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Pandemic Influenza Preparedness Framework

PROGRESS REPORT
1 January 2018 – 30 June 2019

18-month report for the 2018-2019 biennium


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In no event shall WHO be liable for damages arising from its use.
INTRODUCTION

The Pandemic Influenza Preparedness (PIP) Framework is an innovative public health instrument
that brings together Member States, industry, other stakeholders and WHO to implement a global
approach to pandemic influenza preparedness and response. The key goals include: to improve and
strengthen the sharing of influenza viruses with human pandemic potential; and to increase the access
of developing countries to vaccines and other pandemic response supplies.

The Framework includes a benefit-sharing mechanism called the Partnership Contribution (PC). The
PC is collected as an annual cash contribution from influenza vaccine, diagnostic, and pharmaceutical
manufacturers that use the WHO Global Influenza Surveillance and Response System (GISRS). Funds
are allocated for: (a) pandemic preparedness capacity building; (b) response activities during the time
of a pandemic; and (c) PIP Secretariat for the management and implementation of the Framework.

For pandemic preparedness capacity building, activities are implemented according to six outputs
under one outcome in the High Level Implementation Plan (HLIP) II 2018-2023. The technical and
financial investments of countries and other partners, including GISRS, play a critical role in advancing
pandemic preparedness alongside PC investments. Collectively, resources are used to strengthen
pandemic preparedness systems, knowledge and capacities. We thank countries and partners for
their important role and contribution. The progress made and successes achieved are a result of joint
collaboration on common objectives. The PIP PC funding model is described in HLIP II, Section 6.

This report addresses the recommendation from the 2016 PIP Review that WHO develop a progress
report that presents overall success metrics and infographics to illustrate progress in PIP Framework
implementation. The report is published four times a biennium. Technical and financial implementation
for HLIP II and the PIP Secretariat are presented. Milestones are collected every six months and indicators
are collected yearly. All data are presented cumulatively from the beginning of each biennium, in this
case, 1 January 2018.

For financial implementation, progress is reported against biennial workplan allocations. Figures
presented exclude WHO Programme Support Costs (PSC) unless otherwise stated. For the mid-year
reports, income, expenditures and encumbrances are presented, and are based on WHO’s financial
tracking system (GSM). For annual reports, income and expenditures are presented, in line with the
yearly WHO Interim Certified Financial Statement (ICFS).

Many staff across WHO Clusters and Departments in all Major Offices support the implementation of
the PIP Framework. Without their work, dedication and collaboration, there would be no progress to
report on. We extend our sincere thanks to these staff for their invaluable work.

The report is structured as a series of infographics as follows:

• PIP Framework implementation overview (pages 6 – 7)


• Technical and financial implementation progress (pages 8 – 18)
• Financial report including ICFS - Annex A (reported annually only)

For previous reports, see https://www.who.int/influenza/pip/partnership_contribution/en/


ACRONYMS & ABBREVIATIONS
AFR WHO African Region NITAG National Immunization Technical Advisory
Groups
AG Advisory Group
NRA National Regulatory Authority
AMR WHO Region of the Americas
NVDP National Vaccine Deployment Plan
BM Biological Material
PC Partnership Contribution
BOD Burden of Disease
PCR Polymerase Chain Reaction
CC Collaborating Centre
PIP Pandemic Influenza Preparedness
CRP Collaborative Registration Procedure
PIRM Pandemic Influenza Risk Management
CVV Candidate Vaccine Virus
PISA Pandemic Influenza Severity Assessment
DEP Planning for Deployment
PIVI Partnership for Influenza Vaccine Introduction
DFID Department for International Development
(United Kingdom) PQ Prequalification

DG Director-General PSC Programme Support Costs

EB Executive Board PV Pharmacovigilance

EMR WHO Eastern Mediterranean Region QMS Quality Management Systems

EQAP External Quality Assessment Programme RCCE Risk Communications and Community
Engagement
EUR WHO European Region
REG Regulatory Capacity Building
GBT Global Benchmarking Tool
RO Regional Office
GIP WHO Global Influenza Programme
RRT Rapid Response Teams
GISRS Global Influenza Surveillance and Response
System RS Regulatory Systems

GSD Genetic Sequence Data SAGE Strategic Advisory Group of Experts

HAI Human Animal Interface SARI Severe Acute Respiratory Infection

HLIP High-Level Implementation Plan SEAR WHO South-East Asia Region

ICFS Interim Certified Financial Statement SFP Shipping Fund Project

IDP Institutional Development Plan SMTA2 Standard Material Transfer Agreement 2

ILI Influenza-like Illness TAG Technical Advisory Group

IPPP Influenza Pandemic Preparedness Planning TOR Terms of Reference

ISID International Society for Infectious Diseases UNICEF United Nations Children’s Fund

ISST Infectious Substances Shipping Training US CDC United States Centers for Disease Control
and Prevention
IVPP Influenza Virus with Pandemic Potential
US HHS United States Department of Health and
IVTM Influenza Virus Traceability Mechanism Human Services
L&S Laboratory and Surveillance Capacity Building VCM Vaccine Composition Meeting
LMIC Low and Middle Income Countries WER Weekly Epidemiological Record
MA Marketing Authorization WHA World Health Assembly
MS Member State WPR WHO Western Pacific Region
NIC National Influenza Centre WHO World Health Organization
IMPLEMENTATION
OVERVIEW

