-Pfizer (Pfizer) recently announced that the U.S. Food and Drug Administration (FDA) has awarded the Breakthrough Therapy Determination (BTD) of Respiratory Syncytial Virus (RSV) bivalent pre-fusion F subunit vaccine RSVpreF (PF-06928316): is used for elderly people aged 60 and above to undergo active immunization to prevent lower respiratory tract diseases (LRTI) caused by RSV.
Earlier this month, the FDA awarded RSVpreF BTD: for pregnant women, for active immunization to prevent RSV-related LRTI from babies born to 6 months old. In November 2018, the FDA awarded RSVpreF Fast Track Qualification (FTD): Active immunization of for infants through pregnant women to prevent RSV-related LRTI.
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.
This time, the FDA awarded RSVpreF BTD, mainly based on the positive results of 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 dose of 120 μg RSVpreF in human virus challenge models. In September 2021, Pfizer announced the launch of the RENOIR study, a phase 3 clinical trial (NCT05035212), which is evaluating the effectiveness, immunogenicity and safety of single-dose RsVPRF in elderly people aged 60 and above. At present, this research is still underway.
Pfizer Senior Vice President and Head of Vaccine Research and Development said: "The FDA's decision today is an important step in our efforts to protect vulnerable groups, especially the elderly, from certain potentially severe respiratory diseases, including RSV. The clinical and economic burden of RSV is a key need and we look forward to continuing dialogue with the U.S. FDA to accelerate the development of our RSV vaccine candidate."
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 common cold for most young people, but for infants, immunodeficient people and the elderly, it can be life-threatening.
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 the discovery of National Institutes of Health (NIH), which details the key form of RSV used 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.
