1508 Update of the list of citations to ACIP recommendations prescribing child immunization practices and immunizing agents and doses
Update of the List of Citations to ACIP Recommendations Prescribing Child Immunization Practices and Immunizing Agents and Doses [33 Pa.B. 3802] 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 §§ 89.801--89.809, 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 (see 31 Pa. Code §§ 89.801--89.809 (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 Centers for Disease Control 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 §§ 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:
June 21, 2002/Vol. 51/No. 24
* Notice to Readers: Resumption of Routine Schedule for Tetanus and Diphtheria Toxoids
July 5, 2002/Vol. 51/No. 26
* Notice to Readers: Food and Drug Administration Approval of a Fifth Acellular Pertussis Vaccine for Use Among Infants and Young Children--United States, 2002
July 12, 2002/Vol. 51/No. 27
* Notice to Readers: Resumption of Routine Schedule for Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine and for Measles, Mumps, and Rubella Vaccine
July 19, 2002/Vol. 51/No. 28
* Hepatitis B Vaccination Among High-Risk Adolescents and Adults--San Diego, California, 1998--2001
August 2, 2002/Vol. 51/No. 30
* National, State, and Urban Area Vaccination Coverage Levels Among Children Aged 19-35 Months--United States, 2001
* Impact of Vaccine Shortage on Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Coverage Rates Among Children Aged 24 Months--Puerto Rico, 2002
November 8, 2002/Vol. 51/No. RR--17
* Yellow Fever Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2002
November 15, 2002/Vol. 51/No. 45
* Notice to Readers: Use of Anthrax Vaccine in Response to Terrorism: Supplemental Recommendations of the Advisory Committee on Immunization Practices
January 17, 2003/Vol. 52/No. 2
* Update: Influenza Activity--United States, 2002-03 Season
January 24, 2003/Vol. 52/No. SS--1
* Surveillance for Safety After Immunization: Vaccine Adverse Event Reporting System (VAERS)--United States, 1991-2001
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. See 31 Pa. Code § 89.807(b). This information currently appears in 31 Pa. Code §§ 89.801--89.809, Appendix H. The updated information is as follows:
List of Immunizing Agents and Average Wholesale Prices for 2003 Product Name, Company Brand/Product Name NDC Number Unit Dose AWP/Dose* Diphtheria Tetanus acellular Pertussis Vaccine (DTaP):
Aventis Pasteur Tripedia 49281-0298-10 10 × 1 0.5 ml $21.60 GlaxoSmithKline Infanrix 58160-0840-11 10 × 1 0.5 ml $21.60 Diphtheria Tetanus pediatric Vaccine (DT pediatric):
Aventis Pasteur DT Pediatric 49281-0275-10 5.0 ml 0.5 ml $10.91 Diphtheria Tetanus acellular Pertussis/Haemophilus Influenzae B (DTaP-HIB)
Aventis Pasteur TriHIBit 49281-0597-05 5 × 1 0.5 ml $21.15 Tetanus Diphtheria adult Vaccine (Td adult):
Aventis Pasteur Td Adult syringe 49281-0271-10 10 × 1 0.5 ml $13.28 Aventis Pasteur Td Adult 49281-0271-83 5.0 ml 0.5 ml $10.91 Diphtheria, Tetanus, acellular Pertussis, Hepatitis B, Polio (DTaP, Hep B, OPV) GlaxoSmithKline Pediarix 58160-0841-11 10 × 1 0.5 ml $77.24 Haemophilus Influenzae B Vaccine (HIB):
Wyeth-Lederle HibTITER 0005-0104-32 5 × 0.5 0.5 ml $25.54 Aventis Pasteur ActHIB 49281-0545-05 5 × 1 0.5 ml $24.33 Merck & Co. Pedvax HIB 0006-4897-00 10 × 0.5 0.5 ml $24.03 Injectable Polio Vaccine Inactivated (Salk Enhanced IPV):
Aventis Pasteur IPOL 49281-0860-10 5.0 ml 0.5 ml $24.35 Aventis Pasteur IPOL 49281-0860-52 10 × 1 0.5 ml $28.34 Measles Mumps Rubella Vaccine (MMR):
