(CNN) Pfizer says it has enough promising data on its respiratory syncytial virus, or RSV, vaccine designed to protect newborns that it will end enrollment in the study and submit for US Food and Drug Administration approval by the end of the year.
RSV is a common respiratory virus that typically causes mild, cold-like symptoms, but it can cause serious illness, particularly in older adults and infants. Pfizer’s vaccine candidate is administered to pregnant women who then make antibodies that cross the placenta and protect the baby after birth.
“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,” Dr. William Gruber, Pfizer’s senior vice president of vaccine clinical research and development, told CNN.
In the trial, the vaccine was given to pregnant people and appeared to be about 80% effective at preventing severe RSV disease in their infants in the first three months of life. It also cut a baby’s risk of needing to see a doctor for an RSV infection by half.
Potential for first new product in decades
If approved, Pfizer’s inoculation will be the first against RSV and the first new product related to the infection in over two decades.
In March, the FDA designated Pfizer’s RSV vaccine a breakthrough therapy, a status that speeds its review.
“That puts us in a very good position to essentially have something well in advance of next winter,” Gruber said, noting that both Pfizer and the FDA are conscious of the ongoing heavy RSV season in the US
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