外交官的國際新聞導覽及中東中亞的歷史故事 Diplomat's daily news review and history research on Middle East and Central Asia
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2021 年 10 月 2 日 20:18
伊朗新總統易卜拉欣·賴西於 2021 年 8 月 3 日在伊朗德黑蘭收到伊朗最高領袖阿亞圖拉·阿里·哈梅內伊 (Ayatollah Ali Khamenei) 的總統批准令。
伊朗伊斯蘭共和國最高領袖阿里·哈梅內伊在法爾斯省的代表 Lotfollah Dezhkam 在周五的設拉子市佈道中敦促消滅以色列。
這位伊斯蘭教士的煽動者宣稱：“以美國為首的全球傲慢與以色列共謀，試圖推遲一個重要問題的實現，即摧毀猶太復國主義政權。” 反對伊朗伊斯蘭共和國的新聞媒體 Kian Meli 引用了他的言論。三個政權控制的新聞機構——伊斯蘭共和國通訊社、法爾斯新聞和塔斯尼姆——報導了他的演講。
為逃避迫害而逃往德國的伊朗持不同政見者謝娜·沃朱迪 (Sheina Vojoudi) 說：“毛拉越是散佈針對以色列猶太國的仇恨言論，伊朗人民就越意識到以色列是我們的朋友，因為伊朗政權是唯一我們擁有的敵人。他對以色列的仇恨言論並不奇怪……作為伊斯蘭共和國領導人的阿里哈梅內伊呼籲消滅以色列，而德日卡姆是他的代表。”
她補充說：“我們厭倦了他們的反猶太主義。我們與猶太人有著悠久的歷史，我們希望能夠重振 2700 年的友誼。伊斯蘭共和國的反猶太主義是致命的，危及伊朗人和以色列人。該政權指責伊朗持不同政見者是以色列間諜，並呼籲抗議者反對該政權腐敗的以色列特工，並認為他們危害國家安全。我們希望像其他正常國家一樣與以色列的關係正常化。”
伊朗最高領袖阿亞圖拉阿里哈梅內伊於 2021 年 3 月 11 日在伊朗德黑蘭發表電視講話。（來源：哈梅內伊官方網站/通過路透社講義）
Vojoudi 補充說：“為什麼我們的財富要用於資助針對以色列的恐怖主義，而我們的人民卻飽受貧困之苦？世界上的民主國家，特別是歐盟和美國，應該意識到伊斯蘭共和國危險的反猶太主義。該政權盡可能以以色列人和伊朗持不同政見者為目標。這是伊斯蘭共和國的意識形態。伊斯蘭共和國的創始人霍梅尼在他的一次演講中說：“穆斯林必須戰鬥到以色列被消滅為止。” 這就是伊朗伊斯蘭共和國的目的，必須予以製止。”
在民主黨和共和黨政府的領導下，美國政府已將伊朗政權列為國際恐怖主義的主要國家支持者。反誹謗聯盟首席執行官喬納森格林布拉特於 2020 年在眾議院情報和反恐小組委員會作證，稱伊朗政權是否認大屠殺和反猶太主義的最大國家支持者。
中東媒體研究所去年報導稱，阿亞圖拉·德日卡姆在 6 月在 Fars 電視台播出的佈道中說，“在世界戰略問題上，美國不能成為主要決策者……世界各地都在聽到它的崩潰和崩潰的聲音。伊朗民族的呼聲[正在]從美國人自己的口中聽到：'美國去死！'”
Iran Supreme Leader’s rep. calls for destruction of Israel
Iranian dissident: “The more the mullahs spread hate speech against the Jewish State of Israel, the more Iranian people realize that Israel is our friend."
OCTOBER 2, 2021 20:18
Iran's new President Ebrahim Raisi receives the endorsement decree for his presidency from Iran's Supreme Leader Ayatollah Ali Khamenei, in Tehran, Iran August 3, 2021.
(photo credit: OFFICIAL KHAMENEI WEBSITE/HANDOUT VIA REUTERS)
Lotfollah Dezhkam, the representative for the Islamic Republic of Iran’s Supreme Leader Ali Khamenei in Fars Province, urged the elimination of Israel in a Friday sermon in the city of Shiraz.
The Islamic clerical firebrand declared, “The global arrogance led by America with complicity of Israel seeks to delay the realization of an important issue, which is the destruction of the Zionist regime.” Kian Meli, a news outlet opposed to the Islamic Republic of Iran, quoted his remarks. Three regime-controlled news organizations – Islamic Republic News Agency, Fars News and Tasnim – reported on his speech.
Sheina Vojoudi, an Iranian dissident who fled to Germany to escape persecution, said, “The more the mullahs spread hate speech against the Jewish State of Israel, the more Iranian people realize that Israel is our friend, because the regime in Iran is the only enemy that we have. His hate speech against Israel is not surprising…. Ali Khamenei as the leader of the Islamic Republic calls for the annihilation of Israel and Dezhkam is his representative.”
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She added, “We are tired of their antisemitism. We have a long history with the Jewish people and we want to be able to revive that 2700 years of friendship. The Islamic Republic’s antisemitism is lethal and endangers both Iranians and Israelis. The regime accuses Iranian dissidents of being Israeli spies, and calls the protesters against the regime’s corruption Israeli agents, and considers them against the national security. We want to normalize relations with Israel like other normal countries.”
Iran's Supreme Leader Ayatollah Ali Khamenei delivers a televised speech in Tehran, Iran March 11, 2021. (credit: OFFICIAL KHAMENEI WEBSITE/HANDOUT VIA REUTERS)
Vojoudi added, “Why should our wealth be spent on funding terrorism against Israel and our people suffer from poverty? The democratic countries in the world, especially EU and US, should be aware of the Islamic Republic’s dangerous antisemitism. The regime targets Israelis and Iranian dissidents wherever they can. It is the ideology of the Islamic Republic. And Khomeini, the founder of the Islamic Republic, said in one of his speeches, ‘The Muslims must fight until the annihilation of Israel.’ This is what the Islamic Republic in Iran is about and must be stopped.”
The United States government, under both Democratic and Republican administrations, has classified Iran’s regime as the leading state-sponsor of international terrorism. Anti-Defamation League CEO Jonathan Greenblatt testified before the House Subcommittee on Intelligence and Counterterrorism in 2020, calling Iran’s regime the top state sponsor of Holocaust-denial and antisemitism.
The Middle East Media Research Institute reported last year that Ayatollah Dezhkam said in a June sermon that aired on Fars TV, “America cannot be the main decision-maker when it comes to strategic matters in the world…. The sound of America being shattered and of its collapse is being heard all over the world. The shout of the Iranian nation [is] being heard from the mouths of the Americans themselves: ‘Death to America!’”
The audience responded by chanting “Death to America!”
