經過五小時開會,巴西Anvisa的委員會批出了科興疫苗和阿斯利康疫苗的緊急使用權。主導Butantan第三期實驗和疫苗生產的聖保羅州長鬆一口氣,立即在綠色佈景板前喚來一位黑人女護士打下科興疫苗「第一針」。Anvisa公開Butantan呈交的最終數據,顯示科興疫苗的有效率為50.39% (IC95:35.26-61.98)。
由於Butantan跟科興簽定保密協議,疫苗數據和研發內情到現在才正式公諸於世,其中提到疫苗所用到的滅活病毒,是從四名來自中國不同地區的患者的血液中分離出來,以作遴選毒株之用,時間最早可追溯至2020年1月尾。重溫一年前的經過:
2019年12月,武漢市長周先旺向北京通報疫情,未獲授權告知社會;
12月31日,中共首度通報武漢爆發疫情,當時稱未發現明顯人傳人現象,未發現醫護感染;
2020年1月1日,武漢政府清洗華南海鮮市場;
1月3日,衛健委下令存有病毒樣本的實驗室銷毀樣本或送到指定機構,華春瑩事後指當日美國獲中方通報武漢疫情;
1月7日,習近平召開會議對防控工作提出要求;
1月11日,病毒基因序列破解一星期後通報世衛,為期8日的湖北兩會正式召開;
1月14日,世衛質疑疫情可能有限度人傳人;
1月18日,周先旺聽信「有限度人傳人」的講法,批准舉辦萬家宴,4萬個家庭參與,造成大爆發;
1月20日,中共透過鍾南山在央視受訪承認醫護感染,確認人傳人發生,政治局常委當晚緊急開會;
1月21日,中共科技部啟動應急科技攻關項目,鍾南山為組長,推動血漿採集,要求五條路線研發疫苗;
1月23日,武漢宣佈封城,超過500萬人聞訊後逃往各省以至全世界,部分人飛往歐洲登上郵輪;
1月28日,譚德塞抵達北京,習近平接見時說是他親自指揮親自部署抗疫,譚德塞稱讚北京透明,武漢疫情可防可控;
1月30日,世衛宣佈武漢肺炎為全球緊急衛生事件。
由1月21日開組到3月16日批准了第一支武肺重組蛋白疫苗進入第一期臨床實驗,不需要兩個月時間。同一日,莫德納mRNA疫苗宣佈直接展開人體試驗。而國藥和科興研發的滅活疫苗,到4月14日才進入第一第二期試驗,現在卻「遲來先上岸」了。而科興拜託巴西聖保羅政府開始第三期試驗的日期,是7月21日。
不要以為委員會5:0表決批准緊急使用權,就等同Anvisa認可了所呈交的數據。Anvisa的評估報告講明:「整項臨床研究沒有提供免疫源性評估結果,所呈交的唯一結果不足以滿足免疫源性評估。」
Anvisa對不完全數據的其餘評價還包括:
Predicted neutralizing antibody assessments:
Not presented the results forseen in the approved clinical study
Predicted binding antibody assessments:
The data presented was referring to a collection. The individual results were presented in a table, without defining which group they were referring into (Placebo or Control)
Evaluation of predicted seroconversion and cellular immunity:
No provided for in the approved clinical study protocol
安全性
Occurrence of requested adverse reactions (local and systemic) within 7 days after
administration of the second dose:
50.8% in the adult group and 36.4% in the group
of the elderly;
Occurrence of unsolicited adverse reactions (local and systemic) up to 7 days
after administration of the second dose:
9.2% in the adult group and 8.1% in the
elderly group.
