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Board -2022 -Mtg -03-Doc 08
Report to the Board
7-8 December 2022

Subject Gavi ?s Role in Regional and African Vaccine Manufacturing
Agenda item 08
Category For Decision
Section A : Executive Summary
Context
The COVID -19 pandemic demonstrated that vaccine supply security varies by region
and impacts vaccine equity. Limited regional manufacturing capacity, particularly in
Africa, may have contributed to delays in progressing towards equitable access of
COVID -19 va ccines. This renewed commitment at the highest levels of government s
to establish industrial capacities on the continent for both pandemic response and
routine immunisation. The African Union (AU) set out a bold agenda to develop
sustainable local vaccine manufacturing , supported by the European Union (EU), G7,
G20 and international partners. 20 years ? experience in vaccine market shaping,
pooled procurement and design of innovative financial instruments position Gavi w ell
to support the down stream elements of this vision (e.g. via strategically curated
product portfolios ), whilst preserving and, wherever possible, enhancing global market
health for vaccine markets . In June 2022, Gavi?s Board requested that the Alliance
align behind African manufacturing as supportive of pandemic preparedness and
response (PP R) in the context of the Gavi 5.1 strategy. Over the past six months, Gavi
has led ex tensive consultations, including with AU counterparts and the Board , to
develop the four -Pillar strategy described in this paper.
Questions this paper addresses
As interventions are required across the value chain, where should Gavi focus? How
can Gavi help new African market entrants find a pathway to sustainability, whilst
preserving market health? How can Gavi?s processes be adapted to make it easier for
African/regional products to be selected? H ow can Gavi anticipate & manage expected
high initial costs from new entrants, and the risk of price increases (or mar ket exits) by
incumbent supplier s? How can Gavi work with other partners to provide indications of
future demand to manufacturers, whilst respecting its country -led mode l? How could
a new financial instrument best incentivise new manufacturers & investors in Africa ?
Conclusions
Gavi should use its comparative advantage to focus on a downstream approach that
offers clear incentives and a path to commercial viability to partners and investors
operating upstream. This approach has four Pillars: 1) advisory support for antigen &
plat form selection; 2) evolution of Gavi?s market shaping principles; 3) seeking
demand assurances; 4) a new financi al instrument for Africa . The Pillars are designed
to work in synergy as a coherent ?bundle? of interventions, with Pillar 4 lending
significant ly more leverage to Pillars 1 -3 than if Gavi were to deploy 1 -3 only.

Board - 2022 - Mtg - 03 - Doc 09 - Annex A Report to the Board
7 - 8 December 2022
Annex A : COVAX Reporting Framework
Section A: Update on Gavi?s COVAX Facility and COVAX AMC Monitoring,
Evaluation and Learning (MEL) strategy
The table below provides some of the key highlights and updates on progress against
the core elements of Gavi?s COVAX Facility and COVAX AMC MEL Strategy since the
June 2022 Gavi Board.
MEL
strategy
component Key activity Highlights / update ( October 2022 )
Cross -
cutting COVAX Theory
of Change Modest updates to vision and objectives for
2022 made mid - year, in alignment to broader
COVAX Pillar updates. Discussions on updates
for 2023 ongoing.
Monitoring COVAX
Reporting
Framework Reporting against COVAX Reporting
Framework made available for PPC and Board.
Some modest refinements made to 2022
COVAX Reporting Framework (see below)
since June 2022 Board meeting .
Complementar
y monitoring to
COVAX
Reporting
Framework COVAX Facility, Gavi Secretariat teams and
core COVAX partners continue to monitor
aspects of the Facility and AMC to a much
greater extent beyond the metrics currently
captured in the topline Reporting Framework.
Examples include:
? COVID19 Vaccine Deliver y Partnership
outputs focusing on absorption rates , delivery
financing and other key delivery metrics;
? Monitoring of progress across subgrants
funded through COVID19 Delivery Support;
? Other operational metrics and analyses
across supply, allocation, deliveries and in -
country implementation gathered internally.
Core country
monitoring and
reporting on
COVID - 19 /
COVAX COVAX continues to utilise the WHO - UNICEF
electronic Joint Reporting Form COVID - 19
module (monthly reporting) launched in March
2021 to gather core reporting from COVAX
participants. Despite improvements over time,
reporting completeness continues to be an
issue. Concerted efforts are underway with
Pillar partners to improve reporting on priority
population groups in particular.
Recipients of COVID - 19 Delivery Support
grants are expected to report back on a six -
monthly basis to Gavi.

