Friday, March 03, 2023

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35 years of US investment in research led to development of mRNA COVID vaccines


In the three decades leading up to the pandemic, the US government invested $31.9 billion in research that supported the development of mRNA COVID-19 vaccines in 2020, $337 million of which was invested before the pandemic, finds a Brigham and Women's–led study published yesterday in The BMJ.

The researchers searched public databases for government-funded grants on four foundational innovations that directly led to the development of mRNA COVID-19 vaccines, including lipid nanoparticle, mRNA synthesis or modification, spike protein structure, and mRNA vaccine biotechnology from January 1985 to March 2022.

Effort involved 34 NIH research grants  

The team identified 34 research grants funded by the National Institutes of Health (NIH) that were directly related to the development of mRNA COVID-19 vaccines in 2020. In combination with other government grants and contracts, the research totaled $31.9 billion.

Of the $337 million invested before the pandemic, NIH invested $116 million (35%) in basic and translational science related to mRNA vaccine technology, while the Biomedical Advanced Research and Development Authority (BARDA) invested $148 million (44%), and the Department of Defense invested $72 million (21%).

After the pandemic began, $29.2 billion (92%) of US public funds went toward buying 2 billion advance vaccine doses, $2.3 billion (7%) was spent on clinical trials, and $108 million (less than 1%) was directed to manufacturing and basic and translational science.

Overall, the government paid $18.1 billion to Moderna ($16.2 billion [89%] for vaccines) and $13.1 million to Pfizer/BioNTech (mostly for vaccines). One billion doses were set aside for international donation from Pfizer at a much lower price than those for Americans.

"Although the public funding supporting Moderna is widely recognized, Pfizer-BioNTech executives have claimed that the company did not accept any US government support to develop its vaccine," the authors wrote. "However, Pfizer-BioNTech would not have been able to develop an mRNA covid-19 vaccine without the licensed technologies emerging from research funded by US taxpayers."

The researchers noted the study likely underestimates the true prepandemic public investment, because it didn't include those from other countries, foundations, or companies.

Pfizer-BioNTech would not have been able to develop an mRNA covid-19 vaccine without the licensed technologies emerging from research funded by US taxpayers.

"The development of mRNA COVID-19 vaccines during the pandemic was a monumental scientific success and was possible because of the scientific discoveries that took place in the preceding decades," corresponding author Hussain Lalani, MD, MPH, of Brigham and Women's Hospital, said in a Brigham news release

But the authors called for policy reforms and follow-up on technology licenses to ensure that manufacturers are making the vaccines appropriately available to equitably support global public health. "mRNA vaccines have saved millions of lives," Lalani said. "The substantial public investment in research that led to these vaccines should justify equitable and affordable access to these lifesaving vaccines globally."

Public risk, private rewards

In a commentary in the same journal, Victor Roy, MD, PhD, of the Yale School of Medicine, said that while mRNA COVID-19 vaccines are a significant achievement, their development illustrates how society invested in and bore the risk of pursuing such innovation while corporate shareholders reaped most of the rewards.

Fueled largely by the global sale of their COVID-19 vaccines, Moderna and Pfizer have made more than $100 billion in global revenues, which Roy pointed out is more than 20 times the World Health Organization's budget for 2020-21.

"Yet for a vaccine that is estimated to cost $1-3 per dose to manufacture, both Moderna and Pfizer have announced plans to charge more than $110 a dose in the US this year—a price that Moderna’s CEO Stephan Bancel has argued is 'consistent with the value' of these vaccines," he wrote.

Yet for a vaccine that is estimated to cost $1-3 per dose to manufacture, both Moderna and Pfizer have announced plans to charge more than $110 a dose in the US this year.

Victor Roy, MD, PhD

To better direct the value it helped create, Roy argued, the US government should have pursued a goal of global COVID-19 vaccination by guiding decisions about intellectual property and technology transfer.

"Secondly, to achieve public goals, the US government can use its position as a pivotal investor and buyer to set conditions in contracts," he said. "These conditions would relate to pricing and access, technology transfer, and reinvestment in innovation."

Last, Roy said governments should build public investment options to make important health technologies, which would secure supplies during public health crises, allow reinvestment of revenues into domestic innovation and manufacturing, and offer negotiating leverage for fairer agreements with private manufacturers.

"Instead of maximizing value for corporate shareholders, these alternatives would enable governments to translate public investments more fully in the service of public health—a fundamental priority as we examine our response to this pandemic and prepare for the next," he concluded.

Public investment in critical research contributed to the success of mRNA COVID-19 vaccines

Analysis finds that in the 35 years before the Covid-19 pandemic, the U.S. government invested at least $337 million into research that directly led to the mRNA COVID-19 vaccines

Peer-Reviewed Publication

BRIGHAM AND WOMEN'S HOSPITAL

Moderna and Pfizer-BioNTech have recently announced plans to increase the price of their respective mRNA COVID-19 vaccines, thrusting them into the spotlight of debates around drug price hikes. A new study, led by investigators from Brigham and Women’s Hospital, a founding member of the Mass General Brigham health care system, analyzed the role of public funding in the development of mRNA vaccines. In a systematic assessment, the team found that over the last 35 years, three federal agencies—the National Institutes of Health, the Department of Defense, and the Biomedical Advanced Research and Development Authority—invested at least $337 million into critical research, including basic and translational science, and vaccine development that directly led to the mRNA Covid-19 vaccines.

In addition, during the first two years of the pandemic, the U.S. government contributed over $31.6 billion to support clinical trials, manufacturing, and vaccine supply for all Americans and for global donation. These investments include more than $18 billion to Moderna and $13 billion to Pfizer-BioNTech.

“The development of mRNA COVID-19 vaccines during the pandemic was a monumental scientific success and was possible because of the scientific discoveries that took place in the preceding decades,” said Hussain Lalani, MD, MPH, of the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women's Hospital and corresponding author of the BMJ article. “mRNA vaccines have saved millions of lives. The substantial public investment in research that led to these vaccines should justify equitable and affordable access to these lifesaving vaccines globally.”

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