Pandemic Influenza Preparedness Framework | PROGRESS REPORT | 1 January 2018 - 30 June 2019 5
PIP PC collection (As of 30 June 2019)

PERCENTAGE OF TOTAL PC RECEIVED BY YEAR OF INVOICE

30 TARGET
98% 98%
96% 97% 97% 28M
$178M
25
84% /YEAR
MILLION US$

20

15 CONTRIBUTED BY
INDUSTRY b
10

0
2012 a 2013 2014 2015 2016 2017 2018
a
In 2012, contributions were made voluntarily
b
Figure includes PSC. PC collection for previous unpaid contributions and 2018 invoices is in process

PIP PC financial implementation (As of 30 June 2019)

PREPAREDNESS
2018-2019 BIENNIAL BUDGET: $32.1M FUNDED: $30.5M IMPLEMENTED: $20.2M
PIP SECRETARIAT
IMPLEMENTATION BY HLIP II OUTPUT
BIENNIAL BUDGET: $6.8M
US$ in thousands
3,000 FUNDED: $5.2M
2,000 IMPLEMENTED: $3.5M
1,000
3,000 -
20,000
2,000 RCCE RESPONSE
1,000 3,000 TOTAL IN RESERVE
15,000
- 2,000 (WITH PSC & 2018
BOD
1,000 INTEREST): $48M
10,000 3,000 -
2,000 DEP
3,000 1,000
5,000 LEGEND
2,000 - Biennial budget
1,000 IPPP
Funded
- Implemented
-
L&S REG

PIP Framework outcome indicators


OUTCOME
Improved global pandemic influenza preparedness and response through the implementation of the PIP Framework

Indicator 2017 Baseline 2019 Status 2019 Target


% of Member States with zoonotic influenza cases sharing IVPPs with GISRS (N=4) N/A N/A
Indicators are reported annually

 of PC recipient Member States reporting to FluNet


%
(sustainability indicator) (N=37) 84% ≥85%

% of PC recipient Member States reporting to FluID (N=37) 51% 60%


- Pending -

% of Member States with BOD estimates considered by NITAG (N=19) N/A 30%
No. of PC recipient Member States that have implemented regulatory approach 0 10
 of PC recipient Member States that developed or updated a pandemic
%
influenza preparedness plan (N=40)
30% 60%

% vaccine-producing companies that signed an SMTA2 (N=32) 34% 50%

% of Partnership Contributions received in the year of invoice (N=$28M) N/A 100%

6 Pandemic Influenza Preparedness Framework | PROGRESS REPORT | 1 January 2018 - 30 June 2019
Lar
ge
ma / mu
nuf lti-
act nat
ure ion
rs al Small
pa
mu ndem > 7
TOTAL
TOTAL
TOTAL
TOTO
DATE:
TODATE:
DATE: 12 12
MONTHS:
12MONTHS:
MONTHS:
5
12391239
1239 LargeLarge / multi-national
/ multi-national 235
235
235 Medium-sized
Medium-sized M
Small
TOTAL TO DATE: 12 MONTHS: l
PIP Biological Materials shared
a
t i - i c
1239 235
nat p
i o n ro d u
manufacturers manufacturers manufacturer
manufacturers manufacturers Small mMedi
manufactu
al c cti
INLarge / multi-national Medium-sized
PIP BMs RECORDED
INFLUENZA
INFLUENZA
INFLUENZAIN IVTM
VIRUSES
VIRUSES
VIRUSES
WITHWITH
WITH
PANDEMIC
PANDEMIC
PANDEMICPOTENTIAL
POTENTIAL
POTENTIAL INFLUENZA
INFLUENZA
INFLUENZAVIRUSES
VIRUSES
VIRUSES
WITH
WITH
WITH om on o
pa
nie r
anu u
INFLUENZA VIRUSES WITH PANDEMIC
(IVPP)
(IVPP)
(IVPP) POTENTIAL
RECORDED
RECORDED
RECORDED IN
THE
INTHE
THE
INFLUENZA
INFLUENZA
INFLUENZA VIRUS INFLUENZA VIRUSES WITH PANDEMIC
VIRUS
VIRUS PANDEMIC
PANDEMIC POTENTIAL
POTENTIAL
POTENTIAL
RECORDED
RECORDED
RECORDED
(IVPP) RECORDED IN THETRACEABILITY
INFLUENZA
1 SEPTEMBERmanufacturers
TRACEABILITYVIRUS
TRACEABILITYMECHANISM
MECHANISM
MECHANISM (IVTM)
(IVTM)
(IVTM) >75M
IN THE>75M
PANDEMIC
manufacturers
POTENTIAL RECORDED
IN IN
THE
INTHE
THE
IVTMIVTM>5M and <75M
IVTM
>5M TO and DATE: <75M manufacturers
s t <5M <5M
TRACEABILITY MECHANISMFROM 2017 TO pandemic
fa
12 MONTHS: TOTAL

