WHO and prequalification of vaccines
Vaccines Suppliers Meeting
UNICEF Supply Division, Copenhagen, Denmark
3-4 April 2008
Vaccine suppliers meeting | April 2008|
OutlineOutline
? Context
? Pre-requisites for WHO for prequalification
? New challenges and new solutions
Vaccine suppliers meeting | April 2008|
Vaccines prequalification- purposeVaccines prequalification- purpose
? A service provided by WHO to UN purchasing agencies (for vaccines; UNICEF and PAHO Revolving Fund)
? Provides independent opinion/ advice on the quality, safety and efficacy of vaccines, to qualify for purchase by the UN
? Ensures that candidate vaccines are suitable for the target population and meet the needs of the programme
? Ensures continuing compliance with specifications and established standards of quality
Vaccine suppliers meeting | April 2008|
Prequalification contributes to a World Health Organization GoalPrequalification contributes to a World Health Organization Goal
? Definition of “Assured quality Assured quality vaccinesvaccines”? National Regulatory Authority (NRA)
independent from vaccine manufacturer? NRA functional (system + 6 regulatory functions)
? No unresolved problem with vaccines
Guided by Expert Guided by Expert Committee on Committee on Standardization of Standardization of Biologicals (ECBS) Biologicals (ECBS) recommendationsrecommendationson on safetysafety, , efficacy efficacy and and qualityquality issued issued in WHO Technical in WHO Technical Report Series (TRS)Report Series (TRS)
Ensure that ““100%100%””of vaccines used in all national immunization
programmes are of assured quality
Vaccine suppliers meeting | April 2008|
Assured quality vaccines prequalified by WHO
used in 112 countries
used in 112 countries
53% total population
53% total population
65 pre-qualified
vaccines
65 pre-qualified
vaccines
24 manufacturers
24 manufacturers
6developing countries
14industrialized
countries
? India? Indonesia? Senegal
? Cuba
? Brazil? Bulgaria
? Japan? Rep.Korea? USA? Switzerland? Sweden
? Italy
? Germany? The Netherlands? Hungary
? Denmark? France
? Australia? Belgium? Canada
Vaccine suppliers meeting | April 2008|
Vaccines Prequalification- Impact of the project
Vaccines Prequalification- Impact of the project
World Health Organization, HTP/V&B/ATT. LBelgharbi
Number of countriesTotal = 193 countries
84
65
44
UN agency Procuring Producing
NRA andManufacturerstrengthened
Seal of qualityrequirement for procurement
Assured Quality;country's regulatoryresource (often limited) used for other purposes
Vaccine suppliers meeting | April 2008|
Pre-requisites for WHO prequalificationPre-requisites for WHO prequalification
Vaccine suppliers meeting | April 2008|
Vaccines prequalification-PrinciplesVaccines prequalification-Principles
GMP
Reliance on NRA
Meeting WHO requirementsand tender specs
Consistency of finalproduct characteristics
Clinical data
Vaccine suppliers meeting | April 2008|
Vaccines prequalification- Reliance on NRAVaccines prequalification- Reliance on NRA
? The responsible National Regulatory Authority (usually that of the producing country) is independent and functional:
? Meets all the critical indicators required for prequalification purposes following a WHO independent assessment
? The status of the NRA is reassessed at regular intervals
Vaccine suppliers meeting | April 2008|
Vaccine sourceUN agencyUN agency Direct
ProcurementDirect Procurement ProductionProduction
Functionsassuredby NRA ofproducingcountry and
WHO PQ system
Functionsassuredby NRA ofproducingcountry and
WHO PQ system
Fuctions assuredby NRA ofproducingcountry
Fuctions assuredby NRA ofproducingcountry
Regulatory functions depending on vaccine source
Licensing
Access to laboratory
Regulatory inspections
Lot releaseAEFI monitoring
Regulation System
???
?
???
???????
