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Biotech Stocks Facing FDA Decision in August 2023

Pfizer
Pfizer

The FDA decision on Pfizer Inc.’s (PFE) RSVpreF, the vaccine candidate to help prevent respiratory syncytial virus in infants through maternal immunization, is due in August.

RSVpreF, also known as PF-06928316, is proposed for the prevention of medically attended lower respiratory tract illness (MA-LRTI) and severe MA-LRTI caused by respiratory syncytial virus in infants from birth up to six months of age by active immunization of pregnant individuals.

In May of this year, an FDA panel had voted 14 to 0 on effectiveness and 10 to 4 on safety, supporting the approval of RSVpreF.

The FDA usually follows the recommendations of its panels, although it is not required to do so.

If approved, RSVpreF would be the first vaccine for administration to pregnant individuals to help protect against the complications of RSV disease in infants from birth through six months.

PFE closed Friday’s (Jul.28, 2023) trading at $36.07, down 0.36%.