Moderna submits initial data to FDA for its COVID-19 vaccine booster

The U.S. biotech’s boosters may not get regulatory approval in time for planned rollout-date.

On Wednesday, Moderna announced it has initiated its submission of a booster dose of its COVID-19 vaccine mRNA-1273 to the US Food and Drug Administration (FDA) for review. The submission is supported by the results of a Phase II trial that offered a booster dose of mRNA-1273 at a 50µg dose level to participants six months following their second dose. According to the company, neutralizing antibody titers had waned significantly prior to the booster at the six-month mark. The booster at the 50µg dose level boosted neutralizing titers significantly above the Phase III benchmark. Adding that, after a third dose, a similar level of neutralizing titers was achieved across age groups, notably in older adults ages 65 and above.

Moderna also said the safety profile of the third dose was similar to that of the second dose and expects to submit data to the European Medicines Agency and other regulatory authorities globally in the coming days. On Sunday, Dr. Anthony Fauci, a leading infectious disease expert in the U.S., said that officials were likely to receive regulatory approval for Pfizer's COVID-19 vaccine booster doses soon, though the Moderna booster could take a little longer as the company is yet to complete the submission process. The FDA said it will meet to discuss Pfizer's booster application on September 17 but is uncertain whether they will discuss Moderna's shot as the planned rollout by the Biden administration for the boosters is for the week of September 20.