COVID-19 vaccination FOR SAGE DECISION ON 5th JANUARY 2021 - Recommendation on the first mRNA vaccine BNT162b2 - World Health Organization
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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) Values framework on principles and
objectives and target populations – DONE
14th September 2020
2) Roadmap for prioritizing target
Roadmap for populations under different epidemiological
Prioritization and supply scenarios – DONE 5-7 October
and 2020
Recommendation
3) Vaccination recommendations once
3 Steps 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 1
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
Outline of the COMPANY PRESENTATION 30 min
5 Jan 2021
Safety monitoring. S. PAL, WHO 10 min
SAGE
session on Questions 30 min
Covid-19
BioBreak for 10 min
vaccines
Assessment of Evidence (SAGE working group) 30 min
Presentation of draft recommendations. H. NOHYNEK, SAGE 20 min
Discussion 1h
2
Update on
vaccine pipeline,
Introduction to vaccine registration status,
the session 1 vaccine introduction status,
population prioritization roadmap,
observed virus variants.
3
COVID-19 vaccines development landscape
Situation as of 4 January 2020, total 291 candidate vaccines of which 68 in clinical trials, 4 licensed
by stringent regulatory authorities
Moderna
BioNTech/Pfizer
AstraZeneca
Sinopharm
5 January
https://vac-lshtm.shinyapps.io/ncov_vaccine_landscape/ 2021
4
Route and dosing of covid-19 vaccine candidates
5 January
5
2021
Where are the covid-19 vaccine trials taking place ?
5 January
6
2021
Regulatory timeline of key phase III vaccine Legend (best-case scenario)
By End of 2020
candidates
Vx candidates
Estimated approval dates (includes restricted, emergency and conditional authorizations)
FDA EMA MHRA WHO EUL/PQ Other NRA’s
By End of Feb. 2021
From March 2021 / No info
End of Dec.
11 Dec. 20 18 Dec. 2020 2 Dec. 20 Several
2020
18 Dec 20 7 Jan 21 No info Jan. 2021 Several
Between March India (SII
April 21 Feb. 21 30 Dec 20
and June 21 product)
No FDA No EMA End February 21
No info No information
approval approval earliest
No approach to
No info No info No info No information
PQ
Sinopharm / WIBP1 No info No info No info To be confirmed No information
Sinopharm / BIBD2 End February 21
No info No info No info China, UAE
earliest
No info No info No info March 21 No information
No info No info No info To be confirmed Russia
No info May 21 (earliest) No info May 21 (earliest) June 21
1. Wuhan Institue of Biological Products Co Ltd
2. Beijing Bio-Institue of Biological Products Co-Ltd
7
8
9
HIGHLY PRELIMINARY - AS OF JAN 4
COVAX Facility Portfolio – Expected supply timelines
Expected regulatory & WHO PQ timeframe
Expected supply timeframe
Vaccine candidates Q1 2021 Q2 2021 Q3 2021 Q4 2021 Q1 2022
Candidate 1
Candidate 2
Other Candidates
10
Speed, Scale, Access11
Country readiness and delivery – technical resources
Guidance and Tools Trainings
• VIRAT 2.0 and CRD Country Readiness Core Indicator Dashboard • Training packages for health workers
• Operational Guidance on National Vaccine Deployment Plans and national stakeholders
• Vaccine introduction costing tool • Designed with end-users in mind
• Field guide to misinformation management (modular virtual and in-person
• Country level monitoring guidance training)
• Detailed supply & logistics guide • Leverage existing e-learning
• WHO’s Maintaining essential health services: operational platforms: Agora.unicef.org and
guidance for the COVID-19 context (June 1 update)
openwho.orgGuidance 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
12Summary 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 14Compendium of Critical
Questions Background paper with
COVID-19 generic
considerations The outputs
from the SAGE
Values Framework COVID-19 working
group so far
Background paper with
vaccine-specific
Prioritization Roadmap considerations
Vaccine-specific
recommendations based on Interim
Evidence Framework
recommendations for
use (product/platform
specific)
Modeling
Evidence to
Additional considerations Recommendations &
(e.g. current epidemiology)
grading tables
5 January 2021 1Links to documentation
www.who.int/publications/m/item/critical-evidence-questions-for-covid-
19-vaccines-policy-making
www.who.int/publications/i/item/who-sage-values-framework-for-the-
allocation-and-prioritization-of-covid-19-vaccination
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/immunization/policy/sage/SAGE_WG_COVID19_Vaccines
_Modelling_Questions_31July2020.pdf
October 2020 SAGE www.who.int/immunization/sage/meetings/2020/october/SAGE_eYB_Oct2
meeting 020final.pdf?ua=1
Background Paper
5 January 2021 16Acknowledgements Hanna Nohynek Peter Smith Folake Olayinka H. Keipp Talbot Muhammed Afolabi Cristiana Toscano WHO Secretariat Celia Alpuche Yin Zundong Annelies Wilder-Smith Hyam Bashour Klaus Cichutek Joachim Hombach David Durrheim Peter Figueroa Melanie Marti Ruth Faden Adam Finn Nicholas Grassly Gagandeep Kang SAGE Chair Sonali Kochhar David Kaslow Alejandro Cravioto Eusebio Macete Ziad Memish Kayvon Modjarrad Saad B. Omer Sarah Pallas Helen Rees Mary Ramsay Christopher Morgan 5 January 2021 17
Backups
186 main principles
-Human well being
-Equal respect
-Global equity
-National equity
-Reciprocity
-Legitimacy
19
https://apps.who.int/iris/bitstream/handle/10665/334299/WHO-2019-nCoV-SAGE_Framework-Allocation_and_prioritization-2020.1-eng.pdf?sequence=1&isAllowed=y
5 January 19
2021Roadmap 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
Key assumptions:
Community Cluster of No cases, risk
Vaccines are licensed and meet all minimum transmission cases/ of importation
criteria of WHO TPP; sporadic
transmission
Vaccines have at least minimal level efficacy
in older age groups; idem for other Very limited
subpopulations; supply
(1-10%)
NPI continue to be used;
Limited
Vaccine effect on transmission less relevant supply
for early scenarios, but information becomes (11-20%)
available at some point;
Moderate
No account has been taken of supply
seroprevalence and the possible degree of (21-50%)
population protection already established.
5 January 2021 20Vaccine policy - Priority groups for COVID-19 vaccination
Endorsed by SAGE,
published on 19
October 2020
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