信是在申请“紧急使用”之前写的,说已达标,很快就要申请。FDA 有说明，紧急使用的标准一样,不影响疫苗的安全性，但加速了制造管理过程。An EUA does not affect vaccine safety．Instead, it speeds up manufacturing and administrative processes.
-iasra(iasra);
2021-5-29(#13749776@0)+2
FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives.
你那是广泛意义，包括死马当活马医的癌症等。这里说的是疫苗 efforts to speed vaccine development to address the ongoing COVID-19 pandemic have not sacrificed scientific standards, integrity of the vaccine review process, or safety.
-iasra(iasra);
2021-5-29(#13749837@0)
说的好。
-nazacalines(游戏);
2021-5-29(#13749956@0)
Short-term的数据有(around 5000 people, 6 months),可是疫苗long-term(2 years)的数据谁也没有, 怎么批准. 这下好了,大家都在踊跃参加 long term的试用贡献数据. 和新药上市相比, vaccine is the least-regulated market.
-2636029(Rainbow);
2021-5-29(#13749806@0)+3
FDA不会说An EUA does not affect vaccine safety，如果真说了请给出FDA网站的原文。EUA和真正的批准标准都不一样，当然对有效性和安全性的标准也是不一样的
-keysi(K.S);
2021-5-29(#13749815@0)
efforts to speed vaccine development to address the ongoing COVID-19 pandemic have not sacrificed scientific standards, integrity of the vaccine review process, or safety.
-iasra(iasra);
2021-5-29{232}(#13749842@0)+2
FDA is utilizing its various authorities and expertise to facilitate the expeditious development and availability of vaccines that have met the agency’s rigorous and science-based standards for quality, safety, and effectiveness.
但是他并没说EUA has not sacrificed scientific standards, integrity of the vaccine review process, or safety。你可以比较一下EUA和FDA approval批准的标准有什么不同就知道了, 科学标准都不同，怎么可能安全性和有效性的评断都一样呢
-keysi(K.S);
2021-5-29(#13749851@0)+2
其实这几个核心词已经界定了EUA：unapproved medical products or unapproved uses of approved medical products
-the_dumb_one(耷目无神);
2021-5-29(#13749860@0)+1
同一段陈述里：For an EUA to be issued for a vaccine, for which there is adequate manufacturing information to ensure quality and consistency, FDA must determine that the known and potential benefits outweigh the known and potential risks of the vaccine.
-the_dumb_one(耷目无神);
2021-5-29(#13749892@0)
没错，这就是我前面说的，三个环节中，有效性，阿安全性这两个没问题，但在这个环节上的加速：Instead, it speeds up manufacturing and administrative processes.
-iasra(iasra);
2021-5-29(#13749902@0)
我想强调的是这一句： known and potential benefits outweigh the known and potential risks of the vaccine。FDA牺牲的是它自己一向坚持的安全第一的原则，而采取了两害相权取其轻的措施。并不是平素间坚持的不能有risk。
-the_dumb_one(耷目无神);
2021-5-29(#13749908@0)+1
我理解 ”for which there is adequate manufacturing information to ensure quality and consistency“ 并不是说EUA牺牲原则只是在制造过程。FDA的权衡是整体性的。
-the_dumb_one(耷目无神);
2021-5-29(#13749967@0)
文科博士难与工科博士沟通啊，请先去了解FDA批准的三方面。而且quality and consistency已经指出制造的质量控制和批次的 consistency。有效性，与安全性是批准的另两个方面。
-iasra(iasra);
2021-5-29(#13749981@0)
最新消息说Pfizer启动了申请程序，they are initiating the submission process for FDA Biologics License Application for their COVID-19 vaccine. 批准时间是open-ended，但一般需要数月。
-iasra(iasra);
2021-5-29(#13750074@0)+1
For example, elemental impurities is mandatory for any medication on the market start from May, 2020 (rolled out in 2016). That's why our lab is so busy with the elemental impurities testing. I did not get any elemental impurities testing for vaccine.
-2636029(Rainbow);
2021-5-29{121}(#13749829@0)
Class 1 (砷 镉 汞 铅), Class 2a (钴 钒 镍) are a must to test. Based on their toxicity. USP <232>, totally 24 elements.
Shares of Pfizer Inc. rallied to a 7-week high Friday, after the drug maker said it is on track to know whether its potential COVID-19 vaccine is effective...
This means we may know whether or not our vaccine is effective by the end of October. To do so,
-stonegump(Peter);
2021-5-29{197}(#13749846@0)+1
we must accumulate a certain number of COVID-19 cases in our trial to compare the effectiveness of the vaccine in vaccinated individuals to those who received a placebo. 如果是最近，显然不需要这个
Watch Fauci, federal health officials testify about uncertainty over NIH, FDA, & CDC employees’ vaccination rates - May 11, 2021 ONLY AROUND 50% TO 60% !!!!!
-allluckyday(888);
2021-5-29{602}(#13749891@0)+1
Guess how many employees at the NIH, FDA and CDC are estimated to have gotten the shot? They're not sure, maybe about half... Really instills confidence,…
他解释的很好啊，他让你去看 FDA专门针对疫苗的EUA的解释： “FDA has released guidance explaining the conditions that need to be met before a vaccine receives an EUA for COVID-19” 。FDA解释：(#13749842@0)
-iasra(iasra);
2021-5-29(#13750302@0)
:no_upscale()/cdn.vox-cdn.com/uploads/chorus_image/image/68493788/GettyImages_1230032451.0.jpg)
