[CTC] Pressure Grows on U.S. Companies to Share Covid Vaccine Technology

[Arthur Stamoulis]

Useful report from Amnesty below this NYT piece...


https://www.nytimes.com/2021/09/22/us/politics/covid-vaccine-moderna-global.html <https://www.nytimes.com/2021/09/22/us/politics/covid-vaccine-moderna-global.html>

Pressure Grows on U.S. Companies to Share Covid Vaccine Technology
Moderna accepted $2.5 billion in taxpayer money to develop its Covid-19 vaccine. But officials in the U.S. and overseas are having trouble persuading the company to license its technology.

By Stephanie Nolen and Sheryl Gay Stolberg
Sept. 22, 2021
Updated 10:25 a.m. ET

As President Biden convenes heads of state for a Covid-19 summit on Wednesday, pressure is growing on American drug companies — particularly Moderna, the upstart biotech firm that developed its coronavirus vaccine with billions of dollars in taxpayer money — to share their formulas with manufacturers in nations that desperately need more shots.

Last year’s successful race to develop vaccines in extraordinarily short order put companies like Moderna and Pfizer in a highly favorable spotlight. But now, with less than 10 percent of those in many poor nations fully vaccinated and a dearth of doses contributing to millions of deaths, health officials in the United States and abroad are pressing the companies to do more to address the global shortage.

The Biden administration has privately urged both Pfizer and Moderna to enter into joint ventures where they would license their technology to contract manufacturers with the aim of providing vaccines to low- and middle-income countries, according to a senior administration official.

Those talks led to an agreement with Pfizer, announced Wednesday morning, to sell the United States an additional 500 million doses of its vaccine at a not-for-profit price — rather than license its technology — to donate overseas.

The discussions with Moderna have not been fruitful, said the official, who expressed deep frustration with the company but requested anonymity to discuss sensitive information.

A coalition of major drug and vaccine manufacturers in developing countries around the world is drafting an appeal to Mr. Biden asking him to press the companies more aggressively to share the formulations and processes used to make their vaccines.

The World Health Organization has also had trouble getting Moderna to the negotiating table, according to Dr. Martin Friede, a W.H.O. official, and Charles Gore, who runs a United Nations-backed nonprofit organization, Medicines Patent Pool. Both are working with a W.H.O.-backed technology transfer hub in South Africa, set up to teach manufacturers from developing countries how to make mRNA vaccines, a new type of vaccine technology used by both American companies.

“We would love to get a discussion with Moderna, about a license to their intellectual property — this would make life so much simpler, but for the moment all attempts have resulted in no reply,” Dr. Friede said.

At Wednesday’s virtual summit, on the sidelines of the United Nations General Assembly meeting in New York, Mr. Biden will convene heads of state, drug company executives, philanthropic groups and nongovernmental organizations to encourage them to work together toward vaccinating 70 percent of the world’s population by this time next year, according to a draft documentthe White House sent to the summit participants.

Global health advocates say Moderna has a special obligation to share its technology because its vaccine relies in part on technology developed by the National Institutes of Health, and because the company accepted $2.5 billion from the federal government as part of Operation Warp Speed, the Trump administration’s fast-track vaccine initiative.

A Moderna spokeswoman, Colleen Hussey, said in an email message Tuesday night that the company had agreed not to enforce its Covid-related patents and was “willing to license our intellectual property for Covid-19 vaccines to others for the post pandemic period.”

But advocates say the world needs Moderna’s know-how now — not after the pandemic is over.

While sharing the vaccine “recipe” is a vital first step, it is not in and of itself enough to allow for the swift and efficient set up of new mRNA manufacturing locations, said Alain Alsalhani, a vaccines expert with Doctors Without Borders’ access-to-medicines campaign.

“You need someone to share all the process, because it’s a new technology,” he said. “One of the problems we have is that the scientific literature about industrial-scale manufacturing of mRNA vaccines is so slim. This is why it’s not just about a recipe, it’s about an active and full tech transfer.”