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Board -2022 -Mtg -03-Doc 09
Report to the Board
7-8 December 2022

Section A: Executive Summary
Context
Emerging variants and evolution of the COVID -19 pandemic, new vaccine products,
and evolving policy guidance exemplify the continued volatility and uncertainty
surrounding the pandemic. In June 2022, the Board agreed that Gavi continue
admini strating the COVAX Facility in 2023, delegated authority to the CEO to adapt
programmes based on updated World Health Organization (WHO) Strategic Advisory
Group of Experts on Immunization (SAGE) recommendations and approved limited
provision of donated pa ediatrics doses. In line with these decisions and as participants
work toward their own coverage ambitions, COVAX will continue to support AMC
participants? vaccine demand with an increased emphasis on higher -risk groups,
including as new appropriate and r ecommended products enter the market, such as
variant -containing vaccines.
COVAX?s 2023 strategy will bridge to the Gavi 5.1 COVID -19 vaccine investment
approach that would begin in 2024 and is focused on ongoing protection of higher
priority population groups, pending Board approval in December 2022 (D oc 10 ) and
Board approval o f the financial envelope in June 2023. COVAX will also use 2023 to
transition its operating model from one of leading an emergency response to a
programme utilising existing Alliance processes. Some established elements of the
COVAX model will continue in 2023 including retaining the capacity to respond to the
WHO worst -case scenario through the Pandemic Vaccine Pool, while some
components will evolve, such as COVID -19 vaccine delivery support and the
sunsetting of the Humanitarian Buffer, with humanitarian access continuing to be
provided via other means.
Questions this paper addresses
? What progress has COVAX made in 2022 in supporting AMC participants achieve
their COVID -19 vaccination goals?
? What is the state of supply and demand and what are the projections for 2023?
? How does COVAX plan to keep its vaccine portfolio ?fit for purpose ? in 2023,
especially in light of variant -containing vaccines?
? How will COVAX adjust specific initiatives in preparation for the shift from
emergency response to a programme that uses existing Alliance processes?

Subject COVAX : Key Strategic Issues
Agenda item 09
Category For Information

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Board -2022 -Mtg -03 -Doc 10 -Annex A
Report to the Board
7-8 December 2022
Annex A: Impact Modelling
In order to inform Gavi governance deliberations on potential future support for
COVID -19 vaccination in 2024 -2025, the Gavi Secretariat commissioned Imperial
College, London , to generate estimates of the potential impact of COVID -19
vaccination over 2024 -2025 based on several different epidemiological and
programmatic scenarios. As such, this annex leads with their analyses and initial
estimates. We were subsequently able to bring in outputs generated by t he Institute
for Disease Modelling (IDM) from the Bill & Melin da Gates Foundation as a partial
comparator in part to address model uncertainty (noting that their work is based on a
set of similar scenarios and assumptions to Imperial?s, but not an exact match) .
The primary outputs sought from these modelling efforts included cases,
hospitalisations, deaths, years of life lost (YLL) averted as well as cost -effectiveness.
Given th at much of the disease burden is in the elderly, it would be beneficial to
compare DALYs for C OVID -19 vaccines versus other vaccines. Unfortunately , this
was unable to be done given the uncertainties. Instead, YLL was used, which
constitutes the largest po rtion of the DALY s los t. For more details on the specific
scenarios, assumptions and limitations across both Imperial and IDM?s work, technical
summaries have been made available as appendices on Board Effect.
Topline summary based on modelled outputs from Imperial and IDM
Initia l results from both Imperial and IDM suggest the following:
? Modelled estimates from both Imperial and IDM broadly support the proposed
COVID -19 programme in 2024 -2025 being brought for discussion to the Gavi PPC
and Board (yearly boosting of high/highest p riority groups) as laid out in Doc 10 .
Continuing COVID -19 vaccination in 2024 -2025 has benefits, but the overall
expected health impact is lower than that seen earlier in the pandemic.

