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As the COVID-19 pandemic continues to disrupt life as we know
it, it is becoming clearer than ever that a safe and effective
vaccine will be the only way we can go back to "normal". Even then,
once this pandemic ends, we might emerge with a new "normal" as we
are forced to remain vigilant and prepared for future outbreaks to
avoid a repeat of the catastrophic impact this pandemic has had on
communities, healthcare systems, and the economy.
With the world now looking to vaccines to effectively end the
ongoing COVID-19 pandemic, the race to the finish line could be
swifter - although less straightforward - than initially
anticipated. There are seven COVID-19 vaccine candidates already in
clinical testing and nearly 70 in the pipeline; however, a select
few are currently leading the race, and are consequently benefiting
from sizeable contributions from international charities, and
governments that have pledged billions of dollars to not only
expedite the development of promising vaccine candidates but to
also manufacture millions of doses before any clinical data
demonstrating safety and efficacy. Funding contributions by the
Coalition for Epidemic Preparedness Innovations (CEPI) and the US
government's Biomedical Advanced Research and Development Authority
(BARDA) - which have each contributed nearly USD1 billion to
support COVID-19 vaccine research so far - will help support
at-risk production of promising candidates, allowing millions of
people to get immunized quickly if any vaccine-candidates prove to
be successful in clinical testing. The US' BARDA has so far
announced sizeable funding support for Moderna (US)'s, Janssen
(US)'s and Sanofi (France)'s vaccine candidates. CEPI is supporting
eight COVID-19 vaccine development programmes including Moderna's
vaccine candidate, as well as those being developed by Curevac
(Germany), Inovio Pharmaceuticals (US), Novavax (US), the
University of Hong Kong, the University of Oxford, the University
of Queensland and a consortium led by Institut Pasteur.
Millions of doses for Oxford's vaccine candidate in
at-risk production
The Serum Institute of India, the world's largest vaccine
manufacturer, has recently announced that it will mass-produce
around 5 million units per month of The Oxford Vaccine Group's
investigational COVID-19 vaccine (hAdOx1 nCoV-19) ahead of any
clinical data results and can scale up production to 10 million
units per month to potentially have up to 40 million doses by
October. The Oxford vaccine candidate only recently started
clinical testing with a Phase I/II trial set to enroll 1,112
participants in the UK. However, regulators have already
green-lighted an unprecedented regulatory timeline, boosted by
favourable data from animal and primate studies (yet to be
published), as well as previously reported safety data from
clinical trials of similar vaccines for Ebola and Middle East
respiratory syndrome (MERS).
According to the New York Times, a Phase II/III trial for The
Oxford Group's vaccine candidate is set to begin by next month, and
will enroll another 5,000 participants, potentially months
ahead of other candidates that have yet to complete animal
studies.
AstraZeneca (UK) has also recently announced a landmark
collaboration with the University of Oxford aiming to produce 100
million doses of the ChAdOx1 nCoV-19 vaccine, according to the
Financial Times. Although the financial terms of the agreement were
not disclosed, both partners have agreed to operate on a
not-for-profit basis during the course of the pandemic.
Emergency Access to Vaccines by September
Although seven vaccine candidates have already launched into
early-stage clinical testing, and others will be launching very
soon, many have not yet completed animal studies that could rule
out the risk of antibody-dependent enhancement (ADE), also referred
to as vaccine-enhanced disease, before much larger trials can be
initiated. ADE is considered a major safety hurdle in vaccine
development whereby a vaccine could lead to an exacerbated illness
or a worse outcome than would otherwise have been the case. The
Oxford Group appears to have already passed that hurdle, suggesting
that the stockpiles already being produced could quickly make their
way to at-risk populations, such as healthcare workers or the
elderly, under emergency use protocols. If it proves to be
effective, millions of doses could be made available by September,
according to the group. Sarah Gilbert, the Oxford University
professor leading the research efforts on hAdOx1 nCoV-19, is
optimistic that the vaccine candidate has an 80% chance of success
and could be "ready by September". It remains to be seen whether
the UK government will grant emergency approval for use in at-risk
populations.
