NOTICES
Updating the List of Citations to ACIP Recommendations Prescribing Child Immunization Practices and Immunizing Agents and Doses
[41 Pa.B. 1263]
[Saturday, March 5, 2011]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) (act) 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 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:
July 2, 2010, Vol. 59/No. 25
Hepatitis A Vaccination Coverage Among U.S. Children Aged 12-23 Months—Immunization Information System Sentinel Sites, 2006-2009
Hepatitis A vaccine was first licensed as a 2-dose vaccine for children aged >=24 months in 1995. In 1996 and 1999, the Advisory Committee on Immunization Practices (ACIP) recommended routine hepatitis A vaccination for children aged >=24 months in communities with the highest rates of the disease. In August 2005, the minimum age for which the vaccine was licensed was lowered to 12 months, and in May 2006, ACIP recommended routine vaccination of all children aged 12-23 months, regardless of risk category or location. As a result, hepatitis A incidence in the United States reached a historic low in 2007, the most recent year for which data are available. To assess hepatitis A vaccine coverage among children aged 12-23 months from 2006-2009, CDC used data from eight Immunization Information System sentinel sites. Average (unweighted) hepatitis A vaccination coverage with >=1 dose at the sites increased from 17% in 2006 to 47% in 2009. Average full vaccination coverage with >=2 vaccine doses through age 23 months increased from 1% in 2006 to 15% in 2009. Vaccination coverage with >=1 dose increased the most during 2006 through the first quarter of 2007, after which the rate of increase slowed. The 2006 ACIP recommendations for routine hepatitis A vaccination of all children aged 12-23 months resulted in improved coverage, but coverage has plateaued. Immunization programs and vaccine providers should encourage hepatitis A vaccination of all children beginning at age 12 months.
October 8, 2010, Vol. 59/No. 39
Seasonal Influenza Vaccination Coverage Among Children Aged 6 Months-18 Years—Eight Immunization Information System Sentinel Sites, United States, 2009-10 Influenza Season
Annual influenza vaccination was first recommended for children aged 6-23 months and 2-4 years by the Advisory Committee on Immunization Practices (ACIP) in 2004 and 2006, respectively. In August 2008, ACIP expanded its seasonal influenza vaccination recommendations to also include all children aged 5-18 years no later than the 2009-2010 season. To update previous estimates of seasonal influenza vaccination coverage among children aged 6 months-18 years, CDC analyzed data from the eight immunization information system sentinel sites for the 2009-2010 influenza season. The six sentinel site areas in Arizona, Colorado, Michigan, Minnesota, Oregon and Wisconsin consist of subsets of the entire state; the other two sentinel sites consist of the entire state of North Dakota and all of New York City.
Vaccination coverage with influenza A (H1N1) 2009 monovalent vaccine is not included in this report. Average (unweighted) vaccination coverage with >=1 seasonal influenza vaccine doses was 26.3%, a 5.5 percentage point increase from the 2008-2009 season (20.8%). Increases varied by age group, ranging from almost no increase among children aged 6-23 months (55.2% during the 2008-2009 season to 55.7% during the 2009-2010 season) to notable increases among children aged 2-4 years (from 33.0% to 38.4%), 5-12 years (19.0% to 27.1%) and 13-18 years (10.9% to 15.3%). Full vaccination coverage was low during the 2009-2010 season, ranging from 34.7% among children aged 6-23 months to 15.3% among children aged 13-18 years. These findings highlight the need to identify varied strategies and venues for delivering influenza vaccine to different age groups of children to increase vaccination coverage.
December 10, 2010, Vol. 59 No. RR11
Prevention of Pneumococcal Disease Among Infants and Children—Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine
On February 24, 2010, a 13-valent pneumococcal polysaccharide-protein conjugate vaccine (PCV13 (Prevnar 13, Wyeth Pharmaceuticals, Inc., marketed by Pfizer, Inc.)) was licensed by the Food and Drug Administration (FDA) for prevention of invasive pneumococcal disease caused among infants and young children by the 13 pneumococcal serotypes covered by the vaccine and for prevention of otitis media caused by serotypes also covered by the 7-valent pneumococcal conjugate vaccine formulation (PCV7 (Prevnar, Wyeth)). PCV13 contains the seven serotypes included in PCV7 (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) and six additional serotypes (serotypes 1, 3, 5, 6A, 7F and 19A). PCV13 is approved for use among children aged 6 weeks to 71 months and supersedes PCV7, which was licensed by FDA in 2000.