? Initial projections for the proposed 2024 -2025 programme show deaths averted
ranges comparable to the current Gavi core routine immuni sation portfolio (albeit
on the lower end). However, after incorporating costs , the proposed programme
appears to compare relatively less favourabl y from a value -for -money perspective
than Gavi core supported vaccine programmes.

? While expanding the vaccination programme to include broader population groups
such as all adults, adolescents and children results in greater total health impacts,
it is less efficient in tha t the expected cases and deaths averted per fully vaccinated
person declines when including younger age groups in the program.

? Results are highly sensitiv e across several key uncertainties including:
- Epidemiological evolution
- Assumptions around waning i mmunity and affinity maturation
- Vaccine efficacy assumptions across different vaccine products
- Coverage levels assumed at end of 2023 and for 2024 and 2025
- Cost (both procurement and delivery)

Board -2022 -Mtg -03 -Doc 10 -Annex B 1
Report to the Board
7-8 December 2022

Annex B: Looking Ahead and Uncertainties
There are several uncertainties against which we are planning for a future COVID -19
programme and which will influence how the programme will evolve, including:
? Demand: Our ability to predict future demand for the proposed programme is
limited, with several factors impacting countries? abilities to plan, develop, and
execute long -term immunisation plans. The Secretariat is consulting countries to
better understand their appetite for a future COVID -19 vaccine programme. While
there are indications that some countries are eager to begin a COVID -19
programme - and some have already begun integrating COVID -19 vaccines into
their health systems - global demand has waned over 2022 as the world has shifted
out of the acute phase of the pandemic. The Secretariat has used primary vaccine
coverage projections to estimate demand for a future COVID -19 programme
starting in 2024. However, a better understanding of the demand for a COVID -19
programme will emerge from the det ailed Alliance wide demand planning process
in 2023, and the Secretariat will share updated demand projections at the June
2023 Board meetin g.
? Vaccine Products : Depending on the evolution of the virus, it is unclear whether
the current vaccine products wi ll continue to be effective or that manufacturers will
continue to manufacture them. Further evolution of products and implications on
efficacy (including against transmission), durability, required frequency of
boosters, and programmatic feasibility are a lso uncertain.
? Epidemiology of the virus : Although this programme is designed for the WHO?s
current base -case scenario, there is potential for new variants to emerge that could
be more severe or more immune -escaping against current vaccines. Variants
cou ld affect population groups differently, which could impact which demographics
and population cohorts are prioritised for vaccination by SAGE, including the
potential inclusion of different VCVs. Historically, surges have not followed
predictable patterns or seasonality, making planning difficult.
? Impact : Estimating public health impacts for potential future support is challenging
given the number of variables, assumptions and uncertainties involved. Modelled
estimates are highly sensitive and as such, shou ld be considered with appropriate
caution in view of key evidence gaps that exist. As more evidence is generated in
the coming months, for example on vaccine efficacy, these estimates are likely to
change. The Secretariat will continue to engage impact mod elling groups to
generate updates as needed.
? Non -vaccine tools : As COVID -19 becomes endemic, the potential market for new
therapeutics to treat or prevent the symptoms is expected to grow and with it,
industry investment in innovative therapies. If effort s are taken to make these
accessible and affordable, it is possible that the opportunity cost for a country to

