WHO: Summary of the SAGE meeting of April 2015

WHO: Summary of the SAGE meeting of April 2015 pdf, 52k
20 April 2015
[Editor’s text bolding]

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 type 2 oral polio vaccine (OPV2) withdrawal.

SAGE noted that the program had made substantial progress since the October 2014 SAGE meeting. There were no polio cases due to WPV reported in the Middle East and Africa since April 2014 and August 2014, respectively. In polio-¬‐endemic countries there were definite improvements in the quality of supplementary immunization activities, increasing access to children in conflict-¬‐affected areas of Pakistan, improvements in AFP surveillance and expansion of environmental surveillance.

Persistent cVDPV2 transmission was detected only in Nigeria and Pakistan since 2014. The number of cVDPV2 cases declined in both countries after mid-¬‐2014 following increased use of tOPV and targeted use of IPV in Supplementary Immunization Activities (SIAs).

Between March 2015 and March 2016, Nigeria and Pakistan will conduct 7 and 8 large
-¬‐scale tOPV campaigns, respectively, especially targeting areas affected by persistent cVDPV2. IPV will be included in tOPV campaigns in selected highest-¬‐risk areas, and aggressive mopping-¬‐up will be implemented in response to detection of any cVDPV2. Both countries will focus on strengthening routine immunization to further reduce the risk of emergence of new cVDPV2.

SAGE endorsed the proposed cVDPV2 elimination strategies in Nigeria and Pakistan and the programme’s risk-¬‐based approach to prevent and respond to new cVDPV2 emergence in any location.

Overall, 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 risk of continued cVDPV2 transmission is judged to be high. SAGE requested the polio WG to continue monitoring progress towards cVDPV2 elimination and ensuring that remaining challenges are addressed including contingencies for vaccine supplies (IPV, bOPV and tOPV), registration of bOPV for routine use, surveillance sensitivity, and reaching inaccessible children.

The Middle-¬‐Income Countries (MICs) Task Force, a group of nine immunization partners, presented a proposed way forward for coordinated action to enhance sustainable access to vaccines in MICs with focus on non-¬Gavi eligible countries. The Task Force has undertaken a detailed survey of the needs of non-¬‐Gavi MICs and the types of support currently provided to these countries by immunization partners. Based on this and on a modelled analysis of impact, the Task Force agreed that its strategy should address both new vaccine introduction and immunization coverage. Based on consultations and analyses, the Task Force confirmed that the issue of access to affordable prices and timely supply is a main challenge for MICs, yet agreed that this issue should not be tackled in isolation and that activities to consolidate demand are key to success. Four main areas of action have been identified as the pillars of the MIC strategy: i) Strengthening evidence–‐based decision-¬‐making; ii) Enhancing political commitment in specific countries and ensuring financial sustainability of immunization programmes; iii) Enhancing demand for and equitable delivery of immunization services; and iv) Improving access to timely and affordable supply. Within each of these areas, the Task Force has identified a set of focus activities and lead agencies, making this the first comprehensive and coordinated strategy targeting MICs.

Critical to the strategy is the central role of country-¬‐level political and financial commitments to immunization. To foster country ownership, the Task Force designed the strategy as a menu of options, from which countries will be able to select the kinds of assistance they identify as priorities. SAGE acknowledged that the strategy put forward represents a strong proposal for coordinated and comprehensive approach to the MIC issue. SAGE concurred with the direction of the strategy and valued the menu of option approach as a way to tailor activities to the needs of a very heterogeneous group of countries. SAGE also appreciated that the strategy builds upon lessons learnt and existing activities, and perceived this approach as the most efficient way to use resources and achieve impact.

With respect to Ebola vaccines and vaccination SAGE was updated on the status of: 1) the ongoing epidemic, 2) vaccine development, and 3) preparation for supporting countries with vaccine deployment. SAGE was presented with a framework for making recommendations, which aims to adopt a scenario-¬‐based approach for framing recommendations, while also taking a number of programmatic, socio-¬‐cultural and other issues into account. Considerations guiding the use of the framework are: the 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; additional considerations which would frame SAGE’s recommendations. The framework would be adjusted based on the evolution of the current epidemic, the type of regulatory or emergency use authorization given to a vaccine, and on data that become available from clinical trials.

SAGE members expressed concern about the likelihood that efficacy estimates may not be generated from the current phase 3 trials, given the declining number of cases in all three 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 highlighted the importance for transparent and prompt sharing of information on the trial protocols and data from the phase 3 studies and the need for a greater role for WHO in coordinating these trials.

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 the use of vaccines and social and cultural considerations.

SAGE noted the probability that for some vaccines currently under test, efficacy data may not be available by the end of the current outbreak. SAGE further noted that in this scenario, future use of unproven Ebola vaccines should be in the context of a
Study with generation of safety and effectiveness data.

SAGE also discussed the administration of multiple injectable vaccines, the use of interventions aimed at reducing pain and distress at the time of vaccination, maternal vaccination, and pertussis immunization schedules.

The full meeting report will be published in the WHO Weekly Epidemiological Record on 29 May 2015. The meeting documents — including presentations and background readings — can be found at http://www.who.int/immunization/sage/meetings/2015/april/en/index.html