why do we need pdvac? what activities will pdvac oversee?€¦ · advising who on ways to improve...

World Health Organization 17 September, 2014

1

Why do we need PDVAC?

What activities will PDVAC

oversee?

Vasee Moorthy MRCP PhD

WHO Initiative for Vaccine Research,

Dept. Of Immunization, Vaccines & Biologicals,

Geneva

2

Proposed

Areas of Work,

Approaches

and,

Processes

Strategic Directions for Vaccine Research


2

3

Current

status DOV

GOAL

GAP

Current

status DOV

GOAL

GAP PRODUCT

DEVELOPMENT


3

Where can WHO's

vaccine research contribute ?

Assess and/or develop strategies/

approaches to expand coverage

and impact and improve delivery of

vaccines

Contribute to development/availability of

new or better vaccines/delivery

systems to address remaining BoD

Generate and/or synthesize and appraise

evidence for robust policy making

Vac

cin

es/p

rod

uct

s

licen

sed

an

d c

urr

entl

y in

use

Can

did

ate

vacc

ines

/ p

rod

uct

s u

nd

er

dev

elo

pm

ent

6

Gap in our processes identified: overseeing activities

related to upstream vaccine R&D

PDVAC convened during 2014: up to 15 members (13 constituted)

“The Product Development for Vaccines Advisory Committee

(PDVAC) will provide strategic advice and recommendations to

WHO related to vaccines at the Phase 2 stage of clinical evaluation

or earlier. The committee’s remit is for disease areas where there is

substantial disease burden in low and middle income countries, no

vaccines or products currently exist, and there is some ongoing

product development activity which may benefit from guidance from

WHO. This committee may also have a role where first generation

vaccines are licensed but development of improved second

generation products is a priority for WHO.”


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7

PDVAC terms of reference

This committee will be asked to advise on the following areas:

“scanning the horizon” to identify new diseases where there is sufficient priority for WHO to

initiate activities;

consensus building for vaccine trial endpoints for vaccine policy decision making;

initiating roadmap development;

prioritizing and advising on development of WHO preferred product characteristics to guide

target product profiles in use by vaccine manufacturers and funding agencies;

reviewing other WHO products, including methods, protocols, tools and approaches for

accelerating product development;

stimulating research by partners in line with WHO priorities; and

advising WHO on ways to improve public access to information about products in

development.

8

Pathways for WHO Recommendations on

Vaccine Use

SAGE

Relevant existing

technical advisory

committee

Background

Paper Global Advisory

Committee on

Vaccine Safety

Expert committee

on Biological

Standardization

Regional TAGS

Regional

consultations

WHO

Position Paper

WHO DG

Secretariat

SAGE

working group

Input

Request for review of

evidence

Country

Decision

making

Recommendations

Other relevant non immunization

related WHO policy

recommendation making body

Immunization and

Vaccines related

Implementation

Research Advisory

Committee

Industry and

other partners

Product Development for

Vaccines Advisory

Committee


5

9

MODEL:

– Identify partner often from Product Development Partnership

– Provide template

– Submitted pipeline analysis is reviewed by WHO

– Then submitted to committee members

– All will be published on PDVAC website after each meeting

– Core diseases will be reviewed each year including HIV, TB,

malaria

– Certain diseases will be reviewed less often than annually eg,

some pathogen areas with either small disease burden or little

activity.

Pipeline analyses

10

This year the following 19 pathogen specific areas were

requested as pipeline analyses:

HIV, Tuberculosis, Malaria,

Universal influenza, RSV

Group A Streptococcus, S. pneumoniae

Upstream rotavirus, E.coli, Shigella, Paratyphoid, Non-typhoidal

salmonella, campylobacter, norovirus

HSV, Chagas, Leishmaniasis, Schistosomiasis, Human Hookworm

Pipeline analyses


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Objectives

Review the state of progress and challenges of vaccine research

and development and the vaccine pipeline for selected pathogens

and disease areas

Prioritize and rank disease areas where clinical endpoints

consultations and Preferred Product Characteristics (PPCs) should

be developed.

Provide advice and recommendations to WHO on what could be its

specific priorities and role related to promoting and enabling the

development of vaccines for selected pathogens

12

Expected outcomes:

Recommendations for prioritization of WHO’s work

related to early stage vaccine R&D

Consensus reached on a ranking of disease areas

where clinical endpoints consultations and vaccine

Preferred Product Characteristics (PPCs) should be

developed.

Plan of further action 2014-2015 (pending

resources)


7

WHO Activities to encourage and

accelerate development of vaccines in early development

»TRIAL DESIGN: Consensus-building on key

endpoints for vaccine evaluation, including

case definitions (sometimes analysis methods)

» Global R&D roadmaps including strategic goals

to articulate priority unmet public health

needs

» Preferred Product Characteristics to

guide TPP processes

Provision of Trial Design Guidance in Novel

Vaccines Area

Complex Pathology?

Multiple Disease

Manifestations?

Lack of Consensus

on Choice of Endpoints?

Lack of existing

regulatory standards?

Prioritized vs other

requests to WHO?

Need Identified and Prioritized

Initiate Consensus-Building

Coordinate Provision

of Guidance at Phase 2b-3 stage

Forms Part of Consultation Process

for Later Regulatory Standards


8

Guidance on Clinical Evaluation

of Dengue & Malaria Vaccines

Broad

Based

Clinical

Consultation

Regulatory

Consultations

Technical

Report

Series …

•Primary clinical endpoints agreed: in both cases

“non-severe” endpoints were accepted as primary

•Safety: 2-3 years and greater follow-up needed

before consideration of WHO policy

recommendations

2 Strategic goals

reflecting priority unmet

public health needs to be

met by vaccines

13 priority activity areas

spanning research,

vaccine development,

key capacities, policy

and commercialization


9

17

Preferred Product Characteristics:

What they are & what they are not

What they are

Guidance from WHO for vaccine developers to take into account

when designing vaccines and trials at early stage of vaccine R&D

Will need to change in line with the scientific state-of-the-art and

needs of country programmes (with ongoing review process)

What they are not

They are not static exit criteria. Innovation is encouraged and

harnessed to meet public health needs

They do not replace standard policy or PQ processes

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Preclinical

Development

Phase 1 Phase 2 Phase 3

Prequalification

Policy

Recommendations

Linking Vaccine R&D & Public Health:

Preferred Product Characteristics (PPC)

PPC


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Heading in TPP

documents

Guidance for

developers at early

stages

Evidence-based public

health recommendation

process

Assessment of

licensed vaccines for

possible

Prequalification

Indication PPC SAGE PQ team

Target population

& immunization

strategies &

schedules

PPC SAGE PQ team

Clinical

development

Pathways

PPC SAGE PQ team

Safety PPC GACVS & SAGE PQ team

Efficacy, including

endpoints, case

definitions,

PPC SAGE PQ team

Concomitant use PPC SAGE PQ team

Presentation VPPAG PSPQ

Packaging &

inserts

VPPAG PSPQ

Formulation &

Thermostability

VPPAG PSPQ

Labelling & VVM VPPAG PSPQ

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ALL THE MAJOR PRODUCT DEVELOPMENT

PARTNERSHIPS WORKING IN VACCINES

ENGAGEMENT FROM INDUSTRY & MANY

ACADEMIC GROUPS

INTEREST FROM R&D STAKEHOLDERS

HELP FROM WHO CCs (Johns Hopkins, UTMB,

Geneva University Hospital)

Zarifah Reed, Uli Fruth

THANK YOU

why do we need pdvac? what activities will pdvac oversee?€¦ · advising who on ways to improve...

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