[Ip-health] Washington Post: Drug companies defend vaccine monopolies in face of global outcry

Thiru Balasubramaniam thiru at keionline.org
Sun Mar 21 21:49:14 PDT 2021


Drug companies defend vaccine monopolies in face of global outcry
As immunization gap widens between rich and poor countries, the industry
faces a battle over patents and know-how

By Christopher Rowland, Emily Rauhala and Miriam Berger
March 21, 2021 at 2:49 a.m. GMT+1

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.

He never heard back from any of them. The lack of interest has left
Muktadir worried about prolonged coronavirus exposure for millions of
citizens of Bangladesh and other low-income nations throughout Asia and
Africa who are at the back of the global queue for shots.

“Now is the time to use every single opportunity in every single corner of
the world,” Muktadir, whose company is being promoted by the Bangladesh
government for emergency vaccine production, said in a Zoom interview.
“These companies should make deals with as many countries as possible.”

Tracking the covid vaccine: Doses, people vaccinated, by state

The drug companies that developed and won authorization for coronavirus
vaccines in record time 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.

The slow pace of ramping up production and shortages of raw materials have
exacerbated the disadvantages for countries unable to afford the large
outlays to reserve early supplies. Billions of people are left with an
uncertain wait, with most of Africa and parts of South America and Asia not
expected to achieve widespread vaccination coverage until 2023, according
to some estimates.

>From ‘shot shopping’ to overrun signup websites, a look into America’s
vaccine rollout
Challenging immunization efforts across the U.S. has led local and state
officials to improvise strategies on how coronavirus vaccine doses are
distributed. (Luis Velarde/The Washington Post)
But drug companies have rebuffed entreaties to face the emergency by
sharing their proprietary technology more freely 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.

The debate about how to immunize more people overseas is picking up greater
steam in the United States now that President Biden has promised that most
Americans will be vaccinated by July. Some Democrats in Congress, fresh off
approving Biden’s $1.9 trillion pandemic rescue package, 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.

“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.

The fights over vaccine supply are not just over a moral duty of Western
nations to prevent deaths and illness overseas. Lack of supply and lopsided
distribution threaten to leave entire continents open as breeding grounds
for coronavirus mutations. Those variants, if they prove resistant to
vaccines, could spread anywhere in the world, including in Western
countries that have been vaccinated first.

“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.

Baker advised the World Health Organization last year in creating a
technology-sharing pool to help developing countries make coronavirus

But no coronavirus vaccine manufacturer has agreed to participate in the
program, called the COVID-19 Technology Access Pool, the WHO said. Albert
Bourla, the chief executive of Pfizer, last year called the concept

“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.”

More than 4 in 10 health-care workers have not been vaccinated, Post-KFF
poll finds

Last month, United Nations chief António Guterres warned 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.

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 joint report released by the drug industry and the Coalition
for Epidemic Preparedness Innovations earlier this month.

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.

The dire international situation contrasts sharply with the optimism
spreading in the United States.

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

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.

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.

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.

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.

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.

“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 in a letter 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.

Your questions about coronavirus vaccines, answered

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.

“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.”

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.

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.

“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,” Thomas Cueni, director
general of the International Federation of Pharmaceutical Manufacturers and
Associations, said in an email.

“COVID-19 vaccine makers have been making agreements with other vaccine
makers, wherever they are in the world,” he said. “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.”

Most of the companies have announced plans to sell vaccine to Covax or
directly to poorer nations.

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 crisis atmosphere
around the vaccine by suspending doses after blood clots appeared in a tiny
number of individuals who received the shots.

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 told Reuters.
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.”

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the future

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.

“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.

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.

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.

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 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.

“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?”

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.

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.

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.

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.

“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.”

Experts on global health and pandemics are looking for ways to break
through the logjam and create more supply.

“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.”

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.

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.

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.

“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.”

Muktadir, the pharmaceutical chief executive in Bangladesh, already makes
and sells a number of vaccines and other drugs throughout the developing
world. Even after his appeal to help in the global pandemic response was
reported by the Associated Press, he said he has heard nothing from the
vaccine companies.

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

“Incepta is a very, very large, capable, high-quality manufacturing place,”
he said, ”and we are left out because we are in Bangladesh.”

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

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