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Printable Handouts
Navigable Slide Index
- Introduction
- Overview
- Vaccine development: normal circumstances
- Ebola
- Ebola virus transmission and disease
- Ebola outbreaks
- Challenges of accelerated vaccine development
- A diverse & dynamic global collaboration
- V920 Vaccine-ERVEBO™
- Regulatory challenges
- Complex regulatory strategy
- Common technical document complexities
- WHO prequalification collaborative review
- Manufacturing challenges
- Steps for vaccine manufacturing & supply
- Scaling up manufacturing
- Supporting global outbreak response efforts
- Nonclinical development challenges
- Overcoming nonclinical data challenges
- Limited BSL-4 facilities
- An optimized and validated assay
- A bridging strategy to human immunogenecity
- Clinical development challenges
- Clinical development challenges: images
- Overcoming cold-chain/transport challenges
- Military conflict
- Unpredictable outbreaks
- Clinical trial evaluation from phase I through IV
- Efficacy studies started during outbreak decline
- WHO’s “Ebola ça Suffit” ring vaccination trial
- Ring vaccination trial: final efficacy results
- ERVEBO™ overall safety conclusions to date
- ERVEBO™ access prior to licensing
- Summary
- Sincere thanks and acknowledgments
Topics Covered
- Vaccine development under normal circumstances
- Ebola: virus transmission, disease and outbreaks
- Ebola as a case-study for challenges of accelerated vaccine development
- Demonstrating safety, efficacy, and manufacturing consistency
- Challenges in cutting clinical development from 10+ to 5 years
- Vaccine acceleration can be achieved through good partnership
Links
Categories:
Therapeutic Areas:
External Links
Talk Citation
Simon, J. (2020, May 31). Challenges of accelerated vaccine development [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved October 7, 2024, from https://doi.org/10.69645/OUOC6651.Export Citation (RIS)
Publication History
Financial Disclosures
- Commercial/Financial matters disclosed include employment at Merck.
A selection of talks on Vaccines
Transcript
Please wait while the transcript is being prepared...
0:00
My name's Jakub Simon and
I'm the Director of Vaccines Clinical
Research at Merck Research Laboratories.
And today I'll be covering the Ebola
vaccine story as a case study,
to explore challenges and opportunities
of accelerated vaccine development.
And before we start,
I would like you to take a moment to
imagine yourself in an Ebola outbreak.
People around you are getting sick,
6 people that you know got infected,
4 of them died and
reflect on your thoughts.
You want to leave the area, you'll like
a treatment, you'll like a vaccine.
How quickly would you like a treatment or
vaccine available is the topic
of today's discussion.
And we'll cover the Ebola
vaccine case study.
0:44
So we'll start by looking at vaccine
development under normal circumstances,
talk a little bit about Ebola.
And the reason Ebola is a good case study
is it that it covers all of the usual
regulatory manufacturing non clinical and
clinical development
components that we'll explore.
1:01
Vaccine development under normal
circumstances is a complex process
that poses many challenges.
The average development
takes over 10 years and
costs over $2 billion US,
that is billion with a B.
So if you just take two numbers,
those two numbers and
divide them you get over
$200 million per year.
The reason clinical development is so
expensive, is because it is subject to
rigorous oversight that includes testing
by national regulatory authorities.
And that is in order to ensure that
the vaccines are safe, potent and
effective each time that
they're manufactured.
And this is to address vaccine
hesitancy and public distrust.
Proactively, make sure that there aren't
any problems with vaccines and medicines.
Despite these challenges, one of
the most cost effective means to prevent
infectious diseases and
contain outbreaks are vaccines.