NOTICES
Updating the List of Citations to ACIP Recommendations Prescribing Child Immunization Practices and Immunizing Agents and Doses
[40 Pa.B. 5404]
[Saturday, September 18, 2010]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 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 31 Pa. Code Chapter 89, Appendix G remains in full force and effect:
January 15, 2010, Vol. 59(01); 1-4
Recommended Adult Immunization Schedule—United States, 2010
The Advisory Committee on Immunization Practices (ACIP) annually reviews the recommended Adult Immunization Schedule to ensure that the schedule reflects current recommendations for the licensed vaccines. In October 2009, ACIP approved the Adult Immunization Schedule for 2010, which includes several changes. A bivalent human papillomavirus vaccine (HPV2) was licensed for use in females in October 2009. ACIP recommends vaccination of females with either HPV2 or the quadrivalent human papillomavirus vaccine (HPV4). HPV4 was licensed for use in males in October 2009, and ACIP issued a permissive recommendation for use in males. Introductory sentences were added to the footnotes for measles, mumps, rubella, influenza, pneumococcal, hepatitis A, hepatitis B, and meningococcal vaccines. Clarifications were made to the footnotes for measles, mumps, rubella, influenza, hepatitis A, meningococcal, and Haemophilus influenza type b vaccines, and schedule information was added to the hepatitis B vaccine footnote.
Additional information is available as follows: schedule (in English and Spanish) at http://www.cdc.gov/vaccines/recs/schedules/adult-schedule.htm; adult vaccination at http://www.cdc.gov/vaccines/default.htm; ACIP statements for specific vaccines at http://www.cdc.gov/vaccine/pubs/acip-list.htm; and reporting adverse events at http://www.vaers.hhs.gov or by telephone, 800-822-7967.
January 22, 2010, Vol. 59(02); 38-43
Update: Influenza Activity—United States, August 30, 2009-January 9, 2010
The emergence and spread of the 2009 pandemic influenza A (H1N1) virus (2009 H1N1) resulted in extraordinary influenza activity in the United States throughout the summer and fall months of 2009. During this period, influenza activity reached its highest level in the week ending October 24, 2009, with 49 of 50 states reporting geographically widespread disease. As of January 9, 2010, overall influenza activity had declined substantially. Since April 2009, the dominant circulating influenza virus in the United States has been 2009 H1N1. This report summarizes U.S. influenza activity from August 30, 2009, through January 9, 2010.
February 12, 2010, Vol. 59(05); 125-129
Update: Mumps Outbreak—New York and New Jersey, June 2009-January 2010
State and local health departments, in collaboration with CDC, continue to investigate a mumps outbreak that began in New York in June 2009. The index case occurred in a boy aged 11 years who had returned on June 17 from a trip to the United Kingdom, where approximately 7,400 reports of laboratory-confirmed mumps were received by the Health Protection Agency in 2009. He then attended a New York summer camp for tradition-observant Jewish boys, where he became symptomatic on June 28. Subsequently, other camp attendees and a staff member were reported to have mumps, and transmission continued in multiple locations when the camp attendees returned home. As of January 29, 2010, a total of 1,521 cases had been reported, with onset dates from June 28, 2009, through January 29, 2010, a substantial increase from the 179 cases reported as of October 30, 2009. The outbreak has remained confined primarily to the tradition-observant Jewish community, with <3% of cases occurring among persons outside the community. The largest percentage of cases (61%) has occurred among persons aged 7-18 years, and 76% of the patients are male. Among the patients for whom vaccination status was reported, 88% had received at least 1 dose of mumps-containing vaccine, and 75% had received 2 doses. This is the largest mumps outbreak that has occurred in the United States since 2006. Although mumps vaccination alone was not sufficient to prevent this outbreak, maintaining high measles, mumps, and rubella (MMR) vaccination coverage remains the most effective way to prevent outbreaks and limit their size when they occur.
