1832 Updating the list of citations to ACIP recommendations prescribing child immunization practices and immunizing agents and doses

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

[41 Pa.B. 5821]
[Saturday, October 29, 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) 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 in 31 Pa. Code Chapter 89, Appendix G remains in full force and effect:

January 28, 2011, Vol. 60/No. 3

Updated Recommendations for Use of Meningococcal Conjugate Vaccines-Advisory Committee on Immunization Practices (ACIP), 2010

 On October 27, 2010, the Advisory Committee on Immunization Practices (ACIP) approved updated recommendations for the use of quadrivalent (serogroups A, C, Y and W-135) meningococcal conjugate vaccines (Menveo, Novartis; and Menactra, Sanofi Pasteur) in adolescents and persons at high risk for meningococcal disease. These recommendations supplement the previous ACIP recommendations for meningococcal vaccination. The Meningococcal Vaccines Work Group of ACIP reviewed available data on immunogenicity in high-risk groups, bactericidal antibody persistence after immunization, current epidemiology, vaccine effectiveness and cost effectiveness of different strategies for vaccination of adolescents. The Work Group then presented policy options for consideration by the full ACIP. This report summarizes two new recommendations approved by ACIP: 1) routine vaccination of adolescents, preferably at age 11 or 12 years, with a booster dose at age 16 years; and 2) a 2-dose primary series administered 2 months apart for persons aged 2 through 54 years with persistent complement component deficiency (for example, C5-C9, properidin, factor H or factor D) and functional or anatomic asplenia, and for adolescents with human immunodeficiency virus (HIV) infection. CDC guidance for vaccine providers regarding the updated recommendations was also included.

February 11, 2011, Vol. 60/No. 5

Recommended Immunization Schedules for Persons Aged 0 Through 18 Years—United States, 2011

 Each year, the Advisory Committee on Immunization Practices (ACIP) publishes immunization schedules for persons aged 0 through 18 years. These schedules summarize recommendations for currently licensed vaccines for children aged 18 years and younger and include recommendations in effect as of December 21, 2010. Changes to the previous schedules include the following:

 • Guidance has been added for the hepatitis B vaccine schedule for children who did not receive a birth dose.

 • Information on use of 13-valent pneumococcal conjugate vaccine has been added.

 • Guidance has been added for administration of 1 or 2 doses of seasonal influenza vaccine based upon the child's history of monovalent 2009 H1N1 vaccination.

 • Use of tetanus and diphtheria toxoids, and acellular pertussis (Tdap) vaccine among children aged 7 through 10 years who are incompletely vaccinated against pertussis is addressed, and reference to a specified interval between tetanus and diphtheria toxoids (Td) and Tdap vaccination has been removed.

 • Footnotes for the use of human papillomavirus vaccine have been condensed.

 • A routine 2-dose schedule of quadrivalent meningococcal conjugate vaccine (MCV4) for certain persons at high risk for meningococcal disease, and recommendations for a booster dose of MCV4 have been added.

 • Guidance for use of Haemophilus influenzae type b (Hib) vaccine in persons aged 5 years and older in the catch-up schedule has been condensed.

 The National Childhood Vaccine Injury Act requires that health care providers provide parents or patients with copies of Vaccine Information Statements before administering each dose of the vaccines listed in the schedules. Additional information is available from state health departments and from CDC at http://www.cdc.gov/vaccines/pubs/vis/default.htm.

 Detailed recommendations for using vaccines are available from ACIP statements (available at http://www.cdc.gov/vaccines/pubs/acip-list.htm) and the 2009 Red Book (7). Guidance regarding the Vaccine Adverse Event Reporting System form is available online (http://www.vaers.hhs.gov) or [phone].

