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PA Bulletin, Doc. No. 10-239


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

[40 Pa.B. 760]
[Saturday, February 6, 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, 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 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 §§ 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:

August 7, 2009, Vol. 58/No. 30

Evaluation of Rapid Influenza Diagnostic Tests for Detection of Novel Influenza A (H1N1) Virus—United States, 2009

 The recent appearance and worldwide spread of novel influenza A (H1N1) virus has highlighted the need to evaluate commercially available, widely used, rapid influenza diagnostic tests (RIDTs) for their ability to detect these viral antigens in respiratory clinical specimens. As an initial assessment, CDC conducted an evaluation of multiple RIDTs. Sixty-five clinical respiratory specimens collected during April—May 2009 that had previously tested positive either for novel influenza A (H1N1) or for seasonal influenza A (H1N1) or A (H3N2) viruses by real-time reverse transcription-polymerase chain reaction (rRT-PCR) assay were used in the evaluation. The results showed that, although the RIDTs were capable of detecting novel A (H1N1) virus from respiratory specimens containing high levels of virus (as indicated by low cycle threshold (Ct) values), the overall sensitivity was low (40%—69%) among all specimens tested and declined substantially as virus levels decreased (and Ct values increased). These findings indicate that, although a positive RIDT result can be used in making treatment decisions, a negative result does not rule out infection with novel influenza A (H1N1) virus. Patients with illnesses compatible with novel influenza A (H1N1) virus infection but with negative RIDT results should be treated empirically based on the level of clinical suspicion, underlying medical conditions, severity of illness, and risk for complications. If a more definitive determination of infection with influenza virus is required, testing with rRT-PCR or virus isolation should be performed. Additional evaluations of the accuracy of RIDTs in detecting novel influenza A (H1N1) virus should be conducted.

August 7, 2009, Vol. 58/No. 30

Updated Recommendations of the Advisory Committee on Immunization Practices (ACIP) Regarding Routine Poliovirus Vaccination

 This report updates Advisory Committee on Immunization Practices (ACIP) recommendations for routine poliovirus vaccination. These updates aim to: 1) emphasize the importance of the booster dose at age >= years; 2) extend the minimum interval from dose 3 to dose 4 from 4 weeks to 6 months; 3) add a precaution for the use of minimum intervals in the first 6 months of life; and 4) clarify the poliovirus vaccination schedule when specific combination vaccines are used.

August 28, 2009, Vol. 58/No. 33

National, State, and Local Area Vaccination Coverage Among Children Aged 19—35 Months—United States, 2008

 The National Immunization Survey (NIS) estimates vaccination coverage among children aged 19—35 months for 50 states and selected local areas. Healthy People 2010 established vaccination coverage targets of 90% for individual vaccines in the 4:3:1:3:3:1 vaccine series and 80% for the series. This report describes the 2008 NIS coverage estimates for this series and individual vaccines, 7-valent pneumococcal conjugate vaccine (PCV7), >= 2 doses of hepatitis A vaccine (HepA), and hepatitis B vaccination received in the first 3 days of life (HepB birth dose) among children born during January 2005—June 2007. In 2008, 4:3:1:3:3:1 series coverage was 76.1%, compared with 77.4% in 2007; >= 90% coverage was maintained for all recommended series vaccines, except >= 4 doses of diphtheria, tetanus, and acellular pertussis (DTaP) vaccine. Coverage with >= 3 doses of Haemophilus influenzae type b vaccine (Hib) decreased from 2007, likely because of the shortage of Hib vaccine and the recommendation to defer the routine Hib vaccine booster dose administered at age 12—15 months. Substantial variability was observed in individual and series vaccination coverage among states/local areas. Among racial/ethnic groups, coverage varied little and, after adjusting for poverty, coverage estimates were not significantly lower for any groups compared with whites. However, children living below poverty had lower coverage than children living at or above poverty for most vaccines. Sustaining high coverage levels and using effective methods of reducing disparities across states/local areas and income groups remains a priority to fully protect children and limit the incidence of vaccine-preventable diseases.

