21 February 2023 - - The US Food and Drug Administration has accepted for review a Biologics License Application for US-based pharmaceutical company Pfizer Inc's (NYSE: PFE) respiratory syncytial virus 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 immunization of pregnant individuals, the company said.

This decision follows the FDA's Breakthrough Therapy Designation for RSVpreF in March 2022. The FDA has accepted the BLA for priority review and has set a Prescription Drug User Fee Act (PDUFA) action date of August 2023.

In addition, the European Medicines Agency has accepted Pfizer's marketing authorization application under accelerated assessment for its RSV vaccine candidate for both older adults and maternal immunization to help protect infants. A decision is expected in the second half of 2023.

The maternal immunization regulatory submission is supported by the positive top-line results from MATISSE (MATernal Immunization 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.

These data will be presented on February 23 to the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices and, separately, during the ReSViNET Foundation's 2023 Global Conference on Novel RSV Preventive and Therapeutic Interventions.

During the ACIP meeting on February 22-23, the company also will present positive Phase 3 results supporting the regulatory filings of Pfizer's pentavalent meningococcal vaccine (MenABCWY) candidate, as well as Pfizer's 20-valent pneumococcal conjugate vaccine (20vPnC) candidate for pediatric use.

In December 2022, Pfizer announced that the FDA had accepted for review a BLA for its MenABCWY candidate for the prevention of meningococcal disease caused by the most common serogroups in individuals 10 through 25 years of age.

The PDUFA goal date for a decision by the FDA on the MenABCWY application is in October 2023. If approved and recommended, MenABCWY could help simplify the meningococcal vaccination schedule and provide the broadest serogroup coverage of any meningococcal vaccine.

Top-line results from a randomized, active-controlled, and observer-blinded Phase 3 trial of Pfizer's pentavalent meningococcal vaccine candidate (NCT04440163) were previously announced in September 2022.

Similarly, in January 2023, Pfizer announced that the FDA had granted priority review to a supplemental BLA for its 20vPnC candidate for the prevention of invasive pneumococcal disease caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes contained in the vaccine in infants and children 6 weeks through 17 years of age, and for the prevention of otitis media caused by seven of the 20 Streptococcus pneumoniae serotypes contained in the vaccine.

The PDUFA goal date for the FDA's decision on the 20vPnC application is in April 2023. If approved, 20vPnC would have the potential to cover more of the clinically significant remaining burden of infant pneumococcal disease than any other available pneumococcal conjugate vaccine.

In August 2022 Pfizer announced top-line results from its pivotal US Phase 3 study (NCT04382326), which support the FDA application.

RSV is a contagious virus and a common cause of respiratory illness.

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.

Among children younger than five years old in the US, RSV infections account for approximately 2.1 m outpatient visits and 58,000 hospitalizations each year.

Virtually all children get an RSV infection by the time they are 2 years old7, and RSV is a leading cause of hospitalization in children