Moderna Submits Data for FDA Approval of its COVID-19 Vaccine for Booster Dose

Moderna announced it has submitted data to the Food and Drug Administration (FDA) for approval for a booster dose of its COVID-19 vaccine, mRNA-1273. 

“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 a statement.

The company used data from its phase 2 study, which was amended to offer a booster dose of the mRNA-1273 vaccine at the 50 µg dose level to participants 6 months after their second dose.

Neutralizing antibody titers had waned significantly prior to boosting at approximately 6 months.

A booster dose of mRNA-1273 at the 50 µg dose level boosted neutralizing titers significantly above the phase 3 benchmark according to Moderna. After a third dose, a similar level of neutralizing titers was achieved across age groups, notably in older adults (ages 65 and above). The company reported the safety profile after the third dose was similar to that observed previously for 2 doses.

The company said they will submit the trial data for publication of a peer-reviewed journal.

In the coming days, the company said it expects to submit data to the European Medicines Agency and other regulatory bodies for the booster dose.

“We remain committed to staying ahead of the virus and following the evolving epidemiology of SARS-CoV-2,” Bancel said. “We will continue to generate data and transparently share to support governments and regulators as they make evidence-based decisions regarding future vaccination strategies.”

Just last week, the company said it had submitted its data for its formal Biologics License Application (BLA) with the FDA for the 2-shot regimen of the vaccine. “This BLA submission for our COVID-19 vaccine, which we began in June, is an important milestone in our battle against COVID-19 and for Moderna, as this is the first BLA submission in our company’s history,” Moderna CEO Stéphane Bancel, saidat that time. “We are pleased that our COVID-19 vaccine is showing durable efficacy of 93% through 6 months after dose 2.

The filing came from data collected in the company’s phase 3 COVE study. Peer-reviewed data from the COVE Study Group confirmed that mRNA-1273 has shown 93% efficacy in COVID-19 among adult trial participants at high risk for SARS-CoV-2 infection or its complications.

No timeline has been set for formal review by the FDA for the Moderna 2-dose vaccine or booster dose. With the recent full approval of the Pfizer-BioNTech vaccine and the announcement of the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on September 17 to discuss the Pfizer-BioNTech vaccine booster, it is reasonable to expect the meetings and reviews will happen soon for Moderna.