Merck & Co. MMR II 0006-4749-00 0.5 ml 0.5 ml $44.28 Merck & Co. MMR II 0006-4681-00 10 × 0.5 0.5 ml $38.56 Measles Vaccine (Rubeola):
Merck & Co. Atenuvax 0006-4709-00 0.5 ml 0.5 ml $17.73 Merck & Co. Atenuvax 0006-4589-00 10 × 0.5 0.5 ml $14.23 Mumps Vaccine (Mumps): Merck & Co. Mumpsvax 0006-4753-00 0.5 ml 0.5 ml $20.45 Merck & Co. Mumpsvax 0006-4584-00 10 × 0.5 0.5 ml $18.40 Rubella (German Measles):
Merck & Co. Meruvax II 0006-4747-00 0.5 ml 0.5 ml $18.57 Merck & Co. Meruvax II 0006-4673-00 10 × 0.5 0.5 ml $15.85 Hepatitis A Vaccine Pediatric (HEP-A): Merck & Co. VAQTA 0006-4831-00 0.5 ml 0.5 ml $35.30 Merck & Co. VAQTA 0006-4831-38 5 × 0.5 0.5 ml $31.88 Merck & Co. VAQTA syringe 0006-4845-00 0.5 ml 0.5 ml $35.30 Merck & Co. VAQTA syringe 0006-4845-38 5 × 0.5 0.5 ml $33.32 GlaxoSmithKline Havrix 58160-0837-01 0.5 ml 0.5 ml $30.74 GlaxoSmithKline Havrix 58160-0837-11 10 × 0.5 0.5 ml $29.40 GlaxoSmithKline Havrix syringe 58160-0837-50 25 × 0.5 0.5 ml $29.40 GlaxoSmithKline Havrix syringe 58160-0837-46 5 × 0.5 0.5 ml $29.40 GlaxoSmithKline Havrix syringe 58160-0837-50 25 × 0.5 0.5 ml $29.40 GlaxoSmithKline Havrix syringe 58160-0837-58 25 × 0.5 0.5 ml $29.40 Hepatitis A Vaccine Adult (HEP-A):
Merck & Co. VAQTA 0006-4841-00 1.0 ml 1.0 ml $70.60 Merck & Co. VAQTA 0006-4841-38 5 × 1.0 1.0 ml $66.64 Merck & Co. VAQTA syringe 0006-4844-00 1.0 ml 1.0 ml $70.60 Merck & Co. VAQTA syringe 0006-4844-38 5 × 1.0 1.0 ml $66.64 GlaxoSmithKline Havrix 58160-0835-01 0.5 ml 0.5 ml $60.24 GlaxoSmithKline Havrix syringe 58160-0835-41 1 × 0.5 0.5 ml $58.95 GlaxoSmithKline Havrix syringe 58160-0835-46 5 × 0.5 0.5 ml $58.95 Hepatitis B Vaccine (HEP-B):
Merck & Co. (1) Recombivax HB 00006-4980-00 0.5 ml 0.5 ml $27.42 Merck & Co. (1) Recombivax HB 00006-4981-00 10 × 0.5 ml 0.5 ml $26.10 Merck & Co. (2) Recombivax HB 00006-4769-00 0.5 ml 0.5 ml $27.42 Merck & Co. (2) Recombivax HB 00006-4876-00 10 × 0.5 0.5 ml $25.79 Merck & Co. (2) Recombivax HB 00006-4849-00 5 × 0.5 0.5 ml $27.45 Merck & Co. (2) Recombivax HB 00006-4969-00 5 × 0.5 0.5 ml $27.45 Merck & Co. (3) Recombivax HB 00006-4773-00 3.0 ml 0.5 ml $67.10 Merck & Co. (3) Recombivax HB 00006-4775-00 1.0 ml 1.0 ml $67.10 Merck & Co. (3) Recombivax HB 00006-4872-00 10 × 1.0 1.0 ml $66.47 Merck & Co. (3) Recombivax HB 00006-4873-00 10 × 3.0 0.5 ml $66.50 Merck & Co. (3) Recombivax HB 00006-4848-00 5 × 1.0 1.0 ml $67.17 Merck & Co. (3a) Recombivax HB 00006-4995-00 1.0 ml 1.0 ml $66.31 Merck & Co. (3b) Recombivax HB 00005-4995-41 10 × 1.0 1.0 ml $66.31 Merck & Co. (3c) Recombivax HB 00006-4992-00 1.0 ml 1.0 ml $186.62 GlaxoSmithKline (4) Engerix-B 58160-0856-01 0.5 ml 0.5 ml $23.86 GlaxoSmithKline (4) Engerix-B 58160-0856-11 10 × 0.5 0.5 ml $23.86 GlaxoSmithKline (4) Engerix-B syringe 58160-0856-46 5 × 0.5 0.5 ml $23.87 GlaxoSmithKline (4) Engerix-B syringe 58160-0856-50 25 × 0.5 0.5 ml $23.86 GlaxoSmithKline (4) Engerix-B syringe 58160-0856-46 5 × 0.5 0.5 ml $23.87 GlaxoSmithKline (4) Engerix-B syringe 58160-0856-50 25 × 0.5 0.5 ml $23.86 GlaxoSmithKline (4) Engerix-B syringe 58160-0856-58 25 × 0.5 0.5 ml $23.86 GlaxoSmithKline (4) Engerix-B syringe 58160-0856-57 25 × 0.5 0.5 ml $23.86 GlaxoSmithKline (5) Engerix-B 58160-0857-01 1.0 ml 1.0 ml $55.98 GlaxoSmithKline (5) Engerix-B 58160-0857-16 25 × 1.0 1.0 ml $54.56 GlaxoSmithKline (5) Engerix-B syringe 58160-0857-46 5 × 1.0 1.0 ml $54.85 GlaxoSmithKline (5) Engerix-B syringe 58160-0857-50 25 × 1.0 1.0 ml $54.85 (1) Pediatric/Adolescent formulation (preservative-free) @ 5mcg/.5ml (2) Adolescent/infant high risk formulation @ 10 mcg/ml DISCONTINUED
(3) Adult formulation @ 10 mcg/1 ml DISCONTINUE
