VACCINES INFOCUS - GLOBAL & INCLUSIVE
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InFocus
Vaccines
FDA’S PETER MARKS ON ‘ R&D MODELS: GSK & UNICEF ON VACCINE EXCLUSIVE DELOITTE WHITE
FOLLOWING THE SCIENCE’ JANSSEN ACCESS PAPER ON VACCINE SUPPLY
PAGE 6 PAGE 8 PAGE 28 CHAIN
PAGE 31
GLOBAL & INCLUSIVE
JANUARY 2021 In collaboration with:
INFOCUS
Vaccines
Contents JANUARY 2021
page 3 page 16 page 28
PREFACE COLLABORATION VACCINE ACCESS
FEATURE - IMI, World Bank, Swiss INTERVIEW -
page 4 TPH Etleva (Eva) Kadilli,
SNAPSHOT IN FIGURES UNICEF
page 18
page 6 MARKET ACCESS
REGULATORY FEATURE - GAVI
INTERVIEW page 30
REGIONAL PLAYER
Peter Marks, CBER,
US FDA
page 19 INTERVIEW - Charles Chen, MVC
FUNDING MODEL
FEATURE - CEPI
page 8
R&D page 21
INTERVIEW - Emmanuel Hanon, GSK;
CASE STUDY
and Dr Johan Van Hoof, Janssen
FEATURE - Prevenar 13
page 31
WHITE PAPER
FEATURE - Population Health
page 12
COMMERCIAL GROWTH
FEATURE - Global Insights page 22
CASE STUDY
FEATURE - MSD’s Ebola Vaccine
page 13
INFOCUS
FEATURE - Roger page 24 page 39
Connor, GSK NON-COMMERCIALLY VIABLE EXECUTIVE INSIGHT
VACCINES FEATURE - Cyril Schiever, MSD
INTERVIEW - Ole Olesen, EVI
page 14 page 26 page 41
MRNA TECHNOLOGY SUPPLY CHAIN SUPPLY CHAIN
FEATURE - Dr Thomas D. Madden, INTERVIEW - Joe Lewis, Deloitte INTERVIEW - Larry St Onge, DHL
Acuitas Therapeutics
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2 InFocus Vaccines www.pharmaboardroom.com
Preface
L
ong dismissed as the backwaters of healthcare this newly awakened global interest and investment in vac-
innovation, the tremendous value of vaccines cines – and whether the frenetic zeal to discovering and
– the single most cost-effective health inter- deploying COVID-19 vaccines would translate into sus-
vention after clean water – made itself starkly tained and longer-term efforts to support vaccine R&D for
clear in 2020, as the discovery of a novel coro- a whole host of other infectious diseases that continue to
navirus quickly exploded into a full-blown global pan- claim tens of millions of lives annually.
demic that rages on still. This issue of InFocus dedicated to vaccines features a
While billions have since been poured into vaccine variety of global, regional and local stakeholders across
development for COVID-19 and vaccine candidates have the public and private spheres to provide a snapshot
been developed and approved (albeit so far only for emer- of the four thematics at the heart of the vaccine sector:
gency use) at unprecedented speed, sector stakeholders Research & Development, Manufacturing & Supply Chain,
are only cautiously optimistic regarding the longevity of Partnership Models, and Public Health Impact.
2020 2019 2012 2009 2006
COVID-19* EBOLA Hepatitits E Flu A (H1N1) Human papilomavirus (HPV)
1984 1991 1998
The Chicken pox Hepatitis A Lyme disease and Rotavirus
History of 1981 1974
Vaccines Hepatitis B Meningitis
in the 1969
1954 1963 1967
Last Anthrax Measles Parotitis (Mumps) Rubella
Century
1952 1935 1923
Polio Yellow fever Dipththeria
* Leading to conventional approval 1938 1926 1921
Source: Iberdrola; Nature, CDC; WHO Typhoid Whooping cough Tuberculosis
www.pharmaboardroom.com InFocus Vaccines 3
SNAPSHOT IN FIGURES
Vaccination Overview
THE VALUE OF VACCINATION GLOBAL VACCINES MARKET SIZE
2014-2020, BILLION DOLLARS
Every $1 spent on immunization provides a return of $59
up to $44 in the world’s poorest countries. $54
$49
$ $ $ $ $ $ $ $ $40
$44
$ $ $ $ $ $ $ $ $32
$36
$ $ $ $ $ $ $ $
$ $ $ $ $ $ $ $
$ $ $ $ $ $ $ $
$ $ $ $ $ 2014 2015 2016 2017 2018 2019 2020
Source: Return on Investment from Childhood Immunization in Low - And Source:
Middle-Income Countries
THE MOST WIDESPREAD VACCINES AROUND THE WORLD
Share of one-year-olds globally who received full set of immunizations for the following diseases in 2018
Tuberculosis 89%
Tetanus/ diphteria/ whooping cough 86%
Polio 85%
Hepatitis B 84%
HIB* (meningitis) 72%
Measies/ rubella 69%
Yellow Fever** 49%
Pneumococcal disease 47%
*Haemophilus influenzae type b
Rotavirus 35% *Share in 40 countries/ territories affected
Sourcce: WHO, Statista
4 InFocus Vaccines www.pharmaboardroom.com
SNAPSHOT IN FIGURES
Market
TOP GLOBAL VACCINE PRODUCTS BASED RECOMBINANT VACCINES MARKET
ON REVENUE
Global Recombinant Vaccines Market Size
(IN MILLION US DOLLARS)
$5,693
$8.97 $21.00
Billion Billion
2018 2026
$2,380
$2,065 North America Recombinant Vaccines Market
$1,798 Size (2018, USD Billions)
$4.12 Billion
Prevnar 13 Gardasil Pentacel Fluzone
(Pfizer + (Merck & Co) (Sanofi) (Sanofi)
Daewoong) Source: Fortune Business Insights
Source: Fortune (2017)
NEW VACCINE LAUNCHES AS % OF TOTAL GLOBAL SALES
(1997-2017, %)
Existing Vaccines New Launches(1)
100
80
60
40
20
0
1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
(1) Defined as any vaccine that received US Food and Drug Administration approval in preceding 5 years.
