Background: The pace of global progress must increase if the Global Vaccine Action Plan (GVAP) goals are to be achieved by 2020. We administered a two-phase survey to key immunization stakeholders to assess the utility and application of GVAP, including how it has impacted country immunization programs, and to find ways to strengthen the next 10-year plan. Methods: For the Phase I survey, an online questionnaire was sent to global immunization stakeholders in summer 2017. The Phase II survey was sent to regional and national immunization stakeholders in summer 2018, including WHO Regional Advisors on Immunization, Expanded Programme on Immunization managers, and WHO and UNICEF country representatives from 20 countries. Countries were selected based on improvements (10) versus decreases (10) in DTP3 coverage from 2010 to 2016. Results: Global immunization stakeholders (n = 38) cite global progress in improving vaccine delivery (88%) and engaging civil society organizations as advocates for vaccines (83%). Among regional and national immunization stakeholders (n = 58), 70% indicated reaching mobile and underserved populations with vaccination activities as a major challenge. The top ranked activities for helping country programs achieve progress toward GVAP goals include improved monitoring of vaccination coverage and upgrading disease surveillance systems. Most respondents (96%) indicated GVAP as useful for determining immunization priorities and 95% were supportive of a post-2020 GVAP strategy. Conclusions: Immunization stakeholders see GVAP as a useful tool, and there is cause for excitement as the global immunization community looks toward the next decade of vaccines. The next 10-year plan should attempt to increase political will, align immunization activities with other health system agendas, and address important issues like reaching mobile/migrant populations and improving data reporting systems. (C) 2019 Elsevier Ltd. All rights reserved.

Bangladesh introduced hepatitis B vaccine in a phased manner during 2003-2005 into the routine childhood vaccination schedule. This study was designed to evaluate the impact of the introduction of hepatitis B vaccine in Bangladesh by comparing hepatitis B surface antigen (HBsAg) prevalence among children born before and after vaccine introduction and to estimate the risk of vertical transmission of chronic hepatitis B virus (HBV) infection from mother to infant. We also evaluated the field sensitivity and specificity of an HBsAg point-of-care test strip. We selected a nationally representative sample of 2,100 prevaccine era and 2,100 vaccine era children. We collected a 5-mL blood sample from each child. One drop of blood was used to perform rapid HBsAg testing. If a child had a positive HBsAg test result with the rapid test, a blood sample was collected from the mother of the HBsAg-positive child and from the mothers of two subsequently enrolled HBsAg-negative children. All samples were tested for serologic markers of HBV infection using standard enzyme-linked immunosorbent assay. One (0.05%) child in the vaccine era group and 27 (1.2%; 95% confidence interval [CI]: 0.8-1.7%) children in the prevaccine era group were HBsAg positive. Mothers of HBsAg-positive children were more likely to be HBsAg positive than mothers of HBsAg-negative children (odds ratios = 4.7; 95% CI: 1.0-21.7%). Sensitivity of the HBsAg rapid test was 91.2% (95% CI: 76.6-98.1%) and specificity was 100% (95% CI: 99.9-100%). The study results suggest that even without a birth dose, the hepatitis B vaccine program in Bangladesh was highly effective in preventing chronic HBV infection among children.

