On October 25, GSK released positive preliminary results from the Phase III trial (NCT05590403) of the respiratory syncytial virus (RSV) vaccine Arexvy:Arexvy Demonstrates Non-Inferior Immune Response in Adults Aged 50-59 Compared to Adults Aged 60 and Above, Including Subgroups with Underlying Medical Conditions。RSV is an extremely common, airborne RNA virus. The populations at risk are infants, young children, and the elderly. Infection can cause symptoms such as fever and coughing, and in severe cases, may lead to respiratory distress or even complete airway blockage, resulting in respiratory failure and death. Although RSV typically poses a greater threat to infants and the elderly, comorbidities like chronic obstructive pulmonary disease (COPD) or asthma put other individuals at a higher risk of infection.NCT05590403 is a placebo-controlled, observer-blind, randomized, multi-national immunogenicity Phase III trial designed to evaluate the non-inferiority of immune responses and assess the safety in 50-59-year-old participants after receiving a single dose of GSK RSV vaccine compared to elderly individuals with an increased risk of RSV-LRTD. The study evaluated the immune response in 50-59-year-old participants (n=570) with pre-determined stable chronic conditions that increase the risk of RSV disease, including those with chronic lung disease, chronic cardiovascular disease, diabetes, chronic kidney disease, or chronic liver disease.The trial recruited approximately 1,520 participants across eight countries.。The primary endpoint of the trial is the RSV-A and RSV-B neutralizing titers one month after vaccination in the 50-59 age group compared with adults aged 60 and above. The secondary and tertiary endpoints are safety and immunogenicity.The trial is ongoing to collect further immunogenicity data at 6 and 12 months post-vaccination.。According to reports,The safety and reactogenicity data of Arexvy in this trial are also consistent with the results from the initial Phase III program.. The most common adverse events arePain, Fatigue, and Headache, most of which areMild and TransientThe statement did not provide more detailed data, but GSK said it plans to release the trial results at a meeting of the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP).Additionally, GSK CSO Tony Wood stated in a declaration that the Phase III results indicate Arexvy "has the potential to help protect adults aged 50-59." He also mentioned, "We will submit these data for regulatory review as soon as possible, aiming to provide vaccine options for adults in this age group for the first time." The company will present the full findings and analysis results of the trial at a future medical conference.Arexvy is the first RSV vaccine to receive FDA approval. However, its currently approved target population is adults aged 60 years and above. Pfizer's Abrysvo was approved a month later and targets the same age group. Nevertheless,Abrysvo Expanded Its Indication in August to Include Protection for Newborns When Administered to Pregnant Women. Pfizer also announced that month that it would test Abrysvo in people aged 18-60 whose underlying health conditions put them at higher risk. Notably, both GSK's and Pfizer's RSV vaccines were recently featured on TIME Magazine's list of the Best Inventions of 2023.In fact,Regarding the RSV vaccine, GSK and Pfizer are also in a patent dispute.In August 2023, GSK accused Pfizer of infringing on four patents related to the antigen used in Arexvy. In a lawsuit filed with the Federal Court in Delaware, GSK claimed that Pfizer's Abrysvo utilized GSK's protected inventions. GSK is currently seeking a jury trial and monetary compensation. Pfizer has denied these allegations and stated that it will defend its position.GSK Sues Pfizer for Infringement, RSV Vaccine Patent War Begins!）InMarket Performance of ArexvyAccording to GSK's Q2 financial report this year, sales of Arexvy are expected to be lower than those of the blockbuster shingles vaccine Shingrix. However, the administration of Arexvy is anticipated to be a strong growth driver, especially since it was approved ahead of the 2023-2024 RSV season. GSK estimates that about 80 million elderly people in the U.S. are ready to receive their first RSV vaccine. Additionally, GSK stated during Wednesday’s meeting with ACIP,As of mid-October, the vaccine had been administered over 2 million doses in retail settings.In the global RSV vaccine market, in addition to Pfizer and GSK, Moderna's RSV vaccine MRNA-1345 has also been submitted for regulatory approval in multiple countries this July, intended for the prevention of RSV-related lower respiratory tract disease (RSV-LRTD) and acute respiratory disease (ARD) in adults aged 60 years or older.First mRNA RSV Vaccine: Moderna Submits Global Regulatory Application!）References:
[1]GSK Looks to Push RSV Vaccine to Younger Seniors with New Phase III Data. Published: Oct 25, 2023 By Tristan Manalac.
[2]GSK says RSV vaccine triggered immune response in adults as young as 50 years old. Nicole DeFeudis.October 25, 2023 03:00 PM EDT.
