Why Is Moderna (MRNA) Facing Renewed Questions on Vaccine Oversight and Future Regulatory Risk?

• In early September 2025, Moderna faced heightened scrutiny after reports surfaced that U.S. health officials plan to present claims linking COVID-19 vaccines to child deaths at a CDC advisory committee meeting.
• This development has led to uncertainty regarding future vaccine recommendations for children and pregnant women, prompting Moderna and global regulators to reiterate Spikevax's safety record.
• To better understand the implications of this heightened safety scrutiny, we'll explore how potential regulatory shifts could impact Moderna's investment narrative.

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Moderna Investment Narrative Recap

Moderna’s investment narrative centers on belief in long-term value from its mRNA platform and pipeline, with short-term sentiment heavily swayed by trends in COVID-19 vaccine revenues and any new safety developments. The recent news of upcoming CDC scrutiny on vaccine safety introduces additional risk to near-term vaccine uptake and regulatory standing, but is not yet material for longer-term pipeline prospects. Intensifying regulatory questions now appear as the primary risk, taking focus from seasonality and competitive pressures.

In this climate, Moderna’s August 2025 earnings report stands out: management revised 2025 revenue guidance down to US$1.5 billion to US$2.2 billion, citing delayed shipments, while also confirming continued net losses. This adjustment closely tracks the uncertainty created by the recent safety discussions, and demonstrates how external events can directly influence both revenues and market expectations for the company’s most closely watched products.

But against this, investors should be aware of the evolving regulatory landscape and how it could limit...

Read the full narrative on Moderna (it's free!)

Moderna's outlook anticipates $3.5 billion in revenue and $498.6 million in earnings by 2028. This assumes a 4.6% annual revenue growth rate and a $3.4 billion improvement in earnings from current earnings of -$2.9 billion.

Uncover how Moderna's forecasts yield a $44.25 fair value, a 88% upside to its current price.

Exploring Other Perspectives

Simply Wall St Community members produced 26 fair value estimates for Moderna ranging from US$44.25 to US$186.49. With ongoing regulatory scrutiny seen as the biggest near-term risk, consider how such risks can lead to wide disagreement about Moderna’s future earnings potential and value.

Explore 26 other fair value estimates on Moderna - why the stock might be worth over 7x more than the current price!

Build Your Own Moderna Narrative

Disagree with existing narratives? Create your own in under 3 minutes - extraordinary investment returns rarely come from following the herd.

• A great starting point for your Moderna research is our analysis highlighting 1 key reward that could impact your investment decision.
• Our free Moderna research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Moderna's overall financial health at a glance.

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This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

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