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

Transcription

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

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3 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 3H23IP S1 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.

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5 Page(s) Provider-Parent Sample Discussion 5 HPV Facts & Highlights 7 HPV Talking Points 9-10 Vaccine Specific Recommendations Vaccines for Children (VFC) 15 Vaccine Information for Parents Standing Orders for Vaccines Provider Background & Additional Resources Page(s) HPV Preteen & Teen Factsheets Understanding How Vaccines Work Tdap Vaccine Meningococcal Vaccine Flu Vaccine Immunization Schedule for Children 7-18 Years Old Vaccine Information for Parents HPV CANCER PREVENTION 1 2 HPV VACCINE IS CANCER PREVENTION 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. That s 1 person every 20 minutes of every day, all year long. Most of these cancers can be prevented by HPV vaccine. HPV VACCINE IS RECOMMENDED AT THE SAME TIME AS OTHER TEEN VACCINES Preteens need three vaccines at 20 min. Page(s) Posters (11 x 17 ) HPV is Cancer Prevention - Boy Swimming Vaccine Awareness Calendar HPV is Cancer Prevention - Girl HPV is Cancer Prevention - Boy Playing Soccer Meningitis - Dad and Son (English) Meningitis - Dad and Son (Spanish) HPV is Cancer Prevention Infographic Posters & HANDOUTS Page(s) HPV Vaccine - A Guide for Young Adults 85 Protect yourself from HPV Online Resources 89 resources for adolescents

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7 Provider Background and Additional Resources

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9 HPV Vaccination is Cancer Prevention Provider-Parent Sample Discussion PROVIDER SAMPLES: #1 Your child needs three shots today: meningococcal vaccine, HPV vaccine* and Tdap vaccine. Provider Background & Additional Resources 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. #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 and is also included on the flash drive of this toolkit. Please visit for updates on this toolkit. PAGE 5

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11 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. Provider Background & Additional Resources 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% ( ) to 71.7% ( ) 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 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%) PAGE 7

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13 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: Try saying: CDC RESEARCH SHoWS: Try saying: CDC RESEARCH SHoWS: Try saying: CDC RESEARCH SHoWS: Try saying: CDC RESEARCH SHoWS: Try saying: CDC RESEARCH SHoWS: Try saying: CDC RESEARCH SHoWS: Try saying: CDC RESEARCH SHoWS: Try saying: CDC RESEARCH SHoWS: Try saying: 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. 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. Disease prevalence is not understood, and parents are unclear about what the vaccine actually protects against. 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. Parents want a concrete reason to understand the recommendation that 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. 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. 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. 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. 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. Understanding that the side effects are minor and emphasizing the extensive research that vaccines must undergo can help parents feel reassured. 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. Parents want to know that HPV vaccine is effective. 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! Provider Background & Additional Resources PreteenVaccines@cdc.gov CS242429A PAGE 9

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15 Human Papillomavirus Vaccine (HPV) Recommendations and Talking Points 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 Provider Background & Additional Resources 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 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

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17 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. Provider Background & Additional Resources 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 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: 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 years of age with a booster at 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 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. PAGE 13

18 Provider Background & Additional Resources 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. PAGE 14

19 Vaccines for Children (VFC) 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 the following criteria: Provider Background & Additional Resources 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. PAGE 15

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21 Talking with Parents About Vaccine Safety California Immunization Coalition Provider Background & Additional Resources 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 PAGE 17

22 Provider Background & Additional Resources Talking with Parents About Vaccine Safety 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 California Immunization Coalition 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 Thimerosal FAQs Evaluating Health Information on the Web National Network for Immunization Parents Do Vaccines of Kids Cause with That? Infectious (Book) Diseases Parents of Kids with Infectious Diseases 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 th Street, Suite 200 Sacramento, CA (916 ) ext California Immunization Coalition (CIC ) IMM-915 Sept PAGE 18

23 AAP Immunization Resources Adolescent Immunizations: Strategies for Increasing Coverage Rates 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. Provider Background & Additional Resources 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 s to patients or parents prompting them to check their patient portal, which will remind them of vaccinations that are due. For more information, visit: 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 PAGE 19

24 Provider Background & Additional Resources 2. Provider Prompts or Standing Orders AAP Immunization Resources Adolescent Immunizations: Strategies for Increasing Coverage Rates 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: 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 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 Pediatrics, 127, 1, Supplement CDC. Chart of Contraindications and Precautions to Commonly Used Vaccines Accessed on April 12, 2013 at: PAGE 20

25 AAP Immunization Resources Adolescent Immunizations: Strategies for Increasing Coverage Rates 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. Provider Background & Additional Resources 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: AAP Adolescent Immunization: Common Concerns Addressed AAP Communication with Families Web page: CDC Provider Resources for Immunization Conversations with Parents 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. PAGE 21

26 Provider Background & Additional Resources 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: In the meantime, suggest that eligible children receive vaccines at the local health department. Direct parents to learn more about the VFC program at 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 Immunization Quality Practice Improvement Management page page AAP Immunization Adolescents page AAP Immunization Quality Improvement page Last updated: 7/2013 PAGE 22

27 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, MD 1,2, Joseph A. Bocchini Jr, MD 3, Susan Hariri, PhD 2, Harrell Chesson, PhD 2, C. Robinette Curtis, MD 4, Mona Saraiya, MD 5, Elizabeth R. Unger, PhD, MD 6, Lauri E. Markowitz, MD 2 (Author affiliations at end of text) Provider Background & Additional Resources 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 (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 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 MMWR / March 27, 2015 / Vol. 64 / No. 11 PAGE 23

28 Provider Background & Additional Resources 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 Cervarix Gardasil Gardasil 9 VLPs 16, 18 6, 11, 16, 18 6, 11, 16, 18, 31, 33, 45, 52, 58 Manufacturer GlaxoSmithKline Merck and Co., Inc. Merck and Co., Inc. Manufacturing Trichoplusia ni insect cell line infected with L1 encoding recombinant baculovirus Saccharomyces cerevisiae (Baker s yeast), expressing L1 Saccharomyces cerevisiae (Baker s yeast), expressing L1 Adjuvant 500 µg aluminum hydroxide, 50 µg 3-O-desacyl-4 monophosphoryl lipid A 225 µg amorphous aluminum hydroxyphosphate sulfate 500 µg amorphous aluminum hydroxyphosphate sulfate Volume per dose 0.5 ml 0.5 ml 0.5 ml Administration Intramuscular Intramuscular Intramuscular 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 UCM pdf. Package insert available at Package insert available at 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<0.001). For Menactra, the noninferiority criterion was met for all four serogroups, and for Adacel, for diphtheria, tetanus, and all four pertussis antigens. Safety has been evaluated in approximately 15,000 subjects in the 9vHPV clinical development program; approximately 13,000 subjects in six studies were included in the initial application submitted to FDA (2). The vaccine was well-tolerated, and most adverse events were injection site-related pain, swelling, and erythema that were mild to moderate in intensity. The safety profiles were similar in 4vHPV and 9vHPV vaccinees. Among females aged 9 through 26 years, 9vHPV recipients had more injection-site adverse events, including swelling (40.3% in the 9vHPV group compared with 29.1% in the 4vHPV group) and erythema (34.0% in the 9vHPV group compared with 25.8% in the 4vHPV group). Males had fewer injection site adverse events. In males aged 9 through 15 years, injection site swelling and erythema in 9vHPV recipients occurred in 26.9% and 24.9%, respectively. Rates of injection-site swelling and erythema both increased following each successive dose of 9vHPV. MMWR / March 27, 2015 / Vol. 64 / No PAGE 24

29 Morbidity and Mortality Weekly Report TABLE 2. Results of a Phase III efficacy trial comparing 9-valent human papillomavirus (HPV) vaccine (9vHPV) with quadrivalent HPV vaccine (4vHPV), per protocol population* in females aged 16 through 26 years 9vHPV 4vHPV Vaccine efficacy Endpoint-related types Endpoint No. participants Cases No. participants Cases % (95% CI) HPV 31, 33, 45, 52, 58 CIN2, VIN2/3, VaIN2/3 6, , ( ) CIN2 5, , ( ) 6-month persistent infection 5, , ( ) HPV 6, 11, 16, 18 CIN2 5, ,832 1 Anogenital warts 5, ,893 1 Abbreviations: CI = confidence interval; CIN2 = cervical intraepithelial neoplasia grade 2 or 3 or adenocarcinoma in situ; VaIN2/3 = vaginal intraepithelial neoplasia grade 2 or 3; VIN2/3 = vulvar intraepithelial neoplasia grade 2 or 3. Sources: Package insert available at Joura EA, Giuliano AR, Iversen OE, et al. A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women. N Engl J Med 2015;372: * 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). Participants were enrolled from sites in 18 countries; median duration of follow-up was 40 months. Provider Background & Additional Resources TABLE 3. Human papillomavirus (HPV) 6, 11, 16, and 18 seroconversion and geometric mean titers (GMTs*) after 3 doses of 9-valent HPV vaccine (9vHPV) compared with quadrivalent HPV vaccine (4vHPV), per protocol population in females aged 16 through 26 years 9vHPV Seropositivity Assay (clia) No. participants (%) GMT (mmu/ml) No. participants Seropositivity (%) GMT (mmu/ml) Anti-HPV 6 3,993 (99.8) 893 3,975 (99.8) 875 Anti-HPV 11 3,995 (100) 666 3,982 (99.9) 830 Anti-HPV 16 4,032 (100) 3,131 4,062 (100) 3,157 Anti-HPV 18 4,539 (99.8) 805 4,541 (99.7) 679 Abbreviations: clia = competitive Luminex immunoassay; mmu = milli-merck units. Source: Joura EA, Giuliano AR, Iversen OE, et al. A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women, and supplementary appendix. N Engl J Med 2015;372: * The noninferiority criterion for GMTs was met for all four HPV types (p<0.001). 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). Participants were enrolled from sites in 18 countries; median duration of follow-up was 40 months. 4vHPV Health Impact and Cost Effectiveness Introduction of 9vHPV in both males and females was cost-saving when compared with 4vHPV for both sexes in a cost-effectiveness model that assumed 9vHPV cost $13 more per dose than 4vHPV. Cost-effectiveness ratios for 9vHPV remained favorable compared with 4vHPV (9vHPV was costsaving in most scenarios, and the cost per quality-adjusted life year gained did not exceed $25,000 in any scenario) when varying assumptions about HPV natural history, cervical cancer screening, vaccine coverage, vaccine duration of protection, and health care costs, but were sensitive to 9vHPV cost assumptions (17). Because the additional five types in 9vHPV account for a higher proportion of HPV-associated cancers in females compared with males and cause cervical precancers, the additional protection from 9vHPV will mostly benefit females. Recommendations for Use of HPV Vaccines ACIP recommends that routine HPV vaccination be initiated at age 11 or 12 years. The vaccination series can be started beginning at age 9 years. Vaccination is also recommended for females aged 13 through 26 years and for males aged 13 through 21 years who have not been vaccinated previously or who have not completed the 3-dose series (1). Males aged 22 through 26 years may be vaccinated. Vaccination of females is recommended with 2vHPV, 4vHPV (as long as this formulation is available), or 9vHPV. Vaccination of males is recommended with 4vHPV (as long as this formulation is available) or 9vHPV. 2vHPV, 4vHPV, and 9vHPV all protect against HPV 16 and 18, types that cause about 66% of cervical cancers and the majority of other HPV-attributable cancers in the United States (1,12). 9vHPV targets five additional cancer causing types, which account for about 15% of cervical cancers (12). 4vHPV and 9vHPV also protect against HPV 6 and 11, types that cause anogenital warts. 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. 302 MMWR / March 27, 2015 / Vol. 64 / No. 11 PAGE 25

30 Provider Background & Additional Resources What is currently recommended? The Advisory Committee on Immunization Practices (ACIP) recommends routine HPV vaccination at age 11 or 12 years. The vaccination series can be started beginning at age 9 years. Vaccination is also recommended for females aged 13 through 26 years and for males aged 13 through 21 years who have not been vaccinated previously or who have not completed the 3-dose series. Males aged 22 through 26 years may be vaccinated. ACIP recommends vaccination of men who have sex with men and immunocompromised persons through age 26 years if not vaccinated previously. Why are the recommendations being updated now? 9-valent HPV vaccine (9vHPV) was approved by the Food and Drug Administration on December 10, This vaccine targets HPV types 6, 11, 16, and 18, the types targeted by the quadrivalent HPV vaccine (4vHPV), as well as five additional types, HPV types 31, 33, 45, 52, and 58. ACIP reviewed results of a randomized trial among approximately 14,000 females aged 16 through 26 years that showed noninferior immunogenicity for the types shared by 4vHPV and 9vHPV and high efficacy for the five additional types. Other trials in the 9vHPV clinical development program included studies that compared antibody responses across age groups and females and males and concomitant vaccination studies. The evidence supporting 9vHPV vaccination was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework and determined to be type 2 (moderate level of evidence) among females and 3 (low level of evidence) among males; the recommendation was designated as a Category A recommendation (recommendation for all persons in an age- or risk-factor based group). What are the new recommendations? 9vHPV, 4vHPV or 2vHPV can be used for routine vaccination of females aged 11 or 12 years and females through age 26 years who have not been vaccinated previously or who have not completed the 3-dose series. 9vHPV or 4vHPV can be used for routine vaccination of males aged 11 or 12 years and males through age 21 years who have not been vaccinated previously or who have not completed the 3-dose series. ACIP recommends either 9vHPV or 4vHPV vaccination for men who have sex with men and immunocompromised persons (including those with HIV infection) through age 26 years if not vaccinated previously. Administration. 2vHPV, 4vHPV, and 9vHPV are each administered in a 3-dose schedule. The second dose is administered at least 1 to 2 months after the first dose, and the third dose at least 6 months after the first dose (1). If the vaccine schedule is interrupted, the vaccination series does not need to be restarted. If vaccination providers do not know or do not have available the HPV vaccine product previously administered, or Minimum intervals are 1 month between the first and second dose, 3 months between the second and third dose, and 6 months between the first and third dose. Morbidity and Mortality Weekly Report are in settings transitioning to 9vHPV, any available HPV vaccine product may be used to continue or complete the series for females for protection against HPV 16 and 18; 9vHPV or 4vHPV may be used to continue or complete the series for males. There are no data on efficacy of fewer than 3 doses of 9vHPV. Special Populations. HPV vaccination is recommended through age 26 years for men who have sex with men and for immunocompromised persons (including those with HIV infection) who have not been vaccinated previously or have not completed the 3-dose series. Precautions and Contraindications. HPV vaccines are contraindicated for persons with a history of immediate hypersensitivity to any vaccine component. 4vHPV and 9vHPV are contraindicated for persons with a history of immediate hypersensitivity to yeast. 2vHPV should not be used in persons with anaphylactic latex allergy. HPV vaccines are not recommended for use in pregnant women (1). If a woman is found to be pregnant after initiating the vaccination series, the remainder of the 3-dose series should be delayed until completion of pregnancy. Pregnancy testing is not needed before vaccination. If a vaccine dose has been administered during pregnancy, no intervention is needed. A new pregnancy registry has been established for 9vHPV (2). Pregnancy registries for 4vHPV and 2vHPV have been closed with concurrence from FDA (1,18). Exposure during pregnancy can be reported to the respective manufacturer. Patients and health care providers can report an exposure to HPV vaccine during pregnancy to the Vaccine Adverse Event Reporting System (VAERS). Adverse events occurring after administration of any vaccine should be reported to VAERS. Additional information about VAERS is available by telephone ( ) or online at Cervical Cancer Screening. Cervical cancer screening is recommended beginning at age 21 years and continuing through age 65 years for both vaccinated and unvaccinated women (19,20). Recommendations will continue to be evaluated as further postlicensure monitoring data become available. Future Policy Issues A clinical trial is ongoing to assess alternative dosing schedules of 9vHPV. ACIP will formally review the results as data become available. HPV vaccination should not be delayed pending availability of 9vHPV or of future clinical trial data. 9vHPV exposure during pregnancy should be reported to the Merck Pregnancy Registry at telephone ; 4vHPV exposure during pregnancy can be reported to Merck at telephone vHPV exposure during pregnancy can be reported to GlaxoSmithKline at telephone MMWR / March 27, 2015 / Vol. 64 / No PAGE 26

