COVID-19 vaccination

FOR SAGE DECISION ON 5th JANUARY 2021

Progress update and for decision

Recommendation on the first mRNA vaccine

BNT162b2

1

Roadmap for Prioritization and Recommendation

3 Steps

1) Values framework on principles and objectives and target populations – DONE 14th September 2020

2) Roadmap for prioritizing target populations under different epidemiological and supply scenarios – DONE 5-7 October 2020

3) Vaccination recommendations once products have been licensed (or authorized under emergency use) – NOW= iterative, product specific and may be significantly impacted by regulatory regime, EUL vs. full licensure

2

Outline of the5 Jan 2021 SAGEsession on Covid-19 vaccines

Introduction, session objective setting, update on regulatory decisions and

overview of Working Group deliverables. H. NOHYNEK SAGE 15 min

Vaccine safety and efficacy data emerging from Pfizer-BioNTech mRNA

COVID-19 vaccine clinical trials (phase 1-3 trial results).

Risk management plans and other implementation considerations

COMPANY PRESENTATION 30 min

Safety monitoring. S. PAL, WHO 10 min

Questions 30 min

BioBreak for 10 min

Assessment of Evidence (SAGE working group) 30 min

Presentation of draft recommendations. H. NOHYNEK, SAGE 20 min

Discussion 1h

3

Introduction to the session 1

Update on

vaccine pipeline,

vaccine registration status,

vaccine introduction status,

population prioritization roadmap,

observed virus variants.

COVID-19 vaccines development landscapeSituation as of 4 January 2020, total 291 candidate vaccines of which 68 in clinical trials, 4 licensed by stringent regulatory authorities

5 January

2021https://vac-lshtm.shinyapps.io/ncov_vaccine_landscape/

BioNTech/PfizerModerna

AstraZeneca

Sinopharm

4

Route and dosing of covid-19 vaccine candidates

5 January

20215

Where are the covid-19 vaccine trials taking place ?

5 January

20216

7

Regulatory timeline of key phase III vaccine candidates

1. Wuhan Institue of Biological Products Co Ltd

2. Beijing Bio-Institue of Biological Products Co-Ltd

Sinopharm / WIBP1

Sinopharm / BIBD2

Vx candidates

11 Dec. 20 18 Dec. 2020End of Dec. 2020

Several

18 Dec 20 7 Jan 21 Jan. 2021 Several

April 21 Feb. 21Between March and June 21

India (SII product)

No FDA

approval

No EMA

approval

End February 21 earliest

No information

No info No infoNo approach to PQ

No information

No info No info To be confirmed No information

No info No infoEnd February 21 earliest

China, UAE

No info No info March 21 No information

No info No info To be confirmed Russia

No info May 21 (earliest) May 21 (earliest) June 21

FDA EMA WHO EUL/PQ Other NRA’s

Estimated approval dates (includes restricted, emergency and conditional authorizations)

By End of 2020

By End of Feb. 2021

From March 2021 / No info

Legend (best-case scenario)

2 Dec. 20

No info

30 Dec 20

No info

No info

No info

No info

No info

No info

No info

MHRA

8

9

10

COVAX Facility Portfolio – Expected supply timelines

Vaccine candidates

Candidate 1

Candidate 2

Other Candidates

Q1 2021 Q4 2021Q3 2021Q2 2021

Expected regulatory & WHO PQ timeframe

Expected supply timeframe

Speed, Scale, Access

Q1 2022

HIGHLY PRELIMINARY - AS OF JAN 4

Country readiness and delivery – technical resources

11

Guidance and Tools Trainings

• VIRAT 2.0 and CRD Country Readiness Core Indicator DashboardVIRAT 2.0 and CRD Country Readiness Core Indicator DashboardVIRAT 2.0 and CRD Country Readiness Core Indicator DashboardVIRAT 2.0 and CRD Country Readiness Core Indicator Dashboard

• Operational Guidance on National Vaccine Deployment PlansOperational Guidance on National Vaccine Deployment PlansOperational Guidance on National Vaccine Deployment PlansOperational Guidance on National Vaccine Deployment Plans

• Vaccine introduction costing toolVaccine introduction costing toolVaccine introduction costing toolVaccine introduction costing tool

• Field guide to misinformation management

• Country level monitoring guidance

• Detailed supply & logistics guide

• WHO’s Maintaining essential health services: operational guidance for the COVID-19 context (June 1 update)

• Training packages for health workers

and national stakeholders

• Designed with end-users in mind

(modular virtual and in-person

training)

• Leverage existing e-learning

platforms: Agora.unicef.org and

openwho.org

12

Guidance on Developing a National Deployment and Vaccination Plan (NDVP) for COVID-19 Vaccines

• Published on Nov. 16th on the WHO website here

• Built upon existing documents incl. recommendations from the WHO Strategic Advisory Group of Experts (SAGE)

• Includes a suggested template for development of the NDVP

• Will be updated as new information becomes available

https://www.who.int/publications/i/item/WHO-2019-nCoV-Vaccine_deployment-2020.1

Summary of SARS-CoV-2 virus mutations

- Variants identified in UK and South Africa highlight the importance of sequencing of SARS-CoV-2 and

sharing of sequence data internationally.

