Editor's Letter - UN Health Update
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2Q 2020: July 1, 2020
Editor’s Letter
June 2020 witnessed associated risk of COVID-19 infection or
the convening of two death, “our research suggests that health
events highlighting the benefits of deaths prevented by sustaining
important potential routine childhood immunization in Africa far
role of vaccines in outweighs the excess risk of COVD-19 deaths
combatting the COVID associated with vaccination clinic visits,”
pandemic – Digital BIO
For the vaccine industry, the pandemic
and The Global Vaccine Summit (the third
provides an opportunity to reinforce with
replenishment conference for the Gavi
immunization partners and the public its
Alliance 2021-2025). Participants at both
commitment to public health (including
sessions acknowledged the coronavirus as
access and affordability), while at the same
unprecedented in its transmissibility, rapidity,
time emphasizing the critical importance of
breadth of coverage and lethality, – at the
maintaining the proper ecosystem
same time, applauding the Herculean efforts
(sustainable financing, demand certainty,
of the scientific community, industry,
intellectual property protection and public
academia and governments to rise to the
awareness) to support ground-breaking
challenge with safe and effective vaccines.
innovation. Over the coming months,
Working in favor of the immunization policymakers will debate how to strike the
community is the multitude of vaccine right balance between supporting COVID
platform technologies being pursued vaccine innovation and ensuring equitable
simultaneously, together with the innovative, distribution of COVID vaccines as “global
agile regulatory pathways being developed public goods,” The stakes are high. Equitable
to accelerate eventual approval. distribution, while essential, is often used as
Considerable challenges remain, including: “code” for open source access to proprietary
production of sufficient doses at the required technology – which can have the unintended
scale; distribution and allocation at the consequence of disincentivizing critical
national level; access and affordability; and vaccine industry R&D. How that policy
potential vaccine hesitancy. All the while – as debate turns out will critically impact the
reiterated by Gavi stakeholders at the global community’s ability to effectively
Summit – the immunization community respond to this and potential future
must ensure that the COVID “battle” does pandemics. Jacqueline Keith, Vaccines Editor
not come at the expense of routine
immunization against vaccine-preventable Editor-in-Chief: Michele Forzley, JD, MPH
diseases (for example, due to reduction in Editor Emeritus: Susan Crowley
doctor’s visits for childhood vaccination). As Vaccines Editor: Jackie Keith
noted in a recent LSHTM model, where Managing Editor: Nancy Zatzman
authors estimated the impact of continued Publisher: UN Health Update LLC
www.unhealthupdate.com
routine immunization as compared to the Copyright UN Health Update LLC 2020 | All rights reserved.
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Digital BIO: Exploring the “Way and the vaccine industry toward the
common goal of making the vaccine(s)
Forward” on COVID-19 Vaccines
available to everyone who needs them.
The June 8-12 BIO Convention – meeting
digitally due to public health considerations Panel #1: “Leveraging Platforms and
surrounding the coronavirus pandemic – Partnerships to Develop COVID-19
hosted key sessions on the science, Vaccines in Record Time”
challenges, and opportunities for the
Panelists from Novavax, J&J, Sanofi, FDA’s
development of COVID-19 vaccines.
CBER and the National Academy of Medicine
discussed the complexities of researching,
“A Way Forward: Winning the War
developing, and distributing COVID-19
on COVID through Vaccines” vaccines – including pre-clinical and clinical
This three-part plenary session began with a pathways, evolving science, and
“Fireside Chat” with NIH’s Director of NIAID opportunities for collaboration. Key themes:
Anthony Fauci, followed by two panel • The necessity for multiple vaccine
discussions. approaches/platforms to successfully
combat the coronavirus. These various
Dr. Anthony Fauci, Director, National “shots on goal” – recombinant protein-
Institute of Allergy and Infectious based, gene-derived mRNA, inactivated
Diseases, National Institutes of Health virus technologies – will enable a
Describing the SARS-Cov2 virus as his “worst multifaceted response addressing
infectious disease nightmare” – due to the efficacy, manufacturing, and cold chain
virus’s transmissibility, rapidity, breadth of challenges.
coverage and lethality – Dr. Fauci noted that • The opportunities for agile regulatory
the scientific community was just at the review processes – mutually agreed
beginning of understanding the many among national regulatory authorities –
complexities of COVID-19 (including its long- to shorten the approval timeline by
term effects on those contracting and navigating clinical trial stages in parallel,
recovering from the disease). He applauded not step-wise.
