NOTICES

Immunization Practices for Children in Child Care Group Settings

[39 Pa.B. 5091]
[Saturday, August 22, 2009]

   In accordance with 28 Pa. Code § 27.77(c) (relating to immunization requirements for children in child care group settings), the Department of Health (Department), Bureau of Communicable Diseases, Division of Immunization, is updating the list of Morbidity and Mortality Weekly Report (MMWR) publications that contain the Advisory Committee on Immunization Practices (ACIP) recommendations that meet the standards of 28 Pa. Code § 27.77(c). Children in child care group settings as defined by 28 Pa. Code § 27.77(c) are required to be immunized in accordance with the recommendations included in the following publications, as well as those included in previous notices. The Department is providing a summary of the publications for the ease of reference of the public:

1.  January 2, 2009, Vol. 57/No. 51
Recommended Immunization Schedules for Persons Aged 0 Through 18 Years

   The Advisory Committee on Immunization Practices (ACIP) annually publishes immunization schedules that summarize recommendations for currently licensed vaccines for children aged 18 years and younger. Visit the following link to view or download the updated schedule: http://www.cdc.gov/vaccines/recs/schedules/child-schedule.htm.

2.  January 9, 2009, Vol. 57/No. 53
Recommended Adult Immunization Schedule--United States, 2009

   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 2008, ACIP approved the Adult Immunization Schedule for 2009. No new vaccines were added to the schedule; however, several indications were added to the pneumococcal polysaccharide vaccine footnote, clarifications were made to the footnotes for human papillomavirus, varicella, and meningococcal vaccines, and schedule information was added to the hepatitis A and hepatitis B vaccine footnotes.

3.  January 15, 2009, Vol. 58/No. 01
Pneumonia Hospitalizations Among Young Children Before and After Introduction of Pneumococcal Conjugate Vaccine--United States, 1997--2006

   Streptococcus pneumoniae is the leading bacterial cause of community-acquired pneumonia hospitalizations and an important cause of bacteremia and meningitis, especially among young children and older adults. A 7-valent pneumococcal conjugate vaccine (PCV7) was licensed and the Advisory Committee on Immunization Practices formulated recommendations for its use in infants and children in February 2000. Vaccination coverage rapidly increased during the second half of 2000, in part through funding by CDC's Vaccines for Children program. Subsequently, active population- and laboratory-based surveillance demonstrated substantial reductions in invasive pneumococcal disease (IPD) among children and adults. In addition, decreases in hospitalizations and ambulatory-care visits for all-cause pneumonia also were reported. To gauge whether the effects of PCV7 on reducing pneumonia continue, CDC is monitoring pneumonia hospitalizations by using data from the Nationwide Inpatient Sample. This report provides an update for 2005 and 2006, the most recent years for which information is available. In 2005 and 2006, the incidence rates for all-cause pneumonia hospitalizations among children aged < 2 years were 9.1 per 1,000 and 8.1 per 1,000, respectively. In 2006, the rate for all-cause pneumonia among children aged < 2 years was approximately 35% lower than during 1997-1999. Most of this decrease occurred soon after the vaccine was licensed in 2000, and the rates have remained relatively stable since then. The rate for all-cause pneumonia among children aged 2--4 years did not change after PCV7 licensure and has remained stable. Continued monitoring of pneumonia-related hospitalizations among children is needed to track the effects of pneumococcal immunization programs.

