The U.S. Food and Drug Administration is looking to grant full approval to the Pfizer Inc. (NYSE:PFE)-BioNTech SE (NASDAQ:BNTX) COVID-19 vaccine by early September, the New York Times reported Tuesday, citing people involved in the effort.
What Happened: The FDA is looking at a full approval of the vaccine by Labor Day or sooner, even as President Joe Biden said he expected a full approval in early fall, as per the report.
Why It Matters: The FDA is under growing pressure to give full approval to the vaccine, which was approved on an emergency basis last year. Pfizer had applied for full approval of the vaccine in early May.
Full approval will help to boost inoculation rates in the U.S., which is seeing a sharp increase in new coronavirus cases due to the highly transmissible Delta variant of the virus. It could also help clear doubts about the safety of the vaccine.
In July, Pfizer reported a 92% year-over-year surge in second-quarter revenue to $18.9 billion, including COVID-19 vaccine sales of $7.8 billion.
Price Action: Pfizer shares closed 3.9% higher in Tuesday’s regular trading session at $45.68 and further rose almost 0.7% in the after-hours session to $45.68.
BioNTech shares closed 3.4% higher in the regular trading session at $351.81 and further rose 0.9% in the after-hours session to $355.00.
Photo: By US Secretary of Defense on Wikimedia
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