CHMP positive for Spikevax, the updated COVID-19 vaccine containing spike proteins for the XBB.1.5 sublineage of SARS-CoV-2 for active immunization to prevent COVID-19 – Moderna

Moderna, Inc. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for Spikevax, its updated COVID-19 vaccine containing spike proteins for the XBB.1.5 sublineage of SARS-CoV-2 for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals six months of age and older. Following the CHMP’s positive opinion, the European Commission will make an authorization decision on the use of Moderna’s updated COVID-19 vaccine for autumn/winter 2023.

Moderna has generated clinical data of its monovalent XBB.1.5 vaccine candidate showing an immune response against XBB sublineages XBB.1.5, XBB.1.16, and XBB.2.3.2, in addition to BA.2.86, EG.5 and FL.1.5.1 variants. Public health authorities are vigilantly monitoring the BA.2.86 variant, a highly mutated strain of COVID-19 with over 30 mutations as compared to prior Omicron strains, with some governments accelerating COVID-19 vaccination campaigns due to its potential to break through protective immunity generated from previous COVID-19 vaccination or infection. The most common solicited local adverse event for Moderna’s updated COVID-19 vaccine was injection site pain. The most common solicited systemic adverse events include fatigue, headache, myalgia, arthralgia, and chills. Moderna’s updated COVID-19 vaccine’s safety profile is consistent with previous Spikevax formulations.