Following a phase 2 study, Moderna submitted initial data to the FDA for the approval of its COVID-19 booster shot that would be administered 6 months after an individual’s second dose.
Moderna submitted initial data to the FDA based on the results of a phase 2 trial that demonstrated the efficacy of a booster shot of Moderna’s COVID-19 vaccine mRNA-1273. This booster shot would be administered to patients 6 months after their second dose of mRNA-1273.
“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,” said Stéphane Bancel, Moderna’s chief executive officer, in a press release. “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 initial data demonstrated that the booster of mRNA-1273 boosts the neutralizing titers above the phase 3 benchmark and induces an antibody response that significantly increases geometric mean titers of all variants of the COVID-19 virus. The data also showed that the safety profile of the booster shot is similar to that of the second dose of mRNA-1273.
In a prepared statement, Moderna noted that it expects to submit data to the European Medicines Agency and other regulatory authorities in the coming days.
Moderna announces submission of initial data to U.S. FDA for its COVID-19 vaccine booster. Businesswire. News release. September 1, 2021. Accessed September 2, 2021. https://www.businesswire.com/news/home/20210901006016/en