---
title: 紐約時報 疫苗追蹤器 翻譯共筆
image: https://i.imgur.com/TbEkUCg.png
---
# 紐約時報 疫苗追蹤器 翻譯共筆
近期疫情升溫,紐約時報推出[疫苗追蹤器](https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html),更新許多疫苗的現況,可能不少人對此感興趣。在此開啟共筆,歡迎有興趣的朋友自行協助翻譯。
為了縮減內容,疫苗主要以世界常用的疫苗、台灣疫苗與中國核准使用的疫苗為主。
## 貢獻者
- 雨蒼
## 翻譯
### Coronavirus Vaccine Tracker
COVID-19 疫苗追踪器
By Carl Zimmer, Jonathan Corum and Sui-Lee WeeUpdated May 29, 2021
作者:Carl Zimmer、Jonathan Corum 和 Sui-Lee Wee 2021 年 5 月 29 日更新
PHASE 1
階段1
Vaccines testing safety and dosage
疫苗的安全性和劑量測試
51
51
PHASE 2
階段2
Vaccines in expanded safety trials
擴大安全性試驗中的疫苗
36
36
PHASE 3
第三階段
Vaccines in large-scale efficacy tests
大規模功效測試中的疫苗
28
28
AUTHORIZED
授權
Vaccines in early or limited use
早期或有限使用的疫苗
7
7
APPROVED
得到正式認可的
Vaccines approved for full use
獲准全面使用的疫苗
8
8
ABANDONED
棄
Vaccines abandoned after trials
試驗後放棄的疫苗
4
4
Vaccines typically require years of research and testing before reaching the clinic, but in 2020, scientists embarked on a race to produce safe and effective coronavirus vaccines in record time. Researchers are currently testing 92 vaccines in clinical trials on humans, and 28 have reached the final stages of testing. At least 77 preclinical vaccines are under active investigation in animals.
疫苗在進入臨床之前通常需要多年的研究和測試,但在2020年,科學家們開始了在創紀錄的時間內生產安全有效的冠狀病毒疫苗的競賽。研究人員目前正在對 92 種疫苗進行人體臨床試驗,其中 28 種已進入測試的最後階段。至少有 77 種臨床前疫苗正在動物中進行積極研究。
### The Vaccine Testing Process
疫苗測試過程
The development cycle of a vaccine, from lab to clinic.
從實驗室到臨床的疫苗開發週期。
PRECLINICAL TESTING: Scientists test a new vaccine on cells and then give it to animals such as mice or monkeys to see if it produces an immune response.
臨床前測試:科學家在細胞上測試一種新疫苗,然後將其給予小鼠或猴子等動物,看看它是否會產生免疫反應。
PHASE 1 SAFETY TRIALS: Scientists give the vaccine to a small number of people to test safety and dosage, as well as to confirm that it stimulates the immune system.
第一階段安全試驗:科學家將疫苗接種給少數人,以測試安全性和劑量,並確認它刺激免疫系統。
PHASE 2 EXPANDED TRIALS: Scientists give the vaccine to hundreds of people split into groups, such as children and the elderly, to see if the vaccine acts differently in them. These trials further test the vaccine’s safety.
第 2 階段擴展試驗:科學家將疫苗接種給數百人,分成幾組,例如兒童和老人,以查看疫苗在他們身上的作用是否不同。這些試驗進一步測試了疫苗的安全性。
PHASE 3 EFFICACY TRIALS: Scientists give the vaccine to thousands of people and wait to see how many become infected, compared with volunteers who received a placebo. These trials can determine if the vaccine protects against the coronavirus, measuring what’s known as the efficacy rate. Phase 3 trials are also large enough to reveal evidence of relatively rare side effects.
第 3 階段療效試驗:與接受安慰劑的志願者相比,科學家將疫苗接種給數千人,然後觀察有多少人被感染。這些試驗可以確定疫苗是否可以預防冠狀病毒,測量所謂的有效率。 3 期試驗也足夠大,可以揭示相對罕見的副作用的證據。
EARLY OR LIMITED APPROVAL: Many countries have procedures for providing emergency authorizations for vaccines, based on preliminary evidence that they are safe and effective. In addition, some countries such as China and Russia began administering vaccines before detailed Phase 3 trial data was made public. Experts have warned of serious risks from jumping ahead of these results.
早期或有限批准:許多國家都有提供疫苗緊急授權的程序,其依據是疫苗安全有效的初步證據。此外,中國和俄羅斯等一些國家在詳細的 3 期試驗數據公開之前就開始接種疫苗。專家警告說,超前於這些結果會帶來嚴重風險。
APPROVAL: Regulators review the complete trial results and plans for a vaccine’s manufacturing, and decide whether to give it full approval.
批准:監管機構審查完整的試驗結果和疫苗生產計劃,並決定是否給予完全批准。
COMBINED PHASES: One way to accelerate vaccine development is to combine phases. Some vaccines are now in Phase 1/2 trials, for example, which this tracker would count as both Phase 1 and Phase 2.
組合階段:加速疫苗開發的一種方法是組合階段。例如,一些疫苗現在處於 1/2 期試驗階段,該追踪器將其計為 1 期和 2 期。
PAUSED or ABANDONED: If investigators observe worrying symptoms in volunteers, they can pause the trial. After an investigation, the trial may resume or be abandoned.
暫停或放棄:如果研究者在志願者中觀察到令人擔憂的症狀,他們可以暫停試驗,並可在調查後恢復或中止試驗。
### Genetic Vaccines
基因疫苗
Vaccines that deliver one or more of the coronavirus’s own genes into our cells to provoke an immune response.
將冠狀病毒自身基因中的一個或多個傳遞到我們的細胞中以激發免疫反應的疫苗。
#### 輝瑞、BioNTech
PHASE 2 PHASE 3 COMBINED PHASES
階段 2 階段 3 組合階段
APPROVED IN SEVERAL COUNTRIES EMERGENCY USE IN U.S., ELSEWHERE
已在多個國家/地區獲得批准,可在美國和其他地方緊急使用
Pfizer, BioNTech
輝瑞、BioNTech
VACCINE NAME: Comirnaty (also known as tozinameran or BNT162b2)
疫苗名稱:Comirnaty(也稱為 tozinameran 或 BNT162b2)
EFFICACY: 91.3%
功效:91.3%
DOSE: 2 doses, 3 weeks apart
劑量:2 劑,間隔 3 週
TYPE: Muscle injection
類型:肌肉注射
STORAGE: Freezer storage only at –13°F to 5°F (–25°C to –15°C)
儲存:冷凍儲存僅在 –13°F 至 5°F(–25°C 至 –15°C)
On Nov. 9, New York-based Pfizer and the German company BioNTech made history by announcing that their coronavirus vaccine had an efficacy rate of over 90 percent, far surpassing expectations. It was the first time anyone had found such evidence. Just over a month later, on Dec. 11, the Food and Drug Administration granted it the first emergency use authorization ever given by the United States to a coronavirus vaccine. On May 10 the F.D.A. expanded the authorization to children as young as 12.