4.  January 23, 2009 , Vol 58/No.03
Invasive Haemophilus Type B Disease in Five Young Children--Minnesota, 2008

   In 2008, five children aged < 5 years were reported to the Minnesota Department of Health (MDH) with invasive Haemophilus influenzae type b (Hib) disease; one died. Only one of the children had completed the primary Hib immunization series; three had received no doses of Hib-containing vaccine. The five Hib cases are the largest number among children aged < 5 years reported from Minnesota since 1992. The cases occurred during a Hib vaccine recall and continuing Nationwide shortage that began in December 2007. The recall of certain lots of the two Hib-containing vaccines manufactured by Merck & Co., Inc. (West Point, Pennsylvania) and cessation of production of both vaccines left only one manufacturer of Hib vaccine in the United States (Sanofi Pasteur, Swiftwater, Pennsylvania). In response, CDC recommended that health-care providers defer the routine 12--15 month booster dose for children not at increased risk for Hib disease. CDC also emphasized that all children should complete the primary series with available Hib-containing vaccines. However, Minnesota vaccination data indicate that primary Hib series coverage was lower during 2008 than coverage with other vaccines administered at the same ages and lower than Hib coverage in previous years. Increases in Hib cases like the one in Minnesota do not appear to have occurred in other states. The increase highlights the need to ensure that all children complete the primary Hib immunization series. Additional investigation to better elucidate the factors that led to these cases is being conducted by MDH and CDC.

   Three of the five Hib cases in Minnesota occurred in children who had not been vaccinated. One case occurred in a child who was too young to complete the primary series, and a fifth case occurred in a child with an immunodeficiency. Given the prolonged booster dose deferral and reduced primary series coverage in the state, the increase in the number of Hib cases likely reflects increasing carriage and transmission affecting those with suboptimal primary series vaccination coverage, or a weakening of herd immunity. None of the children failed to receive vaccine because of the vaccine shortage. However, MDH is planning evaluations to describe the extent of Hib carriage in the affected communities and understand reasons why some children are not vaccinated. While the shortage continues, completion of the primary series in all children is essential to safeguard individual protection as well as to strengthen herd immunity.

5.  February 6, 2009, Vol. 58/No. RR02
Prevention of Rotavirus Gastroenteritis Among Infants and Children Recommendations of the Advisory Committee on Immunization Practices (ACIP)

   Rotavirus is the most common cause of severe gastroenteritis in infants and young children worldwide. Before initiation of the rotavirus vaccination program in the United States in 2006, approximately 80% of U.S. children had rotavirus gastroenteritis by age 5 years. Each year during the 1990s and early 2000s, rotavirus resulted in approximately 410,000 physician visits, 205,000--272,000 emergency department visits, and 55,000--70,000 hospitalizations among U.S. infants and children, with total annual direct and indirect costs of approximately $1 billion. In February 2006, a live, oral, human-bovine reassortant rotavirus vaccine (RotaTeq® [RV5]) was licensed as a 3-dose series for use among U.S. infants for the prevention of rotavirus gastroenteritis, and the Advisory Committee on Immunization Practices (ACIP) recommended routine use of RV5 among U.S. infants (CDC. Prevention of rotavirus gastroenteritis among infants and children: recommendations of the Advisory Committee on Immunization Practices [ACIP]. MMWR 2006;55[No. RR-12]). In April 2008, a live, oral, human attenuated rotavirus vaccine (Rotarix® [RV1]) was licensed as a 2-dose series for use among U.S. infants, and in June 2008, ACIP updated its rotavirus vaccine recommendations to include use of RV1. This report updates and replaces the 2006 ACIP statement for prevention of rotavirus gastroenteritis. ACIP recommends routine vaccination of U.S. infants with rotavirus vaccine. RV5 and RV1 differ in composition and schedule of administration. RV5 is to be administered orally in a 3-dose series, with doses administered at ages 2, 4, and 6 months. RV1 is to be administered orally in a 2-dose series, with doses administered at ages 2 and 4 months. ACIP does not express a preference for either RV5 or RV1. The recommendations in this report also address the maximum ages for doses, contraindications, precautions, and special situations for the administration of rotavirus vaccine.

