Almost everyone agrees the world needs more Covid-19 vaccines. As we write, some countries have yet to administer even a single dose of vaccine, and current projections suggest many countries will have to wait until 2023 to start widespread vaccination.
Yet debate rages as to why the world is short on vaccines,
and what barriers need to be overcome in order to make and distribute
more. Intellectual property has become a flashpoint in the discussion.
According to the large European and American drug companies currently
making Covid-19 vaccines, the status quo—vaccine scarcity for all
except those who live in a few dozen rich countries—is inevitable and
unfixable. These companies consistently reiterate a basic factual
premise: They are the only ones that can make these vaccines, and they
are making them as fast as they can. Moderna, Pfizer-BioNTech,
AstraZeneca, and Johnson & Johnson are currently on track to ship enough vaccines to vaccinate a majority of adults in the rich countries of the world and to donate and sell a significantly smaller number of doses to low- and middle-income countries, at least until next year.
These companies insist they would make more doses and reach more
people, if only they could—but, alas, they cannot. Moreover, they say,
sharing intellectual property—especially vaccine manufacturing
know-how—will only slow down production.
What prevents vaccine makers from making more vaccines, they say, are
material problems hardwired into the world economy: lack of
quality-controlled factories and ingredients to make vaccines, lack of
freezers to store vaccines, lack of engineers and other professionals to
oversee everything, and so on. “The scarcity of vaccines is not because
of intellectual property but because of regrettable production and
distribution challenges,” wrote Michelle McMurry-Heath, president of one of the leading Big Pharma trade groups. Moderna’s CEO said earlier this month,
“There is no mRNA manufacturing capacity in the world”—and thus no way
to make mRNA-based Covid-19 vaccines any faster than Moderna and
Pfizer-BioNTech are already doing.
But we doubt Big Pharma’s premise. Global vaccine scarcity is not
inevitable—or, at least, it is not primarily dictated by fixed
constraints in the world’s physical capacity to make, store, and
distribute vaccines.
Numerous independent experts have
surveyed supply and distribution chains, interviewed pharmaceutical
companies around the world, and concluded that additional vaccine
manufacturing could be brought online quickly—if not tomorrow, then in a
matter of weeks or months. These estimates are much shorter than the 18 months or more that Moderna and other current market leaders often claim. In fact, in recent weeks, drug companies in Israel, Canada, Bangladesh, South Africa, and Denmark
have all said they have unused vaccine manufacturing capacity that
could be brought online in a matter of months, not years, to fight
Covid-19—but only if the existing incumbent manufacturers (or the
governments that oversee and subsidize those manufacturers) share
resources and knowledge, and create a legal pathway for new entrants to
sell their vaccines.
Shouldn’t a rational incumbent be “eager to find partners with the capabilities to expand production,” as some scholars have written,
so as to sell more doses of its vaccine? Aren’t “all of the vaccine
manufacturers…trying to increase supply as quickly as possible,” as
another has claimed? In our view, there are at least two reasons to be skeptical of that refrain.
First, it is of course true that these companies can make more money
when they sell more doses, and partnering with competitors to outsource
steps of their manufacturing processes may enable them to sell more
doses. (For example, Moderna and J&J have done some outsourcing, cautiously.) But these partnerships impose a tradeoff. They require the manufacturer to share some of its closely guarded trade secrets—precise ingredient lists, detailed instructions for production, and so on. Patent-holders share these secrets judiciously,
protected by nondisclosure agreements and other contracts that strive
to keep control of the valuable knowledge in the their hands, but
inevitably some knowledge “leaks” to the competitor. Incumbents eager to
guard their first-mover advantage in the Covid-19 vaccine
marketplace—and extend that advantage into other disease areas—may
refuse the tradeoff, choosing to keep their secrets close (and forgoing
wider sales of their existing products). Indeed, Moderna and BioNTech
have told investors they are currently applying their mRNA technology
to develop a wide range of new vaccines and treatments for cancer, heart
disease, influenza, HIV, and other diseases, which could become global
blockbusters—unless their global competitors beat them to the punch.
Meanwhile, the Financial Times reported in April that
certain conspicuously unnamed companies “have warned in private meetings
with US trade and White House officials that giving up intellectual
property rights [to Covid-19 vaccines] could allow China and Russia to
exploit platforms such as mRNA, which could be used for other vaccines
or even therapeutics for conditions such as cancer and heart problems in
the future.”