Pfizer, in an emailed statement, noted that it and its partner, BioNTech, had signed a letter of intent, announced last month, with the South African biopharmaceutical company Biovac, which is part of the South African hub, to manufacture Pfizer’s vaccine for African nations. But Biovac will only bottle the vaccine, which does not necessitate sharing the formula. The actual “drug substance” will be made in Europe.

In the absence of voluntary cooperation from the companies, some legal experts and global health advocates say the Biden administration could attempt to force them to share their intellectual property, using the powers of the Defense Production Act, a 1950 law that gives the president broad power over American companies in emergency situations.

Lawrence O. Gostin, a public health law expert at Georgetown University, said Mr. Biden could declare the pandemic a national security threat, which would enable him to “require companies to sign technology transfer contracts in exchange for reasonable compensation,” from either the federal government or manufacturing partners.

“Moderna accepted substantial federal funding under Operation Warp Speed and both Pfizer and Moderna benefited from N.I.H. dollars for the basic research over a decade for mRNA technology,” Mr. Gostin said, adding that the companies “hold a special social and ethical responsibility to share that technology for the benefit of the world.”

Biden administration officials say that forcing the companies to act is not as simple as it sounds, and that an effort to compel them to share their technology would invariably lead to a drawn-out legal battle, which would be counterproductive.

Pfizer and Moderna executives have said that the mRNA production process is so complex, and that there are so few people with experience in it available, that setting up new operations in other parts of the world would not be feasible and could not happen quickly enough to be useful. They say that their combined manufacturing will produce more than enough vaccines to meet global need by the middle of next year and that the fastest way to address vaccine inequity would be through distribution of donated doses.

But some pharmaceutical manufacturing experts and drug-access advocates argue that the events of the last 18 months make it clear that manufacturing in developing countries is going to be crucial to ensuring equitable access.

Many of the donated doses bound for use in Africa, for example, were meant to come from the Serum Institute of India. But five months ago, the Indian government blocked the company from exporting any vaccines, ordering that the supply instead be directed to trying to stanch a raging second Covid wave in that country. (India now says it will allow exports to resume next month.)

“We keep hearing, ‘The vaccines are coming, the vaccines are coming,’ but three million people have died since the Pfizer vaccine was first authorized by the F.D.A.,” said Zain Rizvi, an expert on access to medicines with the advocacy organization Public Citizen.

Moderna and Pfizer have a direct financial interest in keeping their technology to themselves and guarding a competitive advantage not just in the sale of Covid vaccines, which are on track to bring in more than $53 billion in revenue this year, but also other potentially lucrative mRNA vaccines in development, such as one for cancer, H.I.V. and malaria, he said, adding, “They don’t want to stand up a future competitor.”

The coalition of drugmakers in developing countries that is drafting an appeal to Mr. Biden plans to ask the U.S. government to pressure companies for several things: a license for the intellectual property, a license for the technology involved in the manufacturing of the vaccines, the provision of items such as cell lines and assistance in acquiring vital but scarce equipment.

In exchange for sharing its process, Moderna would be compensated with a licensing fee, a percentage of each dose sold.

Even without Moderna’s cooperation, the W.H.O. says its tech transfer hub in South Africa will focus on trying to replicate as closely as possible the Moderna formula, as the gold standard against which to compare candidates from other biotechnology companies, and then teach any manufacturer who wants to make it how to do so at scale.

“If we had Moderna or BioNTech with us, we could get to an approved vaccine in 18 months, but without them we have to go through full development — so it’s 36 months if everything goes perfectly, but it could be longer,” said Dr. Friede, who heads the W.H.O.’s Initiative for Vaccine Research.

Pfizer and Moderna are at a pivotal moment where they can decide what role they want to play in the process, he said. “I’ve made many successful vaccines; with me I have other people who have made successful vaccines,” he said. “What we are actually saying is: ‘We’re going to do this. So you can come in and try and maintain some control by actually producing vaccines locally, or we’re going to do it without you. And then you’ve lost control’.”


https://www.amnesty.org/en/latest/news/2021/09/new-report-shows-leading-covid-19-vaccine-pharma-companies-fuelling-unprecedented-human-rights-crisis/ <https://www.amnesty.org/en/latest/news/2021/09/new-report-shows-leading-covid-19-vaccine-pharma-companies-fuelling-unprecedented-human-rights-crisis/>

