NOTICES
Updating the List of Citations to ACIP Recommendations Prescribing Child Immunization Practices and Immunizing Agents and Doses
[37 Pa.B. 372]
[Saturday, January 20, 2007]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, Bureau of Communicable Diseases, Division of Immunization (Department) 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 (40 P. S. §§ 3501--3508) (act) and regulations promulgated thereunder, 31 Pa. Code 809, 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 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 §§ 89.801--89.809, Appendix G.
The Department is required to update the list of these MMWR publications appearing in 31 Pa. Code §§ 89.801--89.809, Appendix G. See 31 Pa. Code § 89.806(a). The additions to the list are as follows, the remainder of the list at Appendix G remains in full force and effect:
November 3, 2006/Vol. 55/No. 43
Notice to Readers: Improved Supply of Meningococcal Conjugate Vaccine, Recommendation to Resume Vaccination of Children Aged 11--12 Years
In January 2005, a tetravalent meningococcal polysaccharide-protein conjugate vaccine (MCV4) (MenactraTM, Sanofi Pasteur, Inc., Swiftwater, Pennsylvania) was licensed for use among persons aged 11--55 years. The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination with MCV4 for children aged 11--12 years at their regular health-care visit.
October 20, 2006/Vol. 55/No. 41
Update: Guillain-Barré Syndrome Among Recipients of Menactra® Meningococcal Conjugate Vaccine--United States, June 2005--September 2006
In October 2005, reports indicating a possible association between Guillain-Barré Syndrome (GBS) and receipt of meningococcal conjugate vaccine (MCV4) (Menactra®, Sanofi Pasteur, Inc., Swiftwater, Pennsylvania) were made to the Vaccine Adverse Event Reporting System (VAERS).
August 4, 2006/Vol. 55/No. 30
Pertussis Outbreak in an Amish Community--Kent County, Delaware, September 2004--February 2005
Vaccine-preventable disease outbreaks continue to occur among undervaccinated populations in the United States, including contained religious communities. The Amish practice separation from the world through group solidarity and caring for their own. Amish religious doctrine does not prohibit vaccination; however, coverage levels for routine childhood vaccination remain low in many Amish communities.
Varicella Outbreak Among Vaccinated Children--Nebraska, 2004
On November 19, 2004, a school nurse notified the Nebraska Health and Human Services System (NHHSS) of a varicella outbreak in an elementary school (grades kindergarten through 7). In collaboration with local health department officials and CDC, NHHSS initiated a retrospective cohort study to determine the magnitude of the outbreak, assess vaccine coverage and effectiveness, and compare disease severity among vaccinated and unvaccinated students.
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 (AWP) for immunizing agents. Id. This information currently appears in 31 Pa. Code §§ 89.801--89.809, Appendix H.
