Dr Ines I Atmosukarto

ines@lipotek.com.au

Vaccine development and Vaccine

Technology

The image is adapted from the Harvard news release.

 Adaptive response

How do Vaccine

vaccines work? T cell response

1. Preventative (cf drug which is

therapeutic)  given to HUMORAL RESPONSE
healthy people
2. Biological Product CELLULAR RESPONSE
3. Complex manufacturing Antibody Response
4. Manufacturing can affect against Spike protein
product efficacy
How do vaccines work
Vaccine platforms
 How are vaccines developed?

TRADITIONAL APPROACH NOVEL PLATFORM TECHNOLOGIES

Take the virus, grow it & Inactivate it Take the virus and use components from it
Covid-19 vaccine
landscape
Covid-19 vaccines in development
Clinical
development
(normal timeline)
Dr Neni Nurainy
 Criteroa
1. Track record
2. Technology platform – rapid
response
3. Paralel and global response
(multisite/multicenter CT)
4. Regulatory: EUA

Melanie Savile, WHO Briefing Session for Developers on R n D for Covid-19 vaccine, 26 Mei 2020
Biopharmac
eutical
developmen
t is complex

Adapted from Dr Neni Nurainy

11
Inactivated
vaccine (virus)
• Large scale mammalian cell
culture
• Suitable cell line Vaccine is ready
• Potential need for BSL3 if the
virus is BSL3 pathogen
• Know how critical
Attrition rate in pharmaceutical product
development
Drug development is a
lengthy, complex, and costly
process, entrenched with a
high degree of uncertainty
that a drug will actually
succed

The unknown pathophysiology

for many disease makes target
indentification challenging

Regulatory Pressures
Octay Y, Mathias G, Peter S, Martin, C, Frontiers in Pharmacology, 2016
 PHASE 3 Clinical Trial

mRNA

Viral Vector based

Inactivated Vaccine

Protein based Vaccine

 Immunogenicity vs Efficacy

Immunogenicity Efficacy

The ability of the The extent to which the

vaccine to induce vaccine provides a beneficial
an immune result
response in an
individual • Prevention of disease
• Prevention of severe
disease
• Prevention of transmission
Thank you
 Needs and
challenges in
vaccine
development

17
Efficacy (Ph3 trials)
Vaccine development capability – an important but
costly investment