are not eligible for VFC vaccines, even when a claim for the cost of the vaccine and its administration would be denied for payment by the insurance carrier because the plan’s deductible had not been met). Where you can get the vaccine? You can find the vaccine: At any enrolled VFC Program provider (private doctors or clinics, hospitals, public clinics, community clinics, schools based health centers…etc.) Under-insured patients (whose private health insurance does not cover the vaccine) can only be vaccinated with VFC vaccines at Federally Qualified Health Centers (FQHCs), Rural Health Centers (RHCs), or a Local Public Health Department

What is an FQHC? An FQHC is a health center that is designated by the Bureau of Primary Health Care (BPHC) of the Health Resources and Services Administration (HRSA) to provide health care to a medically underserved population.

What is an RHC? An RHC is a clinic located in a Health Professional Shortage Area, a Medically Underserved Area, or a Governor-Designated Shortage Area. RHCs are required to be staffed by physician assistants, nurse practitioners, or certified nurse midwives at least half of the time that the clinic is open.

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California Immunization Coalition


Talking with Parents About Vaccine Safety

A few tips on how to start the discussion Parents and patients are exposed to a wide range of viewpoints on vaccines and vaccine safety. More than ever before, they have questions—and often come in with concerns they’ve learned from friends, discussion groups, TV or on the Internet.

1. Take time to listen. Don’t rush to judge or dismiss them. Many parents want to participate in making an informed decision. Try to address their specific concerns. If necessary, suggest a special consultation appointment to give you extra time.

2. Validate their concerns. It’s a parent’s top job to worry about their children. It’s a provider’s role to help them understand what to worry about regarding health and safety. Even parents who understand the value of immunizations may appreciate some reassurance.

3. Use a “heart and head” approach. Statistics and scientific evidence do not resonate with everyone. You are more likely to reach parents at an emotional level by sharing personal anecdotes of patients with preventable diseases or stories from your family. Personal stories can be powerful motivators.

4. Balance risks and benefits. Help parents understand that not vaccinating is far riskier than vaccinating. Personalizing vaccine preventable diseases as “real threats”, not abstract concepts, or things of the past, can help parents appreciate that disease is more worrisome than possible reactions.

1

California Immunization Coalition (CIC) — IMM-915 Sept. 2008

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Talking with Parents About Vaccine Safety California Immunization Coalition

5. Be flexible. Work with your patients, not against them. Some parents or patients have already made up their minds and you are unlikely to influence those with strong opinions. If the parent requests a reduction or delay in the recommended schedule, you may wish to discuss the risks of waiting

6. Direct them to reliable resources. Research can be an empowering experience for parents. But the volume of information (and misinformation) can be daunting. By connecting parents with credible sources, you can help lessen confusion about conflicting messages they may read about vaccines. Offer them our CIC

Vaccine Safety 10 Facts for Parents fact sheet or you can refer them to these trusted websites.

American Academy of Pediatrics ww w.aap.org/immunization

National Network for Immunization www.immunizationinfo.org www.immunizationinfo.org

www.fda.gov/CBER/vaccine/thimerosal.htm

Parents of Kids with That? Infectious Diseases Do Vaccines Cause (Book) http://www.pkids.org/ www.i4ph.org

Evaluating Health Information on the Web

Parents of Kids with Infectious Diseases

www.immunizationinfo.org/parents/evaluatingWeb.cfm

www.pkids.org

Thimerosal FAQs

The California Immunization Coalition (CIC) is a non-profit, public-private partnership dedicated to achieving and maintaining full immunization protection to promote health and prevent serious illness across the life span.

California Immunization Coalition 909 12th Street, Suite 200 Sacramento, CA 95814 (916 ) 447-7063 ext.333 www.immunizeCA.org 2

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California Immunization Coalition

(CIC ) — IMM-915 Sept. 2008

Immunization coverage rates for adolescents are much lower than they are for younger children. To help your practice increase immunization coverage in adolescents, consider implementing one or more of the strategies below.