66
(IVTM) IVTM
production or or pandemic production or or 2012: pandemic productio
Small 235 VIRUS SUBTYPES RECORDED: 1239
>5 produ
pandemic
30 JUNE 2019: pandemic production TOTAL SINCE
pandemic 1 DECEMBER
production

1205
>75M multi-national companiest >5M and BMs RECORDED <5M
<75M PIPcompanies
medium-sized companies Mcompa
or small companie
545
multi-national companiest medium-sized or psmall
a
me ndem a n d
POTENTIAL manufacturers
INFLUENZA VIRUSES WITHpandemic
A(H1), A(H3),
production or
A(H5), A(H6), A(H7), A(H9)
multi-national companiest
pandemic production
medium-sized(IVPP)
or
companies
pandemic
or small
production
INFLUENZA VIRUSES WITH PANDEMIC POTENTIAL diu
VIRUScompanies
i
m - c p ro
siz
ed d
VIRUS PANDEMIC POTENTIAL RECORDED RECORDED IN THE INFLUENZA

nal Medium-sized
<5M IN THE IVTM Small TRACEABILITY MECHANISM (IVTM)
OF co

manufacturers manufacturers
a
pandemic production
For definition of ‘PIP Biological Materials’, see PIP Framework Section 4.1
CO

38
NC

6 6
or small companies

6 6
LU

0M
DE
>5M and <75M <5M D

6 10 6
6 380M
6 6 10
pandemic production or pandemic production DO
SMTA2
medium-sized companies or small companies
OF OF SE
SS

10
EC OF OF

6 10
SMTA2 WITH VACCINE & ANTIVIRAL MANUFACTURERS SINCE 2013 UCONCLUDED
RE CONCLUDED OF
OF CONCLUDED
CONCLUDED D CO CONCLUDED
CONCLUDED
OF

40M 00
NC

380M 40M 40
LU
Large / multi-national Medium-sized Small DE
Large
Large
Large
/ multi-national
rge / multi-national //multi-national
multi-national
Medium-sized Medium-sized
Medium-sized
Medium-sized
CONCLUDEDSmall CONCLUDED
Small
Small
Small D

M0
CONCLUDED
manufacturers manufacturers manufacturers
manufacturersmanufacturers
manufacturers
manufacturers
manufacturers manufacturers
manufacturers
manufacturers
manufacturers manufacturers
manufacturers
manufacturers
380M 40M
>75M >5M and <75M <5M DO
>75M >75M >5M and <75M
>75M
>75M >5M DOSES
>5M
>5M SECURED
DOSES
<75M
<75MSECURED
<75M <5M <5M DOSES
<5M
<5M SECURED
DOSES SECURED SE DOSES SECURE
DOSES SECU
and
and
and SS

6 manufacturers
10Small
pandemic production orpandemic
pandemic
pandemic
pandemicproduction
pandemic
production
production
productionproduction
or or
or or pandemic
pandemic
pandemicproduction
pandemic
pandemic
productionproduction
production
production
or oror pandemic
pandemic
pandemic
pandemic production
production
production
production EC
multi-national companiest medium-sized or small
companiestcompanies medium-sized companies or or
small
orsmall
small
companies
companies
companies UR
multi-national
multi-national
multi-national
CONCLUDED companiest
companiest medium-sized
medium-sized
DOSES SECURED companies
companies
companies
DOSES SECURED DOSES E SECURED

>400M
D
edium-sized OF
Large / multi-national Medium-sized
0 405M
NEW: 1 additional SMTA2
nufacturers CONCLUDED signed since 1 January 2019
CONCLUDED manufacturers manufacturers

40M 0 405M
M and <75M <5M >75M >5M and <75M
DOSES

6 6 66
6 666610
emic production or
m-sized companies
DOSES pandemic
SECURED production
or small companies
DOSES SECURED pandemic production or
multi-national companiest
pandemic production or
medium-sized companies

DOSES SECURED
6DOSES
76 10
10
10
SECURED DOSES SECURED
OF
OFOF
OF OF
OFOF
OF
CONCLUDED CONCLUDED CONCLUDED
CONCLUDED
CONCLUDED
CONCLUDED CONCLUDED
CONCLUDED
CONCLUDED CONCLUDED
CONCLUDED
CONCLUDED

380M 380M40M
380M
380M 40M 0
40M
40M 405M
000 405M
405M
405M
OF 10
DOSES SECURED

NCLUDED
SMTA2 WITH
DOSES
DOSES
DOSES
DOSES SECURED
DIAGNOSTIC
SECURED
SECURED
SECURED

CONCLUDED
MANUFACTURERS
DOSES
DOSES
DOSES &
DOSES SECURED
ACADEMIC AND
SECURED
SECURED
SECURED
DOSES SECURED
RESEARCH
DOSES
DOSESINSTITUTIONS
DOSES
SECURED
SECURED
SECURED
6 6
OF DOSES
DOSES
DOSES
SECURED
SECURED
SECURED

