review of global activities and achievements for gap since 2006 … · 10 | gap-ii: review of...

Review of global activities and achievements for GAP since 2006

Dr Marie-Paule Kieny

Assistant Director General

Innovation, Information, Evidence and Research

GAP-II: Review of global activities and achievements for GAP since 2006 | 12 July 2011, Geneva2 |

GAP- I (2006): OBJECTIVESGAP- I (2006): OBJECTIVES

OBJECTIVE 1. Increase in seasonal

vaccine influenza use

OBJECTIVE 2. Increase in production

capacity

OBJECTIVE 3. Further research and

development


OBJECTIVE 1.

Increase in seasonal influenza vaccine use

OBJECTIVE 1.

Increase in seasonal influenza vaccine use


INFLUENZA VIRUS SURVEILLANCE INFLUENZA VIRUS SURVEILLANCE


WHO Global Influenza Surveillance and Response System

GISRS* - Activities

WHO Global Influenza Surveillance and Response System

GISRS* - Activities

� Virus monitoring and laboratory response

� Laboratory diagnostics

� Vaccine support – vaccine strain selection and provision

� Capacity building

� Communication and networking

*formerly GISN


GISRS: surveillance of circulating viruses and vaccine composition recommendations

GISRS: surveillance of circulating viruses and vaccine composition recommendations

� 136 National Iinfluenza

Centres (NICs)

� 106 WHO Member States

(MS)

� 6 Collaborating Centres(CCs)

� 4 Essential Regulatory Laboratories (ERLs)

� 12 H5 reference

laboratories


Cumulative number of specimens processed by GISRS

Cumulative number of specimens processed by GISRS

0

500000

1000000

1500000

2000000

2500000

1 5 9 13 17 21 25 29 33 37 41 45 49 53

Weeks

Nu

mb

er

of

sp

ec

ime

ns

2008 2009 2010 2011

Data source: FluNet, Global Influenza Surveillance Network (8 February 2011)


Cumulative Number of Confirmed Human Cases of Avian Influenza A/(H5N1) Reported to WHO(Cambodia, China, Egypt, Indonesia)

Cumulative Number of Confirmed Human Cases of Avian Influenza A/(H5N1) Reported to WHO(Cambodia, China, Egypt, Indonesia)

0

10

20

30

40

50

60

2003 2004 2005 2006 2007 2008 2009 2010 2011

Cambodia

China

Egypt

Indonesia


INFLUENZA VACCINE STRAIN SELECTION

INFLUENZA VACCINE STRAIN SELECTION


Feb Mar Apr May Jun Jul Aug Sep OctWHO

Recom.NRA

SRDRgts

HGR SRD serum

SRD Ag

Batch release

Vacc. available

Seed Vaccine production/formulation/QC

Ag

trial vaccineClinical

Clinical trial MA

Public sectorVaccine manufacturers

Vaccine availabilityTime is of the essence

Vaccine availabilityTime is of the essence

Counting by WEEKS … by DAYS …

North

South


INFLUENZA DISEASE SURVEILLANCE INFLUENZA DISEASE SURVEILLANCE


Impact of seasonal influenza in:

� Temperate countries:World-wide (annual estimates)3

– 250, - 500,000 deaths; extrapolation from industrialized world in 20021Molinari et al. 2007;

2Pitman et al. 2007;

3WHO 2005

� East and SE Asia (Hong Kong SAR, China):– Children and elderly most affected– Mortality rates similar to USA

� Sub-Saharan Africa (1980-2009): – 1-25% of outpatient ARI visits were due to influenza (n=11)

– 0.6-15.6% of children hospitalized for ARI had influenza identified (n=15)

– Influenza was highly seasonal in southern Africa

Disease and epidemiological surveillanceDisease and epidemiological surveillance


INFLUENZA VACCINE POLICY INFLUENZA VACCINE POLICY


Countries Providing Seasonal Influenza Vaccination Countries Providing Seasonal Influenza Vaccination

in National Immunization Schedulein National Immunization Schedule

Source: WHO seasonal influenza survey 2010, 193 WHO Member States. Data as of February 2011

