The US drugmaker’s regulatory filings for maternal immunization are supported by the results of the Phase 3 trial MATISSE, which will be presented to the CDC’s Advisory Committee on Immunization Practices (ACIP)


RSVpreF is a maternal vaccine candidate. (Credit: Markus Spiske on Unsplash)

Pfizer has received the US Food and Drug Administration (FDA) Priority Review for its respiratory syncytial virus (RSV) vaccine candidate RSVpreF (PF-06928316).

The US health regulator accepted Pfizer’s Biologics License Application (BLA) for RSVpreF, and has selected August 2023 as Prescription Drug User Fee Act (PDUFA) action date.

RSVpreF is indicated for active immunisation of pregnant individuals to prevent medically attended lower respiratory tract illness (MA-LRTI) and severe MA-LRTI in new-born infants.

The vaccine has received FDA Breakthrough Therapy Designation in March 2022.

In addition, the European Medicines Agency (EMA) has accepted Pfizer’s marketing authorization application (MAA) for RSVpreF, with a decision expected in the second half of this year.

Pfizer chief scientific officer and vaccine research and development senior vice president Annaliesa Anderson 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.

“We look forward to progressing the review of Pfizer’s RSV maternal vaccine candidate with the FDA and other regulatory authorities, given its significant potential to positively contribute to global health in the prevention of RSV in infants.”

Pfizer’s regulatory submission for maternal immunisation is based on positive top-line results from the Phase 3 MATISSE clinical trial

The study evaluated the efficacy, safety, and immunogenicity of RSVpreF against MA-LRTI and severe MA-LRTI in infants born to healthy women vaccinated during pregnancy.

Pfizer intends to present the study data to the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP).

Last month, Pfizer received the FDA priority review for its 20vPnC candidate to prevent invasive pneumococcal disease (IPD) in individuals aged six weeks through 17 years.

In August last year, the company announced positive outcomes for its 20-valent pneumococcal conjugate vaccine candidate, from a Phase 3 study conducted in infants.