[ Decades-long funding cuts for pandemic preparedness hamper
coordinated distribution and equitable access. We must reimagine how
to make life-saving vaccines available to everyone.]
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OUR VACCINE INFRASTRUCTURE NEEDS A RADICAL OVERHAUL  
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Ravi Gupta
November 13, 2020
Boston Review
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_ Decades-long funding cuts for pandemic preparedness hamper
coordinated distribution and equitable access. We must reimagine how
to make life-saving vaccines available to everyone. _

, Flickr

 

Nearly a year into a pandemic that has killed more than a million
people and laid waste to both public health systems and the global
economy, many have turned their hopes to a vaccine. Optimism has been
buoyed by the historic pace of development of multiple COVID-19
vaccine candidates and the recent news
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that Pfizer, in partnership with the small company BioNTech, has
reported preliminary data on a vaccine candidate showing 90 percent
effectiveness. The arrival of a vaccine in the next few months would
be a remarkable feat, but fundamental questions—beyond basic
assurances of safety and efficacy—remain. Will there be enough
doses, and who will get them?

This is not the first time we face questions of equitably deploying a
vaccine during an outbreak. Eleven years ago, as the H1N1 virus swept
across
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United States and 73 other countries, the World Health Organization
declared the first pandemic in over forty years. H1N1 seemed deadlier
and more transmissible than seasonal influenza. Recollections of the
1918 Spanish flu pandemic’s colossal death toll occupied the
collective psyche. An H1N1 vaccine seemed essential to prevent history
from repeating, much as a COVID-19 vaccine does now.

Development of an H1N1 vaccine progressed rapidly, in large part due
to existing technology and regulatory systems for seasonal influenza
vaccines. But avoiding preventable deaths required ensuring the
vaccine’s prompt manufacturing and equitable distribution within the
U.S. and across the world. Manufacturing delays led to shortages
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that complicated an already halting domestic distribution plan, and by
the time the vaccine supply increased, the pandemic had waned. All
told, 90 of 162 million doses [[link removed]] were
utilized in the United States. The rest were donated to other
countries (after broken pledges to do so earlier) or simply thrown
away. A truth was illuminated that persists today: the prevailing
system of vaccine production and distribution is not designed to
promote equitable access.

Much has changed since the H1N1 pandemic. Technological platforms have
advanced considerably. International institutions have forged
partnerships to prioritize therapeutic and vaccine candidates.
Financing of vaccine development has evolved, with the creation of
non-profit entities like the Coalition for Epidemic Preparedness
Innovations (CEPI).

Yet much remains the same. Vaccine manufacturing remains unprepared
for surges and without a global entity charged with centralized
financing. International legal agreements ensuring equitable access
are non-enforceable. The international hoarding
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and price gouging for personal protective equipment
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early in this pandemic are harbingers for vaccine maldistribution to
the highest bidder. Within the United States, in particular,
decades-long funding cuts for pandemic preparedness and public health
hamper coordinated distribution for efficient access. Surviving a
pandemic requires extraordinary movement on these issues. We must
reimagine how to make life-saving vaccines available to everyone, for
pathogens both new and old.

Deployment of H1N1 vaccines faced a bottleneck that we still face
today: insufficient manufacturing capacity. Coordination between
manufacturers, government agencies, and universities in multiple
continents led to the FDA approval of four H1N1 vaccines within six
months. But enough vaccine could simply not be produced in time. Years
of industry consolidation due to limited profits from vaccine
development had left just three companies
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available to manufacture the majority of global influenza vaccines.
Manufacturing capacity was dependent on well-established but
time-consuming and unpredictable egg-based technology from World War
II, while production lines were already occupied with seasonal flu
vaccines.

Today, the leading COVID-19 vaccine candidates rely on novel
technology that hasn’t yet been deployed at scale. These platforms
have the potential for faster production, but they will likely face
unforeseen difficulties. Messenger RNA (mRNA) vaccines, for
example—like Pfizer and BioNTech’s—require temperatures as low
as -94 degrees Fahrenheit to maintain stability, whereas H1N1 vaccines
were easily stored in small fridges. COVID-19 vaccines will likely
require two doses, doubling the total number needed, while H1N1
vaccines required just one.

