The vaccine contains 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 the autumn and winter period, 2023.
The pharma giant has generated clinical data of its revamped vaccine, 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.
Many public health authorities are currently monitoring the BA.2.86 variant, a highly mutated strain of COVID-19 with over 30 mutations as compared to prior Omicron strains.
As a result, some governments are accelerating COVID-19 vaccination campaigns due to the variant’s potential to break through protective immunity generated from previous COVID-19 vaccination or infection.
The most common adverse events of the vaccine include fatigue, headache, myalgia, arthralgia, and chills.
So far, Moderna has received authorizations for its updated COVID-19 vaccine in the U.S, Canada, Japan, and Taiwan and has submitted regulatory applications worldwide.
Stéphane Bancel, CEO of Moderna, said: “The CHMP's positive recommendation for our updated COVID-19 vaccine is a key milestone given 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.”
“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."