Omicron-Specific Bivalent Booster Candidate Launches Phase 2 Study

Massachusetts-based Moderna, Inc. recently announced that the first participant had been dosed in the Phase 2 study of the Company's Omicron-specific bivalent booster candidate (mRNA-1273.214).

This mRNA vaccine candidate combines Moderna's Omicron-specific booster candidate (mRNA-1273.529) and the Moderna COVID-19 vaccine (mRNA-1273).

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, conducted at about 20 sites in the U.S.

"We are pleased to begin this study of our bivalent booster candidate that includes our Omicron-specific candidate and the Moderna COVID-19 vaccine," said Stéphane Bancel, CEO of Moderna, in a related press release issued on March 10, 2022.

"Our mRNA platform allows us to pivot with speed and flexibility to create a bespoke vaccine to target new variants as they arise."

"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."

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 in the U.K. in collaboration with the National Institute for Health Research.

The Company expects to begin dosing with mRNA-1273.214 in that study soon.

Additional COVID-19 vaccine news is published at PrecisionVaccination.

Note: This press release was edited to render a mobile user experience.