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We evaluated compliance to the ACIP pneumococcal vaccination recommendations issued in 2014 for adults aged ≥ 65 years and in 2012 for adults with high-risk (HR) conditions. The MarketScan® Commercial and Medicare Supplemental databases (January 2007-June 2019) were used to identify the cohorts of interest. Analyses for adults aged ≥ 65 years were adjusted to account for missing vaccination history. Two HR cohorts were identified. The HR1 cohort included patients with immunocompromising conditions, functional or anatomic asplenia, cerebrospinal fluid leak, or cochlear implant. The HR2 cohort included patients with chronic heart, lung, or liver disease; diabetes mellitus; alcoholism; cirrhosis; or cigarette smoking. Full compliance for those aged ≥ 65 years or in the HR1 cohort was defined as receipt of PCV13 and PPSV23, and partial compliance was defined as receipt of PCV13 or PPSV23. For those in the HR2 cohort, full compliance was defined as receipt of PPSV23. Annual compliance rates were estimated using the Kaplan-Meier method. Among those aged ≥ 65 years, partial compliance at 4 years post index was 53% and full compliance was 17% in adjusted analyses. In subjects ≥ 65 years receiving the first vaccination, 42% received the second vaccination by year 4. For the HR1 cohort, partial compliance was 19% and full compliance was 5% at 6 years post index date. For the HR2 cohort, full compliance was 20% at 6 years, with the highest rate in patients with diabetes (27%) and the lowest rate in patients with alcoholism (8%). Additional efforts are needed to maximize compliance to the ACIP pneumococcal vaccine recommendations among adults ≥ 65 years of age and adults with HR conditions including streamlined recommendations and single-dose vaccines. These efforts may subsequently reduce the incidence and burden of pneumococcal disease.

The Advisory Committee on Immunization Practices (ACIP) was created out of the need to formalize vaccine recommendations for the United States. Annually, ACIP delivers recommendations to the CDC director for guidance about United States vaccine use and publishes the Adult Immunization Schedule. Updated schedules feature changes to vaccine recommendations as well as changes to the schedule's usability for physicians. The objective of this study was to determine physicians' attitudes about the Adult Immunization Schedule. Surveys were administered to a sentinel physician network from October 2019 through January 2020. Physicians that responded were comfortable using the Adult Immunization Schedule, but reported confusion about some medical condition-based indications. Physicians reported a lack engagement with mobile applications, CDC Vaccine Schedules and Shots by STFM (the Society for Teachers of Family Medicine). Future work should focus on increasing clarity regarding the recommendations with medical condition-based indications and increasing knowledge of mobile applications for physicians.

Countries face an increasingly complex vaccination landscape. As well as ever-changing infectious disease epidemiology, the number and diversity of vaccine-preventable diseases, vaccine products, and vaccine technologies continue to increase. To ensure that vaccination decision-making is transparent, country-owned and informed by sound scientific evidence, many countries have established national immunization technical advisory groups (NITAGs) to provide independent expert advice. The past decade has seen substantial growth in NITAG numbers and functionality, and there is now a need to consolidate this progress, by further capacity building, to ensure that NITAGs are responsive to the changing face of immunization over the next decade.

National Immunization Technical Advisory Committees (NITAGs) are tasked with the responsibility of guiding ministries of health and national immunization programmes in their policy development processes. Many NITAGs rely on evidence reviewed by the World Health Organization's (WHO) Strategic Group of Experts(SAGE) on immunization and aim to adapt WHO's recommendations to their respective contexts. This relationship took on exceptional importance since the onset of the COVID-19 pandemic, during which NITAGs have expressed a notable struggle to craft appropriate policies on population prioritization and vaccine utilization in the face of supply constraints and complex programmatic and delivery logistics. This online survey was conducted to assess the usefulness of the SAGE guidance documents for COVID-19 vaccine policies and to examine the persisting needs and challenges facing NITAGs. Results confirmed that SAGE recommendations concerning COVID-19 vaccines are easy to access, understand, and adapt. They have been found to be comprehensive and timely under the data and time constrained circumstances confronting SAGE. The Global NITAG Network (GNN) appears to be the most popular vehicle for addressing questions among high income countries, in contrast to lower income countries who favour WHO Country or Regional Offices. NITAGs place much value on interaction with other NITAGs, which requires facilitation and could benefit from increased opportunities, especially within regions. It is further noted that some NITAGs have had to tackle issues during the pandemic not typically considered by SAGE, such as supply chain logistics and vaccine demand. Learning from the COVID-19 experience offers opportunities to strengthen NITAGs and the pandemic recovery effort through the development of more concrete procedures and consideration of more varied types of data, including implementation effectiveness and uptake data. There is also an opportunity for an increasing involvement of Country Office WHO personnel to support NITAGs, while ensuring information and evidence needs of countries are adequately reflected in SAGE deliberations.