Countries without seasonal influenza vaccination in national programme

Countries with seasonal influenza vaccination in national vaccination programm

in 2010

Countries plan to have seasonal influenza vaccination in national programme by

2012

Countries offer seasonal influenza vaccination not

in national programme but in private sector

Countries which data are currently not available

and pending on the new regional survey in 2011


3/46

27/35

7/22

40/53

2/11

8/27

0

10

20

30

40

50

60

70

80

90

100

AFRO AMRO EMRO EURO* SEARO WPRO

2008 JRF survey

2010 WHO and other surveys

6/27

32/35

Member States with Seasonal Influenza in National Immunization Schedule by region

Member States with Seasonal Influenza in National Immunization Schedule by region

%

•* based on VENICE survey in 2008 and JRF survey in 2008 - 2009


Distribution of Seasonal Influenza Vaccine Use2004 - 2009 by WHO Region

Distribution of Seasonal Influenza Vaccine Use2004 - 2009 by WHO Region

Source: IFPMA – Options for the control of influenza (Hong Kong, 3-7 September 2010)


% of countries by region recommending seasonal

influenza vaccination for specific target groups, 2010

% of countries by region recommending seasonal

influenza vaccination for specific target groups, 2010

78%92%85%54%64%WPR

100%100%100%0%100%SEAR

85%100%100%41%22%EUR

89%100%67%22%11%EMR

87%67%90%50%79%AMR

n/an/an/an/an/aAFR

Essential

Personnel

including HCWs

At-risk groupsElderly

>65 AdultsChildren

% of countries by region recommending seasonal influenza vaccination for specific target groups, 2010

Region

Source: WHO 2010 Global Survey for the mapping of seasonal influenza vaccine


At risk groups recommended for annual seasonal influenza vaccination at global level (n=75)

At risk groups recommended for annual seasonal influenza vaccination at global level (n=75)

0 % 10 % 2 0 % 3 0 % 4 0 % 5 0 % 6 0 % 7 0 % 8 0 % 9 0 %

P r e gna nc y

He pa t i c di se a se s

HI V/ A I DS

Ha e ma t o. / me t a bol i c di sor de r s

I mmune D i sor de r s

Re na l

Ca r di ov a sc ul a r

Chr oni c pul mona r y

% Countries

Source: WHO 2010 Global Survey for the mapping of seasonal influenza vaccine


Challenges

� Low proportion of Member States with seasonal influenza vaccination as part of the national immunization programme (46% in 2010, 50% in 2012)

� Few countries are on target to meet WHA 56.19 (75% coverage in elderly),

� High vaccine costs, competing priority and public opinion on thevaccine may play a major role in the above.

� Vaccine coverage data is still very limited as the majority of the Member States are unable to calculate coverage by target group due to the reasons such as its registration system and denominators


PANDEMIC PREPAREDNESS PLAN PANDEMIC PREPAREDNESS PLAN


WHO MS with publicly available Pandemic Preparedness Plans before the Pandemic (H1N1) 2009

WHO MS with publicly available Pandemic Preparedness Plans before the Pandemic (H1N1) 2009

Source: Comparative Analysis of national pandemic influenza preparedness plans, 2011


National Pandemic Preparedness Plans (PPP)National Pandemic Preparedness Plans (PPP)

Cumulative number of countries with

Pandemic Preparedness Plans published

0

20

40

60

80

100

120

140

160

180

2002 2003 2004 2005 2006 2007 2008 2009

Sources: SPC, World Bank, WHO

TOTAL: 168 National PPP

11No data

22002

142009

62008

122007

682006

402005

12004

12003

National PPPYear of Publication


OBJECTIVE 2.

Increase in production capacity

OBJECTIVE 2.

Increase in production capacity


Vaccine Production Targets 2015Vaccine Production Targets 2015

Two targets have been pursued: Target 1 is the 2006 GAP target; Target 2 is based on evidence of herd immunity*.