2021 年 10 月 2 日 21:27
他說，伊朗人面臨三個選擇：回到之前的 2015 年核協議，爆發並進行“前所未有的反抗”，包括武器和繼續濃縮，或者尋求改進的協議，在那裡他們將取得比過去更大的成就。過去的。德黑蘭可能會嘗試用盡與西方的長期談判，同時繼續充實自己。
Yitshak Kreiss 教授和 Tamir Hayman 少將（來源：SHEBA MEDICAL CENTER）
2020 年 1 月，他與阿布·馬赫迪 (Abu Mahdi) 一起在巴格達機場的美國無人機襲擊中喪生時，他一直負責伊朗的地區抱負，並忙於建立從德黑蘭到地中海的陸橋以及伊朗在也門的影響力。伊拉克準軍事人民動員部隊副指揮官穆罕迪斯。
“他也是敘利亞的設計師——這是更大的故事。像他這樣的人並不多。”他說。留下來的人，包括他的繼任者 Esmail Qaani，都是“具有高行政能力但無法處理決策過程的傑出人才。他們沒有權力。”
伊朗婦女手持最高領袖阿亞圖拉阿里哈梅內伊和已故伊朗中將的照片。週三在德黑蘭慶祝伊斯蘭革命 42 週年時，卡西姆·蘇萊曼尼 (Qasem Soleimani)。（來源：MAJID ASGARIPOUR/WANA（西亞新聞社）通過路透社）
Head of Military Intelligence: Iran not getting the bomb any time soon
According to Maj.-Gen. Tamir Hayman, the Islamic Republic has a long way to go before it can threaten Israel.
OCTOBER 2, 2021 21:27
Israel is working in a coordinated way to counter Iran
(photo credit: REUTERS)
Despite enriching uranium at a level not seen before, Iran still has a long way to go before acquiring a nuclear bomb, according to Israel’s Military Intelligence head Maj.-Gen. Tamir Hayman.
According to Hayman, while the levels of enriched uranium are “disturbing,” the Islamic Republic still has a long way to go before acquiring a functioning nuclear bomb that can threaten Israel.
“There is an enriched amount [of uranium] in volumes that we have not seen before and it is disturbing. At the same time, in all other aspects of the Iranian nuclear project, we see no progress,” Hayman said in an interview with Walla News.
“Not in the weapons project, in the financial area, not in any other sector. Therefore the period of time that still remains of two years has not changed. Because even from the moment you have a breakout, there is still a long way to go before a bomb,” he said.
“To the best of our knowledge, the directive has not changed and they are not heading toward a breakout. They are not heading toward a bomb right now: It may be in the distant future.”
The Iranians face three choices, he said: a return to the previous 2015 nuclear deal, break out and go for “unprecedented defiance” including in weapons and continued enrichment or go for an improved agreement where they will achieve far more than they have in the past. Tehran will likely try to exhaust long negotiations with the West while continuing to enrich.
Hayman said that while the “right thing to do” is to act on the side of diplomacy vis-a-vis Iran and its nuclear program, there must be a practical, reliable military option along with the economic and diplomatic tools.
“Let’s just agree with the fact that the right thing to do is to take Iran in the direction we want on the side of diplomacy: an attempt at a better agreement,” he said.
Prof. Yitshak Kreiss and Maj. General Tamir Hayman (credit: SHEBA MEDICAL CENTER)
Iran has always denied seeking nuclear weapons but it is believed that it is continuing to develop the capabilities to produce such an arsenal, as well as ballistic missiles capable of carrying nuclear warheads.
In turn, Israel’s military has asked for a major budget increase so that it can strengthen its attack capabilities should it need to attack Iran’s nuclear program.
ISRAEL HAS also warned repeatedly about Iran’s aspirations of regional hegemony and has carried out hundreds of airstrikes as part of its “war-between-wars” campaign to prevent the transfer of advanced weapons to Hezbollah in Lebanon and the entrenchment of its forces in Syria where they could easily act against the Jewish state.
According to Hayman, even with Tehran deploying advanced anti-aircraft missiles, surface-to-air missiles and more, they continue to have a hard time confronting attacks by the Israel Air Force.
The killing of Qassem Soleimani, the former commander of Iran’s Islamic Revolutionary Guard Corps’ Quds Force, was “one of the most significant and important events in my time,” he said, adding that his assassination made a significant contribution to Israel’s national security.
He had been in charge of Iran’s regional aspirations and had been busy establishing a land bridge from Tehran to the Mediterranean as well as Iranian influence in Yemen when he was killed in an American drone strike at Baghdad’s airport in January 2020 along with Abu Mahdi al-Muhandis, deputy commander of Iraq’s paramilitary Popular Mobilization Forces.
Explaining that there are not many people like Soleimani, he said that the man had a strategic vision and operational capacity where he could get things done in Syria in a short period of time.
“He was also the designer of Syria – that’s the bigger story. There are not many people like him” he said. Those who remain, including his replacement Esmail Qaani, are “brilliant people who have high administrative capacity but they cannot handle the decision-making processes. They have no authority.”
IRANIAN WOMEN hold pictures of Supreme Leader Ayatollah Ali Khamenei and the late Iranian Lt.-Gen. Qasem Soleimani, during the celebration of the 42nd anniversary of the Islamic Revolution, in Tehran on Wednesday. (credit: MAJID ASGARIPOUR/WANA (WEST ASIA NEWS AGENCY) VIA REUTERS)
Soleimani was the man who designed, approved and also acted against Israel, Hayman said.
“He was a dangerous man” and now that he is dead, his vision “is hopeless at the moment. Nobody is interested in it. Not the Russians, and not the Syrian regime.” There is also a “consistent and sustained decline of Iranians in Syria,” he said, adding that while Syrian militias remain, Tehran continues to withdraw its people from the country.
But as Iran removes its people from Syria, Hezbollah remains entrenched there ready to act against Israel.
The Lebanese Shi’ite terror army, he said, “is a tool that can be used once. Like a match.”
Hezbollah is a “sophisticated and aggressive military tool” that if activated by Iran will bring about two things: significant destruction towards its assets and the destruction of the Lebanese state.
If and when Hezbollah will be fully deployed against Israel, the scale of destruction of Lebanon will be difficult to compare to,” Hayman said, explaining that the use of Hezbollah “is a bit like the nuclear dilemma: When do you use doomsday weapons?”
2021 年 10 月 2 日 11:24
2019 年 10 月 4 日，在也門薩那，一名男子和胡塞運動的支持者一起參加集會，慶祝該組織在與沙特阿拉伯接壤的邊界附近取得軍事進展後高呼口號。
居民報告說，在亞丁中央火山口區，政府總部和中央銀行所在的地區發生了猛烈的槍聲。這座城市已經看到國際公認的政府和 STC 之間在控制南部的問題上的緊張關係。
南也門因政府與阿拉伯聯合酋長國支持的 STC 之間的權力鬥爭而陷入癱瘓，最近幾個月引發了對普遍貧困和公共服務差的抗議活動。
他們是沙特阿拉伯領導的聯盟名義上的盟友，該聯盟一直在與與伊朗結盟的胡塞運動作鬥爭，該運動於 2014 年底將政府從首都薩那趕下台，現在控制了也門北部和主要城市中心的大部分地區。
3 月 28 日，一名也門政府武裝人員在也門馬里布向胡塞武裝人員開火。（圖片來源：ALI OWIDHA/REUTERS）
沙特阿拉伯調解了一項旨在結束政府與 STC 之間僵局的協議，包括組建一個包括分離主義者在內的新內閣，但計劃中的部隊重新部署尚未發生。
該聯盟於 2015 年在也門干預了胡塞武裝，但衝突仍在繼續，造成數万人死亡，並將該國推向飢荒的邊緣。
Four killed in fighting between Yemeni separatists
Residents reported heavy gunfire in Aden's central Crater district that houses government headquarters and the central bank.
