Pfizer Inc has reported encouraging top-line results from its Phase 3 clinical trial of ABRYSVO. The trial demonstrates that Abrysvo is well-tolerated and elicits strong neutralizing responses against RSV in immunocompromised adults. A single 120 µg dose of Abrysvo effectively targets both RSV-A and RSV-B, offering substantial protection for this vulnerable population. Pfizer plans to present these findings at an upcoming scientific conference and publish them in a peer-reviewed journal.
The results are from substudy B of the MONeT trial (NCT05842967), which assessed the vaccine in 203 adults with conditions such as non-small cell lung cancer, end-stage renal disease on hemodialysis, autoimmune inflammatory disorders, and solid organ transplant recipients. While both one and two-dose regimens were evaluated, the single-dose regimen showed particularly promising results. The safety profile of Abrysvo was consistent with previous studies.
Additionally, Pfizer has secured US FDA approval for the ACT-O-VIAL® presentation of ABRYSVO, a dual-component vial system intended to streamline vaccine reconstitution and enhance storage efficiency. These findings build on earlier data presented to the Advisory Committee on Immunization Practices (ACIP) and reinforce Abrysvo’s use for older adults and maternal immunization to protect infants from RSV. Pfizer has also obtained various international approvals for ABRYSVO, including from the European Medicines Agency, Argentina’s ANMAT, the UK’s MHRA, Health Canada, and others.
