Moderna has filed a regulatory application seeking approval from the European Medicines Agency (EMA) for its modified Covid-19 vaccine that encodes the spike protein of the SARS-CoV-2 virus’s XBB.1.5 sub-variant.
The company made the filing based on recommendations from the European Centre for Disease Prevention and Control and the EMA, calling for the updating of Covid-19 vaccines to a monovalent XBB.1.5 composition.
This aligns with the recommendations of other regulatory authorities.
Moderna’s monovalent XBB.1.5 vaccine candidate demonstrated an immune response against XBB descendent sublineages, including XBB.1.5, XBB.1.16 and XBB.2.3.2.
The company is filing data with regulatory agencies globally to progress its modified Covid-19 vaccine early for the autumn/winter 2023-2024 inoculation season.
Moderna also made submissions to other agencies, including the US Food and Drug Administration and Health Canada.
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Moderna CEO Stéphane Bancel stated: “We are proud to announce this filing for our updated Covid-19 vaccine and continue to support the European Union in protecting citizens against Covid-19.
“Our preliminary clinical testing showed that our updated Covid-19 vaccine is effective in generating an immune response against the current XBB variants of concern, and we believe it will play a critical role in protecting against severe disease and hospitalisation.”
In March 2023, the company finalised a deal with the government of the Republic of Kenya to set up an mRNA manufacturing plant.