Source: EvaluatePharma, Evaluate, September 2018, evaluate.com; McKinsey analysis
www.pharmaboardroom.com InFocus Vaccines 5
REGULATORY
Peter Marks, CBER, US FDA
FOLLOWING Dr Peter
Marks
THE SCIENCE director, Center
for Biologics
Evaluation
and Research
(CBER), US FDA
Dr Peter Marks MD, PhD, director of the
Center for Biologics Evaluation and Re-
search (CBER) at the US Food and Drug
Administration (FDA), highlights the Cen-
ter’s contributions related to the regula-
tory science behind vaccine development
and his commitment to following the sci-
ence and remaining steadfast to the truth
Peter, could you start by clarifying the mis- dressed the issue of using the Emergency Use
sion of CBER under the US FDA? Authorization (EUA) process that we have here
PETER MARKS (PM): CBER is one of the in the US for COVID-19 vaccines, and also why
smaller FDA centers. Its mission is to facilitate we have promised to take every COVID-19
and consolidate the review of complex biologi- vaccine that comes in with an EUA request or a
cal products, including blood and blood prod- Biologics License Application (BLA) request to
ucts, allergenic products, tissues, cellular and a public advisory committee meeting.
gene therapies, and vaccines. Our guidance was intend-
Due to COVID-19, we have our hands full ed to place some bounda-
right now, since we have to deal with many ther-
apeutics like COVID-19 Convalescent Plasma
ries on what is acceptable
for a COVID-19 vaccine.
Refrain from
and polyclonal immunoglobulins, as well as
COVID-19 vaccines, in addition to work on our
We wanted to make sure
that people had an idea of
getting lost in
existing products such as cell and gene thera- what we are looking for so all the noise [...]
pies. We have an outsized importance presently, that when we receive EUA
with the products we regulate featured routinely or BLA submissions they in the current
in papers every day, so these are certainly inter- are consistent with our
esting times for us. expectations. environment
It is important to note
How has this public and media scrutiny af- here that it is the FDA Chief Scientist that signs
fected the work of the US FDA CBER? off on EUAs. We make a recommendation based
PM: I have taken a pretty strong stance, as on our evaluation, which goes to the Chief
supported by FDA Commissioner Stephen Scientist, who then makes the final decision.
Hahn, to follow the science for these products When it comes to the FDA, it is patently clear
as they are developed. This is one of the reasons that we are here to follow science to bring ben-
we issued a guidance entitled, Development efit to this country and, when possible, to bring
and Licensure of Vaccines to Prevent COVID- benefit to the entire globe. That is only going
19, and also why we have, in our guidance, ad- to happen if we continue to dedicate ourselves
6 InFocus Vaccines www.pharmaboardroom.com
REGULATORY
Peter Marks, CBER, US FDA
to objectively working through the configurations that could advance
evidence, to follow the science, and the field.
to come to independent conclu- One of the things that is hard
sions. This is what we have done for the public to understand is that
and it is what we will contin- infectious diseases are each some-
ue to do during this time. We what unique. Our bodies have learnt
have to remain steadfast to to generate immune responses to
the science … and refrain certain pathogens better than oth-
from getting lost in all the ers. It so happens that for respirato-
noise that is out there in the ry viruses like COVID-19, the body
current environment at this does seem to ultimately generate a
point. good immune response, so we are
The world needs good vac- lucky in some ways. It may even be
cines here and that is what we that the immune response is exuber-
would like to facilitate. ant in elderly people, which is why
they become more severely ill, or
Looking beyond just COVID-19, perhaps the immune response is not
during your time at CBER, what quite right.
have been some of your learnings But in contrast, there are pathogens
when it comes to regulatory sci- and we lack ways to manufacturing like HIV that directly harm the cells
ence for vaccines? vaccines quickly and in large quan- involved in the immune response, in
PM: First, and particularly as a re- tities currently, we are likely to run which case it has proven much hard-
sult of COVID-19, we clearly see the into the same problem again in the er to find vaccine targets.
fundamental importance of quality future. Vaccine manufacturing has Personally, I do have more hope
manufacturing for vaccines. There typically been dominated by batch that we will get there much more
is essentially a new interest in vac- manufacturing but this pandemic quickly with a COVID-19 vaccine
cine manufacturing – and more effi- might ultimately advance vaccine than with vaccines for other diseas-
cient vaccine manufacturing. People manufacturing technologies to in- es like HIV, which, as you know, has
have once again realized that if we clude components of continuous and been a target for the vaccine sector
are having a problem like this today semi-continuous manufacturing in for over a decade now.
the future.
Secondly, we can use immune
correlates of protection in areas to
speed clinical trials. Once we have
immune correlates of protection for
COVID-19, that would facilitate
new trials. We are using clinical
endpoints as a starting point
right now since we lack those.
Thirdly, especially with
COVID-19, we can see nov-
el vaccine technology, which
had previously been used only
in smaller trials, coming to the
forefront. There are two mRNA
vaccines in large Phase III trials, for
instance. There are some interesting
www.pharmaboardroom.com InFocus Vaccines 7
R&D
Vaccine Platforms
R&D AT
In 2014, a major product swap between Novartis and
GSK saw a lot of analysts predicting a gloomy future
for GSK, with many doubts about GSK’s portfolio
HEART
strategy. However, since then, GSK’s vaccines portfo-
lio has outpaced the company’s more traditional phar-
ma portfolio in terms of growth. How are you aiming
to continue that success story in terms of technology
as well as therapeutic fields of focus?
Two contrasting perspectives from the R&D chiefs EMMANUEL HANON(EH): Firstly, we work very
of global vaccine leader GSK and aspiring vaccine closely across GSK R&D and collaborate with our col-
developer Janssen as they discuss the merits of leagues in the pharma organisation as we have comple-
their approaches to the tricky and at times thank- mentary expertise that is hugely beneficial for both parts
less task of vaccine discovery and development. of our organisation. The big differentiator for us versus
others has been and it will continue to be innovation: in-
vesting in the future, finding new platform technologies
that can be applied to more diseases and will allow us to
enter into new fields.
8 InFocus Vaccines www.pharmaboardroom.com
R&D
Vaccine Platforms
The two new fields that we are prioritising children and older adults with three different
are therapeutic vaccines and antimicrobial vaccine candidates in development.
resistance (AMR). The other field of huge interest for GSK is
Most vaccines used today prevent the appear- AMR – antimicrobial resistance. We realise
ance of a disease in the population: vaccinating how dramatic it is to be faced with a pathogen
people before they are exposed to a pathogen. for which there is no treatment. Multi-resistant
For example, flu vaccines are administered to bacteria such as tuberculosis or gonorrhoea
patients before flu season. Therapeutic vaccines are progressively accumulating resistance to
on the other hand have the ability to treat an traditional antibiotics. There is a huge comple-
ongoing disease or to prevent the cyclic evo- mentary intervention that can be made using
lution of that disease. GSK has several vaccine vaccines. Vaccines can be used to prevent cer-
candidates in our platform that have this prop- tain infectious diseases and thereby prevent
erty. Our vaccine preventing shingles is one the use of antibiotics, as well of the misuse of
example and has 90 percent efficacy, across dif- antibiotics, for example for flu. This way, the
ferent ages. It is administered to people many development of antibiotic resistance is slowing
years after they have been infected by the down.
virus and is still able to recalibrate the body’s It is already well documented that resistance
immune system against the virus so that it nev- does not develop, or at least develops much
er comes back, or at least does so with very low slower, against vaccines. That is another really
frequency. interesting avenue to investigate.
