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 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 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. named the company over the concept of modifying RNA (modified + RNA = Moderna) -- a concept pioneered by at the University of Pennsylvania. After Moderna was launched, the company received its first from the federal government when it had just . The Department of Defense played an important role in de-risking , and signaling its promise to private investors. After the Zika virus emerged, the federal government .
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 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 from the NIH towards accelerating the development of an effective COVID-19 vaccine, Moderna also 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 of Moderna's vaccines, including for .
Despite this enormous contribution , Moderna has been allowed to exclusively control decisions about vaccine production and pricing. Not only has Moderna shipped to wealthier countries -- prioritizing orders for booster shots ahead of low-income countries with 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 , 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 .
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 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 to create its own NIH-Moderna COVID-19 mRNA vaccine. However, despite pleas from the organization to to help shorten the production timeline by years, Moderna has refused to do so.
In a 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.
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 campaign. is a research director at Public Citizen's Access to Medicines Program.