Weekly Epidemiological Record (WER) 29 May 2015, vol. 90, 22 (pp. 261–280)

The Weekly Epidemiological Record (WER) 29 May 2015, vol. 90, 22 (pp. 261–280) includes:
Monthly report on dracunculiasis cases, January– April 2015
Meeting of the Strategic Advisory Group of Experts on immunization, April 2015: conclusions and recommendations
[Meeting Report Sections and Editor’s Excerpts]

Report from the WHO Department of Immunization, Vaccines and Biologicals
The report focused on: the implementation of the Global Vaccine Action Plan (GVAP) and the related discussions during meetings of the WHO Governing Bodies at global and regional levels; the programmatic priorities to close the immunization gap; an update on implementation of selected SAGE recommendations; and agenda items on the horizon for future meetings.

The report stressed that reaching the GVAP goals is resource intensive (human and financial) and emphasized the urgent need for adequate investments and focus in order to increase routine immunization coverage which has been almost static, at global level, since 2009 and below the expected 90% coverage.

The report noted the current global short¬age of bacille Calmette–Guérin (BCG) vaccine and proposed interim solutions while stressing the need for the global community to pay more attention and take measures to avoid future shortages of other recommended vaccines.

SAGE took note of regional progress and commended the work carried out to advance regional vaccine action plans and promote activities to strengthen routine immunization.

SAGE stressed that additional disaggregation was needed in the analysis of the progress achieved on the ground, and in identifying bottlenecks for progress, and recommended that reports display disparities observed at subnational levels.

In view of weak infrastructure in some countries with a related inability to deliver vaccines, SAGE called for new politically supported initiatives to mobilize part¬ners and resources to apply technological know-how in fragile countries and find ways to build infrastructure in fragile systems. SAGE reaffirmed the need for solu¬tions that simplify operations on the ground, including delivery technologies such as compact pre-filled auto-disable injection technology. In this context SAGE also acknowledged the importance of the polio infrastruc-ture and noted how it had been critical in helping to deal with the Ebola situation, particularly in Nigeria.

SAGE stressed the importance of applying rigour and science in implementation programme design and eval¬uation of delivery of vaccines, in order to maximize the impact of current and future vaccines and delivery tech¬nologies.

SAGE also stressed the need to draw lessons from the Ebola epidemic regarding mobilization of communities as well as the encouragement of countries and partners to mobilize the private sector.

SAGE supported WHO’s plan to expand guidance beyond the current framework on the use of vaccines in humanitarian emergencies to include guidance on how to re-establish routine vaccination in those settings.

At the January 2015 WHO Executive Board meeting, Member States endorsed a resolution for pre-emptive development of vaccines against emerging infectious diseases such as Ebola virus disease. WHO was asked to provide leadership in supporting a prioritized research agenda. A framework for action in relation to vaccine development was proposed, which would include public health criteria, technical feasibility, regu¬latory pathways, and economic considerations. The issues will be reviewed by SAGE, the Product Develop¬ment for Vaccines Advisory Committee (PDVAC), the Expert Committee on Biological Standardization (ECBS) and other forums, with the aim of reaching an agree¬ment within a year.

A SAGE Working Group on Dengue Vaccine was established in March 2015.
Subject to the completion and conclusions of the vaccine assessment by the European Medicines Agency, it is planned that SAGE and the Malaria Programme Advi¬sory Committee will issue policy recommendations on the use of RTS,S malaria vaccine during a joint session in October 2015.
..1 See http://www.who.int/immunization/sage/en
..2 The complete set of presentations and background materials used for the SAGE meeting of 14-16 April 2015 together with the list of SAGE members and the summarized declarations of interests provided by SAGE members are available at http://www.who.int/immunization/sage/meetings/2015/april/en
Report from Gavi, the Vaccine Alliance
Report of the Global Advisory Committee on Vaccine Safety (GACVS)
Report of the Product Development for Vaccines Advisory Committee (PDVAC

Polio eradication
SAGE reviewed progress towards eradication of wild poliovirus (WPV) and elimination of persistent circulating vaccine-derived poliovirus type 2 (cVDPV2) as well as the plans, preparedness and timeline for with¬drawal of type 2 oral polio vaccine (OPV2).