OCTOBER 2, 2021 11:24
A man chants slogans as he and supporters of the Houthi movement attend a rally to celebrate following claims of military advances by the group near the borders with Saudi Arabia, in Sanaa, Yemen October 4, 2019.
(photo credit: MOHAMED AL-SAYAGHI/REUTERS)
Clashes broke out in the Yemeni city of Aden on Saturday between members of the separatist Southern Transitional Council (STC) and at least four fighters were killed, two security sources said.
Residents reported heavy gunfire in Aden's central Crater district that houses government headquarters and the central bank. The city has seen tension between the internationally recognized government and the STC over control of the south.
The prime minister of the Saudi-backed government returned to Aden last week from Saudi Arabia and is residing at the presidential palace in Crater along with other government ministers. Yemen's president is based in Riyadh.
South Yemen has been paralyzed by the power struggle between the government and the United Arab Emirates-backed STC, leading to protests in recent months over widespread poverty and poor public services.
They are nominal allies under a coalition led by Saudi Arabia which has been battling the Iran-aligned Houthi movement that ousted the government from the capital Sanaa in late 2014 and now holds most of northern Yemen and main urban centers.
A YEMENI government fighter fires at Houthi fighters in Marib, Yemen, March 28. (credit: ALI OWIDHA/ REUTERS)
Saudi Arabia mediated a deal aimed at ending the standoff between the government and the STC, including forming a new cabinet that includes separatists, but a planned troop redeployment has yet to take place.
The coalition intervened in Yemen in 2015 against the Houthis but the conflict has dragged on, killing tens of thousands and pushing the country to the brink of famine.
大多數宗教猶太復國主義者反對政府改革 - 民意調查
2021 年 10 月 2 日 19:44
窗戶上的 Tzohar kashrut 貼紙
（圖片來源：MARC ISRAEL SELLEM）
與此同時，民意調查發現，宗教傳統、傳統和世俗的以色列人的多元化支持這些提議，儘管每個部門的大多數人都沒有聽說過改革，其中涉及廢除首席拉比對 kashrut 監督的壟斷。
數據來自 Panels Politics 為猶太人和猶太復國主義研究所進行的一項民意調查，這是一個新組織，專門研究宗教和傳統部門以及更廣泛的猶太社會對宗教和社會問題的態度。
政府目前正在推進立法，以廢除目前由首席拉比管轄的地方拉比是唯一可以頒發 kashrut 證書的機構，表明餐館或其他食品企業是猶太教的。
取而代之的是，獨立的 kashrut 當局將被允許對任何要求提供服務的企業進行監督，首席拉比將運營一個監督機構，以確保遵守 kashrut 標準。
委員會主席 MK Yulia Malinovsky 在聽證會上指出，由於大量的食品和非食品項目都有 kashrut 許可證，從而增加了項目的成本，這種監管問題影響到所有以色列公民，包括猶太人和非猶太人，宗教的和非宗教的一樣。
MK 將幾種帶有 kashrut 郵票的非食品產品帶到委員會聽證會，包括漂白劑、肥皂、餐具和牙籤，以強調她的觀點，即 kashrut 及其成本影響所有公民的生活。
“這會影響到我們所有人，無處不在……為了使 kashrut 服務值得信賴和定性，他們需要秩序、監督並使當前的系統更有效率，”Malinovsky 說。
在聽證會上，設計提案的 Yamina 的宗教服務部長 Matan Kahana 為改革中最具爭議的部分進行了辯護，即可以按照比首席拉比確定的標準更基本的標準來建立 kashrut 供應商，只要他們支持提供商的標準。
極端保守的宗教猶太復國主義諾姆黨（宗教猶太復國主義黨的一個組成部分）的 MK Avi Maoz 在委員會聽證會上譴責了改革。
“以色列的國家 kashrut 系統是國家的猶太人面孔。拉比亞伯拉罕·艾薩克·哈科恩·庫克（Abraham Isaac Hacohen Kook）建立的首席拉比是猶太國家的靈魂……這個國家沒有其他猶太人的面孔，”毛茲說。
民意調查於 9 月對 1,206 名猶太成年人進行了抽樣，樣本誤差為 +/- 3.1%。
根據這項研究，62% 的以色列猶太人認為該國的 kashrut 系統需要進行重大改變，該系統受到腐敗的影響，並受到首席拉比的壟斷控制，這本身就增加了食品成本。
那些認為需要改革的人包括 64% 的宗教猶太復國主義受訪者、72% 的宗教傳統受訪者和 43% 的極端正統派受訪者，以及 67% 的傳統受訪者和 61% 的世俗猶太人。
儘管聽說過政府提議的 kashrut 系統改革的支持率更高——21% 的人讚成，14% 的人反對——但大多數公眾 (52%) 根本沒有聽說過這些改革.
然而，足有 71% 的宗教-猶太復國主義受訪者表示他們聽說過這些改革。在所有宗教猶太復國主義受訪者中，35% 的人表示反對這些提議，18% 的人表示他們贊成，18% 的人聽說過這些提議但沒有形成意見。
大約 54% 的極端正統派受訪者表示他們聽說過這些提議並反對它們，而只有 1% 的人表示支持。
Georgie 窗戶上的 Tzohar 貼紙（來源：MARC ISRAEL SELLEM）
當被問及當前 kashrut 系統存在的問題時，大約 62% 的人表示首席拉比的壟斷是中央失敗，52% 的人還抱怨它增加了食品成本，46% 的人說系統腐敗。
當被問及所有列出的問題的解決方案是什麼時，超過一半的受訪者 (51%) 表示“取消首席拉比尼特對 kashrut 的壟斷”，而 40% 的受訪者表示對特定失敗進行內部改革是最好的解決方案。
猶太和猶太復國主義研究所創始人丹尼爾·戈德曼 (Daniel Goldman) 回應稱：“民意調查清楚地表明，人們對改變卡什魯特製度的必要性達成了理解和廣泛共識，其中問題的核心是拉比的壟斷地位。”民意調查的結果。
Majority of religious-Zionists oppose gov't kashrut reforms - poll
The Knesset committee has begun its deliberations on government kashrut reforms.
OCTOBER 2, 2021 19:44
A Tzohar kashrut sticker in a window
(photo credit: MARC ISRAEL SELLEM)
A new poll has found that although 62% of the Jewish population in Israel wants serious reform to Israel’s kashrut (kosher) supervision system, a plurality of religious-Zionist Israelis oppose the reforms proposed by the current government.
At the same time, pluralities of religiously-traditional, traditional and secular Israelis support the proposals, the poll found, although majorities in each sector had not heard about the reforms, which involve abolishing the Chief Rabbinate’s monopoly over kashrut supervision.
