Pennsylvania Bulletin

PA Bulletin, Doc. No. 05-515

NOTICES

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

[35 Pa.B. 1836]

   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 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 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 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:

   September 3, 2004/Vol. 53/No. 34

   *  Suspension of Rotavirus Vaccine After Reports of Intussusception--United States, 1999.

   September 17, 2004/Vol. 53/No. 36

   *  Notice to Readers: Pneumococcal Conjugate Vaccine Shortage Resolved.

   September 24, 2004/Vol. 53/No. 37

   *  Childhood Influenza-Vaccination Coverage--United States, 2002-03 Influenza Season.

   September 24, 2004/Vol. 53/No. 37

   *  Notice to Readers: Supplemental Recommendations About the Timing of Influenza Vaccination, 2004-05 Season.

   October 8, 2004/Vol. 53/No. 39

   *  Interim Influenza Vaccination Recommendations, 2004-05 Influenza Season Priority Groups for Influenza Vaccine.

   December 17, 2004/Vol. 53/No. 49

   *  Estimated Influenza Vaccination Coverage Among Adults and Children--United States, September 1--November 30, 2004.

   *  Experiences with Obtaining Influenza Vaccination Among Persons in Priority Groups During a Vaccine Shortage--United States, October--November, 2004.

   December 24, 2004/Vol. 53/No. 50

   *  Updated Interim Influenza Vaccination Recommendations--2004.

   January 7, 2004/Vol. 53/Nos. 51 and 52

   *  MMWR QuickGuide: Recommended Childhood and Adolescent Immunization Schedule--United States, 2005. A copy of this document is available on the Department's website: www.health.state.pa.us.

   The Department is also required to update information regarding 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 Chapter 89, Appendix H. The updated information is as follows:

2005 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 $23.56

sanofi pasteur Daptacel 49281-0286-10 10 × 1 0.5 ml $23.40

GlaxoSmithKline Infanrix 58160-0840-11 10 × 1 0.5 ml $22.23

Diphtheria Tetanus pediatric Vaccine (DT pediatric):

sanofi pasteur DT Pediatric 49281-0275-10 5.0 ml 0.5 ml $10.91

Diphtheria Tetanus acellular Pertussis/Haemophilus Influenzae B (DTaP-HIB):

sanofi pasteur TriHIBit 49281-0597-05 5 × 1 0.5 ml $23.13

Tetanus Diphtheria adult Vaccine (Td adult):

sanofi pasteur (1) Td Adult 49281-0271-83 5.0 ml 0.5 ml $10.91

sanofi pasteur (2) Decavac 49281-0291-10

Diphtheria, Tetanus, acellular Pertussis, Hepatitis B, Polio (DTaP, Hep B, OPV)

GlaxoSmithKline Pediarix 58160-0841-11 10 × 1 0.5 ml $78.71

GlaxoSmithKline Pediarix 58160-0841-46 5 × 1 0.5 ml $78.71

Haemophilus Influenzae B Vaccine (HIB):

Wyeth Pharmaceuticals HibTITER 0005-0104-32 5 × 0.5 0.5 ml $12.77

sanofi pasteur ActHIB 49281-0545-05 5 × 1 0.5 ml $12.17

Merck & Co. Pedvax HIB 0006-4897-00 10 × 0.5 0.5 ml $26.08

Injectable Polio Vaccine Inactivated (Salk Enhanced IPV):

sanofi pasteur IPOL 49281-0860-10 5.0 ml 0.5 ml $24.35

Measles Mumps Rubella Vaccine (MMR):

Merck & Co. MMR II 0006-4749-00 0.5 ml 0.5 ml $22.36

Merck & Co. MMR II 0006-4681-00 10 × 0.5 0.5 ml $20.34

Measles Vaccine (Rubeola):

Merck & Co. Atenuvax 0006-4709-00 0.5 ml 0.5 ml $8.87

Merck & Co. Atenuvax 0006-4589-00 10 × 0.5 0.5 ml $7.51

Mumps Vaccine (Mumps):

Merck & Co. Mumpsvax 0006-4753-00 0.5 ml 0.5 ml $10.23

Merck & Co. Mumpsvax 0006-4584-00 10 × 0.5 0.5 ml $9.72

Rubella (German Measles):

Merck & Co. Meruvax II 0006-4747-00 0.5 ml 0.5 ml $9.29

Merck & Co. Meruvax II 0006-4673-00 10 × 0.5 0.5 ml $8.37

Hepatitis A Vaccine Pediatric (HEP-A):