On November 23, 1965, President Lyndon Johnson announced plans for a 5-year smallpox eradication and measles control program in West Africa that enabled the Centers for Disease Control and Prevention (CDC) to establish a Smallpox Eradication Program in January 1966. Since then, CDC’s global immunization endeavors have encompassed global smallpox eradication, the establishment and growth of the Expanded Program on Immunization (EPI) to strengthen national immunization programs, global efforts to eradicate polio and eliminate measles and rubella, and vaccine introduction into national immunization schedules beyond the original 6 EPI vaccines. CDC has provided scientific leadership, evidence-based guidance, and programmatic strategies to build public health infrastructure around the world, needed to achieve and measure the impact of these global immunization initiatives. This article marks the 50th anniversary of CDC’s global immunization leadership, highlights key historical events, and provides an overview of CDC’s future directions. Before 1955, smallpox and diphtheria-tetanus-pertussis vaccines were the only routinely recommended childhood vaccines in the United States. The roots of global immunization at CDC began after clinical trials for the Salk inactivated polio vaccine (IPV) in 1954. After investigators announced on April 12, 1955, that Salk IPV was safe and effective, large-scale vaccination campaigns were implemented across the United States, and IPV was set to join diphtheria-tetanuspertussis and smallpox vaccines in the childhood vaccination schedule. However, improperly prepared IPV by Cutter Pharmaceuticals used for the vaccination campaigns led to 200 cases of paralysis and 10 deaths. Referred to as the ‘‘Cutter incident,’’ this tragedy set the stage for CDC’s leadership in global immunization, highlighting both the importance of population-based surveillance and CDC’s ability to rapidly analyze data to inform the response to public health emergencies. CDC’s response to the Cutter incident was a major factor leading to the transfer of responsibility for collection and reporting of communicable disease data in 1960 from the National Office of Vital Statistics to CDC. CDC’s use of vaccine-preventable disease (VPD) surveillance data to inform program and policy decisions developed during the Cutter incident has been a foundation of CDC’s mission and subsequent VPD control initiatives. In 1961, incoming CDC Epidemic Intelligence Service Officer Donald Millar was assigned by Epidemic Intelligence Service founder Alexander Langmuir to ‘‘keep an eye on smallpox around the world and see if you can make sense of the trends.’’ This directive led to the formation of a smallpox surveillance unit that grew into the Smallpox Eradication Program. (Global eradication is defined as the worldwide absence of a disease agent in nature as a result of deliberate control efforts that may be discontinued when the agent is judged no longer to present a significant risk of infection.) During the early 1960s, CDC established itself as an organization with the practical capability to implement immunization work in field conditions by supporting US Agency for International Development–funded measles vaccination campaigns in West Africa and by conducting evaluations of jet injectors (medical devices used for vaccination that use a high-pressure narrow stream of fluid to penetrate the skin instead of a hypodermic needle), which

In 1988, the World Health Assembly resolved to eradicate polio worldwide. Since then, four of the six World Health Organization (WHO) regions have been certified as polio-free: the Americas in 1994, the Western Pacific Region in 2000, the European Region in 2002, and the South-East Asia Region in 2014. Currently, nearly 80% of the world's population lives in areas certified as polio-free. Certification may be considered when ≥3 years have passed since the last isolation of wild poliovirus (WPV) in the presence of sensitive, certification-standard surveillance. Although regional eradication has been validated in the European Region and the Western Pacific Region, outbreaks resulting from WPV type 1 (WPV1) imported from known endemic areas were detected and controlled in these regions in 2010 and 2011, respectively. The last reported case associated with WPV type 2 (WPV2) was in India in 1999, marking global interruption of WPV2 transmission. The completion of polio eradication was declared a programmatic emergency for public health in 2012, and the international spread of WPV1 was declared a public health emergency of international concern in May 2014. The efforts needed to interrupt all indigenous WPV1 transmission are now being focused on the remaining endemic countries: Nigeria, Afghanistan, and Pakistan. WPV type 3 (WPV3) has not been detected in circulation since November 11, 2012. This report summarizes the evidence of possible global interruption of transmission of WPV3, based on surveillance for acute flaccid paralysis (AFP) and environmental surveillance.

In 2012, the World Health Assembly declared completion of polio eradication a public health emergency. However, wild poliovirus (WPV) transmission remains endemic in three countries (Afghanistan, Nigeria, and Pakistan). In Nigeria, the National Stop Transmission of Polio (N-STOP) program, under the umbrella of the Nigerian Field Epidemiology and Laboratory Training Program (FELTP), has been developed to implement innovative strategies that address the remaining polio eradication challenges in Nigeria. One N-STOP initiative focuses on locating and vaccinating children aged<5 years in remote nomadic, scattered, and border populations in northern Nigeria, where low polio vaccination coverage likely contributes to ongoing WPV transmission. During August 2012-April 2013, N-STOP conducted field outreach activities that enumerated 40,212 remote settlements, including 4,613 (11.5%) settlements never visited by vaccination teams during previous polio supplemental immunization activities (SIAs). Enumeration resulted in documentation of 906,201 children aged<5 years residing in these settlements, including 53,738 (5.9%) who had never received polio vaccination, and in detection of 211 unreported cases of acute flaccid paralysis (AFP) with onset of illness in the 6 months before enumeration. Sustaining access to underserved populations in remote settlements in future SIAs will increase overall population immunity and should decrease WPV transmission. By providing a flexible and capable workforce consisting of Nigerian citizens, N-STOP is able to support evaluation and implementation of innovative polio eradication strategies in Nigeria while building local public health capacity with a potential to address other public health problems following the eradication of polio from Nigeria.

