Moderna has completed its submission to the US Food and Drug Administration (FDA) seeking authorization of its updated COVID-19 vaccine, which specifically targets the currently dominant strain XBB.1.5.
The company announced on Thursday that it has formally applied for FDA authorization, highlighting the importance of its updated vaccine for this year’s vaccination campaign Reuters.
The decision to develop a monovalent vaccine specifically targeting the XBB.1.5 variant is consistent with FDA’s recent recommendations to manufacturers regarding updates to COVID-19 vaccines. This approach differs from previously used bivalent boosters targeting both the original strain and the Omicron variant.
The bivalent vaccine provides protection against the ancestral strain as well as the BA.4 and BA.5 Omicron subvariants.
Preliminary clinical data presented by Moderna suggest that its XBB.1.5 monovalent vaccine generates a robust immune response against viruses of the XBB lineage. While it awaits FDA authorization, Moderna aims to have an updated vaccine in time for its fall vaccination campaign.
Stéphane Bancel, CEO of Moderna, highlighted the adaptability of its mRNA platform, emphasizing the speed and clinical rigor with which they updated the vaccine against the XBB variant.
“The agility of our mRNA platform has allowed us to update Moderna’s COVID-19 vaccine, Spikevax, to target the XBB variant with rapidity and clinical rigor. We have been working for months to build up sufficient supply and have doses ready to ship in a timely manner autumn vaccination season in the northern hemisphere,” Bancel said in a statement. Press Releases.
“Furthermore, our initial clinical testing demonstrated that mRNA-1273.815 is effective in generating an immune response against an XBB variant of current interest. Over the past three years, Spikevax has consistently reduced hospitalizations and severe disease outcomes due to COVID-19, And we encourage individuals to discuss receiving an updated vaccine with their healthcare provider.”
In its statement, the company acknowledged common side effects reported by recipients, including pain at the injection site, headache, fatigue, muscle pain and chills.
In addition to Moderna, other vaccine makers such as Pfizer/BioNTech and Novavax are also developing vaccine versions targeting XBB.1.5 and other prevalent subvariants.
As authorities prepare for a fall COVID-19 vaccination campaign, similar to the annual flu shot, the focus is now on encouraging individuals to get newer vaccines. According to statistics, only 17% of the US population has received the newer bivalent vaccine since it was launched last year. hill.
Experts worry that immunity against SARS-CoV-2 may not be strong enough this winter if immunizations are not renewed due to observations that protection wanes over time.
Published by Medicaldaily.com