AAP Immunization Resources Adolescent Immunizations: Strategies for Increasing Coverage Rates

1. Patient Reminder-Recall Immunization reminder-recall systems are cost-effective methods to identify and notify families whose children are due soon for immunizations (reminder) or are already behind (recall). Reminder and recall systems are powerful ways to ensure optimal vaccination rates. Staff must first pull a list containing names and contact information of patients who are due or overdue for immunizations prior to attempting contact. Many state immunization information systems (IIS) and electronic health records (EHRs) can run such reports easily – if immunization records and family contact information is updated at every visit. Building those practices into patient flow is key. Methods to remind or recall families include: • Phone calls by office staff Calls placed by office staff tend to be more effective than auto-dialer calls, but often cost more. • Auto-dialers Auto-dialers automatically dial phone numbers and either play a recorded message or connect the call to a live person. Such systems also can be used for appointment reminders. • Mail reminder cards or letters (snail mail) Again, your IIS or EHR may print these for you. Another approach is to have the family fill out the reminder card for the next visit (e.g., dose 2 or 3 of HPV vaccine) when in your office. • Text messages You may want to get families to opt-in for text messages during a visit so your office can send text message reminders to both parents and adolescents. While parents/guardians need to consent for the vaccine, it is useful to include adolescents in the discussion of their own care. • Patient Portals Many EHR systems come with a patient portal option. Practices can use this feature to send e-mails to patients or parents prompting them to check their patient portal, which will remind them of vaccinations that are due. For more information, visit: https://www.aap.org/en-us/advocacy-and-policy/aap-health-initiatives/immunization/Pages/reminder-recall-systems.aspx http://www2.aap.org/immunization/pediatricians/pdf/ReminderRecall.pdf The following is a list of some auto-dialer vendors. Please note that the AAP cannot endorse or recommend specific products or brands. This is only meant to aid you in your selection. Auto-dialer Call-em-all Call Fire Televox Voicent

Website https://www.call-em-all.com/ http://www.callfire.com http://www.televox.com/appointment-reminders/ http://www.voicent.com/autodialers.php

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AAP Immunization Resources Adolescent Immunizations: Strategies for Increasing Coverage Rates 2. Provider Prompts or Standing Orders Provider prompts usually consist of electronic prompts in EHRs or notes in charts. Now, most EHR provider prompts are automatic pop-up alerts that notify the viewer that the patient is due/overdue for an immunization(s). Other EHR provider prompts may show up as a “to-do” task, even if the patient is not scheduled that day for an appointment. Many EHRs have provider prompts pre-installed that can be customized in the office. Standing orders for immunizations include office policies, procedures, and orders to provide recommended immunizations to patients. For example, a standing order might be in place to instruct health care personnel (as allowed by the state) to give a specific vaccine to all patients for whom the vaccine is recommended based on the harmonized immunization schedule. Standing orders should include procedures for vaccinating eligible patients and contraindications. To access sample standing orders for vaccines, visit: http://www.immunize.org/standing-orders/.

3. Strong Provider Recommendation Studies have shown that parents trust their pediatrician’s guidance 1. Be sure to give a strong recommendation for all vaccines on the current immunization schedule. It is important to state that you recommend all vaccines on the schedule and not merely mention that they are available. For example, some providers may shy away from discussing the HPV vaccine. It is especially important to strongly recommend HPV vaccine, as parents often have more questions about it.

4. Include All Recommended Vaccinations at Every Visit It is important to vaccinate whenever possible, because you don’t know when a patient will be back in your office. Use sick-child and chronic care visits as a time to immunize. Be sure to check what vaccinations, if any, are due every time a patient is in the office. Always screen for contraindications. Most vaccines can be given even if the child has a mild illness. 2

5. Provider Feedback Providers change their behavior (e.g., clinical practices) based on feedback that they are different from those of their peers. Consider running an immunization rate report through your EHR or perform a chart audit to determine the percentage of your patients that are up-to-date on immunizations. Benchmark this data against yourself annually. You can also benchmark this data against the national and state (or city) data from the National Immunization Survey. 1

Freed GL, Clark SJ, Butchart AT, Singer DC, and Davis MM. Sources and Perceived Credibility of Vaccine-Safety Information for Parents. 2011. Pediatrics, 127, 1, Supplement 107-112. 2 CDC. Chart of Contraindications and Precautions to Commonly Used Vaccines. 2011. Accessed on April 12, 2013 at: http://www.cdc.gov/vaccines/recs/vac-admin/contraindications-vacc.htm.

