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 utilisation of mRNA technology in the development of a seasonal influenza vaccine reflects a growing industry trend.

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. Currently, three mRNA vaccines are in Phase III development – Pfizer’s qIVR, BioNTech’s BNT-161, and Moderna’s mRNA-1010. Following the Covid-19 pandemic and the swift development of safe and effective vaccines, pharmaceutical companies are strategising to expand their vaccine portfolio by re-purposing their successful COVID mRNA technology into influenza vaccines. Conversely, inactivated influenza vaccines, which dominated patient shares in the 2022-2023 influenza season, comprise only 23% of this pipeline, representing a noticeable shift in the development pipeline from inactivated influenza vaccines to mRNA vaccines.

Currently marketed seasonal influenza vaccines across the 7MM (US, UK, Germany, France, Italy, Spain, and Japan) display a strong safety profile, but efficacy can vary depending on how well the influenza strains included in the vaccine match the strains circulating during the season. According to the US Centers for Disease Control and Prevention (CDC), during the past ten reported US influenza seasons, vaccine effectiveness was approximately 40%, but reached as low as 19% in 2014-2015. The utilisation of mRNA technology in influenza vaccines has the 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 the flu season, thereby allowing for a better match to the season’s circulating influenza strains. Furthermore, mRNA vaccines also have the potential to incorporate large numbers of antigens – a possible future advancement from the current quadrivalent 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). 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.

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