Moderna and the National Institutes of Health (NIH) are disputing who should get credit for a central piece of the company’s COVID-19 vaccine, The New York Times reported on Tuesday.
The biopharmaceutical firm and the government agency have spent years collaborating on vaccine development.
According to the NIH, three scientists at the agency’s Vaccine Research Center played a central role in designing synthetic genetic material that is key to how a person’s immune system responds to the vaccine.
But Moderna claims these scientists ‘did not co-invent’ the vaccine component. A patent application Moderna filed earlier in 2021 lists only its own scientists as inventors of the vaccine.
The conflict may impact the vaccine’s distribution.
If NIH scientists are listed on the patent, the federal government would have grounds to license the vaccine to manufacturing companies outside the U.S., potentially increasing global vaccine supply – and hurting Moderna’s profits.
Moderna and the NIH are in a dispute over credit for a central part of the company’s Covid vaccine, the New York Times reports. Pictured: Moderna’s headquarters in Cambridge, Massachusetts, photographed in May 2020
Dr Kizzmekia Corbett (left) and Dr Barney Graham (right) are two NIH scientists at the center of the dispute. Both collaborated with Moderna on mRNA technology prior to the pandemic
Moderna, a pharmaceutical and biotechnology company based in Cambridge, Massachusetts, did not bring a single commercial product to market before it developed a Covid vaccine.
The company’s vaccine development was aided by the U.S. government, which provided Moderna with almost $10 billion in taxpayer funding during the pandemic.
According to the Times, this includes about $1.4 billion to develop and test the vaccine and $8.1 billion to provide the U.S. government with millions of doses.
Overall, Moderna is set to bring in up to $18 billion in revenue this year – and it already has contracts in place to earn even more in 2022.
The company’s CEO, Stéphane Bancel, has become a billionaire during the pandemic, along with its chairman, co-founders, and an early investor.
Yet the company is seeking to maintain control of all future profits, through a dispute with the NIH over ownership of a key piece of the Moderna Covid vaccine technology.
Prior to the pandemic, Moderna and NIH scientists had worked together for several years on potential vaccine development, using mRNA to stabilize coronavirus spike proteins.
In fact, early news releases from the NIH referred to Moderna’s product as the ‘NIH-Moderna COVID vaccine.’
A December 2020 press release from the NIH celebrating the vaccine’s FDA authorization says that the product was ‘co-developed by investigators from Moderna and NIAID’s Vaccine Research Center.’
Three scientists at the Vaccine Research Center proved to be key parts of this collaboration, the Times reported: Dr John Mascola, Dr Barney Graham and Dr Kizzmekia Corbett.
Corbett has recently been lauded as a science communicator and a role model for black women seeking to enter science fields.
According to the NIH, all three scientists worked with Moderna to develop genetic material that allowed the Covid vaccine to trigger an immune system response.
The NIH maintains that these scientists should be named on Moderna’s patent application, according to The Times.
Yet Moderna filed a patent application in July 2021 that does not list these NIH scientists – it only lists Moderna employees.
Moderna said it had ‘reached the good-faith determination that these individuals did not co-invent’ the vaccine, according to The Times.
Moderna filed a patent application in July 2021 that only listed company employees, not NIH scientists. Pictured: A vial of Moderna’s vaccine, photographed in Thailand, November 2021
This filing was surprising to the NIH, as the agency has been working with Moderna to resolve this dispute for over a year.
‘NIH disagrees with Moderna’s inventorship determination,’ Kathy Stover, a spokeswoman for the NIH branch in charge of vaccine research, told The Times.
‘Omitting NIH inventors from the principal patent application deprives NIH of a co-ownership interest in that application and the patent that will eventually issue from it.’
Meanwhile, a Moderna spokesperson told the Times that ‘only Moderna’s scientists designed’ the vaccine.
Dr John Moore, a Cornell professor of microbiology and immunology who was not involved with the project, told The Times that this disagreement was a matter of ‘fairness and morality at the scientific level.’
Moore said that the NIH and Moderna had worked together for ‘four or five years.’
The vaccine credit dispute is about more than just ownership. If NIH scientists are listed on Moderna’s vaccine patent, then the federal government has a claim to the vaccine.
Such a claim would allow the government to license the tech to manufacturers in other countries – increasing vaccine supply around the world.
In addition, the NIH itself could make money from licensing the patent, which could be used for further research funding.
‘Patents are development monopolies, and in a pandemic it is a terrible idea to have a private corporation have a monopoly on part of a lifesaving technology,’ Zain Rizvi, drug policy expert at the advocacy group Public Citizen, told The Times.
Moderna has already faced criticism from the Biden administration and from global health advocates for failing to provide vaccines to low-income countries.
The company has sent a smaller percentage of its vaccines to low-income countries than any other vaccine provider.
Yet Moderna’s leadership has maintained that the company will not share its technology with other manufacturers.
‘Moderna wants exclusive ownership and control of this patent,’ Christopher Morten, a pharmaceutical patent law expert at Columbia Law School, told The Times.
‘They want to be the only organization that decides where mRNA-1273 is made, how it’s made, who makes it, what price it’s sold for.’
If the dispute with the NIH is not decided by the time the U.S. patent office issues a patent for Moderna’s vaccine technology, the federal government may choose to take Moderna to court.
Some health advocates would likely welcome such a lawsuit, as many have long said that the NIH fails to back down to pressure from the pharmaceutical industry.