Moderna files for FDA authorisation for updated COVID-19 vaccine

Betsy Goodfellow | June 23, 2023 | News story | Research and Development COVID-19, FDA, Immunology, Moderna, Vaccine 

Biotechnology company Moderna has announced that it has completed submission of a regulatory application to the US Food and Drug Administration (FDA) for its updated COVID-19 vaccine.

The updated vaccine contains spike proteins for the XBB.1.5 sublineage of SARS-CoV-2, or COVID-19. The submission follows guidance from the FDA suggesting that COVID-19 vaccines should be updated to a monovalent XBB.1.5 composition. Other global regulators have advised similar measures.

The most common side effects from the updated vaccine were injection site pain, headache, fatigue, myalgia and chills.

The company is currently initiating further applications to other global regulators, aiming to deliver updated COVID-19 vaccines in time for 2023’s autumn/winter vaccination season.

Stéphane Bancel, Moderna’s CEO, commented: “The agility of our mRNA platform has enabled us to update Spikevax, Moderna’s COVID-19 vaccine, to target XBB variants with speed and clinical rigour. We have been working diligently for months to build ample supply, with doses ready to ship in time for the fall vaccination season in the Northern Hemisphere. In addition, our preliminary clinical testing has demonstrated that mRNA-1273.815 is effective in generating an immune response against the current XBB variants of concern. Over the past three years, Spikevax has consistently reduced hospitalisations and severe disease outcomes from COVID-19, and we encourage individuals to speak to their healthcare providers about receiving an updated vaccine.”

Betsy Goodfellow

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