Moderna receives positive opinion from the EMA for Spikevax

Published: 15-Sep-2023

Moderna has revealed the European Medicine's Agency (EMA) has provided positive opinion on its COVID-19 vaccine Spikevax's marketing authorisation

Moderna has announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorisation for Spikevax.

Spikevax is its updated COVID-19 vaccine containing spike proteins for the XBB.1.5 sublineage of SARS-CoV-2 for active immunisation 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 authorisation decision on the use of Moderna's updated COVID-19 vaccine for autumn/winter 2023. 

Our updated COVID-19 vaccine generates a strong human immune response against circulating variants

- Stéphane Bancel, CEO of Moderna

"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, CEO of Moderna.

"We are working with governments across Europe to include our updated COVID-19 vaccine in national vaccination programmes, to ensure a diversified portfolio that provides vaccine choice and access to single dose vial formats, which can limit waste," continued Bancel. 

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.

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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 prole is consistent with previous Spikevax formulations. 

Moderna has received authorisations for its updated COVID-19 vaccine in the US, Canada, Japan, and Taiwan to date and has submitted regulatory applications worldwide.

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