Pfizer says clinical trial data on RSV vaccine promising

Pfizer has announced promising data on its clinical trial on Respiratory Syncytial Virus (RSV) vaccine, adding it will submit application to the U.S. Food and Drug Administration (FDA) by the end of this year.

The bivalent RSV prefusion vaccine candidate, named PF-06928316, was administered to pregnant participants to help protect their infants from RSV disease after birth.

Vaccine efficacy of 81.8 percent was observed against severe medically attended lower respiratory tract illness due to RSV in infants from birth through the first 90 days of life with high efficacy of 69.4 percent demonstrated through the first six months of life, Pfizer said Tuesday.

The vaccine was well-tolerated with no safety concerns for both vaccinated individuals and their newborns, according to Pfizer.

Pfizer plans to submit its first regulatory application to the FDA by the end of 2022.

If approved, Pfizer's RSV vaccine candidate could be the first maternal vaccine available to help prevent this common and potentially life-threatening respiratory illness in young infants.