U.S. Government and Moderna are Strange Bedfellows
Moderna Will Not Share COVID-19 Vaccine Rights with the Government It Collaborated With Prior to Outbreak
U.S. Government and Moderna make strange bedfellows. Who knew that the U.S. Government is a major player in the Big Pharma industry when it comes to manufacturing vaccines?
Prior to the discovery of SARS-CoV-2, the virus that causes COVID-19, researchers at the National Institutes of Health and Moderna have been collaborating on approaches to create vaccinations against coronaviruses.
According to the National Institute of Allergies and Infectious Diseases, documents show a researcher transfer agreement for modern vaccine candidates for the Middle East Respiratory Syndrome coronavirus, known as MERS-CoV. It was signed on December 16, 2019, almost two weeks before the first SARS-CoV-2 case was found in Wuhan, China. It is SARS-CoV-2 that causes COVID-19, the virus that causes SARS.
The University of North Carolina at Chapel Hill received “mRNA coronavirus vaccines candidates” as part of a larger deal between the U.S. National Institute of Allergies and Infectious Diseases (NIAID) and Moderna. The agreement was signed Dec. 12-16, 2019, by a number of researchers.
In February 2020, the agreement was amended to include mRNA vaccine candidates for SARS-CoV-2 and other emerging viruses.
A legal battle over the collaboration between the US Government’s National Institutes of Health (NIH) and pharmaceutical company Moderna over COVID-19 vaccine patents recently came to light. The outcome of the battle will have far-reaching consequences, not just for efforts to contain the epidemic, but also for medications and vaccinations that may be vital in future public health emergencies.
Moderna has proposed to the government that it share ownership of its primary patent in order to resolve the dispute. Whether or not this is sufficient to satisfy the government’s claims, I believe the disagreement highlights serious flaws with the way pharmaceutical and vaccine companies in the United States bring medications and vaccines to market.
Vaccines are allegedly critical in containing the outbreak.
Moderna became the second pharmaceutical company, after Pfizer, to get FDA approval to distribute a COVID-19 vaccine in the United States in December 2020. People have become so accustomed to discussing the “Moderna vaccine” that a critical aspect of its development history risks being overlooked: Moderna was not the sole developer of the vaccine.
Moderna is a relative newcomer to medicine and vaccine marketing, in comparison to many of the other pharmaceutical companies in the COVID-19 vaccine competition. The business, founded in 2010 in Massachusetts, had never brought a product to market until the FDA approved its COVID-19 vaccination in 2020.
Moderna concentrated on the development of mRNA technology throughout the 2010s, raising more than US$2 billion in funding from pharmaceutical companies and other investors. It became publicly traded in 2018.
Even prior to the pandemic, public health organizations prioritized research on coronaviruses and vaccine candidates against emerging infections. The National Institute of Allergy and Infectious Diseases, a component of the National Institutes of Health, signed a cooperative research and development agreement with Moderna in 2015 to collaborate on basic research, including the development of new vaccines. The agreement resulted in concealed funding and scientific help.
U.S. Government and Morderna
Additionally, after the COVID-19 outbreak began, Moderna received nearly $1 billion in funding from the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority. This funding was designated especially for the development of a prospective COVID-19 vaccine.
Moderna honed its messenger RNA technology by developing vaccines against other infectious diseases, including Zika and Chikungunya. According to a report by Knowledge Ecology International (KEI), a nonprofit organization that advocates for the protection of taxpayer investments in patents, that research was funded by approximately $25 million in grants from the Defense Advanced Research Projects Agency (DARPA).
Moderna has not disclosed government assistance in any patents, despite a 1980 Bayh-Dole Act requirement that companies disclose government assistance in patent applications, KEI said. Additionally, Moderna has not disclosed any government involvement in any of the 154 pending patent applications, according to KEI’s report.
Also of note: Details on how Chinese scientists transported deadly viruses from Canada’s National Microbiology Laboratory to China’s Wuhan Institute of Virology have been exposed in newly released access-to-information documents. The shipment arrived only a few months before the Coronavirus outbreak. The records were made public by CBC News. Dr Xiangguo Qiu was the one who sent these lethal viruses to Wuhan, according to the Coronavirus Bioweapon.
U.S. Government and Moderna Scientists Collaborating
Apart from financial support, the federal government played a critical role in the development of Moderna’s vaccine for a variety of reasons. Specifically, federal scientists collaborated with Moderna scientists on various vaccine components.
The significance of federal scientists’ work with Moderna would quickly become clear. This was explicitly acknowledged in a 2019 agreement with a third party, which referred to mRNA vaccine candidates “developed and jointly owned by NIAID and Moderna.” And by late 2020, the United States government was referring to the vaccination as the “NIH-Moderna COVID-19 vaccine.”
While the U.S. government has invested money in other businesses’ COVID-19 vaccines, its close involvement in Moderna’s R&D phases sets it apart.
Moderna has received a total of $2.48 billion in R&D and supply funding from the United States government for its program. This would bring the vaccine’s price per dose to just under $25, significantly less than the $32 to $37 currently being charged. Moderna asserts that it has charged small purchasers.
Despite receiving the most funding support, Moderna’s price is higher than any other Operation Warp Speed deal to date. Sanofi and GlaxoSmithKline received $2.1 billion for the development and distribution of 100 million doses, or $21 per dose. The $1.95 billion deal between Pfizer and BioNTech works out to $19.50 per dose—the company has not accepted any federal funding for R&D or scale-up—while Novavax’s $1.6 billion R&D and supply deal works out to $16 per dose.