February 12, 2010, Vol. 59(05); 133-135
Progress in Immunization Information Systems—United States, 2008
Immunization information systems (IISs) 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 within a defined geographic area. A CDC program goal for 2010 is to achieve >95% participation in an IIS (defined as having two or more recorded vaccinations) among children aged <6 years. To monitor progress toward this goal, CDC annually surveys immunization grantees in 50 states, five cities, and the District of Columbia, using the Immunization Information Systems Annual Report (IISAR). All 56 grantees were asked to complete the IISAR; 52 did so for 2008. This report highlights results from the 2008 IISAR, which indicated that 75% of all United States children aged <6 years (approximately 18 million children) participated in an IIS in 2008, an increase from 65% in 2006. The majority of grantees (82%) reported that their IIS had the capacity to track vaccinations for persons of all ages, compared with 70% in 2006. Data-quality measures of timeliness and completeness indicated that in 2008, 67% of IIS data were received and processed within 30 days of vaccine administration, and data were reported for six of 17 core data elements in >90% of IIS records (both measures are similar to 2006 results). Increased provider use of electronic health record systems can benefit IISs and their users by producing immunization records that are more timely and complete.
March 12, 2010, Vol. 59(09); 258-261
Licensure of a 13-Valent Pneumococcal Conjugate Vaccine (PCV13) and Recommendations for Use Among Children-Advisory Committee on Immunization Practices (ACIP), 2010
On February 24, 2010, a 13-valent pneumococcal conjugate vaccine (PCV13 (Prevnar 13, Wyeth Pharmaceuticals, Inc., a subsidiary of Pfizer, Inc.)) was licensed by theFood and Drug Administration (FDA) for prevention of invasive pneumococcal disease (IPD) caused by the 13 pneumococcal serotypes covered by the vaccine and for prevention of otitis media caused by serotypes in the 7-valent pneumococcal conjugate vaccine formulation (PCV7 (Prevnar, Wyeth)). PCV13 is approved for use among children aged 6 weeks-71 months and succeeds PCV7, which was licensed by FDA in 2000. The Pneumococcal Vaccines Work Group of the Advisory Committee on Immunization Practices (ACIP) reviewed available data on the immunogenicity, safety and cost-effectiveness of PCV13, and on estimates of the vaccine-preventable pneumococcal disease burden. The working group then presented policy options for consideration of the full ACIP. This report summarizes recommendations approved by ACIP on February 24, 2010, for: 1) routine vaccination of all children aged 2-59 months with PCV13; 2) vaccination with PCV13 of children aged 60-71 months with underlying medical conditions that increase their risk for pneumococcal disease or complications; and 3) PCV13 vaccination of children who previously received 1 or more doses of PCV7. CDC guidance for vaccination providers regarding transition from PCV7 to the PCV13 immunization program also is included.
Prevnar 13 Licensure
Vaccine formulation. PCV13 contains polysaccharides of the capsular antigens of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F, individually conjugated to a nontoxic diphtheria CRM197 (CRM, cross-reactive material) carrier protein. A 0.5-mL PCV13 dose contains approximately 2 µg of polysaccharide from each of 12 serotypes and approximately 4 µg of polysaccharide from serotype 6B; the total concentration of CRM197 is approximately 34 µg. The vaccine contains 0.125 mg of aluminum as aluminum phosphate adjuvant and no thimerosal preservative. PCV13 is administered intramuscularly and is available in single-dose, prefilled syringes that do not contain latex.
March 12, 2010, Vol. 59(09); 273
Licensure of a Meningococcal Conjugate Vaccine (Menveo) and Guidance for Use Advisory Committee on Immunization Practices (ACIP), 2010
On February 19, 2010, the Food and Drug Administration (FDA) licensed a quadrivalent meningococcal conjugate vaccine, MenACWY-CRM (Menveo, Novartis Vaccines and Diagnostics). MenACWY-CRM is licensed as a single dose for use among persons aged 11-55 years. The Advisory Committee on Immunization Practices (ACIP) reviewed data from prelicensure clinical trials on the safety and immunogenicity of MenACWY-CRM.