SAGE noted that the programme had made substantial progress since the previous SAGE meeting. No WPV case has been reported in the Middle East or Africa since April 2014 and August 2014, respectively. In polio-endemic countries there were definite improvements in the quality of supplementary immunization activities (SIAs), increasing access to children in conflict-affected areas of Pakistan, improvements in AFP surveillance and expansion of environmental surveillance…

…SAGE concluded that progress towards elimination of persistent cVDPV2 is on track. SAGE recommended that all countries and GPEI should plan firmly for April 2016 as the designated date for withdrawal of OPV2. SAGE will consider delaying OPV2 withdrawal only if the WG reports in October 2015 that the assessed risk of contin¬ued cVDPV2 transmission is high. SAGE requested the polio WG to continue monitoring progress towards cVDPV2 elimination and ensuring that remaining chal¬lenges are addressed including contingencies for vaccine supplies (IPV, bOPV and tOPV), registration of bOPV for routine use, surveillance sensitivity, and reaching inaccessible children. The Working Group will make a full report to SAGE in October 2015, when SAGE may reconfirm April 2016 as the definite date for OPV2 withdrawal.

SAGE endorsed the proposed approach to verification of compliance of poliovirus containment in essential facilities. Under the WHO Global Action Plan (GAP III), facilities planning to handle or store type 2 poliovirus are requested to implement containment measures and appropriately manage associated biorisks. National Regulatory Authorities for containment (NRAcs) are expected to certify facilities according to GAP III. Certification reports are submitted to Regional Certification Commissions (RCCs) for evaluation. In support of this process, RCCs, NRAcs or concerned facilities may request that WHO verify compliance of certified facili¬ties in keeping with GAP III. SAGE requested that the programme consider mechanisms to address the risks associated with research and therapeutic uses of live polioviruses.

Administration of multiple injectable vaccines in a single visit
…SAGE supported the following Good Practice Statement on multiple vaccine injections in a single visit, recognizing that the country context is an important determinant of success and acceptability among caregivers and providers: National vaccination schedules recommending administration of multiple injections in the same visit are widely used and provide benefits insofar as they support timely and efficient vaccination of children. Where studies have evaluated the immunogenicity and safety of co-administered vaccines, these practices are encouraged based on the benefits they confer.

SAGE concluded that countries should not make modifications to recommended immunization schedules with the aim of preventing multiple injections during the same visit when such modifications are not evidence-based…

Reducing pain and distress at the time of vaccination

Sustainable access to vaccines in middle-income countries (MICs): report of the WHO-convened MIC Task Force
The MIC Task Force, a group of 9 immunization part¬ners, presented a proposed strategy for coordinated action to enhance sustainable access to vaccines in MICs. Over the past decade, access to vaccines in MICs has been much debated, fuelled by the fact that the majority of poor people are now in MICs and concern that this group of countries may be missing out on opportunities to introduce new vaccines, as donors focus on low-income countries. In view of this situation and at the request of SAGE, in June 2014 WHO convened the MIC Task Force to develop a coordinated strategy and plan of action.

A comprehensive review of MICs’ performance shows that they are far from attaining the GVAP targets. While 40 MICs are well supported by Gavi, 63 do not benefit from a unified international strategy for action. In these countries, vaccine-preventable disease burden and numbers of unvaccinated children are relatively low compared to the Gavi-supported MICs, but nonetheless substantial and unacceptable. Many of these countries have strong health systems and potential for rapid gains if key barriers are removed. The MIC strategy, aligned with the GVAP time frame (2016–2020), proposes a way forward for non-Gavi countries. Importantly, solutions and platforms set up as part of the strategy would also benefit countries that graduate from Gavi support over time, ensuring sustainability of current investments…

…SAGE acknowledged that the strategy represents a strong proposal for a coordinated and comprehensive approach to the MIC situation. SAGE concurred with the general direction of the strategy and valued the menu of options as an approach to tailoring activities to the individual needs of a heterogeneous group of countries. SAGE appreciated that the strategy builds upon lessons learnt and existing activities as the most efficient way to use resources and achieve impact.