We have another set of vaccines in our pipe-
line which target RSV – a virus that causes res- What do you see as some of the most impor-
piratory disease. It can become a very severe tant recent innovations in vaccinology?
disease and we are working on protecting EH: Over the last 20 years, we have seen
the introduction of new platform technolo-
gies. This means working on a certain vaccine
approach and, once you have collected the
Emmanuel learnings of that approach, you can apply this
Hanon to different pathogens and create a family of
Senior VP, vaccines. This is what we have done in Belgium
Vaccines R&D, with the development of our adjuvant technol-
GSK ogy, where we use a given adjuvant in several
different vaccines.
The benefit of a platform technology is that
you make the investment once but it benefits a
variety of vaccines.
The other up-and-coming technology in
vaccines is messenger RNA vaccines. The
fundamental change with this technology is
that the process of creating these vaccines is
extremely fast. In messenger RNA, the anti-
gen – the identity card of the virus or bacte-
ria, a genetic code – is able to be programmed,
somewhat akin to 3D printer. The body pro-
duces its own vaccine as the body’s own cells
will produce the antigen that can react against
a pathogen, leading to the immune protection.
www.pharmaboardroom.com InFocus Vaccines 9
R&D
Vaccine Platforms
Another reason why messenger RNA manu- The global vaccines market is large-
facturing is so quick is that the manufacturing Our strategy ly dominated by four Big Pharma
process of a molecule for a given vaccine does is to focus on players. Against that backdrop, what
not change depending on which molecule you role do you see Janssen playing?
produce. In other words, your manufacturing well-defined JOHAN VAN HOOF (JVH):
site becomes a multi-antigen manufacturing areas where Our strategy is to focus on well-de-
site, instead of having a manufacturing site fined areas where we can bring new,
for one antigen only (as it is the case for more
we can bring unique and transformational vac-
traditional vaccines). That allows for major new, unique and cines to address high unmet medical
economies of scale in the investment needed transformational needs, and in doing so, become an
for vaccine development. important vaccine player globally.
We have the messenger RNA technolo- vaccines to The areas we are focusing on at
gy in house, but our strategy to develop a address high the moment are respiratory infec-
COVID-19 vaccine is to use a well-established unmet medical tions like respiratory syncytial virus
platform. By doing this, we have potential- (RSV) and a universal flu vaccine; a
ly higher chances of success but will also be need preventative vaccine for HIV, where
able to produce many doses of a successful Dr Johan Van Hoof many have failed in the past; and vac-
vaccine. It does not, however, mean that we Janssen cines for bacterial diseases, because
are not investing in messenger RNA technol- we think vaccines can be a part of the
ogy, which we believe represents the future of solution for the problem that is anti-
vaccines. microbial resistance (AMR) today.
For example, we are developing a
How far away are we from the widespread vaccine for Escherichia coli (E. coli),
emergence of personalised vaccines? which is a major cause of disease,
EH: The notion of personalisation is a
hot topic in the pharma industry today.
Smartphones with health checks drive behav-
iour, and consumers can easily buy microbi- Dr Johan
ome tests that provide information about the Van Hoof
myriad of bacteria and viruses in your gut. Global
There is a possibility that in the future, the Therapeutic
population will be fragmented into mini pop- Area Head of
ulations with specific criteria defined either by Vaccines,
mobile application or by specific diagnostics to Janssen
be done at home. These might trigger specific
behaviours and, among this behaviour, the use
of a vaccine may make sense.
GSK is not, today, pursuing personalised
vaccines to this extent. Other companies use
messenger RNA technology to move quickly
between the genetic part of a pathogen and a
vaccine candidate. They may be able to use the
technology to make vaccines tailored against,
for example, cancer in a patient. This is a pow-
erful example that I would call personalised
vaccination. There are still a lot of challenges
in this field, but it is not impossible.
10 InFocus Vaccines www.pharmaboardroom.comR&D
Vaccine Platforms
sepsis and death, especially in the development of our Ebola vaccine
elderly. regimen, which was approved by the
European Commission earlier this
We certainly
How has Janssen invested in vac- year. The vaccine regimen contains want to have
cine development technology plat- two doses, our Ad26 vaccine and an
forms? Given the complexity of MVA vaccine we in-licensed from multiple tools
vaccine R&D, is it an area where it Bavarian Nordic. Through all these
is better to have as many tools in different projects, we have vaccinat- in our toolbox
the toolbox as possible? ed over 114,000 people, all within a
JVH: We certainly want to have controlled clinical trial setting, so we but it is not
multiple tools in our toolbox but it
is not about acquiring or developing
have been able to observe and evalu-
ate the safety profile of this platform.
about acquiring
a technology just to have it. At the
center of our thinking is the disease
There is a level of confidence there
and we can be reassured that the
or developing a
that we want to tackle – we look at
what we might need to design a vac-
backbone of the Ebola vaccine, for
instance, has been used many, many
technology just
cine, and then we either develop that times in other people. to have it.
