Pfizer yesterday announced that the US Food and Drug Administration (FDA) has accepted it licensing application, which starts the review of its candidate respiratory syncytial virus (RSV) vaccine (RSVpreF) for use in pregnant women to help protect babies against the virus.
In a press release, Pfizer said the FDA's review will be done on a priority basis and that the agency expects a decision in August. In December, the FDA granted priority review of the vaccine for use in older adults.
Pfizer said the data supporting use in pregnant women comes from promising results from a phase 3 trial, which it will present to the Centers for Disease Control and Prevention vaccine advisory group tomorrow.
If approved, RSVpreF would help protect infants at their first breath from the devastating effects of this infectious disease.
RSV, a common and contagious respiratory illness, can cause severe disease in infants, older people, and others who have underlying health conditions. RSV bronchiolitis—a cause of respiratory distress that is sometimes fatal—is the leading cause of infant hospitalization due to viral illness. Currently, there is no RSV vaccine, and treatment options are limited.
Annaliesa Anderson, PhD, senior vice president and chief scientific officer in vaccine research and development at Pfizer, said, "If approved, RSVpreF would help protect infants at their first breath from the devastating effects of this infectious disease, which, though well-known, has been particularly evident throughout this RSV season."