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Board -2022 -Mtg -03 -Doc 10 -Annex C
Report to the Board
7-8 December 2022
Annex C: Modelling Assumptions
Number of doses per year: The Secretariat is basing calculations for the COVID -19
vaccine programme on one booster dose per year based on the assumption that future
vaccines will give more durable protection , limiting the need for more frequent
vaccination. It is also possible that by 2024 most people globally will have either been
infected with COVID -19 at some point and/ or been vaccinated, and this hybrid
immunity will result in one dose per year being sufficient.
Coverage and demand : The programme should aim to support countries to reach
ambitious targets yet be based on realistic assumptions of coverage. We consid ered
comparable rates of coverage to use as proxies for what we may expect for the
COVID -19 context. Alliance demand planning groups project overall primary coverage
in the AMC 91 to be between 40 and 65 percent by end -2023. A drop off from primary
to boos ter coverage has been assumed using HIC data (~18 percent drop off). The
model, therefore, assumes we can expect countries? additional dose coverage rates
to be somewhere between 35 and 55 percent for the proposed programme.
Procurement cost per dose : Sev eral factors will determine the procurement cost per
dose. For the cost factored into this model, we assume that manufacturing will
continue on an ongoing basis, and therefore there will be predictable supply from a
diverse range of suppliers. Current vacc ine technologies will continue to be used, and
fit-for -purpose vaccines, such as variant containing vaccines, will be well -matched
against circulating variant strains. As we integrate into established Alliance processes ,
we will revert to regular tendering processes through UNICEF. Actual future vaccine
prices may be influenced by volumes contracted/procured, level of competition, new
technologies, product preferences, geographic base of manufacturing networks, and
other factors.
Delivery costing : Delivery costing has been calculated with the support of the Delivery
Costing Working Group (DCWG) in September 2022. The DCWG has members from
CoVDP, UNICEF, BMGF, Harvard School of Public Health, MSH, WHO and Gavi. The
costing encompasses several compo nents, including PPE, hand hygiene, per diem for
service delivery, transportation for outreach, training, planning & coordination, social
mobilization, cold chain maintenance, waste m anagement , vax certificates,
pharmacovigilance. Costing excludes ancilla ries (syringes and safety boxes), TA and
cost of vial.

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Board -2022 -Mtg -03-Doc 05
Report to the Board
7-8 December 2022

Subject Risk and Assurance Report
Agenda item 05
Category For Decision
Section A : Executive Summary
Context
The Gavi Board has ultimate responsibility for overseeing the most significant risks of
the Alliance and related mitigation , and for agreeing on overall risk appetite. It
therefore receives an annual comprehensive Risk & Assurance Report (see Annex A).
Questions this paper addresses
The Risk & Assurance Report discusses the most critical risks that could potentially
have an impact on the ability of the Alliance to achieve its mission and strategic goals.
The report has been reviewed and recommended for approval by the Audit & Finance
Committee (AFC). The Gavi Alliance Board is requested to approve the report
attached as Annex A and to provide guidance on the questions outlined below .
Conclusions
This year?s report prioritises 18 top risks, and shows that Gavi?s overall risk profile has
changed, with seven top risks increasing and three top risks decreasing. One risk
exposure is deemed to be outside of Gavi?s risk appetite with intensive mitigation still
ongoing .
Section B : Risk and Assurance Report 202 2
1. Portfolio discussion on top risks to the Alliance
1.1 This is the 7th annual Risk & Assurance Report which discusses the most
critical risks that could potentially have an impact on the ability of the Alliance
to achieve its mission and strategic goals. The report provides an update on
risk management across the Alliance, an analysis of macro -trends affecting
Gavi?s risk profile, an overview of key changes in top risks compared to last
year, and an overview of how current levels of risk compare to Gavi?s risk
appetite ( i.e. its willingness to accept being exposed to certain risks) as per
Gavi?s Risk Appetite St atement 1 approved by the Board. Detailed information
including analysis of each top risk and corresponding mitigation is included in
the annexes. Where applicable, links are made with findings from audits,

