俄羅斯科學家很誠實！自己的報告聲明其衛星V號疫苗含有可複製病毒

俄羅斯科學家很誠實！自己的報告聲明其衛星V號疫苗含有可複製病毒<100個/劑。國際標準是零。

 

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

 

https://www.sciencemag.org/news/2021/04/russias-covid-19-vaccine-safe-brazils-veto-sputnik-v-sparks-lawsuit-threat-and

 

節選：

“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 翻譯：“疫苗生產商和其他公司已經開發了測試，以檢查其產品中是否存在腺病毒複製。 Anvisa說，盡管全球標準對疫苗中存在複製型腺病毒的容忍度為零，但Gamaleya設定了每劑疫苗5000個具有複製能力的病毒顆粒的可接受限度。 Anvisa在新聞發布會上顯示的俄羅斯質量控製文件指出，所測試的批次每劑量含有“少於100個”可複製顆粒。

 

在昨天的新聞發布會上，門德斯還展示了3月份安維薩（Anvisa）官員與疫苗開發者之間在線會議的視頻。在其中一個剪輯中，Anvisa官員問Gamaleya代表為什麽一旦“在您的作品中檢測到RCA發生”就沒有改變生產方法。Gamaleya代表回答說他們知道風險，但是改變流程“會花太多時間。