This report summarizes recommendations approved by the Advisory Committee on Immunization Practices (ACIP) on February 24, 2010, for the use of PCV13 to prevent pneumococcal disease in infants and young children aged <6 years. Recommendations include: 1) routine vaccination of all children aged 2-59 months; 2) vaccination of children aged 60-71 months with underlying medical conditions; and 3) vaccination of children who received >=1 dose of PCV7 previously (CDC. Licensure of a 13-valent pneumococcal conjugate vaccine (PCV13) and recommendations for use among children—Advisory Committee on Immunization Practices (ACIP), 2010. MMWR 2010; 59:258-61). Recommendations also are provided for targeted use of the 23-valent pneumococcal polysaccharide vaccine (PPSV23, formerly PPV23) in children aged 2-18 years with underlying medical conditions that increase their risk for contracting pneumococcal disease or experiencing complications of pneumococcal disease if infected.
The ACIP recommendation for routine vaccination with PCV13 and the immunization schedules for children aged >=59 months who have not received any previous PCV7 or PCV13 doses are the same as those published previously for PCV7 (CDC. Preventing pneumococcal disease among infants and young children: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2000; 49(No. RR-9); CDC. Updated recommendation from the Advisory Committee on Immunization Practices (ACIP) for use of 7-valent pneumococcal conjugate vaccine (PCV7) in children aged 24-59 months who are not completely vaccinated. MMWR 2008; 57:343-4), with PCV13 replacing PCV7 for all doses. For routine immunization of infants, PCV13 is recommended as a 4-dose series at ages 2, 4, 6 and 12-15 months. Infants and children who have received >=1 dose of PCV7 should complete the immunization series with PCV13. A single supplemental dose of PCV13 is recommended for all children aged 14-59 months who have received 4 doses of PCV7 or another age-appropriate, complete PCV7 schedule. For children who have underlying medical conditions, a supplemental PCV13 dose is recommended through age 71 months. Children aged 2-18 years with underlying medical conditions also should receive PPSV23 after completing all recommended doses of PCV13.
The Department is also required to update information relating to immunizing agents and doses that the Department has extracted from ACIP recommendations issued under the standards in 31 Pa. Code § 89.806(a). See 31 Pa. Code § 89.807(b). The Department is also to periodically list the average wholesale price for immunizing agents. Id. This information currently appears in 31 Pa. Code Chapter 89, Appendix H (relating to immunizing agents and doses). The updated information is as follows:
2010 List of Immunizing Agents and Average Wholesale Prices