1 See https://www.gavi.org/news/document -library/risk -appetite -statement or in French:
https://www.gavi.org/fr/actualites/librarie -de -documents/declaration -de -gavi -alliance -sur -lappetit -pour -le-risque

Board -2022 -Mtg -03-Doc 06 -Annex B 1
Report to the Board
7-8 December 2022
Annex B: Gavi ?s future role in Pandemic Preparedness and Response (PPR)

This annex outlines the evolving global health architecture related to pandemic
preparedness and response (PPR) , including Gavi?s historical involvement and
engagement through COVAX , and most recently Ebola Sudan, and provides an
overview of three areas for a potential targeted additional role for Gavi in PPR :
1) R equired capabilit ies for the next pandemic ; 2) Financial innovations ; and 3)
Resilient Routine Immuni sation programmes , with a fourth area ? supporting
African vaccine manufacturing ? presented in separate document . Th ese build
on PPC and Board guidance on Gavi?s potential role in PPR as first presented in June
2022, and refined at the July 2022 Gavi 5.1 mini -workshop, September 2022 Gavi 5.1
deep -dive consultation, and October 2022 PPC meeting. The Board is invited to
provide gui dance on Gavi?s additional future role in PPR as part of the discussion on
Gavi 5.1 .

1. Pandemic Preparedness and Response immunisation landscape

1.1 Over the past two and a half years, a range of profound societal,
geopolitical, economic and technological shifts have occurred, many as
a consequence of the COVID -19 pandemic . The pandemic has disrupted
essential health services, including routine immunis ation , and exacerbated
existing inequities in access to health and immunisation between and within
countries. At the same time, the global community has responded to the
pandemic with unprecedented investments, political attention, and engagement
that allowed new he alth interventions such as COVID -19 vaccines to be
developed and scaled in record time.

1.2 Consequently, the global health architecture has been evolving . The
pandemic required o rganisation s to leverage their comparative advantage s, but
also new structures and actors as illustrated in Figure 1. For example, the
Access to COVID -19 Tools Accelerator (ACT -A) was launched to coordinate
across vaccines, therapeutics and diagnostics. As part of ACT -A, COVAX
brought together CEPI, Gavi, UNICEF and WHO to ensure fair and equitable
access to COVID -19 vaccines. Financial and economic bodies traditionally less
focused on health such as the World Bank, IMF, G7 and G20 also increased
their engagement on the global health security agenda. New regional
collaborat ion mechanisms have been launched, such as the African Vaccine
Acquisition Trust, which aims to secure vaccine doses for African countries.
Bilateral funding and vaccine donations played an important role in the delivery
of COVID -19 vaccines. At the same t ime, the global health landscape has
become more crowded and fragmented. For example, a multitude of players
including the World Bank and multilateral development banks, Gavi, WHO,
UNICEF, AU -AVAT and bilateral donors now fund COVID -19 vaccine delivery,
wh ile other vaccines are almost exclusively supported through Gavi.