tool internally or acquire it external-
Dr Johan Van Hoof
ly. For instance, adjuvants are some- Another priority area for Janssen is Janssen
thing you acquire or produce based the development of a HIV vaccine,
on whether it is needed within your which has been seen by many as the
development strategy. Holy Grail of the industry. What
For our bacterial vaccines, for progress has been made here? Based on that, we could see what
instance, for E. coli, we are using JVH: Having worked in this field type of immune response was needed
bioconjugation, where a bacterial for a long time, we have developed for animals to fall within that catego-
surface polysaccharide from a path- various generations of a HIV vac- ry of being protected after six chal-
ogen is attached to an immunogenic cine, applying the principles of lenges. These were animals with a
protein. translational medicine. The idea is certain level of antibodies and a cer-
For other diseases like HIV, RSV to work with preclinical and animal tain level of cell-mediated immunity
and the Zika virus, we are working models, particularly non-human – and with those thresholds, we saw
with non-replicating vectors, spe- primates (NHP), until we see prom- over 94 percent of animals protected
cifically the adenoviral vector type ising levels of protection, at which after six challenges. Through our ini-
26 (Ad26). We have been develop- moment we enter Phase 1 human tial Phase 1 and 2 data, we saw that
ing this for over ten years and we trials to compare NHP and human it was possible to also achieve those
have accumulated a lot of experi- responses. In that way, going back thresholds in humans, which was
ence. Across these various projects, and forth, we have improved our very encouraging. We started sub-
we have seen consistent results in HIV vaccine formulations, and a few ject enrolment for a Phase 2b trial in
both antibody production – humor- years ago, we reached a point where high-risk women in South Africa in
al immunity – and T-cell responses one particular formulation had as 2017, who have now been vaccinated
– cellular immunity. This is also the much as over 90 percent protection and are being followed up on, and we
platform used for our investigation- compared to placebo vaccinated hope to have a readout of that trial by
al COVID-19 vaccine candidate, animal models. Even after six chal- mid-2021.
and while we are still at a very ear- lenges, 66 percent of the NHP were HIV vaccine development comes
ly stage, our Phase 1 data has also still protected, which was when we with a lot of risk, and we are still in
shown indications of robust humoral started doing in-depth analyses of the middle of the process but we are
and cellular immune responses. Our immune markers to see which were cautiously optimistic about our vac-
Ad26 platform was also used in the correlated with protection. cine candidate.
www.pharmaboardroom.com InFocus Vaccines 11COMMERCIAL GROWTH
Global Insights
TOP GLOBAL VACCINE COMPANIES
Four companies (GSK, Pfizer, Sanofi, and MSD) together occupy over 80 percent of the global market for
vaccines. Moreover, vaccines are an important part of these companies’ revenue streams, making up be-
tween 13 and 21 percent of total revenues in 2019.
GSK Pfizer Sanofi MSD
A2019 overall revenues in USD 46.2 billion 51.8 billion 43.8 billion 46.8 billion
2019 vaccine revenues in USD 9.8 billion
6.5 billion (13%) 6.9 billion (16%) 8.4 billion (18%)
(% of total) (21%)
Shingrix for Prevnar 13/Prevenar 13 for Polio, Pertussis and Gardasil/Gardasil 9 for certain strains
2019 top vaccine product
shingles pneumococcal disease Hib vaccines* of human papillomavirus (HPV)
2019 top vaccine revenue in USD 2.5 billion
5.8 billion (89%) 2.3 billion (33%) 3.7 billion (44%)
(& of total vaccine revenues) (26%)
*Sanofi doesn’t publish sales figures for individual vaccines
INSIGHTS ON VACCINES’ IMPORTANCE TO GLOBAL REVENUES
“We have more than 10 vaccines and medicines “[Sanofi] enjoys a very, very broad
in the late-stage portfolio that could change portfolio and it’s also a leader in vaccine
medical practice and have sales potential in manufacturing … the whole move
excess of one billion dollars – and several, such towards vaccination due to COVID has
as our RSV vaccine in older adults, could have really grown quite a lot and Sanofi is
multibillion dollar potential.” going to benefit from that the next
couple of years.”
Hal Barron - chief scientific officer & president R&D, GSK
(January 2021)
Boris Schlossberg - managing director, BK
Asset Management (December 2020)
“Prevnar 13 is Pfizer’s pneumococcal vaccine
that protects against infections such as “We really wanted to have capacity
pneumonia and meningitis, as well as other to cover the global birth cohort [with
infections caused by pneumococcus including Gardasil]. If you think about the number
ear and sinus. In 2014, the US Centers for of births every year, they’re somewhere
Disease Control and Prevention (CDC) in the order of 125 million globally. If you
recommended the immunization for adults assume basically an 80 percent vaccine
ages 65 and older in addition to young children, coverage rate, you want around 200
typically those under the age of 2, and adults million doses to protect that portion of
with certain chronic conditions. And that sent the population. And that’s kind of the
the profits on Prevnar skyrocketing to USD 23.4 ballpark that we’ve been looking at.”
billion since just 2015.”
Mike Nally - chief medical officer, MSD
Brittany Shoot - Fortune (February 2019) (September 2020)
12 InFocus Vaccines www.pharmaboardroom.comINFOCUS
Roger Connor, GSK
6 Key Points from GSK Vaccines Head
Roger Connor
Roger During the 2020 FT Global Pharmaceutical and Biotechnology Confer-
Connor ence, GSK global vaccines president Roger Connor shared some of his
Global Vaccines insights regarding the reorganization of GSK’s Consumer Health, Phar-
president, GSK maceuticals and Vaccines business units, their pandemic adjuvant sys-
tem technology, and their – and the industry’s overall – commitment to
COVID-19 vaccine safety.
where volume is everything, we felt that was absolutely key …
On GSK’s reorganization and the synergies we also felt that multiple vaccines were going to be needed, so
between pharma and vaccine R&D what we decided to do strategically was to open our adjuvant
“I see the science converging between vaccines and ‘traditional’ technology to the world … [the key question was,] who should
pharma. You will see in our vaccines pipeline [that] we have a we best partner with that would have the biggest impact? … We
breadth of products, we are moving more into older adults, we are very comfortable with our choice of strategy.”
are moving more into therapeutic vaccination, and we have some
joint projects between pharma and vaccines research develop-
On the GSK-Sanofi COVID-19 partnership
ment … we are making sure that the engines in the new GSK
are world-class engines of development … the most exciting bit and doing the right thing
for me is the scientific synergy between the groups and getting “The moment we connected and saw the win-win between us,
that spark going.” both companies moved super fast; we suddenly realized there
was something special we could do here … The world is waiting
for a solution so just being part of this is something special …
On the growing opportunities in older There are collaborations like the GSK-Sanofi collaborations …
adult vaccines and GSK’s shingles vaccine that are being done just because they are the right thing to do …
“It is the science … [our] scientific understanding of the immune We have said that during this pandemic phase, we will discount
system as we get older is getting better. Only 20 years ago, the price of this adjuvant, and we will [reinvest] any profit that we
you say the word vaccine and [people think] that is for kids. make … in the R&D associated with either this vaccine, future
Something like Shingrix®, [which is] for people over 50, that is coronavirus vaccines or pandemic preparedness.”
