<html><head><meta http-equiv="Content-Type" content="text/html; charset=utf-8"></head><body style="word-wrap: break-word; -webkit-nbsp-mode: space; line-break: after-white-space;" class=""><a href="https://www.washingtonpost.com/business/2021/03/20/covid-vaccine-global-shortages/?utm_campaign=wp_todays_headlines&utm_medium=email&utm_source=newsletter&wpisrc=nl_headlines" class="">https://www.washingtonpost.com/business/2021/03/20/covid-vaccine-global-shortages/?utm_campaign=wp_todays_headlines&utm_medium=email&utm_source=newsletter&wpisrc=nl_headlines</a><div class=""><div class="w-100"><h1 class="
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" data-qa="headline" id="main-content"><span data-qa="headline-opinion-text" class="">Drug companies defend vaccine monopolies in face of global outcry</span></h1></div><h2 class="gray-dark mb-sm font-light font--subhead null" data-qa="subheadline">As immunization gap widens between rich and poor countries, the industry faces a battle over patents and know-how</h2><div class=""><br class=""></div></div><div class=""><div class="flex"><div class="items-center"><div class="mb-sm byline flex" data-qa="byline"><div class="font-xxs gray-dark self-center dib font--subhead author-text"><div class="author-names"><div class="dib relative"><span data-qa="author-name-wrapper" class=""></span></div></div></div></div><div class="gray-dark mb-md font--subhead font-xxs" data-qa="timestamp"><div class=" display-date">March 20, 2021 at 9:49 p.m. EDT</div></div></div></div><div class="article-body"><div class="teaser-content"><section class=""><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">Abdul
Muktadir, the chief executive of Bangladeshi pharmaceutical maker
Incepta, has emailed executives of Moderna, Johnson & Johnson, and
Novavax offering his company’s help. He said he has enough capacity to
fill vials for 600 million to 800 million doses of coronavirus vaccine a
year to distribute throughout Asia.</p></div><div class=""></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">He
never heard back from any of them. The lack of interest has left
Muktadir worried about prolonged coronavirus exposure for millions<b class=""> </b>of citizens of Bangladesh and other low-income<b class=""> </b>nations throughout Asia and Africa who are at the back of the <a href="https://www.washingtonpost.com/world/who-chief-warns-of-catastrophic-moral-failure-as-rich-countries-dominate-vaccine-supplies/2021/01/18/033644a0-5978-11eb-a849-6f9423a75ffd_story.html?itid=lk_inline_manual_4" target="_blank" class="">global queue</a> for shots.</p></div></section></div><div class="remainder-content"><section class=""><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">“Now is the time to use every single opportunity in every single corner of the world,” Muktadir, whose company <a href="https://www.thedailystar.net/health/news/we-want-be-self-sufficient-vaccine-production-health-minister-2062877" target="_blank" class="">is being promoted </a>by
the Bangladesh government for emergency vaccine production, said in a
Zoom interview. “These companies should make deals with as many
countries as possible.”</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">The drug companies that developed and won authorization for coronavirus vaccines <a href="https://www.washingtonpost.com/health/2020/12/06/covid-vaccine-messenger-rna/?itid=lk_inline_manual_7" target="_blank" class="">in record time</a>
have agreed to sell most of the first doses coming off production lines
to the United States, European countries and a few other wealthy
nations.</p></div></section></div></div></div><div class=""><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">The slow pace of ramping up production and <a href="https://www.washingtonpost.com/business/2021/02/18/vaccine-fat-lipids-supply/?itid=lk_inline_manual_10" target="_blank" class="">shortages</a> of raw materials have exacerbated the disadvantages for countries unable to afford the large outlays to reserve early supplies.<b class=""> </b>Billions of people are left with an uncertain wait, with most of Africa and parts of South America and Asia<b class=""> </b>not expected to achieve widespread vaccination coverage until 2023, according to <a href="https://www.eiu.com/n/85-poor-countries-will-not-have-access-to-coronavirus-vaccines/" target="_blank" class="">some estimates</a>.</p></div></div><div class=""><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">But drug companies have rebuffed entreaties to face the emergency by sharing their proprietary technology more freely<b class=""> </b>with
companies in developing nations. They cite the rapid development of new
vaccines as evidence that the drug industry’s traditional business
model, based on exclusive patents and know-how, is working. The
companies are lobbying the Biden administration and other members of the
World Trade Organization against any erosion of their monopolies on
individual coronavirus vaccines that are worth billions of dollars in
annual sales.</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">The debate about how to immunize more people overseas is picking up greater steam in the United States now that President Biden <a href="https://www.washingtonpost.com/health/2021/03/02/covid-biden-vaccine-cases/?itid=lk_inline_manual_13" target="_blank" class="">has promised</a> that most Americans will be vaccinated by July. Some Democrats in Congress, fresh off approving Biden’s $1.9 trillion pandemic <a href="https://www.washingtonpost.com/us-policy/2021/03/11/biden-sign-stimulus-covid-relief-congress-checks/?itid=lk_inline_manual_13" target="_blank" class="">rescue package</a>,
