PATIENT COMMUNICATION
Q: How do I best convey the message of how important and effect the HPV vaccine is to my patients?
A: 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 give an effective response. The Centers for Disease Control and Prevention (CDC) research shows these straightforward messages work with parents when discussing HPV vaccine—and are easy for you or your staff to deliver. Use this informational video to help guide the discussion with your patients. CDC has also provided some tips and time savers on how best to talk to patients and parents.
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SERIES COMPLETION
Q: If my patient’s series was started with 4vHPV or 2vHPV, can it be completed with 9vHPV?
A: Yes, Advisory Committee on Immunization Practices (ACIP) recommendations state that 9vHPV may be used to continue or complete a series started with a different HPV vaccine product.
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Q: Are additional 9vHPV doses recommended for a person who started a series with 4vHPV or 2vHPV and completed the series with one or two doses of 9vHPV?
A: There is no ACIP recommendation for additional 9vHPV doses for persons who started the series with 4vHPV or 2vHPV and completed the series with 9vHPV.
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Q: If a series was started with 4vHPV or 2vHPV and will be completed with 9vHPV, what are the intervals for the remaining doses in a three-dose or two-dose series?
A: If the first dose of any HPV vaccine was given before the 15th birthday, vaccination should be completed according to a two-dose schedule. In a two-dose series, the second dose is recommended six to 12 months after the first dose (0, 6-12 month schedule). If the first dose of any HPV vaccine was given on or after the 15th birthday, vaccination should be completed according to a three-dose schedule. In a three-dose series, the second dose is recommended one to two months after the first dose, and the third dose is recommended six months after the first dose (0, 1-2, 6 month schedule). If a vaccination schedule is interrupted, vaccine doses do not need to be repeated. Number of recommended doses is based on age at administration of the first dose.
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Q: If a person desires protection against the five additional types prevented by 9vHPV and has started a series with another HPV vaccine product, what issues should be considered?
A: The majority of all HPV-associated cancers that vaccination can prevent are caused by HPV 16 and HPV 18. These HPV types are prevented by all three vaccines: 2vHPV, 4vHPV, and 9vHPV. The benefit of protection against the five additional types targeted by 9vHPV is limited mostly to females for prevention of cervical cancers and precancers; only a small percentage of HPV-associated cancers in males is due to the five additional types prevented by 9vHPV. Available data show no serious safety concerns in persons who were vaccinated with 9vHPV after having received a three-dose series of 4vHPV at least 12 months earlier. According to the 2014 ACIP recommendations, cervical cancer screening is recommended beginning at age 21 years and continuing through age 65 years for both vaccinated and unvaccinated women.
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Q: If a person desires protection against the five additional types prevented by 9vHPV and has completed a series of 4vHPV, what issues should be considered?
A: The majority of all HPV-associated cancers that can be prevented by vaccination are caused by HPV 16 and HPV 18. These HPV types are prevented by all three HPV vaccines: 2vHPV, 4vHPV and 9vHPV. The benefit of protection against the five additional types targeted by 9vHPV would be mostly limited to females for prevention of cervical cancers and precancers; only a small percentage of HPV-associated cancers in males is due to the five additional types prevented by 9vHPV. Available data show no serious safety concerns in persons who were vaccinated with 9vHPV after having received three doses of 4vHPV. Cervical cancer screening is recommended beginning at age 21 years and continuing through age 65 years for both vaccinated and unvaccinated women (ACIP, 2014).
Markowitz LE, Dunne EF, Saraiya M, et al. Human papillomavirus vaccination: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2014;63:1-30
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Q: What data are available on the number of doses of 9vHPV needed for protection against the five additional types for a series started with 4vHPV and completed with 9vHPV?
A: There are no data on efficacy or immunogenicity of one, two, or three doses of 9vHPV among persons who already have received only one or two doses of 4vHPV. In an immunogenicity and safety clinical trial, three doses of 9vHPV (administered in a 0, 2, 6 month schedule) were given to females who already had received three doses of 4vHPV; the first dose of 9vHPV was administered 12-36 months later (Garland, et al., 2015). After three doses of 9vHPV, more than 98 percent of vaccines developed antibodies to all five additional types. Antibody also was measured after the first dose of 9vHPV; most but not all vaccines in the trial developed antibody against all five additional types. Antibody titers were higher after the third dose than after the first dose. Antibody was not measured after the second dose. In a cross-study comparison, geometric mean antibody titers for the five additional HPV types among persons who received three doses of 9vHPV after three doses of 4vHPV were lower than those of persons who received three doses of 9vHPV without prior HPV vaccination. The clinical significance of the lower antibody titers is not known because there is no established minimum antibody level that correlates with protection. An immunogenicity trial of two doses of 9vHPV has been conducted in HPV vaccine-naïve adolescents aged 9-14 years. In this trial, the two doses were separated by an interval of six or 12 months (FDA, 2016). Results from this trial demonstrated noninferior immunogenicity in adolescents age 9-14 years who received a two-dose series of HPV vaccine at a 0, 6 month schedule or a 0, 12 month schedule, compared with a three-dose series on a 0, 2, 6 month schedule among women in the age group in which efficacy has been demonstrated in clinical trials. Results from this trial support the use of a two-dose schedule in younger adolescents but do not directly address additional 9vHPV vaccination in persons who already received 4vHPV.