Product Name, Company Brand/Product Name NDC Number Unit Dose AWP/Dose* Diphtheria Tetanus acellular Pertussis Vaccine (DTaP): sanofi pasteur Tripedia 49281-0298-10 10 × 1 0.5 ml $27.97 sanofi pasteur Daptacel 49281-0286-10 10 × 1 0.5 ml $28.83 GlaxoSmithKline Infanrix—syringe 58160-0812-46 10 × 1 0.5 ml $23.02 GlaxoSmithKline Infanrix 58160-0810-11 10 × 1 0.5 ml $24.70 Tetanus Diphtheria acellular Pertussis Vaccine (TdaP): sanofi pasteur Adacel 49281-0400-10 10 × 1 0.5 ml $46.15 sanofi pasteur Adacel 49281-0400-15 5 × 1 0.5 ml $46.15 GlaxoSmithKline Boostrix 58160-0842-11 10 × 1 0.5 ml $44.61 GlaxoSmithKline Boostrix—syringe 58160-0842-51 10 × 1 0.5 ml $44.61 Diphtheria Tetanus pediatric Vaccine (DT pediatric): sanofi pasteur DT Pediatric 49281-0278-10 10 × 1 0.5 ml $37.27 Diphtheria Tetanus acellular Pertussis/Haemophilus Influenzae B (DTaP-HIB): sanofi pasteur TriHIBit 49281-0597-05 5 × 1 0.5 ml $56.58 Tetanus Diphtheria adult Vaccine (Td adult): sanofi pasteur Decavac 49281-0291-83 10 × 1 0.5 ml $24.17 sanofi pasteur Decavac 49281-0291-10 10 × 1 0.5 ml $24.17 Merck & Co. Td Vaccine 14362-0111-03 10 × 1 0.5 ml $179.90 Diphtheria, Tetanus, acellular Pertussis, Haemophilus Influenzae B, Polio (DTaP, HIB, IPV): sanofi pasteur Pentacel 49281-0510-05 5 × 1 0.5 ml $92.22 Diphtheria, Tetanus, acellular Pertussis, Polio (DTap, IPV): GlaxoSmithKline Kinrix—syringe 58160-0812-51 10 × 1 0.5 ml $57.00 GlaxoSmithKline Kinrix 58160-0812-11 10 × 1 0.5 ml $57.00 Diphtheria, Tetanus, acellular Pertussis, Hepatitis B, Polio (DTaP, Hep B, IPV): GlaxoSmithKline Pediarix 58160-0811-11 10 × 1 0.5 ml $84.12 GlaxoSmithKline Pediarix—syringe 58160-0811-46 5 × 1 0.5 ml $84.12 Tetanus Toxoid: sanofi pasteur Tetanus toxoid 49281-0820-10 10 × 1 0.5 ml $37.03 Haemophilus Influenzae Type B Vaccine (HIB): sanofi pasteur ActHIB 49281-0545-05 5 × 1 10 mcg $29.00 Merck & Co. Pedvax HIB 00006-4897-00 10 × 1 7.5 mcg $27.32 GlaxoSmithKline Hiberix 58160-0806-05 10 × 1 0.5 ml $8.66 Injectable Polio Vaccine Inactivated (Salk Enhanced IPV): sanofi pasteur IPOL 49281-0860-55 10 × 1 0.5 ml $30.36 sanofi pasteur IPOL 49281-0860-10 5.0 ml 0.5 ml $30.36 Measles Mumps Rubella Vaccine (MMR): Merck & Co. MMR II 00006-4681-00 10 × 0.5 0.5 ml $55.40 Measles Vaccine (Rubeola): Merck & Co. Attenuvax 0006-4589-00 10 × 0.5 0.5 ml $20.48 Meningococcal Conjugate Vaccine (MCV4): sanofi pasteur Menactra 49281-0589-05 5 × 1 0.5 ml $127.64 sanofi pasteur Menactra 49281-0589-15 5 × 1 0.5 ml $127.64 Novartis Menveo 46028-0208-01 5 × 1 0.5 ml $103.41 Meningococcal Polysaccharide Vaccine: sanofi pasteur Menomune-A/C/Y/W-135 49281-0489-91 10 × 1 0.5 ml $130.11 sanofi pasteur Menomune-A/C/Y/W-135 49281-0489-01 each 0.5 ml $130.11 Mumps Vaccine: Merck & Co. Mumpsvax 00006-4584-00 10 × 0.5 0.5 ml $26.54 Rubella Vaccine: Merck & Co. Meruvax II 00006-4673-00 10 × 0.5 0.5 ml $22.83 Hepatitis A Vaccine (HEP-A): Merck & Co. VAQTA—syringe 00006-4096-31 1.0 ml 1.0 ml $77.89 Merck & Co. VAQTA—syringe 00006-4096-06 6 × 1 1.0 ml $77.87 Merck & Co. VAQTA 00006-4841-00 1.0 ml 1.0 ml $76.21 Merck & Co. VAQTA 00006-4841-41 10 × 1 1.0 ml $71.99 Merck & Co. VAQTA Pediatric 00006-4831-41 10 × 0.5 0.5 ml $36.44 GlaxoSmithKline Havrix Ped—syringe 58160-0825-52 10 × 1 0.5 ml $34.34 GlaxoSmithKline Havrix Pediatric 58160-0825-11 10 × 1 0.5 ml $34.34 GlaxoSmithKline Havrix—syringe 58160-0826-46 5 × 1 1 ml $72.68 GlaxoSmithKline Havrix 58160-0826-11 10 × 1 1 ml $72.68 Varicella Virus Vaccine: Merck & Co. Varivax 00006-4826-00 each 1350 pfu $97.41 Merck & Co. Varivax 00006-4827-00 10 × 1 1350 pfu $92.86 Merck & Co. Zostavax 00006-4963-00 each 19400 pfu $193.80 