September 4, 2009, Vol. 58/No. 34

Surveillance for Pediatric Deaths Associated with 2009 Pandemic Influenza A (H1N1) Virus Infection—United States, April—August 2009

 Children aged < 5 years or with certain chronic medical conditions are at increased risk for complications and death from influenza (1—3). Because of this increased risk, the Advisory Committee on Immunization Practices (ACIP) has prioritized influenza prevention and treatment for children aged < 5 years and for those with certain chronic medical and immunosuppressive conditions. CDC monitors child influenza deaths through its influenza-associated pediatric mortality reporting system. As of August 8, 2009, CDC had received reports of 477 deaths associated with 2009 pandemic influenza A (H1N1) in the United States, including 36 deaths among children aged < 18 years. To characterize these cases, CDC analyzed data from April to August 2009. The results of that analysis indicated that, of 36 children who died, seven (19%) were aged < 5 years, and 24 (67%) had one or more of the high-risk medical conditions. Twenty-two (92%) of the 24 children with high-risk medical conditions had neurodevelopmental conditions. Among 23 children with culture or pathology results reported, laboratory-confirmed bacterial coinfections were identified in 10 (43%), including all six children who: 1) were aged >= 5 years; 2) had no recognized high-risk condition; and 3) had culture or pathology results reported. Early diagnosis of influenza can enable prompt initiation of antiviral therapy for children who are at greater risk or severely ill. Clinicians also should be aware of the potential for severe bacterial coinfections among children diagnosed with influenza and treat accordingly. All children aged >= 6 months and caregivers of children aged < 6 months should receive influenza A (H1N1) 2009 monovalent vaccine when available.

September 11, 2009, Vol. 58/No. 35

Oseltamivir-Resistant 2009 Pandemic Influenza A (H1N1) Virus Infection in Two Summer Campers Receiving Prophylaxis—North Carolina, 2009

 Initial testing of the 2009 pandemic influenza A (H1N1) virus found it susceptible to neuraminidase inhibitors (oseltamivir and zanamivir) and resistant to adamantanes (amantadine and rimantadine). Neuraminidase inhibitors have been used widely for treatment and chemoprophylaxis of 2009 pandemic influenza A (H1N1); however, sporadic cases of oseltamivir-resistant 2009 pandemic influenza A (H1N1) virus infection have been reported worldwide, including nine U.S. cases identified as of September 4. On July 14, CDC was contacted by a physician at a summer camp in North Carolina regarding two cases of influenza-like illness (ILI) in adolescent girls receiving oseltamivir chemoprophylaxis during an ILI outbreak that had begun June 18. The two girls stayed in the same cabin, and both received oseltamivir during a mass chemoprophylaxis program in which approximately 600 campers and staff members received oseltamivir or zanamivir. On July 20 and July 22, the North Carolina State Laboratory of Public Health confirmed pandemic H1N1 virus infection in respiratory specimens from both girls. On August 14 and August 19, CDC detected the H275Y mutation (N1 numbering) in neuraminidase from both specimens by pyrosequencing. The H275Y mutation is associated with resistance to oseltamivir; zanamivir susceptibility is retained. A second mutation (I223V) in neuraminidase also was detected in both specimens. This is the first report of oseltamivir resistance in pandemic H1N1 cases with an epidemiologic link. Health-care providers should be aware that antiviral resistance can develop during chemoprophylaxis or treatment with subtherapeutic dosages and should follow published recommendations for antiviral medications.

September 18, 2009, Vol. 58/No. 36

National, State, and Local Area Vaccination Coverage Among Adolescents Aged 13—17 Years—United States, 2008

