俄罗斯科学家很诚实!自己的报告声明其卫星V号疫苗含有可复制病毒<100个/剂。国际标准是零。
Is Russia’s COVID-19 vaccine safe? Brazil’s veto of Sputnik V sparks lawsuit threat and confusion
By Sofia Moutinho, Meredith WadmanApr. 30, 2021 , 5:40 PM
节选:
“Vaccinemakers and others have developed tests to check for replicating adenoviruses in their products. Anvisa said that although the standard worldwide has been zero tolerance for the presence of replicating adenovirus in the vaccine, Gamaleya established an acceptable limit of 5000 replication-capable virus particles per vaccine dose. The Russian quality control documents displayed by Anvisa during the press conference state the batches tested had “less than 100” replication-capable particles per dose.
During yesterday’s press conference, Mendes also showed video of parts of an online meeting in March between officials from Anvisa and the vaccine’s developer. In one of the clips, Anvisa officials ask Gamaleya representatives why they had not changed their production methods once they “had detected the RCA occurrence in your production” The Gamaleya representatives responded that they were aware of the risk, but that changing the process “would take too much time.”
Google 翻译:“疫苗生产商和其他公司已经开发了测试,以检查其产品中是否存在腺病毒复制。 Anvisa说,尽管全球标准对疫苗中存在复制型腺病毒的容忍度为零,但Gamaleya设定了每剂疫苗5000个具有复制能力的病毒颗粒的可接受限度。 Anvisa在新闻发布会上显示的俄罗斯质量控制文件指出,所测试的批次每剂量含有“少于100个”可复制颗粒。
在昨天的新闻发布会上,门德斯还展示了3月份安维萨(Anvisa)官员与疫苗开发者之间在线会议的视频。在其中一个剪辑中,Anvisa官员问Gamaleya代表为什么一旦“在您的作品中检测到RCA发生”就没有改变生产方法。Gamaleya代表回答说他们知道风险,但是改变流程“会花太多时间。