GSK plc (NYSE:GSK) plans to launch a Phase 3 clinical trial in September for its experimental mRNA seasonal influenza vaccine after achieving superior immune responses in mid-stage testing compared to currently licensed vaccines.
Strong Mid-Stage Results
Data presented at the OPTIONS XIII Conference for the Control of Influenza revealed that the company’s vaccine candidate generated higher immune responses against every tested strain than standard and high-dose inactivated vaccines in both younger and older adults.
The trial, known as Flu-028, evaluated safety and immunogenicity in 971 adults aged 18 and older over 181 days.
Participants tolerated the vaccine well, demonstrating acceptable safety profiles.
Targeting Dual Surface Antigens
The upcoming study represents the first Phase 3 trial for an mRNA flu vaccine engineered to target both haemagglutinin and neuraminidase surface antigens.
While standard vaccines focus solely on haemagglutinin, adding neuraminidase targets may enhance overall protection, lower transmission rates, and reduce illness severity.
Following the trial results, the pharmaceutical manufacturer selected the optimized candidate, FLUm3HA.b-3NA, for Phase 3 evaluation.
Addressing Global Health Needs
Sanjay Gurunathan, head of vaccines and infectious diseases research and development at the firm, highlighted that annual global influenza cases reach one billion and cause up to 650,000 deaths, emphasizing the urgent demand for modern immunization methods.
The U.S. Food and Drug Administration granted Fast Track designation to the vaccine candidate in July 2026 for targeted age groups.
GSK Price Action: GSK shares were up 0.46% at $50.48 during premarket trading on Tuesday, according to Benzinga Pro data.
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