Pfizer's maternal respiratory syncytial virus vaccine is ready to submit for FDA approval by the end of the year, CNN reported Nov. 1.
In the trial, Pfizer gave 7,400 pregnant women the vaccine and studied the presence and effectiveness of antibodies passed to the babies. The vaccine was 82 percent effective at preventing severe RSV in hospitalized babies for the first three months of life. After six months, it was 70 percent effective.
"The [study data monitoring committee] recommended, based on the data that we have, that we should go ahead and file, that this offers the potential for a safe and effective vaccine that could really dramatically help to prevent RSV during the winter season," William Gruber, MD, senior vice president of vaccine clinical research and development at Pfizer, told CNN.
If approved, this would be the first RSV vaccine and the first new product related to the infection in over two decades.