11月9日,總部位於紐約的輝瑞公司和德國公司BioNTech宣布,他們的冠狀病毒疫苗有效率超過90%,遠超預期,創造了歷史。這是第一次有人發現這樣的證據。就在一個多月後,即 12 月 11 日,美國食品藥品監督管理局 (FDA) 向其授予了美國有史以來第一次緊急使用冠狀病毒疫苗的授權。 5 月 10 日,FDA 將授權擴大到年僅 12 歲的兒童。
The work on the vaccine began in January 2020, when BioNTech researchers started fashioning a genetic molecule called messenger RNA (mRNA). They created the genetic instructions for building a coronavirus protein, known as spike. When injected into cells, the vaccine causes them to make spike proteins, which then get released into the body and provoke a response from the immune system. In March, BioNTech partnered with Pfizer to scale up the research, launching a clinical trial in May. They gave the vaccine the generic name tozinameran and the brand name Comirnaty
該疫苗的工作始於 2020 年 1 月,當時 BioNTech 的研究人員開始製造一種稱為信使 RNA (mRNA) 的遺傳分子。他們創建了用於構建冠狀病毒蛋白質(稱為刺突)的遺傳指令。當注射到細胞中時,疫苗會導致它們產生刺突蛋白,然後釋放到體內並引發免疫系統的反應。 3 月,BioNTech 與輝瑞公司合作擴大研究規模,並於 5 月啟動了臨床試驗。他們給疫苗起了通用名稱 tozinameran 和品牌名稱 Comirnaty
In Phase 1 trials, the researchers found that Comirnaty caused volunteers to produce antibodies against SARS-CoV-2, as well as immune cells called T cells that respond to the virus. On July 27, the companies announced the launch of a Phase 2/3 trial with 30,000 volunteers. On Sept. 12, Pfizer and BioNTech announced that they would seek to expand the trial to 44,000 participants.
在第一階段試驗中,研究人員發現 Comirnaty 使志願者產生針對 SARS-CoV-2 的抗體,以及對病毒有反應的稱為 T 細胞的免疫細胞。 7 月 27 日,兩家公司宣布啟動 2/3 期試驗,有 30,000 名志願者參與。 9月12日,輝瑞和BioNTech宣布,他們將尋求將該試驗擴大至44,000名參與者。
Through the summer and into the fall, the world focused more and more of its attention on the Pfizer-BioNTech trial. In September, Dr. Albert Bourla, the chief executive of Pfizer, said that as soon as October the Phase 3 trial would deliver enough results to show if the vaccine worked or not. President Trump touted their progress, hinting that a vaccine would be available before the election. But on Oct. 27, Dr. Bourla announced that the volunteers in the trial had yet to experience enough cases of Covid-19 to determine if the vaccines work. Finally, on Nov. 9, Pfizer and BioNTech released their preliminary analysis of the first 94 cases.
從夏天到秋天,全世界越來越關注輝瑞-BioNTech 試驗。 9 月,輝瑞首席執行官 Albert Bourla 博士表示,最快 10 月,第 3 階段試驗將提供足夠的結果來證明疫苗是否有效。特朗普總統吹捧他們的進展,暗示將在大選前提供疫苗。但是在10月27日,Bourla博士宣布試驗中的志願者尚未經歷足夠多的Covid-19病例以確定疫苗是否有效。最後,在 11 月 9 日,輝瑞和 BioNTech 發布了對前 94 例病例的初步分析。
Over the next month, Pfizer and BioNTech released more data on more cases. On Dec. 8 the FDA released their independent analysis of the clinical trials. They determined that Comirnaty has an efficacy rate of 95 percent. While Comirnaty caused no serious side effects, it frequently caused short-lived fatigue, fever, and muscle aches.
在接下來的一個月裡,輝瑞和 BioNTech 發布了更多病例的更多數據。 12 月 8 日,FDA 發布了他們對臨床試驗的獨立分析。他們確定Comirnaty的有效率達95%。雖然 Comirnaty 沒有引起嚴重的副作用,但它經常引起短暫的疲勞、發燒和肌肉疼痛。
On Dec. 2, the United Kingdom gave emergency authorization to Pfizer and BioNTech’s vaccine, followed by many more countries. On Dec. 31, the World Health Organization gave the vaccine an Emergency Use Listing, which will speed up its authorization across the world. In Israel, which took the lead in mass vaccination, researchers found that the vaccine was as effective in the real world as the trials had indicated. A study published by the Centers for Disease Control in March found that the vaccine is 91.3% effective after the second dose. On May 7, Pfizer and BioNTech announced they would seek full F.D.A. approval for their vaccine. The process is expected to take several months.
12 月 2 日,英國緊急授權輝瑞和 BioNTech 的疫苗,隨後還有更多國家。 12 月 31 日,世界衛生組織對該疫苗進行了緊急使用清單,這將加快其在全球的授權。在率先開展大規模疫苗接種的以色列,研究人員發現該疫苗在現實世界中與試驗表明的一樣有效。美國疾病控制中心 3 月份發表的一項研究發現,接種第二劑疫苗後,該疫苗的有效率為 91.3%。 5 月 7 日,輝瑞和 BioNTech 宣布他們將尋求 FDA 對其疫苗的全面批准。這個過程預計需要幾個月的時間。
As the trials progressed, Pfizer and BioNTech also scaled up factories to produce Comirnaty in huge amounts. To secure a supply in advance, the Trump administration awarded Pfizer and BioNTech a $1.9 billion contract in July 2020 for 100 million doses, but The New York Times reported in December that the administration passed up the chance over the summer to secure another 100 million doses. Since then, the Trump and Biden administrations reached agreements for a total of 300 million doses by the summer. In April 2021, the European Union negotiated a deal for 1.8 billion doses, which should close up the massive shortfall they experienced early in their vaccine rollout. In total, BioNTech and Pfizer expect to produce nearly 3 billion doses in 2021.
