Investigational COVID-19 Vaccine Shows Non-Inferior Efficacy vs. Spikevax in Phase III Trial
June 13th 2024Phase III NextCOVE trial shows Moderna’s next-generation, investigational SARS-CoV-2 vaccine mRNA-1283 achieved the primary efficacy endpoint of non-inferiorty compared with Spikevax in preventing COVID-19.
FDA Delays Review of BLA Submission for Moderna's Novel Respiratory Syncytial Virus Vaccine
May 10th 2024Administrative constraints cause FDA to push back its review of data from a pivotal Phase III trial (NCT05127434), which demonstrated favorable clinical safety and efficacy for mRNA-1345, an investigational vaccine found to reduce the incidence of RSV-associated lower respiratory tract disease.