U.S. Food and Drug Administration staff members did not raise new concerns over data on Moderna Inc’s coronavirus vaccine in documents made public on Tuesday, preparing the way for U.S. authorization of a second, easier-to-handle vaccine.
The FDA staff said a two-dose regimen of Moderna’s vaccine was highly effective in preventing confirmed cases of COVID-19. The comments were made in documents prepared for Thursday’s meeting of outside experts, who will discuss whether to endorse a U.S. emergency use authorization (EUA) for the Moderna vaccine.
The FDA reviewers did not raise any specific safety issues with using the vaccine in adults over the age of 18.
They said that serious side effects in the trial of the vaccine represented medical events that occur in the general population at a similar frequency as observed in the study.
The United States has planned to deliver 40 million vaccine doses – enough for 20 million people – this month, which includes both the vaccine from Moderna and the one developed by Pfizer Inc and BioNTech SE, which was granted an (EUA) by the FDA late on Friday.