隨著試驗的進行,輝瑞和 BioNTech 也擴大了工廠規模,大量生產 Comirnaty。為了提前確保供應,特朗普政府於2020年7月與輝瑞和BioNTech簽訂了價值19億美元的1億劑合同,但《紐約時報》 12月報導稱,政府在夏季放棄了再獲得1億劑的機會。 .從那時起,特朗普和拜登政府就在夏季達成了總計 3 億劑疫苗的協議。 2021 年 4 月,歐盟談判達成了 18 億劑疫苗的協議,這應該會彌補他們在疫苗推出初期遇到的巨大短缺。 BioNTech 和輝瑞預計到 2021 年總共生產近 30 億劑。
While Comirnaty has proven highly effective, it was initially a challenging vaccine to distribute because it had to be kept frozen at –94°F (–70°C). On Feb. 19, Pfizer and BioNTech announced that they could keep the vaccine stable at -25°C to -15°C (-13°F to 5°F).
雖然 Comirnaty 已被證明非常有效,但它最初的分發是一種具有挑戰性的疫苗,因為它必須在 –94°F (–70°C) 下冷凍保存。 2 月 19 日,輝瑞和 BioNTech 宣布他們可以將疫苗穩定在 -25°C 至 -15°C(-13°F 至 5°F)。
In January, scientists grew concerned about the emergence of fast-spreading variants that might be able to evade antibodies. A study published in May demonstrated that Comirnaty was somewhat less effective against some variants, but still provided strong protection.
今年 1 月,科學家們開始擔心可能會逃避抗體的快速傳播變異的出現。 5 月發表的一項研究表明,Comirnaty 對某些變體的效果稍差,但仍提供了強大的保護。
Comirnaty is currently being tested in a number of additional trials. In Feb. 2021, the companies announced a study to develop a B.1.351-specific booster. They are also running a trial specifically for pregnant women. The trial will determine whether the vaccine provides as much protection for them as for women who aren’t pregnant, and also gather information on its safety. Comirnaty is also one of several vaccines being tested in an Oxford study to gauge how well alternating doses promote immunity. Preliminary results from a different combination study suggests that a dose of the Astrazeneca vaccine followed by Comirnaty is safe and effective.
Comirnaty 目前正在一些額外的試驗中進行測試。 2021 年 2 月,兩家公司宣布了一項開發 B.1.351 特定助推器的研究。他們還專門針對孕婦進行試驗。該試驗將確定疫苗是否為她們提供與未懷孕婦女一樣多的保護,並收集有關其安全性的信息。 Comirnaty 也是牛津研究中正在測試的幾種疫苗之一,以衡量交替劑量促進免疫力的效果。一項不同聯合研究的初步結果表明,先接種一劑阿斯利康疫苗,然後再接種 Comirnaty 是安全有效的。
Dr. Bourla, the chief executive, said people would “likely” need an additional shot of its vaccine within a year of receiving two doses. He also said that it’s possible that vaccinations could recur each year.
首席執行官 Bourla 博士表示,人們「可能」在接種兩劑疫苗後的一年內需要額外注射一針疫苗。他還說,疫苗接種每年都有可能複發。
For more details, see How the Pfizer-BioNTech Vaccine Works and How Pfizer Makes Its Covid-19 Vaccine.
有關更多詳細信息,請參閱輝瑞 BioNTech 疫苗的工作原理以及輝瑞如何製造其 Covid-19 疫苗。
APPROVED FOR USE IN: Bahrain, Brazil, New Zealand, Saudi Arabia, Switzerland.
批准用於:巴林、巴西、新西蘭、沙特阿拉伯、瑞士。
EMERGENCY USE IN: Argentina, Australia, Botswana, Brunei, Canada, Chile, Colombia, Costa Rica, Ecuador, European Union, Greenland, Guatemala, Hong Kong, Iceland, Iraq, Israel, Japan, Jordan, Kuwait, Lebanon, Liechtenstein, Malaysia, Maldives, Mexico, Moldova, Monaco, Mongolia, Norway, North Macedonia, Oman, Panama, Peru, Philippines, Qatar, Serbia, Singapore, Sri Lanka NEW, South Africa, South Korea, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States, Uruguay. Emergency use validation from the World Health Organization. Recommended for emergency use by the Caribbean Regulatory System.
緊急使用:阿根廷、澳大利亞、博茨瓦納、文萊、加拿大、智利、哥倫比亞、哥斯達黎加、厄瓜多爾、歐盟、格陵蘭、危地馬拉、香港、冰島、伊拉克、以色列、日本、約旦、科威特、黎巴嫩、列支敦士登、馬來西亞、馬爾代夫、墨西哥、摩爾多瓦、摩納哥、蒙古、挪威、北馬其頓、阿曼、巴拿馬、秘魯、菲律賓、卡塔爾、塞爾維亞、新加坡、斯里蘭卡新、南非、韓國、突尼斯、土耳其、烏克蘭、阿拉伯聯合酋長國、英國、美國、烏拉圭。來自世界衛生組織的緊急使用驗證。推薦用於加勒比監管系統的緊急情況。
Updated May 18
5 月 18 日更新
#### Moderna
PHASE 3
第三階段
APPROVED IN SWITZERLAND EMERGENCY USE IN U.S., ELSEWHERE
在瑞士批准在美國和其他地方緊急使用
Moderna, National Institutes of Health
Moderna,美國國立衛生研究院
VACCINE NAME: mRNA-1273
疫苗名稱:mRNA-1273
EFFICACY: More than 90%
功效:90%以上
DOSE: 2 doses, 4 weeks apart
劑量:2 劑,間隔 4 週
TYPE: Muscle injection
類型:肌肉注射
STORAGE: 30 days with refrigeration, 6 months at –4°F (–20°C)
存儲:冷藏30天,–4°F(–20°C),6個月
On Dec. 18., the F.D.A. gave emergency use authorization for a vaccine made by the Boston-based company Moderna. The Moderna vaccine is the second one authorized by the F.D.A., coming a week after the vaccine made by Pfizer and BioNTech.
12 月 18 日,美國食品和藥物管理局授予波士頓公司 Moderna 生產的疫苗緊急使用授權。 Moderna 疫苗是 FDA 授權的第二個疫苗,緊隨輝瑞和 BioNTech 生產的疫苗一周後。
Like Pfizer and BioNTech, Moderna makes its vaccine from mRNA. In recent years, the company has tested mRNA vaccines for a number of diseases, but they have yet to bring one to market. Last January, they began developing a vaccine for the coronavirus.
