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PA Bulletin, Doc. No. 13-1929

NOTICES

Updating the List of Citations to ACIP Recommendations Prescribing Child Immunization Practices and Immunizing Agents and Doses

[43 Pa.B. 6079]
[Saturday, October 12, 2013]

 In accordance with 31 Pa. Code §§ 89.806(a) and 89.807(b) (relating to coverage of child immunizations; and immunizing agents, doses and AWPs), the Department of Health (Department), Bureau of Communicable Diseases, Division of Immunization is updating 31 Pa. Code Chapter 89, Appendices G and H (relating to ACIP recommendations prescribing child immunization practices; and immunizing agents and doses). The Depart-ment has primary responsibility for the interpretation and the implementation of 31 Pa. Code §§ 89.806 and 89.807. See 31 Pa. Code § 89.801(b) (relating to authority and purpose; implementation).

 Health insurance policies are required by the Childhood Immunization Insurance Act (act) (40 P. S. §§ 3501—3508) and regulations promulgated thereunder, 31 Pa. Code Chapter 89, Subchapter L (relating to childhood immunization insurance) to include coverage for certain childhood immunizations, unless the policies are exempted by the act and 31 Pa. Code § 89.809 (relating to exempt policies). The childhood immunizations covered are those that meet Advisory Committee on Immunization Practices (ACIP) standards in effect on May 21, 1992. See 31 Pa. Code § 89.806(a). A list of the Morbidity and Mortality Weekly Report (MMWR) publications containing ACIP recommendations issued under the ACIP standards in effect on May 21, 1992, appears in 31 Pa. Code Chapter 89, Appendix G.

 The Department is required to update the list of these MMWR publications appearing in 31 Pa. Code Chapter 89, Appendix G. See 31 Pa. Code § 89.806(a). The additions to the list are as follows, the remainder of the list in 31 Pa. Code Chapter 89, Appendix G remains in full force and effect:

March 22, 2013, Vol. 62/ No. RR02

Prevention and Control of Meningococcal Disease: Recommendations of the Advisory Committee on Immunization Practices (ACIP)

 This report compiles and summarizes all recommendations from the Center for Disease Control's Advisory Committee on Immunization Practices (ACIP) regarding prevention and control of meningococcal disease in the United States, specifically the changes in the recommendations published since 2005 and describes the process undertaken and the rationale used in support of these recommendations. This report is a comprehensive summary of previously published recommendations and does not contain any new recommendations; it is intended for use by clinicians as a resource. Guidelines for antimicrobial chemoprophylaxis and evaluation and management of suspected outbreaks of meningococcal disease also are provided.

 Meningococcal disease describes the spectrum of infections caused by Neisseria meningitidis, including meningitis, bacteremia and bacteremic pneumonia. Meningococcal disease develops rapidly, typically among previously healthy children and adolescents, and results in high morbidity and mortality. For unknown reasons, incidence has declined since the peak of disease in the late 1990s and approximately 800—1,200 cases are reported annually in the United States. This decline began before implementation of routine use of meningococcal vaccines in adolescents and has occurred in all serogroups. Four vaccines are licensed in the United States and provide protection against four (A, C, W and Y) and two (C and Y) serogroups. Vaccines that protect against serogroup B meningococcal disease are not available in the United States.

 Meningococcal vaccination is recommended for groups at increased risk for disease. These groups include adolescents, persons with certain medical conditions and persons with increased risk for exposure. Among these risk groups, the number of vaccine doses (that is, 2- or 4-dose primary series or a single dose with or without a boosterdose) and vaccine product are determined by the indication for vaccination and age. In certain situations such as special dosing regimens (that is, booster doses or serial vaccination and 2-dose primary series for persons aged >= 2 years), off-label use of meningococcal vaccine has been recommended. Special dosing regimens have been recommended on the basis of data from studies of immunologic response to vaccination, post licensure observational data, and the need for long-term protection in certain risk groups.

 ACIP recommendations for meningococcal vaccination have been summarized. Details regarding dosing (2- or 4-dose primary series or a single dose with or without a booster dose), contraindications, precautions, and special circumstances (e.g., adolescents infected with human immunodeficiency virus (HIV) and asplenic children) are described elsewhere in the report.

 http://www.cdc.gov/search.do?ie=utf8&filter=p&subset=mmwr&sort=date:D:S:d1&as_q=inmeta:date:daterange:2013-01-01..2013-07-01&oe=UTF-8&ud=1&start=130

June 28, 2013, Vol. 62/No. 25

Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine Among Children Aged 6—18 Years with Immunocompromising Conditions: Recommendations of the Advisory Committee on Immunization Practices (ACIP)

 On February 20, 2013, the Advisory Committee on Immunization Practices (ACIP) recommended routine use of 13-valent pneumococcal conjugate vaccine (PCV13; Prevnar 13, Wyeth Pharmaceuticals, Inc., a subsidiary of Pfizer, Inc.) for children aged 6—18 years with immunocompromising conditions, functional or anatomic asplenia, cerebrospinal fluid (CSF) leaks or cochlear implants who have not previously received PCV13. PCV13 should be administered to these children regardless of whether they received the 7-valent pneumococcal conjugate vaccine (PCV7) or the 23-valent pneumococcal polysaccharide vaccine (PPSV23). Recommendations for PPSV23 use for children in this age group remain unchanged. The evidence for the benefits and risks associated with PCV13 vaccination of children with immunocompromising conditions was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework (1). This recommendation reflects a policy change from permissive and off-label recommendation of PCV13 in the pediatric immunocompromised population to a category A recommendation. This report summarizes the evidence considered by ACIP to make this recommendation and reviews the recommendations for use of PCV13 and PPSV23 for children aged 6—18 years.

 Persons with disability who require an alternative format of this notice (for example, large print, audiotape, Braille) should contact Wayne Fleming, Department of Health, Division of Immunizations, Room 1026, Health and Welfare Building, 625 Forster Street, Harrisburg, PA 17120-0701, (717) 787-5681, or for speech and/or hearing impaired persons V/TT the Pennsylvania AT&T Relay Service (800) 654-5984 (TT).

MICHAEL WOLF, 
Secretary

[Pa.B. Doc. No. 13-1929. Filed for public inspection October 11, 2013, 9:00 a.m.]



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