Food and Drug Administration. Prescribing information [Package insert]. Gardasil 9 [Human Papillomavirus 9-valent Vaccine, Recombinant], Merck & Co., Inc. Silver Spring, MD: U.S. Department of Health and Human Services, Food and Drug Administration; 2016.
Garland SM, Cheung TH, McNeill S, et al. Safety and immunogenicity of a 9-valent HPV vaccine in females 12-26 years of age who previously received the quadrivalent HPV vaccine. Vaccine 2015;33:6855-64.
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Q: What data are available on the safety of 9vHPV vaccination after a series started with another HPV vaccine product?
A: In an immunogenicity and safety clinical trial, 9vHPV was compared with placebo in females aged 12-26 years who previously had received three doses of 4vHPV. Among the 608 females evaluated who received 9vHPV, there was an acceptable safety profile (Garland, et al., 2015). Compared with persons in other studies who were vaccinated with 9vHPV and previously had never received any HPV vaccination, those who received 9vHPV after a three-dose 4vHPV series had higher rates of injection site swelling and redness. Otherwise, safety profiles of 9vHPV given to HPV vaccine-naïve persons and 9vHPV given to persons who previously had completed a three-dose 4vHPV series were generally similar.
Garland SM, Cheung TH, McNeill S, et al. Safety and immunogenicity of a 9-valent HPV vaccine in females 12-26 years of age who previously received the quadrivalent HPV vaccine. Vaccine 2015;33:6855-64.
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Q: Is additional vaccination with 9vHPV recommended for persons who have completed a three-dose or two-dose series of either 4vHPV or 2vHPV?
A: There is no ACIP recommendation for additional 9vHPV doses for persons who previously completed a series of 4vHPV or 2vHPV.
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Q: What data are available on efficacy and immunogenicity of 9vHPV when administered after a complete three-dose series of another HPV vaccine product?
A: In an immunogenicity and safety clinical trial, three doses of 9vHPV (administered in 0, 2, 6 month schedule) were given to females who had received three doses of 4vHPV; the first dose of 9vHPV was administered 12 to 36 months later (Garland, et al., 2015). After three doses of 9vHPV, more than 98 percent of vaccines developed antibodies to all five additional types. Antibody was also measured after the first dose of 9vHPV; most but not all of the vaccines in this trial developed antibody against all five additional types. Antibody titers were higher after the third dose than after the first dose. Antibody was not measured after the second dose. In a cross-study comparison, geometric antibody titers for the five additional types among persons who received three doses of 9vHPV after three doses of 4vHPV were lower than those of persons who received three doses of 9vHPV without prior HPV vaccination. The significance of the lower antibody titers is not known because there is no immune correlate of protection. There are no data on immunogenicity or efficacy of 9vHPV when administered after a two-dose series of another HPV vaccine product.
Garland SM, Cheung TH, McNeill S, et al. Safety and immunogenicity of a 9-valent HPV vaccine in females 12-26 years of age who previously received the quadrivalent HPV vaccine. Vaccine 2015;33:6855-64.
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Q: What is the cost effectiveness of three additional doses of 9vHPV for persons who already have received a complete two-dose or three-dose HPV vaccination series?
A: The estimated cost per quality-adjusted life year (QALY) gained for giving an additional three doses of 9vHPV to females aged 13-18 years who already have received three doses of 4vHPV is more than $100,000. Even for giving an additional two doses, the cost per QALY is close to $100,000 (Chesson, et al., 2016). The potential benefit would be lower, and the cost per QALY gained higher, in females older than 18 years and in males of any age. In contrast, routine 9vHPV vaccination in the United States is cost-saving, compared with routine 4vHPV vaccination.
Chesson HW, Laprise JF, Brisson M, Markowitz LE. Impact and cost-effectiveness of 3 doses of 9-valent human papillomavirus (HPV) vaccine among US females previously vaccinated with 4-valent HPV vaccine. J Infect Dis 2016;213:1694-700.
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NONCLINICAL AND ADMINISTRATION
Q: Where can I find more resources on vaccine pricing and product-related expenses?
A: According to the American Academy of Pedatrics (AAP): “The number of vaccines continues to increase and the costs have become increasingly high, necessitating a more business-like approach to payment because of the increased potential for uncompensated costs. For most states, which are non-universal purchase, the direct and indirect expenses in maintaining the vaccine product must be accounted for in a compensation formula that incorporates these factors in the vaccine purchase as well as a margin to incentivize immunizations. For universal purchase states, this means having an acceptable immunization administration fee that also covers compensation for indirect vaccine acquisition and maintenance expenses as there are no direct vaccine purchase costs and no mechanism for paying indirect expenses.” Read more from AAP, and see other resources on vaccine purchase pricing from CDC.
