ModernaModerna (NSDQ:MRNA) announced that it initiated its submission to the FDA for a booster dose of its COVID-19 vaccine.

Cambridge, Massachusetts-based Moderna expects to submit data to the European Medicines Agency and other regulatory authorities around the world in addition to the FDA in the coming days for the booster shot at a 50 µg dose level.

The company amended the Phase 2 study of the mRNA-1273 vaccine to offer a booster dose at the 50 µg dose level to interested participants (344 in total) at six months after receiving their second dose as neutralizing antibody titers had waned significantly prior to boosting at approximately six months.

A booster dose of the vaccine boosted neutralizing titers significantly above the Phase 3 benchmark and, after a third dose, a similar level of neutralizing titers was achieved across age groups, notably in older adults 65 and above. The safety profile was similar to that observed previously for the second dose and an additional analysis showed that a booster induced robust antibody responses and significantly increased geometric titers for all variants of concern, including Beta (32-fold), Gamma (43.6-fold) and Delta (42.3-fold).

“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,” Moderna CEO Stéphane Bancel said in the 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.”