Second, incumbent vaccine makers might, for rational economic reasons, choose not
to make more Covid-19 vaccines. This point is somewhat
counterintuitive, but, to put it bluntly, perpetuating the pandemic is
better for business than ending it. Vaccine makers have strong financial
incentives to keep the virus spreading, at least to some extent. (Matt
Stoller has aptly described
these incentives as “ghoulish.”) This observation is no conspiracy
theory; the companies themselves have acknowledged the profits to be
secured over a medium- to long-term horizon, if the virus endures.
Pfizer’s CFO announced a few months ago that the company “sees significant opportunity”
in Covid’s becoming endemic in the United States, Canada, and other
rich countries—a recurring, perhaps even permanent, fixture of our
lives—which could make Covid-19 vaccines a durable “franchise”
for the company. Particularly devastating from a public health
perspective, and particularly appealing from a franchise-building
perspective, are so-called variants of concern, which may evade existing
immunity. Pfizer’s CFO pointed specifically to “these emerging variants” in response to a Wall Street analyst’s question about “the need to revaccinate annually.” Pfizer has also said
that it plans, at some point in the foreseeable future, to end its
so-called “low-cost” “pandemic pricing”—approximately $20 per dose—and
begin charging more “normal” prices—perhaps as much as $175 per dose.
Moderna’s CEO has similarly stated that Moderna expects to sell annual Covid-19 vaccine booster shots for the foreseeable future, as the virus is “not leaving the planet.” Moderna’s CEO went on
to contemplate Moderna selling an annual booster shot “at your local
CVS store” “that would protect you against the variant of concern
against Covid and the seasonal flu strain.”
As the first-mover vaccine makers have admitted, demand for lucrative
booster shots in rich countries will depend, at least in part, on the
emergence of new variants of concern. Those variants will emerge if—and
only if—the virus continues to spread to some extent. This simple fact
gives the incumbent vaccine makers strong, and horrifying, incentives to
leave people—even large numbers of people—unvaccinated. (Or, perhaps,
half-vaccinated, as people who receive just one dose of a two-dose
regimen remain at substantial risk of infection and illness). Pfizer’s and Moderna’s
projections of handsome profits flowing from their annual booster shot
franchises rely, quietly, on the prospect of unvaccinated people
continuing to become infected by SARS-CoV-2. Their investors are already
coming to rely on these projections.
Would a drug company really do such a thing? Leave people to
die when it has the capacity to save them—either by manufacturing more,
or by sharing with other would-be producers the knowledge and the rights
required to manufacture more? One data point: In the midst of another,
slower-moving epidemic—hepatitis C—one multinational drug maker, Gilead,
“asserted that its primary concern
in developing and marketing [its bestselling hepatitis cure] was to
treat the largest number of HCV patients possible.” Yet a bipartisan
Senate investigation concluded, “In reality, Gilead’s marketing,
pricing, and contracting strategies were focused on maximizing
revenue—even as the company’s analysis showed a lower price would allow
more people to be treated.”
We have no proof that Moderna, Pfizer-BioNTech, J&J, and AstraZeneca are stretching the truth when they say
that they are trying to increase global Covid-19 vaccine supply as
quickly as humanly possible. But we’ve heard these kinds of claims
before—and they have been proven wrong.
In the 1990s and 2000s, for example, HIV drug makers based in the United States and Europe sometimes claimed
that manufacturers in other countries lacked the technical
sophistication to make the drugs safely and reliably; in reality,
manufacturers in India and other countries of the Global South succeeded
in making these drugs, in high quality and on a massive scale, and
ultimately did so more efficiently
than the original makers. (Arguments about manufacturing or
distribution capacity in the Global South often veer into patronizing,
even overtly racist, tropes about “the West’s” supposed scientific
supremacy, as when, in 2000, the editorial board of The Washington Post asserted,
incorrectly, that anti-HIV drugs could not be deployed in the Global
South because the “drugs need to be administered with a precision that
rudimentary health infrastructures cannot aspire to.”)
More recently, earlier in the pandemic, the United States faced shortages
of the anti-Covid-19 drug remdesivir. Gilead, which manufactures
remdesivir and holds patents on the drug, contended that it was making
as much remdesivir as global supply chains permitted. Faced with calls
to license its patents to generic competitors, in an effort to expand
supply, Gilead insisted
that such licenses would be futile: “Proposals to allow generic
manufacturers to make remdesivir ignore the fact that it takes six to 12
months to manufacture remdesivir.” In reality, a generic manufacturer
in Bangladesh succeeded in making remdesivir on commercial scale in less than six months, without help or permission from Gilead, and began exporting to other countries—though not to the United States, where Gilead’s patents and other legal barriers prevent competition.
