COVID-19 Vaccines & Batch Release: Building on existing ...

COVID-19 Vaccines & Batch Release: Building on existing platforms to facilitate reliance during a pandemic

Dr Ute RosskopfScientistWorld Health Organization

3 – 6 November 2020

The views and opinions expressed in the following PowerPoint slides are those of the individual

presenter and should not be attributed to IFPMA, its directors, officers, employees, volunteers,

members, chapters, councils, communities or affiliates, or any organization with which the presenter

is employed or affiliated.

10th Asia Regulatory Conference 2020Building Trust & Partnership to Deliver UHC in Asia

2

Disclaimer

Contents

➢ Vaccines’ testing

➢ Challenges

➢WHO responses to challenges

➢ The WHO-National Control Laboratory Network for Biologicals: Platform and basis for reliance

➢ COVID-19 vaccines - Batch release


3

Vaccines’ testing - Background


4

"Procedure for assessing the acceptability, in principle, of vaccines for purchaseby United Nations agencies"

➢ Created in 1987

➢ Service for purchasing and procuring UN agencies/ international procurement

➢ Provisions: - Priority vaccine for WHO

- Producing country meets WHO vaccine regulation indicators

06/11/2020 5

WHO reviews the vaccine dossier (quality & clinical data)

WHO inspects the manufacturing site

WHO tests the final product & pqd product

Three pillars of vaccine evaluation & post-prequalification monitoring

Vaccines’ testing (cont. 1)

Vaccine published on the WHO website:https://extranet.who.int/gavi/PQ_Web/

Vaccines’ testing (cont. 2)


6

Initial evaluation of a new product – Pre PQ

(WHO TRS no. 978, Annex 6, chapter 3.4)

• Three final lots tested for consistency of final product characteristics

• Testing by two laboratories (plus NCL)

➔WHO test report shared with the manufacturer

Annually performed targeted testing –

Post PQ(WHO TRS no. 978, Annex 6, chapter 10)

• Lots selected by WHO – risk-based approach

• Two to three lots close to expiry dates

• Testing by one laboratory

• Review of annual lot release reports

➔WHO testing outcome and lot release information reported to donors

Testing through contracted

laboratories

• Labs qualified by WHO –performance of audits

• Based on a forecast

15 contract laboratories

to cover > 400 tests

biennium 2020-20^21

➔Paid service - Identical fees for each test parameter

― Globalization of vaccine industry: increasing number of production sites

― Increased complex regulation

― Limited resources of regulatory authorities (developed and developing countries)

― Duplication of efforts through redundant testing and approval of variations

― Non-compliances in test outcomes by importing countries: delay in vaccine access, disruption of vaccine delivery

7

• WHO contracted laboratories test vaccines of

various manufacturers (differences in used

methods)

• Increasing number of complex vaccines (test

and cost intensive)

• Increasing number of applications for

prequalification

• Increased number of prequalified vaccines to

be monitored

• Limited resources (laboratories, WHO)

General WHO

Challenges

Challenges (cont.)


8

Target: Global access to vaccines – Sustainable Development Goal (SDG) 3.8

How to reach global access

to needed safe and efficacious

vaccines in a timely manner?

WHO responses to challenges –WHO test programme


9

- Harmonization of test methodologies (performance of feasibility studies, collaborative studies, PTS and hands-on training courses)

- Change in PQ procedure section 3.4 (endorsed by ECBS, meeting 2014):

― Optimized logistics: Introduction direct shipments of vaccines to WHO test laboratories

― Use of NCL of producing country (testing)

- Use of resources: lot release data gathered by the official

national control laboratory (consent of manufacturers)and technical know-how

WHO response to challenges: WHO-National Control Laboratory Network for Biologicals


10

Creation of a structure and infrastructure to make information available to others, namely – receiving = importing countries.

WHO-National Control Laboratory Network for Biologicals (2017)

https://www.who.int/biologicals/vaccines/regulation_and_quality_control_vaccines/en/

The Network – platform and basis for reliance: Main objectives - Membership

10th Asia Regulatory Conference 2020Building Trust & Partnership to Deliver UHC in Asia 11

- Aims to facilitate access to prequalified vaccines ( or other biological product) through reliance on the batch release testing of the respective Network Members

- Main objective is to share quality information in order to facilitate access to prequalified vaccines through recognition by recipient countries of the lot release decisions of the responsible NRA

- Intention to build mutual confidence amongst members, reduce redundant testing, promote the development of common standards and facilitate the sharing of best practices.

The Network – platform and basis for reliance: What each partner brings to the Network: National authorities


12

Responsible NRAs/NCLs in producing countries have

- Best insight in vaccines and testing methods

- Functional vaccine regulation including lab capacity

- Batch release – part of the national regulation

Expert hub which assures qualityand safety of vaccines - 22 full Network memberships

The Network – platform and basis for reliance: What each partner brings to the Network: WHO


13

- International mandate of 194 Member States and WHA resolution 67.20 concerning networks

- Existing expert hub of qualified NCLs testing for WHO

- Reports on vaccine quality data = WHO test outcome (pre- and post-PQ)

- Reports on vaccine quality data through sharing of lot release data

- Established Terms of Reference & Participation-Confidentiality Agreement

- Secured electronic platform

Information and service center which collects, contributes and distributes quality information in a secure and confidential setting

The Network – platform and basis for reliance: Secured platform - SharePoint


14

COVID-19 vaccines – Batch release


15

- Marketing authorization, emergency use listing, prequalification:Independent batch release as part of the regulation by responsible NCL

- Extreme urgency: pressure on production and quality control testing

- Parallel testing: manufacturer and releasing NCL – timely supply

- Limitations: Shelf life, availability reference reagents, lab capacity, …

- Reliance principle – indispensable for COVID-19 vaccines!Recognition of release certificates by recipient countries

No redundant

testing

Accelerated access to vaccines

COVID-19 vaccines and the Network


16

❖ Forum / platform for discussion – proposed pathways for batch release and testing, test parameter for different vaccine platforms

❖ Use of SharePoint Information already in place: details on releasing NCLs, laboratory informationfile, vaccines released, performed tests, release procedures

Covid-19 vaccine information file

Lot release information (batch listing, certificates,…) (WHO model certificate)

Prerequisite: consent of manufacturers (WHO model letter)

❖ Performance of webinars and meetings - advocacy for recognition > memberships

Recognition

Reliance /

Work sharing

Confidence building

Harmonization / convergence

Information sharing(Source: Swissmedic, Switzerland)

Acknowledgements


17

We thank the donors

Bill and Melinda Gates FoundationUnited Nations Children's FundUnited States Food and Drug Administration

for the funding of our work.

Thank you.Dr Ute Rosskopf

Laboratory Networks and Services Regulation and SafetyRegulation and Prequalification DepartmentAccess to Medicine and Health Products DivisionWorld Health Organization, Geneva, Switzerland

#ARC2020


18

COVID-19 Vaccines & Batch Release: Building on existing ...

Documents

Transcript of COVID-19 Vaccines & Batch Release: Building on existing ...