Should the US government share the Moderna COVID vaccine recipe?

Regulatory NewsRegulatory News | 29 September 2021 |  By 

As much of the developing world struggles to gain access to COVID-19 vaccine doses, some legal experts say the key lies in having the US government share the step-by-step instructions for manufacturing and testing the Moderna mRNA vaccine with other manufacturers.
In a recent Health Affairs blog, Christopher J. Morten, Zain Rizvi, and Ameet Sarpatwari made the case that the US government, through its contract with Moderna, has both access to the details of how the vaccine is made and the legal authority to disclose the information.
“The contract, executed in April 2020, provided Moderna with hundreds of millions of dollars to build its manufacturing capacity. In exchange, Moderna agreed to share knowledge of its manufacturing process with HHS and agreed to give the U.S. government contractually defined ‘unlimited rights’ to use, reproduce, and share knowledge funded under the contract,” Morten, an associate clinical professor of law at Columbia University, and his co-authors wrote.
That contract has been redacted so it’s not possible to interpret the “unlimited rights” phrase conclusively, the authors said, but they called on the Biden Administration to clarify the agreement. Further, if the contract does not give the US government the authority to access and share the necessary information, the Biden Administration could invoke the Defense Production Act to do so, they said.
Global vaccine demand
While there is currently plenty of vaccine supply to meet demand in the US and other developed countries, low-income countries need billions more doses of COVID-19 vaccines. As of mid-September 2021, 5.5 billion vaccine doses had been administrated globally but 80% of them went to high- and upper-middle income countries, according to the World Health Organization (WHO). Due to the lack of supply in low-income countries, just 1.5 vaccine doses have been administered for every 100 people. Africa, for instance, has received 2% of the global vaccine doses administered.
“The longer vaccine inequity persists, the more the virus will keep circulating and changing, the longer the social and economic disruption will continue, and the higher the chances that more variants will emerge that render vaccines less effective,” WHO-Director-General Dr. Tedros Adhanom Ghebreyesus said at a 14 September 2021 press conference.

Morten agreed that the need for technology transfer on vaccine manufacturing is "urgent" and could be put to immediate use. In South Korea, for example, there is unused manufacturing that could be dedicated to COVID-19 vaccine production if the technology were accessible to them, he explained. "We've seen leaders all over the world ask for this," Morten told Focus
Return on investment
The US government is well positioned to ease the global vaccine shortage through technology transfer, specifically by sharing the Moderna mRNA vaccine recipe, Morten and his co-authors argued. The National Institutes of Health (NIH) was a co-inventor of the Moderna vaccine, with the federal government funding the vaccine’s clinical trials and bankrolling the scale-up of Moderna’s manufacturing, with total investments of more than a billion dollars, they wrote.
“American taxpayers helped bring vaccines to development in record time,” Morten and his co-authors wrote. “Now, President Biden has the opportunity to bring vaccines to the world. He can begin by taking a simple yet powerful step: disclosing the vital vaccine manufacturing information the U.S. government has already paid for and already holds.”
The blog post builds on a detailed case laid out by Public Citizen in August 2021, which was authored by Rizvi, a law and policy researcher at the organization, and reviewed by Morten. Public Citizen explains that the government has access to information essential to producing the Moderna mRNA vaccine, including chemical characteristics, raw material sources, manufacturing steps, testing procedures, process control and specifications. Additionally, the group makes the argument that the federal government has the legal authority — through the contract with Moderna, its own coronavirus-related technology patent, and the Defense Production Act — to share this vaccine recipe with manufacturers seeking to make the vaccine in low-income countries.
In October 2020, Moderna announced that it would not enforce its COVID-19 related patents for anyone making vaccines to combat the pandemic and that it would license intellectual property for its COVID-19 vaccine for the post-pandemic period. However, Morten and his co-authors note that Moderna has so far failed to disseminate its vaccine recipe. The company did not respond to a request for comment by press time.
Health Affairs Blog

Editor's note: This article was updated on 29 September to include comments from Columbia's Christopher Morten. 


© 2023 Regulatory Affairs Professionals Society.

Tags: coronavirus, FDA, US, WHO

Discover more of what matters to you