GSK to push mRNA flu vaccine into late-stage trial after mid-stage data show stronger immune response

GSK (GSK) said it will advance its mRNA-based seasonal influenza vaccine candidate into a late-stage clinical trial after mid-stage data showed it generated stronger immune responses than currently approved standard- and high-dose shots in both younger and older adults.

The British drugmaker said the trial will be the first late-stage study of an mRNA flu vaccine designed to target two key surface proteins — haemagglutinin and neuraminidase — an approach GSK said could improve protection against infection and reduce transmission.

GSK intends to begin the pivotal trial this month. The move comes as part of a broader push by chief executive Luke Miels to initiate more than 20 late-stage studies by the end of 2026, following a portfolio review aimed at accelerating drug development ahead of looming patent expirations.

The announcement follows Moderna's (MRNA) receipt of US approval in August for mFlusiva, the first mRNA-based seasonal flu vaccine cleared by regulators, which is authorized for adults aged 50 and older.