The Biden administration may have unilateral rights to the biochemical makeup and manufacturing process of the Moderna COVID-19 vaccine, says a new report from the advocacy group Public Citizen. In a 2020 contract with Moderna, a division of the Department of Health and Human Services agreed to fund much of the vaccine development and manufacturing process, in part in exchange for “access to all documentation and the data generated within the framework of this contract ”. That documentation and data likely includes the “recipe” and process for making the vaccine, according to the report.
The dissemination of this data would allow countries with fewer or less effective vaccines to begin the process of manufacturing the Moderna jab, an important step in bringing the global pandemic under control, especially as the European Union continues to resist the pressure. by Joe Biden for temporary intellectual property. waiver for COVID-19 vaccines.
Wealthy vaccine-producing countries like Germany, France and the United States have pledged to fully immunize their own populations while sharing doses with the developing world. But it is not clear that a sufficient number of doses currently exist to keep this promise. The European Union, for example, is on track to fall short of its target of donating 200 million doses to non-member states by the end of the year. And, by August, COVAX, the World Health Organization’s (WHO) vaccine-sharing initiative, had distributed 188 million vaccines globally, just 19% of the 1.1 billion that the WHO said , are necessary to end the pandemic.
The more unvaccinated people there are in the world, the more likely it is that new variants will emerge, endangering both the vaccinated and the unvaccinated.
The Biden administration’s strategy to expand access to vaccines globally has relied heavily on promoting vaccine patent waivers through negotiations at the World Trade Organization (WTO). But those negotiations have been hampered by strong opposition from European Union member states, meaning unilateral US action may be needed to expand access to vaccines on the scale needed.
Legally, the United States may already have the capacity to do this. Terms between Moderna and the federal government state that the government owns the rights to the vaccine technology developed under the contract, which means it can unilaterally publish or share the data with anyone. Additionally, an essential component of the Moderna vaccine was invented and patented by U.S. government researchers, which means the government could threaten patent infringement action against Moderna if the company refuses to share its know-how. in terms of vaccines.
“Moderna did not invent the vaccine on his own,” said Zain Rizvi, law and policy researcher at Public Citizen and author of the report. “This private company has learned to scale up and increase manufacturing with the taxpayer’s penny. Public money should be accompanied by public obligations.
Moderna’s share price has gone from $ 30 in March 2020 to $ 425 today.
Countries like South Korea have expressed enthusiasm for the intellectual property (IP) that would allow them to manufacture vaccines, and they are confident their manufacturing sectors will be able to exploit it. But efforts to secure it have been rejected by the US government, Korean officials say.
“We asked Washington to transfer the technology for vaccine production, but US officials said it was something that should be decided by the private sector,” a Korean official told Financial Time.
Korean biotech companies are poised to make significant investments to increase the country’s vaccine manufacturing capacity. Making Moderna’s production data available could give these efforts a boost.
The question at the heart of his report, Rizvi said, is whether all data essential to the vaccine manufacturing process is covered by the government contract. Parts of the process may have been developed before the contract came into effect or may be outside the scope of the contract. The federal government would only have “limited” rights to this data and would have to compensate Moderna for its use.
While Rizvi’s analysis argues that the government has “unlimited” rights to all necessary data, the scope of his report was limited by a lack of transparency in the government’s contract with Moderna, he admits. “The part of the contract that says what restricted data is is censored. This is a big problem, and the US government should clarify the scope of the rights it can hold, ”he said.
But judging from what is publicly available, it seems likely that the government has significant rights to vaccine data.
This is true for the Moderna vaccine because, unlike most other COVID-19 vaccine manufacturers, Moderna was not a large pharmaceutical company until it became a major vaccine supplier – in 2019 it produced less than 100,000 doses for all of its products.
The contract between Moderna and the U.S. government included federal support to increase mRNA vaccine manufacturing and expand it to many other places, meaning the technology to do these things may be part of the data the government has to do. American has unlimited rights.
“Based on the publicly available documents, we can say that the US government has made a critical contribution to the process of scaling up and scaling Moderna,” said Rizvi. “These weren’t just minor changes. These are 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 technical know-how, the report says.
Moderna is unlikely to respond favorably to a claim that its most valuable intellectual property is co-owned with the US government. “They will say that some of the technologies that were used to develop the vaccine were things that they had already developed in previous years. . . that the government had fewer rights, ”said James Love, director of Knowledge Ecology International, a nonprofit that studies intellectual property rights in health technologies.
If these arguments prevail, some purchase of Moderna’s intellectual property may be necessary. “There’s still room for buyouts to acquire what you don’t get through all of these other measures,” Love said.
Moderna did not respond to a request for comment.
It’s also possible that Alex Azar, a former pharmaceutical executive who served as Donald Trump’s Health and Human Services secretary, ceded the government’s vaccine rights to Moderna. Without access to the unwritten contract, it is difficult to know for sure.
But even though the Trump administration has ceded the US government’s rights to the Moderna vaccine, the government has another lever: patent rights to a key component of the vaccine. In 2016, a team of researchers working for the U.S. government, Dartmouth College, and the Scripps Research Institute developed and patented technology to produce antibodies that neutralize advanced coronavirus proteins – a piece of molecular engineering essential for development. COVID-19 vaccines.
Moderna and other pharmaceutical companies, including Pfizer-BioNTech and Johnson & Johnson, have used this technology to develop their vaccines, but only Pfizer-BioNTech acquired the rights to the patent. This means that the threat of patent infringement action could be used to convince Moderna to share its vaccine technology, said Christopher Morten, professor of law at Columbia University.
“This is one more tool the US government has to make a meaningful deal with Moderna,” Morten told us. “In return for waiving the potentially multibillion-dollar liability that Moderna faces for using US government technology without his permission, the US government could get Moderna to commit to sharing its process with the WHO. . “
Chemical and technical know-how are not the only obstacles to wider vaccine manufacture. Even if the U.S. government released the data, some level of collaboration with Moderna might still be needed to ensure vaccines were produced safely. “You really need a deep technology transfer,” Love said. “People have to guide you and hold your hand, show you how things are actually done and certify that you do it the same way. “
And material obstacles could also arise. Shortages of both specialized biochemicals like lipid nanoparticles, essential in the manufacture of mRNA vaccines, and more prosaic items like glass vials could make it difficult to increase vaccine production globally. , even if all the necessary knowledge became public.
But while flaws in the supply chain may initially present obstacles, they are probably not insurmountable. “I think the bottlenecks on inputs are an exaggerated problem,” Love said. “In the short term, there are all kinds of supply issues and price hikes, and you can’t get what you need. But as the prices rise, the markets react quite quickly. “