the “targeted and collaborative” biopharma • The need for multi-stakeholder
industry response to the pandemic, and consensus on clinical trial design (e.g.,
predicted that more than one vaccine through NIH’s “Accelerating COVID 19
“winner” would result from industry’s R&D. Therapeutic Interventions and Vaccines”
The U.S. Government (NIH, BARDA, FDA, (ACTIV)) – for example, regarding the
CDC) is supporting industry efforts through endpoint data required to demonstrate
agile regulatory processes, clinical trial efficacy of a COVID vaccine.
collaboration, funding of production capacity • The positive impact of public-private
scale-up and access to the Government’s partnerships, such as CEPI and the Gavi
extensive clinical trial network. On access and Alliance, in providing the predictable
affordability of eventual COVID vaccines, Dr. demand, funding, technical support and
Fauci cautioned against mandatory pricing in-country networks needed to facilitate
policies, calling instead for good faith the research, development and
negotiations between governments, payors distribution of eventual COVID vaccines.
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• The need to “communicate, Gavi Advance Market Commitment for
communicate, communicate” to the COVID-19 Vaccines (Gavi COVAX AMC) – a
public regarding the safety and efficacy guaranteed demand “pull” mechanism to
of COVID vaccines, in order to restore incentivize vaccine company investment in
public confidence and overcome additional manufacturing capacity in order to
hesitancy to vaccinate (with potential produce the initial needed COVID vaccine
resistance estimated at 30%). doses.
• The urgent requirement that the global
Richard Hatchett, CEO, Coalition for
community build on the difficult lessons
Epidemic Preparedness
learned on the COVID outbreak and put
Innovation, summarized
systems in place to respond to likely
CEPI’s mission (to
future pandemics.
support development of
vaccines against
Panel #2: “Global Solutions for
emerging pandemics)
Implementation: From Scale-up to
and reported on CEPI’s
Worldwide Access” partnerships with vaccine companies on the
Representatives from public-private development of COVID vaccines (drawing on
partnerships, industry and academia the criteria of speed, scale and access).
discussed the likely production and access Vaccine company representatives described
challenges following discovery and approval current industry-wide efforts to research and
of efficacious COVID vaccines and described develop COVID vaccines and outlined the
novel approaches to resolving them. daunting challenge of rapidly scaling up
Seth Berkley, CEO of The Gavi Alliance, production of yet unknown vaccines to meet
cited the Alliance’s the projected demand for billions of doses.
model for enhancing Stefane Bancel, CEO, Moderna, noted that
vaccine access in the phase 3 trials of its mRNA
developing countries – vaccine candidate were
combining country- expected to begin in July,
driven immunization and reported that the
plans with market- company was already
shaping strategies and starting – at risk – to invest
industry collaboration – and its for increased production
demonstrated track record of immunizing an capacity. To ramp up production from its
additional 760 million individuals over the current average of 100 million doses per year
past 20 years. On COVID, Dr. Berkley to the anticipated target of 1 billion doses,
described two innovative initiatives – the Moderna was working to ensure sufficient
Access to COVID-19 Tools (act) Accelerator GMP space, trained personnel, and raw
(ACT Accelerator) (focused on enabling the materials. The company has raised $1 billion
speedy discovery of diagnostics, vaccines on the public capital market to fund these
and therapeutics) (and the COVID-19 efforts.
Vaccine Global Access Facility (COVAX). He
also reported on the launch, at Gavi’s recent
successful replenishment conference, of the
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John Markels, President, Global Vaccines, In closing, panelists stressed the importance
Merck, referenced the unprecedented of improved pandemic preparedness – for
collaboration between example, urging that, in the wake of the
vaccine companies – “this COVID pandemic, the global community
is not a race against each consider building a few “never again”
other – it is a race against production facilities to be on hand for future
the virus.” He noted that pandemics. They also emphasized the
the vaccine industry had importance of maintaining routine
been manufacturing at immunization during the COVID outbreak
full capacity prior to the COVID outbreak; and of immunizing unreached “zero dose”
efforts now must be taken to rapidly build children against vaccine-preventable
new capacity in order to have life-saving diseases.
doses available on “day one” of a COVID
vaccine’s release – almost unimaginable Interactive Session: “How will healthcare
given the 3-5 years typically required to systems adapt to the Post-COVID-19
build a state-of-the-art production facility. World?”
