publish time

16/11/2020

author name Arab Times

publish time

16/11/2020

WASHINGTON, Nov 16 : Biotechnology company Moderna announced Monday that its coronavirus vaccine has found to be 94.5 percent effective in the first interim analysis of the Phase 3 study. In a statement, Moderna said this study, "known as the COVE study, enrolled more than 30,000 participants in the US."


"The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine," it indicated. "This first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus five cases observed in the (vaccine) group, resulting in a point estimate of vaccine efficacy of 94.5 percent."


"Preliminary analysis suggests a broadly consistent safety and efficacy profile across all evaluated subgroups," it affirmed. Chief Executive Officer of Moderna Stephane Bancel said "this is a pivotal moment in the development of our COVID-19 vaccine candidate."


"Based on these interim safety and efficacy data, Moderna intends to submit for an Emergency Use Authorization (EUA) with the USFood and Drug Administration (FDA) in the coming weeks," the company noted. It added that it "anticipates having the EUA informed by the final safety and efficacy data (with a median duration of at least 2 months)."

It indicated that by the end of 2020, it expects to have about 20 million doses ready to ship in the US and that it "remains on track" to manufacture 500 million to one billion doses globally in 2021. Last week, Pfizer announced that early data showed its coronavirus vaccine to more than 90 percent effecti