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Nov 6, 2022

After promising trial results for maternal RSV vaccine, Pfizer says it will seek FDA approval this year

Posted by in category: biotech/medical

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.

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