Initial data on the Moderna COVID-19 vaccine (mRNA-1273) booster have been submitted to the Food and Drug Administration (FDA) for review.

According to the Company, data from a phase 2 study showed that a single 50µg dose of mRNA-1273, given as a booster to previously vaccinated individuals 6 months following their second dose (n=344), increased neutralizing antibody titer responses against SARS-CoV-2 above the phase 3 benchmark. Similar levels of neutralizing titers were observed across age groups.

A booster dose at the 50µg dose level was also found to significantly increase geometric mean titers for all variants of concern including  Beta (B.1.351) by 32-fold, Gamma (P.1) by 43.6-fold and Delta (B.1.617.2) by 42.3-fold.

As for safety, the adverse events profile following the booster dose was found to be similar to that seen after dose 2.


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“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, Chief Executive Officer of Moderna. “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 Moderna COVID-19 vaccine is currently authorized for emergency use for active immunization to prevent COVID-19 disease in individuals 18 years of age and older. The vaccine is administered intramuscularly as a 2-dose series (0.5mL each), given 28 days apart.

Reference

Moderna announces submission of initial data to US FDA for its COVID-19 vaccine booster. News release. September 1, 2021. https://www.businesswire.com/news/home/20210901006016/en/Moderna-Announces-Submission-of-Initial-Data-to-U.S.-FDA-for-Its-COVID-19-Vaccine-Booster.