 In recent years, the Advisory Committee on Immunization Practices (ACIP) has recommended three newly licensed vaccines: meningococcal conjugate vaccine (MCV4; 1 dose); tetanus, diphtheria, acellular pertussis vaccine (Tdap; 1 dose); and (for girls) quadrivalent human papillomavirus vaccine (HPV4; 3 doses). ACIP also recommends that adolescents receive recommended vaccinations that were missed during childhood: measles, mumps, rubella vaccine (MMR; 2 doses); hepatitis B vaccine (HepB; 3 doses); and varicella vaccine (VAR; 2 doses). Since 2006, CDC has conducted the National Immunization Survey—Teen (NIS-Teen) to estimate vaccination coverage from a national sample of adolescents aged 13—17 years. This report summarizes results from the 2008 NIS-Teen and, for the first time, includes estimates for each of the 50 states and selected local areas. Nationally, vaccination coverage for the three most recently recommended adolescent vaccinations and one childhood vaccination increased from 2007 to 2008: MCV4 (from 32.4% to 41.8%), Tdap (from 30.4% to 40.8%), >= 1 dose of HPV4 (from 25.1% to 37.2%), and >= 2 doses of VAR among those without disease history (from 18.8% to 34.1%). However, substantial variability in vaccination coverage was observed in 2008 among state and local areas and by race/ethnicity and poverty status. For the first time, the Healthy People 2010 target of 90% coverage among adolescents aged 13—15 years was met for MMR and HepB. Public health agencies should continue annual monitoring of adolescent vaccination coverage levels to identify trends and differences by geographic area, race/ethnicity and poverty status.

Updated Recommendations from the Advisory Committee on Immunization Practices (ACIP) for Use of Hepatitis A Vaccine in Close Contacts of Newly Arriving International Adoptees

 On February 25, 2009, the Advisory Committee on Immunization Practices (ACIP) recommended routine hepatitis A vaccination for household members and other close personal contacts (for example, regular babysitters) of adopted children newly arriving from countries with high or intermediate hepatitis A endemicity. This new recommendation complements previous ACIP recommendations for hepatitis A vaccination for persons traveling from the United States to countries with high or intermediate hepatitis A endemicity (including persons with travel related to international adoption), and postexposure prophylaxis for contacts of persons with hepatitis A. This report introduces the new recommendation and outlines the underlying epidemiologic and programmatic rationale.

Licensure of a Haemophilus influenzae Type b (Hib) Vaccine (Hiberix) and Updated Recommendations for Use of Hib Vaccine

 On August 19, 2009, the Food and Drug Administration (FDA) licensed Hiberix (GlaxoSmithKline Biologicals, Rixensart, Belgium), a Haemophilus influenzae type b (Hib) conjugate vaccine composed of H. influenzae type b capsular polysaccharide (polyribosyl-ribitol-phosphate (PRP)) conjugated to inactivated tetanus toxoid (PRP-T). Hiberix is licensed for use as the booster (final) dose of the Hib vaccine series for children aged 15 months—4 years (before the 5th birthday) who have received previously the primary series of Hib vaccination (consisting of 2 or 3 doses, depending on the formulation). The Advisory Committee on Immunization Practices (ACIP) recommends Hib booster vaccination for children at ages 12—15 months; however, because of the recent shortage of Hib vaccines, many children have deferred the booster dose and therefore require catch-up vaccination. This report summarizes the indications for Hiberix use and provides guidance on Hib booster dose administration based on increasing vaccine supplies. Vaccination recommendations in this report update the previous advisory on Hib booster administration (June 26, 2009), which advised that children with deferred booster doses receive it at the next regularly scheduled visit. Vaccination providers are now recommended to begin recall of children in need of the booster dose when feasible and monovalent Hib vaccine supply in the office is adequate.

September 25, 2009, Vol. 58/No. 37

Updated Recommendation from the Advisory Committee on Immunization Practices (ACIP) for Revaccination of Persons at Prolonged Increased Risk for Meningococcal Disease