This report summarizes the approved indications for MenACWY-CRM and provides guidance from ACIP for its use. The following guidance for use of MenACWY-CRM is consistent with licensed indications and ACIP recommendations for meningococcal conjugate vaccines. MenACWY-CRM consists of two components: 1) 10 µg of lyophilized meningococcal serogroup A capsular polysaccharide conjugated to CRM197 (MenA) and 2) 5 µg each of capsular polysaccharide of serogroup C, Y, and W135 conjugated to CRM197 in 0.5 ml of phosphate buffered saline, which is used to reconstitute the lyophilized MenA component before injection. The reconstituted vaccine should be used immediately, but may be held at or below 77° F (25° C) for up to 8 hours. MenACWY-CRM is administered as an intramuscular injection, preferably into the deltoid region.
The capsular polysaccharide serogroups included in MenACWY-CRM are the same as those contained in Sanofi Pasteur's MCV4 (Menactra). In study participants aged 11-18 years, noninferiority of MenACWY-CRM to MCV4 was demonstrated for all four serogroups using the primary endpoint, hSBA seroresponse (serum bactericidal assay using human complement). The proportions of subjects with hSBA seroresponse were statistically higher for serogroups A, W and Y in the MenACWY-CRM group, compared with the MCV4 group. The clinical relevance of higher postvaccination immune responses is not known. Safety and reactogenicity profiles were comparable to those observed with MCV4.
March 26, 2010, Vol. 59(11); 321-326
2009 Pandemic Influenza A (H1N1) in Pregnant Women Requiring Intensive Care—New York City, 2009
Pregnant women are at increased risk for severe illness and complications from infection with seasonal influenza and 2009 pandemic influenza A (H1N1). To characterize the severity of 2009 H1N1 infection in pregnant women, the New York City Department of Health and Mental Hygiene (DOHMH) conducted active and passive surveillance for cases of 2009 H1N1 infection in pregnant women requiring intensive care. This report summarizes the results of that surveillance, which found that, during 2009, 16 pregnant women and one who was postpartum were admitted to New York City intensive-care units (ICUs). Two women died. Of the 17 women, 12 had no recognized risk factors for severe influenza complications other than pregnancy. All 17 women received antiviral treatment with oseltamivir; however, treatment was initiated <=2 days after symptom onset in only one woman and was begun >=5 days after symptom onset in four women. Because initiation of antiviral treatment <=2 days after onset is associated with better outcomes, pregnant women should be encouraged to seek medical care immediately if they develop influenza-like symptoms, and health-care providers should initiate empiric antiviral therapy for these women as soon as possible, even if >2 days after symptom onset. Health departments and health-care providers should educate pregnant and postpartum women regarding the risks posed by influenza and highlight the effectiveness and safety of influenza vaccination. Obstetricians and other health-care providers should offer influenza vaccination to their pregnant patients.
To identify cases of 2009 H1N1 infection in pregnant and postpartum women, beginning April 25, 2009, DOHMH conducted surveillance for hospitalizations and deaths during three separate periods. Surveillance methods varied as the 2009 H1N1 pandemic evolved and influenza activity changed in New York City. During April to June, DOHMH conducted citywide active surveillance for deaths from 2009 H1N1 and enhanced citywide surveillance for hospitalized cases of influenza in pregnant and postpartum women, actively requesting specimens and testing for 2009 H1N1 at the New York City Public Health Laboratory. During July to September, influenza activity was low in New York City; however, ongoing passive surveillance was conducted for hospitalized patients who tested positive for influenza A. During October to December, citywide surveillance was passive, except active surveillance was reestablished at five sentinel hospitals. During all three periods, data on pregnancy, ICU status, and vital status were collected for all patients hospitalized with 2009 H1N1 throughout New York City. Chart abstractions for all identified cases were conductedby medical epidemiologists at DOHMH. For this case series, a case was defined as severe illness with laboratory-confirmed or probable 2009 H1N1 infection in a woman who was pregnant or postpartum (within 6 weeks of delivery), resulting in admission to an ICU or death.