6.  February 20, 2009, Vol 58/No. 06
Progress Toward Measles Elimination--European Region, 2005--2008

   In 2002, the World Health Organization (WHO) Regional Committee for the European Region (EUR) revised earlier targets to eliminate indigenous measles and achieve rubella control by resolving to: 1) eliminate both diseases in EUR member states by 2010, using a combination of routine and supplementary immunization strategies, and 2) monitor progress toward this goal through improved surveillance. This report summarizes progress toward measles elimination during 2005--2008 and updates a previous report from 2005. In 2005 and 2006, large-scale outbreaks occurred in the eastern EUR member states. However, in 2007 and 2008, overall measles incidence in EUR declined to a historic low of < 10 cases per 1 million population, with the majority of cases reported from Western Europe. During 2005--2007, routine vaccination coverage with 1 dose of measles-containing vaccine (MCV) among children aged 12--23 months in EUR reached a high of 93%--94%, up from 90%--91% during 2000--2004. Nevertheless, two major challenges to measles elimination remain: 1) suboptimal vaccination coverage in many countries, which has led to continued outbreaks and the resurgence of indigenous measles in some Western European countries; and 2) setbacks with implementation of supplementary immunization activities (SIAs) in Eastern Europe in 2008. Achieving the measles elimination goal by 2010 will require: 1) development of approaches to sustain and increase vaccination coverage; 2) promotion of effective outbreak prevention and control measures; and 3) further strengthening of surveillance.

7.  February 27, 2009, Vol. 58/No. 07
Completeness and Timeliness of Reporting of Meningococcal Disease Maine, 2001--2006

   Neisseria meningitidis is an important cause of invasive bacterial disease in the United States, with a total of 1,077 cases of meningococcal disease reported in 2007. The case-fatality ratio is 10%--14%, and 11%--19% of survivors have long-term sequelae. In the United States, approximately 98% of cases of meningococcal disease occur sporadically; outbreaks are uncommon. Chemoprophylaxis is the primary means of preventing meningococcal disease among close contacts of patients in sporadic cases, and the ability of health departments to identify these contacts and provide treatment depends on the completeness and timeliness of disease reporting. To assess these attributes in meningococcal disease surveillance in Maine, the Maine Department of Health and Human Services (MDHHS) analyzed public health surveillance data from MDHHS and hospital discharge data from the Maine Health Data Organization (MHDO) for the period 2001-2006. This report describes the results of that analysis, which indicated that the completeness of reporting of meningococcal disease in Maine during this period was approximately 98%. Of cases reported to MDHHS, 56% were reported within 1 day of hospital admission. Passive disease surveillance efforts appear to have achieved near complete reporting of meningococcal disease in Maine; however, timeliness of reporting was sometimes suboptimal. Evaluation of surveillance efforts should be repeated periodically to determine whether completeness of reporting remains high and timeliness improves.

8.  April 3, 2009, Vol. 58/No. 12
Progress Toward Interruption of Wild Poliovirus Transmission--Worldwide, 2008

   Since 1988, when the Global Polio Eradication Initiative was established, the incidence of polio has decreased from an estimated 350,000 cases annually to 1,655 reported in 2008. Cases of wild poliovirus (WPV) type 2 were last reported in October 1999, and indigenous WPV types 1 and 3 (WPV1 and WPV3) have been eliminated from all but four countries worldwide (Afghanistan, India, Nigeria, and Pakistan). This report updates previous reports and describes overall progress toward global eradication in 2008. Despite accelerated efforts, polio cases increased 26%, from 1,315 cases in 2007 to 1,655 in 2008. This increase primarily resulted from an increase in Nigeria from 285 cases in 2007 to 801 cases in 2008. Resurgent WPV1 transmission in northern states of Nigeria spread to polio-free southern states and eight neighboring countries in 2008. In India, repeated use of monovalent oral poliovirus vaccine (OPV) type 1 (mOPV1) during 2005--2008 interrupted WPV1 transmission in the western districts of the northern state of Uttar Pradesh for > 12 months during 2007--2008; however, in mid-2008, WPV1 imported from the neighboring state of Bihar caused renewed transmission. In Afghanistan and Pakistan, problems in accessing children in conflict-affected areas increased, and an upsurge in WPV1 and WPV3 cases occurred, including an outbreak of WPV1 in Punjab Province, Pakistan. In Africa, during 2008, sustained WPV transmission for > 12 months after importation continued in Angola, Chad, the Democratic Republic of the Congo (DRC), Niger and southern Sudan. Increased political oversight and accountability and improved vaccination outreach to insecure areas are needed to achieve the eradication goal.

