GSK (NYSE:GSK) is aiming to expand the label for its respiratory syncytial virus (RSV) vaccine Arexvy, which was the first to win FDA approval. The firm is now eyeing an extension of the label to include adults aged 50 to 59, bolstered by encouraging preliminary data from a phase 3 study. The recent data from…
An overview of the RSV vaccine candidate landscape in early 2023
Respiratory syncytial virus (RSV) remains a prominent global health concern. Each year, the virus is to blame for 2.1 million outpatient visits for children under 5 years old, according to CDC. Other vulnerable populations, including older adults and immunocompromised individuals, are also at risk. Nevertheless, RSV has long been a research focus. Scientists first identified RSV in 1956.…
Icosavax shares positive early results for VLP vaccine candidate against RSV
The biopharma Icosavax (Nasdaq:ICVX) has announced positive topline interim results from its Phase 1/1b clinical trial of IVX-121, a vaccine candidate with a prefusion stabilized Respiratory Syncytial Virus (RSV) F antigen. The Phase 1 portion of the study enrolled 90 healthy young adults between 18 and 45. The Phase 1b portion included 130 healthy adults…
Agenus and GSK tout positive Phase 3 data for RSV vaccine
Immuno-oncology firm Agenus (Nasdaq:AGEN) and its partner GSK (NYSE:GSK) have announced positive headline results from a pre-specified efficacy interim analysis of the AReSVi 006 Phase 3 trial of an experimental respiratory syncytial virus (RSV) vaccine. RSV infects most children before the age of 2. Some 75,000 to 125,000 children are hospitalized as a result of…
Nirsevimab offers significant protection against RSV in infants in Phase 3 trial
AstraZeneca’s (LON:AZN) and Sanofi‘s (Nasdaq:SNY) nirsevimab had 75% efficacy against lower respiratory tract infections resulting from rr (RSV) in a Phase 3 study. There are currently few treatment options for lower respiratory tract infections stemming from RSV. Two antivirals, palivizumab and ribavirin, are available, while new vaccines are currently authorized. RSV is the most common…
GSK halts Phase 3 RSV maternal vaccine candidate program
GlaxoSmithKline plc (LSE/NYSE:GSK) has announced that it has chosen to stop enrollment and vaccination of studies testing its respiratory syncytial virus (RSV) maternal vaccine candidate in women. The company had announced a voluntary pause of the trials NCT04605159, NCT04980391 and NCT05229068 on February 18. GSK did not elaborate on the reason for halting the trials.…
Moderna launches pivotal trial for mRNA RSV vaccine
The Data and Safety Monitoring Board for Moderna’s (NASDAQ:MRNA) respiratory syncytial virus (RSV) vaccine program has backed the launch of a Phase 3 clinical study of the mRNA-1345 vaccine candidate. The study will focus on adults 60 years and older. RSV leads to approximately 177,000 hospitalizations and 14,000 deaths among adults aged 65 years or…
Janssen begins Phase 3 study for RSV vaccine in adults 60 and older
After recently sharing positive Phase 2b data related to its experimental respiratory syncytial virus (RSV) vaccine in seniors, Janssen (NYSE: JNJ) has launched a Phase 3 study of the vaccine. RSV is common and contributes to serious respiratory illnesses, including pneumonia in the elderly. The virus infects approximately 64 million people annually. The global EVERGREEN…
Moderna wins FDA fast track designation for RSV vaccine
COVID-19 vaccine pioneer Moderna (NSDQ:MRNA) is aiming to develop one of the first mRNA-based vaccines against respiratory syncytial virus (RSV). Now, the FDA has granted fast track designation for mRNA-1345, an experimental single-dose mRNA RSV vaccine in adults 60 and older. Pfizer (NYSE:PFE), Johnson & Johnson (NYSE:JNJ), GlaxoSmithKline (LON:GSK), Novavax (NSDQ:NVAX) and Bavarian Nordic (CPH:BAVA)…
Icosavax wins $100M in funding for clinical trials for bivalent RSV/hMPV vaccine candidate
Virus-like particle (VLP) technology specialist Icosavax has closed $100 million in Series B financing, which it will use for clinical studies and continued development of a SARS-CoV-2 vaccine candidate. One focus of the clinical research will be clinical trials for its bivalent respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) vaccine. RSV is a common…