April 2, 2010, Vol. 59(12); 363-368
Interim Results: State-Specific Influenza A (H1N1) 2009 Monovalent Vaccination Coverage—United States, October 2009 to January 2010
In July 2009, the Advisory Committee on Immunization Practices (ACIP) issued recommendations for the use of influenza A (H1N1) 2009 monovalent vaccine. Distribution of 2009 H1N1 vaccine in the United States began on October 5, using a system that allocated available vaccine to states proportional to their populations. By the end of 2009, approximately 61 million persons had been vaccinated. By January 29, 2010, approximately 124 million doses had been distributed. To provide preliminary state-specific estimates of 2009 H1N1 vaccination coverage as of the end of January, CDC analyzed results from the Behavioral Risk Factor Surveillance System (BRFSS) and the National 2009 H1N1 Flu Survey (NHFS), using data collected during November 2009 to February 2010. This report summarizes the results of that analysis, which found that, by state, estimated 2009 H1N1 vaccination coverage as of the end of January among persons aged >=6 months ranged from 12.9% to 38.8% (median: 23.9%). Median coverage was 36.8% for children aged 6 months to 17 years, 20.1% for adults aged >=18 years, and 33.2% for persons in the ACIP initial target group. The wide variation in 2009 H1N1 vaccination rates among states suggests opportunities for improvement in future seasons, such as maintaining and increasing the reach of networks of private providers as vaccinators and distributing more vaccine through public venues (e.g., schools).
April 30, 2010, Vol. 59(16); 477-484
Interim Results: State-Specific Seasonal Influenza Vaccination Coverage—United States, August 2009 to January 2010
The advent of the 2009 influenza A (H1N1) pandemic in April 2009 made the 2009-10 influenza season highly unusual. Public awareness of the potential seriousness of influenza was heightened by media coverage of pandemic-associated hospitalizations and deaths, especially among younger persons. In the fall, the distribution of two separate influenza vaccines began, with distinct, although overlapping, recommendations from the Advisory Committee on Immunization Practices (ACIP). In addition, 2009-10 was the first full season in which ACIP's recommendation to vaccinate all children aged 5-18 years was implemented. To provide preliminary state-specific estimates of seasonal influenza vaccination coverage, CDC analyzed Behavioral Risk Factor Surveillance System (BRFSS) and National 2009 H1N1 Flu Survey (NHFS) data collected during October 2009-February 2010. By January 31, estimated state seasonal influenza vaccination coverage among persons aged >=6 months ranged from 30.3% to 54.5% (median: 40.6%). Median coverage was 41.2% for children aged 6 months-17 years, 38.3% for adults aged 18-49 years with high-risk conditions, 28.8% for adults aged 18-49 years without high-risk conditions, 45.5% for adults aged 50-64 years, and 69.3% for adults aged >=65 years. These results, compared with the previous season, suggest large increases in coverage for children and a moderate increase for adults aged 18-49 years without high-risk conditions. Health departments should identify best practices that lead to higher vaccination coverage and should support effective vaccination services (for example, school-located vaccination programs and office-based protocols, such as reminder/recall and standing orders).
May 28, 2010, Vol. 59(20); 626-629
FDA Licensure of Bivalent Human Papillomavirus Vaccine (HPV2, Cervarix) for Use in Females and Updated HPV Vaccination Recommendations from the Advisory Committee on Immunization Practices (ACIP)
On October 16, 2009, the Food and Drug Administration (FDA) licensed bivalent human papillomavirus vaccine (HPV2; Cervarix, GlaxoSmithKline) for use in females aged 10 through 25 years. Cervarix is the second human papillomavirus (HPV) vaccine licensed for use in females in the United States. Quadrivalent HPV vaccine (HPV4; Gardasil, Merck & Co, Inc.) was licensed in 2006 for use in females aged 9 through 26 years, and the Advisory Committee on Immunization Practices (ACIP) recommended routine HPV4 vaccination of females aged 11 or 12 years, and catch-up vaccination for females aged 13 through 26 years. This report provides updated recommendations for routine and catch-up vaccination of females with either HPV2 or HPV4.