9.  April 17, 2009, Vol. 58/No. 14
FDA Approval of Expanded Age Indication for a Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine

   On December 4, 2008, the Food and Drug Administration (FDA) approved an expanded age indication for the tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) Boostrix (GlaxoSmithKline Biologicals, Rixensart, Belgium). Boostrix is now licensed for use in persons aged 10--64 years as a single-dose booster immunization; the vaccine initially was licensed for persons aged 10--18 years. This announcement summarizes the indications for use of Boostrix. Complete recommendations of the Advisory Committee on Immunization Practices (ACIP) for Tdap vaccines have been described previously.

   On October 23, 2008, ACIP was presented data on the safety and immunogenicity of Boostrix in adults aged 19--64 years and notified of the impending expanded age indication for Boostrix. Guidance for the use of Boostrix is the same as for Adacel (Sanofi Pasteur, Toronto, Canada), another Tdap vaccine licensed for use in adults.

   Data were reviewed by ACIP from two clinical trials conducted among U.S. adults aged 19--64 years. In both trials, the safety and reactogenicity profiles of Boostrix generally were similar to those of Adacel. For diphtheria and tetanus, immune responses to Boostrix were noninferior. Pertussis antibody concentrations for pertussis toxoid (PT), filamentous hemagglutinin (FHA), and pertactin in the first clinical trial were noninferior to those of infants after a primary diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccination series with Infanrix (GlaxoSmithKline Biologicals, Rixensart, Belgium) in a clinical trial in which efficacy of DTaP also was demonstrated (4--6). Boostrix contains the same three pertussis antigens as Infanrix but in reduced quantities.

10.  June 26, 2009, Vol. 50/No. 24
Progress Toward the 2012 Measles Elimination Goal--Western Pacific Region, 1990--2008

   In 2003, the World Health Organization (WHO) Regional Committee of the Western Pacific Region (WPR) formally declared a measles elimination goal and in 2005, the committee established a target date of 2012 for regional measles elimination. Key strategies recommended by WHO for achievement of measles elimination include: 1) very high >= 95%) vaccination coverage with 2 doses of measles-containing vaccine (MCV1 and MCV2) through routine vaccination and/or supplemental immunization activities; 2) high-quality case-based measles surveillance; and 3) access to an accredited measles laboratory network for testing of suspected measles cases and identification of measles virus genotypes. This report describes progress toward measles elimination in the WPR through 2008. Measles likely has been eliminated or nearly eliminated in 24 of the 37 countries and areas in the WPR (referred to in this report as countries). However, large numbers of measles cases continue to be reported from several countries. During 2008, a total of 131,441 confirmed measles cases (98.4 per million population) were reported from China and 11,015 cases (86.1 per million population) from Japan, two countries that account for 82% of the region's population and > 97% of its confirmed measles cases. Intensified efforts by WPR countries, particularly China and Japan, will be required to achieve the 2012 goal.

11.  June 26, 2009, Vol. 58/No. 24
Updated Recommendations for Use of Haemophilus influenzae Type b (Hib) Vaccine: Reinstatement of the Booster Dose at Ages 12--15 Months

   On December 13, 2007, certain lots of Haemophilus influenzae type b (Hib) vaccine marketed as PedvaxHIB (monovalent Hib vaccine) and Comvax (Hib-HepB vaccine), and manufactured by Merck & Co., Inc., were recalled voluntarily, and the company temporarily suspended production of these vaccines. To conserve the limited supply of Hib-containing vaccines, CDC, in consultation with the Advisory Committee on Immunization Practices (ACIP), the American Academy of Family Physicians (AAFP), and the American Academy of Pediatrics (AAP), on December 18, 2007, recommended that vaccination providers temporarily defer the routine Hib vaccine booster dose administered to most healthy children at age 12--15 months.

