Pharma Focus Asia

Pfizer Gets U.S. FDA Acceptance for Biologics Licence Application for its Respiratory Syncytial Virus Vaccine Candidate

Tuesday, February 21, 2023

Pfizer announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics Licence Application (BLA) 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.

If approved, RSVpreFwould be the first vaccine for administration to pregnant individuals to help protect against the complications of RSV disease in infants from birth through six months.

The maternal immunisation regulatory submission is supported by the positive top-line results from MATISSE (MATernal Immunisation Study for Safety and Efficacy), a Phase 3 clinical trial evaluating the efficacy, safety, and immunogenicity of RSVpreF against MA-LRTI and severe MA-LRTI in infants born to healthy women vaccinated during pregnancy.

RSV is a contagious virus and a common cause of respiratory illness.1 The virus can affect the lungs and breathing passages of an infected individual and can potentially cause severe illness in young infants, older adults, and individuals with certain chronic medical conditions.

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