FDA greenlights Pfizer’s ABRYSVO vaccine for shielding infants from RSV

FDA greenlights Pfizer’s ABRYSVO vaccine for shielding infants from RSV

The US Food and Drug Administration (FDA) has granted approval to Pfizer Inc.’s ABRYSVO, a bivalent Respiratory Syncytial Virus prefusion F (RSVpreF) vaccine. This cutting-edge vaccine is designed for the prevention of Lower Respiratory Tract Disease (LRTD) and severe LRTD caused by RSV in infants. Notably, the vaccine works through active immunization of pregnant individuals […]

Pfizer RSVpreF vaccine candidate gets another FDA breakthrough therapy status

Pfizer RSVpreF vaccine candidate gets another FDA breakthrough therapy status

Pfizer said that PF-06928316 (RSVpreF), its respiratory syncytial virus (RSV) vaccine candidate, has been granted breakthrough therapy designation from the US Food and Drug Administration (FDA). The breakthrough therapy designation is for the use of the vaccine candidate in the prevention of lower respiratory tract disease caused by RSV in patients aged 60 years or […]

Pfizer gets FDA breakthrough status for RSVpreF RSV vaccine candidate

Pfizer gets FDA breakthrough status for RSVpreF RSV vaccine candidate

Pfizer has secured breakthrough therapy designation for its respiratory syncytial virus (RSV) vaccine candidate — PF-06928316 (RSVpreF) from the US Food and Drug Administration (FDA) for the prevention of RSV-associated lower respiratory tract illness in infants from the time of birth up to six months by active immunization of pregnant women. According to Pfizer, the […]

Pfizer begins phase 3 clinical trials of 20vPnC, RSVpreF, and MenABCWY vaccine candidates

Pfizer begins phase 3 clinical trials of 20vPnC, RSVpreF, and MenABCWY vaccine candidates

US pharma giant Pfizer has initiated four phase 3 clinical trials within its present pipeline of investigational vaccines. The company’s 20vPnC, which is a 20-valent pneumococcal polysaccharide conjugate vaccine candidate, will be evaluated in two phase 3 trials NCT04382326 and NCT04379713. Both the late-stage trials will evaluate a four-dose series in infants starting at the […]