� Target 1: Vaccinate 100% of the world with 2 doses of pandemic vaccine within 6 months of availability of pandemic strain

� Target 2: Vaccinate 70% of the world with 2 doses of pandemic vaccine within 6 months of availability of pandemic strain

* protecting one group against a disease by vaccinating another group


Global mapping of production capacityGlobal mapping of production capacity

Global pandemic influenza vaccine production capacity is still insufficient

- Annual vaccine production: ~ 850 million doses

- Estimated annual vaccine production

capacity (2015): 1.7 billion doses

Strategies to increase production capacity include:

�Shifting to higher yielding technologies including live attenuated vaccine and use of adjuvants

�Building (and maintaining) new capacity


Seasonal trivalent vaccine

production capacity (2009 survey)

Seasonal trivalent vaccine

production capacity (2009 survey)

387.7107.5368.6656.7Companies A

483.7112.5461.1852.0*All

96.05.092.5195.3Companies B

2009 planned Northern hemisphere production

(106 doses)

2009 Southern hemisphere production

(106 doses)

2008 Northern hemisphere production

(106 doses)

Total annual capacity

(106 doses)

Manufacturers

Companies A: capacity to produce at least 2.106 doses of novel H1N1 vaccine per week

Companies B: capacity to produce less than 2.106 doses of novel H1N1 vaccine per week

* Not including LAIV (MedImmune)


Even with the projected expansion, multinational capacity will be

insufficient to allow access of developing countries to pandemicvaccine in a timely manner.

Even with the projected expansion, multinational capacity will be

insufficient to allow access of developing countries to pandemicvaccine in a timely manner.

Source: Expert interviews; company statements; news articles; UBS Report: “Flu Vaccine Capacity Outstripping Demand” – Nov. 2006; Oliver Wyman analysis.

0 M

500 M

1,000 M

1,500 M

2,000 M

2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

Future production capacity (2008 – 2016)Seasonal doses per year, assuming 10 months of operation

Cell-culture

Egg-based

634M 652M

888M

1,003M 1,031M

1,094M

1,642M1,717M

Assumed flat (no

current basis for

projection)


GAP Technology Transfer ProjectGAP Technology Transfer Project

� Help developing countries to develop influenza vaccine manufacturing capabilities and capacity for pandemic readiness

� Help achieve sustainable influenza vaccine production capacity


Major AccomplishmentsMajor Accomplishments

� Financial and technical assistance was provided to 11

developing country manufacturers:

– Brazil -- Indonesia -- Mexico -- Thailand

– Egypt -- Iran -- Romania -- Vietnam

– India -- South Korea -- Serbia

� 6 of the 11 have produced clinical lots of pandemic vaccine

� 4 have completed pandemic vaccine clinical trials

� 3 have licensed pandemic vaccine for human use

� A royalty-free licensed for LAIV technology was granted to 2 DC manufacturers. Others are being identified


The boundaries and names shown and the designations used on this map do not imply the

expression of any opinion whatsoever on the part of the World Health Organization

concerning the legal status of any country, territory, city or area or of its authorities, or

concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent

approximate border lines for which there may not yet be full agreement.

©WHO 2010. All rights reserved.

Countries with influenza vaccine

production capacity in 2006

Countries with new or planned influenza

vaccine production capacity after 2006

The boundaries and names shown and the designations used on this map do not imply the

expression of any opinion whatsoever on the part of the World Health Organization

concerning the legal status of any country, territory, city or area or of its authorities, or

concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent

approximate border lines for which there may not yet be full agreement.

©WHO 2010. All rights reserved.

Countries with influenza vaccine

production capacity in 2006

Countries with new or planned influenza

vaccine production capacity after 2006

Instituto ButantanBrazil

BirmexMexico

Serum Instof India

India

BioFarmaIndonesia

Green Cross

Rep of Korea

VacseraEgypt

Razi Institute

Iran

IVAC Vietnam

GPOThaland

TorlakSerbia

CantacuzinoRomania

Countries with influenza vaccine production capacity in 2006 following WHO Technology transfer initiative

Countries with influenza vaccine production capacity in 2006 following WHO Technology transfer initiative


It is essential to:

technical and financial support for the new Sustain both -until registration of a productmanufacturers

National Strengthen capacity of their respective -Regulatory Authorities;

served regions, notably -Initiate new projects in under-Saharan Africa and Central Asia. Eight new -sub

were reviewed in May 2011proposals

- Expand the types of technologies currently available under the GAP

Next steps for the technology transfer

initiative

Next steps for the technology transfer

initiative


OBJECTIVE 3.

Further research and development

OBJECTIVE 3.