2007 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 $26.18 sanofi pasteur Daptacel 49281-0286-10 10 × 1 0.5 ml $26.00 GlaxoSmithKline Infanrix 58160-0840-46 5 × 1 0.5 ml $25.28 GlaxoSmithKline Infanrix 58160-0840-11 10 × 1 0.5 ml $24.70 Tetanus Diphtheria acellular Pertussis Vaccine (TdaP): sanofi pasteur Adacel 49281-0400-10 10 × 1 0.5 ml $42.45 GlaxoSmithKline Boostrix 58160-0842-11 10 × 1 0.5 ml $43.05 GlaxoSmithKline Boostrix 58160-0842-46 5 × 1 0.5 ml $43.05 Diphtheria Tetanus pediatric Vaccine (DT pediatric): sanofi pasteur DT Pediatric (prefilled) 49281-0278-10 0.5 ml 0.5 ml $21.96 Diphtheria Tetanus acellular Pertussis/Haemophilus Influenzae B (DTaP-HIB): sanofi pasteur TriHIBit 49281-0597-05 5 × 1 0.5 ml $51.41 Tetanus Diphtheria adult Vaccine (Td adult): sanofi pasteur Decavac (latex-free) 49281-0291-83 10 × 1 0.5 ml $21.66 Diphtheria, Tetanus, acellular Pertussis, Hepatitis B, Polio (DTaP, Hep B, IPV): GlaxoSmithKline Pediarix 58160-0841-11 10 × 1 0.5 ml $84.12 GlaxoSmithKline Pediarix 58160-0841-46 5 × 1 0.5 ml $84.12 Tetanus Toxoid: sanofi pasteur Tetanus toxoid 49281-0820-10 10 × 1 0.5 ml $22.17 sanofi pasteur Tetanus toxoid 49281-0812-84 15 × 1 0.5 ml $22.32 Haemophilus Influenzae B Vaccine (HIB): Wyeth Pharmaceuticals HibTiter 00005-0104-32 5 × 1 10 mcg $28.38 Wyeth Pharmaceuticals HibTiter 00005-0201-10 10 × 1 10 mcg $25.68 sanofi pasteur ActHIB 49281-0545-05 5 × 1 10 mcg $27.04 Merck & Co. Pedvax HIB 00006-4897-00 10 × 1 7.5 mcg $27.32 Injectable Polio Vaccine Inactivated (Salk Enhanced IPV): sanofi pasteur IPOL 49281-0860-10 5.0 ml 0.5 ml $31.46 sanofi pasteur IPOL 49281-0860-55 5.0 ml 0.5 ml $31.46 Measles Mumps Rubella Vaccine (MMR): Merck & Co. MMR II 00006-4681-00 10 × 0.5 0.5 ml $50.97 Measles Vaccine (Rubeola): Merck & Co. Attenuvax 0006-4589-00 10 × 0.5 0.5 ml $18.84 Meningococcal Conjugate Vaccine (MCV4): sanofi pasteur Menactra 49281-0589-01 each 0.5 ml $98.40 sanofi pasteur Menactra 49281-0589-05 5 × 1 0.5 ml $98.40 Meningococcal Polysaccharide Vaccine: sanofi pasteur Menomune-A/C/Y/W-135 49281-0489-01 each 0.05 mg $103.32 sanofi pasteur Menomune-A/C/Y/W-135 49281-0489-05 5 × 1 0.05 mg $103.32 sanofi pasteur Menomune-A/C/Y/W-135 49281-0489-91 10 × 1 0.5 ml $101.35 Mumps Vaccine: Merck & Co. Mumpsvax 00006-4584-00 10 × 0.5 0.5 ml $24.39 Rubella Vaccine: Merck & Co. Meruvax II 00006-4673-00 10 × 0.5 0.5 ml $20.99 Hepatitis A Vaccine (HEP-A): Merck & Co. VAQTA Pediatric 00006-4831-00 0.5 ml 0.5 ml $38.56 Merck & Co. VAQTA Pediatric 00006-4831-41 10 × 0.5 0.5 ml $36.44 Merck & Co. VAQTA 00006-4841-00 0.5 ml 0.5 ml $76.21 Merck & Co. VAQTA 00006-4841-41 10 × 0.5 0.5 ml $71.99 GlaxoSmithKline Havrix Pediatric 58160-0837-01 each 0.5 ml $34.34 GlaxoSmithKline Havrix Pediatric 58160-0837-46 5 × 1 0.5 ml $34.34 GlaxoSmithKline Havrix Pediatric 58160-0837-11 10 × 1 0.5 ml $34.34 GlaxoSmithKline Havrix 58160-0835-46 5 × 1 1 ml $67.03 GlaxoSmithKline Havrix 58160-0835-11 10 × 1 1 ml $67.03 Varicella Virus Vaccine: Merck & Co. Varivax 00006-4826-00 each 1350 pfu $89.35 Merck & Co. Varivax 00006-4827-00 10 × 1 1350 pfu $85.18 Shingles Vaccine Merck & Co. Zostavax 