mRNA Flu Shot Progresses in Phase 2 Study

CureVac N.V. today announced the dosing of the first participant in a Phase 2 study of the multivalent seasonal influenza vaccine candidate developed in collaboration with GSK.

The study will assess targeted optimizations for improved immune responses of the messenger ribonucleic acid (mRNA) vaccine candidate against the relevant influenza B strain.

The design of the multivalent vaccine candidate (FLU SV mRNA) has been changed to address all three World Health Organization (WHO)-recommended influenza strains and to exclude the influenza B/Yamagata lineage. The three remaining influenza strains include two influenza A strains and one influenza B strain.

This new Phase 2 study in the joint CureVac/GSK seasonal influenza program was initiated following interim data from the Phase 2 part of the ongoing combined Phase 1/2 study in seasonal influenza, which was reported on April 4, 2024.

Dr. Myriam Mendila, Chief Scientific Officer of CureVac, commented in a press release on May 28, 2024, "Historically, it's been challenging to target influenza B strains with a potent vaccine strategy. We are making progress in adapting and optimizing our clinical approach to address this challenge and improve performance against the remaining B strain."

The companies did not disclose a potential availability date for this new flu shot.

In response to the WHO's decision, various flu shot manufacturers intend to release modified vaccines in time for the 2024-2025 flu season in the United States. Last season, about 158 million flu shots were distributed, which was a decrease from the 2022-2023 flu season's 173 million.