a game-changing vaccine for a horrible condition with an effica-
cy of over 90 percent. The secret sauce in that vaccine is our
On ramping up manufacturing
adjuvant system, [which] is proven to have an impact on age-re-
lated decline in immunity. We are using this in other older adult capabilities for their COVID-19 adjuvant
vaccines like our respiratory syncytial virus (RSV) candidate … “The adjuvant technology we have is a backbone technology
if we can switch the world on to older adult vaccination, that will that already exists. It is not a new formulation; it is something
have a very big impact on public health.” we know how to make. We are ramping that capability up but at
least the supply chain exists already. That is why our confidence
in that billion is quite high [GSK has committed to manufactur-
On GSK’s decision to leverage their adjuvant
ing one billion doses of their pandemic vaccine adjuvant sys-
technology in the COVID-19 vaccine race tem in 2021 to support the development of multiple adjuvanted
“We knew we had to play a very important role … we have this COVID-19 vaccine candidates] … to put it in context, GSK typi-
platform technology called an adjuvant[, which] creates an ampli- cally manufactures 700 million doses across all of our vaccines
fied response and reduces the dose you need … in a pandemic … we will do a billion doses of adjuvant alone next year.”
www.pharmaboardroom.com InFocus Vaccines 13MRNA TECHNOLOGY
Dr Thomas D. Madden, Acuitas Therapeutics
MRNA TECHNOLOGY
Dr. Thomas D. Madden, CEO and founder of Acuitas Therapeutics,
outlines the company’s revolutionary lipid nanoparticle (LNP) tech-
nology, their involvement in Pfizer and BioNTech’s COVID-19 vaccine,
and what mRNA vaccines might mean for the future of the biophar-
maceutical industry.
Acuitas Therapeutics’ revolutionary lipid
nanoparticle (LNP) technology
“We have developed an LNP delivery technology to enable our partners to be
able to move new classes of drugs – drugs that are essentially based on bio-
logical molecules or systems – into the clinic and the marketplace. These are
nucleic acid drugs, including RNA interference (RNAi) or soluble RNA (sRNA)
drugs intended to inhibit the production of particular proteins.
More recently, we have focused on working with partners developing mRNA ther-
apeutics. Our delivery system is critical here for two reasons. Firstly, the mRNA
itself is very rapidly broken down within the body, so it needs to be protected
within a carrier system. Secondly, the mRNA also needs to enter cells within the
body in order to be active but it is too big to enter on its own. Our LNP technolo-
gy protects the drug after it has been administered and also delivers it into the
cell cytoplasm so that it can start expressing proteins.
Over the years, we have built a number of different partnerships, including with
BioNTech – one that has culminated in our technology being used in the devel-
opment of COVID-19 vaccines.
The COVID-19 Pfizer, BioNTech and Acuitas
partnership
“When the pandemic hit, BioNTech recognized that our technology could be
used to help them develop a vaccine. We began discussions with them in
January, and then we flew to Germany in early February to meet the German
regulatory authorities, as well as BioNTech, to map out the clinical program nec-
essary to support a COVID-19 vaccine candidate.
Throughout the process, we have been working extremely closely with BioNTech
and Pfizer to support selection of the vaccine candidate, since a number of
different mRNA constructs expressing different proteins were being looked at.
14 InFocus Vaccines www.pharmaboardroom.comMRNA TECHNOLOGY
Dr Thomas D. Madden, Acuitas Therapeutics
We have also supported the work nec- We have also shown that this technol-
essary for the manufacturing scale-up ogy is capable of developing a vaccine
so that our partners are able to provide more rapidly. Therefore, I think this will
as many doses as possible. Pfizer and generate a lot of interest in other vaccine
BioNTech are projecting to manufacture opportunities, as well as in the invest-
1.3 billion doses in 2021, which requires ment of an infrastructure that would allow
a huge commitment. The Acuitas model us to respond much more rapidly, should
is that we transfer our process technol- a new viral threat come along. No one
ogy through specialized cGMP organiza- who has lived through COVID-19 wants
tions, as we do not do manufacturing, to live through a COVID-20 or a COVID-21.
and so we have also worked closely
with these organizations to improve the Personally, I think Big Pharma can some-
manufacturing scale. We helped them times feel trapped by the scale of invest-
see how they could produce much larger ments they have made. If a company has
batches – and much more quickly – which invested USD 5 billion in manufacturing
required some development work to be plants based on a particular technology,
undertaken internally and subsequently it would potentially be political suicide
transferred. to suggest that they move away from
that technology. That is a challenge Big
Pharma faces, so it is a difficult sell to
mRNA – the future suggest that they think about adopting a
new technology.
of the industry?
“When COVID-19 emerged, we quickly rec- But I think we should always be open
ognized that the mRNA vaccine approach to evaluating new ideas and to accept-
was potentially ideally suited for the rap- ing that better approaches may exist out
id development of a vaccine to address there, as opposed to saying that, well, we
COVID-19. Compared to conventional have always done it this way, so we will
approaches taken, where killed or atten- continue to do it this way.
uated viruses – or adenoviral vectors – The good news is that companies do
are used, mRNA vaccines are inherently a seem open to collaboration. There are
much more precise and elegant approach. three major mRNA companies today:
Rather than using an entire virus, we are CureVac, BioNTech and Moderna.
simply providing the instructions to allow Obviously, BioNTech has partnered with
the body to construct a single component Pfizer, and CureVac recently announced
found in the virus that would trigger an a major collaboration with GSK, so there
immune response. I think there are poten- are opportunities to work together to
tial safety and potency advantages with gain expertise and technology from major
this approach. players in this new field.
www.pharmaboardroom.com InFocus Vaccines 15COLLABORATION
IMI, World Bank, Swiss TPH
COLLABORATION:
A VITAL
COMPONENT
Vaccine research, development, manufacturing, supply, administration does not occur in a bubble, but
rather requires the efforts of a variety of stakeholders to realise. Here, representatives of the Innovative
Medicines Initiative (IMI), World Bank, and Swiss Tropical and Public Health Institute (Swiss TPH) outline
the importance of collaboration – both between public and private sector actors, as well as between high,
middle- and low-income countries – to the vaccine industry as a whole.
Dr Pierre Meulien looks at to that, that someone is typically a two- or
three-month-old baby. The safety bar has tra-
how the vaccine industry ditionally been extremely high, for very good
has benefited from public- reasons. Therefore, in normal circumstances,
private collaboration. it typically takes ten to 15 years to develop and
obtain marketing authorization for the wide-
The reason vaccines have been a prime sub- spread use of a vaccine. In the case of Ebola, it
ject for public-private partnerships (PPPs) is Dr. Pierre took five years, which is already an impressive
because of the complexity of vaccine R&D. Meulien record.
