15 Sep, 2023 CureVac highlights shift to mRNA technology in seasonal influenza vaccine development, says GlobalDataPosted in Pharma
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