Moderna Shares Surge 7.72% Intraday, Rally Driven by FDA Approval of mNexspike Vaccine

The share price of Moderna Inc. (NASDAQ: MRNA) reached its highest level since October 2025, surging 7.72% intraday and closing with a 2.12% gain. This marks a significant rebound for the biotech giant, which has faced prolonged financial and regulatory headwinds amid declining demand for its original Spikevax vaccine and evolving public health policies.

A key driver of the rally was the U.S. Food and Drug Administration’s (FDA) approval of Moderna’s next-generation mRNA vaccine, mNexspike. The vaccine, designed for high-risk adults and those with specific health conditions, offers a fifth of the dose of the original Spikevax while maintaining comparable efficacy. However, the FDA’s restrictive eligibility criteria—mirroring those imposed on Novavax—highlight growing regulatory caution around mRNA vaccines, potentially limiting broader market adoption.

Simultaneously, the FDA mandated updated warnings for Moderna’s and Pfizer’s vaccines, emphasizing the risk of myocarditis. While experts argue the risk from vaccination remains lower than natural infection, the expanded labels may dampen public confidence and reduce demand, further pressuring revenue. These developments underscore the delicate balance between innovation and regulatory scrutiny in the post-pandemic vaccine landscape.

Political shifts in public health policy also contributed to market volatility. Recent changes under the Trump administration, including revised vaccination guidelines for children and the cancellation of federal funding for Moderna’s pandemic flu research, have introduced uncertainty. The decision to drop universal vaccination recommendations for healthy children, coupled with expanded myocarditis warnings, could slow uptake of Moderna’s products. Analysts warn that such policy-driven disruptions may delay the commercialization of next-generation vaccines and strain investor confidence.

Despite these challenges, Moderna’s strategic pivot to lower-dose, targeted vaccines like mNexspike signals a long-term effort to adapt to evolving market needs. However, the company’s projected financial losses and revenue declines for 2023 highlight the urgency of diversifying its portfolio beyond pandemic-era products. Upcoming earnings reports and R&D updates will be critical in assessing Moderna’s ability to navigate a complex regulatory and political environment while maintaining its competitive edge in the biotech sector.