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Q: How do I document parental refusal to vaccinate?
A: AAP encourages documenting your discussion with parents about the serious risks of what could happen to an unimmunized or underimmunized child. Provide parents with the appropriate Vaccine Information Statement (VIS) for each vaccine at each immunization visit and answer their questions. For parents who refuse one or more recommended immunizations, document your conversation and the provision of the VIS(s), have a parent sign a Refusal to Vaccinate form, and keep the form in the patient’s medical record. AAP also recommends that you revisit the immunization discussion at each subsequent appointment and carefully document the discussion, including the benefits to each immunization and the risk of not being age-appropriately immunized.
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Q: Where can I find more information for school nurses or parents seeking more about their children’s child immunization schedules?
A: The Texas Immunization Requirement form can be found here. The Texas Department of State Health Services school and child-care immunization requirements and record information can be found at https://www.dshs.texas.gov/immunize/.
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Q: Can pharmacists vaccinate children for HPV?
A: According to the Texas Administrative Code, 22 TAC §295.15 (e), pharmacists involved in the administration of immunizations or vaccinations under their license to practice pharmacy shall meet the following restrictions and requirements:
- Pharmacists may only administer immunizations or vaccinations pursuant to a written protocol from a physician authorizing the administration.
- Pharmacists may administer immunizations or vaccinations to a patient under 14 years of age only upon a referral from a physician who has an established physician-patient relationship with each patient. However, a pharmacist may administer an influenza vaccination to a patient over seven years of age without an established physician-patient relationship.
- Pharmacists may administer immunizations or vaccinations under written protocol of a physician within a pharmacy or at any other location specifically identified in the written protocol. Such other location may not include where the patient resides, except for a licensed nursing home or hospital.
- The authority of a pharmacist to administer immunizations or vaccinations may not be delegated.
- Pharmacists may administer immunizations and vaccinations only when a licensed health-care provider authorized to administer the medication is not reasonably available to administer the medication. For the purpose of this section, “reasonably available” means those times when the licensed health-care provider is immediately available to administer the immunization or vaccine and is specifically tasked to do so.
- Under the provisions of the National Vaccine Injury Compensation Program (NVICP), the health-care provider under whose authority a covered vaccine is administered (i.e., the physician issuing the written protocol) must maintain certain information in the patient’s permanent record. In order for the physician to comply with the provisions of the NVICP, the pharmacist shall provide the physician with the information specified in subsection (g) of this section.
- Before preparing an immunization or vaccine and between each patient contact, the pharmacist shall cleanse his or her hands with an alcohol-based waterless antiseptic hand rub or shall wash his or her hands with soap and water. If gloves are worn, the pharmacist shall change gloves between patients.
- The pharmacist shall comply with all other state and federal requirements regarding immunizations or vaccinations.
According to the Texas Administrative Code, 22 TAC §295.15 (d), pharmacists involved in the administration of immunizations or vaccinations must be under the supervision of a physician. Physician supervision shall be considered adequate if the delegating physician:
- Is responsible for the formulation or approval of the physician’s order, standing medical order, standing delegation order, or other order or protocol and periodically reviews the order or protocol and the services provided to a patient under the order or protocol;
- Has established a physician-patient relationship with each patient under 14 years of age and referred the patient to the pharmacist; except a pharmacist may administer an influenza vaccination to a patient over seven years of age without an established physician-patient relationship;
- Is geographically located so as to be easily accessible to the pharmacist administering the immunization or vaccination;
- Receives, as appropriate, a periodic status report on the patient, including any problem or complication encountered; and
- Is available through direct telecommunication for consultation, assistance, and direction.
According to Texas Occupations Code 554.052, the Texas State Board of Pharmacy shall require a pharmacist to notify a physician who prescribes an immunization within 24 hours after the pharmacist administers the immunization or vaccination. Supervision by a physician is adequate if the delegating physician:
- Is responsible for formulating or approving an order or protocol, including the physician’s order, standing medical order, or standing delegation order, and periodically reviews the order or protocol and the services provided to a patient under the order or protocol;
- Except as provided by [A], has established a physician-patient relationship with each patient under 14 years of age and referred the patient to the pharmacist;
- Is geographically located to be easily accessible to the pharmacy where an immunization or vaccination is administered;
- Receives, as appropriate, a periodic status report on the patient, including any problem or complication encountered; and
- Is available through direct telecommunication for consultation, assistance, and direction.
[A] A pharmacist may administer an influenza vaccination to a patient over seven years of age without an established physician-patient relationship.
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HPV Resource Center