Moderna, Inc. announced that the first participant has been dosed in the Phase 2 study of the Company’s Omicron-specific bivalent booster candidate (mRNA-1273.214), which combines Moderna’s Omicron-specific booster candidate (mRNA-1273.529) and the Moderna COVID-19 vaccine (mRNA-1273).
“We are pleased to begin this study of our bivalent booster candidate that includes our Omicron-specific candidate and the Moderna COVID-19 vaccine. Our mRNA platform allows us to pivot with speed and flexibility to create a bespoke vaccine to target new variants as they arise,” said Stéphane Bancel, Chief Executive Officer of Moderna. “Our goal has been to remain ahead of the virus and we are committed to generating and sharing data with public health authorities as they prepare for the fall booster season.”
This extension of an earlier study will evaluate the immunogenicity, safety, and reactogenicity of mRNA-1273.214 as a single booster dose in adults aged 18 years and older who previously received the two-dose primary series of mRNA-1273 and a 50 µg booster dose of mRNA-1273 with the booster dose being at least three months ago. Moderna expects to enroll approximately 375 participants, which will be conducted at approximately 20 sites in the U.S.
Moderna is also evaluating its Omicron-specific booster candidate (mRNA-1273.529) in a Phase 2 study in the U.S. Separately, the Company is evaluating mRNA-1273.529 in a Phase 3 study the UK in collaboration with the National Institute for Health Research (NIHR). The Company expects to begin dosing with mRNA-1273.214 in that study soon.