Moderna expects to complete submission for FDA full approval this month



Moderna’s Covid-19 vaccine shows 93% efficacy through six months, and the company expects to complete its application for full US Food and Drug Administration approval this month, it said in a news release Thursday.

 “In final analysis of Phase 3 COVE study data, the Moderna COVID-19 Vaccine showed 93% efficacy, with the efficacy remaining durable through six months after administration of the second dose,” the news release said.

“Moderna has initiated the rolling submission process for a Biologics License Application (BLA) for our vaccine in the U.S. and expects to complete its submission in August.”

Moderna initiated its rolling submission for a BLA on June 1.

“I am proud of the progress our teams at Moderna have made in the past quarter in advancing our development pipeline while addressing a global pandemic and quickly establishing global manufacturing and commercial organizations,” Moderna CEO Stéphane Bancel said in the news release. “We now have mRNA candidates in clinical trials across five therapeutic areas including infectious diseases, cardiovascular, oncology, rare disease and autoimmune disorders. We are pleased that our COVID-19 vaccine is showing durable efficacy of 93% through six months, but recognize that the Delta variant is a significant new threat so we must remain vigilant.”

 



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