NOTICES
Updating the List of Citations to ACIP Recommendations Prescribing Child Immunization Practices and Immunizing Agents and Doses
[42 Pa.B. 1929]
[Saturday, April 7, 2012]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 Department 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 at 31 Pa. Code Chapter 89, Appendix G remains in full force and effect:
August 5, 2011, Vol. 60/No. 30
Licensure of a Meningococcal Conjugate Vaccine for Children Aged 2 Through 10 Years and Updated Booster Dose Guidance for Adolescents and Other Persons at Increased Risk for Meningococcal Disease—Advisory Committee on Immunization Practices (ACIP), 2011
In January 2011, the Food and Drug Administration lowered the approval age range for use of MenACWY-CRM (Menveo, Novartis Vaccines and Diagnostics), a quadrivalent meningococcal conjugate vaccine, to include persons aged 2 through 55 years. One other quadrivalent meningococcal conjugate vaccine, meningococcal conjugate vaccine (MenACWY-D) (Menactra, Sanofi Pasteur), is licensed in the United States for prevention of meningococcal disease caused by serogroups A, C, Y, and W-135 among persons aged 2 through 55 years; MenACWY-D also is licensed as a 2-dose series for children aged 9 through 23 months. The Advisory Committee on Immunization Practices (ACIP) recommends that persons aged 2 through 55 years at increased risk for meningococcal disease and all adolescents aged 11 through 18 years be immunized with meningococcal conjugate vaccine. ACIP further recommended, in January 2011, that all adolescents receive a booster dose of quadrivalent meningococcal conjugate vaccine at age 16 years. The article summarizes data supporting the extended age indication for MenACWY-CRM and the interchangeability of the two licensed meningococcal conjugate vaccines.
August 26, 2011, Vol. 60/ No. 33
National and State Vaccination Coverage Among Adolescents Aged 13 Through 17 Years—United States, 2010
The Advisory Committee on Immunization Practices (ACIP) recommends that adolescents routinely receive meningococcal conjugate (MenACWY, 2 doses); tetanus, diphtheria, acellular pertussis (Tdap, 1 dose); and human papillomavirus (HPV, 3 doses) vaccines (influenza vaccine is recommended annually for all persons aged 6 months and older) Center for Disease Control (CDC) tracks vaccination coverage among adolescents aged 13 through 17 years through the National Immunization Survey-Teen (NIS-Teen). To provide updated vaccination coverage estimates, CDC analyzed 2010 NIS-Teen data and compared results with 2009 NIS-Teen estimates. The article summarizes the results of that analysis, which found that coverage increased for all three of the routinely administered adolescent vaccines: Tdap from 55.6% to 68.7%, MenACWY from 53.6% to 62.7%, (among females) >=1 dose of HPV from 44.3% to 48.7%, and >=3 doses of HPV from 26.7% to 32.0%. Vaccination coverage varied widely among states; three states (Massachusetts, Rhode Island and Washington) had coverage of >65% for >=1 dose of all three vaccines (Tdap, MenACWY and HPV). Continued evaluation of vaccination-promoting initiatives, including state vaccination-financing policies, is needed to understand their impact on adolescent vaccination and to promote effective practices.
September 2, 2011, Vol. 60/ No. 34
National and State Vaccination Coverage Among Children Aged 19-35 Months—United States, 2010
The National Immunization Survey (NIS) monitors vaccination coverage among children aged 19-35 months using a random-digit-dialed sample of telephone numbers of households to evaluate childhood immunization programs in the United States. The article describes the 2010 NIS coverage estimates for children born during January 2007-July 2009. Nationally, vaccination coverage increased in 2010 compared with 2009 for >=1 dose of measles, mumps, and rubella vaccine (MMR), from 90.0% to 91.5%; >=4 doses of pneumococcal conjugate vaccine (PCV), from 80.4% to 83.3%; the birth dose of hepatitis B vaccine (HepB), from 60.8% to 64.1%; >=2 doses of hepatitis A vaccine (HepA), from 46.6% to 49.7%; rotavirus vaccine, from 43.9% to 59.2%; and the full series of Haemophilus influenzae type b (Hib) vaccine, from 54.8% to 66.8%. Coverage for poliovirus vaccine (93.3%), MMR (91.5%), >=3 doses HepB (91.8%), and varicella vaccine (90.4%) continued to be at or above the national health objective targets of 90% for these vaccines. The percentage of children who had not received any vaccinations remained low (<1%). For most vaccines, no disparities by racial/ethnic group were observed, with coverage for other racial/ethnic groups in 2010 similar to or higher than coverage among white children. However, disparities by poverty status still exist. Maintaining high vaccination coverage levels is important to reduce the burden of vaccine-preventable diseases and prevent a resurgence of these diseases in the United States, particularly in under vaccinated populations.
October 14, 2011, Vol. 60/ No. 40
Recommendation of the Advisory Committee on Immunization Practices (ACIP) for Use of Quadrivalent Meningococcal Conjugate Vaccine (MenACWY-D) Among Children Aged 9 Through 23 Months at Increased Risk for Invasive Meningococcal Disease
In April 2011, the Food and Drug Administration approved the use of a quadrivalent meningococcal conjugate vaccine (MenACWY-D) (Menactra, Sanofi Pasteur) as a 2-dose primary series among children aged 9 through 23 months. Vaccination with meningococcal polysaccharide vaccine is not recommended for children aged <2 years because of low immunogenicity and short duration of protection in this age group.