(3a) Adult formulation (preservative free) @ 10 mcg/1 ml
(3b) Two dose regimen for 11 through 15 years of age (preservative free) (3c) Dialysis formulation (preservative free) @ 40mcg/1ml
(4) Pediatric formulation @ 10 mcg/0.5 ml
(5) Adult formulation @ 20 mcg/ml
Hepatitis B/HIB
Merck & Co. COMVAX 0006-4898-00 10 × 0.5 0.5 ml $47.98 Hepatitis A & Hepatitis B Vaccine:
GlaxoSmithKline Twinrix 58160-0850-01 1.0 ml 1.0 ml $88.32 GlaxoSmithKline Twinrix 58160-0850-11 10 × 1.0 1.0 ml $86.91 GlaxoSmithKline Twinrix syringe 58160-0850-46 5 × 1.0 1.0 ml $87.21 Influenza (split virus) Vaccine:
Aventis Pasteur Fluzone 49281-0370-15 10 × 0.5 0.5 ml $7.87 Evans Fluvirin 19650-0103-10 5.0 ml 0.5 ml $5.95 Evans Fluvirin/syringe 19650-0103-01 10 × 0.5 0.5ml $8.55 Rabies Vaccine: Aventis Pasteur Imovax Rabies 49281-0250-10 1.0 ml 1.0 ml $144.53 Pneumococcal Vaccine: Wyeth-Lederle Prevnar 0005-1970-67 5 × 0.5 0.5 ml $65.25 Merck & Co. Pneumovax 23 0006-4739-00 2.5 ml 0.5 ml $14.69 Merck & Co. Pneumovax 23 0006-4943-00 10 × 0.5 0.5 ml $16.49 Merck & Co. Pneumovax 23 syringe 0006-4894-00 5 × 0.5 0.5 ml $19.30 Meningococcal Vaccine:
Aventis Pasteur Menomune 49281-0489-05 5 × 0.5 0.5 ml $65.79 Aventis Pasteur Menomune 49281-0489-91 5.0 ml 0.5 ml $62.10 Varicella Virus Vaccine Live (Chickenpox):
Merck & Co. Varivax** 00006-4827-00 10 × 0.5 0.5 ml $65.20 Merck & Co. Varivax** 00006-4826-00 0.5 ml 0.5 ml $68.39 **Comes with a box of 10 vials of diluent (package B: 00006-4309-00)
Gamma Globulin/Immune Globulin (GG/IG):
Bayer Gamimune N 10%*** 0026-0648-12 1 g 2.0 ml $91.11/g Bayer Gamimune N 10%*** 0026-0648-15 2.5 g 2.0 ml $91.11/g Bayer Gamimune N 10%*** 0026-0648-20 5 g 2.0 ml $91.11/g Bayer Gamimune N 10%*** 0026-0648-71 10 g 2.0 ml $91.11/g Bayer Gamimune N 10%*** 0026-0648-24 20 g 2.0 ml $91.11/g ***Dosage will vary depending upon the weight of the child and the disease for which the child is being immunized. 150 Pct AWP/Dose is to be calculated based upon the dosage used.
Hepatitis B Immune Globulin (HBIG):
NABI NABI-HB 59730-4402-01 1.0 ml 1.0 ml $157.50 NABI NABI-HB 59730-4403-01 5.0 ml 5.0 ml $126.00 Varicella-Zoster Immune Globulin (VZIG): Mass. PHBL VZIG**** 52769-0574-66 625 u 250 u $504.00 ****Dosage will vary depending upon the weight of the child. If any portion of a vial is used to immunize a child, and the remainder cannot be used to immunize another individual, the entire vial shall be considered as part of the dosage used. 150 Pct LST/Dose is to be calculated based upon the dosage used.
Rabies Immune Globulin (RIG): Aventis Pasteur Imogam Rabies-HT**** 49281-0190-10 10.0 ml 1.0ml $73.99 Aventis Pasteur Imogam Rabies-HT**** 49281-0190-20 2.0 ml 1.0ml $73.99 ****Dosage will vary depending upon the weight of the child. Each 1.0 ml contains 150 IU units. If any portion of the vial is used to immunize a child, and the remainder cannot be used to immunize another individual, the entire vial shall be considered as part of the dosage used. 150 Pct AWP/Dose is to be calculated based upon the dosage used.
Tetanus Immune Globulin (TIG):
Bayer Baytet syringe 00026-0634-02 250.0 unit/in 1.0 ml $112.50 * Indicates the Estimated Acquisition Cost as stated in 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 Alice Gray, Director, Division of Immunization, Department of Health, P. O. Box 90, Harrisburg, PA 17108-0090, (717) 787-5681, for speech and/or hearing impaired persons, V/TT: (717) 783-6154 or the Pennsylvania AT&T Relay Services at (800) 654-5984 (TT).
CALVIN B. JOHNSON, M.D., M.P.H.,
Secretary[Pa.B. Doc. No. 03-1508. Filed for public inspection August 1, 2003, 9:00 a.m.]
