Moderna Faces Challenges as Vaccine Regulations Shift Under Trump Administration

NEW DELHI, India — Moderna, once hailed during the Trump administration for its Covid-19 vaccine development, is now struggling as regulatory pressures mount. On June 2, 2025, the Food and Drug Administration approved Moderna’s next-generation Covid vaccine, but only for a narrower demographic than the company had hoped. The vaccine is now available solely for older adults and individuals aged 12 to 64 with specific health risks.

Initially, Moderna was a frontrunner with its mRNA technology, which underpins its vaccines. However, after reaping substantial profits from its Covid vaccine, the company neglected to broaden its vaccine pipeline. The shifting priorities of the Trump administration have intensified scrutiny on mRNA technology, influencing efforts to reshape vaccine regulations and development.

Recent actions by the Department of Health and Human Services further complicate matters for Moderna. A $766 million government contract to develop mRNA vaccines for pandemic-level influenza, including bird flu, was canceled. Additionally, the FDA has initiated a new and stricter framework for approving Covid vaccines, necessitating more extensive testing.

As low demand for the Covid vaccine persists, Moderna’s stock has plummeted nearly 35% this year. Once valued at $484, its shares have significantly declined to around $25. Jared Holz, a healthcare strategist at Mizuho, remarked, “It’s just a bad time to be in the vaccine business.”

The regulatory environment has undergone notable changes since Trump’s re-election. The requirement for new Covid vaccines includes randomized and controlled trials for certain age groups, complicating the approval process further. Meanwhile, the FDA continues to operate with fewer staff, creating additional challenges for vaccine manufacturers, including Moderna, who has only three approved vaccines.

In withdrawing its approval application for a combined flu-Covid vaccine, Moderna cited FDA requests for more data on flu vaccines. The firm intends to resubmit the application once additional study results are available later this year. An earlier partnership for the bird-flu vaccine was terminated due to ethical concerns, leaving Moderna in a precarious position.

While Moderna’s vaccines reportedly have a solid safety profile from extensive use, company executives recognize the need to prove the efficacy of their innovative products. Chief Executive Stephane Bancel indicated that while focusing on high-risk Covid vaccination is positive, long-term success will depend on the development of effective vaccines for various diseases.

As 2025 unfolds, Moderna plans further cost-cutting measures, including a $1 billion reduction in spending and trimming its portfolio of experimental drugs. With $8.4 billion remaining as of late March, financial analysts warn that the company must secure additional funding before running out of cash in the next 18 months.

Looking ahead, Moderna’s viability relies on the success of vaccines currently in the pipeline, alongside expectations of increased uptake of its updated Covid-19 shot and potential expansion of its respiratory-syncytial-virus vaccine. Regulatory decision-making from the FDA expected in June will be pivotal for the company’s future.