- As all viruses mutate, sequencing will identify a number of mutations; some more common than

others. Many mutations have no impact on the virus itself; some may be detrimental to the virus; few

may result in an advantage to the virus.

- In order to determine their impact on transmission or vaccines, experiments need to be done with live

virus in advanced laboratories. This takes time from weeks to several months; ongoing in UK and South

Africa. Also vaccine manufacturers are working on understanding the potential impact on VE.

-WHO and partners are working with a group of international scientists, including the WHO Virus

Evolution Working Group, from all over the world to coordinate such research efforts and assess the risk

of select mutations on transmission, diagnostics and vaccines. For the moment there is no evidence that

monoclonal antibodies or vaccines will not work on the variant strain in the UK.

5 January 2021 14

Compendium of Critical Questions

Values Framework

Prioritization Roadmap

Vaccine-specific recommendations based on

Evidence Framework

Modeling

Additional considerations

(e.g. current epidemiology)

15

Background paper with

COVID-19 generic considerations

Background paper with

vaccine-specific considerations

Interim

recommendations for use (product/platform

specific)

Evidence to

Recommendations & grading tables

The outputs

from the SAGECOVID-19 working

group so far

5 January 2021

October 2020 SAGE

meeting

Background Paper

www.who.int/immunization/policy/sage/SAGE_WG_COVID19_Vaccines

_Modelling_Questions_31July2020.pdf

www.who.int/publications/m/item/critical-evidence-questions-for-covid-

19-vaccines-policy-making

www.who.int/publications/m/item/who-sage-roadmap-for-prioritizing-uses-

of-covid-19-vaccines-in-the-context-of-limited-supply

www.who.int/publications/i/item/who-sage-values-framework-for-the-

allocation-and-prioritization-of-covid-19-vaccination

www.who.int/immunization/sage/meetings/2020/october/SAGE_eYB_Oct2

020final.pdf?ua=1

Links to documentation

165 January 2021

17

Acknowledgements

Hanna Nohynek

Folake Olayinka

Muhammed Afolabi

Celia Alpuche

Hyam Bashour

David Durrheim

Ruth Faden

Nicholas Grassly

Sonali Kochhar

Eusebio Macete

Kayvon Modjarrad

Sarah Pallas

Mary Ramsay

Peter Smith

H. Keipp Talbot

Cristiana Toscano

Yin Zundong

Klaus Cichutek

Peter Figueroa

Adam Finn

Gagandeep Kang

David Kaslow

Ziad Memish

Saad B. Omer

Helen Rees

Christopher Morgan

WHO SecretariatAnnelies Wilder-Smith

Joachim Hombach

Melanie Marti

SAGE Chair

Alejandro Cravioto

5 January 2021

18

Backups

19

6 main principles

-Human well being

-Equal respect

-Global equity

-National equity

-Reciprocity

-Legitimacy

https://apps.who.int/iris/bitstream/handle/10665/334299/WHO-2019-nCoV-SAGE_Framework-Allocation_and_prioritization-2020.1-eng.pdf?sequence=1&isAllowed=y5 January

2021

19

Roadmap towards prioritization of target populations:

To support country planning, the Roadmap suggests public health strategies and target priority groups for different levels of vaccine availability in different epidemiologic settings

Community transmission

Cluster of cases/sporadic transmission

No cases, risk of importation

Very limited supply(1-10%)

Limited supply(11-20%)

Moderate supply(21-50%)

20

Key assumptions:

Vaccines are licensed and meet all minimum

criteria of WHO TPP;

Vaccines have at least minimal level efficacy in older age groups; idem for other

subpopulations;

NPI continue to be used;

Vaccine effect on transmission less relevant for early scenarios, but information becomes

available at some point;

No account has been taken of seroprevalence and the possible degree of

population protection already established.5 January 2021

21

Vaccine policy - Priority groups for COVID-19 vaccination

Endorsed by SAGE, published on 19 October 2020