The Biden administration may possess unilateral rights to the biochemical makeup and manufacturing process of the Moderna COVID-19 vaccine, a new report from advocacy group Public Citizen asserts. In a 2020 contract with Moderna, a division of the Department of Health and Human Services agreed to bankroll much of the vaccine development and manufacturing process, partially in exchange for “access to all documentation and data generated under this contract.” That documentation and data likely include the vaccine “recipe” and manufacturing process, the report finds.
Disseminating that data would allow countries with fewer or less effective vaccines available to begin the process of manufacturing the Moderna jab, an important step in getting the worldwide pandemic under control, especially as the European Union continues to resist Joe Biden’s push for a temporary intellectual property waiver for COVID-19 vaccines.
Wealthy vaccine-manufacturing countries like Germany, France, and the United States have pledged to fully vaccinate their own populations while also sharing doses with the developing world. But it’s not clear that a sufficient number of doses currently exist for them to make good on this promise. The European Union, for example, is on track to fall far short of its goal of donating 200 million doses to nonmember states by the end of the year. And, as of August, COVAX, the World Health Organization’s (WHO) vaccine sharing initiative, had distributed 188 million vaccines worldwide, just 19 percent of the 1.1 billion the WHO says are needed to end the pandemic.
The more people that remain unvaccinated worldwide, the likelier it is that new variants will emerge, endangering vaccinated and unvaccinated alike.
The Biden administration’s strategy for expanding worldwide vaccine access has largely relied on pushing for vaccine patent waivers through negotiations at the World Trade Organization (WTO). But those negotiations have been stymied by strong opposition from member states of the European Union, meaning that unilateral American action may be necessary to expand vaccine access on the necessary scale.
Legally, the United States may already have the ability to do so. The terms between Moderna and the federal government specify that the government possesses rights to the vaccine technology developed under the contract, meaning that it can unilaterally publish or share the data with anyone. Furthermore, an essential component of the Moderna vaccine was invented and patented by US government researchers, meaning that the government could threaten a patent infringement suit against Moderna if the company refuses to share its vaccine know-how.
“Moderna did not invent the vaccine by itself,” said Zain Rizvi, law and policy researcher at Public Citizen and author of the report. “This private corporation learned how to scale up and scale out manufacturing on the taxpayers’ dime. Public dollars should come with public obligations.”
Moderna’s stock price has increased from $30 in March 2020 to $425 today.
Government Rights to Vaccine Know-How
Countries such as South Korea have expressed eagerness for the intellectual property (IP) that would allow them to make vaccines, and they are confident that their manufacturing sectors will be able to exploit it. But efforts to secure it have been rebuffed by the American government, Korean officials say.
“We have asked Washington to transfer technology for vaccine production, but US officials said it is something that should be decided by the private sector,” one Korean official told the Financial Times.
Korean biotech companies are poised to make significant investments in increasing the country’s vaccine manufacturing capacity. Making the Moderna production data available could provide a boost to these efforts.
The question at the heart of his report, Rizvi said, is whether all of the data essential to the vaccine manufacture process is covered by the government’s contract. Parts of the process may have been developed before the contract went into effect or may be outside of the contract’s purview. The federal government would have only “limited” rights to this data and would need to compensate Moderna for its use.
While Rizvi’s analysis argues that the government possesses “unlimited” rights to all necessary data, his report’s scope was limited by a lack of transparency in the government’s contract with Moderna, he admits. “The part of the contract that says what is limited-rights data is redacted. That’s a big problem, and the US government should clarify the scope of the rights it may hold,” he said.
But judging from what is publicly available, it seems likely that the government possesses significant rights to the vaccine data.
This is true of the Moderna vaccine because, unlike most other COVID-19 vaccine makers, Moderna was not a large pharmaceutical company before becoming a major vaccine supplier — in 2019, it produced fewer than one hundred thousand doses across all of its products.
The contract between Moderna and the US government included federal support for increasing mRNA vaccine manufacture and expanding it to many more locations — meaning that the technology for how to do those things may be part of the data to which the US government possesses unlimited rights.
“Based off of publicly available records, we can tell that the US government made pivotal contributions to Moderna’s scaling up and scaling out process,” Rizvi said. “These were not just minor modifications. They were substantial contributions.”
The contract also required Moderna to provide the government with copies of documents submitted to the FDA that include the chemical recipe for the vaccine, a component as necessary as the technical know-how, states the report.
Moderna is unlikely to respond favorably to a claim that their most valuable intellectual property is co-owned by the US government. “They’ll argue that some of the technologies that were used to develop the vaccine were things they’d already developed in earlier years . . . that the government had fewer rights in,” said James Love, director of Knowledge Ecology International, a nonprofit that researches intellectual property rights in health care technology.
Should those arguments prevail, some purchase of Moderna’s intellectual property may be necessary. “There’s still space for buyouts to acquire what you don’t get through all those other measures,” Love said.
Moderna did not respond to a request for comment.
Secret Trump Deals?
It’s also possible that Alex Azar, a former pharmaceutical executive who served as Donald Trump’s secretary of Health and Human Services, signed away the government’s vaccine rights to Moderna. Without access to the unredacted contract, it’s difficult to know for sure.
But even if the Trump administration gave away the US government’s rights in the Moderna vaccine, the government possesses another point of leverage: patent rights over a key vaccine component. In 2016, a team of researchers working for the US government, Dartmouth College, and the Scripps Research Institute developed and patented a technology for producing antibodies that neutralize coronavirus spike proteins — a piece of molecular engineering essential in the development of the COVID-19 vaccines.
Moderna and other pharmaceutical companies, including Pfizer-BioNTech and Johnson & Johnson, used this technology in developing its vaccines, but only Pfizer-BioNTech acquired the rights to the patent. This means that the threat of a patent infringement suit could be used to convince Moderna to share its vaccine tech, said Christopher Morten, a law professor Columbia University.
“It’s an extra tool the US government has to cut a meaningful deal with Moderna,” Morten told us. “In exchange for waiving potentially multibillion-dollar liability that Moderna faces for using the US government’s tech without its permission, the US government could get Moderna to commit to sharing its process with the WHO.”
Chemical and technical know-how aren’t the only obstacles to wider vaccine manufacturing. Even if the US government were to publish the data, some level of collaboration with Moderna might still be necessary to ensure that vaccines were being produced safely. “You really need to have deep technology transfer,” Love said. “People need to walk you through it and hold your hand, show you how things are actually done, and certify that you’re doing it the same way.”
And material obstacles might arise as well. Shortages of both specialized biochemical products like lipid nanoparticles, essential to the manufacture of mRNA vaccines, and more prosaic items like glass vials could make it difficult to increase vaccine production on a global scale, even if all necessary knowledge became public.
But while kinks in the supply chain might initially present obstacles, they’re likely not insurmountable. “I think the bottlenecks on inputs are kind of an exaggerated problem,” Love said. “In the short run, there are all kinds of supply problems and spikes in prices, and you can’t get what you need. But as prices rise, markets respond fairly fast.”