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.
GSK, Pfizer RSV Shots Required to Carry Guillain-Barré Syndrome ...
5 days ago · The RSV vaccine space is dominated by GSK and Pfizer, with the former being the undisputed leader. Arexvy was approved in May 2023 — one month ahead of Pfizer’s Abrysvo—and raked in nearly $1.6 billion by the end of 2023. Abrysvo’s 2023 earnings, in comparison, sat at $515 million.
FDA requires Pfizer, GSK to add warning on label of RSV shots
4 days ago · The FDA will require GSK and Pfizer to include on the label of their respiratory syncytial virus (RSV) vaccines a warning about the risk of developing Guillain-Barré syndrome (GBS), a rare ...
Pfizer Announces Top-Line Results of ABRYSVO® for RSV in ...
Aug 12, 2024 · ABRYSVO is a bivalent vaccine that was designed to provide protection against RSV-LRTD, regardless of the virus subgroup. In the prefusion state, the RSV fusion protein (F) is a major target of neutralizing antibodies, serving as the basis of Pfizer’s RSV vaccine.
GSK, Pfizer RSV shots to get warning of rare neurological disorder …
The U.S. FDA is ordering that respiratory syncytial virus (RSV) vaccines marketed by GSK (NYSE:GSK) and Pfizer (NYSE:PFE) contain a warning on labeling of the risk of developing the rare ...
FDA Approves Pfizer’s New RSV Vaccine for Older Adults
On May 31, the U.S. Food and Drug Administration (FDA) approved the second RSV vaccine in the world. The first, from the pharmaceutical company GSK, gained FDA approval earlier in May for...
Pfizer builds case for RSV shot with data from …
Aug 12, 2024 · Pfizer on Monday said its RSV vaccine Abrysvo led to strong immune responses in immunocompromised adults given the shot in a late-stage study. The results came from a substudy of a Pfizer-run Phase 3 trial testing two doses of Abrysvo in adults at risk of severe lower respiratory tract disease associated with respiratory syncytial virus, or RSV.
GSK and Pfizer's RSV vaccines to carry warnings of neurological ...
5 days ago · GSK and Pfizer's respiratory syncytial virus (RSV) vaccines will carry warnings that they can increase the risk of developing a rare neurological disorder, the U.S. Food Drug Administration said ...
Pfizer gets a leg up in RSV as FDA clears jab for all adults
Oct 23, 2024 · A new FDA approval has given Pfizer a broader label for its respiratory syncytial virus (RSV) vaccine Abrysvo than rival shots from GSK and Moderna, but it may not make much of a difference in...
Pfizer’s RSV vaccine cleared by FDA for use in some younger adults
Oct 23, 2024 · The Food and Drug Administration on Tuesday expanded the approval of Pfizer’s RSV vaccine Abrysvo to include adults aged 18 to 59 years who are at an increased risk of disease from respiratory syncytial virus.
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