Pfizer Receives FDA Breakthrough Therapy Designation for RSVpreF Vaccine to Protect Adults Aged 60 and Older

News on March 24, 2022 /BioValleyBIOON/ --Pfizer(Pfizer) recently announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to the respiratory syncytial virus (RSV) bivalent prefusion F subunit vaccine RSVpreF (PF-06928316):For active immunization in individuals aged 60 years and older to prevent lower respiratory tract disease (LRTI) caused by RSV.

Earlier this month, the FDA granted RSVpreF BTD:For pregnant women, active immunization is performed to prevent RSV-related LRTI in infants from birth to 6 months of age.. November 2018,FDAGranting RSVpreF Fast Track Designation (FTD): Prevention of Infant RSV-related LRTI through Active Immunization of Pregnant Women.

BTD is a new drug review channel of the FDA, aimed at accelerating the development and review of new drugs for the treatment of serious or life-threatening diseases, and with preliminary clinical evidence indicating a substantial improvement over existing treatments. Drugs that receive BTD can obtain support during the research and development process, includingFDACloser guidance from senior officials, eligible for rolling review and potential priority review during the review process, to ensure that new treatment options are provided to patients in the shortest possible time.

This timeFDAThe granting of RSVpreF BTD was primarily based on positive results from a Phase 2a proof-of-concept study. The study was conducted in healthy adults aged 18-50 and evaluated the safety, immunogenicity, and efficacy of a single 120μg dose of RSVpreF in a human viral challenge model. In September 2021, Pfizer announced the initiation of the RENOIR study, a Phase 3 trial.Clinical Trial(NCT05035212), is evaluating the efficacy, immunogenicity, and safety of a single dose of RsVPRF in elderly individuals aged 60 years and above. Currently, this study is still ongoing.

Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research and Development at Pfizer, stated: "The FDA's decision today is an important step in our efforts to protect vulnerable populations, particularly the elderly, from certain potentially serious respiratory diseases, including RSV. The clinical and economic burden of RSV represents a critical need, and we look forward to working with the United States...FDA"Carry out continuous dialogue to accelerate the development of our RSV candidate vaccine."

Respiratory Syncytial Virus (RSV) is a common and widespread cause of acute respiratory diseases. The virus is highly contagious and affects the lungs and respiratory tract. RSV infections occur in people of all age groups; for most young individuals, it resembles the common cold, but for infants, immunocompromised individuals, and the elderly, it can be life-threatening.

Currently, there is no vaccine to prevent RSV, and the medical community is limited to providing supportive care for patients. RSVpreF is a candidate RSV vaccine being developed by Pfizer. This vaccine is based on fundamental scientific discoveries, including those made by the U.S. National Institutes of Health (NIH), which detailed the crystal structure of a key form of the viral protein that RSV uses to attack human cells.

NIH research shows that the antibodies protecting humans from RSV infection target a form of this viral protein. Applying insights from this important work, Pfizer developed and tested numerous vaccine candidates, identifying in preclinical evaluations a candidate capable of stimulating a strong antiviral immune response, leading to the current vaccine candidate RSVpreF being evaluated in human trials by Pfizer. RSVpreF consists of two preF proteins, designed to optimize protection against RSV types A and B, and is currently undergoing Phase 3 clinical trials.Clinical Trial. (Bioon.com)

Source of Original Text:Pfizer Granted FDA Breakthrough Therapy Designation for Respiratory Syncytial Virus Vaccine Candidate for the Prevention of RSV in Older Adults