WHO updates PQ and EUL

Carmen Rodriguez, team lead vaccines PQ/EULDepartment of Regulation and Prequalification At the Division of Access to Medicines and Health Products

Copenhagen, 09 November 2021

UNICEF Vaccine industry consultation 2021

Outline of presentation

• Prequalification of vaccines• Post-PQ activities

• PQ in emergencies, stockpiles

• Emergency use listing. • WHO mechanism to facilitate access of covid 19 vaccines

• WHO EUL listed vaccines

• Covid 19 vaccines under assessment

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Features of PQ and EUL

• Review of extensive quality, safety and efficacy and PSPQ for international supply

• Assessment performed by WHO independent experts

• Reliance on WHO Listed Authority (WLA) - abbreviated process under oversight of mature regulators (evaluation and oversight of programmatic aspects by WHO)

• Pre-submission meetings

• Post-PQ monitoring

• Reassessment/requalification

Prequalification (PQ) 1987

• Risk benefit assessment of essential set of quality, safety and efficacy data for use during PHEs

• Rolling review of data

• Assessment performed by WHO independent experts in collaboration with National Regulatory Authorities (WLA)

• Reliance on WLA - abbreviated process under oversight of mature regulators (evaluation and oversight of programmatic aspects by WHO)

• Pre-submission meetings

• Post- deployment monitoring

• Time limited recommendation

• Development should continue for MA/PQ

Emergency Use Listing (EUL) 2015

PQ vaccines 202011 vaccines (13 presentations)

PQ date Vaccine No. Doses Manufacturer Country

21/01/2020Hepatitis B (paediatric)

1Lg Chem Ltd Republic of Korea

28/01/2020Rotavirus (live attenuated)

1 & 2Serum Institute of India Pvt. Ltd. India

07/02/2020Influenza seasonal (Trivalent)

10Seqirus Limited Australia

09/03/2020Diphteria-Tetanus (reduced antigen content)

20Biological E. Limited India

25/03/2020Dengue

5Sanofi Pasteur France

21/04/2020Polio Vaccine - Inactivated (IPV)

5AJ Vaccines A/S Denmark

31/08/2020Polio Vaccine - Oral (OPV) Trivalent

20PT Bio Farma (Persero) India

15/10/2020Influenza, seasonal (Quadrivalent)

10Sanofi Pasteur France

04/12/2020 Typhoid (conjugate) 1 & 5Biological E. Limited India

18/12/2020Influenza Pandemic H5N1

1AstraZeneca Pharmaceuticals LP. UK

21/12/2020Polio Vaccine - Inactivated Sabin (sIPV)

5LG Chem Ltd Republic of Korea

4https://extranet.who.int/pqweb/vaccines/prequalified-vaccines

Vaccines PQ in 2020

5https://extranet.who.int/pqweb/vaccines/prequalified-vaccines

Vaccines PQ in 2021

PQ vaccines 20216 vaccines (7 presentations)

PQ date Vaccine No. Doses Manufacturer Country

18/02/2021Rotavirus (live, attenuated) 1 Serum Institute of India Pvt. Ltd India

26/04/2021Influenza, seasonal (Trivalent) 10 Instituto Butantan Brazil

27/04/2021Ebola vaccine (MVA-BN-Filo

[recombinant])

Ebola vaccine (Ad26.ZEBOV-GP

[recombinant])

1Janssen Vaccines, Branch of Cilag

GmbH InternationalSwitzerland

18/06/2021Rotavirus (live attenuated) 1 & 5

Bharat Biotech International

Limited India

01/06/2021Polio Vaccine - Inactivated Sabin

(sIPV) 1 LG Chem Ltd Republic of Korea

14/10/2021Human Papillomavirus (Bivalent) 1 Xiamen Innovax Biotech Co. Ltd.

People's Republic of

China

Vaccines Post PQ 2020/2021

• Variations

• Annual Report evaluation

• Reassessment

• Targeted testing program

• Monitoring/Investigation of vaccine quality and cold chain complaints

• Monitoring/investigation of Adverse Events following immunization (AEFI)

• Collaborative National Registration

• Technical Review of tenders for UNICEF

Routine and emergency response

Yellow Fever, cholera, meningococcal

Licensed and PQ. Risk mitigation strategies:

secure access

Emergency response

mOPV2 and Ebola

Licensed and PQed.