International trends currently favour greater use of mandatory immunization. There has been little academic consideration or comparison of the existence and scope of mandatory immunization internationally. In this paper, we examine mandatory immunization in 28 Global NITAG (National Immunization Technical Advisory Group) Network (GNN) countries, including countries from every WHO region and World Bank income level classification. We found that although mandatory immunization programs, or mandatory elements within broader immunization programs, are relatively common, jurisdictions vary significantly with respect to the immunizations required, population groups affected, grounds for exemptions, and penalties for non-compliance. We also observed some loose associations with geography and income level. Based on these data, we categorized policies into a spectrum ranging from Narrow to Broad scope.

Respiratory syncytial virus (RSV), is a common cause of serious acute lower respiratory tract illness in infants and young children, causing substantial morbidity and mortality globally. Treatment is mainly supportive and currently there is no licensed preventive vaccine. Clinical trials conducted in the 1960s evaluating a formalin-inactivated RSV vaccine (FI-RSV) in RSV-naïve infants resulted in observations of enhanced respiratory disease (ERD) following subsequent natural RSV infection in vaccinees. In these studies, infants immunized with FI-RSV had higher rates of severe RSV disease compared with controls. This outcome redirected focus on identifying the immunologic mechanisms that precipitated ERD as a prerequisite to further vaccine development. Improved understanding of the immunopathogenesis of ERD derived from animal models has stimulated development of new candidate vaccines and engendered discussions among RSV experts about the safety data needed to advance these products into the clinic, and ultimately, into the target population of RSV-naïve infants. The recognition that multiple products would soon be ready for testing in infants and children prompted the FDA to hold a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to seek perspectives and advice of experts regarding the types and extent of preclinical and clinical data that might be needed to support testing in RSV-naïve infants for specific types of candidate RSV vaccines. Committee members agreed that, if certain conditions are met in preclinical and early clinical studies, it would be reasonable to move forward from studies in adults and older children and into clinical trials evaluating vaccine safety and efficacy in RSV-naïve infants. Herein, we review and summarize perspectives on the discussion regarding recommendations for RSV vaccine development in this population.

The Global Vaccine Action Plan 2011–2020 called for all countries to establish a National Immunization Technical Advisory Group (NITAG) by 2020. The Caribbean, with its unique geographical context of 22 countries/territories, had limited technical expertise to establish individual NITAGs in small countries. The Caribbean Immunization Technical Advisory Group (CITAG) was launched in 2018. This paper describes the Caribbean context for a common framework for policy and evidence-based decision-making for immunization. Challenges in immunization in the region are reviewed and potential solutions are outlined. A recent decline in immunization rates in the Caribbean, along with outbreaks of vaccine-preventable diseases globally, places the region, a premier tourist destination, in a vulnerable position. The CITAG aims to strengthen the policy and evidence-based decision-making process for immunization to enable the Caribbean to remain at the forefront of vaccine-preventable disease elimination.