不良反應方面,報告顯示沒有嚴重不良反應,只有40.1%成人接種位置出現疼痛。而Anvisa不厭其煩地指出了滅活疫苗的另一個關鍵風險,就是抗體依賴增強(ADE)效應,意思是滅活疫苗所誘發的抗體可能會增強病毒的感染能力,令患者的病情加重。中國疾控中心主任高福去年被問到這個問題時對此不置可否,強調「目前新冠疫苗ADE沒有定論」。即是說,需要更多的公測數據才可以確認會否重演登革熱疫苗的滑鐵爐事故。
此外,Anvisa認為科興疫苗的保護期效、注射間隔和劑量多少都是不確定的,老人組的數據也得很少。Anvisa仍然要求Butantan追加數據和澄清,包括5704名受試醫護的有效率和接觸史數據。而整個第三期臨床實驗,亞裔受試者只佔2.5%,其他疫苗都有同樣的通病。
Anvisa在結語不忘戴定頭盔,大意是你們逼我審得這麼倉卒的:「此外,重要的是要注意科興生產的Coronavac仍處於分析中(持續提交),但是有關巴西進行的第三階段研究的文件(有效性和安全性)是在請求臨時授權以供緊急使用之下提交的。」Anvisa再三強調,他們想要的免疫源性數據仍未收到。
還記得之前阿斯利康在巴西的第三期臨床實驗曾經一度中止,全因安慰組死了人嗎?原來科興疫苗的巴西臨床實驗也死過人,還有小產,只是現在才可以透過Anvisa公開:
「73 serious adverse events were reported in 67 study participants. In three of these events the participants evolved to death, but none was related to the product under investigation. Of the 5 reported abortions, only one was assessed as having a causal relationship possible with the product under investigation / placebo. It is noteworthy that the causal relationship of this case is still under discussion between sponsor and clinical center in which the event was reported.」
調查發現事故與產品無關,其中一宗仍在討論,早前都受到保密協議保護。
即管看看香港官方反應,大抵是巴西批准了,他們也鬆一口氣,非常科學。
作者
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【專題訪問 Interview Feature】2019年度香港大學學生會周年大選中央幹事會候選内閣蒼傲訪問(外務篇) | Interview with Prism, the Proposed Cabinet of Executive Committee, The Hong Kong University Students’ Union of Annual Election 2019 (External Affairs)
(Please scroll down for English version.)
中央幹事會候選內閣蒼傲就外務議題接受本台訪問,就不同外務議題立場,包括不反對政府取締民族黨的原因、相信政府DQ議員合法的理據、初一事件有黑幫介入的看法、及對法律制度有信心的理由等發表意見。
訪問節錄如下:
1. 你們的政治光譜/政治立場是甚麼?
我們認為用現有的名詞並不能表達我們莊的政治立場,因為例如本土、港獨等,第一他們並沒有清晰的界定,或是社會一致的定義,我們都認為不論是政治光譜或是政治立場我們作為香港人或是香港接受教育的人,其實我們的立場都會傾向由香港出發。但由香港出發去考慮香港利益時,我們都要考慮時間軸。時間軸的意思是,我們到底在考慮短期還是長期的利益。加上香港的地理位置、經濟結構其實都十分依賴世界上大部份的國家,不論金融、出口產業,所以在考慮香港利益同時,我們都應考慮鄰近國家的政策、議案的推出。所以如果要用幾個字去形容我們的政治立場,我們會選擇「國際視野,本土出發」八個字。前者是考想利益的角度,後者是執行的角度。
2. 你們是否支持香港獨立?
首先我們認為它可以被自由地討論,特別是在大學之內。至於是否贊成香港獨立方面,港獨並非香港現時可執行最好的決策,因為尚有很多的選擇可加以考慮及討論。另外我認為香港內部的問題都非常嚴峻,例如我們在政綱小册子上提到的外務議題,如學生自殺、高樓價、創新科技嚴重落後等問題。這些都是我們內部必須解決和面對的問題,所以我們會將那些內部問題列為最優先需要處理的問題。
3. 你們覺得香港獨立是否合法?
我們認為任何符合法例的討論都是可被接受的,所以我們認為只要某個人或團體在現時完善的法律制度下,加上沒有違反法律,就應可就不同議題提出想法。
4. 你們是否同意香港政府取締香港民族黨?
