The development of the draft Global Vaccine Safety Blueprint 2.0 (GVSB2.0) was presented. The process was initiated and aligned with the Immunization Agenda 2030 and the Sustainable Development Goals. A landscape analysis was conducted during the first semester of 2019 to review progress by the Global Vaccine Safety Initiative in achieving the first Blueprint,²² to build on that Blueprint and to identify gaps and new priorities.

Work on the GVSB2.0 started at the end of June 2019, with identification of major strategic areas, which were:

• governance and systems development;
• coordination of safety systems;
• regulatory framework;
• AE following immunization (AEFI) surveillance, including analysis and causality assessment;
• enhanced vaccine safety communication;
• fragile states and crisis systems and
• an accountability framework.

The document provides high-level strategic guidance according to the maturity achieved by a country. It applies the WHO Global Benchmarking Tool for evaluating indicators of pharmacovigilance in regulatory systems,²³ which are used to measure performance in countries and to assess their maturity. The GVSB2.0 is aligned with the priorities of the Immunization Agenda 2030 and will thus be “people focused”, “country owned”, “partnership based” and “data driven”.

A first draft was submitted for public comments in early October 2019. The document was then revised and re-submitted publicly on 18 November 2019 and discussed at the Global Summit for Vaccine Safety on 2 December 2019. Suggestions, critiques and comments made at the Summit were collected and collated and further discussed with GACVS members and the SAGE Chair on 4 December 2019. It was suggested that, once the strategy has been endorsed, an accompanying “implementation document” be issued to operationalize the strategic guidance.

Major comments from the Summit discussions included integration of specific examples throughout the document, greater clarity regarding the audiences and responsible parties, an enhanced role for stakeholders and the importance of monitoring and evaluation. One important comment was on improving health literacy to combat misinformation. Comments on each strategic area will be considered, and appropriate responses will be incorporated into each chapter by the drafting group and sent to the authors of each strategic area for comments and amendments.

Other considerations suggested by GACVS members were:

• Demonstrate financing and governance at different levels.
• Include research to build trust with evidence.
• Ensure a strong monitoring and evaluation framework for accountability.
• Avoid advocacy in safety communications in GVSB2.0.
• Set links to databases with standardized case definitions and transparency; the guidelines should indicate clear pathways for reporting events.

Before GVSB2.0 is submitted to SAGE for review, questions will be proposed for their consideration and advice. Questions suggested by GACVS members included:

• What strategic shift could be made to move from GVSB1.0 to GVSB2.0?
• Are there strategies for identifying resources and mechanisms for finding funds without using those reserved for vaccination?
• What are the recommendations for moving forward, including possible adjustments to the Global Vaccine Safety Initiative?

The GVSB2.0 secretariat and drafting group will work with SAGE in preparation for the April 2020 meeting. Pending endorsement by SAGE, GVSB2.0 implementation will be discussed at the GACVS meeting in June 2020.

²² Global Vaccine Safety 2.0 background research. Geneva: World Health Organization; 2019 (https://www.who.int/vaccine_safety/publications/2019_Landscape_Analysis.pdf?ua=1, accessed December 2019).

²³ WHO Global Benchmarking Tool (GBT) for evaluation of regulatory systems. Geneva: World Health Organization; 2019 ( https://www.who.int/medicines/regulation/benchmarking_tool/en/, accessed December 2019).

Report of GACVS meeting of 4-5 December 2019, published in the WHO Weekly Epidemiological Record of 24 January 2020

The Committee previously discussed updating the vaccine safety strategy after 2020. At this session, they reviewed preliminary findings from 2 surveys of global stakeholders in preparation for the next version of the vaccine safety blueprint (“Blueprint 2.0”) and to obtain GACVS advice on aligning Blueprint 2.0 with the immunization agenda for 2030.

The findings from surveys of both non-industry and industry stakeholders, conducted in April and May 2019, were reviewed. The survey participants included representatives of academia, civil society, development partners, global agencies, governments, health professionals, manufacturers and the private sector in all 6 WHO regions. The themes included familiarity with the Blueprint and the purpose of Global Vaccine Safety Initiative (GVSI), the usefulness of GVSI resources, the development of new GVSI materials and assessment of suggestions for the future of GVSI and Blueprint 2.0. Of 352 people who received the survey, 208 started and 148 completed it. The replies are still being analysed, but, overall, progress appears to have been made, and many of the findings resemble those of the 2011 landscape analysis, including requests for more training and harmonized methods. When the analysis is complete, the results will be shared with GACVS and the working group drafting the Blueprint 2.0.

