New York November 16 2023

Pfizer RSV Vaccine Shows Promise in Preventing Hospitalizations

New York, November 16, 2023

Pfizer Inc. (PFE) today announced top-line results from a Phase 3 trial of its respiratory syncytial virus (RSV) vaccine, Abrysvo. The vaccine demonstrated a statistically significant reduction in the incidence of RSV-associated lower respiratory tract infections (LRTIs) leading to hospitalization in adults aged 60 years and older.

Key Findings

The trial, known as PREVAIL III, enrolled over 37,000 adults aged 60 years and older. Participants were randomized to receive either a single dose of Abrysvo or a placebo. The primary endpoint was the incidence of RSV-associated LRTIs leading to hospitalization.

The results showed that Abrysvo reduced the incidence of RSV-associated LRTIs leading to hospitalization by 85.7% (95% confidence interval: 77.2% to 90.6%). The vaccine was also well-tolerated, with no serious safety concerns reported.

Significance

RSV is a common and potentially serious respiratory virus that can cause significant morbidity and mortality, especially among older adults. There is currently no approved vaccine to prevent RSV infection.

The results of the PREVAIL III trial suggest that Abrysvo could be an important new tool for preventing RSV-associated hospitalizations in older adults. The vaccine is currently under review by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).