National Immunization Technical Advisory Groups (NITAGs) are multidisciplinary national experts who provide independent, evidence-informed vaccine policy recommendations to national health authorities. An essential NITAG function is to ensure that these decisions are grounded in the best available evidence generated through a systematic, transparent process. However, in many low- and middle-income countries (LMICs), experience with this decision making method is limited. The Task Force for Global Health manages the Partnership for Influenza Vaccine Introduction (PIVI) program in collaboration with the Centers for Disease Control and Prevention, Ministries of Health, corporate partners and others. During 2017, PIVI worked with its country partners and the World Health Organization regional and local offices to assess NITAG strengthening needs and to provide technical assistance in 7 LMIC countries (Laos Peoples Democratic Republic, Mongolia, Vietnam, Armenia, Cote d’Ivoire; Moldova and the Republic of Georgia). Our workshops supported general NITAG capacity building and the evidence-based review process using vaccines of interest to the country. For NITAGs reviewing evidence on seasonal influenza, we developed an influenza resource package to support their review and provide country-relevant information in an easy to use format. Of the seven NITAGs trained, six have applied some of the concepts learnt: revision or development of formal transparent, systematic procedures for their operations; preparation of recommendations on seasonal influenza vaccination using quality-assessed data from systematic searches and local data; and have applied the principles learned for making other new vaccine recommendations. Our experience confirms that LMIC NITAGs are considerably under-resourced without adequate technical support or access to global peer-reviewed literature. Ongoing support from NITAG partners must be secured and creative approaches might be needed to help countries achieve the GVAP 2020 target and support development of sustainable vaccine policies and programs.

Background In 2014 the Kenya National Immunization Technical Advisory Group (KENITAG) was asked by the Ministry of Health to provide an evidence-based recommendation on whether the seasonal influenza vaccine should be introduced into the national immunization program (NIP). Methods We reviewed KENITAG manuals, reports and meeting minutes generated between June 2014 and June 2016 in order to describe the process KENITAG used in arriving at that recommendation and the challenges encountered. Results KENITAG developed a recommendation framework to identify critical, important and non-critical data elements that would guide deliberations on the subject. Literature searches were conducted in several databases and the quality of scientific articles obtained was assessed using the Critical Appraisal Skills Programme tool. There were significant gaps in knowledge on the national burden of influenza disease among key risk groups, i.e., pregnant women, individuals with co-morbidities, the elderly and health care workers. Insufficient funding and limited work force hindered KENITAG activities. In 2016 KENITAG recommended introduction of the annual seasonal influenza vaccine among children 6 to 23 months of age. However, the recommendation was contingent on implementation of a pilot study to address gaps in local data on the socio-economic impact of influenza vaccination programs, strategies for vaccine delivery, and the impact of the vaccination program on the healthcare workforce and existing immunization program. KENITAG did not recommend the influenza vaccine for any other risk group due to lack of local burden of disease data. Conclusion Local data are a critical element in NITAG deliberations, however, where local data and in particular burden of disease data are lacking, there is need to adopt scientifically acceptable methods of utilizing findings from other countries to inform local decisions in a manner that is valid and acceptable to decision makers.

OBJECTIVE The Advisory Committee on Immunization Practices recommends Hepatitis B (HepB) vaccine for previously unvaccinated adults

BACKGROUND: National Immunisation Technical Advisory Groups (NITAGs) are multi-disciplinary expert groups that provide policy-makers with independent, evidence-based advice on vaccination. Between 2008 and 2017, the SIVAC Initiative supported establishment and strengthening of NITAGs in low and lower-middle income countries though its impact was never assessed quantitatively. AIM: To quantitatively assess whether SIVAC support is associated with a faster rate at which NITAGs became functional based on six performance indicators. METHODS: Data from the World Health Organization/Unicef Joint Reporting Form (JRF) from 77 low and lower-middle-income countries were used to examine the time delay between the start of SIVAC support and NITAG functionality using a Cox proportional hazards model. RESULTS: Countries receiving SIVAC support took a mean of 2.00 (95% CI 1.40-2.60) years to reported functionality compared to 2.82 (95% CI 2.05-3.59) years for countries without SIVAC support. We found evidence that SIVAC support is associated with reduced time until NITAG functionality, and this association cannot fully be explained by GDP per capita, percentage of GDP spent on healthcare, or NITAG functionality score at the start of the study period. However, quality of JRF data for the questions used to calculate NITAG functionality were poor, particularly for countries not receiving SIVAC support. CONCLUSION: SIVAC support is likely to have enabled many countries to more rapidly achieve NITAG functionality.