Early identification of persons with chronic HBV infection enables infected persons to receive necessary care to prevent or delay onset of liver disease, and enables the identification and vaccination of susceptible household contacts and sex partners, interrupting ongoing transmission. Testing has been recommended previously to enable primary prevention of HBV infection among close contacts for pregnant women, household contacts and sex partners of HBV-infected persons, persons born in countries with hepatitis B surface antigen (HBsAg) prevalence of more than 8%, persons who are the source of blood or body fluid exposures that might warrant postexposure prophylaxis (e.g., needlestick injury to a healthcare worker or sexual assault), and to enable appropriate treatment for infants born to HBsAg-positive mothers and persons infected with human immunodeficiency virus. Recently, with the increasing availability of efficacious hepatitis B treatment, the Centers for Disease Control and Prevention published new recommendations for public health evaluation and management for chronically infected persons and their contacts and extended testing recommendations to include persons born in geographic regions with HBsAg prevalence of greater than 2%, men who have sex with men, and injection drug users. Patient and provider education, developing partnerships between health departments and community organizations, and other resources will be needed to assure appropriate populations are tested and care provided for persons newly identified as HBsAg-positive.

Ten ischemic cardiac events (ICEs) were reported among 37,901 initial US Department of Health and Human Services (DHHS) smallpox vaccinees. Symptoms developed a median of 10 days after vaccination (range, 0-28 days). The median age of case patients was 56 years (range, 42-65 years), and 60% were male. Seven (70%) of the case patients had >/=3 cardiac risk factors or probable coronary artery disease before vaccination. Two women, 55 and 57 years of age, experienced acute myocardial infarction and fatal cardiac arrests. Background rates of ICEs during a 3-week period for civilian populations that were age and sex matched to DHHS vaccinees were estimated. The observed number of myocardial infarctions exceeded estimated expectations (5 vs. 2) but remained within the 95% predictive interval (PI) (0.6-5.4). New onset angina was observed significantly less frequently than estimated expectations (1 vs. 10; 95% PI, 3.5-15.7). After persons with >/=3 cardiac risk factors or known heart disease were deferred from vaccination, no ICEs were reported among an additional 6638 vaccinees.

Serologic testing for hepatitis B surface antigen (HBsAg) is the primary way to identify persons with chronic hepatitis B virus (HBV) infection. Testing has been recommended previously for pregnant women, infants born to HBsAg-positive mothers, household contacts and sex partners of HBV-infected persons, persons born in countries with HBsAg prevalence of >/=8%, persons who are the source of blood or body fluid exposures that might warrant postexposure prophylaxis (e.g., needlestick injury to a health-care worker or sexual assault), and persons infected with human immunodeficiency virus. This report updates and expands previous CDC guidelines for HBsAg testing and includes new recommendations for public health evaluation and management for chronically infected persons and their contacts. Routine testing for HBsAg now is recommended for additional populations with HBsAg prevalence of >/=2%: persons born in geographic regions with HBsAg prevalence of >/=2%, men who have sex with men, and injection-drug users. Implementation of these recommendations will require expertise and resources to integrate HBsAg screening in prevention and care settings serving populations recommended for HBsAg testing. This report is intended to serve as a resource for public health officials, organizations, and health-care professionals involved in the development, delivery, and evaluation of prevention and clinical services.