April 8, 2011, Vol. 60/No. 1

Measles Imported by Returning U.S. Travelers Aged 6-23 Months, 2001-2011

 In the first 2 months of 2011, CDC received reports of seven imported measles cases among returning United States travelers aged 6-23 months; four required hospitalization. Young children are at greater risk for severe measles, death or sequelae such as subacute sclerosing panencephalitis. Although all seven children had been eligible for vaccination before travel, none had received measles, mumps and rubella vaccine, the only measles-containing vaccine currently available in the United States. To characterize imported measles cases reported in the first 2 months of 2011 in United States travelers aged 6-23 months and compare them with cases in recent years, CDC analyzed data from the National Notifiable Diseases Surveillance System (NNDSS) for the period January 2001 through February 2011. The results of that analysis indicated that, during January through February 2011, a total of 13 imported cases were reported in United States residents, including the seven children aged 6-23 months. During 2001-2010, a total of 159 imported cases were reported in United States residents, including 47 (range: 3-8 per year) in children aged 6-23 months (three of whom had been vaccinated before travel). Because measles remains endemic in much of the world, international travelers should be up-to-date on vaccinations. In accordance with the Advisory Committee for Immunization Practices (ACIP) recommendations, United States children who travel or live abroad should be vaccinated at an earlier age than those living in the United States because of the greater risk for exposure to measles outside the United States, and particularly outside the Americas.

May 27, 2011, Vol. 60/No. 20

Measles-United States, January-May 20, 2011

 Measles is a highly contagious, acute viral illness that can lead to serious complications and death. Endemic or sustained measles transmission has not occurred in the United States since the late 1990s, despite continued importations. During 2001-2008, a median of 56 (range: 37-140) measles cases were reported to CDC annually; during the first 19 weeks of 2011, 118 cases of measles were reported, the highest number reported for this period since 1996. Of the 118 cases, 105 (89%) were associated with importation from other countries, including 46 importations (34 among United States residents traveling abroad and 12 among foreign visitors). Among those 46 cases, 40 (87%) were importations from the World Health Organization European and South-East Asia regions. Of the 118, 105 (89%) patients were unvaccinated. Forty-seven (40%) patients were hospitalized and nine had pneumonia. The increased number of measles importations into the United States this year underscores the importance of vaccination to prevent measles and its complications.

 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 Chapter 89, Appendix H (relating to immunizing agents and doses). The updated information is as follows:

2011 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 x 1	0.5 ml	$27.97
sanofi pasteur	Daptacel	49281-0286-10	10 x 1	0.5 ml	$28.83
GlaxoSmithKline	Infanrix—syringe	58160-0812-46	10 x 1	0.5 ml	$23.02
GlaxoSmithKline	Infanrix	58160-0810-11	10 x 1	0.5 ml	$24.70
Tetanus Diphtheria acellular Pertussis Vaccine (TdaP):
sanofi pasteur	Adacel	49281-0400-10	10 x 1	0.5 ml	$46.15
sanofi pasteur	Adacel	49281-0400-15	5 x 1	0.5 ml	$46.15
GlaxoSmithKline	Boostrix	58160-0842-11	10 x 1	0.5 ml	$44.61
GlaxoSmithKline	Boostrix—syringe	58160-0842-51	10 x 1	0.5 ml	$44.61
Diphtheria Tetanus pediatric Vaccine (DT pediatric):
sanofi pasteur	DT Pediatric	49281-0278-10	10 x 1	0.5 ml	$37.27
Diphtheria Tetanus acellular Pertussis/Haemophilus Influenzae B (DTaP-HIB):
sanofi pasteur	TriHIBit	49281-0597-05	5 x 1	0.5 ml	$56.58
Tetanus Diphtheria adult Vaccine (Td adult):
sanofi pasteur	Decavac	49281-0291-83	10 x 1	0.5 ml	$24.17
sanofi pasteur	Decavac	49281-0291-10	10 x 1	0.5 ml	$24.17
Merck & Co.	Td Vaccine	14362-0111-03	10 x 1	0.5 ml	$22.34
Diphtheria, Tetanus, acellular Pertussis, Haemophilus Influenzae B, Polio (DTaP, HIB, IPV):
sanofi pasteur	Pentacel	49281-0510-05	5 x 1	0.5 ml	$92.22
Diphtheria, Tetanus, acellular Pertussis, Polio (DTap, IPV):
GlaxoSmithKline	Kinrix—syringe	58160-0812-51	10 x 1	0.5 ml	$57.00
GlaxoSmithKline	Kinrix	58160-0812-11	10 x 1	0.5 ml	$57.00
Diphtheria, Tetanus, acellular Pertussis, Hepatitis B, Polio (DTaP, Hep B, IPV):
GlaxoSmithKline	Pediarix	58160-0811-11	10 x 1	0.5 ml	$84.12
GlaxoSmithKline	Pediarix—syringe	58160-0811-46	5 x 1	0.5 ml	$84.12
Tetanus Toxoid:
sanofi pasteur	Tetanus toxoid	49281-0820-10	10 x 1	0.5 ml	$37.03
Haemophilus Influenzae Type B Vaccine (HIB):
sanofi pasteur	ActHIB	49281-0545-05	5 x 1	10 mcg	$29.00
Merck & Co.	Pedvax HIB	00006-4897-00	10 x 1	7.5 mcg	$27.32
GlaxoSmithKline	Hiberix	58160-0806-05	10 x 1	0.5 ml	$8.66
Injectable Polio Vaccine Inactivated (Salk Enhanced IPV):
sanofi pasteur	IPOL	49281-0860-55	10 x 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 x 0.5	0.5 ml	$55.40
Measles Vaccine (Rubeola):
Merck & Co.	Attenuvax	0006-4589-00	10 x 0.5	0.5 ml	$20.48
Meningococcal Conjugate Vaccine (MCV4):
sanofi pasteur	Menactra	49281-0589-05	5 x 1	0.5 ml	$127.64
sanofi pasteur	Menactra	49281-0589-15	5 x 1	0.5 ml	$127.64
Novartis	Menveo	46028-0208-01	5 x 1	0.5 ml	$106.49
Meningococcal Polysaccharide Vaccine:
sanofi pasteur	Menomune- A/C/Y/W-135	49281-0489-91	10 x 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 x 0.5	0.5 ml	$26.54
Rubella Vaccine:
Merck & Co.	Meruvax II	00006-4673-00	10 x 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 x 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 x 1	1.0 ml	$71.99
Merck & Co.	VAQTA Pediatric	00006-4831-41	10 x 0.5	0.5 ml	$36.44
GlaxoSmithKline	Havrix Ped—syringe	58160-0825-52	10 x 1	0.5 ml	$34.34
GlaxoSmithKline	Havrix Pediatric	58160-0825-11	10 x 1	0.5 ml	$34.34
GlaxoSmithKline	Havrix—syringe	58160-0826-46	5 x 1	1 ml	$72.68
GlaxoSmithKline	Havrix	58160-0826-11	10 x 1	1 ml	$72.68
Varicella Virus Vaccine:
Merck & Co.	Varivax	00006-4826-00	each	0.5 ml	$105.29
Merck & Co.	Varivax	00006-4827-00	10 x 1	0.5 ml	$100.38
Merck & Co.	Zostavax	00006-4963-00	each	19400 pfu	$193.80
Merck & Co.	Zostavax	00006-4963-41	10 x 1	19400 pfu	$184.72
Human Papilloma Virus Vaccine:
Merck & Co.	Gardasil	00006-4045-00	each	0.5 ml	$156.50
