Moderna (NASDAQ:MRNA) updated data from a Phase 4 clinical trial for its redesigned COVID-19 vaccine, noting that the mRNA-based shot branded as mNEXSPIKE led to more than a 15-fold increase in neutralizing antibodies on average against the LP.8.1 variant of the virus.
The ongoing trial enrolled adults aged 65 years and older and those aged 12–64 years with one or more medical conditions that make them susceptible to severe forms of COVID. The safety profile of the vaccine, designed for the 2025-2026 respiratory virus season, was in line with data from its prior studies, the company said.
Last week, the Cambridge, Massachusetts-based biotech announced Phase 4 data indicating that the mRNA-based vaccine increased LP.8.1-targeting neutralizing antibodies by more than eightfold on average in the same age groups.
In August, the FDA authorized mNEXSPIKE as well as its rival vaccines from Pfizer (PFE)/BioNTech (BNTX) and Novavax (NVAX) for all adults aged 65 and older and for at-risk individuals aged 6 months to 64 years, based on preclinical data.
“These clinical findings underscore the predictability of preclinical data that supported the recent U.S. Food and Drug Administration approval,” Moderna (NASDAQ:MRNA) said.