The data comes from a poll conducted by Panels Politics for the Institute for Jewish and Zionist Research, a new organization dedicated to examining attitudes to religious and social issues specifically among the religious and traditional sectors, and Jewish society more broadly.
The government is currently advancing legislation which would abolish the present system where local rabbinates, which are under the authority of the Chief Rabbinate, are the only bodies which can issue a kashrut certificate stating that a restaurant or other food business is kosher.
In its place, independent kashrut authorities would be allowed to provide supervision to any business requesting their service, and the Chief Rabbinate would operate a supervisory body to ensure compliance with kashrut standards.
The reforms, which have generated fierce opposition from the Chief Rabbinate as well as the ultra-Orthodox and conservative religious-Zionist parties, were brought to the Knesset Committee for Special National Infrastructure Initiatives and Jewish Religious Services on Thursday in preparation for the next legislative stages.
THE CHIEF Rabbinate of Israel in Jerusalem. (credit: FLASH90)
Committee chairwoman MK Yulia Malinovsky noted during the hearing that since a vast array of food, and non-food items have kashrut licenses, thereby increasing the cost of the item, the issue of such supervision affects all Israeli citizens, Jewish and non-Jewish, religious and non-religious alike.
The MK brought several non-food products that have kashrut stamps to the committee hearing, including bleach, soap, utensils and toothpicks, to emphasize her point that kashrut and its costs touch the lives of all citizens.
“This affects us all, everywhere… In order that kashrut services be trustworthy and qualitative they need order, oversight and making the current system more efficient,” said Malinovsky.
DURING THE hearing, Religious Services Minister Matan Kahana of Yamina, whose office designed the proposals, defended perhaps the most controversial element of the reforms, whereby a kashrut provider could be established with more basic standards than those determined by the Chief Rabbinate, as long as they back the provider’s standards.
Kahana said he did not want to have this track made available but that he was forced to allow for it since the Chief Rabbinate is not cooperating with his proposed reforms. The minister said he would drop this part of the legislation if the Chief Rabbinate began to cooperate.
MK Avi Maoz of the ultra-conservative religious-Zionist Noam Party, a component of the Religious Zionist Party, denounced the reforms in the committee hearing.
“Israel’s state kashrut system is the Jewish face of the state. The Chief Rabbinate, which Rabbi Abraham Isaac Hacohen Kook established, is the soul of the Jewish state… and the state has no other Jewish face,” said Maoz.
“If you remove the Chief Rabbinate’s monopoly from our public lives, you will turn the State of Israel into a state of all its citizens.”
THE POLL was conducted in September on a sample of 1,206 Jewish adults with a sample error of +/- 3.1%.
According to the study, 62% of Israeli Jews think that substantial change is needed to the country’s kashrut system, which suffers from corruption and is controlled by the Chief Rabbinate’s monopoly, which itself increases the cost of food.
Those saying reform is needed include 64% of religious-Zionist respondents, 72% of the religiously-traditional, and 43% of ultra-Orthodox respondents, along with 67% of the traditional, and 61% of secular Jews.
And although there was more support for the government’s proposed reforms to the kashrut system among those who have heard about them – 21% in favor and 14% against – the majority of the general public (52%) has not heard about the reforms at all.
However, fully 71% of religious-Zionist respondents said they had heard of the reforms. Of all religious-Zionist respondents, 35% said they were opposed to the proposals, 18% said they were in favor, and 18% had heard about them but had not formed an opinion.
Some 54% of ultra-Orthodox respondents said they had heard of the proposals and opposed them, compared to just 1% who said they were supportive.
A Tzohar sticker in the window of Georgie (credit: MARC ISRAEL SELLEM)
Asked about existing problems with the current kashrut system, some 62% said that the Chief Rabbinate’s monopoly was a central failing, with 52% also complaining that it increases the cost of food, and 46% saying the system was corrupt.
Asked what the solution was to all of the problems listed, more than half of respondents (51%) said “abolishing the Chief Rabbinate’s kashrut monopoly,” while 40% said internal reforms of specific failings was the best solution.
