CureVac, in collaboration with GSK, recently announced the advancement of its multivalent, modified mRNA seasonal influenza vaccine candidate into Phase II clinical trials. The interim Phase I results reported positive safety and immunogenicity data, citing observed humoral responses in support of the selection of a vaccine candidate to proceed into Phase II testing. CureVac’s utilization of mRNA technology in the development of a seasonal influenza vaccine reflects a growing industry trend, says GlobalData, a leading data and analytics company.

Stephanie Kurdach, Infectious Disease Analyst at GlobalData, comments: “Seasonal influenza vaccines utilizing mRNA technology have great potential to enhance vaccine effectiveness. Influenza vaccines produced with mRNA have a shorter production time than egg-based vaccines, cell-based vaccines, or recombinant vaccines. This decrease in production time will allow for the vaccines to be produced closer to the start of flu season, thereby allowing for a better match to the season’s circulating influenza strains.”

CureVac is among many pharmaceutical companies looking to produce a novel seasonal influenza vaccine via mRNA technology. According to GlobalData, there are currently 60 vaccines within the development pipeline (PI-III) for seasonal influenza, 50% of which are mRNA vaccines. Inactivated influenza vaccines, which dominated patient shares in the 2022-23 influenza season, comprise only 23% of this pipeline.

Kurdach continues: “There is a noticeable shift in the development pipeline from inactivated influenza vaccines to mRNA vaccines. Currently, three mRNA vaccines are in Phase III development – Pfizer’s qIVR, BioNTech’s BNT-161, and Moderna’s mRNA-1010. We can expect to see pharmaceutical companies strategizing to expand their vaccine portfolio by re-purposing their successful COVID mRNA technology into influenza vaccines.”

CureVac’s ongoing Phase I/II study is being conducted in collaboration with GSK, which held a significant share of the seasonal influenza vaccines market in the 7MM* during the 2022-2023 influenza season due to its marketed vaccines, Fluarix Quadrivalent and Flulaval Quadrivalent. Phase I included testing a series of multivalent mRNA vaccine candidates, which contained up to eight separate mRNA constructs per candidate. Each candidate addressed all four of the WHO-recommended flu strains and was tested at different dose levels in 270 healthy adults (age 18-50). The vaccine candidate advancing into Phase II trials is expected to begin testing in Q4 2023 and will expand to include older adults (age 65-85).

Kurdach concludes: “As the development pipeline shifts towards novel production processes and competition grows for new market entrants, GSK is adapting to this change and standing firm to retain its hold as a market leader.”

* US, UK, Germany, France, Italy, Spain, and Japan