首先我們相信香港的法治仍然相當完善,所以就香港一套完整司法制度體系下做出的判決,我們並沒有太多質疑或反對。對於民族黨被政府取締或禁止,社會上有不同聲音,但我們相信我們應遵守絕大部分香港市民都認同是完善的法律體系下作出的任何決策。
5. 你們是否同意香港政府DQ議員?
其實我們由始至終都相信,而坊間一些調查機構都指出香港的法治制度在世界上都名列前茅,所以我們相信這套法治制度可以帶來公平的審訊,所以對於有部分議員被DQ,我們願意相信整個判決過程是公平的,並且有足夠理據去支持政府所作的判決,所以我們對這件事沒有任何特別意見。
6. 你們是否支持人大釋法?
每一個法律的訂立,其實都是由一小部分的精英去開始建構框架,然後隨社會的進步不斷完善。所以法律並非一本已經印刷好的書,而是容許我們不斷修改、去完善,就一些前人的不足作補完。人大釋法亦都如是,我相信重點是我們希望這法列在微調後能得到愈來愈多香港人的支持,這才是一個成功的新詮釋。
7. 你們是否同意一國兩制?
我們支持所有在香港回歸時所簽訂的條文,其中當然包括一國兩制。
8. 你們是否支持國歌法和23條立法?
因為爭議聲非常之多,所以我們不希望對任何未實施或未明文規定的法例作出過多評論。這是對該法案有所偏頗,該法案到最後還有很多相議的空間,所以我們認為政府應充分考慮各種聲音,從而推出一條為大部分港人所接受的法例。
9. 你們對違法達義有何看法?
香港作為擁有完善法律的城市,任何人都有表達訴求或是行動的權利。我們主張每人都有自由去決定自己的事、想表達的聲音,但每人都應為這些行為勇敢承擔相認的法律責任。當然我們更相信這套法律體系是完善和公平的。
10. 你們對初一事件有何看法?
對旺角騷動,很多報紙傳媒都報道了有不法份子甚至黑社會的介入,所以旺角騷動的那一批示威者是否單純為表達而表達的市民呢?
11. 你們是否同意政府以暴動罪控告參與者?
就對這幾名人士進行拘捕的行為,我們希望香港政府有真憑實據去支持,以及整個審訊過程認該要公平。我希望他們得到公平的審訊。
Campus TV has interviewed with Prism, the Proposed Cabinet of Executive Committee, The Hong Kong University Students’ Union, Session 2019, with regards to their treatment of external affairs. Prism has expressed their stance and opinions on various external issues, which include: their not opposing the Hong Kong government’s banning of the Hong Kong National Party, believing in the government’s legitimacy for the disqualification of legislators, believing in the involvement of gangs in the Mong Kok Incident of 2016, and expressing their confidence in the current legal system.
The interview excerpts are as follows:
1. Where do you stand on the political spectrum? / How would you define your political stance?
We believe the current word items are unable to express our Cabinet’s political stance. For example, if you consider the term localism or Hong Kong independence, these groups have not a clear boundary or universal definition given by the society. Whether it be the political spectrum or political stance, us who are Hong Kong-ers or who have been educated in Hong Kong, have a tendency to think from the standpoint of Hong Kong. If we consider the benefits from the standpoint of Hong Kong, we also need to consider the timeline. This (the timeline) means, that we should consider if these benefits are of short term or long term. Therefore, when considering Hong Kong’s benefits, we should also consider the policies and bills of neighbouring countries. Therefore, if we had to define our political stance in terms, it would be “international perspective that comes from a local standpoint”. The former is a consideration to the benefits, the latter is a consideration to the execution.
2. Do you support Hong Kong independence?
Firstly, we think this matter could be discussed freely, especially within the premises of the University. In terms of agreeing with Hong Kong independence, we think that Hong Kong independence is currently not the best option to be executed in Hong Kong, because there are still many other options to consider and discuss about. In addition, I think that Hong Kong’s internal affairs are very severe, like the external affairs that are mentioned in our campaign booklet, for example, students’ suicides, rising property prices, the severely outdated innovation and technology. These are problems that our internal department has to confront and resolve, therefore we put these internal affairs as our priority.