The entry ticket for aspiring vaccine develop- Executive From the public perspective, vaccines are
ers is extremely expensive, and the high price Director, of huge public health interest because of the
is motivated by safety concerns. This is a good Innovative valuable contributions they make to disease
thing, in reality, because vaccinations are pre- Medicines prevention that, honestly, we take for grant-
ventative measures. Every time you vaccinate Initiative (IMI) ed every day. Therefore, the public, academia,
someone, you are injecting a novel substance researchers and the private sector all have to
into someone who is perfectly healthy. To add come together to tackle these challenges.
16 InFocus Vaccines www.pharmaboardroom.comCOLLABORATION
IMI, World Bank, Swiss TPH
Muhammad Ali Prof Dr Jürg
Pate on how the Utzinger highlights
COVID-19 crisis how Switzerland
reinforces the need collaborates with
for pooled resources low- and middle-
Muhammad and communication Prof Dr Jürg income countries
Ali Pate Utzinger
Executive
across borders director, Swiss
(LMICs), and why
Director, on global health TPH this is especially
Innovative
Medicines
challenges. important in vaccine
Initiative (IMI) R&D.
Key priorities include addressing
health workforce shortages and It is important that low- and mid-
ensuring equitable access to new dle-income countries (LMICs) par-
diagnostics, medicines and vaccines. ticipate actively in the COVID-19
We believe that fair and equitable vaccine R&D efforts because that
access to safe and efficacious vac- way, they can ensure that the vac-
cines and therapies, when devel- cines developed ultimately meet
oped, is essential for all countries, their population profiles. If we are
including the poorest, to rebuild looking at a vast country like the
livelihoods and set a course toward Democratic Republic of the Congo
recovery. We are working closely where there is not even a very
with partners across the public and advanced road network, we need a
private sectors to ensure global and vaccine that can reach marginalized
fair access to COVID-19 vaccines, populations in the most remote are-
therapeutics and diagnostics that are as. Vaccines that need to be stored
being developed. at ultra-cold temperatures will pose
To support the most vulnerable considerable logistical challenges
countries, we need to pool resources to reach the most neglected peo-
and coordinate to prevent disruption ple. The fact of the matter is that
of commodities such as medicines. COVID-19 anywhere is COVID-19
This includes resources from govern- everywhere, and hence we need to
ments, donors, multilateral organ- find ways of fair, equitable and rap-
izations, non-governmental organ- id access to essential commodities,
izations, and the private sector. The such as personal protective equip-
pandemic requires that governments ment, novel treatment and ultimate-
prioritize health investments now: ly a vaccine.
the costs are small compared with
the economic costs of not acting.
www.pharmaboardroom.com InFocus Vaccines 17MARKET ACCESS
GAVI
THE GAVI “Since 2011, I have been proudly
serving Gavi as its CEO. During this
ACCESS time my focus has been to use my
MODEL experience, as an epidemiologist
and expert in vaccine development,
to lead Gavi in its mission to
To untie the knot of unaligned or misaligned incen- improve access to new and
tives, public-private partnerships have been estab- underused vaccines and improve
lished to offer novel models for the discovery, devel-
opment and deployment of vaccines to developing coverage and equity in poor
markets. The Global Alliance for Vaccines and Immu- countries. Under my leadership,
nizations (GAVI), the Coalition for Epidemic Prepared-
ness Innovations (CEPI), the Innovative Medicines Ini- in 2015 Gavi successfully raised
tiative (IMI), and the European Vaccine Initiative (EVI) US$ 7.5 billion in commitments
are all examples of global efforts to bridge demand
and supply. during its last replenishment and
G
has helped to reduce vaccine
AVI was established to reshape the global vaccine
market through a number of core elements.
prices and assure a healthy vaccine
It aggregates demand from the world’s poorest market. This supported Gavi’s
countries to define a clear and viable market for
vaccines (GAVI-supported countries today represent more
largest expansion, immunising an
than half the world’s birth cohort), which also gives them the additional 300 million of the world’s
market power to negotiate lower prices from manufacturers
poorest children and preventing
- It combines long-term donor support (79 percent from
governments and 21 percent from private sources) with 5-6 million deaths.”
gradually increasing co-financing payments from partic-
ipating countries to guarantee predictable funding so that
o Countries have the financial security to implement Dr Seth
vaccine programs while maintaining a level of fiscal Berkley
responsibility with GAVI CEO, GAVI
o Manufacturers feel confident enough to make new
investments in production capacity, which help to
decrease manufacturing costs
As an indication of success, for instance, the Advance Market
Commitment program GAVI initiated in 2009 for pneumo-
coccal vaccines is credited to have facilitated the immuniza-
tion of over 184 million children between 2009 and 2018. Two
countries – Mongolia and Bhutan – have been able to ‘gradu-
ate’ and fully self-finance routine immunization programs.
18 InFocus Vaccines www.pharmaboardroom.comFUNDING MODEL
CEPI
CEPI: NEW VACCINES FOR A SAFER WORLD
The Coalition for Epidemic Prepa- founded in Davos by the govern- Since its launch, CEPI has mobi-
redness Innovations (CEPI) is ments of Norway and India, the lized more than US$750 million to
a global par tnership launched Bill & Melinda Gates Foundation, support its mission.