CONCLUDED
6 10 OF
CONCLUDED

40M 10M
0 405M 380M 40M SMTA 2

250,000 25M
SMTA 2

S SECURED DOSES SECURED DOSES SECURED DOSES SECURED


TREATMENT COURSES OFDOSES SECURED SMTA 2

ANTIVIRALS DIAGNOSTIC KITS SYRINGES

SM
TA
2

70 29
SMTA 2
SMTA 2
NEW: SMTA
4 additional
2

SMTA2 signed since SMTA 2SMTA


SMTA 22
BENEFIT-SHARING OFFERS
SMTA2 WITH ACADEMIC
1 January 2019 ACADEMIC & RESEARCH
& RESEARCH INSTITUTIONS
INSTITUTIONS

SMTA 2

PIP Framework governance


The final text of the Analysis on approaches to seasonal influenza and genetic sequence data (GSD) under the PIP Framework,
requested by WHA70 (May 2017), was submitted to the January 2019 Executive Board as part of a broader report by
the Director-General on implementation of the PIP Framework. The report contained a draft decision for consideration of
WHA72. The EB requested WHO to facilitate intersessional work to further advance discussions on the draft decision.

On 11 March 2019, WHO held an information session for Member States and relevant
stakeholders, as well as an informal consultation for Member States to advance work
on the draft decision. An additional five informal consultations for Member States
were held prior to WHA72 to advance consensus on the draft decision. At WHA72
Member States adopted a decision that requests, inter alia, WHO to gather further
information on the sharing of influenza viruses and the handling of influenza GSD.
The decision also amends PIP Framework Annex 2 ‘SMTA 2’, Footnote 1 with a view
to helping ensure continued fairness and equity in the implementation of the PIP
Framework’s access and benefit sharing system.

Pandemic Influenza Preparedness Framework | PROGRESS REPORT | 1 January 2018 - 30 June 2019 7
IMPLEMENTATION
PROGRESS

8 Pandemic Influenza Preparedness Framework | PROGRESS REPORT | 1 January 2018 - 30 June 2019
NOTE TO READERS
 Readers are strongly encouraged to read the
Output Reading Guide below which provides
clarity on the data reported.

OUTPUT READING GUIDE

Biennial budget &


funds implemented
cumulatively at
Output level
Milestones: cumulative progress
Output name & statement (excluding PSC)
updated every six months since
beginning of 2018

Laboratory & surveillance


BIENNIAL BUDGET: $XM | IMPLEMENTED: $XM
OUTPUT: National influenza L&S systems contribute to GISRS for timely risk assessment & response measure

DELIVERABLE A MILESTONES HIGHLIGHTS


Risk and severity of • X additional trainings on PISA were

X X
influenza, including countries conducted in January/June 2019.
at the human-animal from Countries are establishing thresholds

X regions
interface, are routinely and using surveillance data in a
PISA trainings
assessed completed participated range of analyses to inform national
preparedness and response.

• WHO is developing communication

X X
materials to support countries in PISA
X% countries
from implementation.

Outbreak detection
& response trainings X regions
participated
• Countries continue to establish and
strengthen influenza surveillance,
X% investigate acute respiratory disease
events, hold human/animal interface

X
risk assessments and conduct

X countries
trainings to improve outbreak
$XM from investigation capacities. These are
Meetings, workshops,

X regions
essential components of IHR core
IMPLEMENTED joint investigation capacities for public health emergency
& risk assessments participated preparedness.

Funds implemented cumulatively


at deliverable level
(excluding PSC)

Proportion of funds implemented


from the biennial budget Highlights from the latest
six-month reporting
period

Deliverable name

Pandemic Influenza Preparedness Framework | PROGRESS REPORT | 1 January 2018 - 30 June 2019 9
Laboratory & surveillance
BIENNIAL BUDGET: $21.3M | IMPLEMENTED: $14.2M
OUTPUT: National influenza L&S systems contribute to GISRS for timely risk assessment & response measure

DELIVERABLE A MILESTONES HIGHLIGHTS


Risk and severity of • 6 additional trainings on PISA were

15 87
influenza, including countries conducted in January/June 2019.
at the human-animal from Countries are establishing thresholds

5 regions
interface, are routinely PISA trainings
and using surveillance data in a
assessed completed participated range of analyses to inform national
preparedness and response.

• WHO is developing communication

132 58 countries materials to support countries in PISA


24% implementation.
from

6 regions
Outbreak detection • Countries continue to establish and
& response trainings participated strengthen influenza surveillance,
76% investigate acute respiratory
disease events, hold human/

90
animal interface risk assessments

91 countries
and conduct trainings to improve
$5.7M Meetings, workshops,
from outbreak investigation capacities.

6 regions
IMPLEMENTED These are essential components of
joint investigation IHR core capacities for public health
& risk assessments participated
emergency preparedness.

DELIVERABLE B MILESTONES HIGHLIGHTS


Quality influenza virus

98
• In January-June 2019, WHO recognized

91
detection capacity is countries NICs in 3 countries (Bolivia, Dominican
sustained from Republic and Haiti) in addition to the

6 regions
Laboratory trainings, 142 already recognized NICs. The
missions and visits participated total number of NICs will be updated
completed during WHO’s process to review NIC
performance.

38% 2019 EQAP status • The 2019 EQAP panel was sent to
countries in May 2019. EQAP is
1 Contract signed
62% used to monitor, sustain and drive
improvements in virus detection
2 EQAP sent out capacity.