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6. Find an Immunization Champion in Your Practice An immunization champion can serve as a steward and advocate of immunizations in your practice. This role can be filled by any clinical provider. Being the immunization champion should be written into that job description and that provider should have time devoted to perform those tasks. Offices should cross-train staff and appoint a different person to fill-in and complete these duties in case the immunization champion is unavailable. It is also suggested, if the immunization champion is not a physician, that a physician provides oversight to the immunization champion. Since a physician is more likely to have a financial stake in the practice, he/she may ensure that vaccine-related tasks are handled appropriately.


AAP Immunization Resources Adolescent Immunizations: Strategies for Increasing Coverage Rates

7. Educate Patients and Their Parents Educate parents and patients about each recommended vaccine and the disease it prevents. Let parents know that vaccines are safe and effective, and that not vaccinating could put their children at risk for very serious diseases. Take every opportunity to educate parents and patients. Let them know at each visit what vaccines they can expect at their next health supervision appointment and provide handouts on these vaccines and diseases. This allows parents time to consider their questions, find answers, and discuss their most serious concerns with their pediatrician. For more resources on communicating with parents, visit: AAP Risk Communication Videos: http://www2.aap.org/immunization/pediatricians/riskcommunicationvideos.html AAP Adolescent Immunization: Common Concerns Addressed https://www.aap.org/en-us/Documents/immunization_common_concerns_addressed.pdf http://www2.aap.org/immunization/families/faq/AdolescentIZCommonConcerns.pdf AAP Communication with Families Web page: http://www2.aap.org/immunization/pediatricians/communicating.html CDC Provider Resources for Immunization Conversations with Parents http://www.cdc.gov/vaccines/hcp/patient-ed/conversations/index.html

8. Address Costs Vaccinations can be costly, and some families may believe they cannot afford to immunize their children. The Affordable Care Act (ACA) now requires insurance companies to cover the costs of receiving all recommended vaccines, which includes those for teens. If an insurance plan has been unchanged since March 23, 2010, it may be “grandfathered” and may not have to abide by all of the new rules under the ACA. If this is the case, the insurance plan may require your patient’s family to pay co-insurance (a portion of the vaccination cost) or to meet their deductible before paying for vaccination. Speak with parents about options for paying this portion of vaccine costs.

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AAP Immunization Resources Adolescent Immunizations: Strategies for Increasing Coverage Rates If a patient does not have health insurance, has Medicaid, has insurance that does not cover vaccines, or is American Indian or Alaskan Native, he/she qualifies to receive vaccines at no cost through the Vaccines for Children (VFC) Program. If you are not a VFC provider, consider becoming one by contacting your state VFC office. Contact information is available at: http://www.cdc.gov/vaccines/programs/vfc/contacts.html. In the meantime, suggest that eligible children receive vaccines at the local health department. Direct parents to learn more about the VFC program at http://www.cdc.gov/vaccines/programs/vfc/parents/qa-detailed.html.

9.

Hold Vaccine Clinics at Hours that are Convenient for Families

Holding vaccination clinics with special hours (evening or Saturday) at your practice allows for more opportunities for busy adolescents and their parents to access vaccination services. This has been proven to work especially well for influenza vaccine. While other recommended vaccines, such as Tdap, HPV, and meningococcal should be given during the 11 or 12 year old well-child care visit when parents will be given the opportunity to discuss the vaccines - shorter vaccination visits for subsequent doses of HPV and influenza may be more convenient.

More Resources for Your Pediatric Practice AAP Quality Improvement page page AAPImmunization Immunization Practice Management http://www2.aap.org/immunization/pediatricians/practicemanagement.html https://www.aap.org/en-us/Documents/immunization_common_concerns_addressed.pdf AAP Immunization Adolescents page http://www2.aap.org/immunization/pediatricians/adolescents.html AAP Immunization Quality Improvement page http://www2.aap.org/immunization/pediatricians/qualityimprovement.html

Last updated: 7/2013

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Morbidity and Mortality Weekly Report

Use of 9-Valent Human Papillomavirus (HPV) Vaccine: Updated HPV Vaccination Recommendations of the Advisory Committee on Immunization Practices Emiko Petrosky, MD1,2, Joseph A. Bocchini Jr, MD3, Susan Hariri, PhD2, Harrell Chesson, PhD2, C. Robinette Curtis, MD4, Mona Saraiya, MD5, Elizabeth R. Unger, PhD, MD6, Lauri E. Markowitz, MD2 (Author affiliations at end of text)