   Production of Merck Hib vaccine products is still suspended. However, two other Hib-containing vaccines manufactured by Sanofi Pasteur have been available for use in the United States during this shortage: monovalent Hib vaccine (ActHIB) and DTaP-IPV/Hib (Pentacel). Beginning in July 2009, the manufacturer of these two vaccines will increase the number of doses of these two products available for use in the United States, which will result in the supply being sufficient to reinstate the Hib vaccine booster dose.

Reinstatement of Hib Booster Dose

   Effective immediately, CDC, in consultation with ACIP, AAFP, and AAP, is recommending reinstatement of the booster dose of Hib vaccine for children aged 12--15 months who have completed the primary 3-dose series. Infants should continue to receive the primary Hib vaccine series at ages 2, 4 and 6 months. Children aged 12--15 months should receive the booster dose on time. Older children for whom the booster dose was deferred should receive their Hib booster dose at the next routinely scheduled visit or medical encounter. Although supply is sufficient to reinstate the booster dose and begin catch-up vaccination, supply is not yet ample enough to support a mass notification process to contact all children with deferred Hib booster doses.

   Sufficient vaccine will be available to administer the primary series at ages 2, 4 and 6 months and a booster dose on time to children aged 12--15 months. As part of delivering the booster dose to those children for whom it was deferred at the next routinely scheduled appointment or medical encounter, practices should discuss with parents the reasons for the change in recommendation and might consider: 1) reviewing electronic or paper medical records or immunization information system records to identify children in need of a booster dose before physician encounters; 2) evaluating children's vaccination status during their scheduled visit; and 3) sharing immunization schedules with parents to make them aware of this plan.

Use of Combination Vaccines

   During the Hib shortage, children received protection from certain vaccine preventable diseases in their primary vaccination series through various permutations of available combination vaccines (such as, DTaP-IPV/Hib [Pentacel] and DTaP-IPV-HepB [Pediarix]) and monovalent vaccines (such as, ActHib, HepB, and IPV). Therefore, a mismatch might exist between patient vaccination needs and the available stock of different vaccine formulations (such as, combination products versus single-antigen vaccines) in local provider offices. This situation presents a challenge for providers to administer vaccines to ensure appropriate coverage while minimizing extra doses of unneeded vaccine. For example, if a provider is using DTaP-IPV/Hib (Pentacel) vaccine to protect infants against Hib disease, the provider should ensure that adequate stock of monovalent HepB vaccine is available to complete the HepB vaccine series. Children who need the Hib booster and who already have received 4 doses of DTaP should receive monovalent Hib vaccine (ActHIB) as their Hib booster dose. However, if DTaP-IPV/Hib is the only Hib-containing vaccine available, this combination product can be used to complete the series of Hib vaccination, even if the child already has received all the necessary doses of DTaP and IPV.

Information Regarding ActHIB or Pentacel

   Vaccination providers with questions about their supplies of monovalent Hib vaccine (ActHIB) or DTaP-IPV/Hib (Pentacel) purchased with nonpublic funds should contact Sanofi Pasteur's customer service department at (800) 822-2463. Sanofi Pasteur will work directly with physicians to increase allotments of Hib-containing vaccines on the basis of previous purchasing patterns or practice birth cohort and estimates of additional vaccine doses needed. For public vaccine supplies, including Vaccines for Children Program vaccine, providers should contact their state/local immunization program to obtain vaccine.

   This recommendation reflects CDC's assessment of the existing National Hib vaccine supply and will be updated if the supply changes. Updated information about the National Hib vaccine supply is available at http://www.cdc.gov/vaccines/vac-gen/shortages/default.htm.

   Persons with a disability who require an alternative format of this notice (for example, large print, audiotape, Braille) should contact the Department of Health, Heather Stafford, Director, Division of Immunization, Room 1026, Health and Welfare Building, Harrisburg, PA 17120, (717) 787-5681 or for speech and/or hearing impaired persons at V/TT (717) 783-6154 or the Pennsylvania AT&T Relay Service at (800) 654-5984 (TT).

EVERETTE JAMES,   
Secretary

[Pa.B. Doc. No. 09-1582. Filed for public inspection August 21, 2009, 9:00 a.m.]

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