GACVS was then updated on the development and emerging priorities of the post-2020 immunization strategy, the “Immunization Agenda 2030”, which will succeed the Global Vaccine Action Plan, which ends in 2020. The aim of Immunization Agenda 2030 is to set a new vision and strategy for vaccines and vaccination; to develop a compelling, country-centric approach for the next decade and align stakeholders at all levels; to address emerging issues and harness new solutions; and to reignite the importance of vaccines and vaccination for broader health and development agendas. The plan is for 2 components – one for the public and one for the immunization community and other stakeholders. The 6 initial strategic priorities are: systems and integration; equity and access; fragility and emergencies; values and ownership; research and innovation; and sustainability and accountability. The goal is to produce a living document focused on people, country driven, data driven and geared towards broad partnerships. It is intended to address national, regional and global needs.

GACVS then reviewed the main goals of the previous blueprint on vaccine safety and discussed the activities and timelines for completing Blueprint 2.0. The 3 main goals of the initial Blueprint, which was aligned with the “Decade of Vaccines 2011-2020”, were 1) to ensure the safety of vaccination by assisting low- and middle-income countries (LMICs) in having at least a minimal capacity for assessing vaccine safety; 2) to enhance capacity for assessing vaccine safety in countries that introduce newly available vaccine and countries that manufacture and use prequalified vaccines; and 3) to support countries through international collaboration, training and information exchange. The plan for Blueprint 2.0 is to establish a drafting group of technical experts who will collaborate and identify core subjects, form and lead subgroups of subject matter experts and create a draft after discussions, iterations and a stakeholder meeting during the next few months. GACVS will review the draft document at its meeting in December 2019 to obtain WHO clearance and SAGE endorsement in spring 2020.

GACVS suggested that Blueprint 2.0 be aligned with the Immunization Agenda 2030 and be a technical (and living) document. The new version should apply to all countries and not just LMICs, although it should recognize that LMICs have unique constraints and needs that should be addressed. GVSI should continue to implement the Blueprint, and a monitoring and evaluation component should be included to ensure accountability. The plan should be shared with stakeholders for input and be made publicly available for those interested in making comments. The Blueprint should acknowledge the importance and evolving role of consumers. It will be more useful if it focuses on key priorities, with indicators to measure progress and success.

Report of GACVS meeting of 5-6 June 2019, published in the WHO Weekly Epidemiological Record of 12 July 2019

GACVS held a session to review the findings of the 7th meeting on the Global Vaccine Safety Initiative (GVSI) and to propose a process for preparing a second version of the Global Vaccine Safety Blueprint, aligned with WHO’s post-2020 immunization strategy. The GVSI was prepared by a collaborative group of partners from national programme and regulatory agency staff, technical agencies, donors and industry as a mechanism for implementation of the blueprint.⁹ Since its launch in 2012, the GVSI has held 7 meetings in all 6 WHO regions. The network has contributed new resources for vaccine pharmacovigilance, including tools, methods, training packages, standard reporting forms and tools and e-learning packages. A network of websites has been developed (Vaccine Safety Net), the content of which has been verified for reliability and presentation.¹⁰ A first indicator of vaccine safety surveillance has been developed (AEFI reporting ratio of 10 cases per 100 000 surviving infants per year).¹¹ Steady improvement in meeting this goal has been observed since the launch of the GVSI. It was recognized that the roles of GACVS, which is involved in risk assessment, and GVSI, which is a capacity-building forum, are complementary and their interaction could be increased. Vaccine safety systems have improved greatly worldwide but still require dedicated resources and better reporting, data management, signal identification and investigation. In addition, closer collaboration is needed between immunization programmes and regulatory systems.

Progress in the Global Vaccine Safety Observatory was also reviewed. The role of the Observatory is to enhance surveillance capacity by improving access to indicators of national and regional systems through WHO partners. It is a clearing-house for vaccine safety data relevant to GVSI members. Specifically, it presents WHO held data, allowing tracking and comparison of indicators over time and aggregation of region-sensitive data; notifies alerts of recalls or safety signals from national regulatory authorities; provides global mapping of reported vaccine safety events; and includes links to relevant “lessons and stories”, expert sources and relevant data sources.

