Press release
EMA Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Authorization of Moderna’s Updated Covid-19 Vaccine in The European Union
The positive opinion follows the recommendation from regulators and global public health bodies to develop monovalent XBB.1.5 COVID-19 vaccines for
About this update from Moderna, Inc.
[{"type":"text","content":"The positive opinion follows the recommendation from regulators and global public health bodies to develop monovalent XBB.1.5 COVID-19 vaccines for autumn/winter 2023 vaccination campaignsClinical trial data from research assay confirmed Moderna's updated COVID-19 vaccine showed an 8.7 to 11-fold increase in neutralizing antibodies against circulating variants, including BA.2.86, EG.5, and FL.1.5.1 variantsCAMBRIDGE, MA / ACCESSWIRE / September 14, 2023 / Moderna, Inc. (Nasdaq:MRNA) today 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.\"The CHMP's positive recommendation for our updated COVID-19 vaccine is a key milestone given we see increasing transmission of SARS-CoV-2 across Europe. Our updated COVID-19 vaccine generates a strong human immune response against circulating variants, including BA.2.86, EG.5, and FL.1.5.1, and will be a critical tool for protection,\" said Stéphane Bancel, Chief Executive Officer of Moderna. \"We are working with governments across Europe to include our updated COVID-19 vaccine in national vaccination programs, to ensure a diversified portfolio that provides vaccine choice and access to single dose vial formats, which can limit waste.\"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 inject...