The federal government, by way of the National Institute of Health (NIH), and more specifically through the National Institute of Allergy and Infectious Diseases (NIAID)— under the direction of Dr. Anthony Fauci—has been massively funding the development of the Moderna mRNA COVID-19 vaccine with U.S. taxpayer money since the process to develop vaccines for the pandemic got underway. Additionally, scientists from the NIH are involved in some of the associated patents for the mRNA vaccine. As early as 2013, the Defense Advanced Research Projects Agency (DARPA) gave up to $25 million to Moderna to help develop its mRNA technology.
In 2018—amid an otherwise turbulent market and operating at over a quarter-million dollar annual loss—Moderna, based in Cambridge, MA, pulled off one of the biggest IPOs of the year. At the time, the less than ten-year-old firm suddenly had a $7.5 billion valuation—all on approximately $200 million in revenues with roughly $475 million in operating expenses. Fast forward to Q1 of 2021, the biotech company generated $1.73 billion in COVID-19 vaccine-related revenue and achieved profitability for the first time. Their annual forecast hits a staggering $19.2 billion thanks to the convergence of the pandemic and government subsidy. Moderna CEO Stéphane Bancel recently commented:
"Twelve months ago in Q1 2020, Moderna had never run a phase 3 clinical study, never got a product authorized by a regulator, and never made 100 million doses in a single quarter. I am very proud of what the Moderna team has achieved."
In April 2020, Moderna received $483 million from BARDA for COVID-19 vaccine development. Then, in June 2020, BARDA gave the company an additional $472 million to support its late-stage clinical development. Following that, in August 2020, Moderna, who hired close to 150 new team members to gear up for the vaccine task, announced a supply agreement with the U.S. government for an initial 100 million synthetic mRNA (mRNA-1273) COVID-19 vaccines. The government awarded the company up to $1.525 billion with an option to purchase an additional 400 million doses. Of the government deal, Bancel stated:
"We appreciate the confidence of the U.S. government in our mRNA vaccine platform and the continued support. We are advancing the clinical development of mRNA-1273 with the ongoing Phase 3 study being conducted in collaboration with NIAID and BARDA. In parallel, we are scaling up our manufacturing capability with our strategic partners, Lonza, Catalent, and Rovi, to address this global health emergency with a safe and effective vaccine."
Meanwhile, as debates and concerns about vaccinating children increase, the Department of Health and Human Services (HHS) recently announced that BARDA had expanded its collaboration with Moderna to expand the development of "the SARS-CoV-2 mRNA vaccine to include clinical trials with the pediatric population." The web announcement stated:
"BARDA is providing program management support and up to $144 million in funding from the Coronavirus Response and Relief Supplemental Appropriations Act for the Phase 2/3 clinical trial (KidCOVE, NCT04796896) to include approximately 7,000 children ages six months to less than 12 years old."
The KidCove study, formally called "Phase 2/3, Two-Part, Open-Label, Dose-Escalation, Age De-escalation, and Randomized, Observer-Blind, Placebo-Controlled Expansion Study to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Children 6 Months to Less Than 12 Years of Age, " will enroll an estimated 6,750 children. It will last approximately 14 months with up to seven visits to the study site. Compensation will be provided, of which details were not available. Children will be given up to three dose levels of the experimental product in two doses, 28 days apart.
Based on the pandemic and government funding, as previously mentioned, Moderna forecasts COVID-19 sales to reach $19.2 billion, surpassing its initial forecast of $18.4 billion. Some experts question whether there is a continuous need "for taxpayer subsidy for new studies when the company has not only crossed the profitability threshold but also headed to $20 billion in annual turnover from next to nothing in just 24 months." As TrialSite News put it:
"... the company's spectacular trajectory of value creation is in fact inexorably intertwined with government R&D subsidy and pandemic economics. Even when the company went public at the end of 2018 at $23, that value, again based on the confluence of forces, now totals 219.94 for an $88.31 billion market capitalization. The company now has nearly $8 billion in cash just sitting there. Why are the feds subsidizing the KidCOVE study?"