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35 years of US investment in research led to development of mRNA COVID vaccines
March 2, 2023
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 PublicationModerna 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.”
JOURNAL
BMJ
METHOD OF RESEARCH
Data/statistical analysis
SUBJECT OF RESEARCH
Not applicable
ARTICLE TITLE
US public investment in development of mRNA covid-19 vaccines: retrospective cohort study
ARTICLE PUBLICATION DATE
1-Mar-2023
COI STATEMENT
Grant support from Arnold Ventures, Commonwealth Fund, Anthem Public Policy Institute, National Institutes of Health, and Tennessee Department of Mental Health and Substance Abuse Services; HSL is a senior advisor to the Public Good Projects; AS and REB have received consulting fees from the Council for Informed Drug Spending Analysis and Alosa Health, respectively; HSL is a co-founder of ThisIsOurShot and VacunateYa, a national grassroots organization that empowers trusted messengers on social media to spread accurate health information and combat covid-19 vaccine misinformation (unpaid); no other relationships or activities that could appear to have influenced the submitted
US government catalyzed and substantially invested in mRNA covid-19 vaccine development over decades
In the 35 years before the covid-19 pandemic, the US government invested at least $337 million into critical research that led to the mRNA covid-19 vaccines, finds a study published by The BMJ today.
The US government also paid $31.6 billion during the pandemic to support vaccine research, production, and to purchase vaccines for all Americans and for global donation.
These public investments saved millions of lives - and mRNA vaccine technology also has the potential to address future pandemics and treat other diseases. But the researchers point out that products developed with public funding, including mRNA covid-19 vaccines, are often sold at high prices.
As such, they assert that to maximize overall health impact and fairness, greater effort is needed to ensure equitable and affordable access to publicly funded health technologies.
Estimates of the extent of public investment for covid-19 vaccines vary widely. So, a team of US researchers at the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham and Women’s Hospital and Harvard Medical School, set out to assess how much the US government invested in research that directly led to the development of mRNA covid-19 vaccines.
They identified public funding from January 1985 to March 2022 through three primary data sources – the National Institutes of Health (NIH) Research Portfolio Online Reporting Tool Expenditures and Results (RePORTER), the Department of Defense (DoD) Contracts database, and the Biomedical Advanced Research and Development Authority (BARDA) Medical Countermeasures Portfolio.
NIH-funded grants were scored as directly, indirectly, or not likely related to four key innovations underlying mRNA covid-19 vaccines - lipid nanoparticle, mRNA synthesis or modification, prefusion spike protein structure, and mRNA vaccine biotechnology - and were grouped into pre-pandemic (1985-2019) vs pandemic (2020 - March 31, 2022).
The researchers identified 34 NIH-funded research grants that were directly related to mRNA covid-19 vaccines. These grants combined with other identified US government grants and contracts totaled $31.9 billion, of which $337 million was invested pre-pandemic.
Pre-pandemic, the NIH invested $116 million (35%) in basic and translational science while BARDA invested $148 million (44%) and the DoD invested $72 million (21%) into mRNA vaccine development and clinical trials.
After the pandemic started, $29.2 billion (92%) of US public funds purchased vaccines, $2.2 billion (7%) supported clinical trials, and $108 million (less than 1%) invested in manufacturing plus basic and translational science.
This is the first study to systematically catalog the direct pre-pandemic US public investments in mRNA covid-19 vaccines and provides a robust, yet conservative estimate, say the researchers.
But they acknowledge that this study does not include the financial support from other countries, foundations, or companies and is therefore likely a substantial underestimate of the total pre-pandemic investment of public funds.
They suggest policy reforms to improve equitable access to publicly-funded inventions like mRNA covid-19 vaccines could include adding access, affordability, and equity conditions to government contracts, and encouraging public funding agencies to follow up on technology licenses to ensure that manufacturers are making the products appropriately available for the benefit of public health.
The development of mRNA covid-19 vaccines during the pandemic was a monumental scientific success, they write. The substantial role played by public funding should help justify greater efforts by governments to assure equitable and affordable access to this life-saving vaccine in the US and globally.
In a linked editorial, Victor Roy at Yale School of Medicine agrees that the mRNA covid-19 vaccines have been a remarkable achievement.
However, he says their development “also serves as a cautionary tale of a system in which the risks of pursuing innovation were socialized, while the lion’s share of rewards became privatized to corporate shareholders.”
He points out that, since their launch, Moderna and Pfizer have accumulated more than $100bn in global revenues from sales of covid-19 vaccines—more than 20 times the World Health Organization’s biennial budget in 2020-21.
He therefore suggests an alternate innovation strategy that includes directionality, conditionality, and public options.
“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 concludes.
JOURNAL
The BMJ
METHOD OF RESEARCH
Observational study
SUBJECT OF RESEARCH
Not applicable
ARTICLE TITLE
US Public Investment in development of mRNA covid-19 vaccines: retrospective cohort study
ARTICLE PUBLICATION DATE
1-Mar-2023
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