are determined to make sure Americans don’t forget about the rest of
the world as they potentially celebrate Independence Day with a
semblance of normalcy.</p><div class=""><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">“We’re
spending lots of money to save the hospitality industry, the airlines,
travel. It will all come to naught if the rest of the world is not
protected,” said Rep. Jan Schakowsky (D-Ill.), who questioned drug
executives at a recent House hearing over their refusal to share vaccine
patents openly.</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">The fights over vaccine supply are not just over a moral duty<b class=""> </b>of Western nations to prevent deaths and illness overseas.<b class=""> </b>Lack
of supply and lopsided distribution threaten to leave entire continents
open as breeding grounds for coronavirus mutations. Those <a href="https://www.washingtonpost.com/health/2021/03/07/scientists-underestimated-coronavirus-are-racing-keep-up-with-evolution/?itid=lk_inline_manual_17" target="_blank" class="">variants</a>,
if they prove resistant to vaccines, could spread anywhere in the
world, including in Western countries that have been vaccinated first.</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">“It
doesn’t make any sense for rich countries to think they can vaccinate
their own and let the rest of the world live off dribs and drabs,” said
Brook Baker, a Northeastern University law professor.</p><div class=""><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">Baker
advised the World Health Organization last year in creating a
technology-sharing pool to help developing countries make coronavirus
vaccines.</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">But
no coronavirus vaccine manufacturer has agreed to participate in the
program, called the COVID-19 Technology Access Pool, the WHO said.<b class=""> </b>Albert Bourla, the chief executive of Pfizer, last year <a href="https://www.statnews.com/pharmalot/2020/05/28/who-voluntary-pool-patents-pfizer/" target="_blank" class="">called </a>the concept “nonsense.”</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">“Unfortunately,
only limited, exclusive and often non-transparent voluntary licensing
is the preferred approach of some companies, and this is proven to be
insufficient to address the needs of the current COVID-19 pandemic,” the
WHO said in response to questions from The Washington Post. “The entire
population and the global economy are in crisis because of that
approach and vaccines nationalism.”</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">Last month, United Nations chief António Guterres <a href="https://www.washingtonpost.com/world/2021/02/19/pandemic-inequlality-vaccine-g7/?itid=lk_inline_manual_25" target="_blank" class="">warned</a>
that 10 countries had administered 75 percent of all doses by then and
130 countries had not received a single dose. The WHO-linked vaccine
purchasing push, known as Covax, has since delivered some doses to low-
and middle- income countries — but dozens of countries remain without a
single dose, or with a small quantity that falls woefully short of
checking the pandemic.</p></div></div></div></div></div></div><div class=""><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">Of
the potential 10 billion to 14 billion vaccine doses the industry hopes
to produce in 2021 — a range that relies on optimistic projections —
more than two-thirds have been claimed by wealthy and middle-income
countries, according to a <a href="https://www.ifpma.org/wp-content/uploads/2021/03/Summit_Landscape_Discussion_Document.pdf" target="_blank" class="">joint report </a>released by the drug industry and the Coalition for Epidemic Preparedness Innovations earlier this month.</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">The
remaining doses would cover as little as 28 percent of the populations
of 92 of the world’s most impoverished nations, according to the report.</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">The dire international situation contrasts sharply with the<b class=""> </b>optimism spreading in the United States.</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">The
United States has committed nearly $20 billion in subsidies for vaccine
development and advance purchase agreements of hundreds of millions of
doses, mostly spread across six private companies. The upfront
investment was intended to reduce the private-sector financial risk of
rapidly developing the vaccines. It worked. Emergency FDA authorization
of three vaccines — from Pfizer, Moderna, and Johnson & Johnson —
arrived in record time.</p><div class=""><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">Two
more are in the near-term pipeline for Food and Drug Administration
review: shots made by AstraZeneca and Novavax. A sixth vaccine candidate
supported with U.S. funds, from Sanofi, has been delayed for further
clinical trials after it did not trigger a sufficient immune response in
elderly people.</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">These
exclusive franchises are on track to generate billions of dollars in
revenue for the companies. The Moderna vaccine, which was co-developed