31 Acknowledgments ACIP members (membership roster for July 2014 June 2015 available at ACIP HPV Work Group. 1 Epidemic Intelligence Service, CDC; 2 National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, CDC; 3 Louisiana State University Health Sciences Center, Shreveport, Louisiana; 4 National Center for Immunization and Respiratory Diseases, CDC; 5 National Center for Chronic Disease Prevention and Health Promotion, CDC; 6 National Center for Emerging and Zoonotic Infectious Diseases, CDC (Corresponding author: Emiko Petrosky, xfq7@cdc.gov, ) References 1. Markowitz LE, Dunne EF, Saraiya M, et al.; Centers for Disease Control and Prevention (CDC). Human papillomavirus vaccination: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2014;63(No. RR-05): Food and Drug Administration. Highlights of prescribing information. Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant). Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; Available at BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM pdf. 3. Food and Drug Administration. December 10, 2014 Approval letter GARDASIL 9. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; Available at ApprovedProducts/ucm htm. 4. Luxembourg A. Program summary and new 9-valent HPV vaccine trial data. Presentation before the Advisory Committee on Immunization Practices (ACIP), October 30, Atlanta, GA: US Department of Health and Human Services, CDC; Available at gov/vaccines/acip/meetings/downloads/min-archive/min pdf. 5. Ahmed F, Temte JL, Campos-Outcalt D, Schünemann HJ; ACIP Evidence Based Recommendations Work Group (EBRWG). Methods for developing evidence-based recommendations by the Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention (CDC). Vaccine 2011;29: CDC. GRADE evidence tables recommendations in MMWR. Atlanta, GA: US Department of Health and Human Services, CDC; Available at 7. Muñoz N, Bosch FX, de Sanjosé S, et al.; International Agency for Research on Cancer Multicenter Cervical Cancer Study Group. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med 2003;348: Morbidity and Mortality Weekly Report 8. IARC Working Group on the Evaluation of Carcinogenic Risks to Humans. Biological agents. Volume 100 B: a review of human carcinogens. IARC Monographs Eval Carcinog Risks Hum 2012;100(Pt B): Walboomers JM, Jacobs MV, Manos MM, et al. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol 1999;189: Forman D, de Martel C, Lacey CJ, et al. Global burden of human papillomavirus and related diseases. Vaccine 2012;30(Suppl 5):F Serrano B, Alemany L, Tous S, et al. Potential impact of a nine-valent vaccine in human papillomavirus related cervical disease. Infect Agent Cancer 2012;7: Saraiya M. Population-based HPV genotype attribution in HPVassociated cancers. Presented at Anal Intraepithelial Neoplasia Society Conference, March 13 15, 2015, Atlanta, GA. 13. CDC. Human papillomavirus (HPV)-associated cancers. Atlanta, GA: US Department of Health and Human Services, CDC; Available at Hariri S, Unger ER, Schafer S, et al.; HPV-IMPACT Working Group. HPV type attribution in high-grade cervical lesions: assessing the potential benefits of vaccines in a population-based evaluation in the United States. Cancer Epidemiol Biomarkers Prev 2015;24: Lacey CJ, Lowndes CM, Shah KV. Chapter 4: Burden and management of non-cancerous HPV-related conditions: HPV-6/11 disease. Vaccine 2006;24(Suppl 3): Joura EA, Giuliano AR, Iversen OE, et al.; Broad Spectrum HPV Vaccine Study. A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women. N Engl J Med 2015;372: Brisson M. Cost-effectiveness of 9-valent HPV vaccination. Presentation before the Advisory Committee on Immunization Practices (ACIP), October 30, Atlanta, GA: US Department of Health and Human Services, CDC; Available at meetings/downloads/min-archive/min pdf. 18. Food and Drug Administration. Highlights of prescribing information. Cervarix [human papillomavirus bivalent (types 16, 18) vaccine, recombinant]. Silver Spring, MD: US Department of Health and Human Services; Food and Drug Administration; Available at fda.gov/downloads/biologicsbloodvaccines/vaccines/ ApprovedProducts/UCM pdf. 19. Saslow D, Solomon D, Lawson HW, et al. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. J Low Genit Tract Dis 2012;16: Moyer VA; US Preventive Services Task Force. Screening for cervical cancer: US Preventive Services Task Force recommendation statement. Ann Intern Med 2012;156:880 91, W312. Provider Background & Additional Resources 304 MMWR / March 27, 2015 / Vol. 64 / No. 11 PAGE 27

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33 VACCINE INFORMATION STATEMENT HPV Vaccine Cervarix What You Need to Know 1 What is HPV? Genital human papillomavirus (HPV) is the most common sexually transmitted virus in the United States. More than half of sexually active men and women are infected with HPV at some time in their lives. About 20 million Americans are currently infected, and about 6 million more get infected each year. HPV is usually spread through sexual contact. Most HPV infections don t cause any symptoms, and go away on their own. But HPV can cause cervical cancer in women. Cervical cancer is the 2nd leading cause of cancer deaths among women around the world. In the United States, about 10,000 women get cervical cancer every year and about 4,000 are expected to die from it. HPV is also associated with several less common cancers, such as vaginal and vulvar cancers in women and other types of cancer in both men and women. It can also cause genital warts and warts in the throat. There is no cure for HPV infection, but some of the problems it causes can be treated. 2 HPV vaccine: Why get vaccinated? HPV vaccine is important because it can prevent most cases of cervical cancer in females, if it is given before a person is exposed to the virus. Protection from HPV vaccine is expected to be longlasting. But vaccination is not a substitute for cervical cancer screening. Women should still get regular Pap tests. The vaccine you are getting is one of two HPV vaccines that can be given to prevent cervical cancer. It is given to females only. The other vaccine may be given to both males and females. It can also prevent most genital warts. It has also been shown to prevent some vaginal, vulvar and anal cancers. (Human Papillomavirus) 3 Many Vaccine Information Statements are available in Spanish and other languages. See Hojas de información sobre vacunas están disponibles en español y en muchos otros idiomas. Visite Who should get this HPV vaccine and when? Routine vaccination HPV vaccine is recommended for girls 11 or 12 years of age. It may be given to girls starting at age 9. Why is HPV vaccine given to girls at this age? It is important for girls to get HPV vaccine before their first sexual contact because they won t have been exposed to human papillomavirus. Once a girl or woman has been infected with the virus, the vaccine might not work as well or might not work at all. Catch-up vaccination The vaccine is also recommended for girls and women 13 through 26 years of age who did not get all 3 doses when they were younger. HPV vaccine is given as a 3-dose series 1st Dose: Now 2nd Dose: 1 to 2 months after Dose 1 3rd Dose: 6 months after Dose 1 Additional (booster) doses are not recommended. HPV vaccine may be given at the same time as other vaccines. 4 Some people should not get HPV vaccine or should wait 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. Tell your doctor if the person getting vaccinated has any severe allergies, including an allergy to latex. HPV vaccine is not recommended for pregnant women. However, receiving HPV vaccine when pregnant is not a reason to consider terminating the pregnancy. Women who are breast feeding may get the vaccine. Provider Background & Additional Resources PAGE 29

34 Provider Background & Additional Resources Any woman who learns she was pregnant when she got this HPV vaccine is encouraged to contact the manufacturer s HPV in pregnancy registry at This will help us learn how pregnant women respond to the vaccine. People who are mildly ill when a dose of HPV vaccine is planned can still be vaccinated. People with a moderate or severe illness should wait until they are better. 5 What are the risks from this vaccine? This HPV vaccine has been in use around the world for several years and has been very safe. However, any medicine could possibly cause a serious problem, such as a severe allergic reaction. The risk of any vaccine causing a serious injury, or death, is extremely small. Life-threatening allergic reactions from vaccines are very rare. If they do occur, it would be within a few minutes to a few hours after the vaccination. Several mild to moderate problems are known to occur with HPV vaccine. These do not last long and go away on their own. Reactions where the shot was given: - Pain (about 9 people in 10) - Redness or swelling (about 1 person in 2) Other mild reactions: - Fever of 99.5 F or higher (about 1 person in 8) - Headache or fatigue (about 1 person in 2) - Nausea, vomiting, diarrhea, or abdominal pain (about 1 person in 4) - Muscle or joint pain (up to 1 person in 2) Fainting: Brief fainting spells and related symptoms (such as jerking movements) can happen after any medical procedure, including vaccination. Sitting or lying down for about 15 minutes after a vaccination can help prevent fainting and injuries caused by falls. Tell your doctor if the patient feels dizzy or light-headed, or has vision changes or ringing in the ears. Like all vaccines, HPV vaccines will continue to be monitored for unusual or severe problems. 6 What if there is a serious reaction? What should I look for? Look for anything that concerns you, such as signs of a severe allergic reaction, very high fever, or behavior changes. Signs of a severe allergic reaction can include hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, and weakness. These would start a few minutes to a few hours after the vaccination. What should I do? If you think it is a severe allergic reaction or other emergency that can t wait, call or get the person to the nearest hospital. Otherwise, call your doctor. Afterward, the reaction should be reported to the Vaccine Adverse Event Reporting System (VAERS). Your doctor might file this report, or you can do it yourself through the VAERS web site at or by calling VAERS is only for reporting reactions. They do not give medical advice. 7 The National Vaccine Injury Compensation Program The National Vaccine Injury Compensation Program (VICP) is a federal program that was created to compensate people who may have been injured by certain vaccines. Persons who believe they may have been injured by a vaccine can learn about the program and about filing a claim by calling or visiting the VICP website at 8 How can I learn more? Ask your doctor. Call your local or state health department. Contact the Centers for Disease Control and Prevention (CDC): - Call (1-800-CDC-INFO) or - Visit CDC s website at Vaccine Information Statement (Interim) Human Papillomavirus (HPV) Cervarix 5/3/2011 Office Use Only PAGE 30

35 VACCINE INFORMATION STATEMENT HPV Vaccine Gardasil What You Need to Know 1 What is HPV? Genital human papillomavirus (HPV) is the most common sexually transmitted virus in the United States. More than half of sexually active men and women are infected with HPV at some time in their lives. About 20 million Americans are currently infected, and about 6 million more get infected each year. HPV is usually spread through sexual contact. Most HPV infections don t cause any symptoms, and go away on their own. But HPV can cause cervical cancer in women. Cervical cancer is the 2nd leading cause of cancer deaths among women around the world. In the United States, about 12,000 women get cervical cancer every year and about 4,000 are expected to die from it. 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. There is no cure for HPV infection, but some of the problems it causes can be treated. 2 HPV vaccine: Why get vaccinated? The HPV vaccine you are getting is one of two vaccines that can be given to prevent HPV. It may be given to both males and females. This vaccine can prevent most cases of cervical cancer in females, if it is given before exposure to the virus. In addition, it can prevent vaginal and vulvar cancer in females, and genital warts and anal cancer in both males and females. Protection from HPV vaccine is expected to be longlasting. But vaccination is not a substitute for cervical cancer screening. Women should still get regular Pap tests. (Human Papillomavirus) 3 Many Vaccine Information Statements are available in Spanish and other languages. See Hojas de información sobre vacunas están disponibles en español y en muchos otros idiomas. Visite Who should get this HPV vaccine and when? HPV vaccine is given as a 3-dose series 1st Dose Now 2nd Dose 1 to 2 months after Dose 1 3rd Dose 6 months after Dose 1 Additional (booster) doses are not recommended. Routine vaccination This HPV vaccine is recommended for girls and boys 11 or 12 years of age. It may be given starting at age 9. Why is HPV vaccine recommended at 11 or 12 years of age? HPV infection is easily acquired, even with only one sex partner. That is why it is important to get HPV vaccine before any sexual contact takes place. Also, response to the vaccine is better at this age than at older ages. Catch-up vaccination This 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. This vaccine may be given to men 22 through 26 years of age who have not completed the 3-dose series. 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. HPV vaccine may be given at the same time as other vaccines. Provider Background & Additional Resources PAGE 31

