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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


ContextContext


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


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


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


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


Pre-requisites for WHO prequalificationPre-requisites for WHO prequalification


Vaccines prequalification-PrinciplesVaccines prequalification-Principles

GMP

Reliance on NRA

Meeting WHO requirementsand tender specs

Consistency of finalproduct characteristics

Clinical data


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 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


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


WHO RequirementsWHO Requirements

Evolving regulatory Evolving regulatory issuesissues

Global written standardsGlobal written standardsQuality, safety and efficacyQuality, safety and efficacy Global measurement standardsGlobal measurement standards


New challenges and new solutionsNew challenges and new solutions


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


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


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


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


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


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


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

**

**


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


Further informationFurther information

? www.who.int/biologicals

? www.who.int/immunization

? www.who.int/vaccine_safety

WHO and prequalification of vaccines - Home page | … · 2010-09-02 · WHO and prequalification...

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