VACCINE approvalThe article provides information about the FDA's approval of Abrysvo, the first maternal respiratory syncytial virus (RSV) vaccine, for pregnant individuals during the third trimester to prevent severe illness in infants up to 6 months old.Harris, Emily...
"Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States," said Peter Marks, ...
Global vaccine and drugmaker GSKaskedthe FDA in February to expand approval beyond adults 60 and older, citingdatashowing the immune response in adults vaccinated from this younger age group looked similar. Further trials are planned looking at adults between 18 and 49 years old, GSK said, with...
The U.S. Food and Drug Administration on Tuesday approvedPfizer's RSV vaccine for the prevention of lower respiratory tract disease caused by RSV in adults aged 18 to 59 at increased risk of the disease. In June, the U.S. CDCnarrowedits recommendation for the use of respiratory...
3月8日,生物技术公司星锐医药(Starna Therapeutics)宣布新药临床试验申请(IND)获得美国食品药品监督管理局(FDA)批准,他们将进行呼吸道合胞病毒(RSV)mRNA疫苗STR-V003的一期临床试验研究,这家公司专注于靶向递送技术和创新mRNA疗法。这次临床...
"Today's approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA's continued commitment to facilitating the development of safe and effective vaccines for use in the United States," Dr. Peter Marks, dir...
While there were no major safety concerns or serious adverse events found during the clinical trials, four out of the fourteen experts on anindependent FDA advisory committeethat met in May this year said the data presented to them was not adequate enough to vote in favor of vaccine safe...
director of the FDA's Center for Biologics Evaluation and Research. "Today's approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effe...
ABRYSVO’s approval will help offer older adults protection in the anticipated RSV season this fall NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO™ (Respiratory Syncytial Virus Vaccine)...
来源:Vaccine前研 ✎我国科学家发现新冠病毒新血清型,为研发广谱新冠疫苗提供依据 中国科学院微生物研究所的团队发现新冠病毒变异株BA.2.86已演化成新血清型,这一发现对未来的疫苗和抗体研发具有重要意义。研究通过小鼠血清交叉中和分析,确定BA.2.86与现有XBB变异株的抗原性有明显区别,暗示基于XBB的疫苗可能无法充分抵...