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37 VACCINE INFORMATION STATEMENT HPV Vaccine Gardasil -9 What You Need to Know 1 Why get vaccinated? Gardasil-9 prevents many cancers caused by human papillomavirus (HPV) infections, including: cervical cancer in females, vaginal and vulvar cancers in females, and anal cancer in females and males. In addition to these cancers, Gardasil-9 also prevents genital warts in both females and males. In the U.S., about 12,000 women get cervical cancer every year, and about 4,000 women die from it. Gardasil-9 can prevent most of these cancers. HPV infection usually comes from sexual contact, and most people will become infected at some point in their life. About 14 million Americans get infected every year. Many infections will go away and not cause serious problems. But thousands of women and men get cancer and diseases from HPV. 2 HPV vaccine Gardasil-9 is one of three FDA-approved HPV vaccines. It is recommended for both males and females. It is routinely given at 11 or 12 years of age, but it may be given beginning at age 9 years through age 26 years. Three doses of Gardasil-9 are recommended with the second and third dose 1-2 months and 6 months after the first dose. Vaccination is not a substitute for cervical cancer screening. This vaccine does not protect against all HPV types that can cause cervical cancer. Women should still get regular Pap tests. 3 (Human Papillomavirus) Many Vaccine Information Statements are available in Spanish and other languages. See Hojas de información sobre vacunas están disponibles en español y en muchos otros idiomas. Visite Some people should not get this vaccine Anyone who has had a severe, life-threatening allergic reaction to a dose of HPV vaccine should not get another dose. Anyone who has a severe (life threatening) allergy to any component of HPV vaccine should not get the vaccine. Tell your doctor if you have any severe allergies that you know of, including a severe allergy to yeast. HPV vaccine is not recommended for pregnant women. If you learn that you were pregnant when you were vaccinated, there is no reason to expect any problems for you or the baby. Any woman who learns she was pregnant when she got this HPV vaccine is encouraged to contact the manufacturer s registry for HPV vaccination during pregnancy at Women who are breastfeeding may be vaccinated. If you have a mild illness you can probably get the vaccine today. If you are moderately or severely ill, you should probably wait until you recover. Your doctor can advise you. Provider Background & Additional Resources PAGE 33

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39 Introduction to Standing Order Procedures Provider Background & Additional Resources The standing order procedures included in the next section were created by experts at the Immunization Action Coalition ( State law does not allow nurses or medical assistants in a school health center to act on standing orders. To that end, these materials are included as best practices or guidelines. Additionally, these materials may be used to develop internal written guidelines for administration of vaccines following doctor orders. PAGE 35

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41 Standing Orders for Administering Human Papillomavirus Vaccine to Children and Teens Purpose: To reduce morbidity and mortality from human papillomavirus (HPV) infection by vaccinating all children and teens who meet the criteria established by the Centers for Disease Control and Prevention s Advisory Committee on Immunization Practices. Policy: Under these standing orders, eligible nurses and other healthcare professionals (e.g., pharmacists), where allowed by state law, may vaccinate children and teens who meet the criteria below. Procedure 1. Identify all children and teens ages 11 years and older who have not completed the HPV vaccination series. 2. Screen all patients for contraindications and precautions to HPV vaccine: a. Contraindication: a history of a serious allergic reaction (e.g., anaphylaxis) after a previous dose of HPV vaccine or to a HPV vaccine component (e.g., yeast for quadrivalent or 9-valent HPV vaccine [4vHPV or 9vHPV: Gardasil, Merck] or latex for bivalent HPV vaccine [2vHPV: Cervarix, GSK]). For information on vaccine components, refer to the manufacturers package insert ( or go to appendices/b/excipient-table-2.pdf. b. Precautions: Moderate or severe acute illness with or without fever Pregnancy; delay vaccination until after completion of the pregnancy 3. Provide all patients (or, if minors, their parent or legal representative) with a copy of the most current federal Vaccine Information Statement (VIS). You must document, in the patient s medical record or office log, the publication date of the VIS and the date it was given to the patient (parent/legal representative). Provide non-english speaking patients with a copy of the VIS in their native language, if available and preferred; these can be found at 4. Provide 1) either 2vHPV, 4vHPV, or 9vHPV to girls or 2) 4vHPV4 or 9vHPV to boys. Provide either vaccine in a 3-dose schedule at 0, 1 2, and 6 calendar months. Provide routine vaccination with HPV vaccine to girls and boys at age 11 or 12 years; vaccine may be administered to girls or boys as young as age 9 years. Administer 0.5 ml HPV vaccine intramuscularly (22 25g, 1 1½" needle) in the deltoid muscle; the anterolateral thigh muscle may be used if deltoid is inadequate. (Note: a e" needle may be used for children and teens weighing less than 130 lbs [60 kg] for injection in the deltoid muscle only if the subcutaneous tissue is not bunched and the injection is made at a 90 angle.) 5. For children and teens who have not received HPV vaccine at the ages and/or intervals specified in #4, administer one dose at the earliest opportunity and then schedule subsequent doses to complete the 3-dose schedule by observing a minimum interval of 4 weeks between the first and second doses, 12 weeks between the second and third doses, and at least 24 weeks between the first and third doses. 6. Document each patient s vaccine administration information and follow up in the following places: a. Medical chart: Record the date the vaccine was administered, the manufacturer and lot number, the vaccination site and route, and the name and title of the person administering the vaccine. If vaccine was not administered, record the reason(s) for non-receipt of the vaccine (e.g., medical contraindication, patient refusal). b. Personal immunization record card: Record the date of vaccination and the name/location of the administering clinic. 7. Be prepared for management of a medical emergency related to the administration of vaccine by having a written emergency medical protocol available, as well as equipment and medications. For IAC s Medical Management of Vaccine Reactions in Children and Teens, go to To prevent syncope, vaccinate patients while seated or lying down and consider observing them for 15 minutes after receipt of the vaccine. 8. Report all adverse reactions following the administration of HPV vaccine to the federal Vaccine Adverse Event Reporting System (VAERS) at or by calling (800) VAERS report forms are available at This policy and procedure shall remain in effect for all patients of the until (name of practice or clinic) rescinded or until (date). Medical Director s signature: Effective date: Provider Background & Additional Resources For standing orders for other vaccines, go to Technical content reviewed by the Centers for Disease Control and Prevention Immunization Action Coalition Saint Paul, Minnesota Item #P3090 (5/15) PAGE 37

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43 Purpose Policy Standing orders for other vaccines are available at note: This standing orders template may be adapted per a practice s discretion without obtaining permission from IAC. As a courtesy, please acknowledge IAC as its source. standing orders for Administering Influenza Vaccine to Children and Adolescents To reduce morbidity and mortality from influenza by vaccinating all children and adolescents who meet the criteria established by the Centers for Disease Control and Prevention s Advisory Committee on Immunization Practices (ACIP). Where allowed by state law, standing orders enable eligible nurses and other health care professionals (e.g., pharmacists) to assess the need for vaccination and to vaccinate children and adolescents who meet any of the criteria below. Provider Background & Additional Resources Procedure 1 Assess Children and Adolescents for Need of Vaccination against influenza All children and teens 6 months of age and older are recommended to receive influenza vaccination each year. A second dose of influenza vaccine is recommended 4 weeks or more after the first dose for children age 6 months through 8 years if they have not received 2 doses in previous years (not necessarily in the same season). 2 Screen for Contraindications and Precautions Contraindications for use of all influenza vaccines Do not give influenza vaccine to a child or adolescent who has experienced a serious systemic or anaphylactic reaction to a prior dose of the vaccine or to any of its components. For a list of vaccine components, refer to the manufacturer s package insert ( or go to pinkbook/downloads/appendices/b/excipient-table-2.pdf. Contraindications only for use of live attenuated influenza vaccine (LAIV; FluMist, nasal spray) Do not give live attenuated influenza vaccine (LAIV; nasal spray) to a child or adolescent who: has a history of either an anaphylactic or non-anaphylactic allergy to eggs is pregnant is younger than age 2 years is age 2 through 4 years who has experienced wheezing or asthma within the past 12 months, based on a health care provider s statement has immunosuppression (including that caused by medications or HIV) is age 2 through 17 years and is on long-term aspirin therapy received influenza antivirals (e.g., amantadine, rimantadine, zanamivir, or oseltamivir) within the previous 48 hours or will possibly receive them within 14 days after vaccination provides care for a severely immunosuppressed person who requires a protective environment Precautions for use of all influenza vaccines Moderate or severe acute illness with or without fever History of Guillain Barré syndrome within 6 weeks of a previous influenza vaccination Precautions for use of LAIV only Age 5 years or older with asthma Other chronic medical conditions (e.g., other chronic lung diseases, chronic cardiovascular disease [excluding isolated hypertension], diabetes, chronic renal or hepatic disease, hematologic disease, neurologic disease, and metabolic disorders) note regarding patients with hives after eating eggs: For patients with onset of hives only (and not a more serious reaction) after ingesting eggs, health care providers should administer inactivated influenza vaccine (IIV) and observe the patient for at least 30 minutes after receipt of the vaccine for signs of a reaction. Technical content reviewed by the Centers for Disease Control and Prevention Immunization Action Coalition Saint Paul, Minnesota Item #P3074a (8/15) PAGE 39

44 Provider Background & Additional Resources Standing Orders for Administering Influenza Vaccine to Children and Adolescents (continued) page 2 of 3 3 Provide Vaccine Information Statements Provide all patients (or, in the case of minors, their parent, or legal representative) with a copy of the most current federal Vaccine Information Statement (VIS). Provide non-english speaking patients with a copy of the VIS in their native language, if one is available and desired; these can be found at (For information about how to document that the VIS was given, see section 6 titled Document Vaccination. ) 4 Prepare to Administer Vaccine For vaccine that is to be administered intramuscularly, choose the needle gauge, needle length, and injection site according to the following chart: age of child needle gauge needle length injection site Infants age 6 through 11 months " Anterolateral thigh muscle Age 1 through 2 years ¼" Anterolateral thigh muscle or deltoid muscle of arm Age 3 years and older * 1" Deltoid muscle of arm * A 5 8" needle may be used in patients weighing less than 130 lbs (<60 kg) for IM injection in the deltoid muscle only if the skin is stretched tight, the subcutaneous tissue is not bunched, and the injection is made at a 90-degree angle to the skin. For vaccine that is to be administered intranasally or intradermally, prepare the vaccine according to directions in the package insert. 5 Administer Influenza Vaccine according to the age of patient and desired route of vaccination described below: type of vaccine age group dose route instructions Inactivated influenza 6 35 months 0.25 ml Intramuscular (IM) Administer vaccine in anterolateral vaccine (IIV) thigh muscle. Fluzone only Inactivated influenza 3 years and older 0.5 ml Intramuscular (IM) Administer vaccine in deltoid muscle. vaccine (IIV) IIV-intradermal 18 through 0.1 ml Intradermal (ID) Insert needle of the microinjection 64 years system at a 90 degree angle in the deltoid area. Recombinant influ- 18 years and 0.5 ml Intramuscular (IM) Administer vaccine in deltoid muscle. enza vaccine (RIV3) older Intranasal influenza Healthy, age ml (0.1 ml Intranasal spray Spray half of vaccine into each nostril vaccine (LAIV) years and older into each nostril (NAS) while the patient is in an upright position. note: For children age 6 months through 8 years who are receiving influenza vaccine for the first time or who have had a total of only one influenza vaccine dose in all previous years, administer two doses separated by at least 4 weeks. For complete instructions on how to administer influenza vaccine, see How to Administer Intramuscular, Intradermal, and Intranasal Influenza Vaccines at Immunization Action Coalition Saint Paul, Minnesota PAGE 40 Item #P3074a (8/15)

45 Standing Orders for Administering Influenza Vaccine to Children and Adolescents (continued) page 3 of 3 6 Document Vaccination Document each patient s vaccine administration information and follow up in the following places: Medical record: Document the date the vaccine was administered, the manufacturer and lot number, the vaccination site and route, and the name and title of the person administering the vaccine. You must also document, in the patient s medical record or office log, the publication date of the VIS and the date it was given to the patient (parent/legal representative). If vaccine was not administered, record the reason(s) for non-receipt of the vaccine (e.g., medical contraindication, patient refusal). Personal immunization record card: Record the date of vaccination and the name/location of the administering clinic. Immunization Information System (IIS) or registry : Report the vaccination to the appropriate state/local IIS, if available. Provider Background & Additional Resources 7 Be Prepared to Manage Medical Emergencies Be prepared for management of a medical emergency related to the administration of vaccine by having a written emergency medical protocol available, as well as equipment and medications. For IAC s Medical Management of Vaccine Reactions in Children and Teens, go to To prevent syncope in older children, vaccinate patients while they are seated or lying down and consider observing them for 15 minutes after receipt of the vaccine. 8 Report All Adverse Events to VAERS Report all adverse events following the administration of influenza vaccine to the federal Vaccine Adverse Event Reporting System (VAERS) at Forms are available on the website or by calling (800) Standing Orders Authorization This policy and procedure shall remain in effect for all patients of the name of practice or clinic until rescinded or until date. Medical Director s signature Signature date Effective date Immunization Action Coalition Saint Paul, Minnesota Item #P3074a (8/15) PAGE 41