Influenza vaccination remains the most effective tool for reducing seasonal influenza disease burden. Few Low and Middle-Income Countries (LMICs) have robust, sustainable annual influenza national vaccination programs. The Partnership for Influenza Vaccine Introduction (PIVI) was developed as a public-private partnership to support LMICs to develop and sustain national vaccination programs through time-limited vaccine donations and technical support. We review the first 5 years of experience with PIVI, including the concept, country progress toward sustainability, and lesson learned. Between 2013 and 2018, PIVI worked with Ministries of Health in 17 countries. Eight countries have received donated vaccines and technical support; of these, two have transitioned to sustained national support of influenza vaccination and six are increasing national support of the vaccine programs towards full transition to local vaccine program support by 2023. Nine additional countries have received technical support for building the evidence base for national policy development and/or program evaluation. PIVI has resulted in increased use of vaccines in partner countries, and early countries have demonstrated progress towards sustainability, suggesting that a model of vaccine and technical support can work in LMICs. PIVI expects to add new country partners as current countries transition to self-reliance.

A National Immunization Technical Advisory Group (NITAG) is a multi-disciplinary body of national experts that provides evidence-based recommendations to policy-makers, assisting them in making sound immunization policy and programme decisions. The World Health Organization (WHO) Regional Office for Europe is working to strengthen the capacity of newly-established NITAGs and has targeted efforts on low- and middle-income countries. The Regional Office, in collaboration with WHO Headquarters and USA Centers for Disease Control and Prevention (CDC), developed a new training strategy and held training workshops to improve NITAGs' functioning and ability to make evidence-based recommendations. Feedback from countries that participated in trainings indicated that the updated training materials and interactive approach with follow-up technical support enabled them to align their NITAG charters and processes with WHO recommendations. To ensure continued progress, global and regional partners such as WHO and CDC should continue providing technical support to recently established NITAGs.

Passive immunisation with immunoglobulins as post-exposure prophylaxis after contact with measles is recommended by the German Standing Committee on Vaccination (STIKO) particularly for unprotected individuals at high risk of complications for whom active immunization is contraindicated, such as infants

There has been increasing attention to financial conflicts of interest (COI) in public health research and policy making, with concerns that some decisions are not in the public interest. One notable problematic area is expert advisory committee (EAC). While COI management has focused on disclosure, it could go further and assess experts' degree of (in)dependence with commercial interests. We analyzed COI disclosures of members of Québec's immunization EAC (in Canada) using (In)DepScale, a tool we developed for assessing experts' level of (in)dependence. We found great variability of independence with industry and that companies with the highest vaccine sales were predominantly associated with disclosed COIs. We argue that EACs can use the (In)DepScale to better assess and disclose the COIs that affect their experts. Going forward our scale could help manage risk and select members who are less conflicted to foster a culture of transparency and trust in advisors and policy-makers.

Seasonal influenza results in substantial morbidity, mortality and socio-economic burden. The US Advisory Committee on Immunization Practices recommends vaccination of everyone over 6 months of age, but coverage remains substantially below the Healthy People 2020 target of 70% in most age groups. Influenza is different from other vaccine-preventable diseases in several ways that influence vaccine uptake. Although the incidence of most vaccine-preventable diseases is low, there is a perception that these diseases result in significant illness or death. In contrast, seasonal influenza has a relatively high incidence, but there is an incorrect perception of a lower disease severity. The vaccine effectiveness of seasonal influenza vaccines is less than other routine vaccines, varies from season to season between northern and southern hemispheres, and can be low in some seasons. It is also not well recognized that vaccination can attenuate the severity of influenza illness. Finally, the need for annual vaccination is perceived as a burden to busy people. Understanding these differences from the perspective of caregivers and vaccinees might help to improve influenza vaccine uptake. Presenting vaccine effectiveness in terms of clinical outcomes that have the most impact might help to overcome the perceptions that influenza is a non-serious disease and that the vaccine is not effective. The benefits of disease attenuation need to be emphasized in terms of reduced mortality, hospitalization, absenteeism and disruption to daily life. Innovative communication strategies should be adopted, including stronger recommendations from and to healthcare providers, continuous patient education, and social media initiatives employing more emotional and narrative approaches than traditionally used. Finally, access to seasonal influenza vaccination needs to be improved, and barriers such as cost and inconvenience removed. Multiple initiatives have already been successful. The remaining challenge is to translate individual successes into public health policies with corresponding funding and implementation.