Both HPV2 and HPV4 are composed of virus-like particles (VLPs) prepared from recombinant L1 capsid protein of HPV; the two vaccines are not live vaccines. HPV2 is directed against two oncogenic types (HPV 16 and 18). HPV4 is directed against two oncogenic types (HPV 16 and 18) and two nononcogenic types (HPV 6 and 11). Both vaccines have high efficacy against HPV 16 and 18-related cervical precancer lesions. HPV4 also has high efficacy against HPV 6 and HPV 11-related genital warts and HPV 16 and 18-related vaginal and vulvar precancer lesions.
HPV 16 and 18 cause about 70% of cervical cancers; each of the other oncogenic HPV types accounts for a small percentage of all cervical cancers. Other HPV-associated cancers in females include a subset of vulvar, vaginal, anal and oropharyngeal and oral cavity cancers, caused primarily by HPV 16. HPV 6 and 11 cause approximately 90% of genital warts and most cases of recurrent respiratory papillomatosis.
In anticipation of FDA licensure of HPV2, ACIP reviewed data on the immunogenicity, efficacy, and safety of HPV2, as well as information on HPV4. At its October 21, 2009, meeting, ACIP approved updated recommendations for use of HPV vaccines in females.
May 28, 2010, Vol. 59(20); 630-632
FDA Licensure of Quadrivalent Human Papillomavirus Vaccine (HPV4, Gardasil) for Use in Males and Guidance from the Advisory Committee on Immunization Practices (ACIP)
On October 16, 2009, the Food and Drug Administration licensed quadrivalent human papillomavirus vaccine (HPV4; Gardasil, Merck & Co. Inc.) for use in males aged 9 through 26 years for prevention of genital warts caused by human papillomavirus (HPV) types 6 and 11. HPV4 had been licensed previously for use in females aged 9 through 26 years for prevention of HPV 6, 11, 16 and 18-related outcomes (that is, vaginal, vulvar and cervicalprecancers and cancers and genital warts). The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination of females at age 11 or 12 years and catch-up vaccination for females aged 13 through 26 years. On October 21, 2009, ACIP provided guidance that HPV4 may be given to males aged 9 through 26 years to reduce their likelihood of acquiring genital warts; ACIP does not recommend HPV4 for routine use among males. This report presents the ACIP policy statement and summarizes background data. Issues reviewed by ACIP included efficacy, immunogenicity, and safety of the HPV4 vaccine in males, epidemiology of HPV and burden of HPV-associated diseases and cancers in males, cost-effectiveness of male vaccination, and programmatic considerations.
HPV types 6 and 11 cause approximately 90% of genital warts and most cases of recurrent respiratory papillomatosis. Approximately 500,000 cases of genital warts are estimated to occur each year in the United States among sexually active men and women. Direct medical costs related to genital warts are estimated at $200 million per year in addition, genital warts can have an adverse impact on quality of life. HPV-associated cancers in males include certain anal, penile, and oropharyngeal and oral cavity cancers caused primarily by HPV 16.
HPV4 has high efficacy for prevention of genital warts. The phase III efficacy study enrolled 4,065 males aged 16 through 26 years. Participants were enrolled from North America, South America, Europe, Australia and Asia. The efficacy for prevention of genital warts related to HPV types 6, 11, 16 or 18 among males who received all 3 vaccine doses and were seronegative at day 1, and DNA negative day 1 through month 7 to the respective HPV type (per protocol population) was 89.4%; the efficacy for HPV 6 or 11-related genital warts alone was approximately the same. The efficacy for prevention of HPV 6, 11, 16 or 18-related genital warts among males who received at least 1 vaccine dose and regardless of baseline DNA or serology (intent to treat population), was 67.2%, and the efficacy for prevention of genital warts related to any HPV type was 62.1%. No evidence of efficacy was observed among males who were infected with the respective HPV type at baseline. The median duration of follow-up at the time of the study's interim analysis was approximately 2.3 years.