與輝瑞和 BioNTech 一樣,Moderna 用 mRNA 製造疫苗。近年來,該公司已針對多種疾病測試了 mRNA 疫苗,但尚未將一種疫苗推向市場。去年 1 月,他們開始開發針對冠狀病毒的疫苗。
The United States government bankrolled Moderna’s efforts, providing nearly $1 billion in support. In partnership with National Institutes of Health, they found that the vaccine protects monkeys from the coronavirus. Last March, the scientists were the first to put a Covid-19 vaccine into human trials. After those studies yielded promising results, Phase 3 testing on 30,000 volunteers began on July 27.
美國政府為 Moderna 的努力提供了資金,提供了近 10 億美元的支持。他們與美國國立衛生研究院合作,發現該疫苗可以保護猴子免受冠狀病毒的侵害。去年 3 月,科學家們率先將 Covid-19 疫苗用於人體試驗。在這些研究取得可喜的結果後,7 月 27 日開始了對 30,000 名志願者的第三階段測試。
On Nov. 16, Moderna announced the first preliminary data from the trial, followed by the complete data on Nov. 30. The researchers estimated that the vaccine had an efficacy rate of 94.1 percent. While it’s not clear how long this efficacy will last, Moderna has found that after three months the trial participants still have a strong immune defense against the coronavirus. On May 25, 2021, Moderna announced that the vaccine safely provided strong protection to children as young as 12. The company is currently testing the vaccine in babies and young children.
11 月 16 日,Moderna 公佈了該試驗的第一個初步數據,隨後於 11 月 30 日公佈了完整數據。研究人員估計該疫苗的有效率為 94.1%。雖然尚不清楚這種功效會持續多久,但 Moderna 發現,三個月後,試驗參與者仍然對冠狀病毒具有強大的免疫防禦能力。 2021 年 5 月 25 日,Moderna 宣布該疫苗可以安全地為 12 歲的兒童提供強有力的保護。該公司目前正在嬰兒和幼兒中測試該疫苗。
Meanwhile, the company entered deals with several countries to supply the vaccine pending its approval. On Aug. 11 last year, the United States government awarded the company an additional $1.5 billion in exchange for 100 million doses if the vaccine proves safe and effective. Additional negotiations have increased the agreement to 300 million doses by July 2021. On Nov. 25, the company reached an agreement with the European Commission to supply up to 160 million doses. Moderna has made similar deals with other countries including Canada, Japan, Qatar and South Korea. Moderna has also pledged 500 million doses to COVAX, a global vaccine initiative, to supply vaccines to low-income countries. On April 29, Moderna announced they would produce 800 million to 1 billion doses in 2021, and planned to manufacture 3 billion doses in 2022.
與此同時,該公司與幾個國家達成了協議,以供應疫苗,等待其批准。去年 8 月 11 日,如果該疫苗被證明安全有效,美國政府將額外獎勵該公司 15 億美元,以換取 1 億劑疫苗。額外的談判已將協議增加到 2021 年 7 月的 3 億劑。11 月 25 日,該公司與歐盟委員會達成協議,供應多達 1.6 億劑。 Moderna已與其他國家(包括加拿大,日本,卡塔爾和韓國)進行了類似的交易。 Moderna 還承諾向全球疫苗計劃 COVAX 提供 5 億劑疫苗,以向低收入國家提供疫苗。 4 月 29 日,Moderna 宣布他們將在 2021 年生產 8 億至 10 億劑,併計劃在 2022 年生產 30 億劑。
In March, Moderna began a Phase 1 trial of a vaccine made specifically for the B.1.351 variant. A variant-specific booster shot of the Moderna vaccine has yielded positive results in humans and mice. It is also conducting a Phase 1 trial of a new, refrigerator-stable vaccine. Moderna’s vaccine is one of several being tested in an Oxford study that gauges how well alternating doses can boost immunity.
今年 3 月,Moderna 開始了專門針對 B.1.351 變體生產的疫苗的第一階段試驗。 Moderna 疫苗的變體特異性加強注射在人類和小鼠身上產生了積極的結果。它還正在對一種新的,對冰箱穩定的疫苗進行1期試驗。 Moderna 的疫苗是牛津研究中正在測試的幾種疫苗之一,該研究衡量交替劑量對提高免疫力的效果。
For more details, see How Moderna’s Vaccine Works.
有關更多詳細信息,請參閱 Moderna 的疫苗工作原理。
APPROVED FOR USE IN: Switzerland.
批准用於:瑞士。
EMERGENCY USE IN: Canada, European Union, Greenland, Guatemala, Honduras, Iceland, Israel, Japan NEW, Kuwait, Moldova, Mongolia, Norway, Philippines, Qatar, Singapore, South Korea NEW, Taiwan, Thailand, United Kingdom, United States, Vietnam. Emergency use validation from the World Health Organization.
緊急使用:加拿大、歐盟、格陵蘭、危地馬拉、洪都拉斯、冰島、以色列、日本新、科威特、摩爾多瓦、蒙古、挪威、菲律賓、卡塔爾、新加坡、韓國新、台灣、泰國、英國、美國、越南。來自世界衛生組織的緊急使用驗證。
Updated May 21
5 月 21 日更新
### Viral Vector Vaccines
病毒載體疫苗
Vaccines that contain viruses engineered to carry coronavirus genes. Some viral vector vaccines enter cells and cause them to make viral proteins. Other viral vectors slowly replicate, carrying coronavirus proteins on their surface.
含有被設計為攜帶冠狀病毒基因的病毒的疫苗。一些病毒載體疫苗進入細胞並導致它們產生病毒蛋白。其他病毒載體緩慢複製,在其表面攜帶冠狀病毒蛋白。
#### Sputnik V
PHASE 3 EMERGENCY USE IN RUSSIA, ELSEWHERE
俄羅斯其他地方的第 3 階段應急使用
Gamaleya Research Institute
Gamaleya研究所
VACCINE NAME: Sputnik V (also known as Gam-Covid-Vac)
疫苗名稱:Sputnik V(也稱為 Gam-Covid-Vac)
EFFICACY: 91.6%
功效:91.6%
DOSE: 2 doses, 3 weeks apart
劑量:2 劑,間隔 3 週
TYPE: Muscle injection
類型:肌肉注射
STORAGE: Freezer storage. Developing an alternative formulation that can be refrigerated.
儲存:冷凍儲存。開發可冷藏的替代配方。
The Gamaleya Research Institute, part of Russia’s Ministry of Health, has created a vaccine with an efficacy rate of 91.6 percent. The creators of the vaccine published the results of their Phase 3 trial on Feb. 2 in the Lancet.
