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  • Staying Aware of Vaccination Revisions

    A Look at Current MMR, PCV13, and HPV4 Recommendations

     

    As we counsel patients on the topic of vaccinations, it is important that we have the most current recommendations related to common vaccines. Since the 1960s and 1970s, vaccines for prevention of measles, rubella, and mumps were licensed and recommended for use in the United States. Because of the successful vaccination programs we instituted, these diseases are now uncommon in our country. However, because these diseases are common in many other countries, recent outbreaks of import-associated cases of measles and mumps have occurred.

    To protect our population, there are currently two live attenuated vaccines to prevent measles, mumps, and rubella that are licensed and available. The first is the MMR vaccine (measles, mumps, and rubella [M-M-R II, Merck & Co., Inc.]), which is indicated for persons traveling internationally and who are ≥12 months, and infants who are ≥6 months. The second is the MMRV vaccine (measles, mumps, rubella, and varicella [ProQuad, Merck & Co., Inc.]), which is licensed for children aged 12 months through 12 years. Helping us understand recommendations related to these vaccines is the report containing the existing Advisory Committee on Immunization Practices (ACIP) recommendations (published during 1998–2011), including recent revisions adopted by the ACIP on October 24, 2012. The summary includes these recommendations1:

    • For acceptable evidence of immunity, removing documentation of physician diagnosed disease as an acceptable criterion for evidence of immunity for measles and mumps, and including laboratory confirmation of disease as a criterion for acceptable evidence of immunity for measles, rubella, and mumps.
    • For persons with human immunodeficiency virus (HIV) infection, expanding recommendations for vaccination to all persons aged ≥12 months with HIV infection who do not have evidence of current severe immunosuppression; recommending revaccination of persons with perinatal HIV infection who were vaccinated before establishment of effective antiretroviral therapy (ART) with 2 appropriately spaced doses of MMR vaccine once effective ART has been established; and changing the recommended timing of the 2 doses of MMR vaccine for HIV-infected persons to age 12 through 15 months and 4 through 6 years.
    • For measles postexposure prophylaxis, expanding recommendations for use of immune globulin administered intramuscularly (IGIM) to include infants aged birth to 6 months exposed to measles; increasing the recommended dose of IGIM for immunocompetent persons; and recommending use of immune globulin administered intravenously (IGIV) for severely immunocompromised persons and pregnant women without evidence of measles immunity who are exposed to measles.

    Another vaccination of importance is the PCV13 (13-valent pneumococcal conjugate vaccine pneumococcal conjugate) vaccine. In 2010, PCV13 (Prevnar 13, Wyeth Pharmaceuticals, Inc., a subsidiary of Pfizer, Inc.) was licensed by the FDA and recommended by ACIP for children aged 6 weeks through 71 months for the prevention of invasive pneumococcal disease caused by the 13 pneumococcal serotypes included in the vaccine. PCV13 is recommended as a 4-dose series for children starting at age 2 months. On December 30, 2011, the FDA approved PCV13 for prevention of pneumonia and invasive disease caused by PCV13 serotypes among adults aged 50 years and older.2

    Using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework, the ACIP considered available studies to inform its decision-making regarding recommending PCV13 for adults with immunocompromising conditions, functional or anatomic asplenia, CSF leaks, or cochlear implants. Their recommendations are3:

    • Individuals who fit these criteria, and who have not previously received PCV13 or PPSV23, should receive a dose of PCV13 first followed by a dose of PPSV23 at least 8 weeks later.
    • Subsequent doses of PPSV23 should follow current PPSV23 recommendations for high-risk adults. Specifically, a second PPSV23 dose is recommended 5 years after the first PPSV23 dose for persons aged 19 through 64 years with functional or anatomic asplenia and for persons with immunocompromising conditions. A second dose of PPSV23 is not recommended for persons 19 through 64 years of age with cochlear implants or CSF leaks.
    • Those who received one or more doses of PPSV23 before age 65 years for any indication should receive another dose of the vaccine at age 65 years or older if at least 5 years have elapsed since their previous PPSV23 dose. If a dose of PPSV23 was received at age 65 years or later, no additional doses of PPSV23 are recommended.
    • Adults 19 years of age or older with the aforementioned conditions (functional or anatomic asplenia, immunocompromising conditions, or those with CSF leaks or cochlear implants) who have previously received one or more doses of PPSV23 should be given a dose of PCV13 one or more years after the last PPSV23 dose was received. For those who require additional doses of PPSV23, the first such dose should be given no sooner than 8 weeks after PCV13 and at least 5 years since the most recent dose of PPSV23.

    The ACIP also provides recommendations regarding the quadrivalent human papillomavirus (HPV) vaccine, (HPV4; Gardasil, Merck & Co. Inc.), which is directed against HPV types 6, 11, 16, and 18. This vaccine was initially licensed by the FDA for use in females in June 2006, and then in 2009, was licensed for use in males for prevention of genital warts. Subsequently, in December 2010 the FDA added prevention of anal cancer in males and females as an indication. Again using the GRADE framework, the ACIP evaluated information on vaccine efficacy (including data available since October 2009, on prevention of grade 2 or 3 anal intraepithelial neoplasia [AIN2/3], a precursor of anal cancer), vaccine safety, estimates of disease and cancer resulting from HPV, cost-effectiveness, and programmatic considerations. The ACIP’s recommendations as of October 25, 2011 include4:

    • Routine use of HPV4 administered as a 3-dose series in males aged 11 or 12 years. The vaccination series can be started beginning at age 9 years.
    • Vaccination with HPV4 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.

    PDR Network can be a useful resource for information on these and other available vaccinations, as well as other drug types, offering alerts and specific product labeling. Keep current with information on products by using PDR.net. If you use an electronic health record (EHR), please ensure that it includes the PDR drug data feeds, including PDR BRIEF, which delivers updated drug information, full labeling, and safety warnings integrated into your electronic prescribing system. Drug information in EHRs is often months out of date, which is why PDR BRIEF is available at no cost to providers and EHR vendors.

    Salvatore Volpe, MD, FAAP, FACP, CHCQM
    Chief Medical Officer
    PDR Network

     

    Resources
    1. Centers for Disease Control and Prevention. Prevention of Measles, Rubella, Congenital Rubella Syndrome, and Mumps. MMWR 2013;62(No. RR-4):1-40.
    2. Centers for Disease Control and Prevention. Licensure of 13-Valent Pneumococcal Conjugate Vaccine for Adults Aged 50 Years and Older. MMWR 2012;61(21);394-395.
    3. Centers for Disease Control and Prevention. PCV13 Q&A for Providers. 2012. Available at http://www.cdc.gov/vaccines/vpd-vac/pneumo/vac-PCV13-adults.htm. Accessed July 18, 2013.
    4. Centers for Disease Control and Prevention. Recommendations on the Use of Quadrivalent Human Papillomavirus Vaccine in Males — Advisory Committee on Immunization Practices (ACIP), 2011. Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6050a3.htm. Accessed August 8, 2013.