with the United States government and supported with $483 million in
taxpayer backing, is expected to bring in $18.5 billion for the company
this year, Moderna said in February.</p></div></div></div></div><div class=""><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">Pfizer,
which partnered with Germany’s BioNTech, a company that received German
subsidies, has predicted it will get $15 billion from sales of its
vaccine, an estimate that is considered conservative. Pfizer did not
accept U.S. government funding.</p></div></div><div class=""><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">Both
the Pfizer and Moderna vaccines are based on novel messenger RNA
technology that holds potential for other vaccines and drugs against an
array of diseases. That makes the technology especially valuable.</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">Drug
companies are lobbying the Biden administration to block a push at the
WTO by India, South Africa and about 80 other countries for a temporary
waiver on patent protections for the new vaccines. The pharmaceutical
industry argues that innovation as well as vaccine quality and safety
depend on maintaining exclusive intellectual property rights.</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">“Eliminating
those protections would undermine the global response to the pandemic,”
industry executives and the Pharmaceutical Research and Manufacturers
of America, their powerful lobbying group, warned President Biden <a href="https://phrma.org/Public-Communication/Letter-to-President-Biden-from-31-PhRMA-Board-Members" target="_blank" class="">in a letter </a>this
month. Biden has sided with the drug companies so far. The United
States on March 10 joined Britain, the E.U. and Switzerland in blocking
the push for waivers.</p></div><div class=""><p class=""></p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">The
United States, which initially declined to join Covax under President
Donald Trump, last month pledged $4 billion to help pay for vaccine
purchases. But there is just not enough supply in the pipeline for Covax
to satisfy demand in developing countries, say experts on global
health.</p></div></div><div class=""><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">“The
starting point is that we need to make more vaccine,” said Mara
Pillinger, an associate in global health policy and governance at
Georgetown’s O’Neill Institute for National and Global Health Law. “Any
conversation about allocating the limited supply we have now will never
get us where we need to be.”</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">The
companies say they are working furiously to produce more vaccine doses,
using their own factories and licensing agreements with contract
manufacturers with the highest degree of expertise and the most
capacity, most of them in North America, Europe and India.</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">Step-by-step
manufacturing instructions are just as important as intellectual
property rights, because vaccines require multiple complex steps to
produce. It takes highly specialized equipment and workers trained in
biopharmaceutical manufacturing.</p><div class=""><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">“WHO
criticism of industry is showing a lack of understanding for the
complexity of vaccine manufacturing and global supply chain and a
disrespect for the daunting challenge of literally trebling global
vaccine capacity for one single disease almost overnight,”<b class=""> </b>Thomas
Cueni, director general of the International Federation of
Pharmaceutical Manufacturers and Associations, said in an email.</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">“COVID-19 vaccine makers have been making agreements with other vaccine makers, wherever they are in the world,”<b class=""> </b>he said.<b class=""> </b>“Speed
is of the essence; and for these relationships to be established
quickly, you need trust, as well as a total shared commitment to the
quality and safety of COVID-19 vaccines produced.”</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">Most of the companies have announced plans to sell vaccine to Covax or directly to poorer nations.</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">AstraZeneca
has been the most aggressive about creating technology transfer deals
and has priced its vaccine the lowest, for as little as $2.15 per dose
in Europe. But European countries have created a <a href="https://www.washingtonpost.com/world/europe/astrazeneca-covid-europe-third-wave/2021/03/17/94740210-868f-11eb-be4a-24b89f616f2c_story.html?itid=lk_inline_manual_55" target="_blank" class="">crisis atmosphere</a> around the vaccine by suspending doses after blood clots appeared in a tiny number of individuals who received the shots.</p><div class=""><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">Biden
earlier this month announced an initiative to produce 1 billion doses
of Johnson & Johnson’s single-shot vaccine in India, at the
company’s manufacturing partner there, Biological E, by the end of 2022.
Those doses would be targeted to the developing world and could help
boost total production as high as 3 billion in 2022, a company executive
<a href="https://www.reuters.com/article/us-health-coronavirus-johnson-johnson/jj-to-make-up-to-three-billion-covid-19-vaccines-in-2022-chief-scientist-idUSKBN2B32Y0" target="_blank" class="">told Reuters</a>.
