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| DATE | 2021-05-01 |
| FROM | Ruben Safir
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| SUBJECT | Subject: [Hangout - NYLXS] Vaccines and Patents
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wsj.com
India’s Covid-19 Crisis Raises Pressure to Waive Vaccine Patents
Saeed Shah in Islamabad, Yaroslav Trofimov in Dubai and Gabriele
Steinhauser in Johannesburg
12-15 minutes
The explosion of Covid-19 cases in India and other developing nations is
adding momentum to a push to suspend intellectual-property restrictions
on vaccines, putting pressure on Washington, other Western governments
and pharmaceutical companies to do more to address the crisis.
Some 60 developing countries, led by India and South Africa, are
drafting a new proposal to waive the World Trade Organization’s
intellectual-property rules—something they say would allow a significant
increase in vaccine production world-wide. The new proposal will be put
to the organization in the next few days, diplomats say.
Even as some 30% of Americans are fully vaccinated, less than 2% of
Indians are. New Covid-19 cases are at record highs globally, largely
due to an escalation in poor and middle-income countries such as Brazil,
Turkey and Colombia.
Pharmaceutical companies, which are quickly scaling up production to
meet global demand, say waiving the intellectual property on the
vaccines wouldn’t solve supply problems in the short term because
contract producers lack familiarity with new technology behind the
shots—technical know-how that isn’t shielded by patents.
The line this week outside a vaccination center in Mumbai. The Covid-19
surge in India has prompted the government to halt vaccine exports.
Photo: divyakant solanki/Shutterstock
But pressure is building on Western governments, including the U.S. In a
call earlier this week, Indian Prime Minister Narendra Modi pressed
President Biden to support the waiver.
“We have to evaluate whether it’s more effective to manufacture here and
provide supply to the world, or the IP waiver is an option,” White House
press secretary Jen Psaki said this week. She added that Mr. Biden
hasn’t yet made a decision on whether the U.S. will support the waiver
or push for other means to speed up immunization in developing countries.
More than 100 members of Congress support a waiver. A recent letter to
Mr. Biden from Vermont Sen. Bernie Sanders and nine Democratic senators,
including Elizabeth Warren, said that “delaying vaccine deployment in
the developing world to lock in profit-boosting patent protections
threatens the safety of the American public that financed the vaccines
in the first place.”
The WTO rules, known as Trips, were amended to allow for countries to
manufacture a medicine in an emergency, after India and South Africa led
an effort to lift patents for AIDS medication in the 1990s, which
according to the United Nations saved tens of millions of lives in
poorer nations.
Members of the People’s Vaccine Campaign of South Africa protested
outside Johnson & Johnson offices in Cape Town in March to urge the
company to drop intellectual-property protections on its Covid-19 vaccine.
Photo: nic bothma/Shutterstock
Even after the reform in the years after the AIDS crisis, the process is
cumbersome, open to legal challenges and could take years to implement
because every vaccine is based on a large number of separate patents. It
is also aimed at localized disease outbreaks, not a pandemic, so
exporting medicines around the world under this current exemption is
difficult.
The World Health Organization has established a special
technology-transfer pool for Covid-19 vaccines, but so far no
manufacturer has contributed to it.
“The market once again has failed in meeting the health needs of
developing countries,” said U.S. Trade Representative Katherine Tai at a
WTO conference on vaccine equity in April. “Extraordinary times require
extraordinary leadership…This challenge applies equally to the industry.”
A number of large pharmaceutical companies, including Covid-19 vaccine
developers AstraZeneca PLC, Pfizer Inc. and Johnson & Johnson, wrote to
Mr. Biden in March, urging him to oppose the waiver. They stated that
Covid-19 manufacturers can produce a combined 10 billion doses of the
vaccine this year under the existing intellectual-property system.
Campaigners for the waiver, however, say that far less is likely to be
produced this year.
Drug companies say the obstacles to scaling up production include the
need to train technicians, source scarce ingredients and ensure quality
checks. They say there is a limited number of manufacturers capable of
large-scale vaccine production.
A shipment of the Johnson & Johnson vaccine from South Africa arrived
Wednesday in Toronto.
Photo: carlos osorio/Reuters
They also say that there are manufacturing techniques, and biological
components such as cells for some vaccines, that need to be passed on to
set up new assembly lines. Under licensing agreements, such technology
has been passed on to other manufacturers to produce Covid-19 vaccines,
but critics say that not enough of these deals have been done and that
the agreements are opaque.
Last year, the University of Oxford was exploring opening up
intellectual property related to its then-exploratory Covid-19 vaccine
and other pandemic-related science and technology to expedite the
development of no-profit or low-profit shots. But the need for a partner
with extensive experience in clinical trials, regulatory approvals and
manufacturing to launch a vaccine led Oxford to seal an exclusive
arrangement with AstraZeneca.
