Moderna, once hailed as a pandemic hero for its COVID-19 vaccine, now grapples with mounting pressure under the Trump administration’s renewed scrutiny of vaccine development. The company’s shares recently saw a 3.73% bump, but this minor gain belies a deeper crisis: regulatory roadblocks, canceled government contracts, and a broader political assault on mRNA technology. Once buoyed by Operation Warp Speed funding, Moderna faces a stark reversal as the administration targets vaccine mandates and testing standards. With its stock down 35% this year—hovering near pre-pandemic levels of $25—the biotech giant’s future hinges on navigating an increasingly hostile landscape.
The FDA’s recent decision to limit Moderna’s next-generation COVID vaccine to older adults and high-risk individuals aged 12–64 exemplifies these headwinds. This narrower approval undercuts Moderna’s commercial strategy, reflecting tightened regulatory frameworks demanding more rigorous randomized trials for new shots. Simultaneously, the Department of Health and Human Services (HHS) axed a $766 million contract for Moderna’s bird-flu vaccine, citing concerns the mRNA approach was “not scientifically or ethically justifiable.” HHS emphasized safety and trust, controversially claiming the technology remains “under-tested”—a blow to Moderna’s pandemic-era credibility.
Central to this upheaval is HHS Secretary Robert F. Kennedy Jr., a longtime vaccine skeptic who publicly dismissed mRNA vaccines for respiratory diseases as ineffective. His influence is tangible: in May, the CDC reversed routine COVID-19 vaccine recommendations for pregnant women and children. Kennedy’s stance amplifies an ideological shift within the administration, prioritizing anecdotal skepticism over evidence-based science. This environment stifles Moderna, which relies on mRNA for over 90% of its pipeline—including experimental cancer and Lyme disease vaccines now facing heightened regulatory barriers.
Moderna’s struggles are compounded by its failure to diversify beyond mRNA. Post-pandemic, the company leaned heavily on COVID boosters and a respiratory syncytial virus (RSV) vaccine, but both underperformed. RSV sales lagged behind Pfizer and GSK due to slower adoption, while COVID shot demand cratered. With only three approved products, Moderna lacks the buffer enjoyed by rivals like Pfizer, which leverages diverse therapeutics to offset vaccine volatility. Jared Holz, healthcare strategist at Mizuho, notes, “They built a tank for the war, and now the war is over. They don’t have a business anymore.”
Financially, Moderna is burning cash at an unsustainable rate. Q1 2025 reserves fell to $8.4 billion from $9.5 billion in late 2024, with projected year-end liquidity of $6 billion. Analysts warn the company could deplete funds within 18 months without debt financing or equity raises—a path CEO Stéphane Bancel explicitly ruled out. To survive, Moderna slashed R&D spending by 20%, cut staff, and streamlined its drug pipeline. Another $1 billion in cost reductions is planned, but profitability remains elusive until 2028.
Bancel publicly aligns with the administration’s focus on high-risk populations, calling it a “net positive.” Privately, however, Moderna confronts the burden of proving mRNA’s safety anew. After withdrawing its FDA application for a flu-COVID combo shot—likely due to mismatched trial data—it aims to reapply later in 2025. Yet, the regulatory bar keeps rising. The FDA now requires randomized controlled trials for pediatric vaccines, delaying timelines and inflating costs. Moderna’s Norwood manufacturing facility, once buzzing with COVID production, now symbolizes stalled innovation as pipeline candidates crawl toward approval.
The broader implications are chilling for vaccine development. The FDA’s workforce has shed thousands of staff, slowing reviews. Combined with political rhetoric casting doubt on established science, the environment deters investment in novel technologies. Moderna’s setbacks echo across an industry where smaller biotechs lack the capital to endure protracted regulatory fights. Case in point: HHS canceled the bird-flu deal despite Moderna’s positive early-stage data, highlighting how policy shifts override scientific merit.
Despite the turmoil, mRNA’s legacy isn’t easily erased. Moderna’s COVID vaccine administered over a billion doses globally and saved millions of lives. Bancel stresses the company’s commitment to safety, stating, “We wouldn’t want to market a product that’s not efficacious or safe.” Yet, public trust erodes amid misinformation. A Mizuho survey found 30% of Americans now question vaccine efficacy—a statistic Kennedy’s rhetoric exacerbates.
Moderna’s path forward hinges on three near-term catalysts: FDA approval for its RSV vaccine expansion (due in June), stronger uptake of its latest COVID shot, and pipeline breakthroughs in cancer or rare diseases. Failure could force asset sales or partnerships. With shares at $25—down 95% from their $484 peak—investors see existential risk. As regulatory winds shift, Moderna’s story transcends one company; it tests whether evidence-based medicine can withstand political crossfire.