Pfizer recently announced that the U.S. Food and Drug Administration (FDA) has granted the Breakthrough Therapy Determination (BTD): Respiratory Syncytial Virus (RSV) Bivalent Pre-fusion F subunit vaccine (RSVpreF) Breakthrough Therapy Determination (BTD): is used in pregnant women and is actively immunized to prevent RSV-related lower respiratory disease (LRTI) from babies born to 6 months old. In November 2018, the FDA awarded RSVpreF Fast Track Qualification (FTD): Prevent RSV-related LRTIs through active immunization of pregnant women.
BTD is a new drug review channel for the FDA, aiming to accelerate the development and review of new drugs used to treat severe or virgin diseases and have preliminary clinical evidence that it can substantially improve the condition compared with existing therapeutic drugs. Drugs obtained with BTD can be more closely guided by senior FDA officials during research and development, and are eligible for rolling reviews and potential priority reviews during reviews to ensure new treatment options for patients in the shortest time.
FDA awarded RSVpreF BTD, which is based on the results of the Phase 2b proof of concept study (NCT04032093). This is a global, double-blind, placebo-controlled study conducted in healthy pregnant women aged 18-49 who were vaccinated with RSVpreF during the 28-36 weeks of gestation. This study evaluated the safety and immunogenicity of RSVpreF in these healthy pregnant women and their infants, with the aim of enabling infants to gain resistance to RSV-associated lower respiratory tract diseases (LRTIs) through maternal immunity. Pfizer will announce the results of this clinical study in the future.
Pfizer Senior Vice President and Head of Vaccine Research and Development Kathrin "The FDA's decision today is a critical next step in our maternal RSV vaccine candidates toward the regulatory path and an important milestone in our efforts to help address the harmful effects of RSV disease on babies," said Dr. U. Jansen. "If approved by the FDA, this maternal and infant immunity has the potential to be the first vaccine to help vulnerable babies avoid diseases caused by this highly contagious virus in the first few months of birth. We look forward to continuing our conversation with the FDA to accelerate the development of maternal and infant RSV vaccine candidates."
Respiratory syncytial virus (RSV) is a common and common cause of acute respiratory diseases. The virus is highly contagious and affects the lungs and respiratory tract. RSV infection occurs in people of all ages and is like a common cold for most young people, but can be life-threatening for infants, immunodeficient people and older people.
At present, there is no vaccine to prevent RSV, and the medical community is limited to providing supportive care to patients. RSVpreF is an RSV candidate vaccine that Pfizer is developing, which builds on basic scientific discoveries, including a discovery from the National Institutes of Health (NIH), which details the crystal structure of a key form of a viral protein used by RSV to attack human cells.
NIH research shows that antibodies that protect humans from RSV infection target a form of this viral protein. Using insights from this important work, Pfizer has developed and tested many vaccine candidates and identified candidates that can inspire strong antiviral immune responses in preclinical assessments, thus obtaining the vaccine candidate RSVpreF, which is being evaluated in human trials. RSVpreF consists of 2 preF proteins, designed to optimize the protection of RSV types A and B, and is currently undergoing Phase 3 human clinical trials.