 The Advisory Committee on Immunization Practices (ACIP) recommends quadrivalent meningococcal conjugate vaccine, (MCV4) (Menactra, Sanofi Pasteur, Swiftwater, Pennsylvania) for all persons aged 11—18 years and for persons aged 2—55 years at increased risk for meningococcal disease. MCV4 is licensed as a single dose. Because of the high risk for meningococcal disease among certain groups and limited data on duration of protection, at its June 2009 meeting ACIP recommended that persons previously vaccinated with either MCV4 or MPSV4 (Menomune, Sanofi Pasteur) who are at prolonged increased risk for meningococcal disease should be revaccinated with MCV4. Persons who previously were vaccinated at age >= 7 years and are at prolonged increased risk should be revaccinated 5 years after their previous meningococcal vaccine, and persons who previously were vaccinated at ages 2—6 years and are at prolonged increased risk should be revaccinated 3 years after their previous meningococcal vaccine. Persons at prolonged increased risk for meningococcal disease include: 1) persons with increased susceptibility such as persistent complement component deficiencies (for example, C3, properdin, Factor D, and late complement component deficiencies); 2) persons with anatomic or functional asplenia; and 3) persons who have prolonged exposure (for example, microbiologists routinely working with Neisseria meningitidis, or travelers to or residents of countries where meningococcal disease is hyperendemic or epidemic). This report provides the rationale for the new recommendation and updates and replaces previous recommendations for revaccination with MCV4.

 ACIP's Meningococcal Vaccine Work Group reviewed data on the risk for meningococcal disease, antibody titer decline, and the safety and immunogenicity of revaccination with MCV4 at 3 years and 5 years after the first dose of MCV4 or MPSV4. Persons with prolonged increased risk for meningococcal disease have increased susceptibility to the disease or ongoing increased risk for exposure to N. meningitidis, higher levels of serum bactericidal antibody (SBA) against N. meningitidis can provide these groups increased protection against disease. SBA is a measure of the ability of sera to kill a strain of N. meningitidis in the presence of complement. In clinical trials, a baby rabbit SBA titer of 1:128 was used as a conservative correlate of protection. Small subsets of subjects from the MCV4 prelicensure clinical trial were revaccinated 3 years (n = 76) and 5 years (n = 134) after receiving MCV4. Of 71 persons aged 11—18 years at primary vaccination who had been vaccinated with MCV4 3 years previously, 75% and 86% had SBA titers greater than 1:128 for serogroups C and Y, respectively, before revaccination. Of 108 persons aged 2—10 years at primary vaccination who had been vaccinated with MCV4 5 years previously, 55% and 94% had SBA titers greater than 1:128 for serogroups C and Y, respectively, before revaccination. All persons revaccinated with MCV4 in these studies achieved SBA titers greater than 1:128 for serogroups C and Y. Approximately 50%—70% of persons in both the previously vaccinated (n = 210) and vaccine naive groups (n = 323) reported mild to moderate local and systemic adverse events after revaccination (or initial vaccination) with MCV4. However, no serious adverse events were reported in either group (Sanofi Pasteur, unpublished data, 2009).

October 2, 2009, Vol. 58/No. 38

Influenza Vaccination Coverage Among Children Aged 6—23 Months—United States, 2007—08 Influenza Season

 Infants and children aged < 2 years often require medical care for influenza and have higher rates of influenza-related hospitalization than any other age group except persons aged >= 65 years (1). Since 2004, the Advisory Committee on Immunization Practices (ACIP) has recommended seasonal influenza vaccination for all children aged 6—23 months. Full vaccination for these children requires receipt of 2 doses in the current influenza season if they have not been vaccinated previously or received a single dose during the preceding season. To assess influenza vaccination coverage among children aged 6—23 months during September—December of the 2007—08 influenza season, CDC analyzed data from the 2008 National Immunization Survey (NIS). The results of those analyses indicated that, during the 4 months, 40.7% of children aged 6—23 months received >= 1 dose of influenza vaccine, and 23.4% were fully vaccinated. Substantial variability was observed among the 50 states and participating local areas; the percentage of children with full vaccination ranged from 6.4% to 40.9% among states and local areas. Nationally, the percentage of children aged 6—23 months receiving >= 1 dose of influenza vaccine increased from 31.8% in 2006—07 (3) to 40.7% in 2007—08, and the percentage with full vaccination increased from 21.3% to 23.4%; however, influenza vaccination coverage among children remains low. Further study is needed to identify barriers to influenza vaccination and to implement strategies that can increase vaccination coverage with emphasis on attaining full vaccination in this population at greater risk for complications from influenza.

