Pfizer Granted FDA Breakthrough Therapy Designation for RSVpreF Maternal Vaccine to Protect Infants from Birth Through Six Months
Mar 03, 2022 01:22
CST Updated
01:22
Pfizer
Pharmaceutical R&D Developer
FDA
U.S. Food and Drug Administration
News on March 2, 2022 /BioValleyBIOON/ --Pfizer(Pfizer) recently announced that the U.S. Food and Drug Administration (FDA) has grantedRespiratory Syncytial Virus (RSV) Bivalent Prefusion F Subunit Vaccine (RSVpreF)) Breakthrough Therapy Designation (BTD):For pregnant women, active immunization is performed to prevent RSV-related lower respiratory tract illness (LRTI) in infants from birth to 6 months of age.. November 2018,FDAGranting RSVpreF Fast Track Designation (FTD): Prevention of Infant RSV-associated 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 new treatment options are provided to patients in the shortest possible time.
FDAThe granting of BTD for RSVpreF was based on the results of the Phase 2b proof-of-concept study (NCT04032093). This was a global, double-blind, placebo-controlled study conducted in healthy pregnant women aged 18-49, who were vaccinated with RSVpreF during weeks 28-36 of gestation. The study evaluated the safety and immunogenicity of RSVpreF in these healthy pregnant women and their infants.The purpose is to enable infants to acquire the ability to resist RSV-related lower respiratory tract infections (LRTI) through maternal immunization.Pfizer will announce the results of this clinical study in the future.
Kathrin U. Jansen, PhD, Senior Vice President and Head of Vaccine Research and Development at Pfizer, stated: "The FDA's decision today is a critical next step in the regulatory pathway for our maternal RSV vaccine candidate and an important milestone in our efforts to help address the harmful impact of RSV disease on infants."If approved by the FDA, this maternal-infant immunity has the potential to become the first vaccine to help vulnerable infants avoid diseases caused by this highly contagious virus in the first few months after birth.We look forward toFDA"Continue the dialogue to accelerate the development of a maternal 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, the immunocompromised, 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 a 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. Drawing on insights from this important work, Pfizer developed and tested numerous vaccine candidates, identifying in preclinical evaluations a candidate capable of eliciting a strong antiviral immune response. This led to the current vaccine candidate, RSVpreF, which is being evaluated in human trials by Pfizer. RSVpreF consists of two preF proteins, designed to optimize protection against both RSV type A and B, and is currently undergoing Phase 3 clinical trials.Clinical Trial. (Bioon.com)