Introduction The WHO Regional Office for Europe developed the Guide to tailoring immunization programmes (TIP) , offering countries a process through which to diagnose barriers and motivators to vaccination in susceptible low vaccination coverage and design tailored interventions. A review of TIP implementation was conducted in the European Region. Material and methods The review was conducted during June to December 2016 by an external review committee and was based on visits in Bulgaria, Lithuania, Sweden and the United Kingdom that had conducted a TIP project; review of national and regional TIP documents and an online survey of the Member States in the WHO European Region that had not conducted a TIP project. A review committee workshop was held to formulate conclusions and recommendations. Results The review found the most commonly cited strengths of the TIP approach to be the social science research as well as the interdisciplinary approach and community engagement, enhancing the ability of programmes to “listen” and learn, to gain an understanding of community and individual perspectives. National immunization managers in the Region are generally aware that TIP exists and that there is strong demand for the type of research it addresses. Further work is needed to assist countries move towards implementable strategies based on the TIP findings, supported by an emphasis on enhanced local ownership; integrated diagnostic and intervention design; and follow-up meetings, advocacy and incentives for decision-makers to implement and invest in strategies. Conclusions Understanding the perspectives of susceptible and low-coverage populations is crucial to improving immunization programmes. TIP provides a framework that facilitated this in four countries. In the future, the purpose of TIP should go beyond identification of susceptible groups and diagnosis of challenges and ensure a stronger focus on the design of strategies and appropriate and effective interventions to ensure long-term change.

Many healthcare providers are not familiar with the Food and Drug Administration (FDA) vaccine licensure process, the Advisory Committee on Immunization Practices (ACIP) vaccine recommendation process, and how FDA vaccine licensure and ACIP recommendations are related. Vaccines for use in the United States military and civilian populations are licensed by the FDA by several potential pathways but use of licensed vaccines in the civilian population should be based on recommendations made by the ACIP. In performing these distinct activities, FDA and ACIP function under different mandates. In this article, we discuss whether the FDA licensure pathways used to approve a vaccine impacts ACIP recommendation categories for vaccines licensed from 2006 to 2016.

National Immunization Technical Advisory Groups (NITAGs) provide independent, evidence-informed advice to assist their governments in immunization policy formation. However, many NITAGs face challenges in fulfilling their roles. Hence the many requests for formation of a network linking NITAGs together so they can learn from each other. To address this request, the Health Policy and Institutional Development (HPID) Center (a WHO Collaborating Center at the Agence de Médecine Préventive - AMP), in collaboration with WHO, organized a meeting in Veyrier-du-Lac, France, on 11 and 12 May 2016, to establish a Global NITAG Network (GNN). The meeting focused on two areas: the requirements for (a) the establishment of a global NITAG collaborative network; and (b) the global assessment/evaluation of the performance of NITAGs. 35 participants from 26 countries reviewed the proposed GNN framework documents and NITAG performance evaluation. Participants recommended that a GNN should be established, agreed on its governance, function, scope and a proposed work plan as well as setting a framework for NITAG evaluation.

Background Although the incidence of HPV-attributable cancers in males is rapidly increasing, HPV vaccine uptake in males remains poor. While quadrivalent human papillomavirus vaccine (4vHPV) series initiation in males increased following the Advisory Committee Immunization Practices (ACIP) male routine use recommendation, its impact on 4vHPV series completion in males at ACIP-recommended intervals has not been evaluated in large male cohorts. We examined trends and correlates of 4vHPV completion since licensure in males in a large cohort of insured boys before and after the ACIP routine use recommendation. Methods We grouped data from electronic medical records of males aged 9-17years from Kaiser Permanente Southern California health plan who initiated 4vHPV into 3 cohorts by 4vHPV initiation date: licensure and ACIP permissive use: 2009-2010; addition of anal cancer indication: 2010-2011; ACIP routine use: 2011-2013. We estimated adjusted hazard ratios (AHRs) between patient and provider characteristics and vaccination using Marginal Cox proportional hazards models. Results Of 80,800 boys initiating 4vHPV, 24.3% completed the series within 12months with minimal differences across cohorts. Completion decreased with increasing age at initiation (13-17vs. 11-12year olds: AHR=0.85; 95% confidence interval [CI]=0.80, 0.89) and was greater among patients with a primary care provider (AHR=1.28, 95%CI=1.17, 1.41), influenza vaccine recipients (AHR=1.50, 95% CI=1.43, 1.57), and Asian/Pacific Islanders (AHR=1.07, 95% CI=1.00, 1.15), and lower among non-Hispanic Blacks (AHR=0.72, 95% CI=0.65, 0.80) and Hispanics (AHR=0.86, 95% CI=0.81, 0.90) compared to non-Hispanic Whites. Conclusions Despite the ACIP routine use recommendation in males, 4vHPV series completion remained low. 4vHPV initiation at 11-12years and identification of a provider responsible for the adolescents' health care may increase 4vHPV series completion. Given the rapidly increasing incidence of HPV-related cancers in males, it is important to identify measures to increase HPV vaccine series completion, particularly among non-Hispanic Black and Hispanic males.

