Moderna has pledged never to enforce its coronavirus vaccine patents in selected low- and middle-income countries and is launching a new initiative to give external researchers access to its technology.
The announcement comes amid increasing pressure on the U.S. biotech firm, which pulled in more than $12 billion in 2021, to share its technology with initiatives aimed at increasing vaccine manufacturing capacity in low- and middle-income countries.
“It’s a very big announcement,” CEO Stéphane Bancel told POLITICO in an interview. Bancel was visibly excited when he explained that for years his team been working on various infectious diseases but as a small company they had been limited in what they could do. The runaway success of their mRNA coronavirus vaccine has opened new doors. “We want to make sure that we have all the tools to provide the world with a much better response, if God forbid something happens again,” said Bancel.
The mRNA access initiative is about giving academic and government scientists around the world access to the company’s technology so they can develop vaccines targeting neglected diseases or a potential unknown “Disease X.”
The patent pledge expands on Moderna’s previous commitment to not enforce its patents on its coronavirus vaccines during the coronavirus pandemic. But it comes with two caveats — it’s only for coronavirus vaccines and only applies to 92 countries identified through the COVAX vaccine distribution mechanism. That means it doesn’t include some middle-income countries like Botswana and Brazil.
Bancel’s promise followed Moderna’s announcement Monday that it would site a $500 million vaccine production facility in Kenya, after signing a memorandum of understanding with the government. The plant would be capable of making up to 500 million doses of mRNA vaccines a year.
The flurry of news comes ahead of a gathering of global health leaders in London on Tuesday, at which the Coalition for Epidemic Preparedness Innovations (CEPI) will launch a drive to raise $3.5 billion in funding to back its strategy of readying an effective vaccine against a new pathogen within 100 days.
Amazon for vaccines
Moderna’s mRNA vaccine access project is futuristic. Through the program, a scientist, say at the Pasteur Institute in Dakar, inputs an amino acid sequence on Moderna’s website for the vaccine they hope to develop against, say, Lassa fever. They click “order” and, in the U.S., Moderna would make that drug substance and send it back to the lab in Senegal. The researcher would be free to conduct studies and publish research on it, explained Bancel.
If researchers want to go further, Moderna will make the clinical-grade vaccine and on a “case-by-case basis” discuss taking it forward into trials. Moderna plans to expand its vaccine program, and aims to target 15 pathogens including Ebola, TB, HIV, Zika and malaria.
Moderna will retain ownership of its technology, but the researcher will own the biology of the vaccine, said Bancel.
The announcement goes some way toward answering the call for pharmaceutical companies to come to the table with practical solutions to prevent the vastly inequitable distribution of vaccines during the current pandemic from ever happening again. But there are limits to Moderna’s commitments.
The pledge to never enforce patents related to its coronavirus vaccine is restricted to only coronavirus jabs and only applies to certain countries. However, the World Health Organization’s mRNA hub in South Africa will be party to this pledge, despite South Africa not being included in the list of countries the pledge applies to, Moderna confirmed to POLITICO. Where the pledge will be less useful is with the hub’s broader vision, as it has made clear it wants to be able to use the technology behind its vaccine for future non-coronavirus jabs.
Explaining the reasoning for limiting the pledge to coronavirus vaccines, Bancel said that the pandemic was “an exceptional historic event.”
“As you can imagine, we’re investing a lot in R&D,” he said, explaining that it was important for Moderna to earn a return on the investments it makes on other products.
As for the broader call for an intellectual property rights waiver for coronavirus products that’s being blocked at the World Trade Organization, Bancel said that if the patent waiver happened ten years ago “most probably Moderna and BioNTech would not have existed the way they existed.”
“Think about it — before we had one penny of sales, we raised $4 billion that we invested in science,” he said. “Who would invest in biotech companies in the future if they had no certainty that they could get a return if the science works?”
While Moderna hasn’t ruled out working with manufacturers in countries outside the 92 it has identified on “commercially reasonable terms,” Bancel said that working with the WHO’s mRNA hub is “not a good use of our time.”
“We’re still a small company, and we have 44 programs in development. And so if I need to send engineers to the mRNA hub, I need to be explaining which product I’m not going to do or delay,” he said. “Do you want me to delay a cancer drug or a rare disease drug for kids or a CMV [cytomegalovirus] vaccine to prevent birth defects in a pregnant woman getting infected by this virus?”
With the world on course to soon have an oversupply of coronavirus vaccines, Bancel sees the mRNA hub as a “nice to have, not a must have.”
This article is part of POLITICO’s premium policy service: Pro Health Care. From drug pricing, EMA, vaccines, pharma and more, our specialized journalists keep you on top of the topics driving the health care policy agenda. Email [email protected] for a complimentary trial.