00006-4963-00 each 19400 pfu $183.00 Merck & Co. Zostavax 00006-4963-41 10 × 1 19400 pfu $174.42 Human Papilloma Virus Vaccine: Merck & Co. Gardasil (pre-filled) 00006-4109-31 each 0.5 ml $144.00 Merck & Co. Gardasil 00006-4045-00 each 0.5 ml $144.00 Merck & Co. Gardasil (pre-filled) 00006-4109-06 6 × 1 0.5 ml $144.00 Merck & Co. Gardasil 00006-4045-41 10 × 1 0.5 ml $143.70 Rotavirus Vaccine: Merck & Co. Rotateq 00006-4047-31 each 2 ml $80.55 Merck & Co. Rotateq 00006-4047-41 10 × 1 2 ml $75.75 Influenza Virus Vaccine: Novartis Fluvirin 66521-0109-01 10 × 1 0.5 ml $18.24 Novartis Fluvirin 66521-0109-10 10 × 1 0.5 ml $14.81 sanofi pasteur Fluzone 49281-0006-10 10 × 1 0.5 ml $17.45 sanofi pasteur Fluzone 49281-0006-50 10 × 1 0.5 ml $17.45 sanofi pasteur Fluzone 49281-0378-15 10 × 1 0.5 ml $13.29 sanofi pasteur Fluzone Pediatric 49281-0006-25 10 × 1 0.25 ml $17.45 GlaxoSmithKline Fluarix 58160-0873-51 5 × 1 0.5 ml $15.75 MedImmune Flumist 66019-0104-01 10 × 1 0.5 ml $22.29 Hepatitis B Vaccine (HEP-B): Merck & Co. Recombivax HB 00006-4980-00 5mcg/0.5 ml 0.5 ml $30.29 Merck & Co. Recombivax HB 00006-4981-00 10 × 0.5 ml 0.5 ml $28.82 Merck & Co. Recombivax HB 00006-4995-00 10 mcg/ml 1.0 ml $74.44 Merck & Co. Recombivax HB 00006-4995-41 10 × 1.0 ml 1.0 ml $73.68 Merck & Co. Recombivax HB 00006-4992-00 40mcg/ml 1.0 ml $207.36 GlaxoSmithKline Engerix-B Pediatric 58160-0856-11 10 mcg/0.5 ml (10 × 1) 0.5 ml $25.64 GlaxoSmithKline Engerix-B Pediatric 58160-0856-35 10 mcg/0.5 ml (5 × 1) 0.5 ml $25.64 GlaxoSmithKline Engerix-B Pediatric 58160-0856-46 10 mcg/0.5 ml (5 × 1) 0.5 ml $25.64 GlaxoSmithKline Engerix-B syringe 58160-0857-46 20 mcg/ml (5x1) 1.0 ml $60.27 GlaxoSmithKline Engerix-B syringe 58160-0857-11 20 mcg/ml
(10 × 1)1.0 ml $60.27 Hepatitis B / HIB: Merck & Co. COMVAX 00006-4898-00 10 × 0.5 ml 0.5 ml $54.07 Hepatitis A & Hepatitis B Vaccine: GlaxoSmithKline Twinrix 58160-0850-11 10 × 1.0 1.0 ml $94.75 GlaxoSmithKline Twinrix 58160-0850-46 5 × 1.0 1.0 ml $95.07 Pneumococcal Vaccine: Wyeth Pharmaceuticals Prevnar 00005-1970-67 5 × 1 (vial) 0.5 ml $82.95 Wyeth Pharmaceuticals Prevnar 00005-1970-50 10 × 1 (syringe) 0.5 ml $88.29 Merck & Co. Pneumovax 23 00006-4739-00 5 × 1 0.5 ml $28.45 Merck & Co. Pneumovax 23 00006-4739-50 10 × 5 0.5 ml $31.93 Merck & Co. Pneumovax 23 00006-4943-00 10 × 1 0.5 ml $31.93 Measles, Mumps, Rubella, and Varicella Vaccine Merck & Co. ProQuad 00006-4999-00 10 × 0.5 0.5 ml $147.30 Merck & Co. ProQuad 00006-4984-00 10 × 1 0.5 ml $140.53 * Indicates the Estimated Acquisition Cost 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 disability who require an alternative format of this notice (for example, large print, audiotape, Braille), should contact Alice Gray, Director, Department of Health, Division of Immunizations, Room 1026 Health and Welfare Building, Harrisburg, PA 17120 (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).
CALVIN B. JOHNSON, M. D., M.P.H.,
Secretary
[Pa.B. Doc. No. 07-101. Filed for public inspection January 19, 2007, 9:00 a.m.]
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