Noubar Afeyan always keeps a plaque on his desk with the quote: “Trust your crazy ideas.”
The small Massachusetts company formed in 2010, with the hopes of leveraging messenger RNA technology.
Until the pandemic, it was relatively unknown. But in January 2020, when the coronavirus took center stage, Moderna used its mRNA technology to develop a highly effective vaccine against SARS-CoV-2. Now, Moderna is a household name.
Moderna’s newfound success, however, has also put the company in the hot seat over its handling of vaccine manufacturing and global access. Recent patent disputes are further amplifying a difficult question: What does Moderna owe the world during a deadly pandemic?
Many places have said they can make Moderna’s vaccine, critics say, but the company won’t share the technology. The World Health Organization is supporting an effort in South Africa to crack the recipe.
“We think that Moderna, in particular, has an obligation to do much more than it's currently doing to vaccinate the world.”
“We think that Moderna, in particular, has an obligation to do much more than it's currently doing to vaccinate the world,” said Robbie Silverman, a senior manager with Oxfam, the global, anti-poverty group.
Silverman argues that Moderna has an obligation beyond its bottom line because it would not exist without massive government support.
As omicron surges around the world, pressure is also mounting, including from some US lawmakers, for Moderna to more equitably distribute its vaccine, to share its vaccine technology and allow other manufacturers to independently produce the shots.
Over the past year, global demand has far outpaced the mRNA vaccine supply. Moderna produced between 700 million and 800 million doses in 2021 — lower than its initial projection. The company has made billions in profits.
As of late fall, about 1 million of Moderna’s vaccines had gone to low-income countries, with many middle-income countries still waiting on their orders, some of whom paid more than the US for those shots.
That’s in comparison to the 8.4 million Pfizer doses and 25 million single-shot Johnson & Johnson doses that have gone to low-income countries, according to Fortune.
Pfizer and BioNTech didn’t take US government aid for developing their shots but they worked with the Biden administration to expand vaccine supply around the world, and received nearly half a billion dollars from the German government.
“Unfortunately, up until this point, Moderna has really prioritized selling and providing its doses to the ‘global north’ — to rich countries like the United States and Europe, — and really has done very, very little to provide doses to low-income countries around the world.”
“Unfortunately, up until this point, Moderna has really prioritized selling and providing its doses to the ‘global north’ — to rich countries like the United States and Europe, — and really has done very, very little to provide doses to low-income countries around the world,” Oxfam’s Silverman said.
The company received at least $1 billion from the US government’s Operation Warp Speed to bring the vaccine from the lab to clinical trials to approval. That’s in addition to hundreds of millions of dollars in US government purchasing contracts for the vaccine.
Moderna collaborated with scientists from the federal National Institutes of Health to develop the vaccine.
Now, Moderna and NIH are in a patent dispute over ownership of the vaccine. Moderna recently paused its application, but Silverman alleges that the company has been vague about this conflict — even with shareholders.
Silverman said that this cuts to the heart of the issue: “Because if government scientists helped co-create the Moderna vaccine, that would give the United States much more leverage to do more to actually share the technology with other producers in other countries that desperately need it.”
Some experts say the Biden administration could try to require the company to share their intellectual property under the 1950 Defense Production Act, which gives the president a broad set of authorities to influence domestic industry in emergencies.
Oxfam filed a shareholders complaint against Moderna with the Securities and Exchange commission last month, alleging that the company failed to disclose the dispute to the SEC and shareholders and has published misleading statements on the subject.
Brendan Borrell, author of “The First Shots: The Epic Rivalries and Heroic Science Behind the Race to the Coronavirus Vaccine,” a book about the pandemic’s main vaccine developers, said it might be convenient to point the finger at Moderna, but the company can’t bear the full blame for the lack of global vaccine equity.
“I would be cautious to make the company out to be a hero or to be such a villain,” Borrell said.
Central to Moderna’s research and business model, since its beginnings, was to secure patents for what its scientists were doing and discovering.
“Moderna, was a very secretive company in the early days. That was part of their strategy,” Borrell said. “They were a patent-filing machine, I was told.”
This is to be expected in the world of biotech. That way, no one else can make the same product without getting a license from the patent holder, without paying for it. And vice versa. The idea is this encourages big financial risks and innovation.
Moderna did not respond to The World’s request for comment. In an interview last month with Rewired, the company’s CEO, Stefan Bancel, said he couldn’t speak about ongoing disputes.
He said the company has done a lot in the global response.
“As you can imagine, we have been working literally seven days a week since January of 2020, that isn’t a long time to get as many doses as we can out,” Bancel said. “It usually takes three to four years, as everybody knows, to be the manufacturing plant for pharmaceutical products. And there was no such mRNA plant that existed at the time.”
Thomas Cueni, director of the International Federation of Pharmaceutical Manufacturers and Associations, said that Moderna and other manufacturers are scaling up more now.
Last year, it was tough, he said, due to shortages of raw materials and countries imposing export bans on vaccines and other needed supplies.
“Vaccine manufacturing, in particular, biological manufacturing, is extremely challenging. We have seen so many bumps and hitches, but looking overall, we see the biggest vaccination effort in the history of mankind.”
“Vaccine manufacturing, in particular, biological manufacturing, is extremely challenging,” Cueni said. “We have seen so many bumps and hitches, but looking overall, we see the biggest vaccination effort in the history of mankind.”
Manufacturers have managed to produce more than 11 billion vaccines in 2021, but the inequitable distribution is shameful and embarrassing for everyone, Cueni said at a recent forum.
The world lacks a coordinated vaccine distribution system. The onus is also on wealthy countries, he said, to share the doses they’ve reserved.
Despite pledges and targets, only 7% of people in low-income countries have received a single dose, according to an upcoming report from Amnesty International, which described the situation as a catastrophic failure by pharmaceutical companies and wealthy nations alike.
As for Moderna, what it may owe the world during a pandemic might need to get settled on the global stage.
Editor's note: This report reflects the Jan. 3 broadcast date and is subject to change as COVID-19 scenarios evolve quickly.
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