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Moderna Submits Updated COVID-19 Vaccine Application to European Medicines Agency

Monday, July 03, 2023

Moderna, a renowned biotechnology firm focused on mRNA therapeutics and vaccines, announced today that it has officially filed a regulatory application with the European Medicines Agency (EMA) for its revised COVID-19 vaccine. This updated vaccine is designed to encode the spike protein specific to the XBB.1.5 sublineage of SARS-CoV-2.

Moderna's CEO, Stéphane Bancel, expressed pride in the regulatory submission and reiterated the company's commitment to assisting the European Union in protecting its population against COVID-19. Bancel stated that early clinical trials have demonstrated the effectiveness of Moderna's updated vaccine in generating an immune response against the current XBB variants of concern. The company firmly believes that this vaccine will play a vital role in preventing severe illness and hospitalization. Moderna looks forward to collaborating with the EMA to ensure the widespread availability of their updated vaccine across the European Union.

The regulatory application is in line with recommendations from the European Centre for Disease Prevention and Control (ECDC) and the EMA, which advised updating COVID-19 vaccines to include a monovalent XBB.1.5 composition. This recommendation is consistent with guidance from other global regulatory bodies and public health agencies. Moderna has also obtained preliminary clinical data for their monovalent XBB.1.5 vaccine candidate, demonstrating an immune response against descendant sublineages such as XBB.1.5, XBB.1.16, and XBB.2.3.2.

Concurrently, Moderna is actively submitting data to regulatory agencies worldwide, including the U.S. Food & Drug Administration, Health Canada, and other relevant authorities. The objective is to advance the updated COVID-19 vaccine in time for the upcoming autumn/winter vaccination season.

https://investors.modernatx.com/news/news-details/2023/Moderna-Submits-Regulatory-Application-to-the-European-Medicines-Agency-for-Its-Updated-COVID-19-Vaccine/default.aspx

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