Pfizer Seeks FDA Nod To Expand Late-Stage COVID-19 Vaccine Trial

Pfizer Inc PFE and its German partner BioNTech SE 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.

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.

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.

Why It Matters: The New York-based drugmaker has invested $1.5 billion on the COVID-19 vaccine and should it fail to work, it would be “painful” for Pfizer, but at the same time “it will not break the company,” Bourla told CNBC.

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 MRNA, according to the New York Times.

AstraZeneca Plc’s 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.

Price Action: Pfizer shares closed nearly 1.2% higher at $36.07 on Friday and gained 1.05% in the after-hours session. On the same day, BioNTech shares closed almost 6.4% higher at $65.13 and gained nearly 0.4% in the after-hours session.