October 9, 2009, Vol. 58/No. 39

Influenza Vaccination Coverage Among Children and Adults—United States, 2008—09 Influenza Season

 Before 2008, the Advisory Committee on Immunization Practices (ACIP) had recommended annual vaccination for influenza for persons aged >= 50 years, 18—49 years at higher risk for influenza complications, and 6 months—4 years. In 2008, ACIP expanded the recommendations to include all children aged 5—18 years, beginning with the 2008—09 season, if feasible, but no later than the 2009—10 season. This expansion added 26 million children and adolescents to groups recommended for routine influenza vaccination. To assess vaccination uptake among children and adults during the 2008—09 influenza season, CDC analyzed data from the Behavioral Risk Factor Surveillance System (BRFSS) in 19 states, which represent 43% of the U.S. population. This report summarizes the results of the analysis, which indicated that reported influenza vaccination coverage of >= 1 dose was 40.9% for ages 6—23 months, 32.0% for 2—4 years, and 20.8% for 5—17 years. Among adults, reported coverage was 32.1% for persons aged 18—49 years with high-risk conditions, 42.3% for persons 50—64 years, and 67.2% for persons >= 65 years. These results are consistent with previous studies that have found no significant increases in vaccination coverage for any of these age groups over previous seasons. These 2008—09 season estimates provide a baseline for assessing implementation of the 2008 recommendation for school-aged children. Attaining higher coverage rates likely will require additional vaccination programs in schools and expanded vaccination services in provider offices.

Norovirus Outbreaks on Three College Campuses—California, Michigan and Wisconsin, 2008

 Noroviruses are the most common cause of outbreaks of acute gastroenteritis worldwide. Norovirus outbreaks affect persons of all ages and occur in a wide variety of settings (for example, nursing homes, hospitals, restaurants, communities, schools, day care centers, military barracks and cruise ships). During fall 2008, three norovirus outbreaks occurring on college campuses in California, Michigan and Wisconsin were reported to CDC. Public health investigations led by the respective state and local health departments were conducted to characterize the extent of the outbreaks and implement appropriate control measures. This report summarizes the investigations of these outbreaks, which resulted in a total of approximately 1,000 cases of reported illness, including at least 10 hospitalizations, and prompted closure of one of the three campuses. Median duration of the three outbreaks was 19 days (range: 16—20 days), and the attack rates ranged from 1.5% to 12.9%. Because of the potential for widespread infection and rapid transmission on college campuses, efforts to prevent and control norovirus outbreaks in these settings should focus on promoting hand hygiene, environmental disinfection, and exclusion of ill food workers.

October 23, 2009, Vol. 58/No. 41

Reduction in Rotavirus After Vaccine Introduction—United States, 2000—2009

 Worldwide, rotavirus is the leading cause of severe acute diarrhea in children aged < 5 years. In the United States, before introduction of a live, oral pentavalent rotavirus vaccine (RV5) in 2006, rotavirus caused an estimated 20 to 60 deaths, 55,000 to 70,000 hospitalizations, 205,000 to 272,000 emergency department visits, and 410,000 outpatient visits annually. Before 2000, rotavirus had a predictable winter-spring seasonality and geographic pattern in the United States, with activity beginning in the West census region during December—January, extending across the country, and ending in the Northeast region during May—June. A similar but less pronounced trend was observed during 2000—06. To characterize trends and compare the 2007—08 and 2008—09 rotavirus seasons with the prevaccine period 2000—06, CDC analyzed data from the National Respiratory and Enteric Viruses Surveillance System (NREVSS). The results indicated that the 2007—08 and 2008—09 seasons were both shorter and later than the median during 2000—06. The 2008—09 season had 15% more positive rotavirus test results than the 2007—08 season, but the number of positive test results during each season was substantially lower than the median observed during 2000—06. Continued surveillance is needed to characterize the effect of routine childhood rotavirus vaccination on rotavirus disease in U.S. children.

