About GSK’s RSV vaccine
2024年10月24日 · GSK plc (LSE/NYSE: GSK) today announced new preliminary data for Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) in adults aged 18-49 at increased risk for RSV-LRTD due to certain underlying medical conditions and in adults who are immunocompromised.
New RSV Vaccine Label Updated to Note Risk of Rare Guillain …
3 天之前 · The Food and Drug Administration (FDA) will now require labeling changes for 2 respiratory syncytial virus (RSV) vaccines to warn of the potential risk of Guillain-Barré syndrome (GBS) associated with the vaccines. Postmarket observational studies suggest there is an increased risk of GBS during the 42 days following vaccination with Pfizer’s Abrysvo vaccine for RSV and GSK’s Arexvy ...
US FDA approves GSK’s AREXVY, the world’s first respiratory …
2023年5月3日 · Respiratory syncytial virus vaccine, adjuvanted, contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK’s proprietary AS01 E adjuvant. In the US, AREXVY is indicated for the prevention of RSV-LRTD in individuals 60 years of age and older.
New data for AREXVY, GSK’s respiratory syncytial virus vaccine, …
GSK plc (LSE/NYSE: GSK) today announced new preliminary data for AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) in adults aged 18-49 at increased risk for lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) due to certain underlying medical conditions and in adults who are immunocompromised.
GSK presents positive data for AREXVY, its respiratory syncytial …
2024年10月8日 · This is a randomized, placebo-controlled, double-blind, multi-country phase III trial to demonstrate the efficacy of a single dose of GSK's adjuvanted RSV older adult vaccine over three years and following an annual revaccination schedule in adults aged 60 years and above compared to a placebo arm.
FDA approves first vaccine for RSV, a moment six decades in the ... - CNN
2023年5月3日 · After a 60-year scientific quest, the world has its first vaccine to protect against respiratory syncytial virus, or RSV – and more are on the way. On Wednesday, the US Food and Drug Administration...
GSK, Pfizer RSV Shots Required to Carry Guillain-Barré Syndrome ...
2025年1月8日 · A post-marketing review by the FDA detected an increased risk of the autoimmune condition in patients inoculated with GSK’s Arexvy and Pfizer’s Abrysvo, prompting the regulator to require adjustments to the vaccines’ labels.
GSK on top in RSV jab rollout, but is Pfizer closing the gap?
2 天之前 · GSK and Pfizer’s full-year financial results show that the former is currently winning the battle for take-up of their rival respiratory syncytial virus (RSV) vaccines, although, there are...
About Arexvy (respiratory syncytial virus vaccine, adjuvanted) - GSK
2023年6月21日 · New results from the ongoing AReSVi-006 phase III trial show vaccine efficacy against RSV-lower respiratory tract disease and severe disease over two full RSV seasons, including in participants with underlying medical conditions
GSK’s RSV vaccine, Arexvy, accepted under Priority Review in US …
2024年2月6日 · GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has accepted under priority review an application to extend the indication of GSK’s adjuvanted respiratory syncytial virus (RSV) vaccine to adults aged 50-59 who are at increased risk for RSV disease.