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47 Purpose Policy Procedure Standing orders for other vaccines are available at note: This standing orders template may be adapted per a practice s discretion without obtaining permission from IAC. As a courtesy, please acknowledge IAC as its source. standing orders for Administering Meningococcal ACWY Vaccine to Children and Teens To reduce morbidity and mortality from meningococcal disease caused by serotypes A, C, W, or Y by vaccinating all children and teens who meet the criteria established by the Centers for Disease Control and Prevention s Advisory Committee on Immunization Practices. Where allowed by state law, standing orders enable eligible nurses and other healthcare professionals (e.g., pharmacists) to assess the need for and vaccinate children and teens who meet any of the criteria below. 1 Assess children and teens for need of vaccination against meningococcal disease according to the following criteria: Routine meningococcal ACWY vaccination Age years and not previously vaccinated As catch-up for ages years and not previously vaccinated Age 16 through 18 years and in need of dose #2 As catch-up for unvaccinated teens ages 16 through 18 years First-year college students age 19 through 21 years living in a residence hall who were never vaccinated or who were last vaccinated when younger than age 16 years Risk-based meningococcal ACWY vaccination Age 2 months and older with diagnosis of persistent complement component deficiency (an immune system disorder) or diagnosis of anatomic or functional asplenia (including sickle-cell disease); children who are part of an outbreak attributable to a vaccine serogroup; or anticipated travel to a country where meningococcal disease is hyperendemic or epidemic (e.g., the meningitis belt of sub-saharan Africa), particularly if contact with the local population will be prolonged 2 Screen for contraindications and precautions Contraindications: a history of a serious allergic reaction (e.g., anaphylaxis) after a previous dose of meningococcal vaccine or to a meningococcal vaccine component. For information on vaccine components, refer to the manufacturer s package insert ( or go to downloads/appendices/b/excipient-table-2.pdf. Precaution: moderate or severe acute illness with or without fever 3 Provide Vaccine Information Statements Provide all patients (or, in the case of a minor, their parent or legal representative) with a copy of the most current federal Vaccine Information Statement (VIS) available at You must document in the patient s medical record or office log, the publication date of the VIS and the date it was given to the patient (parent/legal representative). Provide non-english speaking patients with a copy of the VIS in their native language, if one is available and desired; these can be found at 4 Prepare to Administer Vaccine Choose the needle gauge, needle length, and injection site according to the following chart: Provider Background & Additional Resources age of patient needle gauge needle length injection site Adolescents (age years) * 1 Deltoid muscle of arm Children (age 3 10 years) * 1 Deltoid muscle of arm Toddlers (age 1 2 years) ¼ Anterolateral thigh muscle Infants (age 2 12 months) Anterolateral thigh muscle * A 5 8 needle may be used in patients weighing less than 130 lbs (<60 kg) for IM injection in the deltoid muscle only if the skin is stretched tight, the subcutaneous tissue is not bunched, and the injection is made at a 90-degree angle to the skin. Technical content reviewed by the Centers for Disease Control and Prevention Immunization Action Coalition Saint Paul, Minnesota Item #P3081a (7/15) PAGE 43

48 Provider Background & Additional Resources Standing Orders for Administering Meningococcal ACWY Vaccine to Children and Teens (continued) page 2 of 2 5 Administer 0.5 ml vaccine via the intramuscular (IM) route Schedule and criteria for routine vaccination with MenACWY age of patient For preteens age 11 through 12 years For teens age 13 through 15 years schedule Give dose #1 of 2-dose MenACWY series. 1 (Dose #2 will be due at age 16 years.) Give catch-up dose #1 of 2-dose MenACWY series. 1 (Dose #2 will be due at age 16 years) For teens age 16 through 18 years Give dose #2 of MenACWY. Separate from dose #1 by at least 8 weeks. 1 Catch-up for teens age 16 through 18 years If no history of prior vaccination with MenACWY, give 1 dose of MenACWY. For first year college students, age 19 If no history of prior vaccination with MenACWY, give 1 dose of MenACWY. 1 through 21 years, living in residence halls If history of 1 dose of MenACWY given when younger than age 16 years, give dose #2 of MenACWY If person is HIV-positive, give 2 doses, 2 months apart. 2. The minimum interval between doses of MenACWY is 8 weeks. Schedule and criteria for MenACWY vaccination in people with underlying medical conditions or other risk factors For children, adolescents, and teens with risk factors as identified in section 1 on the previous page, refer to Menin gococcal Vaccination Recommendations by Age and Risk Factor for Serogroups A, C, W, or Y Protection found at 6 Document Vaccination Document each patient s vaccine administration information and any needed follow-up in the following places: Medical chart: Record the date the vaccine was administered, the manufacturer and lot number, the vaccination site and route, and the name and address and, if appropriate, the title of the person administering the vaccine. If vaccine was not given, record the reason(s) for non-receipt of the vaccine (e.g., medical contraindication, patient refusal). Personal immunization record card: Record the date of vaccination and the name/location of the administering clinic. Immunization Information System (IIS) or registry : Report the vaccination to the appropriate state/local IIS, if available. 7 Be Prepared to Manage Medical Emergencies Be prepared for management of a medical emergency related to the administration of vaccine by having a written emergency medical protocol available, as well as equipment and medications. For IAC s Medical Management of Vaccine Reactions in Children and Teens, go to To prevent syncope in older children, vaccinate patients while they are seated or lying down and consider observing them for 15 minutes after receipt of the vaccine. 8 Report Adverse Events to VAERS Report all adverse events to meningococcal vaccine to the federal Vaccine Adverse Event Reporting System (VAERS) at or by calling (800) VAERS report forms are available at Standing Orders Authorization This policy and procedure shall remain in effect for all patients of the name of practice or clinic until rescinded or until date. Medical Director s signature Signature date Effective date PAGE 44 Immunization Action Coalition Saint Paul, Minnesota Item #P3081a (7/15)

49 Meningococcal Vaccine Recommendations by Age and Risk Factor for Serogroups A, C, W, or Y Protection For preteens age 11 through 12 years For teens age 13 through 15 years For teens age 16 through 18 years Catch-up for teens age 16 through 18 years For first year college students, age 19 through 21 years, living in residence halls A separate vaccine is needed for protection against meningococcal serogroup B disease. MenACWY = Menactra (sanofi) and Menveo (Novartis) MenACWY-D = Menactra Hib-MenCY = MenHibrix (GlaxoSmithKline) MenACWY-CRM = Menveo MPSV = Menomune (sanofi) Routine Recommendations for Quadrivalent Meningococcal Conjugate Vaccine (MenACWY) Give dose #1 of 2-dose MenACWY series.1 (Dose #2 will be due at age 16 years.) Give catch-up dose #1 of 2-dose MenACWY series. (Dose #2 will be due at age 16 years.) Give dose #2 of MenACWY. Separate from dose #1 by at least 8 weeks. If no history of prior vaccination with MenACWY, give 1 dose of MenACWY. If no history of prior vaccination with MenACWY, give 1 dose of MenACWY.1 If history of 1 dose of MenACWY given when younger than age 16 years, give dose #2 of MenACWY.2 Provider Background & Additional Resources Risk-based Recommendations for Persons with Underlying Medical Conditions or Other Risk Factors targeted group by age and/or risk factor primary dose(s) booster dose(s) Travelers to or residents of countries where meningococcal disease is hyperendemic or epidemic, 3 people present during outbreaks caused by a vaccine serogroup, 4 and other people with prolonged increased risk for exposure (e.g., microbiologists routinely working with Neisseria meningitidis) For children age 2 through 18 months For children age 7 through 23 months who have not initiated a series of MenACWY-CRM or Hib-MenCY For age 2 through 55 years If no previous MenACWY dose and either shortterm travel or outbreak-related, give 1 dose For age 56 years and older of MPSV; all others, give 1 dose of MenACWY. People with persistent complement component deficiencies 10 For age 2 through 18 months For children age 7 through 23 months who have not initiated a series of MenACWY-CRM or Hib-MenCY For ages 2 through 55 years Give 2 doses of MenACWY, 2 months apart. For age 56 years and older Give 2 doses of MenACWY, 2 months apart. People with functional or anatomic asplenia, including sickle cell disease For children age 2 through 18 months For children age 19 through 23 months who have not initiated a series of MenACWY-CRM or Hib-MenCY For children age 2 through 55 years For age 56 years and older Give MenACWY-CRM at ages 2, 4, 6 and months. 5 Give 2 doses, separated by 3 months, 6 of MenACWY-CRM (if age 7 23 months) 7 or MenACWY-D (if age 9 23 months). Give 1 dose of MenACWY. 1 Give MenACWY-CRM or Hib-MenCY at ages 2, 4, 6 and months Give 2 doses, separated by 3 months, of MenACWY-CRM (if age 7 23 months) 7 or MenACWY-D (if age 9 23 months). Give MenACWY-CRM or Hib-MenCY at ages 2, 4, 6 and months. Give 2 doses of MenACWY-CRM, 3 months apart. Give 2 doses of MenACWY, 2 months apart. 12 Give 2 doses of MenACWY, 2 months apart. If risk continues, give initial booster after 3 years followed by boosters every 5 years. Boost every 5 years with MenACWY. 8,9 Boost every 5 years with MenACWY. 9 Give MenACWY booster after 3 years followed by boosters every 5 years thereafter. Boost every 5 years with MenACWY. 8,11 Boost every 5 years with MenACWY. 11 Give MenACWY booster after 3 years followed by boosters every 5 years thereafter. Boost every 5 years with MenACWY. 8,11 Boost every 5 years with MenACWY. 11 footnotes 1. If the person is HIV-positive, give 2 doses, 2 months apart. 2. The minimum interval between doses of MenACWY is 8 weeks. 3. Prior receipt of Hib-MenCY is not sufficient for children traveling to the Hajj or African meningitis belt as it doesn t provide protection against serogroups A or W. 4. Seek advice of local public health authorities to determine if vaccination is recommended. 5. Children ages 2 through 18 months who are present during outbreaks caused by serogroups C or Y may be given an age-appropriate series of Hib-MenCY. 6. If a child age 7 through 23 months will enter an endemic area in less than 3 months, give doses as close as 2 months apart. 7. If using MenACWY-CRM, dose 2 should be given no younger than age 12 months. 8. If primary dose(s) given when younger than age 7 years, give initial booster after 3 years, followed by boosters every 5 years. 9. Booster doses are recommended if the person remains at increased risk. 10. Persistent complement component deficiencies include C3, C5 C9, properdin, factor H, and factor D. 11. If the person received a 1-dose primary series, give booster at the earliest opportunity, then boost every 5 years. 12. Children with functional or anatomic asplenia should complete an age-appropriate series of PCV13 vaccine before vaccination with MenACWY-D; MenACWY-D should be given at least 4 weeks following last dose of PCV13. MenACWY-CRM or Hib-MenCY may be given at any time before or after PCV13. Technical content reviewed by the Centers for Disease Control and Prevention Immunization Action Coalition Saint Paul, Minnesota Item #P2018 (7/15) PAGE 45

50 Provider Background & Additional Resources Standing Orders for Administering Tdap/Td to Children Age 7 Years and Older Purpose: To reduce morbidity and mortality from tetanus, diphtheria, and pertussis by vaccinating all children and teens who meet the criteria established by the Centers for Disease Control and Prevention s Advisory Committee on Immunization Practices. Policy: Under these standing orders, eligible nurses and other healthcare professionals (e.g., pharmacists), where allowed by state law, may vaccinate children and teens who meet the criteria below. Procedure 1. Identify children and teens age 7 years and older in need of vaccination against diphtheria, tetanus, and pertussis based on the following criteria: a. lack of documentation of at least 4 doses of diphtheria, tetanus, and pertussis vaccine, with at least one of the doses given after age 4 years and with the most recent dose given a minimum of 4 calendar months after the preceding dose, b. lack of documentation of at least 3 doses of diphtheria and tetanus vaccine (i.e., DT, Td), c. lack of history of pertussis-containing vaccine given at age 10 years or older, d. currently pregnant and no documentation of Tdap given during the current pregnancy, or e. completion of a 3-dose primary series of diphtheria and tetanus toxoid-containing vaccine with receipt of the last dose being 10 years ago or longer. 2. Screen all patients for contraindications and precautions to Td or Tdap: a. Contraindications: a history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose of Td or to a Td or Tdap component. For a list of vaccine components, go to for Tdap only, a history of encephalopathy within 7 days following DTP/DTaP/Tdap not attributable to another identifiable cause b. Precautions: history of Guillain-Barré syndrome within 6 weeks of previous dose of tetanus toxoid-containing vaccine history of an arthus-type hypersensitivity reaction following a previous dose of tetanus or diphtheria toxoid-containing vaccine; defer vaccination until at least 10 years have elapsed since the last tetanus toxoid-containing vaccine moderate or severe acute illness with or without fever For Tdap only, progressive or unstable neurologic disorder, uncontrolled seizures, or progressive encephalopathy until a treatment regimen has been established and the condition has stabilized 3. Provide all patients (or, in the case of minors, their parent or legal representative) with a copy of the most current federal Vaccine Information Statement (VIS). You must document, in the patient s medical record or office log, the publication date of the VIS and the date it was given to the patient (parent/legal representative). Provide non-english speaking patients with a copy of the VIS in their native language, if available and preferred; these can be found at 4. Administer 0.5 ml Td (or a one-time dose of Tdap, if indicated) intramuscularly (22 25g, 1 1½" needle) in the deltoid muscle; the anterolateral thigh muscle may be used if deltoid is inadequate. (Note: a e" needle may be used for patients weighing less than 130 lbs [60 kg] for injection in the deltoid muscle only if the subcutaneous tissue is not bunched and the injection is made at a 90 degree angle.) 5. Schedule vaccination as follows: a. For children and teens age 7 years and older who meet the criteria described in 1 above, administer one dose at the earliest opportunity and then complete the remaining doses (as needed) by observing minimum intervals of 4 weeks between the first and second doses, and 6 calendar months between the second and third doses. A dose of Tdap should be substituted for one of the doses of Td, preferably the first. b. For children and teens age 11 through 18 years without a history of pertussis-containing vaccine given at age 7 years or older, administer Tdap routinely at age 11 through 12 years or as catch-up at 13 through 18 years; no minimum interval since previous Td needs to be observed. c. For pregnant adolescents, administer Tdap during each pregnancy (preferably during 27 through 36 weeks gestation), regardless of number of years since prior Td or Tdap vaccination. d. Administer further boosters as Td every 10 years. 6. Document each patient s vaccine administration information and follow up in the following places: a. Medical chart: Record the date the vaccine was administered, the manufacturer and lot number, the vaccination site and route, and the name and title of the person administering the vaccine. If vaccine was not administered, record the reason(s) for non-receipt of the vaccine (e.g., medical contraindication, patient refusal). b. Personal immunization record card: Record the date of vaccination and the name/location of the administering clinic. 7. Be prepared for management of a medical emergency related to the administration of vaccine by having a written emergency medical protocol available, as well as equipment and medications. To prevent syncope, vaccinate patients while seated or lying down and consider observing them for 15 minutes after receipt of the vaccine. 8. Report all adverse reactions to Td and Tdap vaccines to the federal Vaccine Adverse Event Reporting System (VAERS) at or (800) VAERS report forms are available at This policy and procedure shall remain in effect for all patients of the until rescinded or until (date). (name of practice or clinic) Medical Director s signature: Effective date: For standing orders for other vaccines, go to Technical content reviewed by the Centers for Disease Control and Prevention Item #P3078a (4/13) PAGE 46 Immunization Action Coalition 1573 Selby Ave. St. Paul, MN (651)