In 2017, the Strategic Advisory Group of Experts on Immunization's Assessment Report of the Global Vaccine Action Plan noted the need to "better document the ways in which legislation and regulations have been used to promote or undermine immunization at the national level". Despite National Immunization Technical Advisory Groups (NITAGs) now existing in over 134 countries worldwide, there has been very little academic consideration of their legal underpinnings. In this paper, we compare the legal foundations and authority of 28 NITAGs from the six WHO Regions. All are members of the Global NITAG Network. We categorize the NITAGs based on their legal foundation and on the authority granted to them by their government, organizing them into a taxonomy of models. We then propose legal considerations for governments contemplating establishing or reforming a NITAG.

Background National Regulatory Authorities approve the indications for vaccine use in the product information. Occasionally, National Immunization Technical Advisory Groups (NITAGs) make off-label recommendations for use in different age groups, populations, and dosing schedules from the product information. We sought to determine the rationale, policies and procedures for NITAG off-label recommendations. Methods We conducted an environmental scan of Global NITAG Network members, immunization program managers and regulators in 38 high-, middle- and low-income countries. Participants completed an online survey regarding policies, procedures, and legislation governing development of off-label recommendations. A sub-sample of respondents met for a focus group and interviews which were analyzed qualitatively. Results Thirty-four people responded from 26/38 (68%) countries surveyed; 76% of respondents were NITAG members or immunization program managers. Recommendations for off-label vaccine use were made in 14/26 (54%) countries; the NITAG made those recommendations in 8/14 (57%) countries. Reasons for off-label vaccine recommendations included response to disease outbreaks or vaccine shortages. Only one country had standard operating procedures for developing off-label recommendations while 6/14 (43%) countries had policies for implementing off-label recommendations. Nine respondents from 8 countries agreed to participate in a focus group (n = 6) or individual interviews (n = 3). Barriers to off-label recommendations included legal concerns, lack of standard definition for off-label use, and manufacturer reluctance to update product information. Facilitators included confidence in the decision-making process, and transparency of open communication among stakeholders. Conclusions Best practice guidelines are needed that define off-label use and outline a transparent, evidence-based approach to develop off-label recommendations.

A National Immunization Technical Advisory Group (NITAG) provides independent, evidence-based recommendations to the Ministry of Health for immunization programmes and policy formulation. In this article, we describe the structure, functioning and work processes of Chile's NITAG (CAVEI) and assess its functionality, quality of work processes and outputs, and integration of the committee into the Ministry of Health policy process using the Assessment tool for National Immunization Technical Advisory Groups. Among its strengths, CAVEI's administrative and work plasticity allows it to respond in a timely manner to the Ministry of Health's requests and proactively raise subjects for review. Representation of multiple areas of expertise within the committee makes CAVEI a robust and balanced entity for the development of evidence-based comprehensive recommendations. High ranking profile of the Secretariat structure furthers CAVEI's competences in policymaking and serves as a bridge between the committee and international initiatives in the field of immunizations.