“The poll gives a clear message that there is an understanding and broad consensus for the need to change the kashrut system, where the heart of the matter is the rabbinate’s monopoly,” Institute for Jewish and Zionist Research founder Daniel Goldman said in response to the poll’s findings.
“This sentiment is widespread and includes all sectors and denominations of the Jewish people, including the traditional and the religious for whom kashrut is important and who are not interested in the continued absolute control of the rabbinate.”
以色列本土 COVID-19 疫苗的競爭
2021 年 10 月 2 日 16:26
2021 年 9 月 30 日，衛生工作者在耶路撒冷的 Clalit 臨時衛生保健中心準備 Covid-19 疫苗。
在接受《耶路撒冷郵報》採訪時，以色列BriLife冠狀病毒疫苗之父Shmuel Shapira 教授預測，當該國的疫苗準備就緒時，“它會比今天的公民擁有的更好”。
BriLife 由以色列生物研究所 (IIBR) 開發。夏皮拉在過去八年中一直擔任其董事，並於 5 月卸任。他最近用希伯來語出版了一本關於他去年經歷的書，名為《大流行馬戲團》，講述了以色列為自己的全球大流行解藥而進行的競賽。
2020 年 2 月 1 日一個寒冷的星期六晚上，夏皮拉正在和妻子看電影時，他的手機響了，一個“陌生來電”出現在屏幕上。起初他忽略了嗡嗡聲，但嘗試了四五次後，他回答了。
“我被要求在周日中午與總理本雅明內塔尼亞胡會面，討論在 IIBR 生產疫苗的可能性，”夏皮拉回憶道。
國防部長本尼·甘茨（左）去年在 Ness Ziona 的中心實驗室與時任生物研究所所長 Shmuel Shapira 教授交談。（圖片來源：ARIEL HERMONI/國防部）
IIBR 正在研究的是 Shapira 不會很快分享的信息。該研究所在總理辦公室的主持下運作，並與國防部密切合作。它的戰略和技術能力處於保密狀態。
“我們選擇了一種方法，一方面，它是現代的，另一方面，比其他疫苗製造商選擇的更保守、更不大膽，”夏皮拉說，並解釋說 BriLife 是基於一種已經存在的技術三四年來，已經證明可以成功對抗致命的埃博拉病毒。
BriLife 是一種基於載體的疫苗。該疫苗採用水泡性口炎病毒 (VSV) 並對其進行基因改造，使其在其包膜上表達新型冠狀病毒的刺突蛋白。
本月早些時候，以色列 II 期臨床試驗的最後一名志願者接種了疫苗。NRx 主席喬納森·賈維特教授說，喬治亞州 IIb 期試驗的第一位志願者預計將在 11 月初被刺傷。III 期試驗應在 2 月份開始。
經過三個多月的談判和一年的官僚主義拖延，IIBR 在 7 月授予了 NRx 對 BriLife 的全球獨家開發、製造和營銷權利。
Javitt 說，III 期試驗將涉及 20,000 人，持續大約 6 個月，但“如果疫苗按照我們希望的方式發揮作用，對抗某些新變種，我可以想像一些國家會考慮在某些情況下給予它緊急使用授權。那個時候的三分之一。”
NRx 在簽署之前請了外部專家對 BriLife 進行評估，賈維特說：“人們一致認為，與 IIBR 疫苗相關的創新可能比其他技術更好地應對這種可怕的病毒。”
Hadassah 臨床研究部門主任、該試驗的國家首席研究員 Yossi Caraco 教授說，早期的臨床實驗表明，該疫苗可以更有效地對抗突變並賦予持久的免疫力。他說，與輝瑞和 Moderna 相比，副作用發生率要低得多，而且也不那麼嚴重，而且注射產生的中和抗體水平“令人鼓舞”，甚至“令人鼓舞”。
與 IIBR 或疫苗無關的衛生部 SARS-COV2 疫苗臨床試驗諮詢委員會成員西里爾·科恩教授說，雖然現在說疫苗的功效還為時過早，但他確實相信它已經一個成功的機會，並且在某些時候將成為助推器的好人選。
IIBR 成立於 1952 年，由哈加納的 Hemed Bet 生物戰部門和國防部的另一個研究部門合併而成，後者是在獨立戰爭後成立的。
被定罪的蘇聯間諜 Avraham Marcus Klingberg 是 IIBR 的創始人之一，後來擔任該研究所的副主任。
從一開始，位於“以色列綠色城市”的研究所 Ness Ziona 就具有雙重身份。一方面，它進行與國家利益相關的高度機密的科學研究。另一方面，它作為一個公共研究機構，為開發脊髓灰質炎疫苗和在以色列和國外銷售的品牌藥物做出了貢獻。
該研究所以其與國防相關的研究而自豪。但就其所謂的進攻能力而言，除了以色列沒有簽署 1972 年《生物和毒素武器公約》之外，人們對其所知甚少，而且據國外報導，摩薩德至少兩次試圖使用生物武器暗殺人民。
1998 年 10 月，一架 6 年前在阿姆斯特丹墜毀的 El Al 貨機被發現運載了一批 DMMP，這是一種用於製造沙林神經毒氣的化學品，據一份報告稱，該貨機本打算交付給 IIBR。紐約時報報導。
夏皮拉在 IIBR 工作了八年。他是在擔任希伯來大學公共衛生學院院長和哈達薩大學醫學中心副主任後來到該研究所的。他出版了多本書和數百篇科學論文。
他說，到達 IIBR 一年後，他將研究所的主要任務定義為為大流行做準備，但在沒有支持這一任務的情況下，“我們在雷達下完成了這項任務”。他們專注於提升診斷能力和開發靈活的候選疫苗。
當內塔尼亞胡要求 IIBR 開發疫苗時，該研究所因此做好了準備，並表示可以生產 1000 萬至 1500 萬支疫苗，足以為所有符合條件的公民和巴勒斯坦人接種。
2020 年 8 月 6 日，夏皮拉與總理一起出現在 Zoom 上，並告訴他和公眾，“六個月前，你們派遣我們為以色列國帶來疫苗和抗體。我們已經執行了任務，並且正在以最好的方式執行它。我們有很好的疫苗。這是第一瓶疫苗；從上週四開始，我們就有了疫苗。”
一周後，當夏皮拉向以色列議會提交疫苗時，MK Einav Kabla 說：“我們都期待著關於疫苗的重大消息，該消息將開始結束我們所處的複雜局面，這具有影響在我們生活的方方面面。”
與此同時，以色列與輝瑞籤署了一項協議，到 2020 年 12 月，該國勇敢的疫苗接種運動開始了。
迄今為止，超過 610 萬以色列人至少接受了一次射擊，超過 300 萬次接受了三次射擊。
“我認為以色列公民接種的疫苗不是 A 型疫苗，”夏皮拉說。“我不知道給它打幾級，但一種只能發揮幾個月作用的疫苗遠非完美。”
儘管他不想具體說明，但他在與 Yediot Ahronot 的談話中說，他從“我的親密圈子和與醫生的談話”中了解到，疫苗可能存在“重大”副作用。
美國食品和藥物管理局已於 8 月全面批准輝瑞疫苗。在其批准聲明中，它指出“短期隨訪的可用數據表明，大多數人”從他們經歷的任何副作用中恢復過來。然而，“目前還沒有關於潛在長期健康結果的信息。”
夏皮拉說，任何 65 歲以下接受第三次注射的人都應該被告知它沒有得到 FDA 的批准，告知可能的好處和危害，並要求籤署同意書。
他說，當政府選擇輝瑞並開始看到其初步結果時，它放棄了控制大流行所需的其他衛生措施。它還把 IIBR 及其疫苗拋在了後面。
他告訴《華盛頓郵報》，研究疫苗的 80 名科學家不僅沒有得到他們需要的支持，而且有時他們還面臨政客和其他人的非科學、官僚主義障礙。監管機構工作緩慢。會議很少，而且經常被推遲。決策時間太長了。
政府在該項目中僅投資了 1.76 億新謝克爾，而其他開發 COVID 疫苗的公司的預算為 30 億美元。
當內塔尼亞胡在 2020 年 2 月指示 IIBR 開發冠狀病毒疫苗時，他還談到在以色列建立疫苗工廠。8 月，當 IIBR 宣布準備啟動 I 期臨床試驗時，總理表示，他已要求該研究所在第一次人體試驗的同時開始建立生產工廠，以便以色列做好準備，如果試驗成功。然而，這個製造基地幾乎沒有取得任何進展。
夏皮拉說，他曾多次訪問耶羅漢姆市，耶羅漢姆市市長塔爾·奧哈納 (Tal Ohana) 在之前的一次討論中告訴《華盛頓郵報》，有一項“詳細計劃”，可以在她所在的城鎮開設製造工廠。
“我們真的相信以色列的疫苗，”Ohana 說。“這是實現疫苗獨立的唯一途徑。我真的希望 IIBR 得到食品和藥物管理局的最終確認，然後可以在 Yeroham 開始生產。”
夏皮拉說，在過去的 18 個月裡，以色列的情況並不正常，死亡人數和感染率證明了這一點。但更重要的是，兒童教育和經濟也受到了影響。
The race for Israel's homegrown COVID-19 vaccine
HEALTH AFFAIRS: The father of the BriLife initiative explains Israel’s strategic imperative to have its own vaccine.
OCTOBER 2, 2021 16:26
Health worker prepares a Covid-19 vaccine at a temporary Clalit health care center in Jerusalem, September 30, 2021.
(photo credit: YONATAN SINDEL/FLASH90)
Israel is on the verge of finalizing a COVID-19 vaccine whose creators believe could offer better protection against variants than its international counterparts such as Pfizer.
In an interview with The Jerusalem Post, the father of Israel’s BriLife coronavirus vaccine, Prof. Shmuel Shapira, predicted that when the country’s vaccine is ready, “it will be better” than what its citizens have today.
BriLife was developed by the Israel Institute for Biological Research (IIBR). Shapira served as its director for the last eight years, stepping down in May. He recently published a book in Hebrew on his experience last year called The Pandemic Circus about Israel’s race for its own antidote to the global pandemic.
