Moderna submits data to FDA for COVID-19 vaccine booster
pharmafile | September 2, 2021 | News story | |
Moderna has initiated its submission to the FDA for the evaluation of a booster dose of the Moderna COVID-19 vaccine.
It’s expected that Moderna will submit data to the EMA and other regulatory authorities around the world in the coming days.
Stéphane Bancel, Chief Executive Officer of Moderna, said: “We are pleased to initiate the submission process for our booster candidate at the 50 µg dose with the FDA. Our submission is supported by data generated with the 50 µg dose of our COVID-19 vaccine, which shows robust antibody responses against the Delta variant.
“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.”
The Phase II study of mRNA-1273 was amended to offer a booster dose of mRNA-1273 at the 50 µg dose level to interested participants 6 months following their second dose.
Neutralising antibody titers had waned significantly prior to boosting at approximately six months. A booster dose of mRNA-1273 at the 50 µg dose level boosted neutralising titers 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 three was similar to that observed previously for dose two of mRNA-1273. These data will be submitted to a peer-reviewed publication.
The Moderna COVID-19 Vaccine is authorised for use under an Emergency Use Authorization for active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.
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