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53 Human Papillomavirus A Parent s Guide to Preteen and Teen HPV Vaccination HPV Why vaccinate against HPV at 11 or 12 years of age? The vaccine produces better immunity to fight infection when given at younger ages compared with older ages. Vaccination for HPV is much more effective at preventing disease and cancer if all three doses are administered before someone s first sexual contact. Most American men and women who become sexually active will contract at least one type of HPV virus in their lifetime. Vaccination can reduce their risk of HPV infection. Most people who become infected with HPV do not even know it. HPV is easily spread by skin-to-skin contact during sexual activity. Even if someone does not have sexual intercourse, they can still get HPV. People who choose to have only one lifetime sex partner can still get HPV if their partner has had previous partners who were infected. Both vaccines have been tested in thousands of people around the world and have been proven to have no serious side effects. Both vaccines are highly effective against HPV types that cause most cervical cancers; one of the vaccines, Gardasil, also protects against 90 percent of HPV-associated genital warts. What is HPV? Human papillomavirus (HPV) is a common family of viruses that causes infection of the skin or mucous membranes of various areas of the body. There are over 100 different types of HPV viruses. Different types of HPV infection affect different areas of the body. For instance, some types of HPV cause warts in the genital area and other types can lead to abnormal cells on the cervix, vulva, anus, penis, mouth, and throat, sometimes leading to cancer. How common is HPV? HPV is very common. According to the Centers for Disease Control and Prevention (CDC), most sexually active American men and women will contract at least one type of HPV virus during their lifetime. HPV is considered the most common sexually transmitted disease in the United States. It is the cause of almost all cervical cancers in women and has been linked to the rise of oral cancers in young people in the United States. How serious is HPV? HPV is extremely serious. Approximately 79 million Americans are currently infected with HPV, and about 14 million more become infected each year. In the United States, there are around 12,000 new cervical cancer cases diagnosed annually, and 4,000 women die from cervical cancer every year. Men are affected too. Around 7,000 HPV-associated cancer cases occur in American men each year. How is HPV spread? The most common ways to get an HPV infection is from vaginal or anal sex with an infected person; however, this is NOT the only way to get HPV. Infection can also be acquired from oral sex and any skin-to-skin contact with areas infected by HPV. It is possible to have HPV and not know it, so a person can unknowingly spread HPV to another person. continued on page 2 Vaccine Information for Parents Technical content reviewed by the Centers for Disease Control and Prevention Immunization Action Coalition St. Paul, Minnesota Item #P4250 (11/13) PAGE 49

54 A Parents Guide to Preteen and Teen HPV Vaccination (continued) page 2 of 2 Vaccine Information for Parents Resources for more information Your healthcare provider or local health department CDC s information on vaccines and immunization: vaccines Immunization Action Coalition s vaccine information website: www. vaccineinformation.org Vaccine Education Center at the Children s Hospital of Philadelphia: CDC s Vaccines For Children (VFC) program: programs/vfc/index.html sources American College of Obstetricians and Gynecologists (ACOG) Committee on Adolescent Health Care. Fact Sheet: Human Papillomavirus. Centers for Disease Control and Prevention (CDC). National Center for Chronic Disease Prevention and Health Promotion. HPV and Cancer. CDC. National Center for Emerging and Zoonotic Infectious Diseases. Vaccine Safety: Human Papillomavirus Vaccine. vaccinesafety/vaccines/hpv-vaccine.html safety/vaccines/hpv/index.html CDC. National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. Genital HPV Infection Fact Sheet. STDFact-HPV.htm CDC. National Center for Immunization and Respiratory Diseases. HPV Vaccine-Questions and Answers. vac-faqs.htm CDC. National Center for Immunization and Respiratory Diseases. Preteens and Teens Need Vaccines Too! PreteenVaccines/index.html Reduction in human papillomavirus (HPV) prevalence among young women following HPV vaccine introduction in the United States, National Health and Nutrition Examination Surveys, J Infect Dis Aug 1; 208(3): Related press release: releases/2013/p0619-hpv-vaccinations.html Talk to your healthcare provider today about protecting your son or daughter from HPV infection! Can HPV infection be treated? There is no treatment for HPV infection; there are only treatments available for the health problems that HPV can cause, such as genital warts, cervical changes, and cervical cancer. In some cases, the body fights off the virus naturally. In cases where the virus cannot be fought off naturally, the body is at risk for serious complications, including cancer. What is HPV vaccine? There are two HPV vaccines licensed by the Food and Drug Administration (FDA) and recommended by CDC: Cervarix and Gardasil. Both vaccines protect against cervical cancers in women. One vaccine, Gardasil, also protects against genital warts and cancers of the anus, vagina, and vulva. Both vaccines are available for females. Only Gardasil is available for males. HPV vaccines are given in three shots over six months; it is important to get all three doses to get the best protection. At what age should my son or daughter get HPV vaccine? Routine vaccination with three doses of HPV vaccine is recommended for all 11- and 12-year-old boys and girls. The vaccines can be given as early as 9 years of age. If your son or daughter did not receive the three doses of vaccine at the recommended age, they should still start or complete their HPV vaccine series. Your son can be given the vaccine through the age of 21, and your daughter can be given the vaccine through the age of 26. Check with your healthcare provider to make sure your child is up to date with HPV vaccination. For HPV vaccine to work best, it is very important for preteens to get all three doses before any sexual activity begins. It is possible to get infected with HPV the very first time they have sexual contact with another person, even if they do not have intercourse. Also, the vaccine produces better immunity to fight infection when given at the younger ages compared to the older ages. Are HPV vaccines safe? HPV vaccines have been shown to be very safe. Every vaccine used in the United States is required to go through rigorous safety testing before licensure by the FDA. Both HPV vaccines have been extensively tested in clinical trials with more than 28,000 male and female participants. Since the first HPV vaccine was licensed for use in 2006, more than 50 million doses of HPV vaccine have been distributed in the United States. Now in routine use, these vaccines are continually monitored for safety. In the years of HPV vaccine safety monitoring, no serious safety concerns have been identified. Like other vaccinations, most side effects from HPV vaccination are mild, including fever, headache, and pain and redness in the arm where the shot was given. Are HPV vaccines effective? The vaccines have been shown to be highly effective in protecting against the HPV types targeted by the vaccines. A study looking at HPV infections in girls and women before and after the introduction of HPV vaccines shows a significant reduction in vaccine-type HPV in U.S. teens since the vaccine was introduced. Adapted from a publication developed by the Michigan Department of Community Health, Division of Immunization Immunization Action Coalition St. Paul, Minnesota Item #P4250 (11/13) PAGE 50

55 DISEASES and the VACCINES THAT PREVENT THEM INFORMATION FOR PARENTS HPV Vaccine for Preteens and Teens Last updated JULY 2015 Why does my child need HPV vaccine? This vaccine is for protection from most of the cancers caused by human papillomavirus (HPV) infection. HPV is a very common virus that spreads between people when they have sexual contact with another person. About 14 million people, including teens, become infected with HPV each year. HPV infection can cause cervical, vaginal, and vulvar cancers in women and penile cancer in men. HPV can also cause anal cancer, throat cancer, and genital warts in both men and women. When should my child be vaccinated? The HPV vaccine is recommended for preteen boys and girls at age 11 or 12 so they are protected before ever being exposed to the virus. HPV vaccine also produces a higher immune response in preteens than in older adolescents. If your teen hasn t gotten the vaccine yet, talk to their doctor about getting it for them as soon as possible. HPV vaccination is a series of shots given over several months. The best way to remember to get your child all of the shots they need is to make an appointment for the remaining shots before you leave the doctor s office or clinic. What else should I know about HPV vaccine? Girls need HPV vaccination to prevent HPV infections that can cause cancers of the anus, cervix, vagina, vulva, and the mouth/throat area. Boys need HPV vaccination to prevent HPV infections that can cause cancers of the anus, penis, and the mouth/throat area. HPV vaccination can also prevent genital warts. HPV vaccines have been studied very carefully. These studies showed no serious safety concerns. Common, mild adverse events (side effects) reported during these studies include pain in the arm where the shot was given, fever, dizziness and nausea. Some preteens and teens might faint after getting the HPV vaccine or any shot. Preteens and teens should sit or lie down when they get a shot and stay like that for about 15 minutes after the shot. This can help prevent fainting and any injury that could happen while fainting. Serious side effects from the HPV vaccine are rare. It is important to tell the doctor or nurse if your child has any severe allergies, including an allergy to latex or yeast. HPV vaccine is not recommended for anyone who is pregnant. HPV vaccination is recommended by the Centers for Disease Control and Prevention (CDC), the American Academy of Family Physicians, the American Academy of Pediatrics, and the Society for Adolescent Health and Medicine. How can I get help paying for these vaccines? The Vaccines for Children (VFC) program provides vaccines for children ages 18 years and younger, who are not insured, Medicaid-eligible, American Indian or Alaska Native. You can find out more about the VFC program by going online to and typing VFC in the search box. Where can I learn more? For more information about HPV vaccines and the other vaccines for preteens and teens, talk to your child s doctor or nurse. More information is also available on CDC s Vaccines for Preteens and Teens website at Vaccine Information for Parents CS _B DISTRIBUTED BY: U.S. Department of Health and Human Services Centers for Disease Control and Prevention PAGE 51

56 Actualizado en junio de 2014 ENFERMEDADES y las VACUNAS QUE LAS PREVIENEN INFORMACIÓN PARA LOS PADRES La vacuna contra el VPH para preadolescentes y adolescentes Vaccine Information for Parents Por qué mi hijo/hija necesita la vacuna VPH? Esta vacuna protege contra la mayoría de los cánceres causados por la infección del virus del papiloma humano (VPH o HPV, por sus siglas en inglés). El VPH es un virus muy común que se contagia entre las personas cuando tienen contacto sexual con otra persona. Cada año, alrededor de 14 millones de personas, incluyendo a los adolescentes, se infectan con el VPH. La infección por el VPH puede causar cánceres del cuello del útero, de vagina y de vulva en las mujeres y cáncer del pene en los hombres. El VPH también puede causar cáncer anal, cáncer de la garganta y verrugas genitales tanto en los hombres como en las mujeres. Cuándo se debe vacunar mi hijo/hija? Se recomienda que los preadolescentes, tanto varones como mujeres, se pongan la vacuna contra el VPH a la edad de 11 o 12 años de modo que queden protegidos antes de que se expongan al virus. La vacuna contra el VPH también produce una respuesta inmunitaria más intensa en los preadolescentes que en los adolescentes mayores. Si su adolescente no se haya puesto la vacuna todavía, hable con su médico para que se la pongan lo más pronto posible. La vacuna contra el VPH se administra en 3 dosis. La segunda dosis se debe poner 1 o 2 meses después de la primera y la tercera dosis se debe administrar 6 meses después de la primera. Qué más debo saber sobre la vacuna contra el VPH? Hay dos vacunas contra el VPH. Las niñas entre 11 o 12 años de edad) y las mujeres jóvenes entre 13 y 26 años se deben poner cualquiera de ellas para prevenir el cáncer del cuello del útero. Una de las vacunas también protege contra las verrugas genitales y el cáncer anal tanto en las mujeres como en los hombres. Los niños deben ponerse esta vacuna VPH para prevenir el cáncer anal y las verrugas genitales. Las niñas se pueden poner esta vacuna para prevenir el cáncer del cuello del útero, el cáncer anal y las verrugas genitales. Se ha realizado estudios muy cuidadosos de ambas vacunas contra el VPH y dichos estudios han mostrado que no existe ninguna preocupación grave de seguridad con ellas. Algunos efectos secundarios que se han notificado en estos estudios incluyen dolor en el brazo, en el sitio que se ha puesto la inyección, fiebre, mareos y náusea. Algunos preadolescentes y adolescentes se pueden desmayar luego de recibir la vacuna contra el VPH o cualquier otra vacuna. Los preadolescentes y los adolescentes se deben sentar o recostar cuando se les pone la vacuna y quedarse así por alrededor de 15 minutos después de recibir la inyección. Esto puede ayudar a prevenir los desmayos o cualquier otra lesión que les podría ocurrir al desmayarse. Los efectos secundarios graves de la vacuna contra el VPH son raros. Es importante decirle al doctor o el enfermero de su hijo si tiene alguna alergia severa, entre ellas, alergia contra el látex o la levadura. No se recomienda poner la vacuna contra el VPH a las mujeres que están embarazadas. Los Centros pare el Control y la Prevención de Enfermedades (CDC, por sus siglas en inglés), la Academia Estadounidense de Médicos de Familia, la Academia Americana de Pediatría y la Sociedad de Salud y Medicina para Adolescentes recomiendan vacunas contra el VPH. Cómo puedo obtener ayuda para pagar por estas vacunas? El programa de Vacunas para Niños (VFC, por sus siglas en inglés) proporciona vacunas para niños de hasta 18 años que no tengan seguro, que cumplan con los requisitos para recibir Medicaid o que sean indoamericanos o nativos de Alaska. Puede averiguar más sobre el programa VFC en Internet en ProgramaVacunas. Dónde puedo obtener más información? Para obtener más información sobre las vacunas HPV y las demás vacunas para los preadolescentes y los adolescentes hable con el médico o el enfermero de su hijo. Usted también puede obtener más información disponible en el sitio web Vacunas para Preadolescentes y Adolescentes de los CDC en la siguiente dirección: VacunasPreadolescentes/. CS C DISTRIBUIDO POR: U.S. Department of Health and Human Services Centers for Disease Control and Prevention PAGE 52

