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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