Source – Moderna
On June 22, 2023, a regulatory application for Moderna’s updated COVID-19 mRNA vaccine (mRNA-1273.815), which contains spike proteins for the XBB.1.5 sublineage of SARS-CoV-2, has been submitted to the US Food and Drug Administration.
“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 rigor. 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 hospitalizations and severe disease outcomes from COVID-19, and we encourage individuals to speak to their healthcare providers about receiving an updated vaccine.”
– Stéphane Bancel, CEO of Moderna
Related: COMPREHENSIVE GUIDE TO MRNA VACCINES: ADVANCEMENTS IN COVID-19 IMMUNIZATION
The proposal is based on advice from the US FDA, which suggested that the monovalent XBB.1.5 composition of COVID-19 vaccinations be revised. This is consistent with the recommendations made for a monovalent XBB composition by various authorities and international public health organizations. Moderna was the only business to provide early clinical results at the last VRBPAC that compared monovalent and bivalent vaccinations and demonstrated strong human immune responses against a variety of XBB descendant sublineages, including XBB.1.5, XBB.1.16, and XBB.2.3.2.
Pain at the injection site was the most often reported local adverse event for Moderna’s revised COVID-19 vaccination. The most often reported systemic side effects upon solicitation are headache, weariness, myalgia, and chills.
In order to supply improved COVID-19 vaccines in time for the autumn immunization season, the business is starting new applications to authorities throughout the world.
