Ranna Eardley-Patel CEPI

1. Sensitivity: CEPI Internal
CEPI’s 100 Days Mission
Rapid response, scaling to billions and
enabling access to vaccines
Ranna Eardley-Patel
Sustainable Manufacturing Lead
Vaccine Technology Summit, London
September 15-16, 2022 #100DaysMission

2. Sensitivity: CEPI Internal
2
The Creation of CEPI
Launched at the World Economic Forum at Davos in 2017 as a global coalition to tackle epidemics

3. Sensitivity: CEPI Internal
Governments
Philanthropists
Regulators
Pharmaceutical
Industry
Civil society and
health
organisations
Academia
CEPI's unique connecting
role and extensive networks
allow it to pool and deploy
resources in ways that
nation states
often cannot.
A world in which epidemics and
pandemics are no longer a threat
to humanity.
Vision
To accelerate the development of
vaccines and other biologic
countermeasures against
epidemic and pandemic threats
so they can be accessible to all
people in need.
Mission
CEPI: A global partnership

4. Sensitivity: CEPI Internal
Lassa
Advancement of the first
ever Lassa virus vaccines
into Phase 1 trials
MERS
Advancement of the first
ever MERS vaccine into
Phase 2
Nipah
Advancement of the first
ever Nipah virus
vaccines into Phase 1
trials
Rift Valley Fever
Two vaccine candidates
undergoing preclinical
studies
Chikungunya
First Phase 3 trial of a
Chikungunya vaccine
Ebola
Supported clinical
development
contributing to two Ebola
vaccines achieving
licensure and WHO
prequalification
*Chikungunya was considered by WHO during its 2018 annual review but not shortlisted as a priority disease under the R&D Blueprint
COVID-19
Supported
development of
numerous COVID-19
vaccines & founding
member of the ACT
accelerator/COVAX
Monkeypox
No regrets
investments into
immunoassay
development and
reference antibody
standards prior to
PHEIC
Cross-cutting activities
Includes an array of
enabling projects to
develop standards and
assays, preclinical models,
establishment trial, lab and
manufacturing networks to
support trials as well as
preclinical studies, plus the
largest ever, multi-country
epidemiology study -
ENABLE Lassa
programme
CEPI’s key
achievements
2017-2022
21 vaccines candidates against 5* WHO R&D Blueprint short-listed pathogens
Disease X
Three rapid response
platforms advanced through
Phase I, with potential to
significantly improve speed of
vaccine development against
multiple pathogens

5. Sensitivity: CEPI Internal
2.0
Vision statement
A world in which epidemics and
pandemics are no longer a threat to
humanity
Mission statement
Accelerate the development of
vaccines and other biologic
countermeasures against epidemic
and pandemic threats so they can be
accessible to all people in need
Prepare
for known epidemic
and pandemic
threats
Transform
the response to the
next novel threat
Connect
to enhance and
expand global
collaboration
To develop a safe and effective vaccine in 100
days from the moment that a pathogen is
sequenced and/or the need for a vaccine is
recognised to initial availability for use.
aspiration
100
day

6. Sensitivity: CEPI Internal
If the world had developed a
coronavirus vaccine within 100 days,
the first injections might have been
given in April 2020, when there were
just
2.3 million
cases of COVID-19
rather than on the 8th December,
when
more than 68 million
people had already been infected with
the disease.
The need for speed
#100DaysMission

7. Sensitivity: CEPI Internal
Example metrics:
• Human-to-human transmission
confirmed, with failure of typical
control measures
• Unusual high # severe disease
cases or deaths (e.g., at hospitals
within country / area)
• New infectious diseases pathogen
identified as causative agent
Vaccine made available for
use by respective authorities
e.g., vaccine deployment for public
health intervention to control an
outbreak in agreement with
regulatory authorities
Alert trigger Vaccine available for
emergency use
100
days
We acknowledge this
goal is incredibly
ambitious and have
established it as a north
star, recognizing that
with vision and
collaboration, great
things are possible
CEPI’s aspiration is to develop a vaccine in 100
days from alert trigger to a vaccine available for
use

8. Sensitivity: CEPI Internal
Critical path towards vaccine availability
• Analysis of COVID-19 vaccine development timelines shows that manufacturing is on the critical path to get to first-in-
human
• Manufacturing scale-up and technology transfer is critical to make doses available and equitably accessible
Alert trigger Vaccine available for use
Billions of doses
manufactured
Equitable access
ensured
Candidate
development and
preclinical testing
Early clinical
trials
Large-scale
clinical trial
Regulatory
submissions
Process
development and
Phase I/II
manufacturing
Scale-up and
Phase IIb/III
manufacturing
Process
Qualification
Scale-up and -out,
technology
transfer
Saville, Melanie, et al. "Delivering Pandemic Vaccines in 100 Days—What Will It Take?." New England Journal of Medicine (2022).

