[Ip-health] Moon, Alonso Ruiz, and Vieira in The New England Journal of Medicine: Averting Future Vaccine Injustice

Thiru Balasubramaniam thiru at keionline.org
Mon Jul 19 12:16:38 PDT 2021



Averting Future Vaccine Injustice

Suerie Moon, M.P.A., Ph.D., Adrián Alonso Ruiz, M.Pharm., and Marcela
Vieira, M.P.H.

Both rapid innovation and equitable access to vaccines are necessary to
protect the world from viral pandemics. Today, however, we face gross
inequities in global access to Covid-19 vaccines. As high-income countries,
such as the United States and European countries, have secured a majority
of the world’s vaccine supply (more than twice the volumes needed to cover
their populations1), many low-income countries have barely begun the
immunization process. It will take political courage to end such vaccine
injustice now and political vision to negotiate the binding international
rules needed to avert similar inequities in the future.

In the immediate term, countries that share vaccines with those facing
shortages can save the lives of frontline workers and vulnerable groups,
helping to end the pandemic and reducing the risk of emergence of new and
dangerous variants, while generating an additional $9 trillion for the
global economy with trade, travel, and work fully restored everywhere.2

At the same time, governments need to boost and diversify vaccine
production capacity to Latin America, Africa, and Asia by transferring
technology and ensuring that intellectual property (IP) protections such as
patents do not pose legal barriers to manufacturing.3 The global supply of
Covid vaccines is currently insufficient and uncertain. Restrictions on
exports of both raw materials and finished vaccines from key
vaccine-producing regions, including the United States, Europe, and India,
have exacerbated shortages worldwide and highlighted the risks of relying
on just a few manufacturers. To increase both the volume and the security
of the supply, more than 100 countries have called for the temporary
suspension of international IP rules on Covid-19 countermeasures (including
vaccines, drugs, diagnostics, and other medical equipment). Such a
suspension would strengthen legal certainty for producers, allowing them to
start manufacturing quickly, and expand scientists’ freedom to develop
better, more appropriately adapted vaccines. Expanded production may take
months to bear fruit, but it would be worthwhile, given the likelihood that
SARS-CoV-2 will be circulating for years to come.

In the medium term, governments can negotiate international rules for
access to countermeasures in future pandemics and invest in the scientific
and industrial capacity that give such rules teeth. At the World Health
Assembly meeting in May, member countries agreed to lay the groundwork for
a potential “pandemic treaty.” Access to countermeasures is among the
thorniest issues to untangle, but evidence from Covid-19 vaccines clarifies
what a treaty must do.

First, we believe that governments should legally commit to increasing
long-term public investment in both research and technology development and
should condition those investments on global public interest safeguards
such as contract transparency and open sharing of data, know-how, and IP.
Covid-19 has demonstrated that decades of publicly funded basic research —
$17.2 billion between 2000 and 2019 from the U.S. National Institutes of
Health alone — was necessary for and effective at building the scientific
foundation on which vaccines could be rapidly developed.4 This pandemic has
also illustrated the importance of large-scale public investment for rapid
product development. Starting in early 2020, dozens of governments
individually and jointly (through the Coalition for Epidemic Preparedness
Innovations, or CEPI) infused approximately $5.6 billion of up-front
funding into academic and private-sector vaccine research and development
(R&D) (see figure).

Governments also reduced the financial risk for vaccine producers by
committing, even before vaccines had obtained regulatory approval, to
purchase more than $45 billion worth of these products.1,5 Such large-scale
public funding is necessary for pathogens with pandemic potential, since
market returns are highly uncertain at early stages and yet hesitation to
invest can be fatal.

Nevertheless, it is past time to renegotiate society’s contract with the
pharmaceutical industry for combating pandemics: if taxpayers bear the
lion’s share of risks and costs, private companies should price the
resulting products affordably and openly share the data, technology, and
know-how that have been subsidized. Open knowledge sharing accelerates
innovation by allowing scientists to build rapidly on each other’s
research, helps manufacturers meet global demand, and enables regulators to
assess products more quickly — all critical factors in emergencies.
Adequate public control over knowledge is essential for rapid, open
sharing, given companies’ strong commercial interest in withholding
knowledge from competitors.