November 13, 2009, Vol. 58/No. 44

Effectiveness of 2008—09 Trivalent Influenza Vaccine Against 2009 Pandemic Influenza A (H1N1)—United States, May—June 2009

 Since first reports in April 2009, the 2009 pandemic influenza A (H1N1) virus has spread around the world. The pandemic virus is antigenically distinct from seasonal influenza A (H1N1) viruses targeted by seasonal influenza vaccines. Results from recent serologic studies have suggested that seasonal influenza vaccines are unlikely to provide substantial cross-protection against infection with the pandemic H1N1 virus. However, how serologic results correlate with the complex immune responses that confer clinical protection remains uncertain. To complement the serologic studies and evaluate the effectiveness of 2008—09 trivalent seasonal influenza vaccine against laboratory-confirmed pandemic influenza A (H1N1) illness, CDC used available data to conduct a case-cohort analysis. The analysis used surveillance reports from eight states of persons aged > 18 years with confirmed pandemic H1N1 illness during May—June 2009. Influenza vaccination coverage estimates for these states during the 2008—09 influenza season (September 2008—February 2009) were estimated for the population cohort by using preliminary Behavioral Risk Factor Surveillance Survey (BRFSS) data. The overall vaccine effectiveness (VE) against pandemic virus illness after adjustment for age group and presence of chronic medical conditions that increase the risk for complications from influenza was -10% (95% confidence interval [CI] = -43%—15%). Current evidence from this study and other studies does not suggest that seasonal influenza vaccination either decreases of increases the risk for acquiring pandemic H1N1 illness. To prevent seasonal and pandemic influenza, CDC recommends vaccination with seasonal and pandemic influenza vaccines.

November 20, 2009, Vol. 58/No. 45

Mumps Outbreak—New York, New Jersey, Quebec, 2009

 Mumps is a vaccine-preventable viral infection characterized by fever and inflammation of the salivary glands and whose complications include orchitis, deafness and meningo-encephalitis. In August 2009, CDC was notified of the onset of an outbreak of mumps in a summer camp in Sullivan County, New York. The outbreak has spread and gradually increased in size and is now the largest United States mumps outbreak since 2006, when the United States experienced a resurgence of mumps with 6,584 reported cases. On August 18, public health departments in Sullivan County, New York State and CDC began an investigation into the mumps outbreak, later joined by departments in New York City and other locales. As of October 30, a total of 179 confirmed or probable cases had been identified from multiple locations in New York and New Jersey, and an additional 15 cases had been reported from Canada. The outbreak primarily has affected members of a tradition-observant religious community; median age of the patients is 14 years, and 83% are male. Three persons have been hospitalized. Although little transmission has occurred outside the Jewish community, mumps can spread rapidly in congregate settings such as colleges and schools; therefore, public health officials and clinicians should heighten surveillance for mumps and ensure that children and adults are appropriately vaccinated.

 Mumps cases in the United States have been classified according to the 2008 case definition of the Council of State and Territorial Epidemiologists, and cases in Canada have been classified in accordance with Case Definitions for Diseases Under National Surveillance. Patients in the United States are considered to have age-appropriate vaccinations for mumps if they are aged 1—6 years and have received 1 dose of a mumps-containing vaccine, aged 7—18 years and have received 2 doses of vaccine, or aged 19—52 years and have received 1 dose of vaccine. Patients aged 7—18 years who have received 1 dose are considered to have received a partially age-appropriate vaccination.

December 11, 2009, Vol. 58/No. 48

Safety of Influenza A (H1N1) 2009 Monovalent Vaccines— United States, October 1—November 24, 2009

