GSK (LSE:GSK) presented positive Phase II data for its mRNA seasonal influenza vaccine candidate at the OPTIONS XIII Conference for the Control of Influenza.
The pharmaceutical group said the shot produced higher immune responses against all flu strains tested than licensed standard-dose and high-dose inactivated vaccines, in younger and older adults respectively.
GSK will now start a Phase III efficacy trial in September, the first for an mRNA flu vaccine designed to target both haemagglutinin (HA) and neuraminidase (NA), the two surface proteins that let the virus bind and spread.
Most licensed flu vaccines target HA alone; GSK's candidate also targets NA, which the company says growing evidence links to better protection, milder illness and reduced transmission.
The trial, called Flu-028, tested 971 adults aged 18 and over, comparing different mRNA candidates against licensed age-appropriate vaccines and measuring safety data through 181 days post-vaccination. GSK will carry the optimised B-strain HA candidate, FLUm3HA.b-3NA, forward into Phase III.
"These promising data support the potential to better protect people from flu with a vaccine designed to target both HA and NA," said Sanjay Gurunathan, GSK's head of vaccines and infectious diseases R&D, citing an estimated one billion flu cases and up to 650,000 deaths worldwide each year.
The US Food and Drug Administration granted the candidate Fast Track designation in July, reflecting the targeted age indication.
News Intelligence what this means for the company
GSK's mRNA flu vaccine candidate cleared Phase II with immune responses superior to all licensed comparators across age groups, earning FDA Fast Track designation and clearing the path to Phase III efficacy trials starting September. The dual-target design (HA and NA proteins) is novel for flu vaccines and addresses a mechanistic gap in current licensed shots; if Phase III confirms the Phase II immunogenicity advantage translates to clinical protection, GSK would have a differentiated vaccine in a market worth an estimated $1 billion in annual cases globally.
This is an early-stage vaccine candidate still 18+ months from potential regulatory decision; Phase III efficacy failure is a material risk. Success would add a new revenue stream to GSK's vaccine portfolio, but the timeline and competitive landscape (other mRNA flu programmes exist) mean this is a long-dated upside, not a near-term catalyst.
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