Moderna (NASDAQ:MRNA) saw its stock rise nearly 5% in premarket trading on Monday following the U.S. Food and Drug Administration’s approval of its next-generation COVID-19 vaccine, mNEXSPIKE. The vaccine is authorized for use in adults aged 65 and older, as well as individuals aged 12 to 64 who have at least one underlying condition that heightens their risk of severe COVID-19 illness.
This marks the FDA’s first COVID-19 vaccine approval under its updated, stricter authorization standards. As of May 20, the agency requires vaccine developers to conduct placebo-controlled trials in healthy adults under 65, narrowing the approval scope mainly to higher-risk populations.
Moderna announced it anticipates mNEXSPIKE will be available for the 2025–2026 respiratory virus season. CEO Stephane Bancel described the approval as “an important addition to our toolkit for protecting vulnerable populations from severe COVID-19.”
Compared to the original Spikevax vaccine, mNEXSPIKE can be stored in regular refrigerators, offering longer shelf life and greater logistical ease, especially in regions with limited resources where distribution can be challenging.
The FDA’s decision was based on late-stage clinical trial data showing mNEXSPIKE is non-inferior to Spikevax for people aged 12 and older. In adults over 18, the vaccine demonstrated superior effectiveness.
Analyst Myles R. Minter from William Blair called the approval a “incremental win” for Moderna, particularly amid public skepticism about mRNA vaccines voiced by HHS Secretary Robert F. Kennedy Jr. However, Minter noted that this approval is unlikely to significantly boost Moderna’s COVID-19 vaccine sales, as overall market demand depends heavily on public perception.
Importantly, the FDA’s green light for mNEXSPIKE clears the way for Moderna’s combined flu and COVID vaccine candidate, mRNA-1083, which includes mNEXSPIKE as its COVID-19 component—a key regulatory milestone.
Meanwhile, analysts at TD Cowen expressed some surprise that the FDA did not grant full approval for use in the entire 12-and-older age group.
With waning demand for Spikevax and slower-than-expected uptake of its RSV vaccine, Moderna is focusing more on its next-generation mRNA vaccines. Earlier this month, the company pulled its application for a flu-and-COVID combo vaccine, opting to await additional data from a separate flu vaccine trial.