PPC -2017 -Mtg -03 1




G avi Alliance Programme and Policy Committee Meeting
26 -27 October 2017
Gavi Alliance Offices, Geneva, Switzerland


1. Chair?s report

1.1 Finding a quorum of members present, the meeting commenced at 09. 00
Geneva time on 26 October 2 017 . Richard Sezibera, Programme and Policy
Committee ( PPC ) Chair, chaired the meeting .

1.2 The Chair welcomed participants and in particular the new PPC member , Adar
Poonaw alla.

1.3 The Chair noted that An Vermeersch was joining this meeting as an observer,
pending her formal appointment by the Board as a PPC member to represent the
IFPMA constituency. She would not be taking part in the discussions as Lindsey
Dietschi continued to formally represent the constituency until the end of the
year.

1.4 The Chair informed participants that he had exceptionall y agreed, at the request
of Gavi?s Australian Board member, to allow Sue Graves to observe the meeting
on his behalf. He had also agreed at the request of Jean -Marie Okwo -Bele, who
would be retiring shortly from his position at WHO, to enable Diana Chang B lanc
to accompany him to this meeting as an observer.

1.5 Finally, he indicated that Bernhard Schw ?rtlander and Michel Zaffran from WHO
would join for the session on Polio Transition Planning, along with Mike
McGovern, Chair of the Rotary International Polio Plus Committee and Chair of
the GPEI Transition Management Group (TMG).

1.6 Standing declarations of interest were tabled to the Committee ( Doc 01a in the
Committee pack).

1.7 The minutes of the 11 -12 May 2017 meeting were tabled to the Committee for
information (Doc 01b in the Committee pack). The minutes had been circulated
and approved by no -objection on 28 July 2017 . He also referred to a
recommendation which had been approved by the PPC by unanimous consent
on 2 June 2017 (Doc 01c in the Committee pack).

1.8 The Chair referred to the PPC workplan (Doc 01 d) and the Action Sheet
(Doc 01e). He reminded Committee members t hat they may contribute to the
workplan by raising issues with either himself or the Secretariat. He noted that
Minutes

PPC -2017 -Mtg -04 1




G avi Alliance Programme and Policy Committee Meeting
8 November 2017
Teleconference


1. Declarations of Interest

1.1 Finding a quorum of members present, the meeting commenced at 15.33 Geneva
time on 8 November 2017 . Richard Sezibera, Programme and Policy Committee
(PPC ) Chair, chaired the meeting .

1.2 Standing declarations of interest were tabled to the Committee ( Doc 01 in the
Committee pack).

------

2. Nigeria ? Proposed Principles of Engagement

2.1 Seth Berkley, CEO, introduced this item , recalling that at the PPC meeting on
26 -27 October 2017 the PPC had agreed on a recommendation to submit to the
Board at its meeting in November but had asked to have a further discussion on
the proposed principles of engagement with Nigeria in advance of the Board
meeting.

2.2 He also recalled that the PPC had agreed that the Board would have a discussion
in closed session on other param eters that would enable t he Secretariat to work
with Alliance partners and other stakeholders to bring back a fully developed
transition plan to the PPC in May and subsequently the Board for approval in June
2018. Such parameters would include information on the proposed timelines for
the transition plan as well as the financial parameters.

Discussion

? PPC members agreed that the proposed principles were not intended to be too
detailed but to remain quite broad to enable the Secretariat to work with Alliance
Partners on a framework to guide discussions with the Governance of Nigeria
towards the development of a transition plan .

? PPC members noted that it would be important for the Board to record that what
is being proposed for Nigeria is exceptional, taking into account also that the PPC
recommendation to the Board already foresee s that certain policy flexibilities could
be consi dered as part of the transition plan.

? PPC members noted that it is at that time that indicators for monitoring the
implementation of the plan would also be presented and that it would be important
Minutes

.......
Gavi Alliance
Board and Committee Decisions
2015

PPC -201 7-UC -01








G avi Alliance Programme and Policy Committee Decision
2 June 2017







1. Review of PPC Charter

In accordance with article 2.7.3 and 4.8 of the By -Laws, on a unanimous consent basis
the Gavi Alliance Programme and Policy Committee recommended to the Gavi Alliance
Governance Committee that it:

Request the Gavi Alliance Board to approve the revised and updated Committee Charter
for the Programme and Policy Committee .






Mrs Joanne Goetz
Secretary to the Committee















Minutes

Gavi Alliance Programme and Policy Committee Meeting
2-3 May 2018
Gavi Alliance Offices, Geneva, Switzerland


1. Chair?s report

1.1 Finding a quorum of members present, the meeting commenced at 08 .33 Geneva
time on 2 May 2018 . Richard Sezibera, Programme and Policy Committee ( PPC )
Chair, chaired the meeting .