In 1999, the Global Advisory Committee on Vaccine Safety (GACVS) was established by the World Health Organization (WHO) to provide independent scientific advice on issues relating to the safety of vaccines and immunization. Fifteen years onward, we conducted a multi-faceted review to evaluate the impact, reach and challenges facing GACVS, including the role GACVS plays in informing global, regional and WHO member state vaccine policy. The methods included measures of organizational structure, citation impact, themes approached, and a discussion by previous and current members to evaluate past, present and future challenges. Given the increasing range of data sources and the deployment of many new vaccines, the Committee is facing the complex task of identifying the best available evidence for recommendations on vaccine safety. To help meet the increased demand for public transparency in decision making, GACVS-structured methodology for evidence-based decisions is evolving. GACVS also promotes best practices and capacity building for timely and accurate risk assessment; risk communications; outreach to help countries maintain and, if needed, rebuild public trust in vaccines; and advocacy for bridging the major gaps in vaccine safety capacity globally.

Highlights • The RTS,S Plasmodium falciparum malaria vaccine has received a positive regulatory assessment by EMA. • The CYD-TDV dengue vaccine has been licensed in some middle-income countries. • A Phase 3 HIV vaccine trial is due to be initiated in South Africa during 2016–2017. • The RSV vaccine pipeline is in Phase III clinical development and may reach the licensure submission stage within 4 years. • Group B streptococcal vaccine development is advancing, as is the maternal immunisation agenda., There are more vaccines in development, against a greater number of pathogens, than ever before. A challenge with this exceptional level of activity and investment is how to select and resource the most promising approaches to have the most significant impact on public health. The WHO Product Development for Vaccines Advisory Committee (PDVAC) was established in 2014 to provide strategic advice and recommendations to WHO for vaccines in clinical development that could have a significant impact on public health in low and middle income countries. On 7–9th September 2015, PDVAC was convened for the second time, when the committee reviewed vaccine developments in 24 disease areas. This report summarises the key recommendations from that consultation.

BACKGROUND: In October 2011, the Advisory Committee on Immunization Practices (ACIP) issued updated recommendations that all pregnant women routinely receive a dose of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine. Objectives: We characterized reports to the Vaccine Adverse Event Reporting System (VAERS) in pregnant women who received Tdap after this updated recommendation (2011-2015) and compared the pattern of adverse events (AEs) with the period before the updated recommendation (2005-2010). METHODS: We searched the VAERS database for reports of AEs in pregnant women who received Tdap vaccine after the routine recommendation (11/0½011-6/30/2015) and compared it to published data before the routine Tdap recommendation (01/0½005-06/30/2010). We conducted clinical review of reports and available medical records. The clinical pattern of reports in the post-recommendation period was compared with the pattern before the routine Tdap recommendation. RESULTS: We found 392 reports of Tdap vaccination after the routine recommendation. One neonatal death but no maternal deaths were reported. No maternal or neonatal deaths were reported before the recommendation. We observed an increase in proportion of reports for stillbirths (1.5% to 2.8%), and injection site reactions/arm pain (4.5% to 11.9%) after the recommendation compared to the period before the routine recommendation for Tdap during pregnancy. We noted a decrease in reports of spontaneous abortion (16.7% to 1%). After the 2011 Tdap recommendation, in most reports vaccination (79%) occurred during the third trimester compared to 4% before the 2011 Tdap recommendation. Twenty-six reports of repeat Tdap were received in VAERS; 13 did not report an AE. One medical facility accounted for 27% of all submitted reports. CONCLUSIONS: No new or unexpected vaccine AEs were noted among pregnant women who received Tdap after routine recommendations for maternal Tdap vaccination. Changes in reporting patterns would be expected, given the broader use of Tdap in pregnant women in the third trimester.