Morderna said in a statement: “We do not agree that NIAID scientists co-invented claims to the mRNA (modified nucleotide) sequence of our COVID-19 vaccine. The mRNA sequence was selected exclusively by Moderna scientists using Moderna’s technology and without input of NIAID scientists, who were not even aware of the mRNA sequence until after the patent application had already been filed. Therefore, only our scientists can be listed as the inventors on these claims”.
“This conclusion is supported NIAID’s own patent filings, specifically a separate patent application filed on February 11, 2020 with the University of Texas where NIAID scientists claim to have invented similar subject matter. As a legal and practical matter, the same thing cannot be claimed to be invented twice by the same people working with two different collaborators”.
How it Developed into a Patent Dispute
Moderna filed multiple patents as the vaccine’s research advanced, each one covering a distinct component of the vaccine. US law permits inventors to file patent applications for novel, non-obvious, and useful products or methods. While certain early modern vaccinations – such as the polio vaccine developed by Jonas Salk’s team – were not covered by patents, by the late twentieth century, it was usual for a newly developed vaccine to be covered by one or more patents.
Moderna named experts from the National Institute of Allergy and Infectious Diseases as co-inventors on many patent applications connected to its vaccine. This was the case, for example, in a May 2020 patent application for a vaccination component.
However, in July 2021, Moderna stated unequivocally that it would not include government scientists as co-inventors on a patent application covering a much more critical component of the vaccine: the mRNA sequence used to create the vaccine, dubbed mRNA-1273.
In November 2021, following months of fruitless negotiations with the corporation, government authorities officially contested the company’s decision. Moderna then resorted to Twitter to argue its case, tweeting:
“For those who would seek to twist Moderna’s good faith application of U.S. patent law, nothing could be further from the truth. Moderna remains the only company to have pledged not to enforce its COVID-19 intellectual property during the pandemic”. 10/12
In comparison, the National Institutes of Health asserted that three NIAID scientists — Kizzmekia Corbett, Barney Graham, and John Mascola – made significant contributions to the idea, though they have neglected to disclose how. If this is true, patent law requires that they be named as co-inventors.
However, this controversy is not confined to scientific concepts or technical components of the law. While parents are also used to assessing scientific reputation, their most immediate and dramatic consequence is to grant patent holders enormous control over the covered technology – in this example, the primary component of Moderna’s vaccine.
In practice, by excluding government scientists from the application, Moderna has sole control over how the vaccine is used, if it is licensed, and to whom. If, on the other hand, the government co-owns the vaccine, the federal patent law permits each joint owner to participate in a variety of activities – from manufacturing and selling the vaccine to licensing it – without the approval of the other joint owners.
This is especially true in circumstances of product shortages or potential pricing concerns associated with the vaccine’s commercialization. For example, the United States would be able to permit additional manufacturers to create vaccines using the mRNA-1273 technology. Additionally, it has the ability to route vaccine doses in any direction it wishes, including to low-income countries that have gotten few vaccines thus far.
The current conflict between the government and a rising star in the pharmaceutical business is the latest chapter in a difficult interaction between individuals who play complementary yet diverse roles in the development of medications and vaccines.
On the one hand, the federal government has historically been a critical funder and performer of basic research. On the other hand, it lacks the finances and capability to bring the majority of novel medications and vaccines to market independently.
Thus, the pharmaceutical business plays a critical role in medication creation, which, in my opinion, should be rewarded. Only after a lengthy review and study over a period of years to monitor the effects.
If the NIH is correct about co-ownership of the vaccine, Moderna is abusing a legal weapon to get market dominance — a position it does not deserve. This position of full control becomes even more problematic in light of the large sums of public money spent on the vaccine’s research. This mitigated some of Moderna’s financial risk, even as the business forecasts revenue from vaccine sales of $15 billion to $18 billion in 2021 alone, with much more expected in 2022.
According to the confidential agreement (read below), providers ‘Moderna’ and the ‘National Institute of Allergy and Infectious Diseases (NIAID) have agreed to transfer mRNA coronavirus vaccine candidates’ developed and jointly-owned by NIAID and Moderna to recipients ‘The University of North Carolina at Chapel Hill’ on December 12th, 2019.
The material transfer agreement was signed on December 12th, 2019 at the University of North Carolina at Chapel Hill by Ralph Baric, PhD, and then signed on December 16th, 2019 by Jacqueline Quay, Director of Licensing and Innovation Support at the University of North Carolina.
INVESTIGATION – Bill Gates has an agreement with Moderna that grants him a license to their Covid-19 Vaccine; a vaccine that was produced weeks before the emergence of Covid-19
Even if the NIH wins the patent case, it is critical to recognize the limitations of such a “victory.” The US, for example, would be allowed to license the vaccine and might do so by asking licensees to commit to an equal distribution of vaccination doses.
However, co-ownership would preclude the government from addressing any of the other issues affecting the manufacturing and distribution of COVID-19 vaccines, such as scaling up production or constructing infrastructure to transport vaccination doses.
In such cases, investigators could pore over lab notebooks to discover when Moderna investigators determined the mRNA sequence utilized in the vaccine, and whether this occurred before the NIH team shared its mRNA sequence with the company.
To my viewpoint, the controversy serves as a reminder of the numerous flaws in the way vaccinations are manufactured and given in the United States. And it demonstrates that when taxpayers fund basic research for a drug, they deserve a greater share of the control – and profits – associated with its success.
Indeed, the U.S. government and Morderna are strange bedfellows. How does either get to have rights over a vaccine that neither paid for with their own money? How did U.S. Government and Morderna know to scale up for mass production of vaccines for coronaviruses that have never before contributed to a worldwide pandemic?
STAY TUNED: This dilemma gets stranger by the day.