Merck & Co. VAQTA 0006-4831-00 0.5 ml 0.5 ml $35.30

Merck & Co. VAQTA 0006-4831-41 10 × 0.5 0.5 ml $33.32

Merck & Co. VAQTA syringe 0006-4845-00 0.5 ml 0.5 ml $35.31

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 $31.36

GlaxoSmithKline Havrix 58160-0837-11 10 × 0.5 0.5 ml $29.99

GlaxoSmithKline Havrix syringe 58160-0837-50 25 × 0.5 0.5 ml $29.99

GlaxoSmithKline Havrix syringe 58160-0837-46 5 × 0.5 0.5 ml $29.99

Hepatitis A Vaccine Adult (HEP-A):

Merck & Co. VAQTA 0006-4841-00 1.0 ml 1.0 ml $35.30

Merck & Co. VAQTA 0006-4841-38 5 × 1.0 1.0 ml $33.32

Merck & Co. VAQTA 0006-4841-41 10 × 1.0 1.0 ml $32.37

Merck & Co. VAQTA syringe 0006-4844-00 1.0 ml 1.0 ml $35.30

Merck & Co. VAQTA syringe 0006-4844-38 5 × 1.0 1.0 ml $33.32

GlaxoSmithKline Havrix 58160-0835-01 0.5 ml 0.5 ml $62.35

GlaxoSmithKline Havrix syringe 58160-0835-41 1 × 0.5 0.5 ml $61.01

GlaxoSmithKline Havrix syringe 58160-0835-46 5 × 0.5 0.5 ml $61.01

Hepatitis B Vaccine (HEP-B):

Merck & Co. (1) Recombivax HB 00006-4980-00 0.5 ml 0.5 ml $27.26

Merck & Co. (1) Recombivax HB 00006-4981-00 10 × 0.5 ml 0.5 ml $25.94

Merck & Co. (2) Recombivax HB 00006-4769-00 0.5 ml 0.5 ml $27.26

Merck & Co. (2) Recombivax HB 00006-4876-00 10 × 0.5 0.5 ml $25.62

Merck & Co. (2) Recombivax HB 00006-4849-00 5 × 0.5 0.5 ml $27.28

Merck & Co. (2) Recombivax HB 00006-4969-00 5 × 0.5 0.5 ml $27.28

Merck & Co. (3) Recombivax HB 00006-4773-00 3.0 ml 0.5 ml $35.47

Merck & Co. (3) Recombivax HB 00006-4775-00 1.0 ml 1.0 ml $33.50

Merck & Co. (3) Recombivax HB 00006-4872-00 10 × 1.0 1.0 ml $33.16

Merck & Co. (3) Recombivax HB 00006-4873-00 10 × 3.0 0.5 ml $32.94

Merck & Co. (3) Recombivax HB 00006-4848-00 5 × 1.0 1.0 ml $33.50

Merck & Co. (3a,b) Recombivax HB 00006-4995-00 1.0 ml 1.0 ml $33.50

Merck & Co. (3a,b) Recombivax HB 00006-4995-41 10 × 1.0 1.0 ml $33.16

Merck & Co. (3c) Recombivax HB 00006-4992-00 1.0 ml 1.0 ml $93.31

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 58160-0856-57 25 × 0.5 0.5 ml $23.86

GlaxoSmithKline (5) Engerix-B 58160-0857-01 1.0 ml 1.0 ml $57.63

GlaxoSmithKline (5) Engerix-B syringe 58160-0857-46 5 × 1.0 1.0 ml $56.47

GlaxoSmithKline (5) Engerix-B syringe 58160-0857-50 25 × 1.0 1.0 ml $56.47

(1) Pediatric/Adolescent formulation (preservativefree) @ 5mcg/.5ml

(2) Adolescent/infant high risk formulation @ 10 mcg/ml DISCONTINUED

(3) Adult formulation @ 10 mcg/1 ml DISCONTINUED

(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 $47.99

Hepatitis A & Hepatitis B Vaccine:

GlaxoSmithKline Twinrix 58160-0850-01 1.0 ml 1.0 ml $88.33

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 Vaccine:

sanofi pasteur Fluzone PF 49281-0373-25 10 × 0.5 0.25 ml $25.92

sanofi pasteur Fluzone 49281-0374-11 10 × 1 0.5 ml $12.28

sanofi pasteur Fluzone 49281-0374-15 10 × 1 0.5 ml $9.18

MedImmune Flumist 66019-0101-01 10 × 1 0.5 ml $8.44

Pneumococcal Vaccine:

Wyeth Pharmaceuticals Prevnar 0005-1970-67 5 × 0.5 0.5 ml $71.09

Merck & Co. Pneumovax 23 0006-4739-00 2.5 ml 0.5 ml $21.16

Merck & Co. Pneumovax 23 0006-4739-50 10 × 2.5 ml 0.5 ml $23.75

Merck & Co. Pneumovax 23 0006-4943-00 10 × 0.5 0.5 ml $23.75

Merck & Co. Pneumovax 23 syringe 0006-4894-00 5 × 0.5 0.5 ml $19.31

Varicella Virus Vaccine Live (Chickenpox):