Citing Merck’s experience on development
The focus of this session was the impact of
of the Ebola vaccine – “the right thing to do”
the COVID pandemic on already-strained
– Markel noted that such industry
healthcare systems and innovative responses
engagement is unsustainable without public
being pursued. All panelists concurred that
health funding – “there must be a market for
the pandemic represented an economic, as
public health/pandemic innovation in the
well as a health, crisis and that the decline in
U.S.“
tax revenues resulting from national
Vivien Tsu, of the University of shutdowns has created severe governmental
Washington, focused on budget shortfalls. Officials seeking to reduce
the distribution of COVID healthcare budget expenditures would likely
vaccines at the country level be resorting to their traditional “toolkits” of
– calling on the global pharmaceutical cost containment measures,
community and national including volume controls, reference pricing
officials to begin now to and therapeutic substitution. Meanwhile, the
develop the rationale for pharmaceutical industry is collaborating with
allocation of initial doses payors and reimbursement authorities
among their populations. She added that toward innovative access arrangements –
local communities must be ready to accept taking into account the need to demonstrate
the new COVID vaccines and cautioned tangible downstream savings and enable
against the misinformation that is readily health systems to make the economic case
transmitted on social media. To support for niche treatments. Telemedicine was cited
public confidence in rapidly developed as another innovation being deployed by
COVID vaccines, Dr. Tsu advocated strong health systems to provide cost-effective
pharmacovigilance mechanisms to healthcare. For Europe, the tendency of
supplement the data assembled during the Member States to turn inward during the
accelerated clinical pathway. pandemic was expected to result in greater
fragmentation of the EU market access
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landscape. In China, government health systems and vaccine distribution in
reimbursement authorities were giving the face of the coronavirus pandemic.
greater recognition to the need to support
The funding includes some $0.9 billion in
innovation in pharmaceutical R&D and were
long-term pledges to the International
opening the door to reimbursement
Finance Facility for Immunization (IFFIm),
negotiations with individual pharmaceutical
an innovative finance mechanism raising up-
companies. Key to these innovative
front funding on the capital markets.
approaches: “the common denominator is the
patient.” Gavi also used the occasion to launch the
Gavi Advance Market Commitment for
Gavi Replenishment Conference: COVID-19 Vaccines (Gavi Covax AMC) – an
innovative “pull” mechanism providing
Summoning the Resources for
volume guarantees for future COVID
“Gavi 5.0” (2021-2025) and vaccines in order to incentivize vaccine
Combatting COVID-19 manufacturers to produce sufficient
quantities of those vaccines to immunize
A Global Commitment: $8.8 Billion health care workers, high-risk individuals and
create a buffer of doses for urgent cases. At
The immunization community, world leaders
the Summit, some 15 donors pledged $500
(including 35 Heads of State), NGO’s,
million of the anticipated $2 billion needed
foundations and private industry gathered in
in funding. Of the AMC, Gavi CEO Seth
London on June 4 for The Global Vaccine
Berkley noted “…we now need support to help
Summit, a pledging conference dedicated to
ensure the most vulnerable people in low-
funding the Gavi Alliance’s 2021-25 strategic
and middle-income countries – as well as
plan (seeking to immunize an additional 300
those in high- and upper middle-income
million children in the least-developed
countries – have access to COVID-19
countries) and support the global fight
vaccines.” Launch of the AMC was viewed as
against COVID-19.
a first step toward implementation of the
Final pledges totaled $8.8 billion, surpassing COVID-19 Vaccine Global Access Facility
Gavi’s target of $7.4 billion. Summit Host UK (COVAX), a mechanism intended to pool
came in as the largest donor, pledging the procurement and risk, where high-, middle-
equivalent of £330 million per year over the and low-income countries will buy into a
next five years; other major donors included portfolio of potential COVID vaccines, with
Norway, Germany, the U.S., and the Bill & equitable distribution of successful vaccine
Melinda Gates Foundation. Bhutan, Burkina candidates.(Note: COVAX was launched on
Faso, Cameroon, Finland, Greece, New June 26, 2020 under the auspices of Gavi,
Zealand, Portugal and Uganda joined the CEPI and WHO. Discussions are ongoing on
Summit as first-time Gavi donors. And, Gavi- the framework and mechanisms for the
eligible countries will contribute $3.6 billion initiative.)