June 4, 2010, Vol. 59(21); 657-661
Preliminary Results: Surveillance for Guillain-BarrÍ
Guillain-BarrÍory failure and death. GBS often follows an antecedent gastrointestinal or upper respiratory illness but, in rare cases, can follow vaccination. In 1976, vaccination against a novel swine-origin influenza A (H1N1) virus was associated with a statistically significant increased risk for GBS in the 42 days after vaccination (approximately 10 excess cases per 1 million vaccinations), a consideration in halting the vaccination program in the context of limited influenza virus transmission. To monitor influenza A (H1N1) 2009 monovalent vaccine safety, several Federal surveillance systems, including CDC's Emerging Infections Program (EIP), are being used. In October 2009, EIP began active surveillance to assess the risk for GBS after 2009 H1N1 vaccination. Preliminary results from an analysis in EIP comparing GBS patients hospitalized through March 31, 2010, who did and did not receive 2009 H1N1 vaccination showed an estimated age-adjusted rate ratio of 1.77 (GBS incidence of 1.92 per 100,000 person-years among vaccinated persons and 1.21 per 100,000 person-years among unvaccinated persons). If end-of-surveillance analysis confirms this finding, this would correspond to 0.8 excess cases of GBS per 1 million vaccinations, similar to that found in seasonal influenza vaccines. No other Federal system to date has detected a statistically significant association between GBS and 2009 H1N1 vaccination. Surveillance and further analyses are ongoing. The 2009 H1N1 vaccine safety profile is similar to that for seasonal influenza vaccines, which have an excellent safety record. Vaccination remains the most effective method to prevent serious illness and death from 2009 H1N1 influenza infection; illness from the 2009 H1N1 influenza virus has been associated with a hospitalization rate of 222 per 1 million and a death rate of 9.7 per 1 million population.
June 11, 2010, Vol. 59(22); 687-688
Addition of Severe Combined Immunodeficiency as a Contraindication for Administration of Rotavirus Vaccine
In response to reported cases of vaccine-acquired rotavirus infection in infants with severe combined immunodeficiency (SCID) following rotavirus vaccine administration, both Merck & Co. and GlaxoSmithKline Biologicals have revised the prescribing information and patient labeling for their respective rotavirus vaccine products, pentavalent rotavirus vaccine (RV5) and monovalent rotavirus vaccine (RV1), with approval from the Food and Drug Administration. Merck revised the prescribing information and patient labeling for RV5 in December 2009, and GlaxoSmithKline Biologicals did so for RV1 in February 2010. After the revision to the RV5 prescribing information, CDC sought consultation from members of the former Rotavirus Vaccine Work Group of the Advisory Committee on Immunization Practices (ACIP). On the basis of that consultation and available data, CDC is updating the list of contraindications for rotavirus vaccine. Rotavirus vaccine (both RV5 and RV1) is contraindicated in infants diagnosed with SCID.
SCID includes a group of rare, life-threatening disorders caused by at least 15 different single gene defects that result in profound deficiencies in T- and B- lymphocyte function. The estimated annual incidence of SCID is one case per 40,000-100,000 live births, or a total of approximately 40-100 new cases among infants in the United States each year. SCID usually is diagnosed after an infant has acquired a severe, potentially life-threatening infection caused by one or more pathogens. Infants with SCID commonly experience chronic diarrhea, failure to thrive, and early onset of infections. Chronic, wild-type rotavirus infection has been reported in infants with SCID, with resulting prolonged diarrhea or shedding of rotavirus. Diagnosis and hematopoietic stem cell transplantation before onset of severe infections offer the best chance for long-term survival of SCID patients.
