Sept 23 (Reuters) - Moderna ( MRNA ) said on Tuesday its
updated COVID-19 vaccine formulation elicited a strong immune
response in all adults aged 65 and older, as well as in
individuals aged 12 to 64 with at least one underlying risk
condition.
Preliminary data from an ongoing post-marketing study
indicated that the vaccine, mNEXSPIKE, on average, showed
greater than a 16-fold increase in neutralizing antibodies
against the LP.8.1 variant - currently one of the Sars-CoV-2
variants under monitoring with increasing prevalence globally.
The trial was evaluating safety, tolerability and
immunogenicity of the 2025-2026 formula of mNEXSPIKE. The safety
profile of the vaccine was consistent with previous studies, the
company said.
Moderna ( MRNA ) is betting on its newer messenger RNA vaccines as it
grapples with waning demand for its original COVID-19 shot,
Spikevax, and lower-than-expected uptake of its respiratory
syncytial virus vaccine.
The U.S. Food and Drug Administration had approved mNEXSPIKE
in May, the first endorsement since the regulator tightened
requirements for COVID-19 vaccines and said it plans to require
new clinical trials for approval of annual boosters for healthy
Americans under age 65.
Spikevax is approved for individuals aged 65 and older, and
for those aged six months to 64 who are at risk for severe
disease.
The data for mNEXSPIKE follows additional preliminary
immunogenicity results for the 2025-2026 formula of Spikevax,
Moderna ( MRNA ) said.
Both vaccines for the 2025-2026 season "have demonstrated
strong immune responses against today's top circulating COVID-19
strains", the company said.