Moderna Won’t Run Phase III Vaccine Trials as Skepticism Grows in US: Bloomberg

 

Growing opposition to vaccines in the U.S., driven by recent government policy changes, makes it difficult to see a return on investment in vaccine development, Moderna CEO Stéphane Bancel said this week.

Moderna is scaling down its investments in vaccine development as the U.S. market grows increasingly hostile to immunizations, CEO Stéphane Bancel told Bloomberg News at the World Economic Forum in Davos, Switzerland.

“You cannot make a return on investment if you don’t have access to the U.S. market,” Bancel told Bloomberg, noting that high-level headwinds have made the vaccine market “much smaller.” In particular, the CEO pointed to regulatory roadblocks and diminishing support from health authorities as key problems for Moderna and the vaccine space more broadly.

Moving forward, Bancel told Bloomberg that Moderna will no longer put money into late-stage vaccine studies, though it remains unclear if the CEO was speaking of all vaccines or just those for infectious diseases.

In a note to investors on Thursday, analysts at Jefferies said Bancel “seems inclined to develop [Moderna’s] Phase III vaccines in oncology/rare diseases,” particularly in high-risk patient populations, while “potentially deprioritizing its pre-Phase III vaccines for infectious diseases.” There are at least 11 of these infectious disease programs that could be put on the back-burner, the analysts noted.

Vaccines, Jefferies added, “still have one of the highest ROIs.”

Overall, deprioritizing its infectious disease programs “could help [Moderna] trim costs at a faster clip, providing great visibility to 2028 cash breakeven guide,” Jefferies said.

Since Robert F. Kennedy, Jr. took leadership of the Department of Health and Human Services in February 2025, he has enacted a stream of policies that have made immunization less accessible to Americans and curtailed the industry’s ability to develop new vaccines.

In May last year, for instance, Kennedy officially removed COVID-19 from routine immunization guidelines for healthy children and healthy pregnant women. Then, last August, he scrapped 22 mRNA vaccine research projects, including contracts with major developers such as Pfizer, Sanofi, AstraZeneca and Moderna.

Kennedy has additionally put in position officials who have also thrown up vaccine roadblocks. One key lieutenant, for instance, is CBER Director Vinay Prasad, who last month penned an internal FDA memo claiming that at least 10 children had died “because of” COVID-19 vaccines. Prasad has yet to provide evidence for this claim, and an internal safety review from the FDA stated that the figure is likely overblown.

At the CDC, Kennedy in June unilaterally emptied the Advisory Committee on Immunization Practices, before reforming it over the next couple of months with known vaccine critics.

Bancel joins Pfizer CEO Albert Bourla in criticizing Kennedy and his “anti-science” policies. Also at Davos, Bourla earlier this week referred to HHS’ vaccine policies as “almost like a religion.”

Moderna, which has weathered successive quarters of declining earnings, has been heavily affected by these policy headwinds. In May, the company withdrew the approval application for its combination vaccine for flu and COVID-19. Weeks later, Moderna lost a government bird flu contract potentially worth more than $760 million after HHS terminated the project.

In the months that followed, Moderna implemented a number of measures to slow its cash burn. These include a 10% workforce reduction in July and the discontinuation of three mRNA vaccines in November.

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