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Tuesday, January 25, 2022

Will Moderna Ever Learn to Share?

Who invented mRNA-1273, the COVID-19 vaccine? That is the subject of a newly public dispute between Moderna and the National Institutes of Health (NIH), an issue that one of us recently brought to light in the public realm. For over a year, the NIH has been in discussions with Moderna about naming three of their scientists on a core patent application that covers the vaccine genetic sequence. Moderna has so far denied this request. We found evidence of this in an August 2020 patent filing, in which the company claimed that it had in “good faith” determined that these NIH scientists had not co-invented the technology. The NIH has since said it considers Moderna’s exclusion of their scientists from this patent application “a serious mistake” and has entered into discussions with the manufacturer with support from attorneys in the Department of Justice to resolve this dispute.

The COVID-19 vaccine represents one of the most important medical inventions of the century. Properly acknowledging the contribution of the federal government is central to understanding the role of the public sector in driving the development of these vaccines. But it’s not just scientific credit at stake. Given the pivotal role of the NIH researchers and taxpayer funding in the development mRNA-1273, we believe it is imperative for the U.S. government to exercise more control over the production and pricing of this vaccine.

Since its earliest days, Moderna has benefited immensely from public sector science. Moderna’s founders named the company over the concept of modifying RNA (modified + RNA = Moderna) — a concept pioneered by NIH-funded researchers at the University of Pennsylvania. After Moderna was launched, the company received its first infusion of funding from the federal government when it had just three employees. The Department of Defense played an important role in de-risking mRNA technology, and signaling its promise to private investors. After the Zika virus emerged, the federal government invested another $100 million.

This close collaboration with the federal government eventually led to its partnership with the NIH. Moderna worked with government scientists for years to develop vaccine candidates for other viruses. When the pandemic began, they shifted focus to COVID-19. NIH researchers worked closely alongside Moderna to invent and develop the vaccine, calling it from the start the “NIH-Moderna vaccine.” The NIH claims it sent Moderna the sequence used in its vaccine. But Moderna says it invented the sequence independently, leading to the current patent dispute.

However, it is unquestionable that Moderna received huge federal support. Besides providing research personnel and expertise as well as an extensive clinical trials network from the NIH towards accelerating the development of an effective COVID-19 vaccine, Moderna also received nearly $10 billion in funding from the U.S. government. In addition to dose purchases, these funds underwrote the development of the vaccine and helped the fledgling company establish production capacity. NIH scientists and federal funding have continued to support ongoing clinical trials of Moderna’s vaccines, including for booster shots.

Despite this enormous contribution every step of the way, Moderna has been allowed to exclusively control decisions about vaccine production and pricing. Not only has Moderna shipped 90% of its vaccines to wealthier countries — prioritizing orders for booster shots ahead of low-income countries with less than 8% of their populations having received even a single dose of a COVID-19 vaccine — but also, countries in Africa and Asia have reportedly bought the vaccine for close to $29 per dose, a much higher price than what some wealthy countries paid. And because of this monopoly control over who to supply vaccine doses to and for what price, Moderna has been estimated to be making $1,000 in profit every second.

The U.S. government must step up. Getting federal scientists named on the core mRNA-1273 patent application is a start. If the U.S. were listed as a co-inventor and co-owner on the application, the federal government could allow other manufacturers to use the invention without Moderna’s permission, eliminating one barrier to future production. But to rapidly and comprehensively increase production in the short-term, much more is needed. The federal government can use the Defense Production Act to require Moderna to share technology with other manufacturers to help ramp up global mRNA vaccine production.

For example, the World Health Organization is currently establishing a technology transfer hub in South Africa to create its own NIH-Moderna COVID-19 mRNA vaccine. However, despite pleas from the organization to share the technology to help shorten the production timeline by years, Moderna has refused to do so.

In a recent panel on global vaccine access, David Kessler, MD, the chief science officer of the White House COVID-19 Response Team, pressed Moderna to do more on global access, and stated that the resolve of the U.S. government should not be underestimated. We hope this includes bringing vaccines, including the NIH-Moderna vaccine, to the world. Only then can we begin to see the end of the pandemic for everyone, everywhere.

Reshma Ramachandran, MD, MPP, is a physician-fellow at the National Clinician Scholars Program at Yale School of Medicine. She sits on the board for Universities Allied for Essential Medicines North America who co-hosts the Free the Vaccine campaign. Zain Rizvi, JD, is a research director at Public Citizen’s Access to Medicines Program.

Last Updated November 24, 2021

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Patricia Smith
I like to dream big. I like to dream big. My family is very important for me. My unusual hobby is cheese making. My best qualities are patience and creativity.

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