On a cold Saturday night on February 1, 2020, Shapira was watching a movie with his wife when his phone started ringing and an “unknown caller” appeared on the screen. At first he ignored the buzz, but after four or five attempts, he answered.
“I was asked to come to a meeting on Sunday at noon with Prime Minister Benjamin Netanyahu to discuss the possibility of manufacturing vaccines at IIBR,” Shapira recalled.
“The request was rational,” he said. “We were the only institute capable of planning and manufacturing vaccines. We were already doing it.”
DEFENSE MINISTER Benny Gantz, left, speaks with then-director of the Institute of Biological Research, Prof. Shmuel Shapira, at the center’s laboratory in Ness Ziona, last year. (credit: ARIEL HERMONI/DEFENSE MINISTRY)
What exactly IIBR was working on is information that Shapira is not quick to share. The institute operates under the auspices of the Prime Minister’s Office and works closely with the Defense Ministry. Its strategic and technical capabilities are shrouded in secrecy.
“We manufactured the smallpox vaccination for the entire population of Israel,” Shapira said. “There were other vaccines as well, but I cannot say what they were.”
“We opted for an approach that is, on the one hand, modern and, on the other, more conservative and less bold than the other vaccine makers chose,” Shapira said, explaining that BriLife is based on a technology that has been in existence for three or four years and has already proven to be successful against the deadly Ebola virus.
BriLife is a vector-based vaccine. The vaccine takes the vesicular stomatitis virus (VSV) and genetically engineers it so that it will express the spike protein of the novel coronavirus on its envelope.
Once injected, it does not cause disease by itself. Instead, the body recognizes the spike protein that is expressed on the envelope and begins to develop an immunological response. Moreover, unlike other vaccines, this one binds to the exact cell in the lung that is targeted by the novel coronavirus.
The last volunteer in Israel’s Phase II clinical trial was inoculated earlier this month. The first volunteer in a Phase IIb trial in Georgia is expected to get jabbed at the start of November, NRx chairman Prof. Jonathan Javitt said. The Phase III trial should start by February.
IIBR gave NRx exclusive worldwide development, manufacturing and marketing rights for BriLife in July after more than three months of negotiations and a year of bureaucratic delays.
Javitt said that the Phase III trial will involve 20,000 people and last about six months, but “if the vaccine performs the way we hope it will against some of the new variants, I can imagine some countries thinking about giving it emergency use authorization in a third of that time.”
NRx brought in outside experts to evaluate BriLife before signing, and Javitt said “the feeling was unanimous that there is innovation associated with the IIBR vaccine that potentially addresses this terrible virus better than other technologies.”
Early clinical experiments hold up that the vaccine could be more effective against mutation and confer lasting immunity, said Prof. Yossi Caraco, director of Hadassah’s clinical research unit, who served as the national principal investigator for the trial. He said the rate of side effects is much lower and they are less severe than with Pfizer and Moderna, and the level of neutralizing antibodies the shots produce is “promising” and even “encouraging.”
Prof. Cyrille Cohen, a member of the Health Ministry’s advisory committee for clinical trials on SARS-COV2 vaccines, who is not connected to IIBR or the vaccine, said that while it is too early to tell the vaccine’s efficacy, he does believe it has a chance for success and would be a good candidate for booster shots at some point.
“How will it perform against other vaccines already on the market?” Cohen asked. “The competition is tough.”
IIBR WAS founded in 1952 as a merger of the Hagana’s Hemed Bet biological warfare unit and another research division of the Defense Ministry that had been established after the War of Independence.
Convicted Soviet spy Avraham Marcus Klingberg was among IIBR’s founders and later served as deputy director of the institute.
From its outset, the institute that sits in “Israel’s green city,” Ness Ziona, has had a dual identity. On the one hand, it conducts highly classified scientific research known to be relevant to the country’s national interests. On the other, it serves as a public research institute that contributed to the development of a vaccine for polio and brand name drugs sold in Israel and abroad.
The institute prides itself on its defense-related research. But in terms of its alleged offensive capabilities, little remains known except that Israel has not signed the 1972 Biological and Toxin Weapons Convention and that, according to foreign reports, the Mossad has attempted to use biological weapons at least twice to assassinate people.
In October 1998, it was discovered that an El Al cargo plane that crashed six years prior in Amsterdam was carrying a shipment of DMMP, a chemical used in the manufacturing of sarin nerve gas, which was meant to be delivered to IIBR, according to a New York Times report.
“I don’t want to talk about the reason we are secret or what they say, with all the legends and everything,” Shapira said. “Our only mission is to defend.”
Shapira was at IIBR for eight years. He came to the institute after serving as the head of the Hebrew University’s School of Public Health and deputy director of Hadassah-University Medical Center. He has published several books and hundreds of scientific papers.
A year after arriving at IIBR, he said, he defined the institute’s main mission as preparing for a pandemic, but without support for this mission “we did it under the radar.” They focused on upgrading their diagnosis capabilities and on developing a flexible vaccine candidate.
When Netanyahu asked IIBR to develop the vaccine, the institute was therefore ready, and said it could make 10 million to 15 million vaccine units, enough to inoculate all eligible citizens and the Palestinians.
On August 6, 2020, Shapira appeared on Zoom with the prime minister and told him and the public, “Six months ago, you dispatched us to bring a vaccine and antibodies to the State of Israel. We have carried out the mission, and are carrying it out in the best way possible. We have an excellent vaccine. This is the first vial of the vaccine; since last Thursday, we have a vaccine.”
A week later, when Shapira presented the vaccine to the Knesset, MK Einav Kabla said, “We are all waiting with expectation for the big news about a vaccine that will begin to put an end to the complicated situation we are in, which has implications on every area of our lives.”
IIBR’s success “is the hope of the entire nation of Israel,” she said.
But three months later, Shapira was back at the Knesset complaining that “had we not encountered overregulation, we would have progressed more.”
Meanwhile, Israel signed a deal with Pfizer, and by December 2020 the country’s valiant vaccination campaign began.
To date, more than 6.1 million Israelis have received at least one shot, and more than 3 million three shots.
WHY NOT just give up on developing an Israeli vaccine?
“The pandemic is not over, and there will be another pandemic,” Shapira insisted. “You will see it in your lifetime.”
And he said that Israel having its own vaccine is a strategic initiative.
“Maybe tomorrow we will not have such a good relationship with a certain company” and Israel will not be given the tens of millions of vaccines it needs so fast, he said. “You cannot trust it. Just like we need to be able to bake bread and manufacture artillery, there are certain basic needs that cannot be left for others, especially when dealing with matters of life or death.
“Israel is a country with good scientists and a strong biotech industry. We should be capable of manufacturing vaccines whether Pfizer exists or doesn’t.”
Moreover, he said that in his estimation, Pfizer is not as good as it first appeared.
“I think the vaccine that Israeli citizens are vaccinated with is not an A vaccine,” Shapira said. “I don’t know which grade to give it, but a vaccine that only functions for a few months is far from being perfect.”
He is not anti-vaccination, and he has gotten jabbed three times, but he said he does have some concerns about potential long-term side effects of the vaccine.