Merck & Co. Varivax** 00006-4827-00 10 × 0.5 0.5 ml $33.84

Merck & Co. Varivax** 00006-4826-00 0.5 ml 0.5 ml $35.49

**Comes with a box of ten vials of diluent (package B: 00006-4309-00)

* Indicates the Estimated Acquisition Cost as stated in 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 or Braille) should contact Alice Gray, Director, Division of Immunizations, Department of Health, P. O. Box 90, Harrisburg, PA 17108-0090, (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. 05-515. Filed for public inspection March 18, 2005, 9:00 a.m.]

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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	$23.56
sanofi pasteur	Daptacel	49281-0286-10	10 × 1	0.5 ml	$23.40
GlaxoSmithKline	Infanrix	58160-0840-11	10 × 1	0.5 ml	$22.23

Diphtheria Tetanus pediatric Vaccine (DT pediatric):
sanofi pasteur	DT Pediatric	49281-0275-10	5.0 ml	0.5 ml	$10.91

Diphtheria Tetanus acellular Pertussis/Haemophilus Influenzae B (DTaP-HIB):
sanofi pasteur	TriHIBit	49281-0597-05	5 × 1	0.5 ml	$23.13

Tetanus Diphtheria adult Vaccine (Td adult):
sanofi pasteur	(1) Td Adult	49281-0271-83	5.0 ml	0.5 ml	$10.91
sanofi pasteur	(2) Decavac	49281-0291-10

Diphtheria, Tetanus, acellular Pertussis, Hepatitis B, Polio (DTaP, Hep B, OPV)
GlaxoSmithKline	Pediarix	58160-0841-11	10 × 1	0.5 ml	$78.71
GlaxoSmithKline	Pediarix	58160-0841-46	5 × 1	0.5 ml	$78.71

Haemophilus Influenzae B Vaccine (HIB):
Wyeth Pharmaceuticals	HibTITER	0005-0104-32	5 × 0.5	0.5 ml	$12.77
sanofi pasteur	ActHIB	49281-0545-05	5 × 1	0.5 ml	$12.17
Merck & Co.	Pedvax HIB	0006-4897-00	10 × 0.5	0.5 ml	$26.08

Injectable Polio Vaccine Inactivated (Salk Enhanced IPV):
sanofi pasteur	IPOL	49281-0860-10	5.0 ml	0.5 ml	$24.35

Measles Mumps Rubella Vaccine (MMR):
Merck & Co.	MMR II	0006-4749-00	0.5 ml	0.5 ml	$22.36
Merck & Co.	MMR II	0006-4681-00	10 × 0.5	0.5 ml	$20.34

Measles Vaccine (Rubeola):
Merck & Co.	Atenuvax	0006-4709-00	0.5 ml	0.5 ml	$8.87
Merck & Co.	Atenuvax	0006-4589-00	10 × 0.5	0.5 ml	$7.51

Mumps Vaccine (Mumps):
Merck & Co.	Mumpsvax	0006-4753-00	0.5 ml	0.5 ml	$10.23
Merck & Co.	Mumpsvax	0006-4584-00	10 × 0.5	0.5 ml	$9.72

Rubella (German Measles):
Merck & Co.	Meruvax II	0006-4747-00	0.5 ml	0.5 ml	$9.29
Merck & Co.	Meruvax II	0006-4673-00	10 × 0.5	0.5 ml	$8.37

Hepatitis A Vaccine Pediatric (HEP-A):
Merck & Co.	VAQTA	0006-4831-00	0.5 ml	0.5 ml	$35.30
Merck & Co.	VAQTA	0006-4831-41	10 × 0.5	0.5 ml	$33.32
Merck & Co.	VAQTA syringe	0006-4845-00	0.5 ml	0.5 ml	$35.31
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	$31.36
GlaxoSmithKline	Havrix	58160-0837-11	10 × 0.5	0.5 ml	$29.99
GlaxoSmithKline	Havrix syringe	58160-0837-50	25 × 0.5	0.5 ml	$29.99
GlaxoSmithKline	Havrix syringe	58160-0837-46	5 × 0.5	0.5 ml	$29.99