• An additional 34 missions were


$4M 3 Results received conducted in January-June 2019 to
IMPLEMENTED provide laboratory technical training,
QMS mentoring and NIC pre-
4 Results shared with participating laboratories assessment/designation support.

5 Results published in WER

DELIVERABLE C MILESTONES HIGHLIGHTS


Countries are supported

11 141
• Countries with newly established
to consistently report countries influenza surveillance in 2 regions were
influenza data to global from
supported to commence virological
platforms Regional meetings
held to improve global 6 regions
participated
and epidemiological data reporting to
regional and global platforms.
surveillance systems
• Regions continue to publish

484
surveillance bulletins that report on

112 countries
from
influenza activity including intensity,
spread, severity, virus detections and

6 regions
40% Trainings, missions & characteristics. This feedback facilitates
other types of support participated decision-making as well as continuous
60% for surveillance provided surveillance system improvements.

• To facilitate country influenza data

351
reporting, global and regional

5 regions
platforms are routinely updated
$2.3M to improve data management
Regional bulletins involved
IMPLEMENTED capabilities, user acceptibility and
published
outputs.

10 Pandemic Influenza Preparedness Framework | PROGRESS REPORT | 1 January 2018 - 30 June 2019
Laboratory & surveillance

DELIVERABLE D MILESTONES HIGHLIGHTS


Countries are supported • 18 countries in 3 regions conducted
to share timely
13
trainings in infectious substance
representative influenza
51 countries
shipping in January-June 2019 to
samples with WHO CCs from
certify shippers. Having certified
Trainings on shippers in country laboratories is
infectious substance
shipping completed 4 regions
involved
critical in case of emergence of a
novel virus that needs to be shared
and characterized rapidly.

• 93 countries made 142 shipments of


influenza viruses/clinical specimens
39%
to WHO CCs in January-June 2019.

410
61% This includes 2 countries that made

112 countries
from
shipments from national laboratories
for the first time ever. Regular

6 regions
Shipments made and timely virus sharing facilitates
using the SFP participated the work of GISRS in global risk
$2M management.
IMPLEMENTED

DELIVERABLE E MILESTONES HIGHLIGHTS


Influenza CVVs, virus

20
detection protocols and • 2 new CVVs (H5N6 and H7N4
viruses) were proposed during the
reagents, and reference February 2019 vaccine composition
materials are routinely consultations. Continued selection
Protocols and guidance
updated and development of CVVs is essential
updated, including translations
for global pandemic preparedness as
zoonotic influenza viruses continue
to be identified and evolve both
genetically and antigenically.

3 2
• Key WHO guidance documents
51% on virus sharing and outbreak
49%
investigation1 were translated and
Vaccine Composition new CVVs shared with countries to facilitate
Meeting consultations proposed in latest utilization.
completed VCM
$127K
IMPLEMENTED

1
 ee https://www.who.int/influenza/gisrs_laboratory/ivpp_sharing_guidance/, https://www.who.int/influenza/gisrs_laboratory/seasonal_sharing_guide/ and
S
https://www.who.int/influenza/resources/publications/outbreak_investigation_protocol/

Pandemic Influenza Preparedness Framework | PROGRESS REPORT | 1 January 2018 - 30 June 2019 11
Burden of Disease

Imp plan ed

1
co u
36
lem
3

esta

ntrie
BIENNIAL BUDGET: $2M | IMPLEMENTED: $1.4M
31

enta
blis

s
h

tion
ies
OUTPUT: Influenza disease burden estimates are
ou
nt used
r
ing
s for public health decisions
c d d
fin he
D lis
Bo pub
2
MILESTONE HIGHLIGHTS
DELIVERABLE A

15
Representative 1
Number of countries in each burden of disease estimate
2 3 • Countries are encouraged to publish their
national, regional and development es
tri stage

2
co u
findings and to share their data to inform

15
n

calc
global disease burden ou

36 15 31
regional/global estimates.

ntrie
c

BoDated
D d
Boulate

ul
estimates are available l c • 2 additional countries published BOD findings

s
cacountries
1 countries BOD
countries
for the first time, bringing the total to 37

36
Implementation BoD calculated in BoD findings countries globally of which 19 are LMICs.
plan calculated published

15
established es n
tri o • 5 more countries finished calculating national
un ntati
20% c o e BOD estimates of which all are LMICs. One
l em lan hed additional country updated its estimate in 2019.
Im
p p lis
b countries
ta
es • Work continues with US-CDC to estimate global

3
BoDublishe
co u
31
p
influenza-associated hospitalization burden. To

ntrie
find d
BOD date, 37 countries, including 14 LMICs, have

s
ings
Implementation findings shared their data to inform this estimate.
80% plan published in

37
established in • WHO is working on an influenza pyramid

45
tool to enable countries with limited data to
$745K estimate the comprehensive influenza burden.
countries In June 2019, a WHO consultation was held
IMPLEMENTED countries
with technical experts and Member States and
consensus was reached for the development of
the tool.

