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Moderna Refuses to Share Vaccine Recipe With Africa as Omicron Rises

Moderna projects $18 billion in sales as a handful of countries block an international patent waiver for vaccines.

An employee at the Afrigen biotechnology company and Vaccine Hub facility works in the manufacturing laboratory in Cape Town, on October 5, 2021.

As debate over a proposal to temporarily waive intellectual property protections for COVID vaccines and treatments continues to stall at the World Trade Organization (WTO), members that remain opposed — including the United Kingdom, Switzerland and the European Union — are increasingly being accused of violating human rights on an international scale.

Calls for the WTO to approve the so-called TRIPS waiver for vaccine patents and manufacturing technology are reaching a fever pitch with the emergence of the Omicron variant that was first identified in South Africa. Omicron has prompted travel bans across the world and inflamed tensions over massive global disparities in vaccine access, which experts and advocates have warned for months would allow the virus to mutate and spread outward from lower-income countries where vaccines remain out of reach for most people.

Yet Moderna and other pharmaceutical companies are not sharing “recipes” for COVID vaccines with a South African biotech firm and a World Health Organization (WHO) effort to transfer the technology necessary for making mRNA vaccines to African nations, where only about 1 in 10 people have received at least one dose of the vaccine. In the United States and Europe, monopolies on the crucial technology and know-how needed to make vaccines largely remains controlled by private pharmaceutical companies that received billions of dollars from wealthy governments to develop vaccines — and are now pulling in billions in global profit.

“The spread of new variants is the direct result of the staggering inequitable access to vaccines, therapeutics, diagnostics and other products needed to treat and contain the COVID-19 pandemic,” said Sangeeta Shashikant, a policy advisor for the Third World Network, in a call with reporters last week. “Intellectual property monopolies are causing the inequity.”

Leaders of the Global Nurses Union, which represents 2.5 million health care workers in 28 countries, and the left coalition Progressive International sent a letter to the UN Human Rights Council on Monday decrying global “vaccine apartheid” and demanding an investigation into the countries that continue to block the TRIPS waiver at the WTO. The pandemic has caused a “staggering” number of deaths, the labor and political leaders wrote, with hundreds of thousands of frontline health care workers among them.

“It is now clear: Continued opposition to the patent waiver is resulting in the violation of human rights of peoples across the world,” they wrote.

The Council of Global Unions, which represents some 200 million workers worldwide, also released a statement on Monday urging the U.K., Switzerland, the European Union and Germany to drop their opposition. Critics and U.S. lawmakers have said the EU is representing Germany and the interests of its entrenched pharmaceutical industry by opposing the TRIPS waiver. Last week, human rights attorneys threatened to take legal action under international human rights law if the governments of Norway, Germany, the U.K. and Canada refuse to support the waiver.

“Not only is Switzerland blocking the waiver, but our government is being very non-transparent about its contracts with Big Pharma, such as Moderna,” said Stefanie Prezioso, a progressive Swiss lawmaker and associate professor at Lausanne University, during a press conference on Monday.

In what observers call an ironic twist, a meeting of WTO trade ministers with vaccines on the agenda was postponed this week due to Omicron and new travel restrictions in Switzerland, which hosts WTO meetings in Geneva. Advocacy groups demanded the meeting be postponed because trade ministers from countries in need of vaccines are unable to attend. WTO leaders said negotiations would continue, and the WTO council on intellectual property rights met on Monday.

The conditions in which variants such as Omicron can flourish could have been avoided if the WTO adopted the waiver when it was introduced back in 2020, according to Deborah James, an international trade expert at the Center for Economic and Policy Research. By now, manufacturers would have scaled up the production of generic jabs for distribution in lower-income countries, if a waiver were in place. Still, a ministerial meeting is not needed to approve the waiver, and James said the WTO General Council could do so “this week.”

“You couldn’t make this up if it were a novel,” James said in an interview. “It just shouldn’t be a trade organization that is deciding these things. You know the WTO has a default of always making decisions in favor of corporations.”

As Omicron appeared with its many mutations, the World Health Organization, a South African biotech firm and Africa Centres for Disease Control and Prevention were already rushing to create an mRNA vaccine technology “transfer hub” as part of an effort to replicate Moderna’s vaccine and allow African countries to create their own supply of shots. South Africa’s vaccination rate, just under 25 percent of the population, lags behind most wealthy nations but is still among the highest in Africa.

The biotech company working with the WHO, Afrigen Biotech, hopes to create a vaccine that is less expensive than Moderna’s, which does not require freezers for storage, making doses easier to distribute in lower-income countries, according to the Washington Post. Citing intellectual property protections, Moderna is not sharing its vaccine recipe and other know-how with Afrigen and the WHO technology hub, which would allow Afrigen to develop a generic vaccine much faster. Afrigen would also compete with Moderna in largely untapped markets in lower-income nations. A spokesperson for Moderna did not respond to a request for comment by the time this article was published.

In October 2020, India and South Africa introduced a WTO resolution that would temporarily waive international intellectual property rules for COVID vaccines and treatments. That resolution is now supported by about 100 countries. Proponents say the waiver would allow manufacturers in both countries to create a broad supply of generic vaccines and help lower-income countries negotiate with existing manufacturers.

Wealthy nations have procured nearly 7 billion vaccines while low-income countries have access to about 300 million, according to the Duke Global Health Innovation Center.

Currently, South African and Indian vaccine makers operate under strict licensing agreements with pharmaceutical companies from wealthy nations that invested heavily in development. In some cases, these agreements forced both countries to export doses to wealthier countries instead of serving their own populations.

President Joe Biden said on Friday that he supports a waiver for vaccine patents at the WTO. However, critics note the U.S. has not backed India and South Africa’s proposal specifically, and say intellectual property protections for COVID tests and treatments must also be waived. Biden has repeatedly said that the U.S. has donated more jabs globally than any other nation, but Democrats in Congress have criticized the White House for not doing more to promote the TRIPS waiver during talks with Germany and the EU.

Facing criticism from activists and health groups across the globe, the EU has responded by emphasizing existing flexibilities in the WTO’s international patent rules such as compulsory licensing, which allows a country to issue licenses for making vaccines without permission from patent holders. However, health experts say the EU’s COVID proposals at the WTO do not go far enough, and a blanket waiver is needed for countries to move quickly in making generic vaccines and other supplies without facing legal and regulatory roadblocks in acquiring technology and know-how along the way.

Moderna, for example, has said it won’t prosecute intellectual property violations during the pandemic and plans to build its own vaccine plant somewhere in Africa, but critics say these pledges still fall short of openly sharing the vaccine recipe and other trade secrets with independent efforts to boost manufacturing capacity. Earlier this year, Moderna projected up to $18 billion in sales for 2021 of its mRNA vaccine as billions of people continue to wait for access, according to Doctors Without Borders. Moderna’s vaccine also benefited from a nearly $10 billion investment from the U.S. government, and the company is currently haggling with scientists at the National Institutes of Health over who can take credit for the vaccine.

Opponents of the waiver say intellectual property rules are needed to protect investments in research and development and streamline vaccine production, but supporters say much of the world now agrees that patent monopolies are driving the disparities in vaccine access that allow variants like Omicron to emerge and spread.

“It’s like everybody against [a few] WTO members — EU, Switzerland, Norway and the U.K. — representing the interests of billionaires to become multibillionaires, and so that billionaires can become multibillionaires, millions of people are going to die,” James said in an interview.

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