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. 2022 Mar 15;40(12):1681–1690. doi: 10.1016/j.vaccine.2021.10.062

Table 1.

Key discussion points of the Roundtables.

Stakeholder type Key Challenges and Considerations Perceived benefits of the ECVP and how it could address challenges identified
Vaccine Developers and Manufacturersrepresenting both the developing countries vaccine manufacturers network (Rajinder Suri, DCVMN) and industrialized countries pharmaceutical companies (Ugur Sahin, BioNTech) Key gap between the information in the WHO PPC guidance and what is considered to inform policy recommendations include:
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    defining the vaccine delivery strategy for the target population;

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    vaccine stability and storage requirements and acceptable vaccine presentation in LMIC contexts;

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    prioritization of specific populations (if distinct from target population).
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    A strategic tool to enhance dialogue between the regulators, policy makers and manufacturers to clarify the expectations of each;

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    Process of developing the ECVP will help manufacturers understand the respective roles of the various late-stage stakeholders involved as the vaccine approaches approval and implementation;

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    Increased predictability of the decision-making process at various stages; this might lead to more innovative financing for vaccine development for LMICs;

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    Improve the likelihood that vaccines are programmatically suitable;

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    Help to de-risk investment, accelerate development and availability;

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    Serve as a critical decision-making tool for manufacturers’ investment decisions related to vaccine development, informs strategic planning.
RegulatorsThe regulators included:
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    Dr Boitumelo Semete SAHPRA (South African Health Products Regulatory Authority)

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    Sherry Kurtz, US FDA (Food and Drug Administration)

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    Dr Marco Cavaleri, EMA (European Medicines Agency)

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    Dr Ian Hudson, BMGF (ex-MHRA (Medicines and Healthcare products Regulatory Agency, UK)

 Context: Dr Boitumelo Semete provided context to the regulatory environment in SA and the urgent need for new TB vaccines, to frame the discussion:
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    In SA, TB vaccines for adults and adolescents remain an unmet medical need. Applications for clinical trials and registration of the vaccines are expedited with a dedicated review team

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    Important considerations for regulatory review include Good Manufacturing Practices (GMP) [28] compliance (especially for a vaccine utilizing new antigens or manufacturing processes); clearly defined clinical endpoints, including the rationale for selection of PoI or PoD; the safety of the vaccine, including in PLHIV; immunogenicity; duration of protection; inclusion of adult cohorts that had received the BCG vaccine as children; pharmacovigilance (including for vaccine induced enhanced disease); benefit-risk assessment; effectiveness studies in the context of the country programs; and post marketing surveillance;

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    It would be helpful if attributes from the list above were included in the ECVP for the TB vaccine test case;

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    There is considerable information, including on safety, that has been generated on novel vaccine platforms used for COVID-19 vaccines. This will help regulators to expedite approval of clinical studies with TB vaccine candidates based on these novel platforms;

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    CMA is considerations that could perhaps be discussed for initial licensure of TB vaccines, as these vaccines would address a high unmet need in various parts of the world

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    The EU-M4all [29] (EU-Medicines for all), previously known as the Article 58 procedure, could also possibly be used to support the WHO review process and to expedite the potential prequalification of vaccines to be used in LMICs

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    Joint discussions between regulators, policy makers and other stakeholders are necessary to define the ECVP criteria and ensure a streamlined and predictable way forward for vaccine development and implementation.

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    The ECVP needs to be a living document and would need to be updated if there is significant evidence to support the change (e.g. the disease landscape might change in countries)
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    Early engagement of the regulators with the vaccine developers will help ensure that the developers are aware of the minimum requirements for a vaccine to be authorized and help align expectations. This has proven to be essential for COVID-19 vaccines;

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    There are precedents for joint discussions between regulators and policy makers with the EMA having initiated a pilot project in 2008 that allows vaccine manufacturers to receive simultaneous feedback from the European Union (EU) regulators and Health Technology Assessment bodies (HTABs) on their development plans for medicines. [30] Similar initiatives have also been put in place in a number of individual countries;

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    Harmonization of regulatory requirements enables efficiency and reduces the cost of the development process, ability to use reliance models for authorisation, enables joint reviews and vaccines being available in other countries without having to go through the full regulatory review processes [28];

