Safety review, political shifts and fading demand challenge Moderna as mRNA medicine pushes into broader therapeutic territory.
The US Food and Drug Administration has launched a formal investigation into reports of deaths potentially linked to COVID-19 vaccination, casting an unwelcome shadow over Moderna at a moment when the company is already navigating financial headwinds and a rapidly evolving policy environment. The Department of Health and Human Services confirmed that regulators are reviewing fatalities across multiple age groups, although the FDA has not yet disclosed which cohorts fall under scrutiny. Earlier remarks from FDA Commissioner Marty Makary suggested that young adults and children were already part of the agency’s safety surveillance.
The review was prompted by an internal memo from Vinay Prasad, the FDA’s chief medical and scientific officer, who wrote that COVID shots “probably contributed” to at least ten deaths among children who experienced heart inflammation. The cases stem from an analysis of 96 deaths recorded between 2021 and 2024; they have not been published in a peer-reviewed journal, and the memo offered no details on underlying conditions or vaccine manufacturers. Moderna, for its part, maintains that there are “no new or undisclosed safety concerns in children or in pregnant women” associated with its mRNA vaccine, Spikevax [1].
Longevity.Technology: Regulatory scrutiny is hardly novel in biopharma, yet the FDA’s decision to revisit COVID-vaccine-related deaths arrives at a delicate moment for mRNA medicine; the platform is attempting to move beyond its pandemic identity just as public patience, political consensus and commercial appetite all appear to be thinning. Moderna’s predicament illustrates a broader truth about longevity-relevant technologies – scientific progress may be cumulative, but confidence is not. The safety signals under review remain sparse, unconfirmed and, crucially, unpublished, yet they create an atmosphere in which nuance struggles to compete with narrative. A technology that vaulted into global consciousness in record time now finds itself judged in headlines rather than datasets, which is seldom a helpful place for emerging biomedical platforms to live.
What complicates matters further is the shifting policy climate; vaccine governance has become a proxy battlefield for wider cultural anxieties, and this introduces a volatility that sits uneasily with long-cycle therapeutic development. For older adults – the cohort disproportionately affected by infectious disease and most reliant on preventive tools to safeguard healthspan – uncertainty is not a trivial inconvenience but a material risk. Moderna’s future is therefore tied not only to whether the FDA finds anything consequential in its review, but also to how political decision-making shapes access, investment and trust. It is an irony of modern biotech that the fate of a versatile platform capable of targeting cancer, cardiometabolic disease and, potentially, aging pathways may hinge less on molecular machinery than on the mood of the body politic.
Moderna’s balancing act
Founded in 2010, Moderna shifted from experimental platform company to global name almost overnight when its mRNA technology was authorized for COVID vaccination in 2020. Today the firm lists 35 mRNA candidates in clinical development, spanning infectious disease, oncology, cardiovascular indications and rare genetic disorders – a portfolio that aligns closely with the therapeutic frontiers shaping the longevity landscape.
Yet its commercial trajectory has been far less linear. With pandemic-era demand waning, Moderna’s revenues have fallen by more than 40% over three years, and its market capitalization has contracted to roughly $11 billion. The company holds ample liquid assets and carries little debt, but operational signals are mixed; a Piotroski F-score of 3 points to inefficiencies, and revenue per share has declined. Investor sentiment appears tentative. Moderna’s price-to-sales ratio has risen to a one-year high despite falling sales, and analysts currently cluster around a “hold” recommendation.
The irony is that the company’s long-term scientific agenda remains expansive. Personalized cancer vaccines, gene-encoded therapeutics and mRNA candidates for cardiovascular repair all speak to the modularity and adaptability that once made the platform the darling of biotech investors. The FDA probe therefore comes at an awkward junction – not simply because it heightens scrutiny of Spikevax, but because it risks chilling confidence in the broader mRNA toolkit at a time when multiple longevity-adjacent programs depend on its maturation.
Policy as a variable in biotech innovation
Complicating matters further is a US political climate that has turned vaccination into a live policy battleground. US Secretary of Health and Human Service Robert F Kennedy Jr has restricted COVID vaccination to those over 65 or with underlying conditions, curtailed federal funding for mRNA programs and reversed established recommendations such as the hepatitis B birth dose. These decisions diverge from mainstream scientific guidance and are already shaping uptake patterns; for companies developing next-generation vaccines or immunotherapies, unpredictability in policy is becoming nearly as significant a risk factor as scientific failure.
For older adults – the demographic most affected by infectious disease burden and most relevant to healthspan initiatives – reduced access to preventive tools could have downstream consequences. COVID has repeatedly demonstrated how mitochondrial decline, immune dysregulation and biological age intersect to determine risk; weakening vaccination infrastructure could widen these gaps, particularly as societies age.
mRNA’s trajectory beyond the turbulence
Despite the regulatory and political headwinds, institutional investors continue to hold more than 70% of Moderna’s shares, suggesting confidence in the long-term potential of mRNA platforms. Safety reviews, while uncomfortable, are part of the regulatory fabric and often refine rather than derail emerging technologies. The FDA is conducting a broad evaluation, not issuing conclusions, and key details remain absent; until peer-reviewed analyses are available, interpretation should be cautious.
A horizon worth watching
mRNA may yet prove to be one of the most versatile biomedical tools of this century; whether it reaches its potential will depend not only on regulatory clarity but on public trust, economic resilience and political steadiness. Moderna’s present turbulence serves as a reminder that scientific progress rarely advances in a straight line – and that the future of longevity medicine is shaped as much by the climate around innovation as by the discoveries themselves.
[1] https://investors.modernatx.com/statement-on-the-safety-of-spikevax
