Pfizer's Respiratory Syncytial Virus Vaccine Data Shows Promise In Subgroup Of Younger Immunocompromised Patients

On Monday, Pfizer Inc. PFE released top-line safety and immunogenicity results from substudy B of the ongoing pivotal MONeT Phase 3 trial, evaluating two doses of Abrysvo vaccine in immunocompromised adults aged 18 and older at risk of developing severe respiratory syncytial virus-associated lower respiratory tract disease.

Also Read: Moderna Scores FDA Approval For Its Second Product – Respiratory Syncytial Virus Vaccine.

Abrysvo was well-tolerated during the trial, showing a safety profile consistent with findings from other studies of the vaccine.

While the company evaluated two doses, a single 120 µg dose of Abrysvo generated a strong neutralizing response against both subtypes of RSV, RSV-A, and RSV-B, across all cohorts and age groups in the study.

In June of 2024, at the Advisory Committee on Immunization Practices meeting, Pfizer presented results from a cohort of adults aged 18-59 with certain chronic medical conditions.

Participants demonstrated RSV-A and RSV-B subgroup neutralizing responses non-inferior to the response seen in the Phase 3 RENOIR study of Abrysvo, which previously demonstrated Abrysvo’s efficacy in adults aged 60 or older.

Additionally, the FDA approved Pfizer’s supplemental Biologics License Application for the ACT-O-VIAL presentation of Abrysvo.

This approval allows Pfizer to market a new option alongside its existing needle-free reconstitution kits.

The ACT-O-VIAL System is a dual-component vial system that simplifies the reconstitution of Abrysvo within a single, compact device.

According to a small study by Weill Cornell Medicine and New York-Presbyterian investigators, vaccinating mothers using Abrysvo during late pregnancy to protect their newborns is not associated with an increased risk of preterm birth or other poor outcomes.

The FDA approved the Abrysvo (RSVpreF) vaccine last year. It targets women in their second or third trimesters to prevent RSV infections in newborns during their first six months.

Price Action: PFE stock is up 0.26% at $28.63 during the premarket session at last check Monday.

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