The U.S. Food and Drug Administration now has the two leading COVID-19 vaccines to consider granting emergency use, meaning high-risk Americans could be only weeks away from receiving the treatment.
Moderna said Monday it received another round of positive reports on its candidate and is requesting emergency use authorization, joining Pfizer and becoming the second company to seek authorization. Pfizer and its German partner BioNTech had done so Nov. 20 after similar good news on its candidate vaccine. Moderna will also request conditional approval from the European Medicines Agency.
According to a company release, in Moderna’s clinical trial of 30,000 participants, 196 had confirmed COVID infections. Of those, 185 had received the placebo; only 11 received the active vaccine–an effectiveness rate above 94%. All 30 defined as suffering severe disease were in the placebo group, indicating the vaccine prevents both mild and serious disease.
Shares of Moderna were up more than 12% in premarket trading Monday.
“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease. We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic,” Moderna CEO Stephane Bancel said in a statement.
Bancel told Fox’s “Mornings with Maria” on Monday that the FDA likely would consider the vaccine at a Dec. 17 meeting, and that he hoped for quick approval of the two-dose vaccine.
“Our goal is to start vaccinating Americans within 24 hours after the FDA gives approval,” Bancel said, adding his hope is for high-risk people and front-line and healthcare workers to receive the vaccine in the first quarter of next year, with “every American older than 18 years of age” in the second quarter.
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