NOTICES
Updating the List of Citations to ACIP Recommendations Prescribing Child Immunization Practices and Immunizing Agents and Doses
[37 Pa.B. 6851]
[Saturday, December 22, 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 23, 2007/Vol. 56/No. 46
Notice to Readers: Expansion of Use of Live Attenuated Influenza Vaccine (FluMist®) to Children Aged 2--4 Years and Other FluMist Changes for the 2007-2008 Influenza Season
On October 24, 2007, ACIP recommended that either LAIV or TIV can be used to vaccinate healthy non-pregnant persons aged 2--49 years. For the purposes of this recommendation, healthy persons were defined as persons who do not have an underlying medical condition that predisposes them to influenza complications. ACIP also approved use of FluMist for healthy persons aged 2--18 years under the Federal Vaccines for Children (VFC) program.
October 19, 2007/Vol. 56/No. 41
Update: Prevention of Hepatitis A After Exposure to Hepatitis A Virus and in International Travelers. Updated Recommendations of the Advisory Committee on Immunization Practices (ACIP)
These recommendations replace previous ACIP recommendations for postexposure prophylaxis with immune globulin (IG) incorporating new recommendations for use of single-antigen hepatitis A vaccine and updated recommendations for use of IG postexposure. These recommendations also incorporate and consolidate existing recommendations regarding recommended settings for which postexposure prophylaxis is indicated, including close personal contact with a person with hepatitis A and selected circumstances in which hepatitis A is recognized in a food handler or in a child care center. Also, the updated recommendations leave unchanged the recommendation that postexposure prophylaxis (using vaccine or IG) should be administered as soon as possible. No information exists regarding the efficacy of IG or vaccine if administered > 2 weeks after exposure. The updated recommendations for use of hepatitis A vaccine alone for postexposure prophylaxis do not apply to the combination hepatitis A/hepatitis B vaccine because no data exist regarding the performance of the combination vaccine for prophylaxis after exposure to hepatitis A virus (HAV). The concentration of HAV antigen in the currently available combination vaccine formulation is half that included in the single-antigen vaccine available from the same manufacturer.
October 12, 2007/Vol. 56/No. 40
Notice to Readers: FDA Approval of an Alternate Dosing Schedule for a Combined Hepatitis A and B Vaccine (Twinrix®)
In April 2007, GlaxoSmithKline Vaccine Division (GlaxoSmithKline Biologicals, King of Prussia, Pennsylvania) received approval from the Food and Drug Administration (FDA) for an alternate schedule for Twinrix®, a combined hepatitis A and hepatitis B vaccine. Twinrix was first licensed by FDA in 2001 on a 3-dose schedule (0, 1, and 6 months) for vaccination of persons aged >= 18 years (1). Using the newly licensed, alternate 4-dose schedule, Twinrix doses can be administered at 0, 7, and 21--30 days, followed by a dose at 12 months. Thus, the alternate 4-dose schedule can be useful if vaccination with Twinrix has been initiated and travel or other potential exposure is anticipated before the second dose of Twinrix (or monovalent hepatitis B vaccine) is due, according to the standard 3-dose schedule (that is, 1 month after the first dose). Additional information is available from the manufacturer's package insert (4) and GlaxoSmithKline Vaccines, (800) 366-8900.
September 21, 2007/Vol. 56/No. 37
Influenza Vaccination Coverage Among Children Aged 6--23 Months--United States, 2005-2006 Influenza Season
To assess influenza vaccination coverage among children aged 6--23 months during the 2005-2006 influenza season, data from the 2006 National Immunization Survey (NIS) were analyzed. This report describes the results of that analysis, which indicated that 31.9% of children in this age group received at least 1 dose of influenza vaccine and 20.6% were fully vaccinated according to ACIP recommendations; however, results varied substantially among states. The results underscore the need to continue to monitor influenza vaccination coverage among young children, develop systems to provide childhood influenza vaccination services more efficiently, and increase awareness among health-care providers and caregivers about the effectiveness of influenza vaccination among young children.
Influenza Vaccination Coverage Among Children Aged 6--59 Months--Six Immunization Information System Sentinel Sites, United States, 2006-2007 Influenza Season
In June 2006, the Advisory Committee on Immunization Practices (ACIP) expanded its 2004 recommendation for routine influenza vaccination of children aged 6 through 23 months to include children aged 24--59 months. The 2006 ACIP recommendations also reemphasized that previously unvaccinated children aged < 9 years should receive 2 doses of influenza vaccine administered at least 1 month apart to be fully vaccinated. In 2007, using data from six immunization information system (IIS)* sentinel sites, CDC conducted the first assessment of influenza vaccination coverage among children aged 6--59 months during the 2006-2007 influenza season. The findings demonstrated that, at all six sites, < 30% of children aged 6--23 months and < 20% of children aged 24--59 months were fully vaccinated. Vaccination coverage data from National and State surveys for an influenza season generally are not available until the next influenza season. Rapid assessment of influenza vaccination coverage can help direct activities of state and local public health agencies aimed at increasing the number of children fully vaccinated against influenza.