The company’s vaccine is produced by a network of nine contractor
companies, most in North America and Europe. It said in a statement that
“we continue to seek out new partnerships.”</p></div><div class=""><p class="">Pfizer,
which says it plans to produce 2 billion doses of vaccine in 2021, has
begun selling its vaccine directly to countries. The company said 36
percent of its production will be reserved for middle- and low-income
countries, with nonprofit pricing baked in for the poorest nations.</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">“We
are firmly committed to equitable and affordable access of coronavirus
vaccines for people around the world,” Pfizer spokeswoman Amy Rose said
in an email.</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">Moderna
has said it will make nearly 1 billion doses in 2021. It has only a few
commitments outside of the United States and Europe. It has been
criticized for not yet agreeing to supply doses to Covax.</p></div></div></div></div></div></div><div class=""><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">Moderna
last year said it did not intend to enforce its patents against any
companies making coronavirus vaccines. The announcement generated
positive headlines. But as a practical matter, it is unlikely to have an
impact on the supply of vaccine in the developing world.</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">In
a Zoom call on Feb. 3, John Lepore, Moderna’s senior vice president for
government engagement, told vaccine advocates the company is reluctant
to share details about how to make its vaccine, according to<b class=""> </b>advocates
who participated in the call and were interviewed by The Washington
Post. Lepore said Moderna sees its mRNA vaccine delivery system as a
proprietary platform for other drugs and vaccines in the future, the
participants said.</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">“He
saw this as fundamental to them maintaining proprietary technology,”
said one of the people on the call, James Love, director of Knowledge
Ecology International, a nonprofit advocacy group that is critical of
many monopolistic practices in the drug industry. “Can they really keep
the genie in the bottle that long?”</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">Moderna
did not comment on the conversation but referred to the October patent
pledge. “Our patent pledge stated that, while the pandemic persists,
Moderna will not use its patents to block others from making a
coronavirus vaccine intended to combat the pandemic. There was no
mention of a commitment to transfer our know-how beyond our chosen
partners,” Moderna spokesman Ray Jordan said in an email.</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">Pakistan
has received a small trickle of vaccine doses from China and none from
Western drug companies, even though it is the world’s fifth-largest
country, with about 220 million people.</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">Wajiha
Javed, head of public health and research at Pakistani drug company
Getz Pharma, sees a prolonged crisis on the horizon under the current
vaccination plan.</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">She
said she has sent proposals to multiple coronavirus vaccine
manufacturers to accelerate vaccine supply to Pakistanis and other
customers in the developing world. Getz also has been met with silence,
she said in an interview.</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">“We
say we are ready to do tech transfer, import licensing, fill-finish,”
she said. “We offer everything. We are desperate. Nobody even bothers to
answer back.”</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">Experts on global health and pandemics are looking for ways to break through the logjam and create more supply.</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">“Basically,
you need a global version of Operation Warp Speed,” said Thomas J.
Bollyky, a senior fellow at the Council on Foreign Relations and
director of its Global Health Program, referring to the Trump
administration’s effort to develop vaccines in the United States.
“Operation Warp Speed did not just spend money. It coordinated, it
aligned all the inputs involved, it played a general-contractor role.”</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">Bollyky
ventured that the WHO may have lacked the money or clout to take on big
pharma. He envisioned a diplomatic push, perhaps led by the Group of
20.</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">The
high cost of HIV medications, protected by drug industry patents,
prevented the treatments from reaching Africa in the late 1990s and
created enormous pressure for distribution of low-cost pills. In 2001,
the World Trade Organization carved out an exemption to international
patent protections for public health emergencies. For vaccines, the
industry has said it has scrambled to build new manufacturing capacity
fast enough.</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">Some
argue that drug companies have already proved they can transfer the new
vaccine production to contract manufacturers and licensees in a matter
of months, so there is no reason they can’t continue to expand to a
wider roster of companies.</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">“This
idea that it would take too long to stand up is a dodge,” said
Pillinger, at Georgetown’s O’Neill Institute. “They are sharing the IP
where they see that it is in their financial interest to do so to make
the effort worthwhile.”</p><div class=""><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">Muktadir, the pharmaceutical chief executive in Bangladesh, already<b class=""> </b>makes and<b class=""> </b>sells
a number of vaccines and other drugs throughout the developing world.
Even after his appeal to help in the global pandemic response was <a href="https://apnews.com/article/drug-companies-called-share-vaccine-info-22d92afbc3ea9ed519be007f8887bcf6" target="_blank" class="">reported </a>by the Associated Press, he said he has heard nothing from the vaccine companies.</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">Bangladesh
qualifies as a “least developed country” under WTO rules, which gives
it an automatic intellectual property waiver until 2033. But Muktadir
said he is not interested in attempting to break any of the vaccine
patents. He wants to work with the industry for tech transfer, not
against it.</p></div><div class=""><p data-el="text" class="gray-darkest font-copy ma-0 pb-md font--body">“Incepta
is a very, very large, capable, high-quality manufacturing place,” he
said, ”and we are left out because we are in Bangladesh.”</p></div></div></div></div><div class=""><br class=""></div><div class=""><br class=""><div class="">
Arthur Stamoulis<br class="">Citizens Trade Campaign<br class="">(202) 494-8826<br class=""><br class=""><br class=""><br class="">
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