Overview of WHO revised vaccine prequalification procedure

Transcription

1 Overview of WHO revised vaccine prequalification procedure Carmen Rodriguez WHO/IVB/QSS Vaccine Industry Consultation meeting January 2012 UNICEF SD Copenhagen

2 Purpose of WHO vaccines prequalification programme A service provided to UN purchasing agencies. Provides independent opinion/advice on the quality, safety and efficacy of vaccines for purchase 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

3 Principles GMP Clinical data Consistency of final product characteristics Meeting WHO requirements and tender specifications Reliance on NRA

4 Pre- conditions for PQ evaluation Vaccine is licensed/registered by the responsible NRA (Scientific opinion by EMA accepted) WHO guidelines/recommendations available (published in the WHO Technical Report Series) Listed in the vaccine priority list (low priority vaccines may be postponed depending on workload and no priority vaccines will not be reviewed)

5 Prequalification process Scientific review of quality dossier Scientific review of clinical data Testing of samples Consultation with responsible NRA Site audit to manufacturing facilities Revised procedure in place from January 2012

6 Pre- evaluation and evaluation meetings with manufacturers and NRAs 3 deadlines for submissions, 3 technical review meetings 12 months evaluation (time taken by manufacturer excluded) Clock stop system PQ PROCEDURE GENERAL Increased portfolio of vaccines Prioritization system defined by UN agencies PQ status continuously monitored (before 2-5 years) Information published on WHO website (updated monthly)

7 Australia Belgium Canada Vaccines prequalified by WHO: Status 2010 (assured quality) 15 industrialized country mfrs 8 emerging economy country mfrs 29 manufacturers Denmark France The Netherlands Germany Hungary Italy Japan Rep. of Korea Switzerland Brazil Bulgaria Cuba India Indonesia Russia Senegal Thailand 127 pre-qualified vaccines used in 124 countries Sweden United Kingdom USA 64% total population

8 Rationale for revising the procedure CHANGING LANDSCAPE IN THE VACCINES ARENA Expectations about the PQ programme significantly increased in the last five years, with rich pipeline of novel vaccines, number and diversity of vaccines offered for prequalification has increased, trend expected to continue in coming years Large number of manufacturers working in vaccine development Innovative financing mechanisms accelerate access to greater diversity of vaccines Increased complexity of products, availability of new technologies, multiple production sites and partnerships Manufacturers from countries such as China and Thailand are emerging as important new clients Need to better define programmatically acceptable product characteristics Regulatory challenges (pathways)

9 Scope of the revision Technical Policy Communication

10 Main changes introduced (1) TECHNICAL Development of "Points to Consider" documents to guide manufacturers and reviewers on requirements for PQ: "Clinical considerations for evaluation of vaccines for prequalification" (finalized and published) "Environmental monitoring of clean Rooms in vaccine manufacturing facilities" (finalized and published) "Variations in vaccine manufacturing" (pending) Review based either on PSF or CTD type of dossiers with cross referencing to PSF format Development of procedures subordinated to the main prequalification procedure: updating of documentation to enable implementation of revised procedure (work ongoing) Development of document on acceptable product characteristics "Assessing the Programmatic Suitability of Vaccine Candidates for WHO prequalification" (Final draft endorsed by IPAC)

11 Main changes introduced (2) POLICY Establishment of rules for a risk-based approach to vaccines prequalification (streamlined procedure) Criteria and conditions for applying a streamlined procedure based on collaboration agreements with stringent NRAs (maturity levels to be established in NRA assessment programme) (ongoing) Streamlined procedure to be established Risk-based approach to reassessments (ongoing) Risk-based approach to testing of samples (ongoing) Prequalification pathway for vaccines with a positive Article 58 opinion Streamlined procedure to be established (ongoing) Prioritization process (implemented, process confirmed) Establishment of the Programmatic Suitability for Prequalification Standing Committee (PSPQ Standing Committee) (implemented) Establishment of Annual Product Reports system (ongoing) Regulatory oversight of products manufactured in multiple sites to be agreed upon on case by case basis depending on functionality of the relevant authorities and willingness to take on the required functions (ongoing)

12 Procedure NORMAL Reception of files on deadlines Screening of files for completeness and compliance with programmatic characteristics STREAMLINED Reception of files on deadlines Screening of files for completeness and compliance with programmatic characteristics Does not meet meets Does not meet meets Review by PSPQ SC Not accepted rejection accepted Full evaluation By WHO and external experts (file review Testing Site audit) acceptance Review by PSPQ SC Not accepted Rejection Streamlined evaluation By WHO and external experts (review of accepted reports provided by NRA) acceptance

13 Main changes introduced (3) COMMUNICATION Improved list of prequalified vaccines (providing more details on Pqd product) Implemented Publication of short document providing rationale for acceptance of a specific vaccine (Vaccine Product Assessment Report: VPAR) pending Publication of list of contracted laboratories pending Publication of list of products accepted for evaluation and charts of progress for each product pending Publication of updated priority list for implemented

14 Upcoming changes (1) Multidose vial policy (MDVP) Visual cue Vaccine vial monitor VVM Shipping guidelines

15 Upcoming changes (2) Status MDVP and Visual cue Multi-dose vial policy (MDVP) is outdated and in current environment provides incomplete guidance to health workers More diverse range of presentations available Newer formulations in 'untraditional' format (2 dose liquid with no preservative) Status: Initial internal action plan drafted for revision process Linked to development of visual cue Easy to interpret - Signals what action to take, provides reassurance Independent of any specific vaccine, manufacturer or presentation Status: Identification for field pilot

16 Upcoming changes (3) Vaccine Vial Monitors (VVMs) 2011 revision to PQS performance specification and verification protocol for VVMs VVM will appear on the label of the vaccine regardless its type (liquid or freeze-dried) if the vaccine can be kept in subsequent immunization sessions All vaccines with VVMs on cap or on the neck of an ampoule will be discarded at the end of the session VVM revision reinforces IPAC decision on utility of secondary visual cue Footnote: VVMs are not currently a requirement of MDVP implementation

17 PQ procedure: The road ahead

18 Procedure for expedited review of imported prequalified vaccines for use in national immunization programmes (1) Why is an expedited procedure for registration of WHO prequalified vaccines being proposed? Save resources that can be targeted to other activities (i.e. strengthening post-marketing surveillance, focusing on the detailed review of non-prequalified vaccines) Accelerate the registration procedure without disrupting the supply of the vaccines

19 Procedure for expedited review of imported prequalified vaccines for use in national immunization programmes (2) Which countries can benefit from the procedure? Countries that source their vaccines through UN agencies (i.e. UNICEF) Countries that procure their vaccines directly but that require WHO prequalification as a basis for selection of vaccines for purchase Countries where the national regulations include provisions to shorten the normal regulatory approval process.

20 Procedure for expedited review of imported prequalified vaccines for use in national immunization programmes (3) What is needed in order to implement the procedure? Political decision Integration into the national regulations Technical expertise to review the submission

21 Options being explored Intensified support to key NRAs Intensified risk mitigation evaluations of manufacturers - quality management systems - post-marketing surveillance capacity

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