俄羅斯衛生部下屬的 Gamaleya 研究所研製了一種疫苗,其有效率為 91.6%。疫苗的創造者於2月2日在柳葉刀上公佈了他們的3期試驗結果。
Gamaleya produced the vaccine, initially called Gam-Covid-Vac, from a combination of two adenoviruses called Ad5 and Ad26. Both kinds have been tested as vaccines over a number of years. By combining them, the Russian researchers hoped to avoid a situation in which the immune system could learn to recognize the vaccine as a foreign object that needed to be destroyed. The researchers launched clinical trials in June.
Gamaleya 生產了這種疫苗,最初稱為 Gam-Covid-Vac,由兩種稱為 Ad5 和 Ad26 的腺病毒組合而成。多年來,這兩種疫苗都已作為疫苗進行了測試。通過將它們結合起來,俄羅斯研究人員希望避免出現免疫系統可以學會將疫苗識別為需要銷毀的外來物的情況。研究人員於 6 月啟動了臨床試驗。
By the end of the summer, the trial became bogged down in controversy. On Aug. 11, President Vladimir V. Putin announced that a Russian health care regulator had approved the vaccine, renamed Sputnik V. Yet the Phase 3 trials had not even begun. Vaccine experts decried the move as risky, and Russia later walked back the announcement, saying that the approval was a “conditional registration certificate,” which would depend on positive results from Phase 3 trials. In addition to Russia, volunteers for the trial were recruited in Belarus, the United Arab Emirates, and Venezuela. On Oct. 17, a Phase 2/3 trial was launched in India.
到夏天結束時,試驗陷入了爭議。 8 月 11 日,俄羅斯總統弗拉基米爾·V·普京 (Vladimir V. Putin) 宣布俄羅斯衛生保健監管機構已批准該疫苗,並將其更名為 Sputnik V。 然而,第三階段試驗甚至還沒有開始。疫苗專家譴責此舉是有風險的,俄羅斯後來撤回了公告,稱該批准是「有條件的註冊證書」,這將取決於第 3 階段試驗的積極結果。除俄羅斯外,白俄羅斯、阿拉伯聯合酋長國和委內瑞拉還招募了試驗志願者。 10 月 17 日,在印度啟動了 2/3 期試驗。
On Sept. 4, three weeks after Putin’s announcement, Gamaleya researchers published the results of their Phase 1/2 trial. They found that Sputnik V yielded antibodies to the coronavirus and mild side effects. On Nov. 11, the Russian Direct Investment Fund announced the first preliminary evidence from their Phase 3 trial indicating that the vaccine is effective. Based on 20 cases of Covid-19 among the trial participants, Russian scientists estimated that the vaccine demonstrated 92 percent efficacy.
9月4日,普京宣布這一消息三週後,Gamaleya研究人員公佈了他們的1/2期臨床試驗結果。他們發現人造衛星 V 產生了針對冠狀病毒的抗體和輕微的副作用。 11 月 11 日,俄羅斯直接投資基金公佈了他們的第 3 階段試驗的第一個初步證據,表明該疫苗是有效的。根據試驗參與者中的 20 例 Covid-19,俄羅斯科學家估計該疫苗的有效性為 92%。
By December, the trial had reached its final total of 78 cases. The full details of the trial came out in February, demonstrating a high efficacy after two doses. The trial did not uncover serious side effects. No one who got the vaccine experienced a serious case of Covid-19.
到 12 月,試驗已達到最終總數 78 起。試驗的全部細節於 2 月份公佈,證明了兩次劑量後的療效。該試驗沒有發現嚴重的副作用。接種疫苗的人都沒有經歷過嚴重的 Covid-19 病例。
The trial did not demonstrate how well Sputnik V can block new variants of the coronavirus. In a study posted online in April, researchers studied antibodies from people who had received the vaccine. They found that the Sputnik V antibodies often failed to neutralize the coronavirus, allowing it to infect cells.
該試驗並未證明 Sputnik V 能夠在多大程度上阻止冠狀病毒的新變種。在 4 月份在線發布的一項研究中,研究人員研究了接種疫苗的人的抗體。他們發現 Sputnik V 抗體通常無法中和冠狀病毒,使其能夠感染細胞。
In an unprecedented move in the coronavirus vaccine field, the Gamaleya Institute joined forces in December 2020 with the drugmaker AstraZeneca, which makes a vaccine based on a chimpanzee adenovirus. The two teams combined their vaccines to see if the mixture can increase the efficacy of the AstraZeneca vaccine. The trial began in February.
作為冠狀病毒疫苗領域前所未有的舉措,Gamaleya 研究所於 2020 年 12 月與製藥商阿斯利康(AstraZeneca)聯手,後者生產基於黑猩猩腺病毒的疫苗。兩個團隊將他們的疫苗結合起來,看看這種混合物是否能提高阿斯利康疫苗的功效。試驗於二月開始。
In November 2020, the Russian government began offering Sputnik V within Russia in a mass vaccination campaign. But worry that the vaccine was rushed to approval led to widespread hesitancy. On Dec. 22, Belarus became the first country outside of Russia to register Sputnik V, and since then a number of other countries have followed suit. In Europe, where the vaccine rollout faltered badly, regulators began a rolling review of Sputnik V on March 4. If the European Medicines Agency approved it, many European countries might take up the vaccine.
2020 年 11 月,俄羅斯政府開始在俄羅斯境內開展大規模疫苗接種活動,提供 Sputnik V。但對疫苗被倉促批准的擔憂導致了廣泛的猶豫。 12 月 22 日,白俄羅斯成為俄羅斯以外第一個註冊 Sputnik V 的國家,此後許多其他國家也紛紛效仿。在疫苗推出嚴重受阻的歐洲,監管機構於 3 月 4 日開始對 Sputnik V 進行滾動審查。如果歐洲藥品管理局批准,許多歐洲國家可能會接受該疫苗。
On April 26, the board of Brazil’s vaccine regulator rejected Sputnik V, saying that it contained adenoviruses that had not been properly disabled. Replicating adenoviruses could make the vaccine dangerous. Anvisa, Brazil’s regulatory agency, also complained of incomplete data about the vaccine’s efficacy and safety. The Russian developers pushed back against Anvisa’s claims and said they would sue for defamation. Brazil has also refused to conduct national clinical trials for Sputnik V.
