Pfizer’s ABRYSVO Shows Promise in Phase 3 Study for RSV Prevention

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Pfizer unveils promising outcomes from its Phase 3 clinical trial, MONeT, assessing ABRYSVO’s efficacy and safety in adults aged 18 to 59 at heightened risk for severe respiratory syncytial virus (RSV)-associated lower respiratory tract disease (LRTD).

The trial successfully met its primary endpoints, showcasing ABRYSVO’s ability to elicit immune responses comparable to those observed in older adults. Participants exhibited robust neutralizing responses against RSV subgroups post-vaccination, alongside a significant increase in serum neutralizing titers.

ABRYSVO demonstrated favorable tolerability profiles throughout the study, aligning with previous safety findings. Pfizer achieved its diversity recruitment objectives, ensuring a representative sample reflecting the diverse U.S. population and a balanced distribution across various medical conditions.

With these encouraging results, Pfizer aims to submit the data to regulatory authorities for the expansion of ABRYSVO’s indication to include adults aged 18 and older. The company underscores ABRYSVO’s potential as the first RSV vaccine for this demographic.

Annaliesa Anderson, Ph.D., Senior Vice President and Head of Vaccine Research and Development at Pfizer, expressed optimism regarding ABRYSVO’s role in safeguarding at-risk adults against RSV-associated illnesses, pending regulatory approvals.