in 2017 to develop vaccines to the Wellcome Trust, and the World To date, CEPI has secured finan-
stop future epidemics. CEPI was Economic Forum. cial support from:
CEPI FINANCIAL SUPPORT
THE BILL & MELINDA GATES FOUNDATION · THE EUROPEAN COMMISSION · USAID · THE WELLCOME TRUST
AUSTRALIA HUNGARY MEXICO SINGAPORE
AUSTRIA ITALY NETHERLANDS SWITZERLAND
BELGIUM JAPAN NEW ZEALAND UNITED KINGDOM
CANADA KUWAIT NORWAY ETHIOPIA
DENMARK LITHUANIA PANAMA THE REPUBLIC OF KOREA
FINLAND LUXEMBOURG SAUDI ARABIA INDONESIA
GERMANY MALAYSIA SERBIA
www.pharmaboardroom.com InFocus Vaccines 19FUNDING MODEL
CEPI
TOTAL CONTRIBUTION PER INVESTOR CATEGORY, PERCENTAGE SPLIT 2017-2023
PRIVATE INVESTORS/ EBOLA DRC
FOUNDATIONS 19% RESPONSE 2%
PUBLIC INVESTORS FUNDING GAP EX CHIK &
44% 27% RVF FUNDING 8%
$570bn Eleven $2.8bn
The estimate annual global The number of diseases WHO identified The minimum average cost for
cost of moderately severe to as public health risks due to epidemic progressing one vaccine against
severe pandemics potential and lack of biomedical each of WHO’s 11 priority epidemic
countermeasures infectious diseases
THE 11 PRIORITY EPIDEMIC INFECTIOUS DISEASES:
• CRIMEAN-CONGO HAEMORRHAGIC FEVER • NIPAH DISEASE
• EBOLA VIRUS DISEASE • HENIPAVIRAL DISEASE
• MARBURG VIRUS DISEASE • RIFT VALLEY FEVER
• LASSA FEVER • ZIKA
• MIDDLE EAST RESPIRATORY SYNDROME CORONAVIRUS • DISEASE X (A PATHOGEN CURRENTLY UNKNOWN TO
(MERS-COV) CAUSE HUMAN DISEASE THAT COULD CAUSE A SERIOUS
INTERNATIONAL EPIDEMIC)
• SEVERE ACUTE RESPIRATORY SYNDROME (SARS)
CEPI INVESTMENTS IN PLATFORM TECHNOLOGIES
ATTENUATED VIRUS INACTIVATED VIRAL VECTOR PROTEIN SUBUNIT DNA RNA
· Emergent rVSVNC4AG
· Themis Measles vector Inovio
Lassa
· IAVI rVSVAG DNA
· U. Oxford/ Janssen ChAdOxl
·Themis Meales vector inovio
MERS-CoV
· IDT MVA DNA
· U. Oxford/ Janssen ChAdOxl
Nipah · PHV rVSVAG Profectus Subunit
· U. Tokyo Measles vector
· Colorado State U. r
RVF 3rd gen
Rift Valley Fever
· Wageningen U. r
RVF 2nd gen
Valneva Under negotiation
Chikungunya Themis Measles vector
Live attenuated Inactivated
Source: CEPI Progress Report 2019
20 InFocus Vaccines www.pharmaboardroom.comCASE STUDY
Prevenar 13
THE WORLD’S BESTSELLING
VACCINE – FOR HOW LONG?
With sales of nearly USD 6 billion a year – just over 10 percent of overall revenues – Pfizer’s Prevenar 13
(a Pneumococcal 13-valent Conjugate Vaccine) has emerged pretty quickly as the undisputed champion
since its approval in the European Union in December 2019. Today, it is the most widely used pneumococ-
cal conjugate vaccine in the world, and is included in the pediatric National Immunization Programs in 102
P
countries. In addition, it is the only pneumococcal vaccine approved for use for essentially all age groups.
revenar 13 is a vaccine for the prevention of candidates have received Breakthrough Therapy designa-
serious and potentially fatal pneumococcal tions from the US FDA. US biotech Affinivax also has
infections caused by 13 Streptococcus pneu- a Phase 3 pneumococcal vaccine candidate that targets
moniae (S. pneumoniae) serotypes (1, 3, 4, 5, 24 pneumococcal serotypes and is being developed in
6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Serious pneu- partnership with Astellas. Affinivax’s candidate uses the
mococcal infections can result in pneumonia, blood poi- company’s Multiple Antigen Presenting System (MAPS)
soning, meningitis, permanent brain damage, and even in lieu of the traditional conjugate vaccine platform.
death. Pneumonia is currently the single largest
infectious cause of death among children In other key markets such as China and
under the age of five globally. India, local vaccine manufactur-
ers are also eyeing a piece of the
Prevenar 13 is slated to lose pat- global pneumococcal pie. The
ent protection only in 2026, Chinese regulator approved
offering more breathing a 13-valent pneumococ-
room to the world’s larg- cal conjugate vaccine from
est pharma company, but Chinese drugmaker Walvax
the company already has a Biotechnology in January
next-generation vaccine in 2020 and the company
development – a 20-valent expects to produce at least
pneumococcal conjugate 30 million doses a year. In
vaccine, which covers seven 2018, Pfizer supplied 3.85
additional bacterial strains as million doses of Prevenar 13
well as the 13 already addressed to mainland China – whereas
by Prevenar 13. over 15 million babies were born
that year. At the end of 2020, India
However, Pfizer’s reign within the announced its first indigenous pneu-
pneumococcal vaccine space is coming monia vaccine as well, which had been
under threat as MSD (Merck & Co. in the US developed by the Serum Institute of India (SII) in
and Canada) is also developing a next-gen pneumo- collaboration with international partners like the Bill and
coccal vaccine, though it would only cover 15 bacterial Melinda Gates Foundation. SII touts itself as the world’s
strains. (MSD does have an existing polysaccharide vac- largest manufacturer of vaccines by number of doses pro-
cine, Pneumovax 23, targeting 23 strains, but it is only duced, with every third child in the world immunized by
approved for children two years or older). Both vaccine a vaccine from SII.
www.pharmaboardroom.com InFocus Vaccines 21CASE STUDY
MSD’s Ebola vaccine
LESSONS FROM While outbreaks of the devastating Ebola virus
have – thankfully – generally been highly localized
MSD’S EBOLA
to West Africa, the highly infectious and lethal dis-
ease has generated global trepidation due to its
characteristic haemorrhagic fever, a 50 percent
VACCINE chance of death on average, and the absence of
any approved treatment. The most serious out-
break, occurring in early-2014 and ending two long
DEVELOPMENT: years later, affected nearly 30,000 people and
cause over 11,000 deaths, predominantly in Guin-
BALANCING
ea, Liberia and Sierra Leone, igniting global efforts
to develop a vaccine that could prevent future Eb-
I
ola epidemics.
