Chapter 4: HPV Vaccination - WHO

1 Chapter 4: HPV Vaccination Comprehensive Cervical Cancer control : A guide to essential practice (C4 GEP) February 11, 2013 2 Contents KEY 3 ABOUT THIS Chapter .. 3 ROLE OF THE HEALTH CARE PROVIDER .. 3 HPV VACCINES .. 4 Vaccine protective effect .. 5 Vaccine Safety .. 5 Vaccine Administration and Schedule .. 6 Characteristics of HPV Vaccines .. 7 TARGET POPULATION .. 8 DELIVERY STRATEGIES .. 9 Health Facility-based .. 9 School-based .. 9 Outreach .. 10 Integrated services .. 11 COMMUNITY MOBILIZATION .. 11 OBTAINING CONSENT/ASSENT FOR A GIRL TO GET VACCINATED .. 11 ADDITIONAL RESOURCES .. 13 FREQUENTLY ASKED QUESTIONS .. 14 PRACTICE SHEET 1: Vaccine characteristics and the cold chain .. 17 PRACTICE SHEET 2: Injection safety .. 19 PRACTICE SHEET 3: The immunization session .. 20 PRACTICE SHEET 4: Data collection .. 22 SAMPLE FORM 1: SAMPLE REPORT FORM FOR ADVERSE EVENTS FOLLOWING IMMUNIZATION (AEFI).

2 25 SAMPLE FORM 2. REPORTING OF NATIONAL HPV VACCINE COVERAGE FOR THE WHO-UNICEF JOINT REPORTING FORM .. 27 SAMPLE FORM 3: SAMPLE TALLY SHEET FROM WHO GUIDANCE DOCUMENT ON HOW TO RECORD NUMBER OF HPV DOSES GIVEN ON SINGLE Vaccination DAY ON HPV VACCINE COVERAGE MONITORING .. 28 SAMPLE FORM 4. SAMPLE HPV VACCINE SERVICE PROVIDER LOG BOOK FROM WHO GUIDANCE DOCUMENT ON HPV VACCINE COVERAGE MONITORING .. 30 3 KEY POINTS There are now vaccines that prevent the precursors of cervical cancer. The majority of HPV-associated cancers worldwide are caused by only two HPV types: HPV 16 and 18. HPV 16 and 18 cause about 70% of cervical cancer in all regions of the world. Currently, two prophylactic vaccines against HPV 16 and 18 are licensed in most countries. HPV Vaccination can be added to a comprehensive cervical cancer prevention strategy as a primary prevention tool. Both HPV vaccines have an excellent safety profile and can be co-administered with other vaccines.

3 The primary target population for HPV Vaccination is girls before initiation of sexual activity. The recommended target ages for HPV Vaccination is 9-13 years. Completion of all doses at the specified intervals is recommended. The vaccines cannot treat HPV infection or HPV-associated disease. HPV Vaccination does not replace cervical cancer screening. HPV Vaccination is safe and immunogenic in HIV-infected individuals. There are no contraindications to vaccinating HIV-infected persons with HPV vaccine. One of the two current vaccines also protects against HPV types that cause anogenital warts. ABOUT THIS Chapter This Chapter provides information on HPV Vaccination . It describes the types of vaccines, the outcomes that could be prevented by the vaccines, the target population for the vaccines, and how to organize Vaccination sessions and administer the vaccine. ROLE OF THE HEALTH CARE PROVIDER Because of the many unique features of HPV vaccines, including the target population of 9-13 year old girls, health care providers can play an important role beyond administering the vaccines: they can be a source of information to girls who are eligible for the vaccine, parents, teachers, health care professionals, policy makers, and the general community.

4 HPV vaccine implementation should include educating girls about the benefit of Vaccination , and can provide opportunities to educate their mothers about the need for cervical cancer screening and early treatment. HPV vaccine introduction may also provide the impetus to improve, strengthen, and integrate health services for 9-13 year olds at national, regional, and local levels. For example, health care providers could facilitate adolescent access to other health services for 9-13 year olds. Community 4 health worker networks may be mobilized to assist adolescents to access various services, and vaccine introduction may also serve as an opportunity to improve and facilitate adolescent health education. The role of the vaccine provider includes: link with the role of the teacher and other school officials Education o Educate girls and their parents about HPV vaccine and cervical cancer o Counsel girls to complete the three-dose series o Educate the community about cervical cancer prevention Vaccine management and delivery o Determine eligibility (age, grade/class, pregnancy status, allergies) o Safely administer vaccine to eligible girls o Ensure appropriate management of vaccines, supplies, and waste management.

