What's Happening?
Moderna has announced the termination of its congenital cytomegalovirus (CMV) vaccine program after the investigational vaccine, mRNA-1647, failed to demonstrate strong protection in a Phase III trial.
The vaccine showed an efficacy rate between 6% and 23% in preventing CMV infection among female participants aged 16 to 40. Despite the disappointing results, Moderna's CEO, Stéphane Bancel, expressed a commitment to sharing the data with the scientific community to aid future CMV vaccine development. The CMV program, one of Moderna's longest-running projects, began Phase I development in 2017. The failure of the CMVictory trial was anticipated by some investors, as the study's safety monitoring board had previously indicated that the efficacy marker was not met.
Why It's Important?
The discontinuation of the CMV vaccine program represents a setback for Moderna, which has been a leader in mRNA vaccine technology, particularly with its COVID-19 vaccine. CMV is a common infection that can lead to serious health issues, especially in newborns, making the development of an effective vaccine a significant public health goal. The failure of this program highlights the challenges of developing vaccines for latent viruses, which remain dormant in the body. This outcome may influence investor confidence and impact Moderna's strategy in developing vaccines for other latent viruses, such as Epstein-Barr and shingles.
What's Next?
Moderna plans to continue testing mRNA-1647 in bone marrow transplant patients, where a mid-stage trial is ongoing. The company has stated that the Phase III failure will not affect its full-year guidance or its goal of breaking even by 2028. The broader implications for Moderna's mRNA platform and its application to other vaccine programs will be closely monitored by investors and the scientific community.