During the session, the SAGE Chair presented plans for the post-2020 WHO immunization strategy. It was noted that vaccine safety is part of such planning. The discussion moved toward preparation of the next Global vaccine safety blueprint during 2019. The previous GVSI meeting recommended greater attention to several areas: communication about increased rates of reported AEFI, identification of actual serious vaccine reactions, strategies to respond to and maintain public confidence and no-fault VICPs. In addition, enabling actions, such as dissemination of AEFI surveillance methods, vaccine safety training to local level, regional advisory mechanisms for vaccine safety and novel reporting tools would be valuable.

The WHO Secretariat presented a proposed programme of work for the blueprint during 2019, to be conducted in alignment with the Global Vaccine Action Plan. A landscape analysis was conducted in preparation for the first blueprint, and it was proposed to start by updating that analysis. GACVS discussed some of the proposed programme of work and made many suggestions. For instance, in addition to the goals of the original blueprint, which included minimum capacity for vaccine safety in all low- and middle-income countries and expanded capacity in some middle-income countries, the next safety strategy should apply to all countries. Timelines should be proposed to meet the main strategic goals. Additional indicators and sub-indicators of progress in establishing effective vaccine pharmacovigilance systems should be considered for development and integration into the plan. The partnerships of the GVSI and the Observatory might benefit from expansion to include groups such as the National Immunization Technical Advisory Group network, SAGE and others. Communication case studies could be useful to guide ways to address true safety issues. Communication in general is vitally important, and GACVS has a significant role to play in composing scientific messages for use by risk communicators. Guidance on injury compensation would be useful. Approaches to ensure appropriate safety reporting should be determined and emphasized, and national authorities should commit themselves to establish vaccine safety monitoring as part of the quality assurance of immunization programmes to ensure appropriate reporting. The next Global vaccine safety blueprint should also include preparedness for crisis communication about vaccine safety. The Vaccine Safety Network should be acknowledged as the living network that it has become and would benefit from continued review of clear priorities.

⁹ Global vaccine safety blueprint (WHO/IVB/12.07). Geneva: World Health Organization; 2012.

¹⁰ Vaccine Safety Net. www.vaccinesafetynet.org/

¹¹ Lei et al. Use of a new global indicator for vaccine safety surveillance and trends in adverse events following immunization reporting 2000–2015. Vaccine. 2018;36:1577–1582.

Full report of GACVS meeting of 5-6 December 2018, published in the WHO Weekly Epidemiological Record on 25 January 2019

The Global Vaccine Safety Blueprint, a framework of 8 objectives for enhancing global vaccine safety activities, was last discussed by the Committee in 2012. The Blueprint was later used as the basis for the vaccine safety strategy in the Global Vaccine Action Plan. GACVS provided input to the Blueprint and implemented it in the GVSI. At its meeting in December 2012, the Committee reviewed the GVSI work plan and examined areas of interaction between its own mandate for vaccine safety issues of global importance and that of the GVSI to support global vaccine pharmacovigilance capacity.⁹ GACVS was notified of progress made through the GVSI in achieving its objectives 6 years after launch of the Initiative and was informed about a programme to strengthen global monitoring of vaccine safety, the Global Vaccine Safety Observatory. It also discussed the global vaccine safety strategy in the context of development of the Global Vaccine Action plan after 2020.

The Blueprint vision of effective vaccine pharmacovigilance systems established in all countries has progressed steadily. Countries are reporting AEFI and are meeting indicators of improvement in safety surveillance capacity. Six annual GVSI meetings have brought partners and countries together to build collaborations and plan future activities. Resources, training packages on basic vaccine safety, guidelines, AEFI surveillance and management, signal detection and communications are integral to robust building and maintenance of capacity for vaccine pharmacovigilance and trust in immunization programmes.

GACVS has advocated for the GVSI and supported its objectives on several fronts, from assisting in development of tools and helping to identify priorities to responding to safety concerns raised by countries either during the regular 6-monthly meetings or ad hoc. Five of the 8 strategic objectives of the GVSI benefit directly from input by GACVS: AEFI monitoring, investigation, harmonized tools and methods, technical support platforms and expert advice.

The concept of the Global Vaccine Safety Observatory was discussed. It was conceived as a clearinghouse for data on vaccine safety systems to assist member coun¬tries in achieving the Blueprint objectives. The Observatory will start with 4 regional nodes that provide academic, programmatic, regulatory and technical expertise. The expected outputs of the Observatory include presentation and analysis of relevant data, a website to provide indicators of vaccine safety capacity and links to relevant activities for vaccine vigilance, and an annual report. The products of the Observatory will be disseminated through several activities, some of which have had to evolve and recruit more than minimal capacity to deal with emerging safety issues. Each node will present relevant specialized data to allow members to track and compare progress over time, aggregate more sensitive data regionally, share regulatory recall and safety alerts, map globally reported safety concerns and make links to relevant experience.