New report shows leading Covid-19 vaccine pharma companies fuelling unprecedented human rights crisis
9/22/21
 
·         AstraZeneca, BioNTech, Johnson & Johnson, Moderna, Novavax and Pfizer refused to participate in initiatives to boost global vaccine supply
·         Less than 1% of people in low-income countries are fully vaccinated, compared to 55% in rich countries
·         BioNTech, Moderna and Pfizer set to earn US$130 billion by the end of 2022
·         Ahead of President Biden’s global Covid-19 summit, Amnesty International throws down gauntlet and calls for 2 billion vaccines to be delivered to low and lower-middle income countries before end of the year
Six companies at the helm of the Covid-19 vaccine roll-out are fuelling an unprecedented human rights crisis through their refusal to waive intellectual property rights and share vaccine technology, with most failing to prioritise vaccine deliveries to poorer countries, Amnesty International said today.
In a new report, A Double Dose of Inequality: Pharma companies and the Covid-19 vaccines crisis <https://www.amnesty.org/en/documents/pol40/4621/2021/en/>, the organization assessed six of the companies that hold the fate of billions of people in their hands: AstraZeneca plc, BioNTech SE, Johnson & Johnson, Moderna, Inc., Novavax, Inc. and Pfizer, Inc. It paints a dismal picture of an industry that is woefully failing to respect human rights.
“Vaccinating the world is our only pathway out of this crisis. It should be time to hail these companies, who created vaccines so quickly, as heroes. But instead, to their shame and our collective grief, Big Pharma’s intentional blocking of knowledge transfer and their wheeling and dealing in favor of wealthy states has brewed an utterly predictable and utterly devastating vaccine scarcity for so many others” said Agnès Callamard, Amnesty International’s Secretary General.
“Its plunging parts of Latin America, Africa and Asia into renewed crises, pushing weakened health systems to the very brink and causing tens of thousands of preventable deaths every week. In many low-income countries not even health workers and people at-risk have received the vaccine.”  
“Against the backdrop of these gross inequalities BioNTech, Moderna and Pfizer are set to make US$130 billion combined by the end of 2022. Profits should never come before lives.”
Failing to meet human rights responsibilities
In order to assess their response to the crisis, Amnesty International reviewed each company’s human rights policy, vaccine pricing structure, their records on intellectual property, knowledge and technology sharing, the fair allocation of available vaccine doses, and transparency. It found that to differing degrees, the six vaccine developers had failed to meet their human rights responsibilities.
Out of 5.76 billion doses administered worldwide, a paltry 0.3% have gone to low-income countries with over 79% going to upper-middle and high-income countries. Despite calls to prioritise and collaborate with COVAX Facility, the international instrument aiming to ensure a fair global vaccine allocation, some of the assessed companies have continued to stock up vaccine supplies for states known to be hoarding the vaccine.
All the companies assessed have so far refused to take part in internationally coordinated initiatives designed to boost global supply by sharing knowledge and technology. They have also opposed proposals to temporarily lift intellectual property rights, such as the World Trade Organization Trade Related Intellectual Property Rules (TRIPS) Waiver proposed by India and South Africa.
Further findings included:
·         Pfizer and BioNTech have so far delivered nine times more vaccines to Sweden alone than to all low-income countries combined – less than 1% of their production so far. High prices mean the companies are set to earn over $86 billion in revenues by the end of 2022.
·         Moderna has not yet delivered a single vaccine dose to a low-income country, has provided just 12% of its vaccines to lower-middle income countries, and will not deliver the vast majority of its orders for COVAX until 2022. Higher prices mean it is set to earn over $47bn in revenues by the end of 2022
·         Johnson & Johnson has developed the world’s only single dose vaccine and sells at cost price, yet it will not deliver the vast majority of its commitments to COVAX and the African Union until 2022. They have also refused to grant a license to a Canadian manufacturer offering to manufacture millions more doses.
·         Astrazeneca has delivered the most vaccines to lower income countries, sells at cost price, and has issued some voluntary licenses to other manufacturers. However, it has refused to openly share its knowledge and technology with WHO initiatives and has opposed the TRIPS Waiver.
·         Novavax has yet to be approved for use, but currently plans to provide almost two-thirds of its production to supply COVAX. However, like others, it has refused to share its knowledge and technology and has opposed the TRIPS Waiver.

