A19 December 2014 1 |

Accelerating access to Ebola vaccines

From research to

large-scale use

Dr Marie-Paule Kieny

Assistant Director General HIS

A19 December 2014 2 |

2,164

7,635

7,312

1,327

3,145

1,583

0 2,000 4,000 6,000 8,000 10,000

Guinea

Liberia

Sierra Leone

Cumulative deaths Cumulative cases

Num

ber

of

cases

Ebola response roadmap: Situation report 3 December 2014

Sierra Leone

Liberia

Guinea

A19 December 2014 3 | 3

Ebola recombinant protein

Protein Sciences

(1st trimester 2015 )

DNA expressing Ebola glycoprotein with

electrophoration. Inovio (2015)

Alternate rVSV Ebola vaccine

Profectus

(mid- 2015)

Recombinant rabies virus

Thomas Jefferson Univ. (2015)

Adenovirus, lentivirus and influenza virus

based Ebola candidates. Russian candidates

(2015)

Ebola recombinant nanoparticle

with Matrix M adjuvant

Novavax

(1st quarter 2015)

Ebola vaccines under Preclinical evaluation

Jan 2015 Dec 2015 June 2015

Description, developer

(estimated date when clinical

testing will start)

HPIV-3 live attenuated

Intranasal (two versions), NIAID

(March/April 2015)

Rabies Ebola gp inactivated,

Intranasal, NIAID (2015)

Oral adenovirus 5 Ebola vaccine

Vaxart

(1st quarter 2015)

A19 December 2014 4 |

rVSV-ZEBOV Recombinant vesicular stomatitis virus

It aims to induce EVD-specific immune responses.

NewLink Pharmaceuticals?Merck

ChAd3-ZEBOV

Chimpanzee adenovirus 3 It uses a chimpanzee adenovirus that does not grow,

containing the gene for EVD surface protein.

GSK/NIAID

Ebola vaccines under clinical

evaluation in 2014

Kanapathipillai R et al. N Engl J Med 2014. DOI: 10.1056/NEJMp1412166

Ad26/Ad35/MVA Johnson and Johnson Crucell

A19 December 2014 5 |

Ebola vaccine research and anticipated

development timelines (information available to WHO as of Dec 8, 2014)

Sep Oct Nov Dec Jan Feb Mar Apr May June June Aug

Expected date

start enrollment

Expected date

preliminary results

would be available

ChAd3

rVSV

Ad26

USA P1

Mali

Switzerland

USA

USA

Switzerland

Germany

Gabon

UK P1 P1

P1

P1

P1

P1

P1

P1

Kenya P1

TBD P2

Four African countries P2

USA P2

Guinea P3

Sierra Leone P3

Liberia P3

TBD P3

TBD P1

2014 2015

A19 December 2014 6 |

Matching vaccine supply to potential

target populations

1

10

100

1000

10000

100000

Q3 2014 Q4 2014 Q1 2015 Q2 2015 Q3 2015 Q4 2015

Cu

mula

tive n

um

be

r o

f d

ose

s

(tho

usan

ds-l

og

sca

le)

Anticipated number of doses of Ebola vaccine that would be released

ChAd3 rVSV (1e6) rVSV (1e7) rVSV (5e7) Ad26

All front line workers= 91,600

All adults > 15 years of age= 12 million

All population-3 countries: 20 million

A19 December 2014 7 |

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Ebola vaccines: WHO Oversight RESEARCH AND DEVELOPMENT PATHWAY Strategic and Technical Advisory Committee on Experimental Ebola Therapeutics and Vaccines

(STAC-EE): Review of development plan, expert opinion on protocol design, and interpretation of data

emerging from trials

REGULATORY MATTERS African Vaccine Regulators Forum (AVAREF): Review of IND application: Protocols, IB, Ethics and

informant consent

WHO Advisory Committee on Regulatory Emergency Authorization of unlicensed Ebola Vaccines:

Review of GMP, evidence on safety and efficacy, programmatic suitability. Time limited authorization

for use

SAFETY AND RISK ASSESSMENT WHO Ebola Vaccines Risk Assessment Group and WHO Global Advisory Committee on Vaccine

Safety: Evaluation of safety data and opinion on potential risks and benefits.

POLICY AND IMPLEMENTATION Strategic Advisory Group of Experts (SAGE) : Review of evidence to inform policy considerations for

large scale use, if appropriate

Task Force on Immunization (TFI): Operational implementation and monitoring in Africa

A19 December 2014 8 |

Ebola Vaccines - Key milestones

Sept - Oct 2014 2nd to 3rd Q 2015 Nov-Dec 2014

Agreed protocols

(including Phase 3) trials

across sites

Preparation started of

sites for Phase 3 studies in

Ebola affected countries

Start of Phase 3 trials in

Ebola affected countries

Jan-Feb 2015

Start of Phase 2 trials

Preliminary

results

vaccine efficacy

available

Initial safety and

immunogenicity

from most Phase 1

trials available

Initiation of Phase 1

trials for the two

most advanced

vaccines

A19 December 2014 9 |

Accelerated efforts are underway to evaluate a number of Ebola

vaccines. Preliminary results anticipated:

o Phase 1 data: Dec 2014

o Phase 2 data: 1st Quarter 2015

o Phase 3 data: 2nd to 3rd Quarter 2015

Analysis of anticipated supply and potential target populations

suggest that doses would match demand as follows:

o 1st Quarter 2015: Front line workers

o 3rd Quarter 2015: Adults (older than 15 years of age or geographic target

areas strategies)

o 2nd to 4rd Quarter 2015: All populations in 3 worst affected Ebola

countries

WHO has set in place the required oversight to ensure quality and

compliance with ethical and regulatory matters, to develop policy

recommendations and vaccine roll-out as appropriate

A19 December 2014 10 |

"The vaccine is not the magic

bullet.

But when ready, they may be a

good part of the effort to turn the

tide of this epidemic.”

A19 December 2014 11 | 11

Thank you