阿斯利康关于腺病毒载体疫苗AZD1222官方声明,核心信息:1、英国监管机构批准下,在英国的临床试验重启,但其他地区比如美国尚未获得监管批准重启。按照FDA指南要求,新冠疫苗临床试验至少需入组3万人以上。阿斯利康9月3日刚刚宣布开始符合美国要求的临床开始,预计12月份有早期结果。目前进度明显落后于辉瑞、Moderna、强生三家。2...
也是唯一通过肌肉注射的新冠肺炎抗体，2021年12月获FDA紧急使用授权用于新冠肺炎暴露前预防。
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/moderna-covid-19-vaccine Google Scholar [21] U.S. Food and Drug Administration Janssen COVID-19 Vaccine EUA Letter of Authorization (2021) (Accessed July 6, 2021) https://www.fda.gov/media/146303/down...
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We investigated ChAdOx1 nCoV-19 (AZD1222) vaccine efficacy against SARS-CoV-2 variants of concern (VOCs) B.1.1.7 and B.1.351 in Syrian hamsters. We previously showed protection against SARS-CoV-2 disease and pneumonia in hamsters vaccinated with a single
Following the issuance of the Johnson & Johnson–Janssen emergency use authorization by the FDA, 6 cases of cerebral venous sinus thrombosis with thrombocytopenia were reported among the vaccine recipients. Similar cases of thrombosis with thrombocytopenia syndrome (TTS) were reported after vaccination wit...
et al. Antiviral efficacies of FDA-approved drugs against SARS-CoV-2 infection in ferrets. mBio 11, e01114–01120 (2020). PubMed PubMed Central Google Scholar Ryan, K. A. et al. Dose-dependent response to infection with SARS-CoV-2 in the ferret model: evidence of protection to re-...
Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab. 2021. (Accessed 27th May 2021). Tegally H. et al. Emergence and rapid spread of a new severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) lineage with multiple spike ...
Background Currently, booster dose is needed after 2 doses of non-live COVID-19 vaccine. With limited resources and shortage of COVID-19 vaccines, intradermal(ID) administration might be a potential dose-sparing strategy. Objective To determine immunologic response and reactogenicity of ID ChAdOx1...
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-and-licensure-vaccines-prevent-covid-19 (June, 2020), Accessed 8th Nov 2020 Google Scholar 15 WHO WHO target product profiles for COVID-19 vaccines https://www.who.int/publications/m/item/who-target-product-pro...