Special conditions under PHE

Emergency responsewhen PHEIC is

declared

Pandemic flu

smallpox

License for emergency use pathways

Vaccines for emergency response: WHO stockpiles

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WHO EUL

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Novel oral polio vaccine type 2

Designate lead NRAs in the region: WHO EUL assessment

Facilitation expedited national approval

1. Sharing dossier and EUL reports > 400 reports > 100 countries LMIC and HIC

2. Discussion on outcome of review: Facilitated workshops

One on one discussions with countries.

3. Additional guidance for decision making on expedited authorization

Support to RO and agencies providing relevant docs for actual shipments

4. Post listing changes: > 152 changes clinical, CMC and labelling/packaging changes

5. support countries, RO and agencies to deal with complaints and other issues

Product Evaluation group (PEG): Roster of experts, Regulatory experts all regions.

Technical Advisory group EUL (TAG-EUL): Risk benefit assessmenthttps://extranet.who.int/pqweb/vaccines/TAG-EUL

Collaboration agreement with NRAs of references and others on regulatory oversight

Support to regions & countries

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>100 countries granted EUAs within 15 days post EUL

Over 500 regulatory approvals based on reliance

WHO listed Covid-19 vaccines

PlatformManufacturer /

EUL holder / name NRA of Record Post-EUL commitments

mNRA-based vaccine encapsulated in lipid nanoparticle (LNP)

BioNTech Manufacturing GmbHBNT162b2 / COMIRNATY: Tozinameran (INN)

EMA, US FDA

• CMC updates

• Clinical

• Updated data on the

efficacy/effectiveness

• Updated RMP

• Monthly safety reports,

and Periodic Benefit Risk

Evaluation Reports

(PBRER) every 6 months

• Updated labelling,

shipping validation (if

applicable) and data for

VVM

• Others:

Moderna Biotech, mRNA-1273: elasomeran (INN)

EMA, US FDA

Recombinant ChAdOx1 adenoviral vector encoding the Spike protein antigen of the SARS-CoV-2

AstraZeneca, AB: AZD1222 VaxzevriaEMA, Health Canada, MFDS, MHLW-PMDA, TGA

Serum Institute of India Pvt. Ltd: Covishield (ChAdOx1_nCoV-19)

DCGI

Recombinant, replication-incompetent adenovirus type 26 (Ad26) vectored vaccine encoding the SARS-CoV-2 Spike (S) protein

Janssen–Cilag International NV: Ad26.COV2.S

EMA

Inactivated, produced in Vero cells

Sinopharm / Beijing Institute of Biological Products Co., Ltd. (BIBP)Sinovac Life Sciences Co., Ltd.: CoronavacTM

NMPA

Bharat Covaxin DCGI

Covid 19 vaccines under EUL

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Additional information PQ&EUL:

PQT/VXA procedure [TRS 978, Annex 6 (2013]

http://www.who.int/entity/immunization_standards/vaccine_quality/TRS_978_61st_report_An

nex_6_PQ_vaccine_procedure.pdf

Programmatic Suitability for Prequalification

http://www.who.int/immunization_standards/vaccine_quality/pspq2_v140512.pdf

EUL Procedure and Questions and Answers

https://www.who.int/medicines/regulation/prequalification/prequal-

vaccines/EUL_PQ_Vaccines/en/

Target product profile

https://www.who.int/docs/default-source/blue-print/who-target-product-profiles-for-covid-19-

vaccines.pdf?sfvrsn=1d5da7ca_5&download=true

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Additional information PQ&EUL:

Evaluation criteria and EOI.

https://www.who.int/medicines/regulation/prequalification/prequal-vaccines/resources/1_EOI-

Covid-19_Vaccines.pdf?ua=1

Roadmap https://www.who.int/publications/m/item/roadmap-for-evaluation-of-astrazeneca-

azd1222-vaccine-against-covid-19

Contact: EUL@who.int

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