gr-who pre qualification program

8/8/2019 GR-WHO Pre Qualification Program

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WHO Vaccine

Prequalification

Program

New Cells, New Vaccines V

Global Perspectives


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PATHs vision

A world where

innovation ensures that

health is within reach

for everyone.


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Advancing technologies Strengthening systems

Encouraging healthy behaviors

Improving the health of people around

the world by:

M.Dorgabeko

PATHs mission


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PATHs vaccine development

projects

Pneumococcal disease

Diarrheal disease

Rotavirus

EnterotoxigenicE. coliandShigella

Influenza

Malaria

Meningococcal disease

Japanese Encephalitis


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Establishing partnerships

Partners: industry, academia, nongovernmental

organizations, and government agencies.

Partnerships direct R&D, manufacturing, anddistribution strengths toward novel

technologies.

Collaborations must lead to improved

availability, accessibility, and affordability ofvaccines.

PATH negotiates partnerships to ensure global

access.


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PATH and the WHO

Prequalification Program

WHO Prequalification Program helps

maintain an assurance of Quality Control and

post-marketing surveillance

Some developing country National

Regulatory Authority (NRAs) depend on WHO

prequalification as an assurance of vaccine

quality


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WHO Vaccine Prequalification

Program

The World Health Organization through its

Department of Immunization, Vaccines

and Biologicals, provides advice to theUnited Nations Childrens Fund (UNICEF)

and other United Nations agencies on the

acceptability, in principle, of vaccines

considered or purchase by such agencies.


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Principles

Reliance on National Regulatory Authority of the

producing country

Understanding of production process and qualitycontrol (QC) methods

Production consistency ensured through good

manufacturing practices (GMP) compliance

Random testing for compliance with specifications

Monitoring complaints in the field


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National Regulatory Authority

Reliance on the national regulatory authority

(NRA) of the country of manufacture which is

required to be "functional", i.e. meeting thepublished WHO NRA indicators for

prequalification purposes.


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NRA Functional Indicators

Statutory basis (Legislative) for establishment of

regulatory system and enforcement power

Quality system(s) for each NRA function

Independence of the regulatory system in decision

making

Recall system with mechanism to ensure the properdisposition/disposal of affected lots

NRA institutional development plan

Transparency and public accountability


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High Priority Vaccines

Bivalent oral polio vaccine (bOPV) (1,3)

Dengue vaccine

DTwP-HepB-HiB

Inactivated polio vaccine (IPV)

Influenza seasonal vaccines

Measles and measles-containing vaccines

Meningitis A containing conjugate vaccines

Monovalent oral polio vaccines (1,2,3)

Pneumococcal vaccines

Rotavirus vaccine

Yellow fever vaccine


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Obligations after prequalification

is granted Annual reporting

Reassments

Monitoring continued compliance with

specifications through targeted testing

program

Monitoring vaccine quality complaints or

AEFIs from the field (Adverse Events FollowingImmunization)


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Annual Reporting

Summary of changes/variations to the product(s)

Production and distribution data

GMP inspections (if PQ product within scope)

Summary of post PQ commitments from

manufacturer

Adverse Events Following Immunization

Reports of Quality complaints/recalls

Notification of problem/constraint in production or quality

control that might affect international supply, volume or lead

time


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Reassessments

Stringency of oversight exercised by responsible NRA

Prior experience with manufacturer and specific product

Variations of the product indicated in Annual Reports

Interruptions of production/supply to UN agencies

Reported quality complaints and AEFIs

Any failure to meet WHO recommendations/specifications

of the offer to bid

Results from targeted testing of batches supplied to UN

agencies


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Assurance of Continued

Acceptability

Reassessments at requested intervals

Targeted testing program of lots supplied

through UN agencies

Monitoring for failure to meet specifications

Follow up of complaints and reports ofadverse event following immunization.


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Vaccine Vial Monitors (VVM)


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What is a VVM?

A vaccine vial monitor (VVM) is a label containing a

heat sensitive material which is placed on a vaccine

vial to register cumulative heat exposure over time.

VVM is the only tool among all time temperature indicators that

is available at any time in the process of distribution and at the

time a vaccine is administered indicating whether the vaccine

has been exposed to a combination of excessive heat over timeand whether it is likely to have been damaged. It clearly

indicates to health workers whether a vaccine can be used.

(WHO)


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How Does the VVM Work?


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VVM Reaction Rates

Category (Vaccine) Days

+37C

Days

+25C

Time to end

point +5C

VVM 30 (High stability) 30 193 >4 years

VVM 14 (Medium stability) 14 90 >3 years

VVM 7 (Moderate stability) 7 45 >2 yearsVVM 2 (Least stability) 2 NA 225 days

Vaccine Vial Monitor Reaction Rates by Category of Heat Stability


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Lessons Learned from VVM

use

VVMs prevent delivery of heat-damaged vaccine

VVMs detect cold chain problems

VVMs facilitate outreach

VVMs are cost effective

When heat exposure occurs, VVMs indicate which

vials can be saved

Lessen cold chain requirements

VVMs facilitate a multi dose vial policy


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George A. Robertson, PhDSenior Technical Advisor

Vaccine Development Global [email protected]

202.822.0033

WWW.PATH.ORG

gr-who pre qualification program

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