During its February 2015 meeting, the Advisory Committee on Immunization Practices (ACIP) recommended 9-valent human papillomavirus (HPV) vaccine (9vHPV) (Gardasil 9, Merck and Co., Inc.) as one of three HPV vaccines that can be used for routine vaccination (Table 1). HPV vaccine is recommended for routine vaccination at age 11 or 12 years (1). ACIP also recommends vaccination for females aged 13 through 26 years and males aged 13 through 21 years not vaccinated previously. Vaccination is also recommended through age 26 years for men who have sex with men and for immunocompromised persons (including those with HIV infection) if not vaccinated previously (1). 9vHPV is a noninfectious, virus-like particle (VLP) vaccine. Similar to quadrivalent HPV vaccine (4vHPV), 9vHPV contains HPV 6, 11, 16, and 18 VLPs. In addition, 9vHPV contains HPV 31, 33, 45, 52, and 58 VLPs (2). 9vHPV was approved by the Food and Drug Administration (FDA) on December 10, 2014, for use in females aged 9 through 26 years and males aged 9 through 15 years (3). For these recommendations, ACIP reviewed additional data on 9vHPV in males aged 16 through 26 years (4). 9vHPV and 4vHPV are licensed for use in females and males. Bivalent HPV vaccine Recommendations for routine use of vaccines in children, adolescents and adults are developed by the Advisory Committee on Immunization Practices (ACIP). ACIP is chartered as a federal advisory committee to provide expert external advice and guidance to the Director of the Centers for Disease Control and Prevention (CDC) on use of vaccines and related agents for the control of vaccine-preventable diseases in the civilian population of the United States. Recommendations for routine use of vaccines in children and adolescents are harmonized to the greatest extent possible with recommendations made by the American Academy of Pediatrics (AAP), the American Academy of Family Physicians (AAFP), and the American College of Obstetricians and Gynecologists (ACOG). Recommendations for routine use of vaccines in adults are harmonized with recommendations of AAFP, ACOG, and the American College of Physicians (ACP). ACIP recommendations approved by the CDC Director become agency guidelines on the date published in the Morbidity and Mortality Weekly Report (MMWR). Additional information about ACIP is available at http://www.cdc.gov/vaccines/acip/.

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(2vHPV), which contains HPV 16, 18 VLPs, is licensed for use in females (1). This report summarizes evidence considered by ACIP in recommending 9vHPV as one of three HPV vaccines that can be used for vaccination and provides recommendations for vaccine use.

Methods From October 2013 to February 2015, the ACIP HPV Vaccine Work Group reviewed clinical trial data assessing the efficacy, immunogenicity, and safety of 9vHPV, modeling data on cost-effectiveness of 9vHPV, and data on burden of type-specific HPV-associated disease in the United States. Summaries of reviewed evidence and Work Group discussions were presented to ACIP before recommendations were proposed. Recommendations were approved by ACIP in February 2015. Evidence supporting 9vHPV use was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework (5) and determined to be type 2 (moderate level of evidence) among females and 3 (low level of evidence) among males; the recommendation was categorized as a Category A recommendation (for all persons in an age- or risk-factor–based group) (6).

HPV-Associated Disease HPV is associated with cervical, vulvar, and vaginal cancer in females, penile cancer in males, and anal cancer and oropharyngeal cancer in both females and males (7–10). The burden of HPV infection also includes cervical precancers, including cervical intraepithelial neoplasia grade 2 or 3 and adenocarcinoma in situ (≥CIN2). The majority of all HPV-associated cancers are caused by HPV 16 or 18, types targeted by 2vHPV, 4vHPV and 9vHPV (2,11,12). In the United States, approximately 64% of invasive HPV-associated cancers are attributable to HPV 16 or 18 (65% for females; 63% for males; approximately 21,300 cases annually) and 10% are attributable to the five additional types in 9vHPV: HPV 31, 33, 45, 52, and 58 (14% for females; 4% for males; approximately 3,400 cases annually) (1,12,13). HPV 16 or 18 account for 66% and the five additional types for about 15% of cervical cancers (12). Approximately 50% of ≥CIN2 are caused by HPV 16 or 18

