US FDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review

Pfizer

21 February 2023 - US FDA has set an action date for August 2023.

Pfizer today announced that the US FDA has accepted for review a biologics license application for its respiratory syncytial virus (RSV) vaccine candidate PF-06928316 or RSVpreF for the prevention of medically attended lower respiratory tract illness (MA-LRTI) and severe MA-LRTI caused by RSV in infants from birth up to six months of age by active immunisation of pregnant individuals.

Read Pfizer press release

Michael Wonder

Posted by:

Michael Wonder

Posted in:

US , Vaccine , Priority review , Dossier