in co-payments toward the cost of buying
vaccines. The funds will be utilized to From the vaccine industry…
support routine immunization in Gavi-
eligible countries, as well as to strengthen The five vaccine companies supplying
Human Papilloma Virus (HPV) vaccine –
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MSD, GSK, Innovax, Serum Institute of India ensure sustained interest, in the face of
and Walvax – committed to increasing the “we’ve made our donation; let’s move
supply, making it possible for up to 84 on” phenomenon? How do we promote
million girls in low-income countries to be understanding of the hard work that is
immunized, potentially averting an estimated involved in developing a vaccine, and
1.4 million future cervical cancer deaths. maintain enthusiasm in the inevitable
case that certain vaccine candidates
AstraZeneca was the first vaccine company
experience setbacks?
to sign on to the Covax AMC, pledging to
• How to allocate resources between
guarantee production of 300 million doses of
implementation of Gavi 2021-2025
the COVID-19 vaccine it is developing in
(immunizing an additional 300 million
cooperation with the University of Oxford –
children and saving 7-8 million lives)
assuming the vaccine receives regulatory
and combatting COVID-19? How does
authority licensure or WHO pre-qualification.
Gavi build on synergies between the two
The company pledged to operate on a “not-
objectives and ensure that routine
for-profit” basis for the duration of the
immunization continues to be provided
coronavirus pandemic.
to both the “zero dose” children (not yet
Serum Institute of India announced its reached with childhood vaccines) and the
commitment to supply Gavi with 10 million estimated 80 million children at risk of
doses of pneumococcal conjugate vaccine missing scheduled routine vaccines due
(PCV) at $2.00 per dose – becoming the third to disruptions caused by the
vaccine manufacturer to sign on to the PCV coronavirus?
AMC. • How to manage the “equitable
distribution” of COVID vaccines?
Triumphing over Disease Numerous Summit donors stressed the
At the close of the Summit, UK Prime need for equal access between high-,
Minister Boris Johnson noted “together we middle- and low-income countries. As
rise to fulfill the greatest shared endeavor of stated in a recent Lancet editorial, “The
our lifetime – the triumph of humanity over nationalist and competitive approaches
disease, now and for the generations that taken by a few high- income countries to
follow.” get hold of a small supply of vaccines
could result in excessive casualties in
Editor’s Note: In the wake of the resounding other parts of the world. Global solidarity
success of The Global Vaccine Summit, Gavi is needed instead, and resources must be
stakeholders and the immunization pooled and shared.” How will the newly
community will be called upon to address launched COVAX access facility arrive at
compelling issues. For example: the envisioned “negotiated price” with
vaccine suppliers, and by what formula
• How to maintain the current pro-
will distribution among countries be
vaccine momentum and manage
made?
expectations – in the words of Bill
Gates at the Summit, “never before have
more people been more aware of the
importance of vaccines.” How can Gavi
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NOT FOR CIRCULATION OUTSIDE SUBSCRIBER ORGANIZATION 6• How to provide vaccine manufacturers • How to promote confidence in
with the needed R&D incentives to eventual COVID vaccines, in the face
research, develop and produce COVID of growing vaccine hesitancy? To gain
vaccines at scale, while responding to a better understanding of public
demands that COVID vaccines to be perceptions regarding potential COVID
treated as “global public goods”? How vaccines, the Vaccine Confidence Project
will immunization stakeholders avoid the of the London School of Hygiene and
unintended consequences of Tropical Medicine has launched a study
disincentivizing vaccine companies utilizing survey research and social media
through “equitable distribution”-driven monitoring to measure prevailing
demands for open source access to attitudes regarding measures to contain
proprietary technology? Clearly, the and treat COVID-19. And, the
COVAX AMC is a step in the right International Coalition of Medicines
direction; the “devil is in the details” for Regulatory Authorities (ICMRA) –
the COVAX access facility. How will the representing 29 regulatory authorities
vaccine industry weigh in on the specifics around the world – recently issued
of this new instrument? statements intended to assure healthcare
professionals and the general public “
Editor’s Note: And finally more questions to that the regulatory processes for the
be answered in the months and years ahead. authorisation and safety monitoring of
Hopefully, there will be opportunities for vaccines are robust, independent and
productive interaction between the focus firmly on public health.”
immunization community and the vaccine
industry on these and other issues.
• How to ensure that the product
presentations of COVID vaccines are
suitable for immunization systems in
both the developed and developing
countries where they will be
distributed? What decision-makers will
be identifying the COVID vaccine target
product profile, and will the desired
product characteristics be communicated
to vaccine companies in sufficient time to
be reflected in the development of
specific vaccine candidates?
• How to build sufficient production
capacity by drawing on the networks
of developed and developing country
suppliers? What is the role of Gavi
stakeholders in promoting those
networks?
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