4 月 26 日,巴西疫苗監管機構董事會否決了人造衛星 V,稱其含有未正確禁用的腺病毒。複製腺病毒可能會使疫苗變得危險。巴西監管機構 Anvisa 也抱怨有關疫苗有效性和安全性的數據不完整。俄羅斯開發商反駁 Anvisa 的說法,並表示他們將起訴誹謗。巴西也拒絕為人造衛星 V 進行國家臨床試驗。
In January 2021, Gamaleya researchers started a trial in which they gave people only the first dose of Ad26 adenoviruses, the same adenovirus in Johnson & Johnson’s single-dose vaccine. They dubbed this one-dose version “Sputnik Light.” On Feb. 12, the director of the Gameleya center said in a television interview that it would likely provide only four to five months of protection. Russia announced on May 6 that Sputnik Light provided an efficacy of 79.4 percent but did not publish the details of the study or say how long the efficacy would last. The Russian Ministry of Health said Sputnik Light provides sufficient protection on its own to be used without a second injection. Sputnik Light received authorization for use in Russia on May 6.
2021 年 1 月,Gamaleya 研究人員開始了一項試驗,他們只給人們接種了第一劑 Ad26 腺病毒,這與強生公司的單劑量疫苗中的腺病毒相同。他們將這種單劑量版本稱為「人造衛星之光」。 2 月 12 日,Gameleya 中心主任在接受電視採訪時表示,它可能只提供四到五個月的保護。俄羅斯於 5 月 6 日宣布 Sputnik Light 提供了 79.4% 的功效,但沒有公佈研究細節或說明功效將持續多長時間。俄羅斯衛生部表示,Sputnik Light 本身提供了足夠的保護,無需第二次注射即可使用。 Sputnik Light 於 5 月 6 日獲得在俄羅斯使用的授權。
For more details, see How Gamaleya’s Vaccine Works.
有關更多詳細信息,請參閱 Gamaleya 疫苗的工作原理。
EMERGENCY USE IN: Albania, Algeria, Angola, Antigua and Barbuda, Argentina, Armenia, Azerbaijan, Bahrain, Bangladesh, Belarus, Bolivia, Bosnian Serb Republic, Cameroon, Congo Republic, Djibouti, Ecuador NEW, Egypt, Honduras, Gabon, Ghana, Guatemala, Guinea, Guyana, Hungary, India, Iran, Iraq, Jordan, Kazakhstan, Kenya, Kyrgyzstan, Laos, Lebanon, Maldives NEW, Mali, Mauritius, Mexico, Moldova, Mongolia, Montenegro, Morocco, Myanmar, Namibia, Nepal, Nicaragua (including Sputnik Light), North Macedonia, Pakistan, Palestinian Authority, Panama, Paraguay, Philippines, Russia (including Sputnik Light), San Marino, Serbia, Seychelles, Slovakia, Sri Lanka, St. Vincent and the Grenadines, Syria, Tunisia, Turkey, Turkmenistan, United Arab Emirates, Uzbekistan, Venezuela (including Sputnik Light) NEW, Vietnam, Zimbabwe.
緊急使用:阿爾巴尼亞、阿爾及利亞、安哥拉、安提瓜和巴布達、阿根廷、亞美尼亞、阿塞拜疆、巴林、孟加拉國、白俄羅斯、玻利維亞、波斯尼亞塞族共和國、喀麥隆、剛果共和國、吉布提、厄瓜多爾新、埃及、洪都拉斯、加蓬、加納、危地馬拉、幾內亞、圭亞那、匈牙利、印度、伊朗、伊拉克、約旦、哈薩克斯坦、肯尼亞、吉爾吉斯斯坦、老撾、黎巴嫩、馬爾代夫新、馬里、毛里求斯、墨西哥、摩爾多瓦、蒙古、黑山、摩洛哥、緬甸、納米比亞、尼泊爾、尼加拉瓜(包括Sputnik Light),北馬其頓,巴基斯坦,巴勒斯坦權力機構,巴拿馬,巴拉圭,菲律賓,俄羅斯(包括Sputnik Light),聖馬力諾,塞爾維亞,塞舌爾,斯洛伐克,斯里蘭卡,聖文森特和格林納丁斯,敘利亞,突尼斯,土耳其、土庫曼斯坦、阿拉伯聯合酋長國、烏茲別克斯坦、委內瑞拉(包括 Sputnik Light)新增、越南、津巴布韋。
Updated May 25
5月25日更新
#### University of Oxford, AstraZeneca
PHASE 2 PHASE 3 COMBINED PHASES
階段 2 階段 3 組合階段
APPROVED IN BRAZIL EMERGENCY USE IN E.U., ELSEWHERE
巴西在歐盟和其他地方的緊急情況下獲得批准
University of Oxford, AstraZeneca
牛津大學阿斯利康
VACCINE NAME: Vaxzevria (also known as AZD1222, or Covishield in India)
疫苗名稱:Vaxzevria(在印度也稱為 AZD1222 或 Covishield)
EFFICACY: 76% in a U.S. study.
功效:在美國研究中為 76%。
DOSE: 2 doses
劑量:2劑
TYPE: Muscle injection
類型:肌肉注射
STORAGE: Stable in refrigerator for at least 6 months
儲存:在冰箱中穩定至少 6 個月
A vaccine designed by the University of Oxford and produced by the British-Swedish company AstraZeneca has emerged as a key element in the effort to meet the global demand for Covid-19 vaccines. With an efficacy of 76 percent, the vaccine — now known as Vaxzevria — is being produced in vast quantities at a low price. Because it only needs to be refrigerated rather than frozen, it can be used far more widely than mRNA vaccines. But Vaxzevria’s journey has been turbulent, jolted by confusing messages from AstraZeneca, high-profile worries about safety, and difficulties with manufacturing.
由牛津大學設計並由英國-瑞典公司阿斯利康生產的疫苗已成為滿足全球對 Covid-19 疫苗需求的關鍵因素。這種疫苗(現在稱為Vaxzevria)的功效為76%,以低廉的價格大量生產。因為它只需要冷藏而不是冷凍,所以可以比mRNA疫苗更廣泛地使用。但 Vaxzevria 的旅程一直動盪不安,受到來自阿斯利康 (AstraZeneca) 令人困惑的信息、對安全的高調擔憂以及製造困難的衝擊。
In early 2020, Oxford researchers developed the vaccine by genetically engineering an adenovirus that normally infects chimpanzees. When they gave the vaccine to monkeys, they found that it protected the animals from the disease.
2020 年初,牛津大學的研究人員通過基因工程開發了一種通常會感染黑猩猩的腺病毒。當他們給猴子接種疫苗時,他們發現它可以保護動物免受疾病的侵害。
Teaming up with AstraZeneca, they followed up with a Phase 1/2 trial. The vaccine developers did not detect any severe side effects in the trial, while observing that the vaccine raised antibodies against the coronavirus as well as other immune defenses. AstraZeneca and Oxford then embarked on late-stage trials in the United Kingdom, South Africa, and elsewhere. But the researchers ran the trials independently, making it difficult to combine their results into a single clear picture of how well the vaccine worked. Making matters murkier, they gave different amounts of the vaccine to different people and also waited anywhere from four to twelve weeks to deliver the second dose.