Hepatitis B vaccination is the most effective measure to prevent hepatitis B virus (HBV) infection and its consequences, including cirrhosis of the liver, liver cancer, liver failure, and death. In adults, ongoing HBV transmission occurs primarily among unvaccinated persons with behavioral risks for HBV transmission (e.g., heterosexuals with multiple sex partners, injection-drug users [IDUs], and men who have sex with men [MSM]) and among household contacts and sex partners of persons with chronic HBV infection. This report, the second of a two-part statement from the Advisory Committee on Immunization Practices (ACIP), provides updated recommendations to increase hepatitis B vaccination of adults at risk for HBV infection. The first part of the ACIP statement, which provided recommendations for immunization of infants, children, and adolescents, was published previously (CDC. A comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States: recommendations of the Advisory Committee on Immunization Practices [ACIP]. Part 1: immunization of infants, children, and adolescents. MMWR 2005;54[No. RR-16]:1-33). In settings in which a high proportion of adults have risks for HBV infection (e.g., sexually transmitted disease/human immunodeficiency virus testing and treatment facilities, drug-abuse treatment and prevention settings, health-care settings targeting services to IDUs, health-care settings targeting services to MSM, and correctional facilities), ACIP recommends universal hepatitis B vaccination for all unvaccinated adults. In other primary care and specialty medical settings in which adults at risk for HBV infection receive care, health-care providers should inform all patients about the health benefits of vaccination, including risks for HBV infection and persons for whom vaccination is recommended, and vaccinate adults who report risks for HBV infection and any adults requesting protection from HBV infection. To promote vaccination in all settings, health-care providers should implement standing orders to identify adults recommended for hepatitis B vaccination and administer vaccination as part of routine clinical services, not require acknowledgment of an HBV infection risk factor for adults to receive vaccine, and use available reimbursement mechanisms to remove financial barriers to hepatitis B vaccination.

This report is the first of a two-part statement from the Advisory Committee on Immunization Practices (ACIP) that updates the strategy to eliminate hepatitis B virus (HBV) transmission in the United States. The report provides updated recommendations to improve prevention of perinatal and early childhood HBV transmission, including implementation of universal infant vaccination beginning at birth, and to increase vaccine coverage among previously unvaccinated children and adolescents. Strategies to enhance implementation of the recommendations include 1) establishing standing orders for administration of hepatitis B vaccination beginning at birth; 2) instituting delivery hospital policies and procedures and case management programs to improve identification of and administration of immunoprophylaxis to infants born to mothers who are hepatitis B surface antigen (HBsAg) positive and to mothers with unknown HBsAg status at the time of delivery; and 3) implementing vaccination record reviews for all children aged 11-12 years and children and adolescents aged <19 years who were born in countries with intermediate and high levels of HBV endemicity, adopting hepatitis B vaccine requirements for school entry, and integrating hepatitis B vaccination services into settings that serve adolescents. The second part of the ACIP statement, which will include updated recommendations and strategies to increase hepatitis B vaccination of adults, will be published separately.

Hepatitis E has a world-wide distribution and causes substantial morbidity and mortality in some developing countries, particularly among pregnant women. Hepatitis E virus (HEV) has recently been cloned and sequenced, and new diagnostic tests have been developed. These tests have been used to begin to characterize the natural history and epidemiological features of HEV infection. Experimental vaccines have also been developed that offer the potential to prevent hepatitis E. However, much remains to be learned about HEV, including the mechanisms of transmission, the reservoir(s) of the virus, and the natural history of protective immunity in order to develop effective strategies to prevent this disease.

What’s Inside? Ask the Experts ........................................................ 1 Vaccine Highlights .................................................... 4 Hepatitis B Virus Transmitted in U.S. Long-Term–Care Facilities ............................... 5 PPV23: CDC answers your questions ..................... 7 Vaccine Storage & Handling: Four resources ........ 10 Immunization Resources Order Form .................... 11 Support IAC Today! ................................................ 12 (continued on page 8) Editor’s note: The Immunization Action Coalition thanks William L. Atkinson, MD, MPH; Andrew T. Kroger, MD, MPH; Eric E. Mast, MD, MPH; and Linda A. Moyer, RN, of the Centers for Disease Control and Prevention (CDC) for answering the following questions for our readers. Dr. Atkinson is a medical epidemiologist, and Dr. Kroger is a medical officer, both at CDC’s National Immunization Program. Dr. Mast is chief, Prevention Branch, and Ms. Moyer is an epidemiologist, both at CDC’s Division of Viral Hepatitis.