1.2 The Chair welcomed participants and in particular new PPC member s Ahmed
Abdallah, Vandana Gurnani, Kate O?Brien, Michael Kent Ranson , Princess
Nothema Simelela and An Vermeersch .

1.3 The Chair noted that in the absence of Jason Lane, Danny Graymore , Board
member for the UK/Qatar constituency, was join ing the meeting for the first day.
He would be welcome to take part in the discussions but as an observer would not
be in a position to take part in the decision -making processes .

1.4 The Chair informed participants that Tania Cernuschi from WHO would be joining
for the session on Middle I ncome Countries : Situational Analysis and Dan Walter
and Diana Chang -Blanc from WHO would be joining for the session on Gavi?s
Engagement in P olio Eradication.

1.5 The Chair referred to the survey which PPC members are invited to complete after
each m eeting . He noted some of the feedback from the meeting in October 2017 ,
which was generally positive . He also noted that , in his assessment, the
Committee was now in position to focus more on interactions between the
Committee members themselves and between the Committee and the S ecretariat
going forward. The aim of the assessments is to make the work of the Committee
and ultimately the Board, more efficient and effective.

1.6 Standing declarations of interest were tabled to the Committe e ( Doc 01a in the
Committee pack). It was recorded, in the context of the discussion to take place in
relation to IFFIm and CEPI, that Helen Rees is Chair of the CEPI Scientific Board.

1.7 The minutes of the joint meeting with the EAC on 25 October 2017 and the PPC
meeting s of 26 -27 October 2017 and 8 November 2017 were tabled to the
Committee for information (Doc 01b , 01c and 01d in the Committee pack). The
minutes had been circulated and approved by no -objection on 7 and 8 February
2018 .

1.8 The Chair referred to the PPC workplan (Doc 01 e) and the Action Sheet
(Doc 01f). He reminded Committee members that they may contribute to the
workplan by raising issues with either himself or the Secretariat.
Minutes

PPC -2018 -Mtg -03 1




Gavi Alliance Programme and Policy Committee Meeting
18 -19 October 2018
Gavi Alliance Offices, Geneva, Switzerland


1. Chair?s report

1.1 Finding a quorum of members present, the meeting commenced at 09.05 Geneva
time on 18 October 2018 . Richard Sezibera, Programme and Policy Committee
(PPC ) Chair, chaired the meeting.

1.2 The Chair welcomed participants and noted that as he had to leave the m eeting
at the end of the first day to return to Rwanda to attend to important matters of the
state he had requested the Secretariat to the review the order of items to be
discussed at the meeting, as per the revised agenda share d with PPC members
the eveni ng before . He also informed PPC members that he had asked Kate
O?Brien to chair the meeting in his absence, which she had kindly agreed to do as
such short notice.

1.3 The Chair noted that Helen Rees was joining the meeting by phone. He also noted
that in the absence of Jason Lane, Danny Graymore , Board member for the
UK/Qatar constituency, was join ing the meeting in person, as was Irene Koek
Board member for the US/Australia/Japan/South Korea constituency, in the
absence of Susan McKinney . The Chair wel comed both Board members to take
part in the discussions but noted that as observer s, they would not be in a position
to take part in the decision -making processes.

1.4 The Chair informed participants that Sylvie Brian d from WHO would be joining for
the sessi on on Gavi Support for Yellow Fever Diagnostic Capacity and Michel
Zaffran from GPEI would be joining for the session on Gavi?s Support for IPV post
2020.

1.5 The Chair also informed participants that Dr. Ngozi Okonjo -Iweala , Gavi Board
Chair, would be joini ng the meeting by phone for the afternoon of the second day.

1.6 The Chair referred to the survey which PPC members are invited to complete after
each meeting. He noted that comments from the survey after the May PPC
meeting were generally positive. He also noted that, in response to a request from
the PPC, the questionnaire this time will focus more on interactions between the
Committee members themselves and between the Committee and the Secretariat.