DELIVERABLE B MILESTONE HIGHLIGHTS


Disease burden findings

15
• 11 additional countries, 10 from the Americas
are communicated Shared/communicated BOD and one from the Western Pacific Region, shared
to national and estimates to decision-making BOD estimates with decision-making bodies
international expert countries bodies including one country that shared its economic
bodies in a format that burden results. Information was shared with
promotes evidence- MOH authorities and/or medical associations.
based decision making • A WHO consultation was held to discuss the
guidance needed for countries in the decisional
process for influenza policy. Member States,
academics and technical experts shared lessons
learnt and ideas for ways forward. Participants
37% highlighted the importance to ensure national
BOD data are available when opportunities
63% arise (e.g. outbreak, unexpected event, media
attention, etc.). A toolkit to direct the use of
BOD data for decision in influenza disease
prevention and mitigation strategies will be
developed.
$648K
IMPLEMENTED

12 Pandemic Influenza Preparedness Framework | PROGRESS REPORT | 1 January 2018 - 30 June 2019
Regulatory capacity building
BIENNIAL BUDGET: $2.7M | IMPLEMENTED: $1.6M
OUTPUT: Timely access to quality-assured influenza pandemic products is supported

DELIVERABLE A MILESTONES HIGHLIGHTS


National regulatory
17
• Based on the result of WHO benchmarking
capacity for pandemic using GBT, regulatory capacities (RS,
influenza products is MA, PV) of one additional PIP priority
strengthened Refinements made to WHO country increased in both percentage of
Global benchmarking tool implementation and maturity levels. This
achievement was the result of five years of

2
WHO support and country efforts. Two other
countries conducted self-benchmarking
in anticipation of future external WHO
Countries WHO benchmarked benchmarking missions.
• Regulators from 10 countries were placed
44%

3
56% at stringent NRAs to observe processes and
incorporate relevant practices into their own
regulatory functions. This capacity-building
Countries self-benchmarked approach through mentoring also facilitates
collaboration and networking between NRAs
which is critical for global preparedness.

6
$892K
IMPLEMENTED 4 countries • The computerized GBT was enhanced and
released as version 12.0 to improve user-

1 region
from
IDP follow-up visits acceptability and assessment consistency.
• A systematic literature review is underway on
the safety profile of influenza vaccines used

16
IDP implementation
20 countries
from
in countries to update the information sheet
about observed rates of influenza vaccine
reactions. The WHO information sheets

6 regions
& technical support are used to inform routine immunization
activities programmes, vaccine introduction initiatives
and risk communication during emergencies.

DELIVERABLE B MILESTONES HIGHLIGHTS


Adoption of regulatory
• Regulatory pathways to accelerate approval
pathways that accelerate

5
WHO regulatory of products during emergencies include PQ
approval for use of preparedness guidelines and CRP. WHO continues to advocate and
pandemic influenza translated to languages raise knowledge among regulators about
products is promoted these approaches.

• 17 countries, including 10 targeted by

6
PIP, participated in a CRP meeting in May

46 countries
2019. Regular meetings to streamline and
from build confidence in CRP is critical for MA of
38% Workshops/trainings influenza products now and during a future
62%
conducted to
implement the PIP 6 regions pandemic.

regulatory guidelines • Planning is underway to support 18 countries


linking national from three regions to implement their
IPPP & NVDP for regulatory approach for timely approval of
pandemic influenza pandemic influenza products and to link it
$706K vaccines to other components of IPPP. This will be
IMPLEMENTED completed by December 2019.

Pandemic Influenza Preparedness Framework | PROGRESS REPORT | 1 January 2018 - 30 June 2019 13
Risk Communications & Community Engagement
BIENNIAL BUDGET: $2.2M | IMPLEMENTED: $1M
OUTPUT: Tools and guidance are available for countries to enhance influenza risk communication
and community engagement

DELIVERABLE A MILESTONES HIGHLIGHTS


Countries and front- • A global consensus on meeting country

16
line responders have RCCE technical needs was reached by
access to resources WHO regional RCCE leads in May 2019.
for influenza risk The path forward included prioritizing
communication, Influenza guidance/courses resources required to enhance RCCE
community available on OpenWHO preparedness and response for
countries. The adaption and roll out of
engagement and
the European 5-step package2 were
social science-based deemed relevant in all regions for
interventions

16
countries to strengthen this IHR core
capacity.
•T
 he Risk Communications Essentials
OpenWHO advocacy & online courses were translated and
marketing events made available in 2 languages (French,
Portuguese) to facilitate uptake in
49% different countries.
51% •F
 unded by other sources, OpenWHO.
org now contains modules on Incident

4 5
Management System in 5 languages
to support countries in establishing the
RCCE factors mapped in priority countries procedures for coordinating emergency
$421K response including pandemic influenza.
IMPLEMENTED OpenWHO has now become an
enterprise system.