Merck & Co. Zostavax 00006-4963-41 10 × 1 19400 pfu $184.72 Human Papilloma Virus Vaccine: Merck & Co. Gardasil 00006-4045-00 each 0.5 ml $150.51 Merck & Co. Gardasil 00006-4045-41 10 × 1 0.5 ml $150.18 Merck & Co. Gardasil—syringe 00006-4109-06 6 × 1 0.5 ml $152.54 Merck & Co Gardasil—syringe w/o needle 00006-4109-09 6 × 1 0.5 ml $152.54 GlaxoSmithKline Cervarix 58160-0830-11 10 × 1 0.5 ml $128.75 GlaxoSmithKline Cervarix-syringe 58160-0830-46 5 × 1 0.5 ml $128.75 Rotavirus Vaccine: Merck & Co. Rotateq 00006-4047-41 10 × 1 2 ml $83.35 GlaxoSmithKline Rotarix 58160-0805-11 10 × 1 1.0ml $122.85 Influenza Virus Vaccine: Novartis Fluvirin 66521-113-02 10 × 1 0.5 ml $18.24 Novartis Fluvirin 66521-113-10 10 × 1 0.5 ml $14.81 Sanofi pasteur Fluzone 49281-0010-10 10 × 1 0.5 ml $14.74 Sanofi pasteur Fluzone 49281-0010-50 10 × 1 0.5 ml $14.74 Sanofi pasteur Fluzone 49281-0386-15 10 × 1 0.5 ml $13.26 Sanofi pasteur Fluzone Pediatric 49281-0010-25 10 × 1 0.25 ml $15.64 GlaxoSmithKline Fluarix 58160-0873-46 5 × 1 0.5 ml $15.75 MedImmune Flumist 66019-0108-10 10 × 1 0.2 ml $22.31 Merck & Co. Afluria 33332-010-01 10 × 1 0.5 ml $11.00 Merck & Co. Afluria 33332-110-10 Multidose 0.5 ml $10.25 Hepatitis B Vaccine (HEP-B): Merck & Co. Recombivax HB Hepatitis B vaccine (Recombinant) Dialysis Formulation 00006-4992-00 each 1.0 ml $165.29 Merck & Co. Recombivax HB Pediatric 00006-4981-00 10 × 0.5 ml 0.5 ml $27.85 Merck & Co. Recombivax HB 00006-4995-00 1.0 ml 1.0 ml $71.64 Merck & Co. Recombivax HB 00006-4995-41 10 × 1.0 ml 1.0 ml $70.81 Merck & Co. Recombivax HB syringe 00006-4094-31 1.0 ml 1.0 ml $73.31 Merck & Co. Recombivax HB syringe 00006-4094-06 6 × 1.0 ml 1.0 ml $73.31 Merck & Co Recombivax HB syringe w/o needle 00006-4094-09 6 × 1.0 ml 1.0 ml $73.31 GlaxoSmithKline Engerix-B Pediatric 58160-0820-11 10 × 1 0.5 ml $25.49 GlaxoSmithKline Engerix-B Pediatric 58160-0820-46 5 × 1 0.5 ml $25.49 GlaxoSmithKline Engerix-B Pediatric 58160-0856-35 5 × 1 0.5 ml $25.49 GlaxoSmithKline Engerix-B syringe 58160-0821-51 10 × 1 1.0 ml $62.85 GlaxoSmithKline Engerix-B syringe 58160-0821-11 10 × 1 1.0 ml $62.85 Hepatitis B / HIB: Merck & Co. COMVAX 00006-4898-00 10 × 0.5 ml 0.5 ml $52.27 Hepatitis A & Hepatitis B Vaccine: GlaxoSmithKline Twinrix 58160-0815-11 10 × 1.0 1.0 ml $103.43 GlaxoSmithKline Twinrix—syringe 58160-0815-46 5 × 1.0 1.0 ml $103.43 Pneumococcal Vaccine: Pfizer Prevnar 13 0005-1971-02 10 × 1 0.5 ml $135.00 Merck & Co. Pneumovax 23 00006-4739-00 2.5 ml 2.5 ml $197.93 Merck & Co. Pneumovax 23 00006-4943-00 10 × 1 0.5 ml $44.43 Measles, Mumps, Rubella, and Varicella Vaccine Merck & Co. ProQuad 00006-4999-00 10 × 0.5 0.5 ml $149.24
* Indicates the Estimated Acquisition Cost (EAC) as stated in the Department of Public Welfare, Office of Medical Assistance Programs, Medical Assistance Regulations at 55 Pa. Code § 1121.55 (relating to method of payment).
Persons with a disability who require an alternative format of this notice (for example, large print, audiotape or Braille) should contact 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,
Acting Secretary
[Pa.B. Doc. No. 11-391. Filed for public inspection March 4, 2011, 9:00 a.m.]
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