1. Are given to healthy people
2. Usually administered to large nr of people
3. Are needed across the globe + be affordable for everyone
4. May need to protect for a long period of time
5. Need to be convenient to administer
6. Take significant time and investment to be developed
- Prophylactic to healthy, therapeutics to sick
- Safety of vaccines is even more important than for medicine, since we give it to healthy
people (and they may never be exposed to the pathogen!)
1: VACCINE DISCOVERY
Vaccines focus on the early phases, this is not easy!
1.1: HIGH ATTRITION RATE IN EARLY STAGES OF VACCINE DISCOVERY
- Multiple discovery projects are required to ensyre pipeline sustainability
o Pipeline: develop several vaccines, for several occasions. There are
all kind of targets, most of them fail, so you need a lot of discovered
Ags + make decisions early on (because it is expensive + takes a lot
of time for vaccine discovery)
- Decisiveness is key decide ‘do we continue or not?’
o On both asset level + portfolio level
- Adopt ways of working in discovery that ensure flexibility and sustainability
HOW TO OPTIMIZE DISCOVERY? (EXAM) this is essential to do!
1. Identify & prioritize the right disease target
2. Determine early on mandatory vs desired product characteristics
3. Select the right vaccine approach/technological platform
4. Validate the vaccine concept early on early ‘de-risking’
a. Fail fast, fail cheap! Identify ‘bad’ products really early on in development!
, These are mandatory characteristics!
We are going to discuss them 1 by 1
A: IDENTIFY AND PRIORITIZE THE RIGHT DISEASE TARGET
A1: CRITERIA FOR SELECTING AND PRIORITIZING NEW DISEASE TARGETS
1. Medical need, disease burden and economical burden
2. Pathogenesis and disease understanding
3. Protective immune response
4. Technical feasibility
5. Clinical feasibility
1: MEDICAL NEED, DISEASE BURDEN & ECONOMICAL BURDEN
- Economical: if you are sick you cannot go to work/school + it costs a lot of money to treat
people
- By vaccinating, we want less spreading of the virus, and prevent that people get sick
- Look at the disease incidence & severity
o If there are only 2 people per year sick, and just with a cough = this is not sufficient to
start vaccine development!
o Does it appear every year? Which people are impacted? …
- Disease impact
o Individual vs society
o Short term vs long term (how long are you sick? Chronic illness?)
o Direct vd indirect costs of the disease
2: PATHOGENESIS & DISEASE UNDERSTANDING
- We need to understand how a virus/bacteria is causing disease so that we can interfere
with its working mechanisms and make a vaccine
- Causality between the pathogen & disease
o Correlation with virus replication? more virus, then also more sever ill?
o Correlation with immune response? (IR on itself can also be harmful)
- Factors driving severity:
o Does everybody get sick? Co-infections? Other factors?
3: PROTECTIVE IMMUNE RESPONSE
- A vaccine does not protect against infection. You can still get infected, but you just won’t get
(that) sick anymore
1. Protective role of Abs
a. Do animal studies (inject it with the pathogen > take blood sample: are there Abs?)
b. Protective mAbs – protective role of maternally derived Abs?
2. Protective role of T-cells
a. Do animal studies
b. Disease in patients with allogenic bone marrow transplant
c. IR associated with disease resolution
, - Be aware of prior (un)successful vaccine trials
4: TECHNICAL FEASIBILITY
- Large upscaling of the vaccine product has to be possible, otherwise we cannot help that
much people
o Upscaling to produce millions of dose per year!
- Is it possible to induce a broad protection against all strains & STs of the pathogen with only
a few antigens/vaccine components?
- Is there a vaccine approach that can deliver the desired immune response? (desired: Abs and
CD8+ T-cells)
- Will the cost of goods be compatible with the estimated vaccine price?
5: CLINCAL FEASIBILITY
- Is it possible to proof a concept early on in development? (this is necessary)
o Is there a population with increased disease incidence?
- Can we show efficacy with a reasonable nr of volunteers?
- Can we identify and enroll the necessary nr of volunteers in clinical trials? How many
countries and centers?
- Is there an immunological endpoint that can help:
o Selecting the final dose/formulation?
o Predicting vaccine efficacy?
CRITERIA FOR SELECTING AND PRIORITIZING NEW DISEASE TARGETS: PRIORISATION GUIDE
PRIORISATION OF VACCINE DEVELOPMENT: DECISION MAKING GUIDE
1. Technical feasibility
2. Public health value
3. Time scale & cost of development
Decision making guide: helps in making a decision whether or not vaccine development can
be continued or not (for companies)
1: TECHNICAL FEASIBILITY
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