The Department is also required to update information relating to immunizing agents and doses that the Department has extracted from ACIIP recommendations issued under the standards in 31 Pa. Code §§ 89.801—89.809, Appendix H (relating to immunizing agents and doses). The updated information is as follows:
2010 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 $27.22 sanofi pasteur Daptacel 49281-0286-10 10 x 1 0.5 ml $28.06 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 $44.46 sanofi pasteur Adacel 49281-0400-15 5 x 1 0.5 ml $44.46 GlaxoSmithKline Boostrix 58160-0842-11 10 x 1 0.5 ml $44.61 GlaxoSmithKline Boostrix—syringe 58160-0842-46 5 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 $36.23 Diphtheria Tetanus acellular Pertussis/Haemophilus Influenzae B (DTaP-HIB): sanofi pasteur TriHIBit 49281-0597-05 5 x 1 0.5 ml $55.02 Tetanus Diphtheria adult Vaccine (Td adult): sanofi pasteur Decavac 49281-0291-83 10 x 1 0.5 ml $23.09 sanofi pasteur Decavac 49281-0291-10 10 x 1 0.5 ml $23.09 Diphtheria, Tetanus, acellular Pertussis, Haemophilus Influenzae B, Polio (DTaP, HIB, IPV): sanofi pasteur Pentacel 49281-0510-05 5 x 1 0.5 ml $89.65 Diphtheria, Tetanus, acellular Pertussis, Polio (DTap, IPV): GlaxoSmithKline Kinrix—syringe 58160-0812-46 5 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 $32.30 Haemophilus Influenzae Type B Vaccine (HIB): sanofi pasteur ActHIB 49281-0545-05 5 x 1 10 mcg $28.18 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 $29.50 sanofi pasteur IPOL 49281-0860-10 5.0 ml 0.5 ml $29.50 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 $123.94 sanofi pasteur Menactra 49281-0589-15 5 x 1 0.5 ml $123.94 Novartis Menveo 46028-0208-01 5 x 1 0.5 ml $103.41 Meningococcal Polysaccharide Vaccine: sanofi pasteur Menomune-A/C/Y/
W-13549281-0489-91 10 x 1 0.5 ml $123.94 sanofi pasteur Menomune-A/C/Y/
W-13549281-0489-01 each 0.5 ml $126.34 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 1350 pfu $97.41 Merck & Co. Varivax 00006-4827-00 10 x 1 1350 pfu $92.86 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 $150.51 Merck & Co. Gardasil 00006-4045-41 10 x 1 0.5 ml $150.18 Merck & Co. Gardasil—syringe 00006-4109-06 6 x 1 0.5 ml $152.54 Merck & Co Gardasil—syringe w/o needle 00006-4109-09 6 x 1 0.5 ml $152.54 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 49281-0010-10 10 x 1 0.5 ml $14.74 Sanofi pasteur Fluzone 49281-0010-50 10 x 1 0.5 ml $14.74 Sanofi pasteur Fluzone 49281-0386-15 10 x 1 0.5 ml $13.56 Sanofi pasteur Fluzone Pediatric 49281-0010-25 10 x 1 0.25 ml $15.64 GlaxoSmithKline Fluarix 58160-0873-46 5 x 1 0.5 ml $15.75 MedImmune Flumist 66019-0107-01 10 x 1 0.2 ml $19.70 Merck & Co. Afluria 33332-010-01 10 x 1 0.5 ml $11.00 Merck & Co. Afluria 33332-110-10 Multidose 0.5 ml $10.25 Hepatitis B Vaccine (HEP-B): Merck & Co. Recombivax HB
Hepatitis B vaccine (Recombinant)
Dialysis Formulation00006-4992-00 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 $135.00 Merck & Co. Pneumovax 23 00006-4739-00 2.5 ml 2.5 ml $197.93 Merck & Co. Pneumovax 23 00006-4943-00 10 x 1 0.5 ml $44.43 Measles, Mumps, Rubella, and Varicella Vaccine Merck & Co. ProQuad 00006-4999-00 10 x 0.5 0.5 ml $149.24 * 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 § 1121.55 (relating to method of payment).
Persons with disability who require an alternative format of this notice (for example, large print, audiotape, Braille), should contact the Department of Health, Division of Immunizations, Room 1026, Health and Welfare Building, 625 Forster Street, Harrisburg, PA 17120-0701, (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).
EVERETTE JAMES,
Secretary
[Pa.B. Doc. No. 10-1797. Filed for public inspection September 17, 2010, 9:00 a.m.]
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