Emergency Vaccination and Stockpiles (EVS)

Development of an operational

plan for distribution of Ebola

vaccines Alejandro Costa

Emergency vaccination and stockpiles

Emergency Vaccination and Stockpiles (EVS)

Goal: best use of limited supplies

Principles

– Equity and transparency, pre-established criteria

– Appropriate; scientific and ethical use

– Information sharing

– Decisions made by consensus

Deployment plan

Emergency Vaccination and Stockpiles (EVS)

WHO stockpile mechanism - components

1. Criteria for release, distribution, use (vaccination strategy)

2. Decision making process: ICG, IHR, PIP, Expert Committee

3. Procurement, donation, governance

4. Logistic feasibility: storage, transport, security, areas in conflict,

acceptability

5. Regulatory: license, WHO PQ, EUA

6. Ethical and legal: informed consent, liability

7. Financing: emergency funds

Emergency Vaccination and Stockpiles (EVS)

WHO stockpiles

WHO

stockpile

Vaccine

availability

Criteria for

release and use

Vaccination

strategy

Regulatory

status

Feasibility/

ethics

Data

collection

Men, YF, OCV Limited Confirmed cases, EPI

data, district

prioritization

Control/ stop

the epidemic

Vaccines

licensed and PQ

Acceptability,

security

Vaccination

quality and

AEFIs

Pandemic

influenza

Limited ++ National

preparedness plan,

HCWs, children,

pregnant women

Mitigate

mortality and

morbidity

PQ. Not

licensed in all

recipient

countries

Cold chain

Prioritization

among

population

Not enforced

Smallpox Limited PHEIC, Close

contacts

Control, stop the

epidemic

Not licensed, not

PQ, expired

Security,

informed

consent

AEFI

mOPV2 Sufficient Confirmed

transmission. EPI

district data. Children

< 5y/o, <15 y/o

Time from

withdrawal.

Control, stop the

epidemic

PQ, not licensed

in all recipient

countries

Countries in

conflict

M&E, no more

WPV2/VDPVs

Ebola Limited ++++ HCWs, all population

at risk

Prioritization by

district??

Not licensed, not

PQ

Security in big

cities

Safety and

efficacy

Emergency Vaccination and Stockpiles (EVS)

Proposed criteria for deployment according

to vaccine availability 1. HCWs prioritization criteria

– # number of cases,

– size of the treatment unit,

– occupation, highest risk

– feasibility and data collection

2. All HCWs in the 3 or 5 affected countries

3. Most affected districts in SL, Guinea and Liberia:

– results of phase II/III already available, vaccine efficacy

– impact of vaccination

– feasibility of vaccination (district size, security, logistics)

– age groups, sex, pregnant women

4. Vaccination strategy: mass vaccination entire country, ring vaccination, borders

Emergency Vaccination and Stockpiles (EVS)

Deployment plan for emergency use Ebola

vaccines

Oct 2014 Dec 2014 Feb 2015 > Apr 2015

Vaccine availability #doses

VSV 800 3,000 ? ?

ChAd3 260 10,000 100,000? ?

Vaccine demand: Clinical

trial phase I #doses

VSV 250 - - -

ChAd3 260 - - -

Vaccine demand: Clinical

trial phase II/III #doses

VSV - 3,000 - -

ChAd3 - ? - -

Vaccine demand: potential

plan vaccination

Estimated # doses

HCWs Most

affected

all HCW +

essential staff

Most affected

districts

Entire 3

countries

1,000 20,000 ? 21,500,000

Total needed 2,570 23,000 ?

Emergency Vaccination and Stockpiles (EVS)

Decision making for vaccine deployment

Proposed Partnership: WHO secretariat, Technical expertise in

Ebola + Emergency response + Logistics and implementation

capacity

1. Médecins sans Frontiers (MSF),

2. International Federation Red Cross (IFRC),

3. Global Health Network (GHN),

4. International Severe Acute Respiratory and Emerging Infection Consortium

(ISARIC),

5. African Regulatory Forum (AVAREF)

Emergency Vaccination and Stockpiles (EVS)

Legal and regulatory issues

Ownership, WHO donation

Country request for vaccine, liability

Informed consent

NRA authorization for vaccine use

Data collection sharing