At the root of the manufacturing problem is a near exclusive reliance
on the private sector, which has limited incentives for preemptive
investment. As a result, funding hastily flows from public coffers to
private companies to bolster manufacturing capacity once an outbreak
has already begun. During the H1N1 pandemic, the U.S. government
awarded contracts [[link removed]] to
manufacturers to upgrade their facilities and start vaccine
production. With COVID-19, we’ve seen a dizzying number of
agreements between governments and private companies to scale
production, among them agreements facilitated by the U.S.
public-private partnership Operation Warp Speed.

Of course, it isn’t feasible to expect immediate global availability
of sixteen billion doses. But a reactive approach to vaccine
production grounded in a market-based logic de-emphasizes the
long-term readiness and preparation needed for efficient and equitable
deployment of a vaccine in a pandemic.

We need an alternative approach that centers on maintaining public
manufacturing facilities to respond to the acute needs of an outbreak
_before_ it happens. In the wake of H1N1, the U.S. government invested
in developing four manufacturing sites in concert with a university
and private companies. But these facilities lacked sustained
development and were unequipped
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for rapid, mass production during the COVID-19 pandemic.

In the past few months, substantial Operation Warp Speed funds have
gone to the Texas A&M University System and Emergent Solutions to
partner with vaccine developers to manufacture doses. It remains to be
seen whether an injection of funds at this moment will help construct
and maintain a sustainable, public manufacturing sector for future
outbreaks. We should recognize that preparedness is not a novel
concept; epidemiologists and national security experts alike have been
arguing about its importance for decades. Twenty years ago, science
journalist Laurie Garrett characterized the collapse of global health
infrastructure as a “betrayal of trust.” We are witnessing the
effects of that betrayal today.

An initial vaccine shortfall necessitates thoughtful distribution to
enable equitable global access. The H1N1 pandemic exposed glaring
disparities between rich and poor nations in procuring vaccines.
Before a pandemic was even declared, developed countries placed large
advance orders
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manufacturers. The World Health Organization secured small donation
commitments [[link removed]] from
developed countries and manufacturers for developing countries. The
United States pledged to donate 10 percent of its vaccines, but as
H1N1 cases and vaccine shortages increased, it rescinded its offer
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Canada and Australia permitted exports
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from their domestic manufacturers only after their own citizens were
immunized. Eventually, 78 million doses—an inadequate amount to
begin with—were donated to 77 countries, but the worst of the
pandemic had already passed [[link removed]].

Fears of such vaccine nationalism—countries prioritizing their own
populations at the expense of a globally coordinated strategy—have
materialized in the current pandemic, too. Multilateral advance market
commitments, a form of payment to manufacturers predicated on proof of
a successful vaccine, are meant to equitably allocate vaccines among
countries. Various advance market commitments (AMCs) have been
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proposed
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and created for COVID-19 vaccines, including $2 billion in urgent
funding specifically for low- and middle-income country AMCs as part
of an effort by the COVAX facility
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international collaboration between the World Health Organization,
CEPI, and Gavi, the Vaccine Alliance [[link removed]]—to
deliver 2 billion doses globally by the end of 2021. (COVAX estimates
the total cost for delivering on its plan to be $18.1 billion.)

Though advance market commitments such as the Gavi-led pneumococcal
vaccine fund have been used successfully
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criticism of its price and lack of transparency
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COVID-19 is the first test of whether they can function during a
pandemic affecting wealthy and poor countries simultaneously.
Bilateral agreements between manufacturers and individual wealthy
countries who seek to guarantee their own supply have undermined the
COVAX advance market commitment and precluded efficient and equitable
global allocation of potential vaccines. Pfizer and BioNTech, for
instance, have yet to sign any agreements to provide developing
countries
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with their vaccine, and the majority of their initial supply has
already been claimed by wealthier countries.

An enforceable trade and investment agreement is needed
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Sadly, simply beginning these discussions seems too advanced when the
Trump administration has amazingly sought to withdraw funding and
support from the World Health Organization and refused to join
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COVAX—even though more than 150 countries
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have joined.

