gr-who pre qualification program
Post on 09-Apr-2018
220 Views
Preview:
TRANSCRIPT
-
8/8/2019 GR-WHO Pre Qualification Program
1/22
WHO Vaccine
Prequalification
Program
New Cells, New Vaccines V
Global Perspectives
-
8/8/2019 GR-WHO Pre Qualification Program
2/22
2
PATHs vision
A world where
innovation ensures that
health is within reach
for everyone.
-
8/8/2019 GR-WHO Pre Qualification Program
3/22
3
Advancing technologies Strengthening systems
Encouraging healthy behaviors
Improving the health of people around
the world by:
M.Dorgabeko
PATHs mission
-
8/8/2019 GR-WHO Pre Qualification Program
4/22
4
PATHs vaccine development
projects
Pneumococcal disease
Diarrheal disease
Rotavirus
EnterotoxigenicE. coliandShigella
Influenza
Malaria
Meningococcal disease
Japanese Encephalitis
-
8/8/2019 GR-WHO Pre Qualification Program
5/22
5
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.
-
8/8/2019 GR-WHO Pre Qualification Program
6/22
6
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
-
8/8/2019 GR-WHO Pre Qualification Program
7/22
7
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.
-
8/8/2019 GR-WHO Pre Qualification Program
8/22
8
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
-
8/8/2019 GR-WHO Pre Qualification Program
9/22
9
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.
-
8/8/2019 GR-WHO Pre Qualification Program
10/22
0
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
-
8/8/2019 GR-WHO Pre Qualification Program
11/22
11
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
-
8/8/2019 GR-WHO Pre Qualification Program
12/22
12
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)
-
8/8/2019 GR-WHO Pre Qualification Program
13/22
13
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
-
8/8/2019 GR-WHO Pre Qualification Program
14/22
14
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
-
8/8/2019 GR-WHO Pre Qualification Program
15/22
15
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.
-
8/8/2019 GR-WHO Pre Qualification Program
16/22
16
Vaccine Vial Monitors (VVM)
-
8/8/2019 GR-WHO Pre Qualification Program
17/22
17
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)
-
8/8/2019 GR-WHO Pre Qualification Program
18/22
-
8/8/2019 GR-WHO Pre Qualification Program
19/22
19
How Does the VVM Work?
-
8/8/2019 GR-WHO Pre Qualification Program
20/22
20
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
-
8/8/2019 GR-WHO Pre Qualification Program
21/22
21
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
-
8/8/2019 GR-WHO Pre Qualification Program
22/22
22
George A. Robertson, PhDSenior Technical Advisor
Vaccine Development Global Programgrobertson@path.org
202.822.0033
WWW.PATH.ORG
top related