Moderna has early in-human data showing its next-generation COVID-19 vaccine, mNEXSPIKE, has the potential to offer strong immune protection against the latest rapidly spreading SARS-CoV-2 virus.
Moderna’s updated mNEXSPIKE vaccine showed an average greater-than-16-fold increase in neutralizing antibodies against the LP.8.1 sublineage in individuals 12 years of age or older, the company said Tuesday. The result comes from a postmarketing clinical study of the latest 2025-26 formula of mNEXSPIKE, which is designed to target LP.8.1.
By comparison, the company’s first-generation mRNA vaccine, Spikevax, generated a greater-than-eightfold increase in LP.8.1-neutralizing antibodies across the same age groups, Moderna said.
The FDA approved the updated mNEXSPIKE formula in August for individuals aged 12 to 64 with at least one underlying condition that puts them at high risk for severe COVID as well as for all adults 65 and older.
As part of its postmarketing commitments to the FDA, Moderna is conducting a single-arm phase 3b/4 study in those age groups and a placebo-controlled phase 4 trial in adults ages 50 to 64 without high-risk conditions.
The FDA’s recent approvals for the LP.8.1-adapted COVID shots were mostly based on preclinical data.
There was a brief period of confusion about whether additional in-human clinical trials would be required before the approval of an updated COVID shot after the Department of Health and Human Services in April said “all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure.” At that time, it was unclear whether seasonal vaccines, such as those for the flu and COVID, would be subject to that requirement.
The latest clinical data “underscore the predictability of preclinical data” that supported the FDA’s approval of the new formula of mNEXSPIKE, Moderna said in its Sept. 23 release.
The safety profile of the vaccine in the postmarketing study was so far consistent with previous studies, according to the company.
While the updated flu and COVID shots have reached the market without additional regulatory hiccups, the FDA’s top vaccines official, Vinay Prasad, M.D., has suggested that the agency will put up new requirements before vaccine makers can promote coadministration of multiple shots.
In a decision memo related to Pfizer and BioNTech’s updated COVID shot Comirnaty, Prasad said randomized, controlled trials of multiple vaccines—with clinical disease outcomes as the primary endpoint—will be required for any claims of coadministration or “some sequence of the vaccines."