SAGE called on partners to support implementation of the strategy and on countries to take advantage of the proposed solutions.

SAGE noted that prompt implementation of the MIC strategy is particularly important given the impending graduation of several large Gavi countries, which will require long-term solutions to be put in place…

Ebola vaccines and vaccination
…In parallel with the vaccine trials, WHO and partners, including the 3 most affected countries, have established a framework to develop guidelines to support planning, implementing and monitoring vaccination once a vaccine becomes available for use, according to SAGE recommendations.

A proposed framework for making recommendations was presented, which aims to adopt a scenario-based approach, while also taking account of a number of programmatic, socio-cultural and other factors. Considerations guiding the use of the framework are: specific scenario relating to the epidemiology and the type of authorization for vaccine use; objectives for vaccination (primary – stopping transmission, secondary – individual protection); prioritization of target populations; and additional considerations which would inform SAGE’s recommendations. The framework would be adjusted based on evolution of the current epidemic, the type of regulatory or emergency use authorization given for a vaccine, and on the data that become avail¬able from the clinical trials.

In the discussion that followed, it was noted that the quality of the reported disease data had limitations and that the data on cultural and other factors that may have contributed to differences in the epidemic patterns were not fully captured in the national databases. However, there was confidence that the available data correctly reflected the epidemic patterns and the relative incidence of disease in different age groups.

SAGE members expressed concern about the likelihood that efficacy estimates may not be generated from the phase 3 trials, given the declining number of cases in all 3 countries and felt that the trials must also contribute additional data (including those related to programmatic aspects) that could inform recommendations. Noting WHO’s unique position to coordinate the development of Ebola vaccines, SAGE stressed the importance of transparent and prompt sharing of information on the trial protocols and data from the phase 3 clinical trials, and the need for a greater role for WHO in facilitating the sharing of information so that results between studies will generate the greatest benefit for policy decision-making.

SAGE supported the proposed framework for making recommendations, but asked that it be made explicit that the identification and prioritization of target populations for vaccination will be based on a thorough assessment of risks (from disease as well as from vaccination) and benefits. It was recognized that the final recommendations would be driven by the evolution of the current epidemic, the conditions laid down in the regulatory authorization for use of vaccines and social and cultural considerations.

SAGE recommended that the further development of the Emergency Use Assessment and Listing procedure being developed by WHO, which would allow use of a vaccine in the context of a Public Health Emergency of Inter¬national Concern, be done in close consultation with relevant regulatory authorities, including those of the affected countries.

SAGE again noted the probability that efficacy data for any of the Ebola vaccines may not be available by the end of the current outbreak, and therefore recom¬mended that future use of unproven Ebola vaccines should be in the context of studies that would generate safety and effectiveness data.

Maternal vaccination during pregnancy
SAGE encouraged WHO to promote more implementation research to generate generalizable data on the best ways to integrate maternal immunization into routine antenatal care in low resource settings. SAGE also encouraged the Regional Office for the Americas to document the successful regional experience of deliver¬ing influenza vaccine to pregnant women.

It was considered unnecessary to establish a SAGE working group to review maternal influenza immunization at present, given that substantial data still being generated will not be available until late 2015–2016. SAGE emphasized the importance of the maternal immunization platform, in general, and called upon WHO to affirm its commitment to building the evidence base to strengthen vaccine delivery during pregnancy, as it has great potential for infection prevention in high-risk groups worldwide.

Pertussis vaccination schedules