As the Trump administration erodes U.S. infrastructure supporting infectious disease vaccines, mRNA heavyweight Moderna plans to pull away from late-stage clinical trial investments in the area.
“We do not foresee investing in new phase 3 studies in a foreseeable futures [sic] in vaccines,” Moderna’s CEO Stéphane Bancel told Bloomberg TV, placing emphasis on the word “new.”
When asked if the anti-vaccine climate is going to affect Moderna’s business and ability to develop more vaccines, Bancel said, “100%.”
You cannot make a return on investment if you don’t have access to the U.S. market, or because of delays—regulatory-wise—or because your market is much smaller, because you don’t have a recommendation by the government,” Bancel said yesterday on the sidelines of the World Economic Forum in Davos, Switzerland.
Currently, the company touts 12 viral or bacterial vaccine programs in phase 2 development or earlier, according to its online pipeline.
When reached for comment, a Moderna spokesperson pointed to the company’s priorities set out in its Nov. 20 earnings release. At the time, the mRNA specialist announced the discontinuation of four clinical mRNA programs and outlined a three-year business strategy with the goal of boosting revenue by 10% in 2026.
“Over the next three years, we expect to build a large seasonal vaccine franchise for at-risk populations and invest the cash generated into oncology and rare disease therapeutics,” Bancel said at the time.
The November release also outlines Europe as “a significant market for respiratory virus vaccines.”
The Moderna spokesperson declined to comment on future plans for its current phase 2 infectious disease programs.
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Bancel’s comments come days after Pfizer CEO Albert Bourla, Ph.D., rebuked Health and Human Services Secretary Robert F. Kennedy Jr., describing the lawyer’s stance on vaccines as “anti-science.”
Just a few years ago, Moderna and Pfizer raced to develop and deliver COVID-19 vaccines—Spikevax and Comirnaty, respectively—to abate the worldwide pandemic. Their efforts and success prompted major revenue and investment not only into their companies but into the biopharma industry itself.
But over the last year, U.S. mistrust in vaccines has continued to accelerate, as long-time vaccine conspiracist RFK. Jr. divests and dismantles federal infrastructure for the science. Just this month, the CDC overhauled the longstanding U.S. childhood vaccine schedule, removing broad vaccination recommendations for COVID, flu, rotavirus, meningitis, hepatitis A and hepatitis B.
For Bancel, the falling-out means Moderna is turning its focus toward cancer. Earlier this week, the company shared five-year data for its Merck & Co.-partnered cancer vaccine, which, when combined with Keytruda, cut the risk of cancer recurrence or death by 49% in comparison to Keytruda alone.
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The move isn’t shocking, as Moderna’s Kyle Holen, M.D., head of development, therapeutics and oncology, told Fierce in October that most of the company’s upcoming investigational new drug applications will be in the oncology space. Holen cited the political climate for developing infectious disease vaccines and “a huge unmet need in cancer” as reasons behind the decision.
Though Moderna is moving away from vaccines for infectious diseases, Bancel has expressed disappointment about the action.
“It is sad for us to see that. Vaccines that have been proven for decades helping people around the world are not recommended anymore,” he told Bloomberg TV.
“If you look at all healthcare interventions, getting a vaccine is one of the highest return investments in the same year—not 10 or 20 years out—to prevent cardiac attack,” the leader said about COVID-19 and flu vaccines, noting that the inoculations also prevent hospitalizations related to severe illness.
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“We tend to forget that hospitalization is a big deal,” Bancel continued. “If you are 67 years old, you get hospitalized—in a week, you can lose 10% of your muscle mass. Ten percent muscle mass doesn’t seem a lot like this, but it might mean the difference between you being able to live a high-quality life and your life becoming living from your bed to your sofa. So that’s the message about vaccines.”