MMWR / March 27, 2015 / Vol. 64 / No. 11

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Morbidity and Mortality Weekly Report

TABLE 1. Characteristics of the three human papillomavirus (HPV) vaccines licensed for use in the United States Characteristic

Bivalent (2vHPV)*

Quadrivalent (4vHPV)†

9-valent (9vHPV)§

Brand name VLPs Manufacturer Manufacturing

Cervarix 16, 18 GlaxoSmithKline Trichoplusia ni insect cell line infected with L1 encoding recombinant baculovirus 500 µg aluminum hydroxide, 50 µg 3-O-desacyl-4’ monophosphoryl lipid A 0.5 ml Intramuscular

Gardasil 6, 11, 16, 18 Merck and Co., Inc. Saccharomyces cerevisiae (Baker’s yeast), expressing L1 225 µg amorphous aluminum hydroxyphosphate sulfate 0.5 ml Intramuscular

Gardasil 9 6, 11, 16, 18, 31, 33, 45, 52, 58 Merck and Co., Inc. Saccharomyces cerevisiae (Baker’s yeast), expressing L1 500 µg amorphous aluminum hydroxyphosphate sulfate 0.5 ml Intramuscular

Adjuvant Volume per dose Administration

Abbreviation: L1 = the HPV major capsid protein; VLPs = virus-like particles. * Only licensed for use in females in the United States. Package insert available at http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ UCM186981.pdf. † Package insert available at http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM111263.pdf. § Package insert available at http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM426457.pdf.

and 25% by HPV 31, 33, 45, 52, or 58 (14). HPV 6 or 11 cause 90% of anogenital warts (condylomata) and most cases of recurrent respiratory papillomatosis (15).

9vHPV Efficacy, Immunogenicity, and Safety In a phase III efficacy trial comparing 9vHPV with 4vHPV among approximately 14,000 females aged 16 through 26 years, 9vHPV efficacy for prevention of ≥CIN2, vulvar intraepithelial neoplasia grade 2 or 3, and vaginal intraepithelial neoplasia grade 2 or 3 caused by HPV 31, 33, 45, 52, or 58 was 96.7% in the per protocol population* (Table 2) (2,16). Efficacy for prevention of ≥CIN2 caused by HPV 31, 33, 45, 52, or 58 was 96.3% and for 6-month persistent infection was 96.0% (16). Few cases were caused by HPV 6, 11, 16, or 18 in either vaccine group. Noninferior immunogenicity of 9vHPV compared with 4vHPV was used to infer efficacy for HPV 6, 11, 16, and 18. Geometric mean antibody titers (GMTs) 1 month after the third dose were noninferior for HPV 6, 11, 16, and 18; in the 9vHPV group, >99% seroconverted to all nine HPV vaccine types (Table 3). Two immunobridging trials were conducted. One compared 9vHPV in approximately 2,400 females and males aged 9 through 15 years with approximately 400 females aged 16 through 26 years. Over 99% seroconverted to all nine HPV vaccine types; GMTs were significantly higher in adolescents aged 9 through 15 years compared with females aged 16 through 26 years. In a comparison of 4vHPV with 9vHPV in approximately 600 adolescent females aged 9 through 15 years, 100% seroconverted to HPV 6, 11, 16, and 18 in both * Females who received all 3 vaccinations within 1 year of enrollment, did not have major deviations from the study protocol, were naïve (polymerase chain reaction [PCR] negative and seronegative) to the relevant HPV type(s) before dose 1, and who remained PCR negative to the relevant HPV type(s) through 1 month after dose 3 (month 7).

groups, and GMTs were noninferior in the 9vHPV group compared with the 4vHPV group. Immunogenicity in males aged 16 through 26 years was compared with females of the same age group in a separate study. In both females and males, >99% seroconverted to all nine HPV vaccine types, and GMTs in males were noninferior to those in females (4). The immunogenicity of concomitant and nonconcomitant administration of 9vHPV with quadrivalent meningococcal conjugate vaccine (Menactra, MenACWY-D) and tetanus, diphtheria, acellular pertussis vaccine (Adacel, Tdap) was evaluated. The GMTs were noninferior for all nine HPV vaccine types in the co-administered group (all p