Several commercial and "in-house" assays have been developed for the detection of antibodies to hepatitis E virus, a major causative agent of enterically transmitted non-A non-B hepatitis. As these kits contain a variety of synthetic peptides or recombinant proteins, greater standardisation is required. A collaborative study was therefore carried out to assess the suitability of a freeze dried preparation designated 95/584 to serve as a reference reagent for hepatitis E virus serum IgG. Preparation 95/584, which is a serum from a previously infected individual, was assayed along with four coded samples, one of which D, was a coded duplicate of 95/584, and three individual sera, coded A, B and C. These preparations were sent to seven laboratories in five countries who tested them in eight different enzyme immunoassays. In most laboratories the coded duplicate gave a mean potency of within 20% of the candidate reference reagent despite the wide range of assays used. However, the potencies of the coded samples which were from different individuals gave somewhat variable potencies relative to the candidate reference reagent. This is not surprising as each sample will have varying proportions of antibodies against individual viral proteins and result in the variation in results observed. Nevertheless, this material will be of use in the standardisation of diagnostic tests for use in sero-prevalence studies and for assessing immunity. Preparation 95/584 was found to be suitable to serve as a reference reagent for hepatitis E serum IgG and has been established as an interim Reference Reagent for Human anti-hepatitis E serum. Each ampoule contains 50 Units per ampoule.

The methods that have been used to estimate the clinical and economic impact of vaccination programmes are not always uniform, which makes it difficult to compare results between economic analyses. Furthermore, the relative efficiency of vaccination programmes can be sensitive to some of the more controversial aspects covered by general guidelines for the economic evaluation of healthcare programmes, such as discounting of health gains and the treatment of future unrelated costs. In view of this, we interpret some aspects of these guidelines with respect to vaccination and offer recommendations for future analyses. These recommendations include more transparency and validation, more careful choice of models (tailored to the infection and the target groups), more extensive sensitivity analyses, and for all economic evaluations (also nonvaccine related) to be in better accordance with general guidelines. We use these recommendations to interpret the evidence provided by economic evaluation applied to viral hepatitis vaccination. We conclude that universal hepatitis B vaccination (of neonates, infants or adolescents) seems to be the most optimal strategy worldwide, except in the few areas of very low endemicity, where the evidence to enable a choice between selective and universal vaccination remains inconclusive. While targeted hepatitis A vaccination seems economically unattractive, universal hepatitis A vaccination strategies have not yet been sufficiently investigated to draw general conclusions.

BACKGROUND:Hepatitis B virus infection causes substantial morbidity and mortality in the United States. Sexual activity is the most commonly reported risk factor among persons with acute hepatitis B, yet hepatitis B vaccine coverage among adolescents and adults with high-risk sexual practices is low. Sexually transmitted disease (STD) clinics are potentially efficient settings for vaccine administration to persons with high-risk sexual practices; however, little is known about hepatitis B vaccination activities in these settings.GOAL:To gain information about policies and activities for vaccinating against hepatitis B in STD clinic settings.STUDY DESIGN:In April 1997, a questionnaire was sent to managers of 65 federally funded STD programs in state and local health departments. A similar survey was sent to 89 STD clinic managers in November 1997.RESULTS:The response rate among program managers was 97% (63/65). Forty-eight percent considered hepatitis B prevention a program responsibility; 21% had developed and distributed written policies to prevent hepatitis B through vaccination; and 27% had developed policies to encourage hepatitis B education activities. The response rate among clinic managers was 82% (73/89). Forty-five percent reported that their STD clinics had implemented policies recommending hepatitis B vaccination and health education activities. Program managers and clinic managers reported that lack of funding to cover the cost of the vaccine, and lack of resources to provide prevaccination counseling, administer vaccine, and track clients for vaccine series completion were the primary barriers to the implementation of hepatitis B vaccination programs.CONCLUSIONS:To enhance hepatitis B vaccination in STD clinics, existing funding sources must be accessed more effectively. Supplemental funding mechanisms for the cost of vaccine and resources for implementing vaccination programs also need to be identified. Additionally, STD clinics and programs should continue to propose and implement hepatitis B vaccination policies.