他們與阿斯利康合作,進行了 1/2 期試驗。疫苗開發人員在試驗中沒有發現任何嚴重的副作用,同時觀察到疫苗產生了針對冠狀病毒的抗體以及其他免疫防禦。阿斯利康和牛津隨後開始在英國、南非和其他地方進行後期試驗。但是研究人員獨立進行了試驗,因此很難將他們的結果合併成一張關於疫苗效果如何的清晰圖片。更令人困惑的是,他們給不同的人接種了不同數量的疫苗,並且還要等待 4 到 12 週的時間才能接種第二劑。
On Dec. 8, AstraZeneca and Oxford published the first scientific paper on a Phase 3 clinical trial of a coronavirus vaccine. The trial demonstrated that the vaccine can protect people from Covid-19, but it left many questions unresolved about the results. Nevertheless, the vaccine’s low cost and ease of storage made it attractive to countries looking for a way out of the pandemic. The United Kingdom and Argentina were the first countries to give the vaccine emergency authorization, on Dec. 30. On Jan. 3, India approved a version called Covishield, made by the Serum Institute of India. On Feb. 16 the World Health Organization recommended the vaccine for emergency use in adults 18 or older. Brazil gave full approval to the vaccine on March 13. In the same month, Covax began delivering millions of doses of the vaccine to low- and middle-income countries. The company expects a total annual manufacturing capacity of two billion doses.
12 月 8 日,阿斯利康和牛津大學發表了第一篇關于冠狀病毒疫苗三期臨床試驗的科學論文。該試驗表明,該疫苗可以保護人們免受 Covid-19 的侵害,但它對結果留下了許多懸而未決的問題。儘管如此,該疫苗的低成本和易於儲存使其對尋求擺脫大流行的國家具有吸引力。 12 月 30 日,英國和阿根廷是首批給予疫苗緊急授權的國家。1 月 3 日,印度批准了由印度血清研究所製造的名為 Covishield 的版本。 2 月 16 日,世界衛生組織建議將該疫苗用於 18 歲或以上成年人的緊急使用。巴西於 3 月 13 日完全批准了該疫苗。同月,Covax 開始向低收入和中等收入國家提供數百萬劑疫苗。該公司預計年總生產能力為 20 億劑。
Yet even after millions of people began receiving the vaccine, new concerns arose. In South Africa, a small trial failed to demonstrate that it protected people against the variant B.1.351, which has become predominant in the country. On Feb. 7, South Africa halted plans for a rollout of 1 million doses of the AstraZeneca vaccine.
然而,即使在數百萬人開始接種疫苗之後,新的擔憂也出現了。在南非,一項小型試驗未能證明它可以保護人們免受變種 B.1.351 的侵害,該變種已在該國占主導地位。 2 月 7 日,南非停止了推出 100 萬劑阿斯利康疫苗的計劃。
In March 2021, another concern emerged. European medical regulators became concerned about a small number of cases of blood clots in younger people who received Vaxzevria. The European Medicines Agency concluded that the vaccine had a very rare side effect in which people suffered blood clots in large veins combined with low platelets. The regulators emphasized that the vaccine is effective and the benefits it provided outweighed the small risk of its side effects. In response some countries chose to minimize the risk by restricting the vaccine to older people. In May, Norway permanently removed Vaxzevria from their vaccination program.
2021 年 3 月,出現了另一個擔憂。歐洲醫療監管機構開始關注少數接受 Vaxzevria 治療的年輕人出現血栓的情況。歐洲藥品管理局的結論是,該疫苗具有非常罕見的副作用,即人們在大靜脈中出現血栓並伴有低血小板。監管機構強調,該疫苗是有效的,它提供的好處超過了其副作用的小風險。作為回應,一些國家選擇通過限制老年人接種疫苗來最大限度地降低風險。 5 月,挪威將 Vaxzevria 從其疫苗接種計劃中永久刪除。
The United States has not yet authorized Vaxzevria, despite the lavish support it provided for its development. In 2020, the government gave AstraZeneca $1 billion to pay for research, clinical trials, and manufacturing. That summer, the company promised it would distribute Vaxzevria in the United States as soon as that October. But a concern about the health of a volunteer in the U.S. clinical trial stalled the study for seven weeks. AstraZeneca did not deliver the results of the trial until March 2021--only to be rebuked by its expert advisors for cherry-picking data. Two days later, the company announced that a fuller look at the trial showed that the vaccine had an efficacy of 76 percent against Covid-19, and 100 percent efficacy against severe disease and hospitalization. AstraZeneca is preparing its application to the F.D.A. for full authorization.
美國尚未授權 Vaxzevria,儘管它為其發展提供了大量支持。 2020 年,政府向阿斯利康提供了 10 億美元用於研究、臨床試驗和製造。那年夏天,該公司承諾最早將於當年 10 月在美國分銷 Vaxzevria。但對美國臨床試驗志願者健康的擔憂使這項研究停滯了七週。阿斯利康直到 2021 年 3 月才公佈試驗結果——只是被其專家顧問斥責挑選數據。兩天后,該公司宣布,對試驗進行更全面的研究表明,該疫苗對 Covid-19 的有效性為 76%,對嚴重疾病和住院治療的有效性為 100%。阿斯利康正在準備向 FDA 提交申請以獲得完全授權。
Even while it was running clinical trials, AstraZeneca reached agreements with a number of manufacturers in order to produce billions of doses of Vaxzevria. But in January 2021, it admitted that it would fall short of its promised delivery of vaccines to the European Union. Its shortfall grew only worse in March when India, facing an explosion of new cases, blocked export of the vaccine from its factories. On April 26, the European Commission announced it had filed a lawsuit against the company for breach of contract.
即使在進行臨床試驗時,阿斯利康也與多家製造商達成協議,以生產數十億劑 Vaxzevria。但在 2021 年 1 月,它承認將無法實現向歐盟交付疫苗的承諾。其短缺在 3 月份變得更糟,當時印度面臨新病例激增,阻止其工廠出口疫苗。 4月26日,歐盟委員會宣布已對該公司提起違約訴訟。
Yet India still struggled to vaccinate its own citizens while cases and deaths skyrocketed. The United States came under intense criticism for holding back raw materials India needed to make its own supply of Covishield. On April 25, the Biden administration announced it would partially lift its ban. But critics also point to a stockpile of millions of doses of AstraZeneca’s vaccine that the United States started building up last year. Now that the United States has enough vaccines from other companies to protect all its own citizens, there are calls to ship AstraZeneca’s vaccines to India and other countries in dire need. On April 25, Dr. Anthony Fauci said the United States government was considering sending the vaccines.
