NOTICES
DEPARTMENT OF HEALTH
Advisory Committee on Immunization Practices Recommendations Prescribing Child Immunization Practices; Immunizing Agents and Doses
[35 Pa.B. 5190] 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 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 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 at Appendix G remains in full force and effect:
August 5, 2005/Vol. 54/No. 30
Tiered Use of Inactivated Influenza Vaccine in the Event of a Vaccine Shortage
The United States has experienced disruptions in the manufacture or distribution of inactivated influenza vaccine during three of the last five influenza seasons. Delays in delivery of influenza vaccine or vaccine shortages remain possible, in part, because of inherent time constraints in manufacturing the vaccine, given the annual updating of influenza vaccine strains and uncertainties regarding vaccine supply (including licensure of new vaccine preparations).
July 29 2005/Vol. 54/No. 29
National, State and Urban Area Vaccination Coverage Among Children Aged 19-35 Months--United States, 2004
The National Immunization Survey (NIS) provides vaccination coverage estimates for children aged 19-35 months for each of the 50 states and 28 selected urban areas. This report summarizes results from the 2004 NIS, which indicated Nationwide increases in coverage with at least one dose of varicella vaccine (VAR), pneumococcal conjugate vaccine (PCV), and the 4:3:1, 4:3:1:3:3 and 4:3:1:3:3:1 vaccine series. These levels represent an important accomplishment by exceeding for the first time the Healthy People 2010 goal of greater than or equal to 80% coverage for the 4:3:1:3:3 vaccine series.
Immunization Information System Progress--United States, 2003
One of the National Health Objectives for 2010 is to increase to at least 95% the proportion of children aged less than 6 years who participate in fully operational, population-based immunization registries (objective 14-26). Immunization registries are confidential, computerized information systems that collect and consolidate vaccination data from multiple health-care providers, generate reminder and recall notifications and assess vaccination coverage. A registry with added capabilities, such as vaccine management, adverse event reporting, lifespan vaccination histories, and interoperability with electronic medical records (EMRs), is called an immunization information system (IIS). This report summarizes data from the Centers for Disease Control's (CDC) 2003 Immunization Registry Annual Report, a survey of IIS grantees in 50 states, five cities and the District of Columbia that receive funding under section 317b of the Public Health Service Act. The findings of the 2003 IRAR indicate that approximately 44% of United States children aged less than 6 years participated in an IIS. In addition, 76% of public vaccination provider sites and 36% of private vaccination provider sites submitted immunization data to an IIS during the last 6 months of 2003. Increasing health-care provider participation by linking EMRs to IISs is vital to meeting the National health objective.
July 1, 2005/Vol. 54/No. 25
Notice to Readers: Satellite Broadcast on Immunization Update 2005
The CDC's National Immunization Program and the Public Health Training Network will present a live satellite broadcast, ''Immunization Update 2005,'' on July 28, 2005, from 9 to 11:30 a.m. EDT, and a rebroadcast of the same program that day from 12 to 2:30 p.m. EDT. Both broadcasts will include a live question-and-answer session, during which participants Nationwide can interact with course instructors via toll-free telephone lines.
July 30, 2005/Vol. 54/No. 21
Prevention and Control of Meningococcal Disease: Recommendations of the Advisory Committee on Immunization Practices (ACIP)
In January 2005, a tetravalent meningococcal polysaccharide-protein conjugate vaccine ([MCV4] Menactra,TM manufactured by Sanofi Pasteur, Inc., Swiftwater, Pennsylvania) was licensed for use among persons aged 11-55 years. CDC's ACIP recommends routine vaccination of young adolescents (defined in this report as persons aged 11-12 years) with MCV4 at the preadolescent health-care visit (at age 11-12 years). Introducing a recommendation for MCV4 vaccination among young adolescents might strengthen the role of the preadolescent visit and have a positive effect on vaccine coverage among adolescents. For those persons who have not previously received MCV4, ACIP recommends vaccination before high-school entry (at approximately age 15 years) as an effective strategy to reduce meningococcal disease incidence among adolescents and young adults. By 2008, the goal will be routine vaccination with MCV4 of all adolescents beginning at age 11 years. Routine vaccination with meningococcal vaccine also is recommended for college freshmen living in dormitories and for other populations at increased risk (that is, military recruits, travelers to areas in which meningococcal disease is hyperendemic or epidemic, microbiologists who are routinely exposed to isolates of Neisseria meningitidis, patients with anatomic or functional asplenia and patients with terminal complement deficiency). Other adolescents, college students and persons infected with human immunodeficiency virus who wish to decrease their risk for meningococcal disease may elect to receive vaccine.