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    The review process is expedited as regulators can rely on clinical trials conducted in other countries
Country and Regional level representativesThis panel included:
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    TB vaccine researchers (Prof. Shabir Mahdi, Wits University)

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    RITAG chairs (Dr Chris Morgan, WHO Western Pacific Region)

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    WHO Regional TB advisors (Dr Askar Yedilbayev, WHO European Region)

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    Representative from a TB civil society organization (Mike Frick, Treatment Action Group)

 Context: Prof. Shabir Mahdi opened this round table by describing the policy decision making process in South Africa, with respect to new TB vaccines:
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    SA is an upper middle-income country (UMIC) with concomitant HIV and tuberculosis epidemics. TB remains the leading cause of death among PLHIV;

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    There is considerable political commitment from the SA government to address TB, including having a Directorate focussed on TB in the Department of Health;

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    It will be necessary to demonstrate vaccine effectiveness in the target population of adolescents and adults. PLHIV are a critically important subpopulation;

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    This environment places the country in a very favourable position to first licence and implement new TB vaccines. As an UMIC, SA would procure and deploy the vaccine on their own.

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    The vaccine regimen (number of doses required/fully immunized person), duration of protection and the vaccine cost effectiveness would be important considerations;

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    Regarding vaccine implementation strategy for adolescents, it might be possible to leverage the school-based human papillomavirus (HPV) vaccination platform, although this is specifically targeted to young girls in some countries;

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    It will be necessary undertake implementation research in parallel with the efficacy trials, to ensure that the vaccine can be effectively provided to the priority populations;

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    Community engagement on how best to deliver and create demand for vaccines is crucial;

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    Policy and implementation priorities for TB vaccines will differ between high burden countries and settings where TB incidence is comparatively low.
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    ECVP’s will help clarify the role that a vaccine will play in disease control strategies, in complementing other interventions for that disease, that acknowledges the vaccines particular characteristics (for example: disease sparing compared with transmission reduction);

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    A ECVP can help flag aspects of the vaccine’s cost-effectiveness, programmatic suitability, service delivery platforms, and other implementation considerations, including the potential for co-administration with other vaccines;

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    National and regional engagement will be enabled to start considerably earlier than the usual process to develop WHO policy recommendations and prequalification, so that the vaccine’s attributes are aligned with programmatic needs and the vaccine can be included in the budget of the National TB programs;

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    Assessment of how the vaccine is expected to fit within existing regional and national TB disease prevention strategies, programs, and models of care is important at the midpoint of the ECVP development process, to ensure coherence with existing guidance on TB control measures, and to think beyond mass campaigns alone to integrate vaccines into existing health systems in a routine and sustained manner;

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    Given the different policy-making criteria between countries, it will be important to tailor recommendations within the ECVP process by setting. However, it is likely that there will be generic principles that can be included in the TB vaccine-specific ECVP, regarding common categories of policy or implementation evidence that are relevant, and in relation to the stage at which different stakeholders need to be engaged
Donor and Procurement agenciesThe panel included representatives from:
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    BMGF (Dr Ann Ginsberg)

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    EDCTP (Dr Pauline Beattie)

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    UNICEF (Yalda Momeni)

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    UNITAID (Dr Draurio Barreira)
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    Ensuring adequate and affordable vaccine supply and equitable access in LMICs could be encouraged by having more than one vaccine on the market with programmatic suitability;

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    The development of a healthy market driven by visibility and certainty of demand in LMICs;

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    Require early visibility on disease “hotspots” and priority countries, as well as harmonized regulatory requirements across all countries
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    ECVP could play a pivotal role in the market shaping, that is required in parallel to Phase 3 trials, for strategic procurement planning, and accelerating the timelines of vaccine introduction in LMICs

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    By providing clarity on expectations for data, the ECVP will enable better informed engagement with vaccine manufacturers, and will provide increased visibility on elements of market shaping strategy, e.g. through UNICEF's vaccine industry consultation mechanism [31]

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    Could support in planning activities and increasing collaboration between donor agencies e.g. to help support Phase 3 and implementation research for vaccines for priority diseases in LMICs

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    ECVP could support manufacturers advance preparation and planning for registration, focusing on priority countries.

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    By harmonizing regulatory requirements and streamlining the process, manufacturers would have visibility and clarity on the process, largely contributing to time and cost effectiveness.