?Regulatory functions
Authorization of clinical trials
Vaccine suppliers meeting | April 2008|
31
7751
1512
13
0102030405060708090
UN Agency Procuring Producing
Achieved Not achieved
Number of countries exercising all regulatory functions relevant to their
source of vaccine, Dec.2007
Num
ber
of c
ount
ries
65 Countries
44 Countries
84 Countries
Vaccine suppliers meeting | April 2008|
WHO RequirementsWHO Requirements
Evolving regulatory Evolving regulatory issuesissues
Global written standardsGlobal written standardsQuality, safety and efficacyQuality, safety and efficacy Global measurement standardsGlobal measurement standards
Vaccine suppliers meeting | April 2008|
New challenges and new solutionsNew challenges and new solutions
Vaccine suppliers meeting | April 2008|
New challengesNew challenges
? Regulation of new vaccines :– Responsibility falls more on Developing Countries, which are increasingly
producing new vaccines, and less on industrialized Countries, which are losing their manufacturing base
– Countries have insufficient expertise and experience to assess data and dossiers (Manufacturing, preclinical and clinical data, etc.)
? NRAs must acquire new skills
? Clinical trials for new vaccines– Are being run in ANY country, no matter the expertise/strength of their
National Regulatory Authority
?Quality of the trials must be guaranteed
Vaccine suppliers meeting | April 2008|
Source of vaccinesUN agencyUN agency ProcureProcure ProduceProduce
National Regulatory Functions recommended for vaccine development
Regu
lator
y fu
nctio
ns
???
?
???
???????
?Regulatory functions
? ?CTs : Clinical trials, UN: United Nations, AEFI: Adverse Events Following Immunization
Marketing Autorization & Licensing activities
Laboratory access
Regulatory inspections
Lot release
Authorization & monitoring of CTs
Postmarketing: AEFI
Regulatory system
For countries conducting Clinical Trials
Vaccine suppliers meeting | April 2008|
Responding to challengesResponding to challenges
? Development of new regulatory pathways
? Development of new support mechanisms for regulatory authorities
? Revision of the prequalification and NRA assessment procedures
? Defining priorities for prequalification
? Sentinel networks for new vaccine safety evaluations
Vaccine suppliers meeting | April 2008|
African Vaccine Regulators Forum (AVAREF)
African Vaccine Regulators Forum (AVAREF)
? Initiated in 2006 to support NRA assessment of clinical trial applications and monitoring of clinical trials as well as evaluating clinical data in registration dossiers
? Consists of plenary meetings (2 to date) plus support activities between meetings; joint WHO/HQ/AFRO activity
? 19 countries involved; NRA and National Ethics Committee representatives
? Highly appreciated
Vaccine suppliers meeting | April 2008|
AVAREF achievementsAVAREF achievements
An historical moment : For the 1st time in Africa, regulators and ethics committee members from Burkina Faso, The Gambia, Ghana, Ethiopia and Mali conducted an inspection of Good Clinical Practice (GCP) inspection of phase ii observer-blind, randomized, active controlled clinical trial of meningococcal a conjugate vaccine at the Centre for Vaccine Development (CVD), Bamako, Mali; January, 2007
Vaccine suppliers meeting | April 2008|
Global Network for Post-marketing Surveillance of New Vaccines
Global Network for Post-marketing Surveillance of New Vaccines
?To support WHO vaccine prequalification system with safety data in post-marketing phase
Objectives:
? Ensure standardised approach to monitoring serious adverse events
? Identify/address potential safety signals in timely manner
? Ensure adequate safety information to support vaccination policy and recommendations?may include recommendations for more controlled
studies e.g., in response to "signals" of potential adverse reactions
Vaccine suppliers meeting | April 2008|
Global PMS Network: Functional structureGlobal PMS Network: Functional structure
*
*
Uppsala Monitoring Centre
(Signal detection)
Network management group: Member countries, WHO (ROs + HQ),
experts/advisors (descriptive analysis, time series, trends,
rates, specific studies)* Monthly, or “ad hoc”reporting
** Quarterly feed-back
NRA/EPI/National PV Centre
(data collection, validation,
descriptive analysis)
UNICEF/PAHO RFManufacturersTechnical oversight
cttee/GACVS
**
**
Vaccine suppliers meeting | April 2008|
ConclusionsConclusions
? Vaccine prequalification and supporting activities have:
- Strengthened NRA's
- Increased supply of vaccine of assured quality
? Vaccine prequalification and supporting activities will:
- Continue to respond to new challenges such as establishing PMS surveillance network
- Respond to increasing demand
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