Meanwhile, the director of the Chinese Center for Disease
Control and Prevention, Gao Fu, has announced that an unnamed
COVID-19 vaccine could be developed and ready for emergency use by
special groups in September 2020, with the rest of the population
gaining access in early 2021. There are at least three vaccine
programmes in China under clinical development, including ones by
Sinovac, CanSino (China), and the Wuhan Institute.
Pfizer (US) and BioNTech (Germany)'s BNT162 vaccine candidates
are also under clinical development and potentially not too far
behind. Pfizer's Chief Scientific Officer, Mikael Dolsten,
announcing on a call with investors that following initial data
release, anticipated in May/June, the company would launch expanded
trials that could support "emergency use or accelerated approval"
potentially by October. The two companies have started to ramp up
manufacturing capacity at risk to provide global access to a
successful vaccine as soon as regulatory approval is granted.
Millions of vaccine doses could be available by the end of 2020,
and then capacity could be rapidly expanded to produce hundreds of
millions of doses in 2021, according to Pfizer.
It is also worth noting that emergency approval does not equate
to full regulatory approval. IHS Markit does not anticipate full
approval of a vaccine before early 2021, with forecasts for
sufficient mass production that could meet entire population demand
coming a little later in 2022.
Many factors could impact vaccine access, including
protectionist policies
While the Oxford group's vaccine appears to be one of the
leading candidates currently in development, several factors could
affect the candidate's availability timeline. First, as the
COVID-19 outbreak winds down slowly in the UK, it is unclear
whether researchers will be able to extract sufficient information
regarding the vaccine's safety and efficacy by September or will
need to rely on other trials in other outbreak areas. Second, any
of the candidates could encounter unexpected hurdles during testing
that could result in termination of development, including
potential safety signals such as ADE or lackluster efficacy, that
may only become apparent in late-stage testing. Third, although
manufacturing capacity has already started ramping up at risk,
billions of units will be needed to vaccinate the entire population
of the planet in a timely and equitable manner. This may take a
while, unless more collaboration agreements and more pledges to
share resources are made.
The World Health Organization (WHO), CEPI, the European
Commission, and other partners including the Bill & Melinda
Gates Foundation (BMGF) have recently launched the Access to
COVID-19 Tools (ACT) Accelerator, "a landmark, global and
time-limited collaboration to accelerate the development,
production and equitable global access to new COVID-19 essential
health technologies." The global initiative will likely support
greater relaxation of patent exclusivity rights on innovative
products including treatments and vaccines and calls for
unprecedented levels of cooperation through licensed-manufacturing
deals. The US and China are notably absent from this initiative. In
parallel to this concerted effort, the European Union along with
its partners will be working on raising EUR7.5 billion in initial
funding through a global pledging marathon for COVID-19
diagnostics, treatments and vaccines. According to European
Commission President, Ursula von der Leyen, "We need to bring the
world, its leaders and people together against coronavirus", adding
"We need to develop a vaccine, to produce it and deploy it to every
corner of the world. And we need to make it available at affordable
prices."
Millions of units of the Oxford group vaccine candidate are
being produced across Europe and India, facilitated by
collaborations with pharmaceutical companies AstraZeneca (UK) and
Merck KGaA (Germany) as well as contract manufacturing firms Halix
BV (Netherlands), Advent (Italy), and Cobra Bio AB (Sweden/UK). The
group has yet to reach a manufacturing agreement in North America,
according to the New York Times, potentially because pharmaceutical
manufacturers in the US would not be granted exclusive rights for
investing in the candidate, thereby providing little financial
incentive for companies. The Oxford group has confirmed they are
not patenting the vaccine.
During a pandemic, would it be wise to ignore the significant
benefits of a coordinated global effort to solve the world's
biggest problem?