1.7 Standing declarations of interest wer e tabled to the Committee (Doc 01a in the
Committee pack).
Minutes

Gavi

Re port to the Board

Annex A: Update on the i mplementation of the Policy on Fragility,
Emergencies and Refugees
1. The Policy on Fragility, Emergencies and Refugees (approved by the Board
in June 2017) outlines the principles guiding Gavi's approach in countri es
facing fragility challenges/ emergencies, or hosting refugees and enables
Gavi to offer greater flexibility and tailored support to better meet these
countries? specific needs. The Secretariat de veloped an internal Operational
Guideline (OG) ( Appendix 6 to the October 2017 Alliance update on Country
Programmes ) to guide Country Programmes staff to identify needs in these
countries and to follow the appropriate process for approving flexibilities
under the policy.
2. An overview of the decision making process and the approval authority for
granting flexibilities is included in the OG. Stakeholders 1 dealing with
immunisation in emergencies and for refugees reviewed the draft OG and
suggested that in so me time -constrained circumstances a leaner review and
recommendation process may be required to ensure a timely decision by
the CEO on certain flexibilities. Notably, when a faster and simplified
process is warranted the Managing Director, Country Programm es, in
consultation with the Alliance Coordination Team, would make a
recommendation to the CEO. In addition, the procedure for approval of
additional no -cost extensions is consistent with what has already been
detailed in a separate Secretariat OG. 2 Addit ional no -cost extensions are
considered during the quarterly regional review group meetings, chaired by
the Managing Director, Country Programmes.
3. Internal and external stakeholders have been consulted in the development
of the OG including relevant Secret ariat teams, Alliance partners, and the
Gavi CSO Constituency. The OG also describes how to track flexibilities at
the Secretariat level for monitoring and evaluating the implementation of the
policy. Examples of recently approved flexibilities include:
a) In May 2017 UNICEF in Rwanda requested vaccines to cover
approximately 3000 refugees from Burundi. Gavi will provide support for
PCV, Penta, Rota, MR and syringes , with UNICEF or UNHCR
potentially meeting the associ ated co -financing requirements.
b) In 2016 Uganda received an unprecedented influx of almost one million
refugees from South Sudan. In May 2017 the Ugandan EPI, together
with UNICEF, requested support for an immunisation campaign
targeting refugee children up to the age of 5 (PCV , Penta and Measle s
-2nd dose) and for additional doses for routine immunisation of refugees
to be added to the country?s 2018 Annual Vaccine Renewals request.
In -country partners during the Joint Appraisal in July 2017 agreed on
the importance of this undertaking and UNICE F has committed to share
the costs of the vaccines. Gavi has agreed to grant support for additional
doses (routine and campaign) targeting the refugee children.

1 Including relevant Secretariat teams, Alliance partners, and the Gavi CSO Constituency 2 OG on Reprogramming, Reallocation and No -cost Extension

1



Board -2017 -Mtg -3-Doc 12

Section A: Introduction
? The Vaccine Investment Strategy ( VIS ) is Gavi?s bespoke prioritisation
approach for new investments in vaccines. It is developed every five years
to inform Gavi?s strategic and funding cycle. Twice before, Gavi has
developed a VIS and as a result added ne w vaccines to its portfolio and
committed to other types of vaccine investments .1
? The VIS 2018 ha s three phases: 1) development of an evaluation approach
for v accines for endemic disease prevention through routine immunisation
(for decision at this meeting ); 2) narrow ing of these candidates to a shortlist ,
and development of an evaluation approach for vaccine investments for
epidemic response ; (for Board decision in June 2018 ); 3) final
recommendations including details on the scope and nature of Gavi?s
investment (for decision at the end of 2018).
? A Steering Committee (SC) 2 provides scientific and technical input into the
VIS process. The SC met on 11 -12 September 2017 (meeting summary in
Appendix 5) and provided guidance on the overall VIS methodology, the list
of candidates and the evaluation approach as described below.
Section B: Vaccine Investment Strategy: methodology
Stakeholder consultations
1.1 The Secretariat conducted initial consultations with Gavi Board members
and via a survey to Alliance stakehold ers (160 responses) . S ummary
findings from these consultations are in A ppendix 2. Questions focused on
the relative importance of different types of vaccine investment s (e.g.
routine immunisation versus outbreak response), strategic consideration of
specif ic development objectives (e.g. global health security) , evaluat ion

1 In 2008, Gavi?s Board prioritised Japanese encephalitis (JE), rubella, HPV and typhoid conjugate
vaccines. In 2013, Gavi?s Board made investment decisions for three vaccines: expanded yellow
fever campaigns; support for a global stockpile of oral cholera vaccine, including the opportunity to
generate impact data; and investment in a ?learning agenda? for rabies vaccine. The Board
requested monitoring of new data on maternal influenza vaccine impact and a re -assessment of
the RTS,S malaria vaccine once it h ad been recommended for use by SAGE, and subsequently in
2015 approved funding for implementation pilots conducted by WHO. 2 List of members in Appendix 4
SUBJECT : VACCINE INVESTMENT STRATEGY: METHODOLOGY
Agenda item: 12
Category: For Decision
Report to the Board
29 -30 November 2017

Gavi

Report to the Board
Annex C : Criteria for vaccines for endemic disease prevention through routine immunisation

Annex C : Criteria for vaccines for endemic disease prevention through routine
immunisation
Criteria Draft indicators (to be further developed)
Ranking criteria