August 31, 2007/Vol. 56/No. 34
National, State, and Local Area Vaccination Coverage Among Children Aged 19--35 Months--United States, 2006
The National Immunization Survey (NIS) provides vaccination coverage estimates among children aged 19--35 months for each of the 50 states and selected urban and county areas. This report describes the findings of the 2006 NIS, which indicated increases in national coverage with pneumococcal conjugate vaccine (PCV) and varicella vaccine, (VAR) and a stable coverage level for the 4:3:1:3:3:1 vaccine series (that is, >= 4 doses of diphtheria, tetanus toxoid, and any acellular pertussis vaccine [DTaP]; >= 3 doses of poliovirus vaccine; >= 1 dose of measles, mumps, and rubella vaccine [MMR]; >= 3 doses of Haemophilus influenzae type b [Hib] vaccine; >= 3 doses of hepatitis B vaccine [HepB]; and >= 1 dose of VAR).
National Vaccination Coverage Among Adolescents Aged 13--17 Years--United States, 2006
This is the first report of national adolescent vaccination-coverage estimates based on provider-reported vaccination histories. The results indicate that in 2006, the Healthy People 2010 target for adolescents aged 13--15 years had not been met for any of the vaccines. Before development of NIS-Teen, national estimates of adolescent vaccination coverage were determined primarily from data collected from the National Health Interview Survey (NHIS), which is based on parental recall rather than provider records.
August 10, 2007/Vol. 56/No. 31
Notice to Readers: Revised Recommendations of the Advisory Committee on Immunization Practices to Vaccinate All Persons Aged 11--18 Years with Meningococcal Conjugate Vaccine
In June 2007, ACIP revised its recommendation to include routine vaccination of all persons aged 11--18 years with 1 dose of MCV4 at the earliest opportunity. Persons aged 11 to 12 years should be routinely vaccinated at the 11 to 12 years health-care visit as recommended by ACIP. ACIP continues to recommend routine vaccination for persons aged 19--55 years who are at increased risk for meningococcal disease: college freshmen living in dormitories, microbiologists routinely exposed to isolates of Neisseria meningitidis, military recruits, travelers to or residents of countries in which N. meningitidis meningitis is hyperendemic or epidemic, persons with terminal complement component deficiencies, and persons with anatomic or functional asplenia.
July 13, 2007 / Vol. 56 / No. 27
Hepatitis A Vaccination Coverage Among Children Aged 24--35 Months--United States, 2004-2005
The National Immunization Survey (NIS) provides vaccination coverage estimates among noninstitutionalized children aged 19--35 months for the 50 states and selected cities and counties. To obtain vaccination data, NIS conducts a random-digit--dialed telephone survey of households and a mail survey of the children's vaccination providers.
