Pfizer’s ABRYSVO Shows Promise in Immunocompromised Adults

Pfizer Inc. has announced positive top-line safety and immunogenicity data from a substudy of its ongoing Phase 3 MONeT trial evaluating ABRYSVO for the prevention of respiratory syncytial virus (RSV) in immunocompromised adults. The data showed a single dose of the vaccine was well-tolerated and generated a strong immune response across various immunocompromised patient groups.
 
The substudy enrolled 203 adults with conditions such as cancer, kidney disease, autoimmune disorders, and organ transplants. While the trial evaluated two doses, a single 120 µg dose of ABRYSVO demonstrated robust neutralizing antibodies against both RSV-A and RSV-B strains.
 
“Immunocompromised adults, such as patients with cancer or autoimmune disorders, have a substantially increased risk of experiencing severe complications from RSV, yet there are currently no vaccines approved for those aged 18 to 59 in the U.S.,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. “We are encouraged by the positive top-line data from this study, which provide important evidence that ABRYSVO has the potential to address a significant unmet need in this vulnerable population.”
 
Pfizer plans to submit these data to regulatory authorities and present the findings at an upcoming scientific conference.
 
In addition to the positive substudy results, the company announced FDA approval of the ACT-O-VIAL presentation of ABRYSVO, offering a new administration option for healthcare providers.
 
The news follows earlier positive data on ABRYSVO in other high-risk adult populations, including those aged 18-59 with chronic medical conditions.
 
Pfizer’s RSV vaccine, ABRYSVO, was previously approved for adults aged 60 and older.