AMBITION n 2019, MSD (Merck & Co. in the US and Canada)
won that race when its vaccine, ERVEBO®, was
WITH REALITY approved by the European Medicines Agency
(EMA) and the US FDA. All in all, it took just
over five years for ERVEBO® to move from Phase
22 InFocus Vaccines www.pharmaboardroom.comCASE STUDY
MSD’s Ebola vaccine
1 trials to regulatory approval, a sig- authors highlighted, “in order to
nificant advancement from the typ- Over 300,000 accelerate vaccine access to African
ical ten to 15 years it typically takes countries, the World Health Orga-
for vaccines to complete that journey. people were nization’s Prequalification Team
However, ERVEBO® is not just vaccinated (WHO-PQT) in collaboration with
MSD’s triumph. The Ebola vaccine the EMA and AVAREF [the African
was initially discovered as a biode- through various Vaccines Regulatory Forum] devel-
fense vaccine at the Public Health emergency access oped an innovative facilitated pro-
Agency of Canada (PHAC). Once effi- cess (roadmap) for decision making
cacy was established in animal stud- programs on the acceptability of the vaccine
ies, a multitude of actors, both private for registration. This allowed the
and public, were assembled to take company to make simultaneous sub-
the Ebola vaccine candidate through Particularly relevant to the current missions to EMA, WHO-PQT, and
clinical development. National gov- COVID-19 pandemic, the authors regulatory authorities in 14 African
ernments from Canada, the US and also flagged the challenges with the countries, with EMA acting as the
Africa; agencies like the US National necessary manufacturing scale-up. reference agency.” Once ERVEBO®
Institutes of Health (NIHs) and the US For instance, they noted that “tech- was conditionally approved in the
Biomedical Advanced Research and nology transfer and the establish- EU in November, the WHO grant-
Development Authority (BARDA); ment of a new manufacturing facility ed prequalification within 36 hours,
global institutions like the World has many steps and requires signif- and a month later, African countries
Health Organization (WHO), the icant time to execute (3-4 years is began to approve the vaccine, result-
Wellcome Trust, Gavi and Medecins typical for a new vaccine). There is ing in near-simultaneous approval
San Frontieres (MSF) – all came on limited understanding outside of vac- of the much needed vaccine in the
board. cine manufacturers and regulators on areas where it was most desperately
Part of this extensive collabora- the rigorous requirements leading to needed. For the MSD team, the take-
tion was necessary because, in spite approval of a vaccine manufacturing away when it comes to COVID-19
of MSD being one of the Big Four facility.” Furthermore, “manufactur- vaccines is that “regulatory agencies
vaccine players globally, the phar- ing site selection for vaccines is a should prepare for the simultaneous
ma company nevertheless lacked any complex decision … [with] multiple approval of candidates in multiple
prior experience with Ebola virus or factors, such as existing space, tech- countries. WHO’s leadership will be
clinical development expertise in the nical capability, infrastructure, and needed to facilitate innovative review
specific West African countries. capacity.” processes and collaborative mecha-
In addition, as Jayanthi Wolf [exec- For that reason, the authors exhort- nisms to expedite approvals.”
utive director, Global Regulatory ed, “all parties involved must work to Prior to regulatory approval, dur-
Affairs, at MSD] et al. identified in balance the desire to be ambitious ing the 2018-2020 Ebola outbreak
an article (“Applying lessons from (e.g., rapid development timelines) in the Democratic Republic of the
the Ebola vaccine experience for with execution realities and stake- Congo, over 300,000 people were
SARS-CoV-2 and other epidemic holder expectations. Aggressive time- vaccinated through various emer-
pathogens”) regarding lessons learnt lines are enticing for public health gency access programs. MSD has
from MSD’s Ebola vaccine develop- partners, but also require “right-first- announced that licensed doses of
ment experience, each entity played time” execution to qualify the facil- ERVEBO® should be commercially
a specific contributory role across the ity and manufacturing process, for available in Q3 2020. While prices
broad global partnership, spanning which the probability of success for a have still not been officially set, the
aspects including preclinical stud- new vaccine is likely medium to low.” company has committed to pricing
ies, Good Manufacturing Practices Another important lesson is the the single-dose injection at the low-
(GMP) materials, clinical studies, central role that the WHO has to est possible access price for poor and
public health responses and so on. play in rapid global approvals. The middle-income countries.
www.pharmaboardroom.com InFocus Vaccines 23NON-COMMERCIALLY VIABLE VACCINES
Ole Olesen, EVI
LOOKING LONG-TERM
Ole Olesen, executive director of the European Vaccine Initi- pandemic has reignited global interest in vac-
ative (EVI), outlines the mission of EVI to support the devel- cine development, which is fantastic.
opment of non-commercially viable vaccines as well as to Of course, there has been similar events in
create a global vaccine infrastructure. the past such as the SARS outbreaks, the Ebola
virus in West Africa and the flu pandemic but
Ole, you joined the European Vaccine Initi- in those cases, the sudden interest ended up
ative (EVI) in January 2020 as executive di- being relatively short-lived. This time, however,
rector. Could you share the important work COVID-19 has had such a major impact glob-
that EVI is doing within the global vaccine ally that I believe it will be different. The other
space as well as your motivations for joining outbreaks were also much more geographically
the organization? limited and in general never really hit the devel-
OLE OLESEN (OO): EVI is a non-profit oped countries in Europe or North America,
organization focusing on vaccine development, where, the reality is, most of the funding and
and we have two fundamental missions. The also industrial activity are based.
first one is to support the development of new As a vaccine community, we can continue to
or improved vaccines that can have a major im- refer to this for many years to come – and we
pact on global health but are not commercially should in order to remind the world that with
viable and the pharma industry therefore is re- relatively small amounts of money consistently
luctant to invest in. We try to bridge that gap. invested in vaccine development and public
The second one is to work with other vaccine health programs, we can avoid outbreaks with
development organizations, academia, biotech such major economic impact in the future.
and industry to create a network, and vaccine
infrastructure, of stakeholders and partners While more people seem to know about vac-
for cross-cutting vaccinology related to aspects cines, it is unclear that many truly under-
like pre-clinical development, standardization stand the mechanics of the vaccine industry.
of assays for vaccine development, capacity What should organizations like EVI do to
building and advocacy. address this?
OO: As a community, we have to seize this
With COVID-19 vaccine development up- opportunity to stress that vaccine development
dates making headlines almost every day, needs a long-term perspective. With the sup-
how has the pandemic affected the state of port of the European Commission, EVI has
the overall vaccine industry? been working for some years to establish a
OO: Looking at the big picture, the COVID- sustainable vaccine research infrastructure in
19 situation has generated a lot of global inter- Europe that can connect individual research
est in vaccines, whether from public funders teams and boost the development of new vac-
and private investors or amongst the general cines. This is an important step, but the vaccine
Ole Olesen public. Whereas previously vaccines were a sector will need sustained and substantial in-
Executive Director, little out of fashion, and the sector was rather vestments in infrastructure, vaccinology, im-
European Vaccine dusty and forgotten, now, people can see the munology and related sciences over a long pe-
Initiative (EVI) importance of vaccine R&D quite clearly. The riod. That is one of the messages that we should
24 InFocus Vaccines www.pharmaboardroom.comYou can also read