Further research and development


GOAL:

Support the development of evidences needed to strengthen

public health guidance and actions essential for limiting the

impact of influenza on individuals and populations

WHO Public health research agenda for influenzaWHO Public health research agenda for influenza

Stream 1. Reducing risk of emergence of pandemic

influenza

Stream 2. Limiting spread of pandemic, zoonotic and seasonal influenza

Stream 3. Minimizing impact of pandemic, zoonotic and seasonal influenza

Stream 4. Optimizing treatment of patients

Stream 5. Promoting development and application of

modern public health tools in influenza control


Research Recommendations :

• Determining disease burden and social impact

• Improve immunogenicity, availability and delivery of influenza vaccines

• Public health policies to reduce the impact of disease

Stream 3. Minimizing the impact of influenzaStream 3. Minimizing the impact of influenza


Currently licensed Influenza Vaccine Production technologies

Currently licensed Influenza Vaccine Production technologies

� Egg-derived inactivated split

� Egg-derived inactivated whole virion

� Tissue-culture derived inactivated virus (split or whole)

� Egg-derived Live Attenuated Influenza Vaccine (LAIV)


Characteristics of current influenza vaccines

Characteristics of current influenza vaccines

� Safe and efficacious

� Formulated and standardized based on HA content to induce neutralizing antibodies

� Vulnerable to drift/shift of HA and NA

� Long established production processes primarily in eggs

� Require constant reformulation (northern and southern hemispheres)

� Suffer from unpredictable yields and growth properties

� Poorly responsive to surge capacity for a pandemic outbreak


Goal:

Development of technology that will address unmet needs

Low Cost

Capacity

Safety

Rapid Response

Simple Manufacture

• Live attenuated influenza viruses (LAIV)

• Recombinant virus-like

particles (VLPs)

• Plant-based production of

vaccines• “Universal” influenza vaccine

Need for new high performance

Platform Technologies

Need for new high performance

Platform Technologies


An additional GAP strategy (since 2008)An additional GAP strategy (since 2008)

� Ensure access to pandemic vaccine in low and middle

income countries through establishment of a stockpile of

H5N1 vaccine

� 150 million doses pledged by manufacturers

� Logistics and strategy under review by the WHO Strategic

Advisory Group of Experts in Immunization (SAGE) in the

light of lessons learnt during the pandemic


Advisory structures in WHO for GAPAdvisory structures in WHO for GAP

� SAGE H5N1 Working Group

(Chaired by Dr Supamit)

� SAGE H1N1 Working Group (Chaired by Dr Salisbury)

� SAGE influenza Working Group (Chaired by Dr Miller)

� TAG for the Technology

transfer initiative

� GAP Advisory Group (Chaired by Dr Pathom)

Our most sincere gratitude for their critical strategic

and technical advice


Current context of the GAPCurrent context of the GAP


Current ContextCurrent Context

IHR RC PIP

GAP

TechTransfer

R&D

VaccineVaccine

Antivirals

Diagnostics

Virus sharingSurveillance

Preparedness

Research agenda

Responds


IHR recommendationsIHR recommendations

Recommendation 7. Revise pandemic preparedness guidance.

Recommendation 8. Develop and apply measures to assess severity.

Recommendation 11. Set up advance agreements for vaccine

distribution and delivery.

Recommendation 14. Reach agreement on sharing of viruses and access to vaccines.

Recommendation 15. Pursue a comprehensive influenza research programme.


PIP Framework PIP Framework

� Pandemic influenza preparedness system for sharing of H5N1 and other influenza viruses with human pandemic potential

� Pandemic influenza preparedness benefit sharing system � Pandemic risk assessment and risk response

� Provision of PIP Candidate Vaccine Viruses

� Provision of diagnostic reagents and test kits

� Provision of reference reagents for potency determination of vaccines

� Laboratory and influenza surveillance capacity building

� Regulatory capacity building

� Antivirals stockpiles

� Pandemic influenza preparedness vaccine stockpile

� Access to vaccines in the inter-pandemic period for developing countries

� Access to pandemic influenza vaccines

� Tiered pricing

� Technology transfer

� Sustainable and innovative financing mechanisms


ConclusionConclusion

My personal assessment:

� Impressive progress over five years

� Clear need to pursue and amplify the effort in all GAP

strategies

Next steps:

� Seek your collective input and advice

� Revise the GAP strategies >>> GAP - II

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