Health impact
Total future deaths averted 2020 -2035, and per 100,000
vaccinated
Total future cases averted 2020 -2035, and per 100,000
vaccinated
Economic impact Financial risk protection (e.g. cases of poverty or catastrophic
health expenditure averted)
Equity and social
protection impact
Disproportionate impact of disease on vulnerable groups, e.g.,
rural poor, urban slum residents, internally displaced populations
Special benefits of vaccination for women and girls
Potential to increase geographical equity in Ga vi support
(between countries/regions)
Global health
security impact
Epidemic potential of disease
Impact of antimicrobial resistance (AMR) on disease treatment
and impact of vaccination on antimicrobial use
Value for money Vaccine procurement cost per death averted
Vaccine procurement cost per case averted
Secondary criteria

Other impact
Total U5 deaths averted 2020 -2035, and per 100,000 vaccinated
Total DALYs averted 2020 -2035, and per 100,000 vaccinated
Vaccine procurement cost per DALY averted
Gavi comparative
advantage
Degree of vaccine market challenges / Gavi market shaping need
Potential for catalytic effect from Gavi investment
Broader health
systems benefits Fit with prioritised immunisation delivery platforms
Implementation
feasibility
Ease of supply chain integration
Need for health care worker behaviour change
Feasibility of vaccination time point
Need for demand promotion (e.g., acceptability, understanding of
disease burden)
Long -term fiscal space implications
Alternate
interventions
Optimal use of current and future alternative interventions
(prevention and treatment)
Cost

Vaccine cost Total procurement cost to Gavi and countries, 2020 -2035
Operational cost Incremental in -country operational costs per vaccinated person
Additional
implementation
costs
Additional costs for introduction, monitoring, etc. (e.g.
surveillance costs; training costs; partner or technical assistance
costs)

Excerpt from PPC paper section 4 (sections 4.2 -4.4) as relevant to the criteria in
proposed decision):
The proposed criteria reflect alignment with Gavi?s mission, strategic and global
priorities identified in consultations, lessons learned in the 2013 VIS, additional
analyses on measures of value and impact (e.g., economic impact and global health
security), and SC guidance. T he table includes preliminary indicators to illustrate

1 1

Annex B: VIS candidates

Annex B : VIS candidates
Category Candidate Likely Vaccination Strategy Licensure Status
Vaccines for endemic disease prevention

through routine immunisation

Diphtheria Routine Diphtheria -containing
Booster Licensed
Tetanus Routine Tetanus Toxoid -
containing Booster Licensed
Pertussis Routine Pertussis -containing
Booster Licensed
Hepatitis B Birth Dose Licensed
Oral cholera vaccine Preventive Campaigns in
Endemic Settings Licensed
Meningitis C, Y, W, X Multivalent Conjugate Vaccines
in Routine & Campaigns Licensed
Hepatitis E Campaigns in Humanitarian
Settings Licensed
Hepatitis A Routine Immunisation Licensed
Dengue Routine Immunisation Licensed
Influenza Routine Maternal Immunisation Licensed
RSV Routine Maternal Immunisation Under Development
(Phase 3)
RSV mAb Prophylactic Neonatal Use in
High -risk Populations Licensed
Rabies Post -exposure Prophylaxis Licensed
Rabies Ig/mAb Post -exposure Prophylaxis Licensed (mAb in
development)
Malaria (RTS,S) Implementation Pilot Phase 2;
Future Routine Use
Licensed
(Implementation
pilots)
Vaccine investments
for epidemic preparedness
Chikungunya Outbreak Response Under Development
(Phase 2)
Zika virus Outbreak Response Under Development
(Phase 2)
Ebola Outbreak Response Under Development
(Phase 3)
Influenza Pandemic Response Licensed
IPV
IPV post -eradication Routine Immunisation Licensed

1 1
Report to the Board
Annex A: Implications/Anticipated impact

Annex es

Annex A : Implications/Anticipated impact
? Risk implication and mitigation . There is some uncertainty regarding data
availability for a number of the candidates, such as around disease burden,
licensure timelines or a clear vaccination policy. The Secretariat will consult with
relevant experts to ensure that analyses are informe d by latest evidence. Outputs
of these analyses will include clear explanations of any drivers of uncertainty. Risks
related to specific VIS investment recommendations will be reflected in future
papers.
? Impact on countries . Impact in Gavi countries is a key criterion in deciding on new
vaccines. All vaccines under consideration have potential for public health impact
in Gavi countries. The evaluation criteria also include indicators around
implementation feasibility, to capture the potential additional ne eds or challenges
that new vaccines with novel delivery strategies might pose in countries. If the
menu is expanded, financial sustainability considerations will be even more critical
for country decisions to access support for a new vaccine.
? Impact on A lliance . The VIS is an Alliance -wide process with significant
stakeholder engagement. This will include extensive consultations with Board
members and technical stakeholders from across the Alliance. VIS
recommendations will consider roles and responsibili ties of Allliance partners in the
implementation of new programmes.
? Legal and governance implications . There are no legal implications with respect
to the recommendations presented in this report.