Portfolio Approach VIC - 9 November 2021 - UNICEF
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Portfolio Approach
VIC – 9 November 20211 Portfolio principles
2 Current portfolio composition
Contents
3 Supply forecast
2Classified as Restricted
Principles for inclusion of new candidates in Covax portfolio
(1) Benefits of the vaccine candidates
Principle Description Metric A (TPP preferred) (1) Metric B (TPP critical / minimal) (1)
Combines indicators for Safety, Safety: Safety and reactogenicity sufficient Safety: (a) Outbreak - Safety and reactogenicity
Efficacy and Duration of protection. to provide a highly favourable benefit/risk whereby vaccine benefits outweigh safety risks. (b)
Considers published data and profile in the context of observed vaccine LT - Safety and reactogenicity sufficient to provide a
starting/ongoing studies on efficacy efficacy highly favourable benefit/risk profile in the context
against new variants, as well as Efficacy: At least 70% efficacy (on of observed vaccine efficacy; with only mild,
Clinical potential of technology platform for population basis, with consistent results in transient adverse events related to vaccination.
Differentiation rapid adaptation the elderly) (2) Efficacy: Clear demonstration of efficacy (on
Duration of protection: Confers protection population basis) ideally with ~50% point estimate.
for at least 1 year Endpoint may be assessed vs. disease, severe
disease, and/or shedding/transmission (2)
Duration of protection: Confers protection for at
least 6 months
Breadth of
Optimal target product profile (TPP) Optimal TPP across age groups and type of population
indication
Product stability and storage, incl. Higher storage temperatures and higher Outbreak: Shelf life of at least 12 months as low as
cold-chain requirements and dose thermostability will greatly enhance vaccine – 60-70°C, and demonstration of at least 2- week
regimen characteristics distribution and availability and are thus stability at 2-8°C.
strongly preferred. LT: Storage at -20°C or higher; Vaccine vial monitor
Option for purchase in trays/boxes Vaccine vial monitor (VVM): Proof of (VVM): Proof of feasibility and intent to apply a
Ease of with varying numbers of doses; 0.5 feasibility and intent to apply a VVM to the VVM to the primary container.
implementation ml for any dose, whether primary or primary container (3)
booster; and Vax Vial Monitors
(VVM) = Preferred, but not
mandatory principles
(1) Metrics refer to preferred and critical/minimal scenarios in WHO Target Product Profile (TPP); https://www.who.int/blueprint/priority-diseases/key-action/WHO_Target_Product_Profiles_for_COVID-19_web.pdf
(2) Vaccines currently under development may not be able to demonstrate efficacy pre-EUL and will use immunogenicity data compared to vaccines with EUL. The level of immune response should give reasonable
likelihood to predict a level of efficacy of 70 or 50% efficacy. 3
(3) cf. Preferred characteristics in WHO Target Product ProfileClassified as Restricted
Principles for inclusion of new candidates in Covax portfolio
(2) Suitability to the COVAX portfolio
Principle Description Metric A (TPP preferred) (1) Metric B (TPP critical / minimal) (1)
Achieving “Total system Weighted average price per dose accounting for AMC pricing system in selected candidates.
effectiveness” (as per Healthy
Price/
Market Framework), taking into NB: we will take into consideration total system effectiveness, however consider delivery costs
Affordability*
consideration total cost of delivery as part of the "Ease of Implementation" criteria to avoid double counting.
(4)
Geographic Diversification of Location of supplier / manufacturer
distribution* supplier/manufacturing base
Supplier’s willingness and ability Metrics to assess Supplier Performance may include:
to supply at large scale to AMC • Track record of the supplier (e.g. performance history supplying UNICEF)
countries. COVAX will assess • Vaccine policy
robustness of plans in place, Metrics to assess Supply Robustness (internal & external) may include:
Supplier
availability of adjuvants, etc.). • Domestic manufacturing constraints imposed by country governments which impact supply
Readiness to Scale
• Supplier capacity: bilateral commitments by the supplier
• Robustness of manufacturing, capacity, etc.
