Moderna (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 of mRNA 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.
The prime and boost doses of the vaccine are at a 100 µg dose level. Conversely, the dose level of the Pfizer-BioNTech BNT162b2 vaccine is 30 µg.
An article recently published in JAMA found that Immunoglobulin G (IgG) levels to the SARS-CoV-2 receptor binding domain spike protein were higher in Moderna vaccine recipients compared with Pfizer recipients. In a preboost blood draw, BNT162b2 levels were 5.9 μg/mL compared to 19.1 μg/mL for mRNA-1273. In postboost blood draw, levels were 45.9 μg/mL and 68.5 μg/mL, respectively.
Moderna announced that a booster dose of its 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.”
Filed Under: clinical trials, Drug Discovery, Drug Discovery and Development, Infectious Disease
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