Merck & Co.	Gardasil	00006-4045-41	10 x 1	0.5 ml	$156.18
Merck & Co.	Gardasil—syringe	00006-4109-06	6 x 1	0.5 ml	$158.00
Merck & Co	Gardasil—syringe w/o needle	00006-4109-09	6 x 1	0.5 ml	$158.00
GlaxoSmithKline	Cervarix	58160-0830-11	10 x 1	0.5 ml	$128.75
GlaxoSmithKline	Cervarix—syringe	58160-0830-46	5 x 1	0.5 ml	$128.75
Rotavirus Vaccine:
Merck & Co.	Rotateq	00006-4047-41	10 x 1	2 ml	$83.35
GlaxoSmithKline	Rotarix	58160-0805-11	10 x 1	1.0 ml	$122.85
Influenza Virus Vaccine:
Novartis	Fluvirin	66521-113-02	10 x 1	0.5 ml	$18.24
Novartis	Fluvirin	66521-113-10	10 x 1	0.5 ml	$14.81
Sanofi pasteur	Fluzone	49281-0011-10	10 x 1	0.5 ml	$15.58
Sanofi pasteur	Fluzone	49281-0011-50	10 x 1	0.5 ml	$15.58
Sanofi pasteur	Fluzone	49281-0388-15	10 x 1	0.5 ml	$14.01
Sanofi pasteur	Fluzone Pediatric	49281-0111-25	10 x 1	0.25 ml	$16.53
GlaxoSmithKline	Fluarix	58160-0873-46	5 x 1	0.5 ml	$15.75
MedImmune	Flumist	66019-0108-10	10 x 1	0.2 ml	$22.31
Merck & Co.	Afluria	33332-0010-01	10 x 1	0.5 ml	$13.05
Merck & Co.	Afluria	33332-0111-10	Multidose	0.5 ml	$12.15
Hepatitis B Vaccine (HEP-B):
Merck & Co.	Recombivax HBHepatitis B vaccine (Recombinant) Dialysis Formulation	00006-4992-00	each	1.0 ml	$165.29
Merck & Co.	Recombivax HB Pediatric	00006-4981-00	10 x 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 x 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 x 1.0 ml	1.0 ml	$73.31
Merck & Co	Recombivax HB syringe w/o needle	00006-4094-09	6 x 1.0 ml	1.0 ml	$73.31
GlaxoSmithKline	Engerix-B Pediatric	58160-0820-11	10 x 1	0.5 ml	$25.49
GlaxoSmithKline	Engerix-B Pediatric	58160-0820-46	5 x 1	0.5 ml	$25.49
GlaxoSmithKline	Engerix-B Pediatric	58160-0856-35	5 x 1	0.5 ml	$25.49
GlaxoSmithKline	Engerix-B syringe	58160-0821-51	10 x 1	1.0 ml	$62.85
GlaxoSmithKline	Engerix-B syringe	58160-0821-11	10 x 1	1.0 ml	$62.85
Hepatitis B / HIB:
Merck & Co.	COMVAX	00006-4898-00	10 x 0.5 ml	0.5 ml	$52.27
Hepatitis A & Hepatitis B Vaccine:
GlaxoSmithKline	Twinrix	58160-0815-11	10 x 1.0	1.0 ml	$103.43
GlaxoSmithKline	Twinrix—syringe	58160-0815-46	5 x 1.0	1.0 ml	$103.43
Pneumococcal Vaccine:
Pfizer	Prevnar 13	0005-1971-02	10 x 1	0.5 ml	$141.75
Merck & Co.	Pneumovax 23	00006-4739-00	2.5 ml	0.5 ml	$60.20
Merck & Co.	Pneumovax 23	00006-4943-00	10 x 1	0.5 ml	$67.58
Measles, Mumps, Rubella, and Varicella Vaccine
Merck & Co.	ProQuad	00006-4999-00	10 x 0.5	0.5 ml	$160.12

 * This publication was prepared in accordance with the Childhood Immunization Insurance Act (40 P. S. §§ 3501—3508). Merck & Co., Inc. has indicated their intent to no longer provide or validate AWP pricing of Merck vaccine. Use of information is voluntary and should not be relied upon. We encourage readers to review the specific statutes, regulations and other interpretive materials.

 ** Indicates the Estimated Acquisition Cost (EAC) as stated in the Department of Public Welfare, Office of Medical Assistance Programs, Medical Assistance Regulations 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, Braille), should contact the Department of Health, Division of Immunizations, Room 1026, Health and Welfare Building, 625 Forster Street, Harrisburg, PA 17120-0701, [phone], or for speech and/or hearing impaired persons V/TT [phone], or the Pennsylvania AT&T Relay Service at [phone] (TT).

ELI N. AVILA, MD, JD, MPH, FCLM, 
Secretary

[Pa.B. Doc. No. 11-1832. Filed for public inspection October 28, 2011, 9:00 a.m.]