Carmen Rodriguez Hernandez, World Health Organization, … · WHO PREQUALIFICATION PROGRAMME Assuring vaccine quality: Overview of Prequalification Carmen Rodriguez Hernandez, World

WHO PREQUALIFICATION PROGRAMME

Assuring vaccine quality: Overview of

Prequalification

Carmen Rodriguez Hernandez,

World Health Organization, EMP/RHT/PQT

[email protected]

¨

mailto:[email protected]


Outline

• Overview on Prequalification • Purpose

• Principles

• Condition

• Process

• Timelines

• Post PQ monitoring activities

• Strategic priorities

• Activities to facilitate access of vaccines


Prequalification

• Ensures the quality, efficacy and safety of

medicines, vaccines and immunization devices

and diagnostics. • Medicines:

– Prequalification programme for medicines (finished dosage forms)

– Prequalification of active pharmaceutical ingredients (APIs)

– Prequalification of quality control (QC) laboratories

– Expanding access to priority essential medicines: HIV/AIDS, Tuberculosis,

Malaria, Reproductive Health and some other disease categories

(e.g.NTD)

• Vaccines and immunization devices:

– Ensures that candidate vaccines are suitable for the target population and

meet the needs of the programme


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


Principles

GMP

Reliance on NRA

Meeting WHO requirements and tender specifications

Consistency of final

product characteristics

Clinical data


Pre-conditions for PQ evaluation

Reliance on the National Regulatory Authority (NRA) of the

exporting country

NRA must be assessed as functional as a result of successful

evaluation using the WHO NRA assessment tool

NRA’s functional status needs to be sustained over time

Continued regulatory oversight by NRA is required as well as

communication with WHO about potential problems with the

vaccine

Agreements are established with the NRAs for information exchange

when a vaccine is about to be prequalified


Pre-conditions for PQ evaluation

• Vaccine is licensed/registered by the responsible NRA (Scientific opinion by EMA accepted)

• WHO guidelines/recommendations approved by the ECBS are 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)


Prequalification process

Scientific review of quality dossier

Scientific review of clinical data

Testing of samples

Consultation with responsible NRA

Site audit to manufacturing facilities


Prequalification process: timelines (clock stop)

Submission of variation

Screening

90 days internal time

Submission of application for PQ

Screening (30 days + 90 days if there is PSPQ deviation)

270 days internal time


Monitoring performance of PQed vaccines

Targeted testing by WHO contracted labs: Once a year

testing of samples of lots shipped to countries to

ensure continuing compliance with specifications

Monitoring and resolution of complaints and reports of

AEFIs (with collaboration of the responsible NRA)

Reassessments frequency defined on risk analysis

basis

Assessment of variations to PQed vaccines,

http://www.who.int/immunization_standards/vaccine_q

uality/variations_pq_vaccine/en/

http://www.who.int/immunization_standards/vaccine_quality/variations_pq_vaccine/en/

http://www.who.int/immunization_standards/vaccine_quality/variations_pq_vaccine/en/


Access

Facilitate access to quality

products for developing countries

Single standard of quality

(WHO recommended requirements)

Consolidated investigation, reporting

and communication in response

to quality or safety concerns

Implementation of an

expedited/facilitated registration

procedure for prequalified vaccines

in receiving countries

Mechanisms to minimize wastage of

vaccines, facilitate outreach

(VVMs, MDVP, CTC)


Mali, polio campaign,

Photos: WHO/Olivier Ronveaux

Nati

on

al co

ld r

oo

m d

uri

ng

th

e c

am

paig

n

Contribution development

of Controlled Temperature Chain

Project Optimize: PATH/WHO

Transport to health centre

Nicaragua, rotavirus delivery, Photo: Gates Foundation

12 |


Implementation of Procedure for expedited review of

imported prequalified vaccines for use in national

immunization programmes (WHO/IVB/07.08)

Firstly used

for registration

of MenAfriVac in

26 countries of

the belt


Accelerated national registration of WHO-prequalified pharmaceutical products and vaccines.


Revision of procedure

WHO

NRA

Manufacturers

Agreement Facilitated

license

|

16 |

Principles of the procedure

1. Procedure is voluntary for manufacturers and NRAs and

providing benefits to both parties.

2. With consensus from manufacturer, full PQ dossier and

site audit report plus initial testing results will be shared

with interested NRAs to facilitate national regulatory

decisions making (registrations, variations, withdrawals).