 The Food and Drug Administration (FDA) licensed the first 2009 influenza A (H1N1) monovalent vaccines (''H1N1 vaccines'') on September 15, 2009. The H1N1 vaccines are available as a live, attenuated monovalent vaccine (LAMV) for intranasal administration and as monovalent, inactivated, split-virus or subunit vaccines for injection (MIV). The licensure and manufacturing processes for the monovalent H1N1 vaccines were the same as those used for seasonal trivalent inactivated (TIV) or trivalent live, attenuated influenza vaccine (LAIV); none of these vaccines contains an adjuvant. Vaccine safety monitoring is an important component of all vaccination programs. To assess the safety profile of H1N1 vaccines in the United States, CDC reviewed vaccine safety results for the H1N1 vaccines from 3,783 reports received through the United States Vaccine Adverse Event Reporting System (VAERS) and electronic data from 438,376 persons vaccinated in managed-care organizations in the Vaccine Safety Datalink (VSD), a large, population-based database with administrative and diagnostic data, in the first 2 months of reporting (as of November 24). VAERS data indicated 82 adverse event reports per 1 million H1N1 vaccine doses distributed, compared with 47 reports per 1 million seasonal influenza vaccine doses distributed. However, no substantial differences between H1N1 and seasonal influenza vaccines were noted in the proportion or types of serious adverse events reported. No increase in any adverse events under surveillance has been seen in VSD data. Many agencies are using multiple systems to monitor H1N1 vaccine safety. Health-care providers and the public are encouraged to report adverse health events that occur after vaccination.

