Moderna on Thursday said it had started a study of a booster shot that combines a formulation designed to fend off Omicron variant with the company’s current Covid-19 vaccine.
The company in a statement said the first participants in the study had been given the experimental shot in the phase 2 study of Omicron-specific bivalent booster candidate, which combines the company’s current Covid-19 vaccine.
"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," the Moderna CEO added.
This extension of an earlier study will evaluate the immunogenicity, safety, and reactogenicity of the Omicron-specific bivalent booster candidate as a single booster dose in adults aged 18 years and older who previously received the two-dose primary series of COVID-19 vaccine and a booster dose at least three months ago.
The company expects to enroll 375 participants, which will be conducted at approximately 20 sites in the US.
Separately, Moderna said it is evaluating Omicron-specific booster candidate in a phase 3 study in the UK in collaboration with the National Institute for Health Research (NIHR). The company expects to begin dosing with Omicron-specific bivalent booster the candidate in that study soon.
Pfizer Inc. is also studying a vaccine that combines an omicron-targeting candidate with its approved vaccine.
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