3. Do you think that Hong Kong independence is legal?
We believe any discussion that is in compliance with the law is acceptable. Therefore, we think that under the current, comprehensive legal system, with no breaching of the law, a person or group should be allowed to speak their thoughts on different issues.
4. Do you agree with Hong Kong government’s banning of the Hong Kong National Party?
Firstly, we believe that Hong Kong’s rule of law is still quite comprehensive. Therefore, we do not have much hesitation nor opposition for a judgment that is based on what we consider to be an intact judicial system of Hong Kong. In terms of the banning of the Hong Kong National Party, the society has different voices, but we believe we ought to obey the judgment that comes from what the majority of Hong Kong considers to be a comprehensive legal system.
5. Do you agree with Hong Kong government’s disqualification of legislators?
Actually, we have since the very beginning believed in Hong Kong’s rule of law as quite a frontrunner in the world; this has been backed by some survey organisations within the community too, so we believe that this rule of law can bring out a fair trial. Therefore, in regards to the disqualification of some legislators, we willingly believe that the entirety of the judgment process has been fair, with sufficient arguments to back up the government’s verdict. We do not express any special opinions towards this incident.
6. Do you support the Standing Committee of the National People's Congress’ Interpretation of the Basic Law (SCNPC's Interpretation of BL, or Interpretation of the Basic Law by the SCNPC)?
For the enactment of every legislation, it starts from a small portion of elites that begin to build its (the legislation’s) framework, it then continues to be improved as society grows. For this reason, the law is not a printed book, it allows us to continually amend, better, and complete items that are left neglected or faulted by predecessors. This applies for the SCNPC's Interpretation of BL, I believe the most important thing is, we hope to gain more Hong Kong-ers’ support under these fine-tunings (by the SCNPC's Interpretation of BL), we think this is what counts as a successful re-interpretation of the law.
7. Do you agree with the constitutional principle of “one country, two systems”?
We support all the terms that were signed in the Handover of Hong Kong, and this definitely includes the principle of “one country, two systems”.
8. Do you support the National Anthem Bill and the enactment of Article 23?
Due to the many controversies on this matter, we do not wish to comment on any legislation that has yet to be implemented or stipulated in explicit terms. This would be a prejudice on the said bill(s). These bills still have a lot of room for negotiation, so we believe the government should consider different voices, so as to introduce a legislation that is accepted by the majority of Hong Kong-ers.
9. What are your views on the idea of achieving justice by violating the law?
Hong Kong is a city with a comprehensive legal system; anyone has the right to express their own appeal or action. We advocate that everyone has the freedom to decide for their own deeds and express their own thoughts, but everyone should also be responsible to bear the consequences of their actions. Needless to say, we definitely believe that our legal system is perfect and fair.
10. What are your views on the Mong Kok Incident in 2016?
With regards to the Mong Kok unrest, many media sources have reported about the involvement of many illegal parties, and even that of gangs or triads. So, are the demonstrators in the Mong Kok unrest really with pure intentions to speak up, for the sake of expressing themselves as Hong Kong citizens?
11. Do you agree with the government’s decision to charge participants (of the Mong Kok Incident in 2016) with the offence of rioting?
With regards to the arrest of those participants, we hope that the Hong Kong government has had solid evidence to support (their arrest), and that the trial process has been fair. I hope they receive a fair trial.
___________________________________
二零一九年度香港大學學生會周年大選其他候選人包括候選常務秘書麥嘉晉、校園電視候選內閣、學苑候選編輯委員會及候選普選評議員。
2019年度周年大選中央諮詢大會將於一月二十一日至一月二十五日在中山廣場舉行,時間為下午十二時半至二時半。
Other candidates for the Annual Election 2019 include the Proposed General Secretary Mak Ka Chun Eugene, the Proposed Cabinet of Campus TV, the Proposed Editorial Board of Undergrad, and the Proposed Popularly Elected Union Councillor.
The Central Campaign for Annual Election 2019 will be held from the 21st to 25th of January at the Sun Yat-sen Place, from 12:30 to 14:30.
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