2008 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 58160-0810-46 5 × 1 0.5 ml $25.28 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 $44.46 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 $27.96 Diphtheria Tetanus acellular Pertussis/Haemophilus Influenzae B (DTaP-HIB): sanofi pasteur TriHIBit 49281-0597-05 5 × 1 0.5 ml $50.86 Tetanus Diphtheria adult Vaccine (Td adult): sanofi pasteur Decavac 49281-0291-83 10 × 1 0.5 ml $22.67 sanofi pasteur Decavac 49281-0291-10 10 × 1 0.5 ml $22.67 Diphtheria, Tetanus, acellular Pertussis, Hepatitis B, Polio (DTaP, Hep B, OPV): GlaxoSmithKline Pediarix 58160-0811-11 10 × 1 0.5 ml $84.12 GlaxoSmithKline Pediarix 58160-0811-46 5 × 1 0.5 ml $84.12 Tetanus Toxoid: sanofi pasteur Tetanus toxoid 49281-0820-10 10 × 1 0.5 ml $25.49 sanofi pasteur Tetanus toxoid 49281-0812-84 15 × 1 0.5 ml $23.24 Haemophilus Influenzae Type B Vaccine (HIB): 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 $27.36 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 $53.36 Measles Vaccine (Rubeola): Merck & Co. Attenuvax 0006-4589-00 10 × 0.5 0.5 ml $19.72 Meninigococcal Conjugate Vaccine (MCV4): sanofi pasteur Menactra 49281-0589-05 5 × 1 0.5 ml $107.17 sanofi pasteur Menactra 49281-0598-15 5 × 1 0.5 ml $107.17 Meningococcal Polysaccharide Vaccine: sanofi pasteur Menomune-A/C/Y/W-135 49281-0489-01 each 0.05 mg $109.24 sanofi pasteur Menomune-A/C/Y/W-135 49281-0489-91 10 × 1 0.5 ml $107.17 Mumps Vaccine: Merck & Co. Mumpsvax 00006-4584-00 10 × 0.5 0.5 ml $25.55 Rubella Vaccine: Merck & Co. Meruvax II 00006-4673-00 10 × 0.5 0.5 ml $21.98 Hepatitis A Vaccine (HEP-A): Merck & Co. VAQTA 00006-4096-31 1.0 ml 1.0 ml $77.89 Merck & Co. VAQTA 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 00006-4831-00 0.5 ml 0.5 ml $38.56 Merck & Co. VAQTA Pediatric 00006-4831-41 10 × 0.5 0.5 ml $36.44 GlaxoSmithKline Havrix Pediatric 58160-0825-46 5 × 1 0.5 ml $34.34 GlaxoSmithKline Havrix Pediatric 58160-0825-11 10 × 1 0.5 ml $34.34 GlaxoSmithKline Havrix 58160-0826-46 5 × 1 1 ml $69.80 GlaxoSmithKline Havrix 58160-0826-11 10 × 1 1 ml $69.79 Varicella Virus Vaccine: Merck & Co. Varivax 00006-4826-00 each 1350 pfu $93.73 Merck & Co. Varivax 00006-4827-00 10 × 1 1350 pfu $89.32 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 00006-4109-31 each 0.5 ml $144.75 Merck & Co. Gardasil 00006-4045-00 each 0.5 ml $144.75 Merck & Co. Gardasil 00006-4109-06 6 × 1 0.5 ml $144.75 Merck & Co. Gardasil 00006-4045-41 10 × 1 0.5 ml $144.45 Rotavirus Vaccine: Merck & Co. Rotateq 00006-4047-31 2 ml 2 ml $85.25 Merck & Co. Rotateq 00006-4047-41 10 × 1 2 ml $80.18 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 $16.19 GlaxoSmithKline Fluarix 58160-0873-46 5 × 1 0.5 ml $15.75 MedImmune Flumist 66019-0104-01 10 × 1 2 ml $17.70 CSL Biotherapies Afluria 33332-0107-10 Multidose 0.5 ml $13.05 CSL Biotherapies Afluria 33332-0007-01 10 × 1 0.5 ml $17.25 Hepatitis B Vaccine (HEP-B): Merck & Co. Recombivax HB 00006-4980-00 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 1.0 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 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 00006-4992-00 1.0 ml 1.0 ml $207.36 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 $25.64 GlaxoSmithKline Engerix-B 58160-0821-46 5 × 1 1.0 ml $60.27 GlaxoSmithKline Engerix-B syringe 58160-0821-11 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 58160-0815-11 10 × 1.0 1.0 ml $99.10 GlaxoSmithKline Twinrix 58160-0815-46 5 × 1.0 1.0 ml $99.43 Pneumococcal Vaccine: Wyeth Pharmaceuticals Prevnar 00005-1970-50 10 × 1 0.5 ml $94.88 Merck & Co. Pneumovax 23 00006-4739-00 2.5 ml 2.5 ml $156.47 Merck & Co. Pneumovax 23 00006-4739-50 10 × 5 2.5 ml $159.65 Merck & Co. Pneumovax 23 00006-4943-00 10 × 1 0.5 ml $35.12 Measles, Mumps, Rubella, and Varicella Vaccine Merck & Co. ProQuad 00006-4999-00 10 × 0.5 0.5 ml $148.64 Merck & Co. ProQuad 00006-4984-00 each 0.5 ml $155.81 * 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 Heather Stafford, Director, Division of Immunizations, Department of Health, Room 1026, Health and Welfare Building, 7th and Forster Streets, Harrisburg, PA 17120-0001, (717) 787-5681 or for speech and/or hearing impaired persons, V/TT the Pennsylvania AT&T Relay Service at (800) 654-5984 (TT).
CALVIN B. JOHNSON, M. D., M.P.H.,
Secretary
[Pa.B. Doc. No. 07-2368. Filed for public inspection December 21, 2007, 9:00 a.m.]
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