The Advisory Committee on Immunization Practices (ACIP) Meningococcal Vaccine Work Group reviewed data from four clinical studies on the safety and immunogenicity of MenACWY-D in healthy children aged 9 through 23 months. The pivotal immunogenicity study was a Phase III, multicenter, U.S. trial measuring seroresponse 30 days after 2 doses of MenACWY-D. Antibody titers were measured using a serum bactericidal assay containing human complement (hSBA). Seroresponse was defined as the proportion of subjects with hSBA titers of >=1:8, the accepted measure of protection. The first dose of MenACWY-D was administered alone at age 9 months, followed by a second dose administered alone (n = 404) or concomitantly with measles, mumps, rubella, and varicella vaccine (n = 302) or 7-valent pneumococcal conjugate vaccine (PCV7) (n = 422) at age 12 months. The percentage of subjects with hSBA titers >=1:8 was >90% for all meningococcal serogroups except serogroup W135 (>80%).
Immune responses to childhood vaccines recommended by ACIP at age 12 months, administered concomitantly with MenACWY-D, were evaluated in a separate randomized, multicenter, U.S. trial. After coadministration of MenACWY-D and PCV7, lower geometric mean concentrations (GMCs) of antipneumococcal immunoglobulin G (IgG) were observed compared with corresponding IgG GMCs when PCV7 was administered without MenACWY-D. The noninferiority criteria (twofold differences in IgG GMCs) for the prespecified pneumococcal endpoints were not met for serotypes 4, 6B, and 18C. However, the IgG antibody responses to the seven pneumococcal vaccine serotypes were still robust. For an individual, the clinical relevance of decreased pneumococcal antibody responses to three of seven vaccine serotypes is not known. No data are available on the immune responses to coadministered MenACWY-D and a CRM197-based 13-valent pneumococcal conjugate vaccine. The most common solicited adverse events for MenACWY-D included injection site tenderness and irritability; no serious adverse events were attributed to MenACWY-D.
November 4, 2011, Vol. 60 No. 43
Invasive Pneumococcal Disease and 13-Valent Pneumococcal Conjugate Vaccine (PCV13) Coverage Among Children Aged <=59 Months—Selected United States Regions, 2010-2011
On March 12, 2010, the Advisory Committee on Immunization Practices (ACIP) published recommendations for use of a newly licensed, 13-valent pneumococcal conjugate vaccine (PCV13) to replace the 7-valent vaccine (PCV7) for all children and for a supplemental dose for those aged 14 through 59 months. PCV is given routinely to children at ages 2, 4 and 6 months, and a booster dose is given at 12-15 months. PCV13 includes antigens of six pneumococcal serotypes in addition to those in PCV7. Children only vaccinated with PCV7 are susceptible to those six serotypes, which can cause invasive pneumococcal disease (IPD) and death. During 2010 and 2011, CDC evaluated available data to assess the occurrence of PCV13-type IPD cases and PCV13 vaccination coverage among children aged <=59 months. During May 1, 2010-April 30, 2011, 63 vaccine-eligible children with IPD caused by a serotype that would have been prevented by PCV13 were identified within 12 study regions. Most of those children were aged 24 through 59 months and were vaccinated completely with PCV7 but had not received the recommended supplemental dose of PCV13. Immunization Information System (IIS) sentinel site data from March 2010-June 2011 indicated that the proportion of PCV7-vaccinated children who had received the PCV13 supplemental dose was only 37%. Similarly, among children aged <=59 months requiring additional primary series doses, PCV13 coverage was only 46%. Given the potential for missed PCV13 vaccination, health-care providers should recommend PCV13 vaccination for all eligible children aged 14 through 59 months during all visits, and continue to ensure receipt of the full PCV13 primary series for younger children.
In June 2011, a girl in California, aged 2 years, died of IPD caused by serotype 19A, one of six serotypes included in PCV13 but not in PCV7. The child had received 3 doses of PCV7 but had not received PCV13. The California Department of Public Health identified an additional 30 PCV13-eligible children who had developed nonfatal IPD caused by the pneumococcal serotypes not covered by PCV7 and who became ill after PCV13 was recommended by ACIP. In August 2011, a health advisory was sent to California health-care providers to remind them of ACIP's recommendation for PCV13 use. To determine if other areas of the country were identifying cases of PCV13-type IPD among children eligible to receive PCV13 and to assess PCV13 vaccination coverage among children aged <=59 months, CDC assessed data from 12 geographic regions participating in its ongoing PCV13 Vaccine Effectiveness Evaluation and from eight IIS sentinel sites.
Disclaimer
This publication was prepared in accordance with the Childhood Immunization Insurance Act. First Databank has ceased publishing the Blue Book Average Wholesale Prices (AWP) data field for all drugs as of September 29, 2011. Until a relevant industry or governmental organization develops a viable, generally accepted alternative price benchmark to replace Blue Book AWP data the Department will no longer provide a list of immunizing agents and AWP pricing.
Persons with a disability who require an alternative format of this notice (for example, large print, audiotape, Braille) should contact the 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 (717) 783-6514, or the Pennsylvania AT&T Relay Service at (800) 654-5984 (TT).
ELI N. AVILA, MD, JD, MPH, FCLM,
Secretary
[Pa.B. Doc. No. 12-618. Filed for public inspection April 6, 2012, 9:00 a.m.]
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