“The main advantage of mRNA vaccines is that they can be designed very quickly. The disadvantage is that their technology is unknown, raising all kinds of safety issue questions – certainly for long-term side effects,” Shapira said.
Though he did not want to be specific, he said in a conversation with Yediot Ahronot that he knows from “my close circle and conversations” he has had with doctors that there are “significant” side effects that could be associated with the vaccine.
“I don’t think that they were covered up on purpose, but I think digging deeper into the possibility of side effects was less convenient” when running a mass vaccination campaign, he told the Post. “I don’t think anyone tried hard enough to look for side effects…. A year is a very short experiment.”
The US Food and Drug Administration has given full approval to the Pfizer vaccine in August. In its statement of approval, it noted that “available data from short-term follow-up suggest that most individuals” recovered from any side effects they experienced. However, “information is not yet available about potential long-term health outcomes.”
He also said that the booster campaign was decided on “too hastily” and that he does not believe Israel was transparent in admitting to citizens that giving them a third shot was “experimental.”
Shapira said anyone under 65 who is getting the third shot should be informed that it was not approved by the FDA, told what the benefits and harms might be, and asked to sign a consent form.
“I am a man who is aware of what secrets are and respects secrets,” Shapira explained. “But there was a lack of transparency. Why were parts of the Pfizer contract hidden? Why were coronavirus cabinet meeting minutes hidden? I think there was too much business and too little science. In a battle between science and business, science should win.”
In his new book, he describes Israelis as “guinea pigs” who “paid a fortune to be part of an experiment,” though he said in the interview that this is not necessarily a bad thing.
“I don’t think anyone did Israel a big favor. We paid a big price for these vaccines – more than any other country. And the other thing we paid with is something more valuable, data,” he said. “I think it was the right decision to vaccinate the population with the available vaccine… but Israel became a lab for the first and second doses of the vaccine, and now we are doing it again with the third dose.
“Being a guinea pig is not necessarily bad. You can be smart mice,” he continued. “Whether it was a mistake or not, we’ll only know in the future.”
And he pointed out the paradox that Israel is among the most vaccinated countries in the world with one of the highest infection and mortality rates.
“If the vaccination is so good, why are so many people sick?” Shapira asked.
He said that when the government chose Pfizer and started to see its preliminary results, it abandoned the other health measures necessary to control the pandemic. It also left IIBR and its vaccine behind.
“I have documentation that proves government officials worked to delay our progress for months on end,” he said.
He told the Post that not only were the 80 scientists working on the vaccine not given the support they needed, but sometimes they faced nonscientific, bureaucratic obstacles by politicians and others. The regulatory bodies worked slowly. Meetings were infrequent and often delayed. Decision-making took too long.
The government invested only NIS 176 million in the project, compared to the $3 billion budgets of other companies working on a COVID vaccine.
“It was really David versus Goliath, and we did it,” Shapira said. “We had this really good product in our hands, and now the people of Israel cannot enjoy it.”
IN HIS book The Pandemic Circus, he also talks about the government’s mismanagement of the pandemic and calls for a government inquiry into its actions.
“I heard and saw it all and was often shocked or stunned into disbelief by what had transpired,” Shapira wrote.
But he said the goal is not to throw the country’s leaders under the bus, but to learn for the next time around.
His advice is multifaceted.
First, he said, Israel needs to establish a better communications program, like it had during the Gulf War, when one voice offered twice daily updates, explained what was happening and told the public what is best to do.
Data should be more accurate, as well, he charged. The Health Ministry numbers were often inconsistent and played a role, he believes, in the government’s zigzags.
Shapira said that Israel needs to better tap into its mayors.
And, of course, he said that the country needs to invest in building a vaccine manufacturing facility that could be ready for next time.
When Netanyahu instructed IIBR in February 2020 to develop a coronavirus vaccine, he also spoke of establishing a vaccine factory in Israel. In August, when IIBR announced it was ready to launch a Phase I clinical trial, the prime minister said that he had asked the institute to start setting up the production plant, parallel with the first human trials, so that Israel would be ready if the trials were successful. However, little or no progress was made on this manufacturing site.
Shapira said he took several visits to the city of Yeroham, whose mayor, Tal Ohana, told the Post in a previous discussion that there is a “detailed plan” for launching a manufacturing facility in her town.
She had said she hoped that this facility would manufacture BriLife.
“We really believe in the Israeli vaccine,” Ohana said. “It is the only way to be vaccine independent. I really hope that IIBR gets final confirmations from the Food and Drug Administration and can then begin manufacturing in Yeroham.”
Shapira said he is “skeptical” and “cynical” that such a factory will ever be established, even though “it is feasible” and “I think it should happen.”
He said that “now everyone is talking about vaccines. But when, God willing, this will all be over, then we will move on to other priorities and everyone will forget.”
Shapira said that for the last 18 months, things were not run properly in Israel, and the death toll and infection rate prove it. But more than that, children’s education and the economy suffered, too.
“Everyone counts death, but we should be counting things that are harder to measure, like emotional damage, post-trauma – many people in Israel are scratched up,” he said. “The pandemic has been managed like a circus, and I think we are going to pay a lot for it.”