Finally, as the Decade of Vaccines will be completed by 2020, a new vaccine strategy is being developed, which will be aligned with the recently approved WHO General Programme of Work 2019–2023 in support of the sustainable development goal for health. GACVS therefore recommends close collaboration to ensure that the global vaccine safety strategy is well positioned in the new global approach to immunization.

⁹ See No. 6, 2013, pp. 69–70.

Full report of GACVS meeting of 6-7 June 2018, published in the WHO Weekly Epidemiological Record of 20 July 2018

In 2011, WHO and a group of partners developed the Global Vaccine Safety (GVS) Blueprint, a strategic document with a vision of establishing effective vaccine pharmacovigilance systems in all countries.⁶ The GVS Blueprint is a part of the Global Vaccine Action Plan, which was endorsed by the World Health Assembly in May 2012. The Global Vaccine Safety Initiative (GVSI) was set up to implement the Blueprint and is advised by the GVSI planning group. The Blueprint strategic goals, which GVSI is expected to achieve during 2012–2020, include: (1) ensuring minimal capacity in vaccine safety for all LMICs; (2) promoting enhanced vaccine pharmacovigilance activities in countries with specific needs; and (3) establishing a global technical support structure.

GACVS reviewed the development of the GVSI workplan and the display of its products through its website.⁷ The GVSI identified activities to cover the 8 strategic goals of the Blueprint through a broad network of stakeholders engaged in global vaccine pharmacovigilance. An activity portfolio has been developed as a management tool for implementing the Blueprint. In the portfolio, activities are prioritized based on their expected impact, feasibility and desirability. The portfolio provides initiators, managers and donors of each activity with due recognition for their respective roles. It is also a resource for all stakeholders in global pharmacovigilance to help identify ongoing efforts, allow for better synergies, minimize duplications and enable resource mobilization. The WHO regional offices lead country support in capacity building and in addressing vaccine safety concerns. Currently, the portfolio includes 94 activities, 31 of which have been identified in the first priority category.

GACVS examined areas of interactions between its mandate to advise on vaccine safety issues of global importance and that of the GVSI to support and strengthen global vaccine pharmacovigilance capacity. GACVS recognizes that the GVSI strategies are required to improve vaccine safety systems and develop networks to strengthen the monitoring, evaluation and response to vaccine safety issues. The rapid development of activities expected to be associated with the GVSI will also generate a complex network of stakeholders where roles and responsibilities should be defined as clearly as possible. The GVSI addresses many aspects that intersect with the work of other established groups. The complementarity of advice from vaccine safety bodies with that of other immunization and public health advisory groups requires particular attention, both at global and regional levels. GACVS identified several areas where the GVSI should clearly outline the leading role of WHO as a global convener in health monitoring and systems. In addition, efforts should include: involving regional and national immunization technical advisory groups with vaccine safety assessment and communication efforts; use of existing academic and educational institutions to expand vaccine safety training resources, engagement of vaccine producers in promoting information exchange; and active development of a roster of vaccine pharmacovigilance experts with appropriate cultural awareness and geographical proximity to support country demands.

The GVSI proposes solutions for a number of unmet needs in vaccine safety. The Blueprint framework has the potential to involve many new players in a broad collaborative effort. Yet the increased volume of activities and attention will generate competition and competency issues, requiring clear accountability and quality assurance. GACVS therefore proposed a thorough analysis of how the complex needs for vaccine safety can best be addressed and development of an accountability framework for all stakeholders participating in the GVSI. The role of GACVS with respect to the GVSI will remain at the consultancy and advisory level, providing independent evaluation of the evidence for the global vaccine safety issues identified by and for WHO. The rapidly increasing number of proposed activities will also require a more comprehensive system of prioritization with appropriate criteria. The committee is well positioned to help set those criteria, with a focus on ensuring that technical partners’ activities meet the needs of LMICs in strengthening their vaccine safety capacities.

⁶See http://extranet.who.int/iris/restricted/bitstream/10665/70919/1/WHO_IVB_12.07_eng.pdf.

⁷See http://www.who.int/vaccine_safety/initiative/en/

Full report of GACVS meeting of 5-6 December 2012, published in the WHO Weekly Epidemiological Record on 8 February 2013