With legally binding commitments for up-front public funding of vaccine
R&D, IP monopolies would not be necessary to induce innovation. Governments
could make their funds go further by pooling them through regional or
global vehicles such as CEPI, which is mandated to secure global access to
the vaccines that result from its investments. Early in the pandemic,
governments acting unilaterally largely invested in companies based in
their own countries.5 Though unsurprising, this approach generates smaller,
riskier portfolios for each country and ensures neither equitable access
nor adequate global supply.

In contrast, CEPI developed a geographically diverse portfolio of vaccine
candidates that spread out both scientific and manufacturing risk. Some
companies that received large-scale grants from CEPI (AstraZeneca and
Novavax) made stronger commitments to allocate supply to developing
countries, price their vaccines affordably, and transfer technology than
did some other companies (Moderna and Pfizer). With funding from 17
governments, the European Union, foundations, and firms, CEPI was among the
world’s three largest public R&D investors (having committed over $1.4
billion, more than 90% of it public funds, primarily for R&D but also for
manufacturing), alongside the United States ($2.3 billion) and Germany
($1.5 billion).5 More in-depth evaluation of CEPI is needed to elucidate
the factors that facilitated and impeded global access in this pandemic,
and to provide lessons for the future. Nevertheless, it offers proof of
principle that governments can invest together in vaccine R&D, up front, at
risk, at scale, and for access.

In a context of geopolitical competition, however, not all governments may
be willing to cooperate so closely on the sensitive security issue of
pandemic vaccines. The United States, Europe, Russia, and China all rapidly
developed Covid-19 vaccines that have now been deployed globally. A network
of regional funds could complement a global entity like CEPI by investing
in vaccine developers closer to home, while agreeing to coordinate and
adopt common binding rules for transparency, pricing, and sharing of data
and technology. Successful vaccine development anywhere could then mean
vaccines produced and accessible everywhere.

Beyond funding, binding international rules are critical for ensuring rapid
sharing of pathogen samples and related data. The sharing of genomic
sequencing data on SARS-CoV-2 by scientists in China on the publicly
accessible GISAID platform in January 2020 jump-started the development of
diagnostics and vaccines worldwide. Rapid international sharing of genomic
sequencing data has also been essential for tracking emerging variants. But
such data sharing rests on soft norms of scientific cooperation and is not
reliable. International sharing of physical pathogen samples is also
critical but lagged behind the flow of sequencing data. An international
agreement could mandate rapid, open sharing of both samples and data,
contingent on guaranteed access to the resulting benefits (e.g., research
results, scientific credit, training opportunities, and countermeasures)
for the originating researchers and countries. The 2011 Pandemic Influenza
Preparedness Framework developed by member countries of the World Health
Organization (WHO) established such a quid pro quo: all countries agreed to
share influenza samples with a WHO laboratory network in exchange for
assured access to at least some vaccines and other technologies that
companies would subsequently develop. The political bargain that this
framework struck provides a foundation on which to build stronger rules
covering all pathogens and data.

After vaccines are developed, there is likely to be at least an initial
scarcity of global supply. Ideally, all governments would commit to consume
only their fair share and to permit exports of vaccines produced in their
jurisdictions. But such promises are not politically credible. A more
reliable strategy is to build scientific and industrial capacity to develop
and produce adequate volumes of countermeasures in all regions and to
negotiate rules ensuring that knowledge and technology are globally shared,
even when physical products are not. Using and expanding regional
manufacturing hubs today are necessary steps toward ending the current
pandemic and preparing for the next one.

In 2013, governments rejected the chance to advance a WHO treaty
establishing an international public fund for medicines R&D and rules
making the resulting technology openly accessible. We should not lose the
opportunity now to craft international laws that would make future pandemic
vaccines available to all as global public goods and avert a repeat of the
ethical, epidemiologic, and economic catastrophe that is unfolding today.

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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