AstraZeneca has since built a web of more than 20 manufacturing
partners, including the Serum Institute of India, with ambitious plans
to help deliver vaccines to lower- and middle-income countries through
Covax, a WHO-supported facility.
The enormous surge of infections in India, however, prompted New Delhi
to halt Covid-19 vaccine exports. Covax has shipped just 50 million
doses around the world, out of a goal of two billion by the end of the year.
Ugur Sahin, CEO of BioNTech SE, which makes a vaccine with Pfizer Inc.,
said this week his company could issue special licenses to other
manufacturers, but dismissed calls to waive the intellectual property,
saying it would take a year to master the technology and ensure quality
control. Last year, it took a monthslong transfer of the messenger RNA
technology for Pfizer to be able to produce the vaccine at scale because
the technology is so new.
India Gets Help With Covid Surge That Threatens Global Pandemic Fight
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0:00 / 2:19
1:36
India Gets Help With Covid Surge That Threatens Global Pandemic Fight
India Gets Help With Covid Surge That Threatens Global Pandemic Fight
The U.S. and other countries are stepping in to help as India's new
coronavirus cases continue to set daily records. The crisis there
highlights how one country's surge could have ripple effects in the
global battle against the pandemic. Photo: Adnan Abidi/Reuters
“We don’t want to have a low-quality vaccine in Africa,” Dr. Sahin said.
According to a July 2020 report by McKinsey, it normally takes 18 to 30
months for a contract manufacturer to adapt the technology needed to
make vaccines. But, the report says, that can be compressed to as little
as six months.
Backers of the waiver proposal say there are more than a dozen
drugmakers in developing countries that have passed quality checks by
the WHO and the U.S. Food & Drug Administration and that could be
equipped to produce the shots. That would require a transfer of the
technical know-how from vaccine makers and funding from institutions
such as the World Bank.
While India and South Africa first called for lifting patent
restrictions last October, the developing nations’ new pitch at the WTO
will have tighter language limiting the scope and duration of the
measures, in an effort to make it more acceptable to the U.S. and other
rich countries, diplomats say.
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Pharmaceutical companies in countries such as India, Bangladesh, South
Africa and Senegal say they have the capacity to produce vaccines within
a few months if Western manufacturers license or share their technology.
Chinese and Russian Covid-19 vaccine manufacturers, meanwhile, are
already pursuing licensing agreements in nations that include Brazil,
Serbia and India.
Bangladesh’s Incepta Pharmaceuticals Ltd., for example, says it has a
production line that could make 350 million doses a year of protein
sub-unit vaccines, such as that developed by Novavax Inc. Among the
vaccines Incepta, which has 10,000 employees, already makes are shots
against cholera and hepatitis B. The company also says it has a
“fill-and-finish” facility that could transfer another 500 million doses
from bulk containers to final-use vials, saying that it could easily do
this for mRNA vaccines.
“We have a tremendous facility here lying idle. It is very frustrating,”
said the company’s chairman, Abdul Muktadir, who dismissed safety
concerns as “pure nonsense.”
Bangladesh’s Incepta Pharmaceuticals, a vaccine producer with facilities
near Dhaka, says it has production lines that could be used to make
vaccine ingredients and fill vials.
Photo: Al-emrun Garjon/Associated Press
Mr. Muktadir said he was ready to pay to use the intellectual property
rights, but that his offer of a licensing deal received no response from
U.S. manufacturers.
In Canada, where there is a shortage of vaccines, Ontario-based Biolyse
Pharma has spent months trying to get a license, but received no offers,
according to spokesman John Fulton. Its plant, capable of making 50
million doses a year, stands unused.
Pfizer-BioNTech and Moderna haven’t licensed their Covid-19 vaccines to
any producers in the developing world so far.
BioNTech’s Mr. Sahin said this week that his company was contemplating
potential production in South America and Africa, but offered no details.
A spokesman for Moderna said that actively sharing the know-how with
manufacturers in the developing world would have pulled resources away
from its own efforts to produce hundreds of millions of doses during the
pandemic. He declined to say whether Moderna opposed the Trips waiver
proposal.
Johnson & Johnson has struck a deal with India’s Biological E. Ltd. to
produce its shots, while a plant in South Africa has been contracted to
fill the vaccine into vials.
—Jenny Strasburg and Bojan Pancevski contributed to this article.
Write to Saeed Shah at saeed.shah-at-wsj.com, Yaroslav Trofimov at
yaroslav.trofimov-at-wsj.com and Gabriele Steinhauser at
gabriele.steinhauser-at-wsj.com
India's Covid-19 Crisis
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