SAGE extraordinary meeting Policy recommendations on the use of AZD1222 vaccine - Dr Kate O'Brien - WHO, Director, Department of Immunization ...
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SAGE extraordinary meeting Policy recommendations on the use of AZD1222 vaccine Dr Kate O’Brien – WHO, Director, Department of Immunization, Vaccines and Biologicals 08 February 2021
Note: The designations employed and the presentation of these materials do not imply the expression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. 2
State of Vaccines: key numbers (data at 8 February 2021)
• 64 days since first countries started vaccinating1 and 42 days since
all EU countries received vaccines
• 131 million vaccine doses have been administered:
o ~86% of these doses have been administered in 10 countries
o At least 8 different vaccines (3 platforms) have been administered2
• Campaigns have started in 74 economies:
o incl. 52 HICs, 12 UMICs, 9 LMIC and 1 LIC
o Pfizer-BioNTech vaccine is by far the most used vaccine (56 economies using it),
followed by Moderna (16 economies), Oxford/AZ (10 economies) and Sinopharm (7
economies)
1. Dec. 8, 2020 in the UK (Pfizer)
2. Pfizer, Moderna, Gamaleya, Sinovac, Sinopharm, SII, Bharat Biotech, AZ
3
Source: Our World in data; Bloomberg
PRELIMINARY
State of Vaccines: rollout has started in 74 economies
(data at 8 Feb 2021) Status of Vx roll out per income group
> 50% of countries
25% < X ≤ 50%
# of economies % of economies
# of economies where 10% < X ≤ 25%
where
≤ 10%
Economies classified per income vaccination has vaccination has
by income level1 group started started List of economies where vaccination has started
Andorra, Austria, Bahrain, Belgium, Bermuda, Canada, Cayman Islands, Channel Islands,
Chile, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Faroe Islands, Finland, France,
High income Germany, Greece, Greenland, Gibraltar, Hungary, Iceland, Ireland, Isle of Man, Israel,
83 52 63% Italy, Kuwait, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Monaco,
economies (HICs)
Netherlands, Norway, Oman, Panama, Poland, Portugal, Romania, Saudi Arabia,
Seychelles, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, UAE, UK, USA
Argentina, Brazil, Bulgaria, China, Costa Rica, Ecuador, Indonesia, Maldives,
Upper-middle Mexico, Russia, Serbia, Turkey
income economies 56 12 21%
(UMICs)
Algeria, Bangladesh, Bolivia, Egypt, India, Morocco, Myanmar, Nepal, Sri Lanka
Lower-middle
income economies 50 9 18%
(LMICs)
Guinea
Low income
29 1 3%
economies (LICs)
-
Total 218 74 34%
3 LMICs have started campaigns over the last 5 days: Bolivia,
4
1. World Bank classification (2021)
Source: World Bank; Our World in data; Bloomberg; Reuters
Bangladesh and Nepal 4
PRELIMINARY – THIS LIST MAY NOT BE EXHAUSTIVE
Which economies are using which vaccine(s)?
(data at 8 Feb 2021)
Incl. Canada, Chile, Costa Rica, EU, Israel, Kuwait, Mexico,
Oman, Saudi Arabia, UK, USA (non-exhaustive list)
56
Bangladesh, Brazil,
India, Maldives, Algeria,
Morocco, Argentina,
Myanmar, Nepal, Bolivia,
Seychelles, Sri Guinea, Brazil,
Lanka, UK Serbia Chile,
Russia China,
16 Indonesia,
Turkey
10 India
7 6 5
1
Pfizer Moderna AZ (UK) / Sinopharm Gamaleya Sinovac Covaxin
BioNTech Covishield
• 43 countries are using 1 vaccine vs. 31 countries using 2 vaccines (or more)
• 76% of countries are using the Pfizer-BioNTech vaccine 5
5
Source: Our World in data
Status of vaccines with efficacy results
COVAX Facility
Products
Release of efficacy Reported
Manufacturer results #Participants efficacy Severe disease
Pfizer/BioNTech Published full study 43,000 95% 10 (9 in placebo vs. 1 in
results (Nov. 18) vaccine group)
Moderna Published full study 30,000 94.1% 30 (30 in placebo (incl. 1
results (Nov. 30) death vs. 0 in vaccine group)
AstraZeneca Published interim 12,390 62-90% 18 (16 in placebo vs. 2 in
results (Jan. 9) vaccine group)
Published interim 21,977 91.6% 20 (20 in placebo vs. 0 in
Gamaleya
results (Feb. 2) vaccine group)
Press release Interim 13,000 50.4% No information given
Sinovac
results (Jan. 12)
Press release Interim 21,977 79% No information given
Sinopharm results (Dec. 31)
Press release Interim 15,000 89.3% 1 (1 in placebo vs. 0 in
Novavax UK results (Jan. 28) vaccine group)
Press release Interim 43,783 66-72% Definition of efficacy is
Johnson & Johnson US results (Jan. 28) against moderate to severe
disease
1. The Lancet on AZ/Oxford, The Lancet on Sputnik V, Bloomberg on Sinovac, Bloomberg on Sinopharm, Novavax website, J&J website
6
Additional investments through CEPI and by the COVAX Facility are currently in negotiation
7
https://www.gavi.org/sites/default/files/covid/covax/COVAX%20Supply%20Forecast.pdf 7
5 Step Process was used to develop the List of 1st
Wave of COVAX Participants (Pfizer Vx)
1. All COVAX Participants that responded to the EoI were considered (72 total)
2. Priority was given to COVAX Participants that had not started vaccination, met all of the readiness
criteria1 and, for SFPs, were within the Pfizer price point (48)
3. COVAX Participants were then grouped by WHO Region and AMC/SFP status to ensure all
Regions/groups would be represented (i.e. in line with the primary learning objective2)
4. Participants in each group were then ranked by their 28-day mortality rate as a proxy for the risk
of health care worker exposure (i.e. high COVID-19 mortality = high exposure)
5. Eligible COVAX Participants were selected from each group up to 18 maximum that can be covered
& supported with limited Pfizer vaccine quantities in the 1st wave in February
1. as assessed by Regional Review Committees and COVAX Country Readiness & Delivery Team (both of which include WHO technical staff)
2. the primary objectives of (i) learning & (ii) having a meaningful public health impact were outlined in the COVAX/Gavi call for EoIs (6 January 2021)
8
1st wave Pfizer vaccine distribution Health Impact
18 participants allocated Pfizer doses Learning
18 participants allocated
Pfizer doses:
First 10 participants with
highest mortality (1st per RO,
Ukraine Mongolia
AMC & SFP group)
Bosnia and Moldavia
Herzegovina
Georgia
Tunisia Second highest mortality - 8
West Bank
Bhutan
Republic
of Korea
participants (2nd participant in
and Gaza
all AMC groups & 2 SFC
Cabo Verde groups with rate >0)
Colombia Philippines
El Salvador
Maldives
Rwanda
Peru
Bolivia
South Africa
Note: The designations employed and the presentation of these materials do not imply the expression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory or area or of its authorities, or
concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement.