57 DISEASES and the VACCINES THAT PREVENT THEM INFORMATION FOR PARENTS Vaccines for Preteens and Teens: What Parents Should Know Last updated JUNE 2014 Why does my child need vaccines now? Vaccines aren t just for babies. Some of the vaccines that babies get can wear off as kids get older. And as kids grow up they may come in contact with different diseases than when they were babies. There are vaccines that can help protect your preteen or teen from these other illnesses. What vaccines does my child need? Tdap Vaccine This vaccine helps protect against three serious diseases: tetanus, diphtheria, and pertussis (whooping cough). Preteens should get Tdap at age 11 or 12. If your teen didn t get a Tdap shot as a preteen, ask the their doctor or nurse about getting the shot now. Meningococcal Vaccine Meningococcal conjugate vaccine protects against some of the bacteria that can cause meningitis (swelling of the lining around the brain and spinal cord) and septicemia (an infection in the blood). Preteens need the first meningococcal shot when they are 11 or 12 years old and a second meningococcal shot at age 16. Teens who got the meningococcal shot when they were 13, 14, or 15 years old should still get a second shot at age 16. Older teens who haven t gotten any meningococcal shots should get one dose as soon as possible. HPV Vaccine Human papillomavirus (HPV) vaccines help protect both girls and boys from HPV infection and cancer caused by HPV. Two HPV vaccines protect girls from the types of HPV that cause most cervical cancer. One HPV vaccine also helps protect both girls and boys from anal cancer and genital warts. HPV vaccines are given to preteens as 3 shots over 6 months when they are 11 or 12 years old. Preteens and teens who haven t started or finished the HPV vaccine series should ask the doctor or nurse about getting them now. Flu Vaccine The annual flu vaccine is the best way to reduce the chances of getting seasonal flu and spreading it to others. Even healthy preteens and teens can get very sick from the flu and spread it to others. While all preteens and teens should get a flu vaccine, it s especially important for those with chronic health conditions such as asthma, diabetes, and heart disease to get vaccinated. The best time to get the flu vaccine is as soon after it s available in your community, ideally by October. While it s best to be vaccinated before flu begins causing illness in your community, flu vaccination can be beneficial as long as flu viruses are circulating, even in January or later. When should my child be vaccinated? A good time to get these vaccines is during a yearly health checkup. Your preteen or teen can also get these vaccines at a physical exam required for sports, school, or camp. It s a good idea to ask the doctor or nurse every year if there are any vaccines that your child may need. What else should I know about these vaccines? These vaccines have all been studied very carefully and are safe. They can cause mild side effects, like soreness or redness in the part of the arm where the shot was given. Some preteens and teens might faint after getting a shot. Sitting or lying down when getting a shot and then for about 15 minutes after the shot, can help prevent fainting. Serious side effects are rare. It is very important to tell the doctor or nurse if your child has any serious allergies, including allergies to yeast, latex, or chicken eggs, before they receive any shots. How can I get help paying for these vaccines? The Vaccines for Children (VFC) program provides vaccines for children ages 18 years and younger, who are not insured, Medicaid-eligible, American Indian or Alaska Native. You can find out more about the VFC program by going online to www. cdc.gov and typing VFC in the search box. Where can I learn more? Talk to your child s doctor or nurse about what vaccines they may need. You can also find more information about these vaccines on CDC s Vaccines for Preteens and Teens website at Vaccine Information for Parents CS _D DISTRIBUTED BY: U.S. Department of Health and Human Services Centers for Disease Control and Prevention PAGE 53

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59 Understanding How Vaccines Work Last reviewed Februar y 2013 For more information on vaccines, vaccine-preventable diseases, and vaccine safety: Diseases that vaccines prevent can be dangerous, or even deadly. Vaccines greatly reduce the risk of infection by working with the body s natural defenses to safely develop immunity to disease. This fact sheet explains how the body fights infection and how vaccines work to protect people by producing immunity. The Immune System The Body s Defense Against Infection To understand how vaccines work, it is helpful to first look at how the body fights illness. When germs, such as bacteria or viruses, invade the body, they attack and multiply. This invasion is called an infection, and the infection is what causes illness. The immune system uses several tools to fight infection. Blood contains red blood cells, for carrying oxygen to tissues and organs, and white or immune cells, for fighting infection. These white cells consist primarily of B-lymphocytes, T-lymphocytes, and macrophages: Macrophages are white blood cells that swallow up and digest germs, plus dead or dying cells. The macrophages leave behind parts of the invading germs called antigens. The body identifies antigens as dangerous and stimulates the body to attack them. Antibodies attack the antigens left behind by the macrophages. Antibodies are produced by defensive white blood cells called B-lymphocytes. T-lymphocytes are another type of defensive white blood cell. They attack cells in the body that have already been infected. The first time the body encounters a germ, it can take several days to make and use all the germ-fighting tools needed to get over the infection. After the infection, the immune system remembers what it learned about how to protect the body against that disease. The body keeps a few T-lymphocytes, called memory cells that go into action quickly if the body encounters the same germ again. When the familiar antigens are detected, B-lymphocytes produce antibodies to attack them. How Vaccines Work Vaccines help develop immunity by imitating an infection. This type of infection, however, does not cause illness, but it does cause the immune system to produce T-lymphocytes and antibodies. Sometimes, after getting a vaccine, the imitation infection can cause minor symptoms, such as fever. Such minor symptoms are normal and should be expected as the body builds immunity. Once the imitation infection goes away, the body is left with a supply of memory T-lymphocytes, as well as B-lymphocytes that will remember how to fight that disease in the future. However, it typically takes a few weeks for the body to produce T-lymphocytes and B-lymphocytes after vaccination. Therefore, it is possible that a person who was infected with a disease just before or just after vaccination could develop symptoms and get a disease, because the vaccine has not had enough time to provide protection. Types of Vaccines Scientists take many approaches to designing vaccines. These approaches are based on information about the germs (viruses or bacteria) the vaccine will prevent, such as how it infects cells and how the immune system responds to it. Practical considerations, such as regions of the world where the vaccine would be used, are also important because the strain of a virus and environmental conditions, such as temperature and risk of exposure, may be different in various parts of the world. The vaccine delivery options available may also differ geographically. Today there are five main types of vaccines that infants and young children commonly receive: Live, attenuated vaccines fight viruses. These vaccines contain a version of the living virus that has been weakened so that it does not cause serious disease in people with healthy immune systems. Because live, attenuated vaccines are the closest thing to a natural infection, they are good teachers for the immune system. Examples of live, attenuated vaccines include measles, mumps, B Vaccine Information for Parents PAGE 55

60 Vaccine Information for Parents Types of Vaccines continued and rubella vaccine (MMR) and varicella (chickenpox) vaccine. Even though these vaccines are very effective, not everyone can receive them. Children with weakened immune systems for example, those who are undergoing chemotherapy cannot get live vaccines. Inact ivated vaccines also fight viruses. These vaccines are made by inactivating, or killing, the virus during the process of making the vaccine. The inactivated polio vaccine is an example of this type of vaccine. Inactivated vaccines produce immune responses in different ways than live, attenuated vaccines. Often, multiple doses are necessary to build up and/or maintain immunity. Toxoid vaccines prevent diseases caused by bacteria that produce toxins (poisons) in the body. In the process of making these vaccines, the toxins are weakened so they cannot cause illness. Weakened toxins are called toxoids. When the immune system receives a vaccine containing a toxoid, it learns how to fight off the natural toxin. The DTaP vaccine contains diphtheria and tetanus toxoids. Subunit vaccines include only parts of the virus or bacteria, or subunits, instead of the entire germ. Because these vaccines contain only the essential antigens and not all the other molecules that make up the germ, side effects are less common. The pertussis (whooping cough) component of the DTaP vaccine is an example of a subunit vaccine. Conjugate vaccines fight a different type of bacteria. These bacteria have antigens with an outer coating of sugar-like substances called polysaccharides. This type of coating disguises the antigen, making it hard for a young child s immature immune system to recognize it and respond to it. Conjugate vaccines are effective for these types of bacteria because they connect (or conjugate) the polysaccharides to antigens that the immune system responds to very well. This linkage helps the immature immune system react to the coating and develop an immune response. An example of this type of vaccine is the Haemophilus influenzae type B (Hib) vaccine. Vaccines Require More Than One Dose There are four reasons that babies and even teens or adults for that matter who receive a vaccine for the first time may need more than one dose: For some vaccines (primarily inactivated vaccines), the first dose does not provide as much immunity as possible. So, more than one dose is needed to build more complete immunity. The vaccine that protects against the bacteria Hib, which causes meningitis, is a good example. In other cases, such as the DTaP vaccine, which protects against diphtheria, tetanus, and pertussis, the initial series of four shots that children receive as part of their infant immunizations helps them build immunity. After a while, however, that immunity begins to wear off. At that point, a booster dose is needed to bring immunity levels back up. This booster dose is needed at 4 years through 6 years old for DTaP. Another booster against these diseases is needed at 11 years or 12 years of age. This booster for older children and teens and adults, too is called Tdap. For some vaccines (primarily live vaccines), studies have shown that more than one dose is needed for everyone to develop the best immune response. For example, after one dose of the MMR vaccine, some people may not develop enough antibodies to fight off infection. The second dose helps make sure that almost everyone is protected. Finally, in the case of the flu vaccine, adults and children (older than 6 months) need to get a dose every year. Children 6 months through 8 years old who have never gotten the flu vaccine in the past or have only gotten one dose in past years need two doses the first year they are vaccinated against flu for best protection. Then, annual flu shots are needed because the disease-causing viruses may be different from year to year. Every year, the flu vaccine is designed to prevent the specific viruses that experts predict will be circulating. The Bottom Line Some people believe that naturally acquired immunity immunity from having the disease itself is better than the immunity provided by vaccines. However, natural infections can cause severe complications and be deadly. This is true even for diseases that most people consider mild, like chickenpox. It is impossible to predict who will get serious infections that may lead to hospitalization. Vaccines, like any medication, can cause side effects. The most common side effects are mild. However, many vaccine-preventable disease symptoms can be serious, or even deadly. Although many of these diseases are rare in this country, they do circulate around the world and can be brought into the U.S., putting unvaccinated children at risk. Even with advances in health care, the diseases that vaccines prevent can still be very serious and vaccination is the best way to prevent them. Adapted from the National Institute of Allergy and Infectious Diseases, Understanding Vaccines For more information on vaccines call 800-CDC-INFO ( ) or visit PAGE 56

61 Tdap Vaccine s a parent, you do everything you can to Aprotect your children s health. The Tdap vaccine can help protect not only your child s health but also the health of those around them, like babies who are too young to be vaccinated. Tdap and whooping cough The Tdap shot protects against three diseases: tetanus, diphtheria, and pertussis or whooping cough. Whooping cough is the most common of those diseases and spreads very easily through coughing and sneezing. It can cause a bad cough that makes someone gasp for air after coughing fits. This cough can last for many weeks, which can make preteens and teens miss school and other activities.though not very common, whooping cough can also lead to complications like cracked ribs and pneumonia, even among healthy preteens and teens. Whooping cough can be deadly for babies, especially those who are too young to have protection from their own vaccines.the majority of reported whooping cough deaths are in babies younger than 3 months old. Often babies get whooping cough from their older brothers or sisters, like preteens or teens, or other people in the family. DISEASES and the VACCINES THAT PREVENT THEM Updated November 2014 Tdap vaccination is recommended for preteens at ages All preteens should get one Tdap shot when they are 11 or 12 years old. If your teen is 13 years old up through 18 years old and hasn t gotten the vaccine yet, talk to their doctor about getting it for them right away. Babies and little kids get shots called DTaP to protect them from diphtheria, tetanus, and whooping cough. But as kids get older, the protection from the DTaP shots starts to wear off.this can put your preteen or teen at risk for serious illness.the Tdap vaccine is a booster shot that helps protect your preteen or teen from the same diseases that DTaP shots protect little kids from. Whooping cough vaccines work Even though whooping cough shots don t provide lifelong protection, on time vaccination can still help protect preteens from whooping cough. As a result of whooping cough vaccines, we no longer see 200,000 cases of whooping cough each year. Getting vaccinated is Vaccine Information for Parents Is Tdap vaccine safe? The Tdap shot has been studied very carefully and is safe. It is recommended by the Centers for Disease Control and Prevention, the American Academy of Family Physicians, the American Academy of Pediatrics, and the Society for Adolescent Health and Medicine. The Tdap vaccine can cause mild side effects, like redness and soreness in the arm where the shot was given, headache, fever, or tiredness. Some preteens and teens might faint after getting the Tdap vaccine or any other shot. To help avoid fainting, preteens and teens should sit or lie down when they get a shot and then for about 15 minutes after getting the shot. Serious side effects from reactions to the Tdap shot are rare. The Tdap vaccine can safely be given at the same time as the other recommended vaccines, including the HPV, meningococcal, and influenza vaccines. Learn more about all of the recommended preteen vaccines at DISTRIBUTED BY: PAGE 57

