FDA Requires Warning for Guillain-Barré Syndrome in Prescribing ...
2025年1月7日 · The FDA requires a GBS warning for RSV vaccines Abrysvo and Arexvy due to increased risk within 42 days post-vaccination. Clinical trials and postmarketing data show rare GBS cases, with Arexvy reporting more adverse events than Abrysvo.
RSV Vaccine Labeling Updated With Guillain-Barré Syndrome …
5 天之前 · The prescribing information for Abrysvo ® (respiratory syncytial virus [RSV] vaccine) and Arexvy ® (RSV vaccine, adjuvanted) has been updated to include a new warning regarding the risk of Guillain-Barré syndrome (GBS) following vaccination.. To assess the risk of GBS with these vaccines, the FDA conducted a postmarketing observational study that used Medicare …
New data for Arexvy, GSK’s respiratory syncytial virus 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.
RSV Vaccines Will Carry Warning for Guillain-Barré Syndrome
4 天之前 · Arexvy was initially approved on May 3, 2023, for prevention of LRTD associated with RSV in adults aged 60 years or more, and has since been approved for the same indication in adults aged 50-59 ...
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 Presents Positive Data for AREXVY, Its Respiratory Syncytial …
2024年10月8日 · AREXVY is the world’s first RSV vaccine and was approved based on exceptional efficacy in adults aged 60 and older including those who are at increased risk due to certain underlying medical...
GSK Posts New Data From Phase III Study on RSV Vaccine Arexvy
2024年10月10日 · New data from GSK's phase III study evaluating a single dose of RSV vaccine Arexvy indicates protection over three RSV seasons in adults aged 60 years and above.
GSK's Arexvy excels in two trials for at-risk patients age 18-49
2024年10月24日 · Preliminary results from two trials showed that GSK’s respiratory syncytial virus (RSV) vaccine Arexvy has potential in younger adults with certain risk factors to prevent disease, potentially...
GSK's RSV Vaccine Arexvy Gets FDA Nod for Adults 50-59 Years
2024年6月10日 · Arexvy is currently approved in the United States, Europe, Japan and several other countries in adults aged 60 and more for the prevention of lower respiratory tract disease (LRTD) caused by...
Arexvy Looks Promising for RSV Protection in Younger At-Risk …
2024年11月4日 · New data for Arexvy, GSK’s respiratory syncytial virus vaccine, show potential to help protect a broader group of adults at increased risk for RSV disease. News release. GSK. October 24, 2024.