3. No interference with national legislation, decision

making process and regulatory fees – but PQ expertise

is available to NRAs.

|

17 |

Principles of the procedure

4. Each participating authority commits to adopt

registration decision within 90 days after having access

to full PQ reports .

5. The NRA has the right to :

– decline to adopt procedure for specific products

– decide differently from PQ, but keep PQ informed and

clarify the reasons for deviation.

|

18 |

Win-win situation

NRAs

– Availability of WHO assessment and inspection outcomes to support national decisions

– Opportunity to learn from PQ assessors and inspectors

– Saving internal capacities

• WHO and UN agencies

– Prequalified vaccines are available sooner

– Feed-back on WHO prequalification outcomes

Manufacturers – Harmonized data for PQ and national registration

– Accelerated and more predictable registration


POLIO ERADICATION AND ENDGAME STRATEGIC PLAN 2013-2018

The Strategic Advisory Group of Experts on

Immunization (SAGE), recommended in 2012 the withdrawal of the

type 2 component of oral polio vaccine (OPV) from

routine immunization programmes in all

countries, facilitated by the introduction of at least one dose of IPV

Weekly epidemiological record wer 8901

The last case of wild poliovirus type 2 (WPV2)

was seen in 1999

88% of the total of the circulating vaccine derived poliovirus (cVDPV) cases

in recent years were caused by the vaccine derived type 2 strain

Introduction of IPV by 2015 and

bOPV by 2016 in all countries

www.who.int/immunization/diseases/poliomyelitis/inactivated_polio_vaccine/en/

www.polioeradication.org

http://www.who.int/immunization/diseases/poliomyelitis/inactivated_polio_vaccine/en/

http://www.polioeradication.org


Facilitating license of IPV: PQ pathway

WHO

NRA

Manufacturers

Agreement

Joint review

Facilitated license


Path forward facilitating license of IPV

Joint review

AFRO countries

20-24 October 2014 Turkey

Francophone countries:

Benin, Burkina Faso, Cameroon, Cote

d’Ivoire, Mali, Senegal, Togo

Anglophone countries:

Botswana, Ethiopia, Ghana, Sierra Leone,

Tanzania, Uganda, Zambia, Zimbabwe : ENGLISH

SEARO countries

10-14 November Thailand

Bhutan, Myanmar and Sri Lanka


Facilitating license of other PQed vaccines

Vaccine Country Pneumococcal vaccine Prevenar 13 Pfizer United States

Eritrea

Lesotho

Sudan

Inativated polio vaccine SP France

Sudan

DTwP-hepatitis B-Hib vaccine Serum Institute of India (SII)

Nigeria

Measles SII Nigeria

Tetanus SII Nigeria

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23 |

Access of vaccines

Regulatory Access of vaccines

Requirements eg polio, flu

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24 |

Path forward

Endorsement by relevant committees

Advocacy workshops and joint reviews:

– EURO, AFRO, SEARO

– AMRO, WPRO

Capacity building activities: Rotational fellowships and

participation of regulators in PQ assessments


Relevant PQ information


uality/pq_system/en/


uality/pq_suppliers/en/


uality/quality_issues/en/


uality/pq_revision2010/en/


uality/ps_pq/en/


uality/expedited_review/en/

http://www.who.int/immunization_standards/vaccine_quality/pq_system/en/

http://www.who.int/immunization_standards/vaccine_quality/pq_system/en/

http://www.who.int/immunization_standards/vaccine_quality/pq_suppliers/en/

http://www.who.int/immunization_standards/vaccine_quality/pq_suppliers/en/

http://www.who.int/immunization_standards/vaccine_quality/quality_issues/en/

http://www.who.int/immunization_standards/vaccine_quality/quality_issues/en/

http://www.who.int/immunization_standards/vaccine_quality/pq_revision2010/en/




http://www.who.int/immunization_standards/vaccine_quality/ps_pq/en/

http://www.who.int/immunization_standards/vaccine_quality/ps_pq/en/

http://www.who.int/immunization_standards/vaccine_quality/expedited_review/en/

http://www.who.int/immunization_standards/vaccine_quality/expedited_review/en/

Carmen Rodriguez Hernandez, World Health Organization, … · WHO PREQUALIFICATION PROGRAMME Assuring vaccine quality: Overview of Prequalification Carmen Rodriguez Hernandez, World

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