Board -2022 -Mtg -03-Doc 06 -Annex C 1
Report to the Board
7-8 December 2022
Annex C: Gavi 5.1 operationalisation and financial considerations
Th is Annex gives a high -level overview of the approach to operationalising the key
shifts in Gavi 5.1. It also includes an overview of the financial implications , in line with
financial forecast v20 (see Doc 04). More details on the operationalisation and
financial implications of the HPV programme relaunch, the COVID -19 programm e for
2024 -2025 and regional manufacturing diversification can be found in Docs 0 7, 08 and
10 .
Operationalising Gavi 5.1
? Implementing the Gavi 5.1 priorities will require acceleration and some
adjustments to Gavi?s funding levers . The Alliance will continue to
reprogramme ongoing funding to countries, accelerate the Full Portfolio
Planning (FPP) and Equity Accelerator Funding (EAF) applications to prevent
further backsliding of routine immunisation, catch up missed children and
accelerate the zero -do se agenda ( see Doc 02). If approved by the Board, p lans
for the relaunch of HPV will be included when appropriate as a priority . To
enable the timely relaunch of the HPV programme , the Secretariat will work
with countries to reallocate funding within ongoing HSS grants or approve new
funding where required (see Doc 07). This approach , coupled with concerted
efforts across the Alliance in support to countries , represents the most rapid
opportunity for countries to incorporate support to HPV into their HSS grants .
The Secretariat will closely monitor the additional investments in the HPV
relaunch and if needed go back to the PPC and the Board to ensure the
progr amme is appropriately funded. The Secretariat will continue to monitor the
use of the COVID -19 vaccine Delivery Support (CDS) and explore how CDS
could further support routine immunisation, building on the pivot initiated with
the focus of the recently launched CDS3 1 (see Doc 09). P ending the final Board
decision in June 2023, Gavi will operationalise the HSIS support for the
COVID -19 programme and implement the scale up of information systems in
WKH FRQWHxW RI *DvL?V HxSDQGHG UROH LQ 335 (see Annex B) .
? The modalities of PEF support will be adjusted to allow effective
operationalisation of Technical Assistance (TA) required in Gavi 5.1 .
Pending Board approval of the HPV relaunch , the PEF funding will be rapidly
allocated through Targeted Country Assistance (TCA) , Foundational Support
(FS) , and Strategic Focus Areas (SFAs ). These resources will be pivota l to
deliver on strategic shift 3 of the HPV relaunch programme (i.e . ?(QKDQFLQJ
technical assistance through PEF, TCA , and )6? ), and complement the current
TA support at global, country, and sub -national levels . Additional PEF funding
will be made available for the COVID -19 immunisation programme in 2024 and
2025 pending final Board approval of the programme in June 2023. The

1 CDS is increasingly being focused on integrating COVID -19 vaccination into RI, the new CDS3 envelope
launched in July (total USD 748 million) prioritises such investments into COVID -19 integration (see doc 7)

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Board -2022 -Mtg -03-Doc 06


Report to the Board
7-8 December 2022
Subject Gavi 5.1 (including Pandemic Preparedness and Response )
Agenda item 06
Category For Decision
Section A: Executive Summary
In light of the impact of the COVID -19 pandemic on global health and immunisation, the
Board , at its April 2022 retreat , asked for a renewed focus on Gavi?s 5.0 priorities and to
lay out how COVID -19 vaccination , COVAX and its learnings will come together with
Gavi?s core strategy. This is being articulated as Gavi 5.1.
Gavi 5.1 is not a new strategy but rather a natural ev olution of 5.0 ; serving as a
bridge to 6.0 and reflecting the changing context in recent years. Building on the
lessons from the pandemic, Gavi 5.1 recognises the profound societal, geopolitical,
economic and technological shifts that have transformed the environment the Alliance
operates in. It also acknowledges the new challenges to global health security posed by
the increasing number of outbreaks of vaccine preventable diseases. Gavi 5.1 was
developed through a consultative process between June and Nove mber 2022,
involving Board and Programme and Policy Committee ( PPC ) members, country
stakeholders and the Alliance.
Gavi 5.1 will continue the 5.0 focus on preventing further backsliding of routine
immunisation (RI) , catching -up missed children, and reach ing zero -dose children
and missed communities . The introduction of key Gavi -supported vaccines not yet
included in countries? national schedules will continue at pace and remain central. The
Alliance will accelerate its support to help countries optim ise their vaccine portfolio and
prioritise the most critical vaccines in an evidence -based, country -driven way. Gavi 5.1
continues to highlight the importance of improving the sustainability of immunisation
programmes and ensuring healthy markets . It will entail an evolution of the Alliance?s
role in Pandemic Preparedness and Response (PPR) , including increased support
to regional manufacturing diversification . Gavi 5.1 would also see a relaunch of the
Human Papilloma virus (HPV ) vaccine programme, a nd include a COVID -19 vaccine
programme for 2024 and 2025 depending on the evolving epidemiology of the disease .
Docs 0 8, 07, and 10 respectively describe these three latter areas in detail.
This document provides an overview of the updated Gavi 5.0 strateg ic framework
(strategy ?one pager? ) for Gavi 5.1 . The Alliance?s future contribution to PPR , cutting
across all four strategic goals is summarised in Annex B of this document . The approach
to operationalising the 5.1 strategy, and the financial implications are included in
Annex C. The Board is requested to approve the targeted updates to the strategy
?one -pager? and provide guidance on the Alliance?s future role in PPR. Of note, i t is
proposed that the 5.0 strategy indicators and targets will remain unchanged . Gavi will
monitor on an ongoing basis whether updates are needed. The Secretariat will revert to
the PPC and Board on progress in implementing Gavi 5.1 on a bi-annual basis as part
of regular progress updates on the Alliance?s strategy .