62 the best way to prevent whooping cough and its complications.those who get a whooping cough shot and still get whooping cough are much more likely to have a mild illness compared to those who never received the vaccine.vaccinated preteens and teens will have fewer coughing fits, shorter illness, and are less likely to crack a rib or develop pneumonia, among other benefits. Help paying for vaccines The Vaccines for Children (VFC) program provides vaccines for children ages 18 years and younger who are uninsured, Medicaid-eligible, or American Indian/Alaska Native. Learn more about the VFC program at gov/features/vfcprogram/ Whether you have insurance, or your child is VFCeligible, some doctors offices may also charge a fee to give the vaccines. Callie s story: Callie could have caught whooping cough from anyone. Vaccine Information for Parents On Christmas Eve 2009, Katie and Craig welcomed their daughter Callie Grace into the world. After trying for 5 years to have a child and suffering several miscarriages the couple considered Callie their miracle baby. Callie was born 6 weeks early, but she was healthy and strong and came home after only 2 weeks in the hospital. In January, when she was a month old, Callie developed a soft, dry cough. It sounded like when a child mimics their parent to get attention. I took her to the doctor, Katie recalls. The doctor did not find any serious signs of illness, so he sent them home. However, over the next couple of days, Callie s condition worsened. She continued to cough, and she also became pale, lethargic, and suddenly lost her healthy appetite. Katie took Callie back to the doctor, and while they waited, Callie stopped breathing. A nurse was able to get Callie breathing again, and they were rushed to the hospital by ambulance. At the hospital, nurses and doctors flocked to our room, Katie remembers. It was truly overwhelming. I was scared and Callie was screaming. Callie was admitted to the Pediatric Intensive Care Unit, where the staff ran tests to try to find out what was wrong. After a couple of days of monitoring, they started her on antibiotics, while still waiting on test results. During Callie s second day at the hospital, she seemed to be doing better and her parents were hopeful that she d recover. But the next night, Callie stopped breathing again. Family members watched helplessly from behind a glass wall as doctors tried for 45 minutes to revive her. Tragically, Callie could not be saved. She was only 5 weeks old. We never dreamed we d lose her, Katie said. A few days later, the family found out that whooping cough was the cause of Callie s death. We could not believe it, Katie says, We were so careful to not expose her to a lot of people, Katie says. The first dose of DTaP vaccine is recommended at 2 months of age but babies are not fully protected until they get all the recommended doses. Callie was too young to even get her first dose of DTaP. Babies need whooping cough vaccination on time, but there s another important way to protect them. Pregnant women should get Tdap in the 3rd trimester of each pregnancy. Family members and others who are around babies, including child and teenage siblings, should be up-to-date with whooping cough shots. Callie could have caught whooping cough from anyone even from someone in the hospital right after she was born. People with even a slight cough might have whooping cough but not know it. I urge people to be sure they get the Tdap booster shot, Katie says. Getting that shot could save a life. For more information about the vaccines recommended for preteens and teens: 800-CDC-INFO ( ) PAGE 58

63 Meningococcal Conjugate Vaccine As a parent, you do everything you can to protect your children s health now and for the future. The meningococcal conjugate vaccine (MenACYW) can protect your child from meningococcal disease, which can lead to death in as little as 48 hours. Meningococcal disease The meningococcal conjugate vaccine protects against four strains of the bacteria that cause meningococcal disease.these infections don t happen often, but are usually very dangerous when they do.the two most severe and common forms of meningococcal disease are meningitis and septicemia. Meningitis is an infection of the fluid and lining around the brain and spinal cord that can lead to brain damage, hearing loss, learning disabilities, and even death. Septicemia is a bloodstream infection, which can lead to loss of an arm or leg and even death. Even if they get treatment, about 1 in 10 people with meningococcal disease will die from it. The bacteria that cause meningococcal disease spread from person to person when people have close or lengthy contact with someone s saliva, like through kissing or coughing.teens and young adults are at increased risk for meningococcal disease. Living in close quarters, like in the same household, a dorm, or military barrack, can also increase the risk of getting meningococcal disease. Meningococcal disease can become very serious, very quickly.the meningococcal conjugate vaccine is the best way to protect teens from getting meningococcal disease. More about meningitis When someone has meningococcal meningitis, the protective membranes covering their brain and spinal cord, known as the meninges, become infected and swell.the symptoms of meningitis include sudden When does my child need the vaccine? DISEASES and the VACCINES THAT PREVENT THEM Updated November 2014 onset of fever, headache, and stiff neck.there are often additional symptoms, such as Nausea Vomiting Photophobia (increased sensitivity to light) Altered mental status (confusion) The symptoms of meningococcal meningitis can appear quickly or over several days.typically they develop within 3-7 days after exposure. If you think your child has any of these symptoms, call the doctor right away. More about septicemia When someone has meningococcal septicemia, the bacteria enter the bloodstream and multiply, damaging the walls of the blood vessels and causing bleeding into the skin and organs. Symptoms of septicemia may include: Fatigue Vomiting Cold hands and feet Cold chills Severe aches or pain in the muscles, joints, chest, or abdomen (belly) Rapid breathing Diarrhea In the later stages, a dark purple rash If you think your child has any of these symptoms, call the doctor right away. Preteens should get their first meningococcal shot when they are 11 or 12 years old, before they become teens and their risk is higher. Teens need a second shot when they are 16 years old, so they stay protected when their risk is the highest. Teens who got the meningococcal conjugate vaccine for the first time when they were 13, 14 or 15 years old should still get the second shot when they are 16 years old. If your teen never got the meningococcal shot, you should talk to their doctor about getting it as soon as possible. This is really important if they are about to move into a college residence hall as a first-year student or go into the military. Vaccine Information for Parents DISTRIBUTED BY: CS249472G PAGE 59

64 Is the meningococcal shot safe? Yes.The meningococcal conjugate vaccine has been studied very carefully and is safe and effective. It is recommended by the Centers for Disease Control and Prevention, the American Academy of Family Physicians, the American Academy of Pediatrics, and the Society for Adolescent Health and Medicine. Like many vaccines, the meningococcal shot may cause mild side effects, like redness and soreness where the shot was given (usually in the arm).a few people who get the vaccine will get a low-grade fever. Some preteens and teens might faint after getting the meningococcal conjugate vaccine or any shot.to help avoid fainting, preteens and teens should sit or lie down when they get a shot and then for about 15 minutes after getting the shot. Serious side effects from the vaccine are rare. The meningococcal conjugate vaccine can safely be given at the same time as the other recommended vaccines, including the HPV,Tdap, and influenza vaccines. Learn more about all of the recommended preteen vaccines at Help paying for vaccines The Vaccines for Children (VFC) program provides vaccines for children ages 18 years and younger who are uninsured, Medicaid-eligible, or American Indian/Alaska Native. Learn more about the VFC program at Features/VFCprogram VFCprogram/ Whether you have insurance, or your child is VFC-eligible, some doctors offices may also charge a fee to give the vaccines. Vaccine Information for Parents Kayla s story: Twelve hours later, I was fighting for my life. It was in the spring of 2000 when meningococcal disease forever altered the course of my life. One day in elementary school, I began feeling sick and went to see the school nurse. Suspecting it was the flu, the nurse sent me home to rest. Twelve hours later, I was fighting for my life. I woke up at 3 a.m. covered in a blotchy, purple rash and had difficulty walking. Panicked and desperate, I crawled to my parents room, so they could rush me to a hospital. The doctors told my parents that I had meningococcal disease and that I only had a 10 percent chance of survival. Ultimately, I spent a total of 11 months in the hospital receiving various surgeries, going through rehabilitation, and learning how to walk again. I don t go a single day without feeling the effects of this disease. I lost my legs below the knee, some of my fingers, and function in my kidneys. The disease moves so fast and can be deadly if not caught in time. When the doctors told me and my parents I had meningococcal disease, we had never heard of it nor that there was a vaccine that could have prevented it. Shortly after I got meningococcal disease, four girls in my city contracted the disease. Public health officials were able to trace the cases back to an outing that we all attended with our local girls club. It s a very real disease with very real symptoms. Vaccination is the best way to protect yourself and your loved ones against this serious disease. All preteens need the meningococcal vaccine to be protected from meningitis and septicemia. For more information about the vaccines recommended for preteens and teens: 800-CDC-INFO ( ) PAGE 60

65 DISEASES and the VACCINES THAT PREVENT THEM INFORMATION FOR PARENTS Flu Vaccine for Preteens and Teens Last updated JUNE 2014 Why does my child need the flu vaccine? The flu is an illness that infects the nose, throat, and lungs caused by influenza viruses. Flu spreads when infected people cough or sneeze. Flu can cause mild to severe illness, and in some cases it can cause death. While most preteens and teens who get sick with the flu recover within a couple of weeks, some will get complications like sinus infections, or pneumonia (a serious lung infection). Preteens and teens who have chronic health problems like diabetes (type 1 and 2) or asthma, are at a greater risk for complications from the flu, but even healthy adolescents can get very sick from the flu. The flu usually causes a cough, runny or stuffy nose, body aches, fatigue (tiredness) and sometimes fever. Flu spreads easily when sick people cough, sneeze, or talk. When should my child be vaccinated? Preteens and teens should get the flu vaccine every year, ideally by October. However, as long as flu viruses are circulating, vaccination should continue throughout the flu season, even in January or later. Flu vaccine is available at your child s doctor s office or clinic, and sometimes other places like the local health department, pharmacies, urgent care clinics, grocery stores, and schools. You can find a flu vaccination clinic near you with the vaccine finder at What else should I know about the flu vaccine? Flu vaccines can be given to preteens and teens in two ways: Most flu shots are made from killed flu viruses. This vaccine is a shot that is given in the arm. The nasal spray flu vaccine is made with live, but weakened, flu virus. This vaccine is sprayed up the nose. Preteens and teens with chronic health conditions, like asthma, diabetes, or heart disease should NOT get the nasal spray vaccine and instead get the flu shot. Talk to your child s doctor or nurse about which flu vaccine is best for your preteen or teen. Both types of flu vaccine have been studied carefully and are safe. They cannot cause the flu. The annual flu vaccine is recommended for preteens and teens by the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices, the American Academy of Family Physicians, the American Academy of Pediatrics, and the Society for Adolescent Health and Medicine. Both flu vaccines can sometimes cause mild, flu-like symptoms. The most common side effects from a flu shot are a sore arm and a low fever or achiness. The nasal spray flu vaccine might cause congestion, runny nose, sore throat, or cough. These mild effects usually go away a day or two after vaccination. Serious side effects from either type of flu vaccine are rare. It is very important to tell the doctor or nurse if your preteen or teen has a severe allergy to chicken eggs. How can I get help paying for these vaccines? The Vaccines for Children (VFC) program provides vaccines for children ages 18 years and younger, who are uninsured, Medicaid-eligible, American Indian or Alaska Native. You can find out more about the VFC program by visiting or typing VFC in the search box of the CDC homepage ( Where can I learn more? Talk to your child s doctor or nurse to learn more about the flu vaccine and any other vaccines your preteen or teen needs. There is more information about these vaccines on CDC s Vaccines for Preteens and Teens website at Vaccine Information for Parents CS _E DISTRIBUTED BY: U.S. Department of Health and Human Services Centers for Disease Control and Prevention PAGE 61

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67 INFORMATION FOR PARENTS 2016 Recommended Immunizations for Children 7-18 Years Old Talk to your child s doctor or nurse about the vaccines recommended for their age. Flu Influenza Tdap Tetanus, diphtheria, pertussis HPV Human papillomavirus Meningococcal MenACWY MenB Pneumococcal Hepatitis B Hepatitis A Inactivated Polio MMR Measles, mumps, rubella Chickenpox Varicella 7-8 Years 9-10 Years Years Years Years More information: Preteens and teens should get a flu vaccine every year. Preteens and teens should get one shot of Tdap at age 11 or 12 years. Both girls and boys should receive 3 doses of HPV vaccine to protect against HPVrelated disease. HPV vaccination can start as early as age 9 years. All year olds should be vaccinated with a single dose of a quadrivalent meningococcal conjugate vaccine (MenACWY). A booster shot is recommended at age 16. Teens, years old, may be vaccinated with a MenB vaccine. These shaded boxes indicate when the vaccine is recommended for all children unless your doctor tells you that your child cannot safely receive the vaccine. These shaded boxes indicate the vaccine should be given if a child is catching-up on missed vaccines. These shaded boxes indicate the vaccine is recommended for children with certain health or lifestyle conditions that put them at an increased risk for serious diseases. See vaccine-specific recommendations at This shaded box indicates the vaccine is recommended for children not at increased risk but who wish to get the vaccine after speaking to a provider. Vaccine Information for Parents PAGE 63

