FDA grant Breakthrough Therapy Designation for RSV vaccine candidate in older adults
pharmafile | March 25, 2022 | News story | Medical Communications |
Pfizer has announced that its respiratory syncytial virus (RSV) vaccine candidate has received Breakthrough Therapy Designation from the FDA, for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age or older.
In the US alone, among older adults, RSV infections account for approximately 177,000 hospitalisations, and 14,000 deaths each year.
In children younger than five years old in the US, approximately 2.1 million outpatient visits, and 58,000 hospitalisations occur each year due to RSV.
The vaccine, PF-06928316 or RSVpreF, demonstrated efficacy in a proof-of-concept Phase IIa study, evaluating the safety, and immunogenicity of a single dose of the vaccine in a human viral challenge model in healthy adults aged 18 to 50 years of age.
The FDA decision was primarily informed by this trial.
Pfizer also recently initiated the Phase III RENOIR trial, evaluating the efficacy, immunogenicity, and safety of a single dose of RSVpreF, in adults aged 60 years and older. The study remains ongoing.
Breakthrough Therapy Designations are aimed at speeding up both the development and the review of treatments targeted at serious or life-threatening conditions.
RSV is a contagious virus, and a common cause of respiratory illness. It can affect the lungs and breathing passages of an infected individual, and can be potentially life-threatening for young infants, children with chronic medical conditions, and older adults.
RSV is a disease for which there are currently no prophylactic, therapeutic, or vaccine options for older adults, and the medical community is limited to offering only supportive care for adults with the illness.
Pfizer’s investigational RSV vaccine candidate builds on foundational basic science discoveries, including those made at the National Institutes of Health (NIH), detailing a crystal structure of Prefusion F, a key form of the viral fusion protein that RSV uses to attack human cells. The NIH research showed that antibodies specific to this were highly effective at blocking virus infection, suggesting a Prefusion F-based vaccine may confer optimal protection against RSV.