DELIVERABLE B MILESTONES HIGHLIGHTS


Technical assistance • In May 2019, 13 African countries were

12
is provided to supported to elaborate the RCCE

66 countries
countries to plan and component of their IPPP. WHO is
exercise influenza risk Trainings, missions and from supporting these countries to complete
communication and
6 regions
other type of technical and test these plans.
community engagement support provided participated
involving •D
 iscussions were held with 11 SEAR
country IHR focal points to prioritize
and plan RCCE activities in 2020-2021.
RCCE was the top request for technical
assistance among the 11 SEAR
Implementation of global partnerships & networks for effective countries represented. The high level
45% commitment to RCCE will facilitate
RCCE capacity
strengthening of this IHR core capacity.
55%

26 26 6 4 • In collaboration with BMGF and other


stakeholders, WHO is developing
minimum quality standards and
Partners Partners Plans of Evidence of indicators for community engagement.
$617K identified contacted action approach This will facilitate a common approach
developed alignment
IMPLEMENTED available to all-hazards preparedness and
response including pandemic influenza.

2
 mergency risk communication (ERC) 5-step capacity-building package. WHO Regional Office for Europe, Copenhagen Denmark. http://www.euro.who.int/en/
E
health-topics/emergencies/international-health-regulations/emergency-risk-communications/emergency-risk-communications-tools/national-health-emergency-risk-
communication-training-package

14 Pandemic Influenza Preparedness Framework | PROGRESS REPORT | 1 January 2018 - 30 June 2019
Planning for Deployment
BIENNIAL BUDGET: $1.5M | IMPLEMENTED: $701K
OUTPUT: Plans for effective & efficient deployment of pandemic supplies are optimized

DELIVERABLE A MILESTONES HIGHLIGHTS


A common approach
to manage global
2
• 17 countries from 2 regions participated
deployment operations is in PIP Deploy Gaming Exercises to test
developed and regularly the ‘pandemic cascade’ model from
country vaccine request to vaccine
tested with stakeholders PIP Deploy refinements to facilitate planning,
administration. More countries from 3
and deployment partners allocation and coordination
regions are expected to conduct the
exercise by December 2019 to help
review and improve their NVDPs.

11 • WHO is scoping the criteria needed to


support pandemic vaccine allocation
71
44% countries decision-making and developing an
56% Advocacy from
meetings for a overarching framework for managing

6 regions
common approach deployment operations. This will form the
completed basis for having a common approach to
manage global deployment operations
and will lead to the development of
$459K relevant SOPs with stakeholders.
IMPLEMENTED

DELIVERABLE B MILESTONES HIGHLIGHTS


National deployment
• Technical support on NVDP development

5
planning process is was provided to 18 LMICs including 6
revised and updated countries that did not receive donated
vaccines during 2009 pandemic. Countries
Global guidance tools revised
1 2 3 are encouraged to link NVDPs to their
IHR (2005) National Action Plan for Health
1 1 0 Security or to seasonal influenza systems

8
39% to facilitate a sustainable systems-
Country Kick-off Draft approach for deployment of products at

28 from
engagement & meeting report
61%
concurrence completed countries
completed the time of a pandemic.
Trainings, missions,
visits & other
4 regions
4
• Infographics to assist countries update
types of technical 5 their deployment plans were translated

0 1
support provided into 2 UN languages (Russian, French).
to update NVDP
$243K This will facilitate update of WHO
IMPLEMENTED Stakeholders Final guidance.
workshop sustainability
held assessment
report

DELIVERABLE C MILESTONES HIGHLIGHTS


Technical assistance • Sustainability assessments allow countries
to develop policies for Number of countries in each phase of the sustainability to sustain local production (where
sustainable influenza assessment process applicable) and encourage national
vaccine procurement 1 2 3 procurement of seasonal influenza
and production is Country Kick-off Draft
vaccines with the goal of increasing
provided to countries engagement meeting report pandemic preparedness.

0 1 0
& concurrence completed completed
• Advocacy meetings were held in
2 countries to discuss sustainable
production/procurement and target
Deliverable C activities 4 5 groups in the context of pandemic
are currently supported preparedness.
Stakeholders Final sustainability
by US DHHS through workshop assessment report
Cooperative Agreement • In alignment with RCCE (output 4),

0 2
held available
GH14-1420 between WHO convened HQ and regional office
US CDC and WHO. PIP stakeholders; mapped internal activities
funds were not used to on influenza vaccine acceptance and
date. demand; and identified priorities and
action items to improve the development

2
Milestone/indicator of evidence-based influenza immunization
reporting continues programmes.

42 countries
as this Deliverable is
within HLIP II scope and Trainings, missions, from • In collaboration with PIVI, 3 countries
PC funds may be used visits & other are piloting the manual for influenza
in future. types of technical
support provided 5 regions immunization of health workers.

Pandemic Influenza Preparedness Framework | PROGRESS REPORT | 1 January 2018 - 30 June 2019 15
Influenza Pandemic Preparedness Planning
BIENNIAL BUDGET: $2.4M | IMPLEMENTED: $1.3M
OUTPUT: National pandemic influenza preparedness & response plans are updated in the
context of all-hazards preparedness and global health security

DELIVERABLE A MILESTONES HIGHLIGHTS


Countries are Number of PC recipient MS currently developing/ • Countries are at different stages and are taking various
supported to develop, revising their IPPP approaches in updating their IPPPs. Approaches
test and update their include integrating influenza plans within broader
multi-hazards plans, engaging sub-national authorities
pandemic influenza
Planning meeting early in the IPPP development process, establishing
preparedness plan held/workshop technical working groups to elaborate sections such
1 completed as risk communications or hospital preparedness,

12 and involving different sectors as well as NGOs in the


planning process.

