“My hope is a lot of patients that have had hesitancy about the mRNA vaccines, because they’re using novel and new technology, will be less reluctant to get vaccinated for COVID-19 using a traditional vaccine like Novavax,” he toldMNT. “It will be interesting to see how it compares...
To evaluate the effectiveness of a single booster dose of the Moderna COVID-19 Vaccine, Bivalent for individuals 18 years of age and older, the FDA analyzed immune response data among approximately 600 individuals 18 years of age and older who had previously received a two-dose primary series ...
On August 23rd, 2021, the FDA formally granted full approval COVID-19 vaccine by Pfizer and BioNTech, now with brand name Comirnaty, for individuals 16 years of age and older.The decision will replace the emergency use authorization (EUA) granted by the agency last December. What does it ...
[6] https://science.sciencemag.org/content/early/2020/11/11/science.abe8499.full [7] https://www.statnews.com/2020/12/10/tracking-the-fda-advisory-panel-meeting-on-the-pfizer-biontech-covid-19-vaccine/ [8] https://www.newyorker.com/news/daily-comment/the-fdas-advisory-committee-recomme...
近日，美国食品药品监督管理局（下称FDA）发布《COVID-19相关医疗器械紧急使用授权过渡计划》指导文件（最终版）。FDA设置过渡期，应是考虑到：对于器械制造商、器械分销商、医疗机构、医疗保健提供者、患者、消费者和机构等，需要一定的时间，以便从新冠大流行期间专有的政策和行动中转换至正常状态。FDA寻求鼓励和促进...
生物技术公司 Watmind 在新闻稿中宣布,FDA 已向一款非处方 (OTC) 三合一流感和新冠肺炎检测试剂授予紧急使用授权 (EUA)。该检测试剂旨在用于家庭和即时诊断,可在 15 分钟内同时检测新冠肺炎、甲型流感和乙型流感。 SpeedySwab COVID + FLU A&B 自测试剂是与美国国立卫生研究院的快速加速诊断独立测试评估计划合作开...
对于已经获得EUA的新冠疫苗,开发公司如果基于已有的原型疫苗(prototype vaccine)开发针对突变病毒的改良疫苗(modified vaccine),FDA提出以下建议。 临床前研究数据 在安全性方面,如果改良疫苗使用同样的制造商和制造过程,可能不需要提供额外的毒理学研究。与疫苗平台和原型疫苗相关的数据可以用于做出批准决定。
生物技术公司 Watmind 在新闻稿中宣布,FDA 已向一款非处方 (OTC) 三合一流感和新冠肺炎检测试剂授予紧急使用授权 (EUA)。该检测试剂旨在用于家庭和即时诊断,可在 15 分钟内同时检测新冠肺炎、甲型流感和乙型流感。 SpeedySwab COVID + FLU A&B 自测试剂是与美国国立卫生研究院的快速加速诊断独立测试评估计划合作开...
A：不这么做，实际上已经有很多受试者离开研究去接受其他EUA的疫苗了。这个strategy的目的其实是可能keep...
Janssen Biotech has submitted an application seeking EUA for its investigational single-dose Covid-19 vaccine candidate, to the US FDA.