Moderna Announces Preliminary Booster Data and Updates Strategy to Address Omicron Variant

Authorized booster (50 µg of mRNA-1273) increases Omicron neutralizing antibody levels approximately 37-fold; a 100 µg booster dose of mRNA-1273 increases Omicron neutralizing antibody levels approximately 83-fold

Moderna will continue to advance an Omicron-specific booster (mRNA-1273.529) to clinical trials

Conference call to be held Dec. 20 at 8:00 a.m. ET
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced preliminary neutralizing antibody data against the Omicron variant following the Company’s booster candidates at 50 µg and 100 µg dose levels. The currently authorized 50 µg booster of mRNA-1273 increased neutralizing antibody levelsagainst Omicron approximately 37-fold compared to pre-boost levels and a 100 µg dose of mRNA-1273 increased neutralizing antibody levelsapproximately 83-fold compared to pre-boost levels.

“The dramatic increase in COVID-19 cases from the Omicron variant is concerning to all. However, these data showing that the currently authorized Moderna COVID-19 booster can boost neutralizing antibody levels 37-fold higher than pre-boost levels are reassuring,” said Stéphane Bancel, Chief Executive Officer of Moderna. “To respond to this highly transmissible variant, Moderna will continue to rapidly advance an Omicron-specific booster candidate into clinical testing in case it becomes necessary in the future. We will also continue to generate and share data across our booster strategies with public health authorities to help them make evidence-based decisions on the best vaccination strategies against SARS-CoV-2.”

As previously described, the Company is continuously advancing booster candidates to address emerging variants of concern (VOC). The strategy includes evaluating the prototype vaccine (mRNA-1273) at the authorized booster dose (50 µg) and a higher dose (100 µg), multivalent candidates that incorporate previous VOCs (mRNA-1273.211, mRNA-1273.213) also at 50 µg and 100 µg, and VOC-specific booster candidates (Delta, Omicron). Booster candidates are being evaluated in ongoing Phase 2/3 studies of approximately 300-600 participants per arm.

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