• 1 country finalized its plan which was officially


endorsed to facilitate pandemic preparedness actions.
44% 14 additional countries wrote/revised their plans in
56% January-June 2019. Several countries are planning to
IPPP written conduct exercises to test components of their plans
or revised in 2019.
2

$1.3M
19 • WHO conducted a Member State survey on pandemic
influenza preparedness and the report was published
in June 2019. Priorities identified through the survey
IMPLEMENTED involving 104 countries include developing plans
for non-pharmaceutical interventions and managing
excess mortality during a pandemic.

IPPP • 2 regions conducted in-depth reviews of existing


3 endorsed national plans and provided recommendations

1
to enhance preparedness. Key recommendations
included the need for more defined response actions
and better description of links and roles of different
sectors and agencies during a pandemic.

• WHO continues to provide technical guidance to

5 4 countries
from
support countries in updating and exercising their
plans. This includes preparation of simulation exercise
scenarios to test IPPPs and developing guidance on
2 regions
IPPP exercises
use of non-pharmaceutical interventions during an
completed in
influenza pandemic.

16 Pandemic Influenza Preparedness Framework | PROGRESS REPORT | 1 January 2018 - 30 June 2019
PIP Framework Secretariat
BIENNIAL BUDGET: $6.8M | IMPLEMENTED: $3.5M
OUTPUT: The PIP Secretariat leads, manages and supports implementation of the PIP Framework

DELIVERABLE A MILESTONES HIGHLIGHTS

14
Promote the effective Meetings held and reports submitted to WHO DG • WHA72 (May 2019) adopted a
implementation of the or governing bodies to support implementation of decision requesting WHO to carry
PIP Framework in a section 7 of the PIP Framework out further work on issues related to
changing environment influenza virus sharing and genetic
Status of the Analysis requested by WHA 70(10) sequence data. The decision also
includes the first amendment to the
PIP Framework (Footnote 1, Annex
2 “SMTA2”) which will help ensure
continued fairness and equity in the
Fact sheets Information Draft analysis implementation of the PIP Framework
developed session held published access and benefit sharing system.
53%
47% • An information session, a mission
briefing, and six informal consultations
for Member States were held to help
prepare for WHA72 discussions.
MS & other Analysis submitted to Analysis submitted
stakeholders and discussed by to and discussed • The PIP Advisory Group met from
$1.7M consulted EB144 (January 2019) at WHA72 12-15 March 2019. Its meeting
IMPLEMENTED report which included several

49 Advocacy materials/events completed to promote


the PIP Framework to stakeholders
recommendations, was accepted by
the Director-General.3

DELIVERABLE B MILESTONES HIGHLIGHTS


Collect, implement, Status in 2019 project • PC 2019 invoices were issued to 39
monitor and report management cycle manufacturers in July 2019, which is
on the Partnership earlier than in previous years. This will
Contribution Planning enable more timely collection of funds
Invoices sent in the year of invoice.
by 30 June 7
• 15 ‘Highlights from the Field’ were
PC funds
distributed by published in the Influenza Newsletter
31 December 2019 only, to share PIP’s country
impact and first-time successes. One
Reporting

15
Implementation notable story was South Sudan’s

6
51% establishment of influenza sentinel
49% surveillance, laboratory testing
PC implementation capacity and reporting of results to
updates published Site monitoring global surveillance platforms.
in newsletter visits
• Workplan development for 2020-
Monitoring
$1.2M 2021 commenced in February 2019.
Work plan Workplans are built on 2018-2019
IMPLEMENTED compliance checks: achievements, coordination with other
Jan - June 3 influenza investments and coherence
July - Dec at the global, regional and country
level. The workplans are expected to
be approved in November 2019.

DELIVERABLE C MILESTONES HIGHLIGHTS


Negotiate and plan • 5 SMTA2s were concluded between
to operationalize the January-June 2019. One with the
Number of SMTA2s in negotiation
Standard Material Transfer influenza vaccine manufacturer KM
Agreements 2 (SMTA2) Biologics (8% donation and 2%
reserved pricing), and four with the
following academic institutions:
Pennsylvania State University, University

45%
2 1 3 of South Dakota, Cornell University
and the University of Alabama at
Birmingham.
55% With manufacturers With manufacturers With academic • In total, 13 SMTA2s have been
of vaccines and/or of other pandemic & research concluded with manufacturers of
antivirals related products institutions vaccines and/or antivirals, 2 with
manufacturers of other pandemic
$544K related products, and 70 with academic
IMPLEMENTED and research institutions, to date.

3
PIP Advisory Group meeting reports can be found here: https://www.who.int/influenza/pip/pip_meetings_consultations/en/

Pandemic Influenza Preparedness Framework | PROGRESS REPORT | 1 January 2018 - 30 June 2019 17
World Health Organization
20 Avenue Appia
1211 Geneva 27
Switzerland

PIP Framework Secretariat


pipframework@who.int

www.who.int/influenza/pip/en

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