More than four years ago, President Donald Trump heralded the arrival of safe and effective messenger RNA (mRNA) vaccines for COVID-19. He called them “a monumental national achievement” and “one of the greatest miracles in the history of modern-day medicine.”
The mRNA platform enabled scientists to begin work on a vaccine within days of the publication of COVID-19’s genetic sequence. Clinical trials for an mRNA vaccine began weeks later, just five days after the World Health Organization declared COVID-19 a pandemic.
But earlier this month, Secretary of Health and Human Services Robert F. Kennedy Jr. announced the cancellation of more than $500 million in HHS contracts through the Biomedical Advanced Research and Development Authority (BARDA) that supported mRNA vaccine development. Trump himself seemed indifferent to the attack on arguably the most widely praised legacy of his first term. “That was now a long time ago, and we’re onto other things,” Trump said when asked this month about Operation Warp Speed—the program that helped speed COVID vaccine development.
Researchers and former biosecurity officials argue the administration’s turn against mRNA will only leave the United States less able to respond to future disease and public health threats, even as geopolitical adversaries like China ramp up on investments in the technology.
Kennedy’s criticism of the COVID mRNA vaccines as having “fail[ed] to protect effectively against upper respiratory infections like COVID and flu” is in keeping with his anti-vaccine stance and multifront rollback of vaccine policy since taking over at HHS. His stated justifications for pulling back from mRNA vaccines rely on misrepresented studies and unsupported claims about safety and effectiveness. “The idea that mRNA vaccines ‘failed’ because they didn’t block all respiratory infections reveals a fundamental misunderstanding of immunology,” explained Jake Scott, an infectious disease researcher and professor at Stanford University School of Medicine. “No vaccine for flu, RSV, or COVID has ever done that. The goal is preventing severe disease, and mRNA vaccines delivered.”
Kennedy’s advisers at HHS have made even more outlandish and unsupported claims about mRNA vaccines. Steven Hatfill—a virologist who in May joined the HHS Administration for Strategic Preparedness and Response, the office responsible for preparing against pandemic and biosecurity threats—said earlier this month on Steve Bannon’s podcast, “There was no benefit to risk ratio for taking a messenger RNA vaccine. In fact, it was more dangerous to take a vaccine than it was to contract COVID-19 and be hospitalized with it.”
Studies have estimated that COVID vaccines prevented more than 3 million additional deaths and 18 million hospitalizations in the U.S. alone. The vaccine platform is particularly valuable for pandemic response because of the speed at which mRNA vaccines can be developed and updated to fight newly emergent viruses and strains. The “whole virus” vaccines that Kennedy says HHS will prioritize in lieu of mRNA utilize much older vaccine technology. These vaccines use inactivated or “whole killed” viruses to trigger an immune response. Cultivating these vaccines requires growing and purifying viruses in a lab, an expensive and time consuming process.
But mRNA vaccines use RNA to deliver a protein from the virus—not the virus itself—that triggers an immune response. Vaccines can be formulated, as was the case with COVID, almost as soon as the genetic code of the virus is known without the need to have a live sample of the virus itself, let alone grow large quantities of it in a lab.
Kennedy said that canceled grants are part of a “wind-down” and “broader shift” away from investments in mRNA vaccines. Instead, HHS will prioritize “whole-virus vaccines and novel platforms.” The move followed the May cancellation of more than $700 million in HHS funding to Moderna for developing mRNA influenza vaccines, including one against bird flu that had shown promising results in an early clinical trial. The termination also ended the government’s “right to purchase pre-pandemic influenza vaccines.” The company said in a statement it will “explore alternatives for late-stage development and manufacturing” for the bird flu vaccine.
In the short term, companies will likely shrink or end their work on the BARDA-funded projects. “The 22 terminated projects worth $500 million represent the expensive late-stage development that BARDA uniquely funds—Phase 3 trials, manufacturing scale-up, and strategic stockpiling that private companies can’t afford,” argued Scott, the Stanford infectious disease researcher.
Over the longer term, biotech investments in mRNA vaccines could fall off, and some investors are already considering pulling back from mRNA vaccines. For the development and innovations that continue, researchers predict the work will find a home in other countries looking to capitalize on the vacuum left by the Trump administration. “The research is going to continue, but it’s going to continue in Europe and Asia and China,” said Drew Weissman, the University of Pennsylvania researcher whose work on mRNA enabled COVID vaccine development and earned him a Nobel Prize.
For that reason, scientists and health officials who served in the first Trump administration have decried Kennedy’s decision, saying HHS is surrendering a crucial biosecurity tool. “Ending BARDA’s investment in mRNA technology creates a national security vulnerability,” said Chris Meekins, the deputy assistant secretary in the HHS pandemic and biosecurity preparedness office during Trump’s first term. “These tools serve as a deterrent to prevent other nations from using certain biological agents.” Jerome Adams, the surgeon general during Trump’s first term, issued a more dire warning: “People are going to die because we are cutting short funding for this technology.”
Falling behind on mRNA technology would be like losing an arms race, according to Rick Bright, who served as BARDA director during the first Trump administration. He called mRNA technology the “equivalent of a missile defense system for biology … Adversaries who invest in this technology will be able to respond faster to outbreaks, protecting their populations sooner than we can. Right now, the United States has a decisive advantage in mRNA science, manufacturing capacity and regulatory expertise. But in an era where biological threats can be engineered, losing this competitive edge would leave the United States vulnerable and dependent on others for lifesaving tools.”
The COVID pandemic provided something of a case study in the costs of lacking the most promising biotechnology. Jeff Coller, the director of the Johns Hopkins University RNA Innovation Center whose graduate student helped design the Moderna COVID vaccine, explained to The Dispatch that China relied on “whole virus” or attenuated virus for its COVID vaccines during the pandemic. “It didn’t work nearly as effectively as the mRNA vaccines,” he said of China’s response. When a pandemic viruses mutates, mRNA vaccines can also be quickly updated. “If you have an emergent pandemic, an emergency situation, where you desperately need to get this vaccine out to the population, or people are going to lose their lives, mRNA, no question, is the way to go,” Coller added.
China seems to have taken this to heart. Outside of the U.S., the country currently hosts the most clinical trials for mRNA vaccine candidates. “China is doubling down on this, and soon will be the global leader in mRNA based medicines and therapeutics,” Coller said, warning that in future pandemics the U.S. could be forced to acquire vaccines from China. Sen. Bill Cassidy, the GOP senator whose vote advanced Kennedy’s nomination for HHS secretary, said canceling the mRNA contracts “conceded to China an important technology needed to combat cancer and infectious disease.”
Coller is also a founder of the Alliance for mRNA Medicines, an advocacy group consisting of biotech and pharmaceutical companies and leading mRNA research centers. He said the group’s members have begun to contemplate moving their work elsewhere in light of the administration’s turn against mRNA. “It was really a shot across the bow, a warning that the United States is really not a friendly nation for this technology,” Coller said. “Many of the membership that are involved in the mRNA business recognize that and say, ‘Look, we’re going to have to develop our technologies in other countries, move our brick and mortar somewhere else’ because while the United States is retreating from the technology, most other countries are not.”