Despite most companies receiving billions of dollars in government funding and advance orders, vaccine developers have monopolized intellectual property, blocked technology transfers, and lobbied aggressively against measures that would expand the global manufacturing of these vaccines. Their continued inaction has caused human rights harms suffered by the billions of people still unable to access a lifesaving Covid-19 vaccine.
100-day countdown
“Today marks 100 days until the end of the year. We’re calling on states and pharmaceutical companies to drastically change course and to do everything needed to deliver 2 billion vaccines to low and lower-middle income countries starting now. No one should spend another year suffering and living in fear,” said Agnès Callamard.
“Today marks 100 days until the end of the year. We’re calling on states and pharmaceutical companies to drastically change course and to do everything needed to deliver 2 billion vaccines to low and lower-middle income countries starting now.”
Agnès Callamard, Secretary General
To coincide with the publication of today’s report, Amnesty International is launching a global campaign – backed by the World Health Organisation and High Commissioner for Human Rights – to hold states and big pharma to account. The 100 Day Countdown: 2 billion Covid-19 vaccines now! is demanding that the World Health Organisation’s target of vaccinating 40% of the population of low and lower-middle income countries by the end of the year is met. We are calling upon states to urgently redistribute the hundreds of millions of excess doses currently sitting idle and for vaccine developers to ensure that at least 50% of doses produced go to these countries. If states and pharma companies continue down their current path, there will be no end in sight for Covid-19.

“Armed with billions of dollars of tax-payers money and expertise from research institutions, pharmaceutical companies have played a pivotal role in developing life-saving vaccines. But now they must take immediate action to provide billions more people with the chance to be inoculated. To achieve a fair and rapid roll-out, vaccine developers must prioritise deliveries to countries that need them most and suspend their intellectual property rights, share their knowledge and technology and train qualified manufacturers to ramp-up production of Covid-19 vaccines,” said Agnès Callamard.
As President Biden is set to announce new commitments to fight the coronavirus pandemic including fully vaccinating 70 percent of the world’s population by next September, at a summit today (22nd Sept), Agnès Callamard said:
“Covid-19 vaccines must be readily available and accessible for all. It is up to governments and pharma companies to make this a reality. We need leaders like President Biden, to put billions of doses on the table and deliver the goods, otherwise this is just another empty gesture and lives will continue to be lost.”
Amnesty International is also calling on states to ensure that health facilities and medicines, are available, accessible, acceptable and of good quality to everyone. They must adopt laws and policies to ensure pharmaceutical companies conform with human rights standards.
Amnesty International wrote to each company before publication. Five companies – AstraZeneca, Moderna, Pfizer, BioNTech and Johnson & Johnson – responded. The companies acknowledge that fair and equitable distribution, particularly in low-income countries, is essential, but all companies have failed to meet these aspirations and fulfil their human rights responsibilities.
Background
Amnesty International’s report did not assess in detail the Russian and Chinese companies that are producing billions of doses, as these companies disclose less corporate information. This lack of transparency makes it impossible to conduct a full assessment. However, like all companies, they also have human rights responsibilities. They, too, have not distributed their vaccines equitably, reserving the majority of doses for domestic consumption, and failed to join knowledge and technology sharing pools.
Data on the distribution of vaccines, projected production and revenue forecasts for each company was drawn from Airfinity, a data science company. Data on vaccination rates in different countries was taken from Our World In Data.
Using data from these sources, Amnesty has calculated that an additional 1.2 billion people in low and lower-middle income countries would need to be vaccinated by the end of the year to meet the WHO’s target of vaccinating 40% of the population in these countries. This would require over 2 billion vaccines. If just 50% of the world’s projected vaccine production until the end of the year was distributed to low and lower-middle income countries, it would provide 2.6 billion vaccines.
 
Arthur Stamoulis
Citizens Trade Campaign
(202) 494-8826
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