- GSK's seasonal, mRNA-based influenza vaccine is progressing to a Phase III study after securing a safety and efficacy win in a mid-stage trial, potentially poising it to become a market competitor to Moderna's newly approved mRNA shot, mFlusvia.
- The Phase IIa trial (Flu-028) randomized 971 adults to evaluate GSK's mRNA flu vaccine against standard and high-dose comparators.
- Positive results presented at the OPTIONS XIII Conference showed higher immune responses and an acceptable safety profile.
- GSK will progress an optimized B-strain HA form of its vaccine to Phase III, expected to begin in September 2026.
- Moderna's mRNA flu shot mFlusvia received FDA approval in August 2026.
- GSK's Phase III will be the first to evaluate an mRNA flu vaccine targeting both HA and neuraminidase (NA).
- New preventative options for seasonal flu could be particularly beneficial for public health as an estimated one billion cases and 650,000 deaths globally are linked to the virus each year.
- mRNA vaccines can be updated and produced much faster than standard vaccines, a key advantage given the flu vaccine is updated annually to target each season’s strain.
GSK's mRNA-based influenza vaccine is set to enter Phase III trials after demonstrating safety and efficacy in mid-stage studies. This vaccine, which targets both hemagglutinin (HA) and neuraminidase (NA) proteins, aims to enhance immune responses compared to traditional flu shots.
The Phase IIa trial involved 971 adult volunteers who received varying doses of GSK's vaccine or standard comparators. Results showed that recipients of GSK's multivalent jab experienced higher immune responses than those given standard and high-dose flu shots. GSK's head of vaccines, Sanjay Gurunathan, noted that this dual-targeting approach could significantly improve flu protection.2
The vaccine's development is timely, as seasonal flu is responsible for approximately one billion cases and 650,000 deaths globally each year. If successful, GSK's vaccine will compete directly with Moderna's mFlusvia, which received FDA approval in August 2026 and is projected to generate $831 million in sales by 2032.
GSK plans to initiate the Phase III trial in September 2026, marking a significant step in the evolution of flu vaccination strategies. The company aims to provide a more effective option for public health, especially as flu vaccines are updated annually to combat circulating strains.
“The Phase IIa trial enrolled 971 adults and showed higher immune responses than standard and high-dose comparators. GSK's Phase III, set to begin September 2026, will be the first to evaluate an mRNA flu vaccine targeting both HA and NA, potentially offering better protection against flu.”
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