• Supplier's access to materials and reagents
• Constraints on adjuvants
Countries’ expressed interest in a Country preference as expressed in CCP
product. This however may be
Country Product less relevant for new candidates
Preference that may not have had a chance to
develop a track record yet
(4) Health Market Framework: https://www.gavi.org/sites/default/files/document/healthy-markets-framework--public-overviewpdf.pdf 4
(*) These are more relevant for Covax from a pillar perspective, rather than individual participants1 Portfolio principles
2 Current portfolio composition
Contents
3 Supply forecast
5UPDATED ON 2 NOV 2021
COVAX Facility Supply
Product-specific portfolio overview
There are currently eleven
PRELIMINARY AND SUBJECT TO ASSUMPTIONS
vaccines in the COVAX
portfolio:
COVAX Total Available Supply, M doses, 2021 and 2022
Committed doses1 Optional doses1 1. SII: Covovax ("NVX-CoV2373")
Dose donations2 Under discussion/negotiation 691 6,585
2. SII: Covishield ("AZD1222")
620 5,894
200 3. Pfizer/BioNTech: BNT162b2
300
170 170 4,774
350
200 4. Moderna: mRNA 1273
380
414 5. Clover Biopharmaceuticals: SCB-
500 2019 (CpG1018/Alum)
550
1,000 6. Sinovac: CoronaVac
1,040 7. Novavax : NVX-CoV2373
8. Janssen J&J4: Ad26COV2.S
3
Signed Dose Total Adjusted
deals donations Total 9. AstraZeneca: ChAdOx1-S
Secured supply from Supply from non-binding Adjustment for [recombinant] ("AZD1222")
legally-binding agreements agreements and donations single-dose
candidates5
10. Sinopharm: BBIBP-CorV
1 “Committed doses” are doses that the COVAX Facility is required to procure. “Optional doses” are doses that the COVAX Facility has the option to procure in the future, but is not
required to purchase. Once optional doses are exercised, they become committed doses. 11. Sanofi-GSK: Recombinant Protein
2 “Dose donations” estimated based upon donor commitments to share new doses bilaterally with COVAX. The transfer of COVAX allocations from SFPs to AMC Participants are
already included in the volumes secured by COVAX from legally-binding agreements.
3 US support has allowed COVAX to secure an additional 1B Pfizer/BioNTech doses. Reflecting US funding above its original pledge, 700M of these are recorded as a donation.
4 COVAX has signed an Advance Purchase Agreement (APA) with Janssen for 200M doses; negotiations for up to an additional 300M doses are ongoing as per the Memorandum
of Understanding announced on 18 December 2020. 6
5 In these supply forecasts, volumes for single-dose regimen candidates have been doubled to ensure comparability with two-dose candidates.1 Portfolio principles
2 Current portfolio composition
Contents
3 Supply forecast
7UPDATED ON 2 NOV 2021
COVAX Facility Supply Forecast
Ranged forecasts under low, most likely, and high scenarios
PRELIMINARY AND SUBJECT TO ASSUMPTIONS
COVAX Forecasted Supply, Cumulative, M doses, 2021 and 20221 THREE BIGGEST DRIVERS OF
UNCERTAINTY FOR COVAX
Low scenario2 Most likely scenario2 High scenario2
2,480 SUPPLY
High: 1,380 - Timing and extent to which export
30% controls in India are eased. While
coverage3
2,005 vaccine have started being exported
from India, the exact volumes and
phasing of volumes for COVAX is still
1,645 under discussion.
20%
coverage3 - Manufacturers prioritizing supply
Reflects COVAX doses 1,300
released to date from global manufacturing
1,010 networks to COVAX, allowing
COVAX to access doses that it has
10%
720 already secured and paid for under its
coverage3 existing APAs.
490
370 Low: 1,160
260 - Timely regulatory approval of
160 candidates that COVAX has signed
35 50 80
10 10 deals with including those being
developed by Novavax, SII-Novavax,
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar and Clover.
2021 2022
1 Timing of available supply is based on anticipated date of release by manufacturer, at which point doses become available for delivery. Timing of delivery to countries will be lagged
due to need for local regulatory approvals, supply agreements, country readiness, export licenses, logistics, etc. Volumes for single-dose regimen candidates doubled to ensure
comparability across vaccines. Volumes include dose donations that are committed to being delivered through COVAX. Volumes have been rounded to nearest 5M.
2 Scenarios are based on best available information from manufacturers and analysis from Gavi and UNICEF on the impact and likelihood of potential mitigation efforts. 8
3 Coverage refers to proportion of total population in AMC91 Participants that could be fully vaccinated with available volumes, assuming India receives 20% of AMC-funded volumes.You can also read