Why might today’s Covid-19 vaccine-making
giants—Moderna, Pfizer-BioNTech, J&J, and AstraZeneca—insist on the
premise that they are making vaccines as fast as they can, even if they
know the premise is false? Because they—like HIV/AIDS drug-makers in the 2000s and Gilead during remdesivir shortages—face
real pressure from governments, civil society, and patients to make
more vaccines, and faster. In the face of mass death and horrible
suffering in India, Brazil, Iran, and other countries, Americans are increasingly calling on their government to intervene more actively, to use existing legal authority to exert greater control over Covid-19 vaccines. (The mRNA and J&J vaccines rely on foundational coronavirus vaccine technology invented in a US government lab—the
National Institute of Allergy and Infectious Diseases, led by Dr.
Anthony Fauci. Other key components were developed in universities; the
Pfizer-BioNTech vaccine, for example, would not work without a
lipid-based delivery system technology developed by researchers at the University of British Columbia. All of today’s Covid-19 vaccines were funded
in substantial part by government funding all over the world,
strengthening the case for greater public oversight and control of
vaccine manufacturing and distribution.) Thoughtful, detailed proposals from Public Citizen, PrEP4All, and others in civil society
include calls to waive (or issue compulsory licenses to) the
incumbents’ patents; to compel the incumbents to share their secret
manufacturing processes; and to invest billions in publicly governed
vaccine-manufacturing facilities.
To dismiss these calls out of hand, avoid difficult policy debates,
and protect the status quo, the incumbents fall back on their shaky
premise: Vaccine scarcity is lamentable but inevitable. They claim that
any government intervention will, at best, be useless and foolish, and,
at worst, devastating to the entire pharmaceutical and biotech sectors.
Given the incentives that the incumbents have to maintain control
over Covid-19 vaccines—to, in effect, manufacture scarcity—we think
there is ample reason to doubt their account of what is and what is not
possible. Prior to the pandemic, few would have thought
developing, manufacturing, and distributing even a single vaccine in
less than a year would be feasible. Moderna’s factory in Massachusetts
is a former Polaroid facility,
which had never produced a single commercial drug or vaccine prior to
Covid-19. Through unprecedented efforts and collaboration across
industry, academic researchers, health care professionals, government
agencies, and multilateral organizations all over the world—and massive
amounts of public funding directed to vaccine developers alongside other
incentives—we succeeded in generating safe and effective Covid-19
vaccines in record time.
To get vaccines to everyone who needs them, we need to do even more.
We can indeed expand supply significantly by the end of 2021, but only
with bold government action
that combines big public investment with compulsory transfer of the
incumbents’ trade secrets. (This transfer could be achieved by the US
government’s using the Defense Production Act, or perhaps the threat of a patent infringement lawsuit brought against vaccine manufacturers by the US government itself.). It will take months, not weeks or days. We won’t know how long it will take unless we try. Other vaccines are in the pipeline,
but given the dire need in many parts of the world we should make every
effort to scale up global production of the vaccines we already know
work—including by compelling Pfizer-BioNTech, Moderna, J&J, and
AstraZeneca to share the manufacturing know-how they have come to
control.
What we should not do is accept big pharma’s premise, or trust big
pharma to solve the pandemic on its own initiative, any time soon.
:extract_focal()/https%3A%2F%2Fstatic01.nyt.com%2Fimages%2F2021%2F08%2F19%2Fworld%2F19afghanistan-briefing-lede-name-04%2F19afghanistan-briefing-lede-name-04-videoSixteenByNine3000.jpg)
:extract_focal()/https%3A%2F%2Fstatic01.nyt.com%2Fimages%2F2021%2F08%2F19%2Fworld%2F19afghanistan-ledeall5%2Fmerlin_193433295_7fc09316-c669-4eb6-9dc0-3aa5268708a6-articleLarge.jpg%3Fquality%3D75%26auto%3Dwebp%26disable%3Dupscale)
:extract_focal()/https%3A%2F%2Fwww.thenation.com%2Fwp-content%2Fuploads%2F2021%2F05%2Fsouth-africa-covid-vaccine-ap-img.jpg)
/cloudfront-eu-central-1.images.arcpublishing.com/prisa/FZPA35IRUNAAXFLVF2AY2CWXNY.jpeg)