The absence of a global strategy encompassing high-risk populations is
morally reprehensible, but it also makes no biological or economic
sense. The virus will continue to spread without coordination for
vaccine allocation based on need. Elements of international
integration and global travel that accelerated this pandemic will
perpetuate transmission. Global trade and tourism will further suffer.
COVID-19 has far surpassed H1N1’s scale, but a fundamental lesson
remains: going it alone is a strategy in which no one emerges
victorious.

Until enough vaccines are produced, the United States will face
similar challenges of equitable allocation and distribution
domestically. The availability of H1N1 vaccine within the United
States was beset by distribution difficulties despite extensive
planning. Autopsies [[link removed]] of H1N1
vaccination efforts demonstrate how vaccines were distributed to
states without accounting for their projected need. Ill-conceived
tracking systems for vaccine administration and unclear communication
about multiple vaccine formulations and target groups created
misperceptions.

COVID-19 vaccine distribution promises to be even more
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complicated
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given multiple encouraging candidates, which may only be efficacious
in certain populations and require multiple doses. In a recent missive
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the Centers for Disease Control and Prevention placed responsibility
on state and local health departments to identify vaccine target
groups, manage vaccination plans, and track administration. This seems
reasonable, but it fails to account for the decades of inexplicable,
myopic funding cuts to state and local health departments.

Public health departments will be hard-pressed not only to overcome
existing racial and class disparities in health care access and
vaccination rates but also to address inequities in infections and
deaths from coronavirus due to structural racism. As with seasonal
influenza vaccines, there were troubling inequities in H1N1 vaccine
rates among African Americans
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were particularly vulnerable [[link removed]]
to infection because of poverty, chronic medical conditions, inability
to socially distance, and lower health care access. Baseline
disparities and underfunding of public health departments complicate
efforts to avoid similar mistakes with COVID-19, which has been
devastatingly concentrated among Black, Latinx, and Native American
communities.

A National Academies of Science, Engineering, and Medicine report
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released last month detailed a plan for equitable allocation of
COVID-19 vaccines, and to its credit, includes an assessment of social
vulnerability as an underlying principle for allocation. To the extent
possible, black and brown communities, members of which constitute
large proportions of essential workers unable to socially distance
from home, must be prioritized for vaccine allocation.

Moreover, state Medicaid programs, which provide insurance coverage
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for nearly a third of the Black and a third of the Latinx nonelderly
U.S. population, also face barriers to equitably delivering vaccines.
Low Medicaid reimbursement rates for providers preclude their ability
to vaccinate individuals fully and rapidly
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During H1N1, states were left to determine their own reimbursement
rates, but for COVID-19, federal support is needed to help increase
providers’ ability to reach communities of color.

In so many ways, we are in unprecedented territory. But though the
players have changed—a novel coronavirus, innovative vaccine
technologies, newly formed international organizations—the game is
in many other ways the same: constantly playing catchup, rewarding
those with influence, unable to collectively share the fruits of human
ingenuity. Nothing about this is immutable.

There are signs of progress, and lawmakers have taken notice. Senator
Elizabeth Warren and Representative Jan Schakowsky proposed the
COVID-19 Emergency Manufacturing Act of 2020, which seeks to establish
a public system for manufacturing medicines and vaccines. If enacted,
the legislation would require COVID-19 products be made available for
free domestically and at cost internationally. Congresswoman
Schakowsky also introduced the Make Medications Affordable by
Preventing Pandemic Price-gouging Act, which prohibits monopolies on
new, taxpayer-funded COVID-19 drugs and waives exclusive licenses for
any drugs during a public health emergency.

The key is to extend these early steps beyond this pandemic. COVID-19
has been hailed as a once in a generation pandemic. But in this
century alone we have experienced outbreaks with the potential to
convert into a pandemic every few years. Old diseases spread unabated
and new, more lethal viruses lie tentatively dormant. Without any
changes to the underlying drivers—climate change, unchecked
deforestation, increasing global travel—why should we expect that
this pattern will change?

A pandemic exacerbates chronic, vexing problems, but it also sharpens
our understanding of them. Crises offer rare opportunities to
fundamentally change the paradigm of producing and delivering
life-saving vaccines to everyone. While vaccines are far from a
cure-all
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when it comes to fighting outbreaks, they are undeniably important.
The arrival of a COVID-19 vaccine may return us to normal, but we must
do better than normal—both for this pandemic and the inevitable next
one.

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