Board -2022 -Mtg -03-Doc 07 -Annex A 1
Report to the Board
7-8 December 2022
Annex A : HPV programme relaunch risks and implications
Secretariat risks/implications:
? HR: anticipated workload for the HPV programme relaunch will substantially
increase per the proposed ambition and necessary shifts, therefore budget
include s support for Secretariat and Alliance partners (for breakdown of budget
please see Annex F).
? Operation al: to facilitate iterative and adaptive implementation, grant processes
will need to be reviewed and adapted with lens of simplicity, flexibility, and agility
to allow for rapid disbursement, timely course correction and iterative
implementation , and ther efore accompanied by real -time monitoring and clear
indicators, including lessons learned, to measure and evaluate impact and inform
future investments in Gavi 6.0.
? Reputational: if there is slow HPV uptake including due to operational
complexities and fund availability , the Alliance will not reach its proposed ambition
of 86 million girls . To mitigate this, there will be close financial tracking and review
of existing processes to identify, escalate and resolve bottlenecks that may aris e.
Country risks/implications:
? Country bandwidth: countries have an increasing workload beyond their routine
programmes, including COVID -19, new vaccine introductions such as malaria,
outbreak response , and zero -dose agenda that could compromise focus on HPV
vaccination. To mitigate this risk the proposal includes consultations with countries
and HPV TCA funding to country, including support to EPI for dedicated country
coordinators ( e.g., per experience for Sierra Leone?s introduction) and allocation
fra mework which will account for programmatic readiness and competing priorities
before moving countries forwards. In the case of former Gavi -eligible countries,
dedicated support for new vaccine introductions ? including country -specific
technical assistance ? is available through the MICs Approach.
? Decision -making: Lack of a regulatory pathway to achieve licensure for 1-dose
may create inconsistency between PQ status and country decision for 1-dose
therefore challenges may occur on the decision -making pathway for 1 -dose
(e.g. National Regularity Authorities, National Immunisation Technical Advisory
Groups). This will be addressed through PEF including TCA (e.g. development of
normative guidance, simu lation models on the long -term benefit / risk and costs
implications of adopting single -dose , facilitation of NITAGs), leveraging existing
funded HPV technical bodies (e.g. HPV Vaccine Acceleration Program Partners
Initiative (HAPPI) Consortium Single -Dose HPV Vaccine Evaluation Consortium,
the Coalition to Strengthen the HPV Immunization Community (CHIC), Choice
Optimization for Immunization: Country Exercises in Sustainability (CHOICES)
projects ) and WHO /UNICEF to advise manufacturers and countries to nav igate the
regulatory implications that could arise due to the inconsistency in labelling (e.g.
leverage lessons learned from off -label IPV fractional doses recommendation).

Gavi