68 Vaccine Information for Parents Vaccine-Preventable Diseases and the Vaccines that Prevent Them Diphtheria (Can be prevented by Tdap vaccination) Diphtheria is a very contagious bacterial disease that affects the respiratory system, including the lungs. Diphtheria bacteria can be passed from person to person by direct contact with droplets from an infected person s cough or sneeze. When people are infected, the diptheria bacteria produce a toxin (poison) in the body that can cause weakness, sore throat, fever, and swollen glands in the neck. Effects from this toxin can also lead to swelling of the heart muscle and, in some cases, heart failure. In serious cases, the illness can cause coma, paralysis, and even death. Hepatitis A (Can be prevented by HepA vaccination) Hepatitis A is an infection in the liver caused by hepatitis A virus. The virus is spread primarily person-to-person through the fecal-oral route. In other words, the virus is taken in by mouth from contact with objects, food, or drinks contaminated by the feces (stool) of an infected person. Symptoms can include fever, tiredness, poor appetite, vomiting, stomach pain, and sometimes jaundice (when skin and eyes turn yellow). An infected person may have no symptoms, may have mild illness for a week or two, may have severe illness for several months, or may rarely develop liver failure and die from the infection. In the U.S., about 100 people a year die from hepatitis A. Hepatitis B (Can be prevented by HepB vaccination) Hepatitis B causes a flu-like illness with loss of appetite, nausea, vomiting, rashes, joint pain, and jaundice. Symptoms of acute hepatitis B include fever, fatigue, loss of appetite, nausea, vomiting, pain in joints and stomach, dark urine, grey-colored stools, and jaundice (when skin and eyes turn yellow). Human Papillomavirus (Can be prevented by HPV vaccination) Human papillomavirus is a common virus. HPV is most common in people in their teens and early 20s. It is the major cause of cervical cancer in women and genital warts in women and men. The strains of HPV that cause cervical cancer and genital warts are spread during sex. Influenza (Can be prevented by annual flu vaccination) Influenza is a highly contagious viral infection of the nose, throat, and lungs. The virus spreads easily through droplets when an infected person coughs or sneezes and can cause mild to severe illness. Typical symptoms include a sudden high fever, chills, a dry cough, headache, runny nose, sore throat, and muscle and joint pain. Extreme fatigue can last from several days to weeks. Influenza may lead to hospitalization or even death, even among previously healthy children. Measles (Can be prevented by MMR vaccination) Measles is one of the most contagious viral diseases. Measles virus is spread by direct contact with the airborne respiratory droplets of an infected person. Measles is so contagious that just being in the same room after a person who has measles has already left can result in infection. Symptoms usually include a rash, fever, cough, and red, watery eyes. Fever can persist, rash can last for up to a week, and coughing can last about 10 days. Measles can also cause pneumonia, seizures, brain damage, or death. Meningococcal Disease (Can be prevented by meningococcal vaccination) Meningococcal disease is caused by bacteria and is a leading cause of bacterial meningitis (infection around the brain and spinal cord) in children. The bacteria are spread through the exchange of nose and throat droplets, such as when coughing, sneezing or kissing. Symptoms include nausea, vomiting, sensitivity to light, confusion and sleepiness. Meningococcal bacteria also cause blood infections. About one of every ten people who get the disease dies from it. Survivors of meningococcal disease may lose their arms or legs, become deaf, have problems with their nervous systems, become developmentally disabled, or suffer seizures or strokes. Mumps (Can be prevented by MMR vaccination) Mumps is an infectious disease caused by the mumps virus, which is spread in the air by a cough or sneeze from an infected person. A child can also get infected with mumps by coming in contact with a contaminated object, like a toy. The mumps virus causes swollen salivary glands under the ears or jaw, fever, muscle aches, tiredness, abdominal pain, and loss of appetite. Severe complications for children who get mumps are uncommon, but can include meningitis (infection of the covering of the brain and spinal cord), encephalitis (inflammation of the brain), permanent hearing loss, or swelling of the testes, which rarely results in decreased fertility. Pertussis (Whooping Cough) (Can be prevented by Tdap vaccination) Pertussis is caused by bacteria spread through direct contact with respiratory droplets when an infected person coughs or sneezes. In the beginning, symptoms of pertussis are similar to the common cold, including runny nose, sneezing, and cough. After 1-2 weeks, pertussis can cause spells of violent coughing and choking, making it hard to breathe, drink, or eat. This cough can last for weeks. Pertussis is most serious for babies, who can get pneumonia, have seizures, become brain damaged, or even die. About two-thirds of children under 1 year of age who get pertussis must be hospitalized. Pneumococcal Disease (Can be prevented by pneumococcal vaccination) Pneumonia is an infection of the lungs that can be caused by the bacteria called pneumococcus. This bacteria can cause other types of infections too, such as ear infections, sinus infections, meningitis (infection of the covering around the brain and spinal cord), bacteremia and sepsis (blood stream infection). Sinus and ear infections are usually mild and are much more common than the more serious forms of pneumococcal disease. However, in some cases pneumococcal disease can be fatal or result in longterm problems, like brain damage, hearing loss and limb loss. Pneumococcal disease spreads when people cough or sneeze. Many people have the bacteria in their nose or throat at one time or another without being ill this is known as being a carrier. Polio (Can be prevented by IPV vaccination) Polio is caused by a virus that lives in an infected person s throat and intestines. It spreads through contact with the stool of an infected person and through droplets from a sneeze or cough. Symptoms typically include sore throat, fever, tiredness, nausea, headache, or stomach pain. In about 1% of cases, polio can cause paralysis. Among those who are paralyzed, About 2 to 10 children out of 100 die because the virus affects the muscles that help them breathe. Rubella (German Measles) (Can be prevented by MMR vaccination) Rubella is caused by a virus that is spread through coughing and sneezing. In children rubella usually causes a mild illness with fever, swollen glands, and a rash that lasts about 3 days. Rubella rarely causes serious illness or complications in children, but can be very serious to a baby in the womb. If a pregnant woman is infected, the result to the baby can be devastating, including miscarriage, serious heart defects, mental retardation and loss of hearing and eye sight. Tetanus (Lockjaw) (Can be prevented by Tdap vaccination) Tetanus is caused by bacteria found in soil, dust, and manure. The bacteria enters the body through a puncture, cut, or sore on the skin. When people are infected, the bacteria produce a toxin (poison) that causes muscles to become tight, which is very painful. Tetanus mainly affects the neck and belly. This can lead to locking of the jaw so a person cannot open his or her mouth, swallow, or breathe. Complete recovery from tetanus can take months. One out of five people who get tetanus die from the disease. Varicella (Chickenpox) (Can be prevented by varicella vaccination) Chickenpox is caused by the varicella zoster virus. Chickenpox is very contagious and spreads very easily from infected people. The virus can spread from either a cough, sneeze. It can also spread from the blisters on the skin, either by touching them or by breathing in these viral particles. Typical symptoms of chickenpox include an itchy rash with blisters, tiredness, headache and fever. Chickenpox is usually mild, but it can lead to severe skin infections, pneumonia, encephalitis (brain swelling), or even death. If you have any questions about your child s vaccines, talk to your healthcare provider. Last updated on 03/28/2016 CS A PAGE 64

69 INFORMACIÓN PARA LOS PADRES 2016: Vacunas recomendadas para los niños desde los 7 hasta los 18 años de edad Hable con el médico o la enfermera de su hijo acerca de las vacunas recomendadas para su edad. Vacuna antimeningocócica Vacuna contra la varicela Vacuna contra el sarampión, las paperas y la rubéola Vacuna inactivadas contra la polio Vacuna contra la hepatitis A Vacuna contra la hepatitis B Vacuna neumocócica MenACWY MenB Vacuna contra el VPH (Virus del papiloma humano) Vacuna Tdap (Tétanos, difteria, tosferina) Vacuna contra la influenza (gripe) 7-8 Años 9-10 Años Años Años Años Los adolescentes de 16 a 18 años, pueden ser vacunados con la MenB. Todos los niños y niñas de 11 y 12 años deben ser vacunados con una dosis única de la vacuna antimeningocócica conjugada cuatrivalente (MenACWY). Se recomienda una dosis de refuerzo a los 16 años. Tanto las niñas como los niños deben recibir 3 dosis de la vacuna contra el VPH para protegerlos contra las enfermedades relacionadas con este virus. La vacunación contra el VPH puede comenzar desde los 9 años de edad. Los preadolescentes y adolescentes deben recibir una inyección de la vacuna Tdap a los 11 o 12 años de edad. Más información: Los preadolescentes y adolescentes deben recibir una vacuna contra la influenza todos los años. Estas casillas sombreadas indican que la vacuna se debe administrar a un niño que esté poniéndose al día con las vacunas. Estas casillas sombreadas indican cuándo se recomienda la vacuna para todos los niños, a menos que el médico le diga que su hijo no puede recibir en forma segura la vacuna. Estas casillas sombreadas indican que la vacuna se recomienda para los niños que no tengan un mayor riesgo, sino que quieran vacunarse después de hablar con un proveedor de atención médica. Estas casillas sombreadas indican que la vacuna se recomienda para niños con ciertas afecciones o situaciones de estilos de vida que los ponen en mayor riesgo de enfermedades graves. Vea las recomendaciones específicas de las vacunas en acip-recs/index.html (en inglés). Vaccine Information for Parents PAGE 65

70 Vaccine Information for Parents PAGE 66

71 POSTERS AND HANDOUTS

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73 If there were a vaccine against cancer, wouldn t you get it for your kids? HPV vaccine is cancer prevention. Talk to the doctor about vaccinating your year old sons and daughters against HPV. Distributed by: Insert logo here CS C

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75 Older kids (adolescents, preteens, tweens, and teens) need vaccinations too, including Tdap, Meningococcal, HPV, and flu. Ask your child s doctor or nurse if your child needs immunizations to protect against serious diseases. Distributed by: Insert logo here CS B

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77 If there were a vaccine against cancer, wouldn t you get it for your kids? HPV vaccine is cancer prevention. Talk to the doctor about vaccinating your year old sons and daughters against HPV. Distributed by: CS A

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79 If there were a vaccine against cancer, wouldn t you get it for your kids? {{ Please insert perforated 11 x 17 sized poster here. File name: C 4 Poster- HPV Cancer- Boy - Soccer - resized }} HPV vaccine is cancer prevention. Talk to the doctor about vaccinating your year old sons and daughters against HPV. Distributed by: Insert logo here CS C

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81 {{ Please insert perforated 11 x 17 sized poster here. File name: C 5 Poster- Meningitis- English - resized }} Older kids (adolescents, preteens, tweens, and teens) need vaccinations too, including Tdap, Meningococcal, HPV, and flu. Ask your child s doctor or nurse if your child needs immunizations to protect against serious diseases. Distributed by: Insert logo here CS F

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83 CS E Usted sabía que habría días como este. {{ Please insert perforated 11 x 17 sized poster here. File name: C 6 Poster- Meningitis- Spanish- resized }} Pero sabía que sus pre-adolescentes y adolescentes necesitan vacunas? Departamento de Salud y Servicios Humanos Centros para el Control y la Prevención de Enfermedades Los niños mayores, preadolescentes y adolescentes necesitan vacunas también incluyendo las vacunas Tdap, meningocócica, HPV y la de la influenza. Pregúntele al doctor o enfermera de su hijo si necesita vacunas para protegerlo contra enfermedades graves.

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85 HPV CANCER PREVENTION HPV VACCINE IS CANCER PREVENTION HPV vaccine protects against HPV types that most commonly cause anal, cervical, oropharyngeal, penile, vaginal, and vulvar cancers. 1 Every year in the U.S., 27,000 people get cancer caused by HPV. 20 min. That s 1 person every 20 minutes of every day, all year long. Most of these cancers can be prevented by HPV vaccine. HPV VACCINE IS RECOMMENDED AT THE SAME TIME AS OTHER TEEN VACCINES {{ Please insert 2 perforated 11 x 17 sized poster here. File name: C 7 - HPV Cancer Prevention- resized }} Preteens need three vaccines at 11 or 12. They protect against whooping cough, cancers caused by HPV, and meningitis. Vaccines for your year old: Tdap HPV Meningococcal 3 HPV VACCINE IS BEST AT YEARS Preteens have a higher immune response to HPV vaccine than older teens While there is very little risk of exposure to HPV before age 13, the risk of exposure increases thereafter. Parents and healthcare professionals are the key to protecting adolescents from HPV cancers. VACCINATE YOUR YEAR OLDS. Distributed by: Insert logo here U.S. Department of Health and Human Services Centers for Disease Control and Prevention NCIRDig

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89 HPV* Vaccine A Guide for Young Adults * human papillomavirus HPV is a very common virus that can lead to: Cancers of the mouth and throat Cancer of the cervix Cancer of the penis, vagina, vulva, or anus Genital warts HPV vaccine can prevent these! Do I really need HPV vaccine? Yes! You should get HPV vaccine because it can prevent some types of cancer and genital warts. Do I need it if I haven t had sex yet? Yes! You don t have to have sex to catch HPV, but sex increases your risk. You can get HPV by skin-to-skin intimate contact. People can get and spread HPV without knowing it. It s best to get vaccinated before you ever have sex. Should I get HPV vaccine if I ve already had sex? Yes! You still need to get vaccinated even if you have had sex. The vaccine provides a lot of protection. Why do I need 3 shots? You need 3 HPV shots to be fully protected. I didn t get the vaccine at age 11 or 12. Should I get it now? Yes! HPV vaccination is recommended for people ages 9 through 26. Even though it is ideal to get HPV vaccine as a preteen, it is still highly effective in teens and young adults. Is HPV vaccine safe? Yes! Millions of doses of HPV vaccine have been given without any problem. You may get a sore arm. Occasionally, a few people faint, so sit for 15 minutes after getting the vaccine. Make sure you get all 3 HPV shots. Complete your series! For more information on vaccines for teens and young adults, visit or adults When Should I Get HPV Vaccine? Have your healthcare provider fill in this chart about when you should be vaccinated. vaccine dose recommended #1 For people ages 9 26 years date dose given or due Adapted with permission from the Academic Pediatric Association #2 1 2 months after vaccine dose #1 #3 At least 6 months after vaccine dose #1 Technical content reviewed by the Centers for Disease Control and Prevention Saint Paul, Minnesota Item #4251 (2/15) resources for adolescents PAGE 85

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91 Protect yourself from HPV... Get vaccinated! What is HPV? Human papillomavirus (HPV) is the most common sexually transmitted disease (STD) in the U.S. HPV can lead to cervical cancer in women, as well as other oral and genital (sex organ) cancers in men and women. HPV also causes genital warts. How do you catch it? HPV is usually spread during sex. You can spread (or get) the virus without knowing it. Sometimes babies become infected from their mothers during birth. Is it serious? Yes. HPV is the main cause of cervical cancer. In the U.S., about 10,000 women get cervical cancer every year, and about 4,000 die from it. HPV can also lead to cancers of the vagina, vulva, penis, anus, throat, and mouth. Am I at risk? If you ever have sex, you are at risk. At least half of sexually active people get infected with HPV at some point in their lives. How can I protect myself from HPV? I m vaccinated! Vaccination is the best way to prevent HPV infection. The vaccine is most effective if you get it before becoming sexually active. However, if you are already sexually active, you should still get vaccinated. Ask your healthcare provider if you need this vaccine! Both girls and boys should get 3 doses of HPV vaccine, starting at around age years. Older teens and young adults should also start or complete their HPV vaccine series. For other vaccine handouts in this series, visit s For more information, visit Technical content reviewed by the Centers for Disease Control and Prevention 1573 Selby Avenue Saint Paul, Minnesota Item #P4406 (5/I3) PAGE 87 resources for adolescents

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93 Online Resources for Adolescents Video telling teens major reasons why they should get all vaccines video and website. -Resources for teens on vaccines and other health materials. Short video on HPV disease and prevention Children s Hospital of Philadelphia Vaccine Education Center. Watch videos from doctors and view other valuable resources resources for adolescents PAGE 89