9. Sensitivity: CEPI Internal
The paradigm shift will
involve systematic
front-loading of
preparedness
activities & breaking
the firewall between
development and
intervention
Readiness: Prepare
the toolkit,
infrastructure and
partnerships
Pre-outbreak
Development of rapid
response platforms,
vaccine libraries and
critical reagents
Response: Adapt,
create & test the
pathogen-specific
vaccine
Between outbreak
& initial vaccine
availability for use
Shift from prototype
vaccines to pathogen-
specific activities &
scale-up vaccine
manufacturing
Rollout and
review: Release
vaccine & expand
clinical evidence
Post initial
availability for use
Continued
surveillance after
initial authorisation
e.g., broken firewall
between development
and intervention
Response time can be 100 days under
specific circumstances
Point of outbreak Available for use

10. Sensitivity: CEPI Internal
#100DaysMission
Shorten every step of the
vaccine development process
If we combine the best-in-class work from
every stage, we could shave off around two
months (vs Pfizer’s record of 326 days).
Think of it as a Formula 1 pitstop. In the 1950s,
it took 60 seconds to change a wheel. Thanks
to incremental improvements over the years, it
now takes just two seconds – because every
step has been perfected.
1 2 3 4

11. Sensitivity: CEPI Internal
#100DaysMission
1 2 3 4
Vaccine libraries: What
has COVID-19 shown us?
Before COVID-19, scientists were already
working on vaccines against MERS and SARS
(also part of the coronavirus family).
What those scientists learned enabled them to
pivot quickly and respond at lightning speed
when COVID-19 emerged.
We can replicate this approach for other virus
families.

12. Sensitivity: CEPI Internal
#100DaysMission
Completing as many pieces of the puzzle as we can
before a new virus emerges (Disease X).
We need to develop a library of ‘prototype vaccines’ against virus families
that can be swiftly adapted.
CEPI* is prioritising vaccine libraries for up to 10 virus families that pose
the greatest risk to public health.
Our aim is to establish clinical proof of concept for vaccines against these
virus families over the next five years.
This is a mammoth task. We anticipate it being a shared global project
with CEPI playing a leadership/connecting role.
1 2 3 4
*By working with leading experts to systematically rank each family based on its Disease X potential. To do this, we’re looking at potential for outbreak transmission
or zoonotic spillover, ability to mutate, mode of transmission, and other factors.

13. Sensitivity: CEPI Internal
#100DaysMission
Building vaccine manufacturing
capacity closer to outbreaks.
A globally distributed network would enable
rapid access to vaccine doses in low- and
middle- income regions.
It could also allow for vaccine production to
take place closer to the source of an outbreak.
Plus promotion of vaccine uptake?
1 2 3 4

14. Sensitivity: CEPI Internal
#100DaysMission
Making a calculated shift in the
way we do clinical trials and
regulation.
In future emergencies, the rapid rollout of
vaccines based on pre-established safety data
should go hand-in-hand with the ongoing
review of real-world evidence of efficacy.
This represents a change in the traditional
mindset, but acceptable if no short-cuts are
made, only parallelisation.
1 2 3 4

15. Sensitivity: CEPI Internal
15
15
Which technical innovations do we need to enable equitable access to
essential or emergency vaccines ?
• Novel formulations and format that are easy to distribute and administer
• Lower cost of goods
• Globally distributed manufacturing including LMICs
• ?
Billions of doses
Ensure equitable access

16. Sensitivity: CEPI Internal
"Human ingenuity can render our careful projections
irrelevant and make our boldest aspirations seem timid."
—Melinda French Gates and Bill Gates, Gates Foundation Goalkeepers report
#100DaysMission