April 12, 2024- Pfizer Inc. announced positive top-line immunogenicity and safety data from the ongoing pivotal Phase 3 clinical trial (NCT05842967) MONeT (RSV IMmunizatiON Study for AdulTs at Higher Risk of Severe Illness),evaluating a single dose of ABRYSVO versus placebo in adults 18 to 59 years of age at risk of developing severe respiratory syncytial virus (RSV)-associated lower respiratory tract disease (LRTD).
Adults with certain underlying chronic conditions are at increased risk of developing, and being hospitalized for, RSV-associated LRTD. Among US adults 18 to 49 years of age, 9.5 percent have a chronic condition that puts them at risk of severe RSV disease and this percentage rises to 24.3 percent among persons 50 to 64 years of age.
However, no RSV vaccines have been approved for use in adults 18 to 59 years of age. The MONeT study was initiated to address this significant unmet need by investigating the immunogenicity and safety of ABRYSVO in adults aged 18 to 59 at increased risk for RSV disease, such as those with asthma, diabetes, and chronic obstructive pulmonary disease.
Participants demonstrated RSV-A and RSV-B subgroup neutralizing responses non-inferior to the response seen in the Phase 3 (NCT05035212) RENOIR study of ABRYSVO in more than 34,000 adults aged 60 or older where vaccine efficacy was previously demonstrated.