Positive top-line data from phase III RENOIR trial of RSVpreF in older adults for respiratory syncytial virus

The bivalent vaccine candidate is composed of two preF proteins selected to optimize protection against RSV A and B strains.

RSV disease is characterized by several respiratory symptoms varying from mild to more severe disease, with more severe disease having more symptoms. A pre-planned, interim analysis of Pfizer’s RSVpreF efficacy conducted by an independent, external Data Monitoring Committee (DMC) to assess protection against RSV-associated lower respiratory tract illness (LRTI-RSV) defined by two or more symptoms demonstrated vaccine efficacy: 66.7% (96.66% CI: 28.8%, 85.8%). This positive result enabled Pfizer to look at the more severe disease primary endpoint of LRTI-RSV defined by three or more symptoms, where vaccine efficacy of 85.7% (96.66% CI: 32.0%, 98.7%) was observed. The DMC also indicated the investigational vaccine was well-tolerated, with no safety concerns. Based on these results, Pfizer plans to submit a Biologics License Application (BLA) to the FDA for RSVpreF and to prepare submissions for other regulatory authorities in the coming months.

Pfizer intends to present results of this interim analysis at a future medical congress and will submit the results for peer-review in a scientific journal.

The Phase III RENOIR trial is a global, randomized, double-blind, placebo-controlled study designed to assess the efficacy, immunogenicity, and safety of a single dose of RSVpreF in adults 60 years of age and older. To date, RENOIR has enrolled approximately 37,000 participants, randomized to receive 120?g RSVpreF or placebo in a 1:1 ratio. Enrollment up to approximately 40,000 participants continues in the Southern Hemisphere to accumulate cases during their first season.

Burden of RSV in Older Adults : RSV is a contagious virus that in healthy individuals can cause serious respiratory illness. The virus can affect the lungs and breathing passages of an infected individual and can be potentially life-threatening for older adults and adults with certain medical conditions. Each year it is estimated that 336,000 older adults are hospitalized globally due to RSV. In the United States alone, RSV infections in older adults account for approximately 177,000 hospitalizations and 14,000 deaths each year. RSV is a disease for which there are currently no prophylactic or therapeutic options for older adults and the medical community is limited to offering only supportive care for adults with the illness.