Moderna has initiated its submission to the US Food and Drug Administration (FDA) for the evaluation of a booster dose of its COVID-19 vaccine mRNA-1273.
The FDA submission is supported by the results of a Phase II trial that offered a booster dose of mRNA-1273 at the 50µg dose level to participants six months following their second dose.
A booster dose of mRNA-1273 boosted neutralising antibody titers that had waned prior to boosting significantly above the Phase III benchmark. After a third dose, a similar level of neutralising titers was achieved across age groups, notably in older adults (ages 65 and above).
The safety profile following dose 3 was similar to that observed previously for dose 2 of mRNA-1273.
“We are pleased to initiate the submission process for our booster candidate at the 50µg dose with the FDA. Our submission is supported by data generated with the 50µg dose of our COVID-19 vaccine, which shows robust antibody responses against the Delta variant,” said Stéphane Bancel, CEO of Moderna.
“We remain committed to staying ahead of the virus and following the evolving epidemiology of SARS-CoV-2. We will continue to generate data and transparently share to support governments and regulators as they make evidence-based decisions regarding future vaccination strategies,” he added,
Moderna expects to submit data to the European Medicines Agency (EMA) and other regulatory authorities around the world in the ‘coming days’.
