Editors’ note: Shortly after this piece was published, Moderna announced that the FDA had reversed its decision and will review Moderna’s application for a new flu vaccine.
On Dec. 30, 2020, I took the first of two flights to Boston, double-masked and anxious, to roll up my sleeve at Moderna’s manufacturing site just outside the city.
A year earlier, I hadn’t even known the company existed. Now, I was an executive there, part of a team responding to a global catastrophe.
After the nurse administered my first dose, we looked at each other — both of us a little teary-eyed — and said thank you. It was a moment of profound human connection, born of a year of collective trauma and a sudden, palpable sense of hope.
I remember standing in that plant outside Boston — one Moderna had fortuitously built less than two years before the pandemic — looking at massive containers of vaccine material. I remarked to our head of manufacturing that the number of doses we were producing in that one facility was astonishing.
While preparing for a visit from the governor, we talked about the highly skilled jobs we were creating. The energy in our labs near Kenmore Square was electric. We drew great scientific minds from the very epicenter of discovery in Cambridge, benefiting from a unique proximity to the world’s leading research institutions.
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It was clear that the science, the talent, and the commonwealth were in a perfect, symbiotic embrace. It felt right to me that this was all happening in Massachusetts, where some of the earliest advancements in American vaccination occurred.
In our conference rooms, I sat with the executive team making decisions to accelerate programs that had been dreams for decades. Because we had become a revenue-generating company, we could finally “de-risk” the pipeline and move vaccines forward from the lab into trials and closer to the clinic.
We invested in a vaccine for cytomegalovirus (CMV), an underrecognized virus that is the leading cause of infant hearing loss. Perhaps most moving was the promise of an mRNA vaccine for respiratory syncytial virus (RSV). For decades, research into RSV had been stymied by past failures, leaving no way to prevent the thousands of infant respiratory deaths that occur worldwide every year. We had hope that our platform technology could be used to respond rapidly to emerging disease threats and, once its safety and efficacy were well established, unlock the ability to move through regulatory processes with greater speed to save lives.
But today, that spirit of possibility is being replaced by a chilling reality. All of that hope is now hitting a wall of regulatory unpredictability and malice as policy.
The FDA recently refused to review Moderna’s application for its mRNA flu vaccine. The decision was framed as technical — centered on questions about trial design and comparator standards — but that is a pretext.
It is part of health secretary Robert F. Kennedy Jr.’s broader campaign to undermine vaccine confidence and weaken longstanding vaccine recommendations. In his first year as our nation’s chief health officer, he has promoted debunked vaccine safety claims, downplayed the harms of infectious diseases, attacked doctors and vaccine makers, and dismantled key elements of federal vaccine policy.
With these actions, the United States government is signaling to innovators, to investors, and to the world that it is no longer committed to leading in vaccine science.
In response, even before the FDA decision on the mRNA flu vaccine, Moderna’s CEO announced that the company will no longer invest in new Phase 3 trials for infectious diseases. Vaccines for Epstein-Barr, herpes, and shingles — tools that could prevent untold chronic illness — have been shelved. As he put it at the World Economic Forum in January: “You cannot make a return on investment if you don’t have access to the U.S. market.”
Developers depend on regulatory clarity. Vaccine manufacturing requires years of investment, complex global supply chains, and enormous financial risk. Companies make those bets on the assumption that standards will be rigorous but stable. When regulation feels grounded in shifting interpretations rather than reasoned scientific judgment, it creates the appearance of pretext rather than principle.
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The risk is not abstract. The United States has long been the global leader in vaccine innovation not only because of scientific expertise but because our regulatory system — while tough — has been trusted. When that trust erodes, investment moves.
If we make it untenable to develop next-generation vaccines here, companies will not stop innovating; they will simply innovate elsewhere. And Americans will be the ones left waiting.
Industry is not the enemy.
In my career, I have worked inside two major vaccine manufacturers. Despite the vilification that has become popular in some corners, my colleagues and I went to work every single day with a public health mindset. The pharmaceutical industry is not the enemy. When companies do well, public health does well. It is a symbiotic relationship, not a conspiracy.
When we substitute bias for science, cherry-pick data to justify predetermined outcomes, or cloak ideological skepticism in technical rulings, the consequences ripple outward. Public health depends on institutions that follow evidence consistently — not selectively.
The cost of neglecting to lead will not be measured in headlines today. It will be measured in preventable illnesses, infant respiratory deaths that could have been avoided, and the diminished preparedness of a nation that has forgotten how to value the very innovation that once saved it.
Richard Hughes IV is a partner with the law firm Epstein Becker Green and a professorial lecturer in law at the George Washington University Law School. He previously served as vice president of public policy at Moderna.