 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 §§ 809.801—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 × 1 0.5 ml $27.22
sanofi pasteur Daptacel 49281-0286-10 10 × 1 0.5 ml $28.06
GlaxoSmithKline Infanrix 58160-0810-46 5 × 1 0.5 ml $23.02
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
sanofi pasteur Adacel 49281-0400-15 5 × 1 0.5 ml $44.46
GlaxoSmithKline Boostrix 58160-0842-11 10 × 1 0.5 ml $44.61
GlaxoSmithKline Boostrix 58160-0842-46 5 × 1 0.5 ml $44.61
Diphtheria Tetanus pediatric Vaccine (DT pediatric):
sanofi pasteur DT Pediatric 49281-0278-10 10 × 1 0.5 ml $36.23
Diphtheria Tetanus acellular Pertussis/Haemophilus Influenzae B (DTaP-HIB):
sanofi pasteur TriHIBit 49281-0597-05 5 × 1 0.5 ml $55.02
Tetanus Diphtheria adult Vaccine (Td adult):
sanofi pasteur Decavac 49281-0291-83 10 × 1 0.5 ml $23.09
sanofi pasteur Decavac 49281-0291-10 10 × 1 0.5 ml $23.09
Diphtheria, Tetanus, acellular Pertussis, Haemophilus Influenzae B, Polio (DTaP, HIB, IPV):
sanofi pasteur Pentacel 49281-0510-05 5 × 1 0.5 ml $89.65
Diphtheria, Tetanus, acellular Pertussis, Polio (DTap, IPV):
GlaxoSmithKline Kinrix 58160-0812-46 5 × 1 $57.00
GlaxoSmithKline Kinrix 58160-0812-11 10 × 1 $57.00
Diphtheria, Tetanus, acellular Pertussis, Hepatitis B, Polio (DTaP, Hep B, IPV):
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 $32.30
MassBiologics (Akorn, Inc) Tetanus toxoid
Haemophilus Influenzae Type B Vaccine (HIB):
sanofi pasteur ActHIB 49281-0545-05 5 × 1 10 mcg $28.18
Merck & Co. Pedvax HIB 00006-4897-00 10 × 1 7.5 mcg $27.32
GlaxoSmithKline Hiberix 58160-0806-05 10 × 1 0.5 ml $8.66
Injectable Polio Vaccine Inactivated (Salk Enhanced IPV):
sanofi pasteur IPOL 49281-0860-55 10 × 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 × 0.5 0.5 ml $55.40
Measles Vaccine (Rubeola):
Merck & Co. Attenuvax 0006-4589-00 10 × 0.5 0.5 ml $20.48
Meningococcal Conjugate Vaccine (MCV4):
sanofi pasteur Menactra 49281-0589-05 5 × 1 0.5 ml $123.94
sanofi pasteur Menactra 49281-0589-15 5 × 1 0.5 ml $123.94
Meningococcal Polysaccharide Vaccine:
sanofi pasteur Menomune-A/C/Y/W-135 49281-0489-91 10 × 1 0.5 ml $123.94
sanofi pasteur Menomune-A/C/Y/W-135 49281-0489-01 each 0.5 ml $126.34
Mumps Vaccine:
Merck & Co. Mumpsvax 00006-4584-00 10 × 0.5 0.5 ml $26.54
Rubella Vaccine:
Merck & Co. Meruvax II 00006-4673-00 10 × 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 × 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 00006-4831-41 10 × 0.5 0.5 ml $36.44
GlaxoSmithKline Havrix Pediatric 58160-0825-51 10 × 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 $72.68
GlaxoSmithKline Havrix 58160-0826-11 10 × 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 × 1 1350 pfu $92.86
Merck & Co. Zostavax 00006-4963-00 each 19400 pfu $193.80
Merck & Co. Zostavax 00006-4963-41 10 × 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 × 1 0.5 ml $150.18
Merck & Co. Gardasil syringe 00006-4109-06 6 × 1 0.5 ml $152.54
Merck & Co Gardasil syringe w/o needle 00006-4109-09 6 × 1 0.5 ml $152.54
Rotavirus Vaccine:
Merck & Co. Rotateq 00006-4047-41 10 × 1 2 ml $83.35
GlaxoSmithKline Rotarix 58160-0805-11 10 × 1 1.0 ml $122.85
Influenza Virus Vaccine:
Novartis Fluvirin 66521-112-02 10 × 1 0.5 ml $18.24
Novartis Fluvirin 66521-112-10 10 × 1 0.5 ml $14.81
Sanofi pasteur Fluzone 49281-0008-10 10 × 1 0.5 ml $12.70
Sanofi pasteur Fluzone 49281-0008-50 10 × 1 0.5 ml $12.70
Sanofi pasteur Fluzone 49281-0382-15 10 × 1 0.5 ml $11.52
Sanofi pasteur Fluzone Pediatric 49281-0008-25 10 × 1 0.25 ml $15.64
GlaxoSmithKline Fluarix 58160-0873-46 5 × 1 0.5 ml $15.75
MedImmune Flumist 66019-0107-01 10 × 1 0.2 ml $19.70
CSL Biotherapies Afluria 33332-109-01 Multidose 0.5 ml $13.20
CSL Biotherapies Afluria 33332-009-01 10 × 1 0.5 ml $17.40
Hepatitis B Vaccine (HEP-B):
Merck & Co. Recombivax HB
Hepatitis B vaccine
Dialysis Formulation
00006-4992-00 each 1.0 ml $165.29
Merck & Co. Recombivax HB Pediatric 00006-4981-00 10 × 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 × 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 × 1.0 ml 1.0 ml $73.31
Merck & Co Recombivax HB syringe w/o needle 00006-4094-09 6 × 1.0 ml 1.0 ml $73.31
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 $25.49
GlaxoSmithKline Engerix-B 58160-0821-46 5 × 1 1.0 ml $62.85
GlaxoSmithKline Engerix-B syringe 58160-0821-11 10 × 1 1.0 ml $62.85
Hepatitis B / HIB:
Merck & Co. COMVAX 00006-4898-00 10 × 0.5 ml 0.5 ml $52.27
Hepatitis A & Hepatitis B Vaccine:
GlaxoSmithKline Twinrix 58160-0815-11 10 × 1.0 1.0 ml $103.43
GlaxoSmithKline Twinrix 58160-0815-46 5 × 1.0 1.0 ml $103.43
Pneumococcal Vaccine:
Wyeth Pharmaceuticals Prevnar 00005-1970-50 10 × 1 0.5 ml $100.51
Merck & Co. Pneumovax 23 00006-4739-00 2.5 ml 2.5 ml $197.93
Merck & Co. Pneumovax 23 00006-4943-00 10 × 1 0.5 ml $44.43
Measles, Mumps, Rubella, and Varicella Vaccine
Merck & Co. ProQuad 00006-4999-00 10 × 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).


[Pa.B. Doc. No. 10-239. Filed for public inspection February 5, 2010, 9:00 a.m.]

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