5 Provide training and education to teachers and other school officials to educate girls and to facilitate Vaccination sessions where school-based delivery is implemented. Record keeping and reporting o Record information on girls who are vaccinated, including name, date of birth or age, and date, type of vaccine and dose number received o Maintain tally sheets for regular data collection and reporting o Manage and report adverse events following immunization (AEFI) HPV VACCINES Two HPV vaccines are currently available worldwide:, a bivalent vaccine, against HPV types 16 and 18 (these two types cause 70% of cervical cancers in most of the world) and a quadrivalent vaccine, against HPV 16 and 18 as well as HPV 6 and 11 (6 and 11 are responsible for benign anogenital warts and recurrent respiratory papillomatosis, a disease where recurrent growths occur in the airways, frequently on the vocal cords).

6 Neither vaccine contains a live virus; therefore, they don t act by causing an infection. Both vaccines are prophylactic (prevent HPV infections) and are most effective when administered prior to infection with HPV, which is acquired by most individuals shortly after sexual debut. The vaccines are not therapeutic (cannot be used to treat existing HPV and HPV-related disease), nor do they have any effect on progression to disease (precancer and cancer) in persons who have HPV infection at the time of Vaccination . 5 Vaccine protective effect Data from several large clinical trials of HPV vaccines have demonstrated very high efficacy of both vaccines against initial and persistent infection with the HPV types in the vaccines and associated conditions in young women aged 15-26 years who had not been exposed to the HPV types targeted by the vaccine. At the planned end of the vaccine trials for both vaccines, HPV 16- or 18-related cervical intraepithelial neoplasia grade 2 and 3 (precancer) and adenocarcinoma in situ were measured.

7 These cervical precancerous lesions are used as proxy for cervical cancer. Trial results indicate very high efficacy for protection against these cervical lesions in women who were DNA negative in the cervix and did not have antibodies in their blood stream for HPV 16 and 18 at the time of Vaccination . Clinical trials of the quadrivalent vaccine also measured genital warts as a primary endpoint. As with cervical lesions, the trial results showed high efficacy of the quadrivalent HPV vaccine against genital warts (also called condyloma) in those who were proven not infected with HPV 16 and 18 by serum and cervical tests at the time of Vaccination . Antibody to HPV 16 and 18 studies were conducted for both vaccines in girls aged 9-15 years. Results from the studies indicate that over 99% of vaccinated women developed antibodies after Vaccination , and that antibody titres were higher in the girls who were 9-15 years old compared to those who were 16-26 years old.

8 There are on-going studies to determine the exact duration of HPV vaccine protection. However, it is reassuring that there has been no evidence of waning immunity nine years after Vaccination in women who were vaccinated as part of the clinical trials in the early 2000s. Booster doses are not currently recommended. There is preliminary evidence of cross-protection (protection against infections caused by other disease-associated HPV types that are not included in the current vaccines), and the extent and duration of protection is under study. Vaccine Safety Evidence to date Safety studies of both HPV vaccines were conducted in thousands of women around the world prior to licensure. Results of the studies demonstrated that both vaccines were well tolerated with no major safety concerns for either vaccine. Post-licensure, the most common adverse events reported in vaccinated girls in the United States have involved injection site pain and swelling.

9 Similar post-marketing surveillance from other countries including Australia, United Kingdom, Malaysia, Italy, and Netherlands has not identified any new health risks other than mild adverse events such as fever, dizziness, and nausea. In the United States, syncope (fainting) has been reported after HPV 6 vaccine administration. Syncope can occur after any medical procedure and is not uncommon in adolescents following receipt of any vaccine. It is recommended that adolescents should be seated during HPV vaccine administration, and observed for 15 minutes afterwards to avoid possible fainting. Precautions and contraindications HPV vaccine should not be given to people who have experienced severe allergic reactions after a previous vaccine dose or to a component ( , yeast) of the vaccine. HPV vaccines are not recommended for use in pregnancy. If a girl becomes pregnant after initiating the Vaccination series, the remainder of the regimen should be delayed until after completion of the pregnancy.

10 In the event that the HPV vaccine is inadvertently administered to a girl who is pregnant, no intervention is necessary. Although HPV vaccines are recommended in young girls before onset of sexual activity, available data do not indicate any safety concerns if the quadrivalent vaccine is administered while a girl is lactating. There are no published results from studies on the bivalent vaccine. HPV Vaccination of boys and men for prevention of cervical cancer is not recommended as a strategy at this time because it is not as cost-effective in for reduction of cervical cancer as vaccinating 70% or more of target aged young girls. Vaccine Administration and Schedule This paragraph refers to WHO current recommendations, for the latest WHO recommendation on the HPV vaccine schedule are found at: Both vaccines are administered in a schedule of currently 3 doses within 6 months. The dose for each vaccine is administered intramuscularly using mL of liquid suspension.