GSK plc (NYSE: GSK) is moving its experimental mRNA seasonal flu vaccine into a Phase 3 clinical trial starting in September, following mid-stage data that showed superior immune responses compared to currently licensed vaccines.
GSK's mRNA Flu Shot Outperforms Licensed Vaccines, Heads to Phase 3
MarketDash
GSK's experimental mRNA flu vaccine shows superior immune responses in mid-stage trials, setting the stage for a Phase 3 study this September.
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Strong Mid-Stage Results
At the OPTIONS XIII Conference for the Control of Influenza, GSK presented data from the Flu-028 trial, which enrolled 971 adults aged 18 and older and followed them for 181 days. The vaccine candidate generated higher immune responses against every tested strain than both standard and high-dose inactivated vaccines, in younger and older adults alike. Participants tolerated the vaccine well, with acceptable safety profiles.
Targeting Dual Surface Antigens
The upcoming Phase 3 study is notable because it's the first for an mRNA flu vaccine engineered to target both haemagglutinin and neuraminidase surface antigens. Standard vaccines only focus on haemagglutinin, but adding neuraminidase targets could enhance overall protection, lower transmission rates, and reduce illness severity. After reviewing the trial results, GSK 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 GSK, emphasized the urgent need for modern immunization methods, noting that annual global influenza cases reach one billion and cause up to 650,000 deaths. 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 market data.
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