FDA Alert: FDA Requires Guillain-Barré Syndrome (GBS) Warning …
6 days ago · Abrysvo was initially approved on May 31, 2023, for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. Subsequently, FDA has approved the vaccine for the following: ... Subscribe to our newsletter for the latest medication news, new drug approvals and ...
FDA Urges Guillain-Barré Syndrome Warning On Labels Of RSV …
4 days ago · (RTTNews) - The FDA has required the manufacturers of the RSV Vaccines Abrysvo and Arexvy to add a new warning to their labels about the potential risk of Guillain-Barré Syndrome following ...
FDA Requires Warning for Guillain-Barré Syndrome in Prescribing ...
6 days ago · The news release noted that background risks of GBS in the study population can influence excess GBS case estimates and may differ between studies and analyses within a study. 1. In clinical trials supporting the original FDA approval of Abrysvo, approximately 22,000 individuals received the vaccine and 22,000 received placebo.
FDA Requires Guillain-Barré Warning for Abrysvo and Arexvy
3 days ago · The association between vaccination with Abrysvo and Arexvy and GBS was evaluated among Medicare beneficiaries 65 years of age and older between May 2023 through July 2024. The FDA found that there was an estimated nine excess cases of GBS per million doses of Abrysvo and an estimated seven excess cases of GBS per million doses of Arexvy
U.S. FDA Approves Pfizer’s RSV Vaccine ABRYSVO® for Adults …
Oct 22, 2024 · ABRYSVO now offers the broadest RSV vaccine indication for adults, which previously included those 60 years and older. Additionally, it remains the only RSV immunization approved for pregnant individuals at 32 through 36 weeks of gestation to protect infants from birth up to 6 months of age.
FDA Approves First Vaccine for Pregnant Individuals to Prevent …
FDA approves Abrysvo for immunization at 32 through 36 weeks gestational age of pregnancy to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus...
Pfizer Announces Top-Line Results of ABRYSVO® for RSV in ...
Aug 12, 2024 · Participants demonstrated RSV-A and RSV-B subgroup neutralizing responses non-inferior to the response seen in the Phase 3 (NCT05035212) RENOIR study of ABRYSVO, which previously demonstrated ABRYSVO’s efficacy in a population of adults aged 60 or older.
FDA Approves Pfizer's Respiratory Syncytial Virus Vaccine Abrysvo …
Oct 23, 2024 · On Tuesday, the FDA approved Pfizer Inc’s (NYSE: PFE) Abrysvo (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, to prevent lower respiratory...
MONeT: RSV Vaccine Abrysvo Meets Endpoints in Adults 18 to 59 …
Apr 9, 2024 · Positive topline data were announced from the phase 3 MONeT trial evaluating a single dose of Abrysvo ® (respiratory syncytial virus vaccine) in adults 18 to 59 years of age at risk for developing severe respiratory syncytial virus (RSV)-associated lower respiratory tract disease (LRTD).
FDA Requires Guillain-Barré Syndrome Warning on 2 RSV Vaccines
4 days ago · The FDA announced it has required safety labeling changes to the prescribing information for both the RSV vaccines to include a warning for the rare neurological disorder, Guillain-Barré Syndrome (GBS). 1 The agency said it conducted a postmarketing observational study that assessed the risk of GBS following vaccination with Abrysvo and Arexvy.
- Some results have been removed