Moderna (MRNA) Faces Multiple Regulatory Challenges

On May 31, Bloomberg reported that the FDA recently granted Moderna Inc. (NASDAQ:MRNA) a narrower approval for its next-generation COVID-19 vaccine. The authorization is now limited to adults aged 65 and older, as well as individuals aged 12 and above with at least one risk factor for severe illness or underlying medical conditions. Previously, the approval was more comprehensive and applied to all individuals aged 12 and above, regardless of their health status.

Quite understandably, this policy adjustment aligns with the FDA’s updated stance that additional COVID-19 boosters for healthy adults and children require further evidence to support their continued use. As a result, Moderna is facing a more challenging regulatory environment in the United States. Recent decisions by the Department of Health and Human Services (HHS) reflect increasing scepticism toward mRNA-based vaccines under HHS Secretary Robert F. Kennedy Jr., a longtime critic of vaccines, according to the Bloomberg report.

A scientist in a lab coat creating a vaccine for infectious diseases in a lab environment.

Although Moderna’s updated vaccine showed improved performance in older adults and benefits from enhanced storage and dosing efficiency, demand has weakened partly because people no longer feel the need to get booster shots. According to the latest CDC data, only 23% of U.S. adults have received the most recent booster. In response, the company plans to bundle its COVID and flu vaccines into a single dose to drive higher uptake by capitalizing on the broader acceptance of the flu vaccine.

Separately, a day earlier, Moderna experienced another setback. Its $766 million contract with HHS to develop an mRNA-based bird flu (H5N1) vaccine was terminated. While early-stage trial data were promising, the agency raised concerns about safety and ethics regarding further funding of the mRNA program. Moderna stated it would explore alternative development paths for the H5N1 candidate.

To summarize, this indicates that U.S. vaccine policy is shifting toward a new direction. However, in the near term, Moderna’s revenue visibility may remain clouded by regulatory headwinds and reduced demand.

Moderna Inc. is an American pharmaceutical and biotechnology company that focuses on RNA therapeutics, primarily mRNA vaccines. It specializes in vaccines that use a copy of a molecule called messenger RNA (mRNA) to carry instructions for producing proteins, thereby triggering an immune response.

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