U.S. FDA: No safety concerns to preclude emergency use of Moderna's coronavirus vaccine
The U.S. Food and Drug Administration (FDA) on Tuesday said safety data supported a favorable profile of Moderna's COVID-19 vaccine, and there are no specific safety concerns identified that would preclude the issuance of an Emergency Use Authorization (EUA) for the jab.
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. EUA for the Moderna vaccine.
The U.S. on Monday started its massive vaccination campaign after granting authorization for Pfizer-Biontech's COVID-19 vaccine last week.