Pfizer Seeks FDA Nod To Expand Late-Stage COVID-19 Vaccine Trial
PFE) and its German partner BioNTech SE (NASDAQ: BNTX) said Saturday they are seeking the United States Food and Drug Administration approval to expand the late-stage clinical trial of their COVID-19 vaccine, by significantly upping the number of participants and increasing their diversity.
statement.” data-reactid=”20″>What Happened: The trial, subject to FDA approval, would include nearly 44,000 participants, while the initial recruitment goal was set at 30,000, Pfizer said in a statement.
The drugmaker said the expansion will allow it to add people from a diverse background in the trial, including adolescents as young as 16, and people with chronic but stable HIV.
The drugmaker is expecting a conclusive efficacy readout of the late-stage trial by the end of October.
interview Sunday that he expects its vaccine to be distributed before the end of the year, provided it’s safe and effective.” data-reactid=”27″>Pfizer CEO Albert Bourla told CNBC in an interview Sunday that he expects its vaccine to be distributed before the end of the year, provided it’s safe and effective.
distribute two potential vaccines thought to be made by Pfizer and Moderna Inc (NASDAQ: MRNA), according to the New York Times.” data-reactid=”29″>The U.S. Centers for Disease Control and Prevention notified all states earlier this month to get ready to distribute two potential vaccines thought to be made by Pfizer and Moderna Inc (NASDAQ: MRNA), according to the New York Times.
AZN) vaccine, which too is undergoing late-stage testing, has resumed trials after they were halted globally because of a volunteer developing symptoms of a rare neurological disorder.
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