Many experts on vaccination are convinced that efforts should be made to encourage increased collaboration between National Immunization Technical Advisory Groups on immunization (NITAGs) worldwide. International meetings were held in Berlin, Germany, in 2010 and 2011, to discuss improvement of the methodologies for the development of evidence-based vaccination recommendations, recognizing the need for collaboration and/or sharing of resources in this effort. A third meeting was held in Paris, France, in December 2014, to consider the design of specific practical activities and an organizational structure to enable effective and sustained collaboration. The following conclusions were reached: (i) The proposed collaboration needs a core functional structure and the establishment or strengthening of an international network of NITAGs. (ii) Priority subjects for collaborative work are background information for recommendations, systematic reviews, mathematical models, health economic evaluations and establishment of common frameworks and methodologies for reviewing and grading the evidence. (iii) The programme of collaborative work should begin with participation of a limited number of NITAGs which already have a high level of expertise. The amount of joint work could be increased progressively through practical activities and pragmatic examples. Due to similar priorities and already existing structures, this should be organized at regional or subregional level. For example, in the European Union a project is funded by the European Centre for Disease Prevention and Control (ECDC) with the aim to set up a network for improving data, methodology and resource sharing and thereby supporting NITAGs. Such regional networking activities should be carried out in collaboration with the World Health Organization (WHO). (iv) A global steering committee should be set up to promote international exchange between regional networks and to increase the involvement of less experienced NITAGs. NITAGs already collaborate at the global level via the NITAG Resource Centre, a web-based platform developed by the Health Policy and Institutional Development Unit (WHO Collaborating Centre) of the Agence de Médecine Préventive (AMP-HPID). It would be appropriate to continue facilitating the coordination of this global network through the AMP-HPID NITAG Resource Centre. (v) While sharing work products and experiences, each NITAG would retain responsibility for its own decision-making and country-specific recommendations.

In October 2016, the Advisory Committee on Immunization Practices (ACIP) updated the human papillomavirus (HPV) vaccination recommendation to include a 2-dose schedule for U.S. adolescents initiating the vaccine series before their 15th birthday. We analyzed records for >4 million persons aged 9–17 years receiving any HPV vaccine by the end of each quarter during January 1, 2014–September 30, 2016 from six Immunization Information Systems Sentinel Sites, and reclassified HPV vaccination up-to-date coverage according to the updated recommendations. Compared with HPV vaccination up-to-date coverage by the 3-dose schedule only, including criteria for either a 2-dose or 3-dose schedule increased up-to-date coverage in 11–12, 13–14, and 15–17 year-olds by 4.5–8.5 percentage points. The difference between 3-dose up-to-date coverage and 2- or 3-dose up-to-date coverage was greatest in late 2016. These data provide baseline HPV vaccination coverage using current ACIP recommendations.

We identified 16 Advisory Committee on Immunization Practices (ACIP) presentations from 2012 to 2016 that indicated 'cost' or 'economic' content. Characteristics were reviewed, abstracted, and tabulated to quantify and assess the transparency and consistency of economic evidence presented to ACIP. To assess transparency, we documented if each study identified author affiliation, conflicts of interest, study limitations, a clearly described model structure and other model attributes. To assess consistency, we identified the frequency of specific modeling choices, including the perspective, types of health outcomes considered, inclusion of specific types of costs, discount rate, and use of sensitivity analyses. Our results indicate that the content in these presentations appear to be transparent overall and consistent in several important areas, such as study perspective and health outcomes. However, we find the inclusion of particular types of direct costs, indirect costs, program costs, and sensitivity analyses are areas that could improve consistency.

Purpose Measure the preferences of decision makers and researchers associated with the Advisory Committee on Immunization Practices (ACIP) regarding the recommended format for presenting health economics studies to the ACIP. Methods We conducted key informant interviews and an online survey of current ACIP work group members, and current and previous ACIP voting members, liaison representatives, and ex-officio members to understand preferences for health economics presentations. These preferences included the presentation of results and sensitivity analyses, the role of health economics studies in decision making, and strategies to improve guidelines for presenting health economics studies. Best-worst scaling was used to measure the relative value of seven attributes of health economics presentations in vaccine decision making. Results The best-worst scaling survey had a response rate of 51% (n = 93). Results showed that summary results were the most important attribute for decision making (mean importance score: 0.69) and intermediate outcomes and disaggregated results were least important (mean importance score: −0.71). Respondents without previous health economics experience assigned sensitivity analysis lower importance and relationship of the results to other studies higher importance than the experienced group (sensitivity analysis scores: −0.15 vs. 0.15 respectively; relationship of the results: 0.13 vs. −0.12 respectively). Key informant interviews identified areas for improvement to include additional information on the quality of the analysis and increased role for liaisons familiar with health economics. Conclusion Additional specificity in health economics presentations could allow for more effective presentations of evidence for vaccine decision making.