研究表明，實驗性抗病毒藥物莫奈拉韋可能對已知的 COVID-19 毒株有效。
2021 年 10 月 2 日 03:50
2018 年 7 月 12 日，在美國新澤西州拉威市默克公司園區門口看到的默克標誌。
根據專家們稱讚為治療該病毒的潛在突破的數據，默克公司開發的一種實驗性抗病毒藥丸可以將最有可能感染嚴重 COVID-19 的人死亡或住院的機率減半。
默克和合作夥伴 Ridgeback Biotherapeutics 表示，他們計劃盡快尋求美國對該藥丸的緊急使用授權，並在全球範圍內進行監管申請。
約翰霍普金斯大學健康安全中心的高級學者 Amesh Adalja 說：“一種可以在這種程度上影響住院風險的口服抗病毒藥物將改變遊戲規則。”
掃描電子顯微鏡圖像顯示 SARS-CoV-2，也稱為新型冠狀病毒（來源：US NIAID-RML/Handout via REUTERS）
“這將改變圍繞如何管理 COVID-19 的對話，”默克首席執行官羅伯特戴維斯告訴路透社。
III 期試驗的結果使默克公司的股價上漲了 9% 以上，結果如此強勁，以至於在外部監測員的建議下，該研究被提前停止。
正在開發類似 COVID-19 療法的 Atea Pharmaceuticals Inc 的股價因消息而上漲超過 21%。
COVID-19疫苗製造商 Moderna Inc 的股價下跌了 10% 以上，而輝瑞 (Pfizer) 的股價下跌了不到 1%。
Jefferies 分析師 Michael Yee 表示，投資者相信“如果有一種簡單的藥丸可以治療 COVID，人們就會不那麼害怕 COVID，也不太願意接種疫苗。”
輝瑞和瑞士製藥商羅氏控股公司也在競相開發一種易於給藥的 COVID-19 抗病毒藥丸。目前，只有必須靜脈注射的抗體混合物才被批准用於非住院患者。
白宮 COVID-19 響應協調員傑夫·齊恩茨 (Jeff Zients) 週五表示，莫奈拉韋是“一種潛在的額外工具……可以保護人們免受 COVID-19 的最壞結果的影響”，但補充說，疫苗接種“仍然遙遙無期，這是我們對抗 COVID 的最佳工具- 19。”
在默克公司的研究中，一項計劃對 775 名患者進行的中期分析著眼於有嚴重疾病風險的人的住院或死亡情況。研究發現，在連續五天每天兩次服用莫諾匹拉韋的患者中，有 7.3% 的人住院治療，並且在治療後 29 天沒有人死亡。相比之下，安慰劑患者的住院率為 14.1%。安慰劑組也有八人死亡。
Ridgeback 首席執行官溫迪·霍爾曼 (Wendy Holman) 在一份聲明中說：“迫切需要可以在家中進行的抗病毒治療，以使 COVID-19 患者遠離醫院。”
科學家們歡迎這種潛在的新療法，以幫助預防該病毒引起的嚴重疾病，該病毒已導致全球近 500 萬人死亡，其中 70 萬人在美國。
牛津大學新興傳染病教授彼得霍比說：“一種安全、負擔得起且有效的口服抗病毒藥物將是抗擊 COVID 的巨大進步。”
該研究招募了實驗室確診的輕度至中度 COVID-19 患者，這些患者的症狀不超過五天。所有患者至少有一個與不良疾病結果相關的危險因素，例如肥胖或年齡較大。
這家美國製藥商表示，預計到 2021 年底將生產 1000 萬個療程的藥物。
該公司與美國政府簽訂了合同，以每門課程 700 美元的價格供應 170 萬個莫努匹韋課程。
一位美國衛生官員告訴路透社，如果需要，美國政府可以選擇額外購買多達 350 萬個療程。該官員要求匿名，因為他們無權對合同發表公開評論。
Molnupiravir 還在一項 III 期試驗中進行研究，以防止暴露于冠狀病毒的人感染。
默克公司的官員表示，目前尚不清楚 FDA 的審查需要多長時間，但默克公司研究實驗室負責人迪恩·李表示，“他們將努力在這方面積極開展工作。”
COVID-19 Merck pill works against variants, research shows
Research shows that the experimental antiviral drug molnupiravir is likely to be effective against known COVID-19 strains.
OCTOBER 2, 2021 03:50
The Merck logo is seen at a gate to the Merck & Co campus in Rahway, New Jersey, US, July 12, 2018.
(photo credit: REUTERS/BRENDAN MCDERMID)
An experimental antiviral pill developed by Merck & Co could halve the chances of dying or being hospitalized for those most at risk of contracting severe COVID-19, according to data that experts hailed as a potential breakthrough in how the virus is treated.
If it gets authorization, molnupiravir, which is designed to introduce errors into the genetic code of the virus, would be the first oral antiviral medication for COVID-19.
Merck and partner Ridgeback Biotherapeutics said they plan to seek U.S. emergency use authorization for the pill as soon as possible and to make regulatory applications worldwide.
"An oral antiviral that can impact hospitalization risk to such a degree would be game-changing," said Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security.
Current treatment options include Gilead Sciences Inc's infused antiviral remdesivir and generic steroid dexamethasone, both of which are generally only given once a patient has already been hospitalized.
Scanning electron microscope image shows SARS-CoV-2, also known as novel coronavirus (credit: U.S. NIAID-RML/Handout via REUTERS)
"This is going to change the dialog around how to manage COVID-19," Merck Chief Executive Robert Davis told Reuters.
Existing treatments are "cumbersome and logistically challenging to administer. A simple oral pill would be the opposite of that," Adalja added.
The results from the Phase III trial, which sent Merck shares up more than 9%, were so strong that the study is being stopped early at the recommendation of outside monitors.
Shares of Atea Pharmaceuticals Inc, which is developing a similar COVID-19 treatment, were up more than 21% on the news.
Shares of COVID-19 vaccine makers Moderna Inc were off more than 10%, while Pfizer was down less than 1%.
Jefferies analyst Michael Yee said investors believe "people will be less afraid of COVID and less inclined to get vaccines if there is a simple pill that can treat COVID."
Pfizer and Swiss drugmaker Roche Holding AG are also racing to develop an easy-to-administer antiviral pill for COVID-19. For now, only antibody cocktails that have to be given intravenously are approved for non-hospitalized patients.
White House COVID-19 response coordinator Jeff Zients said on Friday that molnupiravir is "a potential additional tool… to protect people from the worst outcomes of COVID," but added that vaccination "remains far and away, our best tool against COVID-19."
A planned interim analysis of 775 patients in Merck's study looked at hospitalizations or deaths among people at risk for severe disease. It found that 7.3% of those given molnupiravir twice a day for five days were hospitalized and none had died by 29 days after treatment. That compared with a hospitalization rate of 14.1% for placebo patients. There were also eight deaths in the placebo group.
"Antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed,” Wendy Holman, Ridgeback's CEO, said in a statement.
'A HUGE ADVANCE'
Scientists welcomed the potential new treatment to help prevent serious illness from the virus, which has killed almost 5 million people around the world, 700,000 of them in the United States.
“A safe, affordable, and effective oral antiviral would be a huge advance in the fight against COVID," said Peter Horby, a professor of emerging infectious diseases at the University of Oxford.
The study enrolled patients with laboratory-confirmed mild-to-moderate COVID-19, who had symptoms for no more than five days. All patients had at least one risk factor associated with poor disease outcome, such as obesity or older age.
Drugs in the same class as molnupiravir have been linked to birth defects in animal studies. Merck has said similar studies of molnupiravir – for longer and at higher doses than used in humans – indicate that the drug does not affect mammalian DNA.
Merck said viral sequencing done so far shows molnupiravir is effective against all variants of the coronavirus including the highly transmissible Delta, which has driven the recent worldwide surge in hospitalizations and deaths.
It said rates of adverse events were similar for both molnupiravir and placebo patients, but did not give details.
Merck has said data shows molnupiravir is not capable of inducing genetic changes in human cells, but men enrolled in its trials had to abstain from heterosexual intercourse or agree to use contraception. Women of child-bearing age in the study could be pregnant and also had to use birth control.
The U.S. drugmaker said it expects to produce 10 million courses of the treatment by the end of 2021.
The company has a U.S. government contract to supply 1.7 million courses of molnupiravir at a price of $700 per course.
Davis said Merck has similar agreements with other governments, and is in talks with more. Merck said it plans a tiered pricing approach based on country income criteria.
The U.S. government has the option to purchase up to an additional 3.5 million treatment courses if needed, a U.S. health official told Reuters. The official asked to remain anonymous because they were not authorized to comment publicly on the contract.
Merck has also agreed to license the drug to several India-based generic drugmakers, which would be able to supply the treatment to low- and middle-income countries.
Molnupiravir is also being studied in a Phase III trial for preventing infection in people exposed to the coronavirus.
Merck officials said it is unclear how long the FDA review will take, although Dean Li, head of Merck's research labs, said, "they are going to try to work with alacrity on this."