This report updates previous reports from ACIP concerning prevention and control of meningococcal disease. It also provides updated recommendations regarding use of the tetravalent meningococcal polysaccharide vaccine (MPSV4) and on antimicrobial chemoprophylaxis.
April 15, 2005/Vol. 54/No. 14
Notice to Readers: National Infant Immunization Week--April 24 through 30, 2005
National Infant Immunization Week is April 24 through 30, 2005. The theme this year is ''Vaccination: an Act of Love. Love Them. Protect Them. Immunize Them.'' This annual event emphasizes the importance of timely infant and childhood vaccination, one of the most effective ways to protect infants and children from potentially serious diseases.
April 8, 2005/Vol. 54/No. 13
Update: Influenza Activity--United States, 2004-05 Season Notice to Readers
This report summarizes influenza activity in the United States during October 3, 2004, through March 26, 2005, updates the previous summary, and describes the composition of the 2005-06 influenza vaccine. Influenza activity was moderate in the United States overall, but varied by region. Preliminary data collected through the seven components of the CDC Influenza Surveillance System indicate that national influenza activity peaked in early-February.
50th Anniversary of the First Effective Polio Vaccine--April 12, 2005
April 12, 2005, marks the 50th anniversary of the announcement that the polio vaccine, developed by Jonas Salk and his team of scientists at the University of Pittsburgh, worked. ''Safe, effective, and potent'' were the words used to announce to the world that an effective vaccine had been found against a disease that once paralyzed 13,000--20,000 persons each year in the United States.
April 1, 2005/Vol. 54/No. 12
Estimated Influenza Vaccination Coverage Among Adults and Children--United States, September 1, 2004 through January 31, 2005
In response to the unexpected shortfall in the 2004-05 influenza vaccine supply, CDC recommended in October 2004 that vaccine be reserved for persons in certain priority groups, including persons aged 65 years or older and 6-23 months, persons aged 2-64 years with conditions that increased their risk for influenza complications, residents of chronic-care facilities, close contacts of infants aged less than 6 months, and health-care workers with direct patient contact. To monitor influenza vaccination coverage during the 2004-05 season, the Behavioral Risk Factor Surveillance System, an ongoing, state-based, telephone survey of civilian, noninstitutionalized persons, added new questions to collect information on priority status and the month and year of vaccination for adults and children. This report is based on analysis of data collected during February 1 through 27, 2005, regarding respondent-reported receipt of influenza vaccination during September 1, 2004, through January 31, 2005. The results of this analysis indicated that influenza vaccination coverage levels through January 2005 among adults in priority groups nearly reached those in recent years, whereas coverage levels among adults not in priority groups were approximately half of levels in 2003, in part because 9.3% of those unvaccinated persons in nonpriority groups declined vaccination this season. The results further suggested that designation of the priority groups successfully directed the Nation's influenza vaccine supply to those at highest risk. In addition, vaccination coverage among children aged 6-23 months was notable (48.4%), given that 2004-05 was the first year this group was recommended for influenza vaccination.
February 18, 2005/Vol. 54/No. 6
Hepatitis A Vaccination Coverage Among Children Aged 24-35 Months--United States, 2003
This report is the first National analysis of hepatitis A vaccination coverage among children. The results indicate that, in 2003, vaccination coverage levels with at least 1 dose of hepatitis A vaccine for children aged 24-35 months varied from 6.4% to 72.7% in areas where routine vaccination is recommended. In addition, hepatitis A vaccination coverage rates for children aged 24-35 months are lower than overall rates for other vaccines recommended for children. Sustaining and improving vaccination coverage among young children is needed to ensure continued declines in hepatitis A incidence in the United States.
