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.
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 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...
FDA Alert: FDA Requires Guillain-Barré Syndrome (GBS) Warning …
4 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 ...
CDC recommends new vaccine to help protect babies against …
Sep 22, 2023 · RSV is the leading cause of hospitalization for U.S. infants. This new vaccine, Pfizer’s bivalent RSVpreF vaccine (trade name Abrysvo TM), has been shown to reduce the risk of RSV hospitalization for babies by 57 percent in the first six months after birth.
Pfizer Announces Top-Line Results of ABRYSVO® for RSV in ...
Aug 12, 2024 · First assessment from an RSV vaccine study in immunocompromised adults show ABRYSVO was well-tolerated and generated strong neutralizing responses after a single dose in adults ≥ 18 years of age
FDA Requires Guillain-Barré Syndrome Warning on 2 RSV Vaccines
2 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.
FDA Urges Guillain-Barré Syndrome Warning On Labels Of RSV …
2 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 Approves Abrysvo to Treat Adults 18 to 59 Years of Age at …
Oct 23, 2024 · Abrysvo is the first RSV vaccine approved for adults aged 18-49 at increased risk for RSV-LRTD due to chronic conditions. The vaccine targets the RSV fusion protein, a major neutralizing antibody target, providing protection against RSV-A and RSV-B.
FDA Requires Guillain-Barré Warning for Abrysvo and Arexvy
1 day 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