9
Regulatory timeline of key Vx candidates (data as of Feb
8th)
https://extranet.who.int/pqweb/key-resources/documents/status-covid-19-vaccines-within-who-eulpq-evaluation-process
Legend (timing of approval)
Approval / Emergency use
Between. Jan and Feb. 2021
From March 2021
Estimated dates of approval / Emergency use
No info
Country reliance on PQ
Vx candidates FDA MHRA EMA WHO EUL/PQ
Dec. 12, 2020 Dec. 2, 2020 Dec. 21, 2020 Dec. 31, 2020
Jan. 2021 onwards
Emergency Use Emergency Use Cond. Authorization1 Emergency use Key messages
Dec. 18, 2020 Jan. 8, 2021 Jan. 6, 2021
End of Feb 2021 March 2021 onwards
Emergency Use Emergency Use Cond. Authorization1 • Pfizer: WHO EUL on Dec.
AZ with EMA as authority of
April 20212
Dec. 30, 2020 Jan. 29, 2021 Between March and Between April and July 31st with EMA as authority
reference Emergency Use3 Cond. Authorization1 April 21 21 onwards
of record; ongoing country
AZ South Korea w/ MFDS 2nd half of Feb 2021
Korea as authority of record Not applicable Not applicable Not applicable
(Earliest)
March 2021 onwards reliance on PQ
SII /AZ vaccine (Covishield) with
DCGI India as authority of record - - - Mid-February 2021 • AZ: WHO EUL expected at
the earliest in 2nd half of
No FDA approval No EMA approval March 2021 (Earliest) April 2021 onwards February with MFDS (South
No approach yet to
Korea) as authority of
* EUL/PQ* record
Sinopharm /
WIBP4 • SII/AZ: WHO EUL expected
mid-February with DCGI
Sinopharm / BIBP5 March 2021 (Earliest) April 2021 onwards
(India) as authority of
March 2021 April 2021 onwards
record
Expected info from
Gamaleya
April-May 2021
May 2021 (earliest) June 2021 onwards
(earliest)
1. Conditional marketing authorization 2. According to the chief adviser for the U.S. COVID-19 vaccine program (Dec. 30, 2020; Source) 3.Temporary authorisation of supply of the vaccine in the emergency use setting (which is distinct from a marketing
authorisation) 4. Wuhan Institute of Biological Products Co Ltd 5. Beijing Bio-Institue of Biological Products Co-Ltd
SOURCE: https://extranet.who.int/pqweb/sites/default/files/documents/Status_COVID_VAX_01Feb2021.pdf; https://www.bloomberg.com/graphics/covid-vaccine-tracker-global-distribution/
*. SII/Novavax needs to be specified
10SAGE working to issue policy recommendations, coordinated
with Regulatory process Past date Earliest expected date
Sept/Oct 2020 Dec 2020 Jan 2021 Feb Mar
WHO EUL
regulatory SII/AZ Moderna
WHO EUL Sinovac, Sinopharm,
timeline Oxford/AZ
Pfizer/BioNTech CanSinoBIO
Dec 31
Sept/Oct 2020 Jan 2021 Feb Mar
Values Guidance on Interim recs Interim recs Interim recs Sinopharm tbd
framework prioritization of Pfizer/BioNTech Moderna Oxford/AstraZeneca J&J tbd
Sep 14 target populations Jan 5 Jan 25 Feb 8
SAGE
Nov 13
meetings
& policy
recommen
dations
https://www.who.int/publications/i/item/who-sage-values-framework-for-the-allocation-and-prioritization-of-covid-19-vaccination https://www.who.int/publications/m/item/who-sage-roadmap-for-
prioritizing-uses-of-covid-19-vaccines-in-the-context-of-limited-supply
https://www.who.int/publications/i/item/WHO-2019-nCoV-vaccines-SAGE_recommendation-BNT162b2-2021.1
https://www.who.int/publications/i/item/interim-recommendations-for-use-of-the-moderna-mrna-1273-vaccine-against-covid-19
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