Hepatitis A Vaccine Adult (HEP-A):
Merck & Co.	VAQTA	0006-4841-00	1.0 ml	1.0 ml	$35.30
Merck & Co.	VAQTA	0006-4841-38	5 × 1.0	1.0 ml	$33.32
Merck & Co.	VAQTA	0006-4841-41	10 × 1.0	1.0 ml	$32.37
Merck & Co.	VAQTA syringe	0006-4844-00	1.0 ml	1.0 ml	$35.30
Merck & Co.	VAQTA syringe	0006-4844-38	5 × 1.0	1.0 ml	$33.32
GlaxoSmithKline	Havrix	58160-0835-01	0.5 ml	0.5 ml	$62.35
GlaxoSmithKline	Havrix syringe	58160-0835-41	1 × 0.5	0.5 ml	$61.01
GlaxoSmithKline	Havrix syringe	58160-0835-46	5 × 0.5	0.5 ml	$61.01

Hepatitis B Vaccine (HEP-B):
Merck & Co.	(1) Recombivax HB	00006-4980-00	0.5 ml	0.5 ml	$27.26
Merck & Co.	(1) Recombivax HB	00006-4981-00	10 × 0.5 ml	0.5 ml	$25.94
Merck & Co.	(2) Recombivax HB	00006-4769-00	0.5 ml	0.5 ml	$27.26
Merck & Co.	(2) Recombivax HB	00006-4876-00	10 × 0.5	0.5 ml	$25.62
Merck & Co.	(2) Recombivax HB	00006-4849-00	5 × 0.5	0.5 ml	$27.28
Merck & Co.	(2) Recombivax HB	00006-4969-00	5 × 0.5	0.5 ml	$27.28
Merck & Co.	(3) Recombivax HB	00006-4773-00	3.0 ml	0.5 ml	$35.47
Merck & Co.	(3) Recombivax HB	00006-4775-00	1.0 ml	1.0 ml	$33.50
Merck & Co.	(3) Recombivax HB	00006-4872-00	10 × 1.0	1.0 ml	$33.16
Merck & Co.	(3) Recombivax HB	00006-4873-00	10 × 3.0	0.5 ml	$32.94
Merck & Co.	(3) Recombivax HB	00006-4848-00	5 × 1.0	1.0 ml	$33.50
Merck & Co.	(3a,b) Recombivax HB	00006-4995-00	1.0 ml	1.0 ml	$33.50
Merck & Co.	(3a,b) Recombivax HB	00006-4995-41	10 × 1.0	1.0 ml	$33.16
Merck & Co.	(3c) Recombivax HB	00006-4992-00	1.0 ml	1.0 ml	$93.31
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	58160-0856-57	25 × 0.5	0.5 ml	$23.86
GlaxoSmithKline	(5) Engerix-B	58160-0857-01	1.0 ml	1.0 ml	$57.63
GlaxoSmithKline	(5) Engerix-B syringe	58160-0857-46	5 × 1.0	1.0 ml	$56.47
GlaxoSmithKline	(5) Engerix-B syringe	58160-0857-50	25 × 1.0	1.0 ml	$56.47

(1) Pediatric/Adolescent formulation (preservativefree) @ 5mcg/.5ml
(2) Adolescent/infant high risk formulation @ 10 mcg/ml DISCONTINUED
(3) Adult formulation @ 10 mcg/1 ml DISCONTINUED
(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	$47.99

Hepatitis A & Hepatitis B Vaccine:
GlaxoSmithKline	Twinrix	58160-0850-01	1.0 ml	1.0 ml	$88.33
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 Vaccine:
sanofi pasteur	Fluzone PF	49281-0373-25	10 × 0.5	0.25 ml	$25.92
sanofi pasteur	Fluzone	49281-0374-11	10 × 1	0.5 ml	$12.28
sanofi pasteur	Fluzone	49281-0374-15	10 × 1	0.5 ml	$9.18
MedImmune	Flumist	66019-0101-01	10 × 1	0.5 ml	$8.44

Pneumococcal Vaccine:
Wyeth Pharmaceuticals	Prevnar	0005-1970-67	5 × 0.5	0.5 ml	$71.09
Merck & Co.	Pneumovax 23	0006-4739-00	2.5 ml	0.5 ml	$21.16
Merck & Co.	Pneumovax 23	0006-4739-50	10 × 2.5 ml	0.5 ml	$23.75
Merck & Co.	Pneumovax 23	0006-4943-00	10 × 0.5	0.5 ml	$23.75
Merck & Co.	Pneumovax 23 syringe	0006-4894-00	5 × 0.5	0.5 ml	$19.31

Varicella Virus Vaccine Live (Chickenpox):
Merck & Co.	Varivax**	00006-4827-00	10 × 0.5	0.5 ml	$33.84
Merck & Co.	Varivax**	00006-4826-00	0.5 ml	0.5 ml	$35.49

**Comes with a box of ten vials of diluent (package B: 00006-4309-00)
* Indicates the Estimated Acquisition Cost as stated in 55 Pa. Code § 1121.55 (relating to method of payment).