Moderna’s recent FDA whiplash has dealt vaccinemakers a difficult question: What will become of a highly regulated industry faced with unpredictable directives?
The FDA last week refused to review Moderna’s application for an mRNA-based flu vaccine, saying the study lacked a comparator arm reflecting “the best-available standard of care” for adults ages 50 and older. Yesterday, the U.S. regulator reversed course, accepting a revised application that split the age cohorts and agreed to an additional post-market study for adults over the age of 65.
The back and forth from the FDA reflects a year of turbulence under HHS secretary Robert F. Kennedy Jr., a longtime anti-vaccine activist and critic of mRNA technology, alongside Center for Biologics Evaluation and Research Director Dr. Vinay Prasad.
Moderna CEO Stephane Bancel sounded off on the challenges these turnarounds foster within the biopharma industry and their effect on innovation during a Feb. 13 earnings call after the FDA’s initial refusal to file.
“When expectations and review timelines are unpredictable, companies face greater risk and can hesitate to invest, slowing the development of breakthrough medicines,” Bancel said. “This delays patient access and increases overall healthcare costs. Sustained regulatory uncertainty frightens U.S. leadership in innovative medicines.”
For Moderna, the shift has meant shelved programs, vanished contracts and lost jobs.
Other pharma giants with long-held programs in the space have been able to weather the storm based on the diversity of their portfolios. But vaccine sales on their own have suffered along with fewer shots in arms in 2025.
Here is what biopharma leaders have recently said about vaccine earnings in 2025, the outlook moving forward and how they view the immunization business overall in light of changes at the regulatory and public health level.
“It’s a different world when you start discussing vaccines.”
Albert Bourla
CEO, Pfizer, interview with Wall Street Journal
Pfizer CEO Albert Bourla has dealt directly with the Trump administration on drug pricing but has also been outspoken about the U.S. health agency’s approach to vaccines, calling Kennedy’s rhetoric “anti-science” in an interview with the Wall Street Journal last month. The company, with partner BioNTech, was the first to get a COVID-19 vaccine across the regulatory finish line, only to see sales fall dramatically thereafter.
Unlike Moderna, Pfizer has a lot more going on than mRNA technology, and so the backlash against the technology hasn’t been as detrimental to the company’s top and bottom lines. The pharma giant’s Prevnar family of pneumococcal vaccines remained a major blockbuster in 2025 with almost $6.5 billion in revenue worldwide despite a 2% drop in the U.S. market.
“Nothing has changed for Beyfortus in terms of recommendation or coverage. Now, will it create — and to what extent — confusion for parents and HCPs? Too early to say.”
Thomas Triomphe
EVP of vaccines, Sanofi, on an earnings call with shareholders
A more than 9% rise in sales of the RSV vaccine Beyfortus in 2025 gave Sanofi hope that the 2023-approved shot was beginning to catch on in the market. And vaccine head Thomas Triomphe looks at U.S. immunization recommendations as a fluctuating target at best. He also made the point on the full-year earnings call in January that recommendations don’t necessarily affect how patients and healthcare professionals regard the vaccine, and that it will take more time to see the full effects of the policy shift.
Still, overall vaccine sales dropped more than a percentage point with flu, COVID-19 and other vaccines dragging down the total, and Sanofi leaders expect sales to decline again in 2026.
“From a business perspective, [Gardasil] remains important for the company, but … it is no longer a key growth driver.”
Robert Davis
CEO, Merck & Co., at the J.P. Morgan Healthcare Conference
Merck & Co. CEO Robert Davis made it clear earlier this year that the HPV vaccine Gardasil is still a stable part of the pharma giant’s product portfolio. But it’s also facing modest growth. He highlighted that the shot stands apart as an “anti-cancer vaccine” rather than a pediatric or seasonal immunization like many others.
But in light of rhetoric from U.S. health agencies, Davis views a decline in dose recommendations by the CDC as a concern not just for Merck but for public health.
“It’s manageable overall,” Davis said. “I’m more concerned about it from a health policy perspective than I am, frankly, as a financial matter for the company.”