2005 List of Immunizing Agents and Average Wholesale Prices
Product Name, Company Brand/Product
NameNDC 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 $25.99 GlaxoSmithKline Infanrix 58160-0840-11 10 × 1 0.5 ml $22.22 Diphtheria Tetanus pediatric Vaccine (DT pediatric): sanofi pasteur DT Pediatric 49281-0275-10 5.0 ml 0.5 ml $21.82 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 $22.70 sanofi pasteur (2) Decavac 49281-0291-10 10 × 1 $37.80 Diphtheria, Tetanus, acellular Pertussis, Hepatitis B, Polio (DTaP, Hep B, OPV) GlaxoSmithKline Pediarix 58160-0841-11 10 × 1 0.5 ml $75.70 GlaxoSmithKline Pediarix 58160-0841-46 5 × 1 0.5 ml $75.70 Haemophilus Influenzae B Vaccine (HIB): Wyeth Pharmaceuticals HibTITER 0005-0104-32 5 × 0.5 0.5 ml $25.54 sanofi 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 $25.44 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 $44.72 Merck & Co. MMR II 0006-4681-00 10 × 0.5 0.5 ml $43.19 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 $15.95 Meninigococcal Vaccine (MCV4): sanofi pasteur Menactra 49281-0589-01 $88.56 sanofi pasteur Menactra 49281-0589-05 $88.56 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 $20.65 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 $17.78 Hepatitis A Vaccine Pediatric (HEP-A): Merck & Co. VAQTA 0006-4831-00 0.5 ml 0.5 ml $34.56 Merck & Co. VAQTA 0006-4831-41 10 × 0.5 0.5 ml $32.66 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 $33.31 GlaxoSmithKline Havrix 58160-0837-01 0.5 ml 0.5 ml $30.11 GlaxoSmithKline Havrix 58160-0837-11 10 × 0.5 0.5 ml $28.79 GlaxoSmithKline Havrix syringe 58160-0837-50 25 × 0.5 0.5 ml $28.79 GlaxoSmithKline Havrix syringe 58160-0837-46 5 × 0.5 0.5 ml $28.79 Hepatitis A Vaccine Adult (HEP-A): Merck & Co. VAQTA 0006-4841-00 1.0 ml 1.0 ml $68.35 Merck & Co. VAQTA 0006-4841-38 5 × 1.0 1.0 ml $66.64 Merck & Co. VAQTA 0006-4841-41 10 × 1.0 1.0 ml $64.73 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 $29.92 GlaxoSmithKline Havrix syringe 58160-0835-41 1 × 0.5 0.5 ml $29.28 GlaxoSmithKline Havrix syringe 58160-0835-46 5 × 0.5 0.5 ml $29.28 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 $25.93 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 $33.46 Merck & Co. (3) Recombivax HB 00006-4775-00 1.0 ml 1.0 ml $33.49 Merck & Co. (3) Recombivax HB 00006-4872-00 10 × 1.0 1.0 ml $33.15 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 $33.49 Merck & Co. (3a,b) Recombivax HB 00006-4995-41 10 × 1.0 1.0 ml $33.15 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 $23.07 GlaxoSmithKline (4) Engerix-B 58160-0856-11 10 × 0.5 0.5 ml $23.07 GlaxoSmithKline (4) Engerix-B syringe 58160-0856-46 5 × 0.5 0.5 ml $23.07 GlaxoSmithKline (4) Engerix-B syringe 58160-0856-50 25 × 0.5 0.5 ml $23.07 GlaxoSmithKline (4) Engerix-B syringe 58160-0856-57 25 × 0.5 0.5 ml $23.07 GlaxoSmithKline (5) Engerix-B 58160-0857-01 1.0 ml 1.0 ml $55.35 GlaxoSmithKline (5) Engerix-B syringe 58160-0857-46 5 × 1.0 1.0 ml $54.24 GlaxoSmithKline (5) Engerix-B syringe 58160-0857-50 25 × 1.0 1.0 ml $54.24 (1) Pediatric/Adolescent formulation (preservative-free) @ 5 mcg/.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) @ 40 mcg/1 ml (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 $84.96 GlaxoSmithKline Twinrix 58160-0850-11 10 × 1.0 1.0 ml $83.60 GlaxoSmithKline Twinrix syringe 58160-0850-46 5 × 1.0 1.0 ml $83.88 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 $12.27 sanofi pasteur Fluzone 49281-0374-15 10 × 1 0.5 ml $9.18 MedImmune Flumist 66019-0101-01 10 × 1 0.5 ml $16.20 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 $23.27 Merck & Co. Pneumovax 23 0006-4739-50 10 × 2.5 ml 0.5 ml $26.12 Merck & Co. Pneumovax 23 0006-4943-00 10 × 0.5 0.5 ml $26.12 Merck & Co. Pneumovax 23 syringe 0006-4894-00 5 × 0.5 0.5 ml $19.30 Varicella Virus Vaccine Live (Chickenpox): Merck & Co. Varivax** 00006-4827-00 10 × 0.5 0.5 ml $72.02 Merck & Co. Varivax** 00006-4826-00 0.5 ml 0.5 ml $75.53 *Indicates the Estimated Acquisition Cost (EAC) as stated in the Department of Public Welfare, Office of Medical Assistance Programs, Medical Assistance Regulations at 55 Pa. Code § 1121.56 (relating to drug cost determination).
**Comes with a box of 10 vials of diluent (package B: 00006-4309-00) Persons with disability who require an alternative format of this notice (for example, large print, audiotape, 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) 783-6154 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. 05-1727. Filed for public inspection September 16, 2005, 9:00 a.m.]
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