Moderna: Clinical update on bivalent COVID-19 booster platform

Moderna: Clinical update on bivalent COVID-19 booster platform

April 20, 2022 Off By Author

Moderna has announced new clinical data on its bivalent COVID-19 booster platform including data on the company’s first bivalent booster candidate, mRNA-1273.211, which includes mutations found in the Beta variant of concern, several of which have been persistent in more recent variants of concern including Omicron.

Moderna said in its press release that A50 µg booster dose ofmRNA-1273.211 demonstrated superiority against Beta, Delta and Omicron variants of concern one month after administration. Superiority continued six months after administration for Beta and Omicron variants of concern as well. A50 µg booster dose ofmRNA-1273.211 was generally well tolerated with a reactogenicity profile comparable to a booster dose of mRNA-1273 at the 50 µg dose level. The manuscript is available as a preprint through Research Square.

“We are pleased with these data for our first bivalent booster candidate, mRNA-1273.211. We believe that these results validate our bivalent strategy, which we announced and began pursuing in February 2021. The results indicate that mRNA-1273.211 at the 50 µg dose level induced higher antibody responses than the 50 µg mRNA-1273 booster, even when additional variants of concern were not included in the booster vaccine,” said Stéphane Bancel, Chief Executive Officer of Moderna. “Our latest bivalent booster candidate, mRNA-1273.214, which combines the currently authorized Moderna COVID-19 booster with our Omicron-specific booster candidate, remains our lead candidate for the fall 2022 Northern Hemisphere booster​. We look forward to sharing initial data on mRNA-1273.214 later in the second quarter. We believe that a bivalent booster vaccine, if authorized, would create a new tool as we continue to respond to emerging variants.”

Moderna is developing updated booster candidates to address the continued evolution of the SARS-CoV-2 virus, including monovalent and bivalent candidates targeting multiple variants of concern. The company said that its primary focus has been on the bivalent booster approach to maintain high neutralizing antibody titers while improving breadth of immunity to variants.​ Moderna also noted that it has multiple bivalent booster candidates that have been evaluated to date, which include mRNA-1273.211 (9 spike protein mutations, based on the Beta variant), and mRNA-1273.214 (32 spike protein mutations, based on the Omicron variant).​ mRNA-1273.211 includes four mutations and mRNA-1273.214 includes 32 mutations present in the Omicron variant of concern.