然而,在病例和死亡人數激增的情況下,印度仍在努力為本國公民接種疫苗。美國因阻止印度生產 Covishield 所需的原材料而受到強烈批評。 4月25日,拜登政府宣布將部分解除禁令。但批評者還指出,美國去年開始建立數百萬劑阿斯利康疫苗的庫存。現在美國有足夠的其他公司的疫苗來保護所有本國公民,有人呼籲將阿斯利康的疫苗運送到印度和其他急需的國家。 4 月 25 日,安東尼·福奇博士表示,美國政府正在考慮發送疫苗。
Meanwhile, AstraZeneca and Oxford are continuing research on the vaccine. On Feb. 14, they announced they would start trials on children as young as six. In an unprecedented move in the coronavirus vaccine field, they announced on Dec. 11 that they would collaborate with the Russian creators of the Sputnik V vaccine, which is also made from adenoviruses, to see if a combination with Sputnik V might increase the efficacy of the Oxford-AstraZeneca vaccine. The trial started in February 2021. Another combination trial is currently underway between the Oxford-AstraZeneca, Pfizer, Moderna and Novavax vaccines. Preliminary results from a different combination study suggests that a dose of Vaxzevria followed by the Pfizer and BioNTech vaccine is safe and effective. Oxford researchers have found that Vaxzevria works well as a third booster shot. AstraZeneca and Oxford are also working on a new version of the vaccine tailored to the B.1.351 variant and are testing a version that can be delivered as a nasal spray.
與此同時,阿斯利康和牛津大學正在繼續對該疫苗進行研究。 2 月 14 日,他們宣布將開始對年僅 6 歲的兒童進行試驗。他們在冠狀病毒疫苗領域採取了前所未有的舉措,12 月 11 日宣布,他們將與同樣由腺病毒製成的 Sputnik V 疫苗的俄羅斯創造者合作,看看與 Sputnik V 的組合是否可能提高疫苗的功效。牛津-阿斯利康疫苗。該試驗於 2021 年 2 月開始。 另一項聯合試驗目前正在進行牛津-阿斯利康、輝瑞、Moderna 和 Novavax 疫苗之間的聯合試驗。一項不同聯合研究的初步結果表明,先接種一劑 Vaxzevria,然後接種輝瑞和 BioNTech 疫苗是安全有效的。牛津大學的研究人員發現,Vaxzevria 作為第三次加強注射效果很好。阿斯利康(AstraZeneca)和牛津大學(Oxford)也在研究針對 B.1.351 變體定制的新版本疫苗,並正在測試一種可以作為鼻腔噴霧劑給藥的版本。
For more details, see How the Oxford-AstraZeneca Vaccine Works.
有關更多詳細信息,請參閱牛津-阿斯利康疫苗的工作原理。
APPROVED FOR USE IN: Brazil.
批准用於:巴西。
STOPPED USE IN: Denmark, Norway.
停止使用:丹麥,挪威。
EMERGENCY USE IN: Algeria, Angola NEW, Antigua, Argentina, Australia, Bahamas, Bahrain, Bangladesh, Barbados, Bhutan, Botswana, Brazil, Brunei, Cambodia, Canada, Chile, Colombia, Costa Rica, Cyprus NEW, Dominican Republic, Ecuador, Egypt, El Salvador, Ethiopia, European Union, Fiji, Georgia, Ghana, Greenland, Guatemala, Haiti NEW, Honduras, Hungary, Iceland, India, Indonesia, Iran, Iraq, Jamaica, Japan NEW, Kenya, Kuwait, Liechtenstein, Malaysia, Maldives, Mexico, Moldova, Mongolia, Morocco, Namibia, Nepal, Nigeria, North Macedonia, Norway, Pakistan, Papua New Guinea, Peru, Philippines, Rwanda NEW, Saudi Arabia, Seychelles, Sierra Leone, Sri Lanka, Solomon Islands, South Africa, South Korea, Sudan, Taiwan, Thailand, Uganda NEW, Ukraine, United Kingdom, Vietnam, Zambia. Emergency use validation from the World Health Organization. Endorsed by the Africa Regulatory Taskforce. Recommended for emergency use by the Caribbean Regulatory System.
緊急使用:阿爾及利亞、安哥拉新、安提瓜、阿根廷、澳大利亞、巴哈馬、巴林、孟加拉國、巴巴多斯、不丹、博茨瓦納、巴西、文萊、柬埔寨、加拿大、智利、哥倫比亞、哥斯達黎加、塞浦路斯新、多米尼加共和國、厄瓜多爾、埃及、薩爾瓦多、埃塞俄比亞、歐盟、斐濟、格魯吉亞、加納、格陵蘭、危地馬拉、海地新、洪都拉斯、匈牙利、冰島、印度、印度尼西亞、伊朗、伊拉克、牙買加、日本、肯尼亞、科威特、列支敦士登、馬來西亞、馬爾代夫,墨西哥,摩爾多瓦,蒙古,摩洛哥,納米比亞,尼泊爾,尼日利亞,北馬其頓,挪威,巴基斯坦,巴布亞新幾內亞,秘魯,菲律賓,盧旺達新,沙特阿拉伯,塞舌爾,塞拉利昂,斯里蘭卡,所羅門群島,南非、韓國、蘇丹、台灣、泰國、烏干達 NEW、烏克蘭、英國、越南、贊比亞。來自世界衛生組織的緊急使用驗證。得到非洲監管工作組的認可。推薦用於加勒比監管系統的緊急情況。
Updated May 21
5 月 21 日更新
#### 科興
PHASE 3
第三階段
APPROVED IN CHINA EMERGENCY USE IN OTHER COUNTRIES
在中國獲准在其他國家緊急使用
CanSino Biologics, Academy of Military Medical Sciences
CanSino Biologics, 軍事醫學科學院
VACCINE NAME: Convidecia (also known as Ad5-nCoV)
疫苗名稱:Convidecia(也稱為 Ad5-nCoV)
EFFICACY: 65.28%
功效:65.28%
DOSE: Single dose
劑量:單劑量
TYPE: Muscle injection
類型:肌肉注射
STORAGE: Refrigerated
儲存:冷藏
The Chinese company CanSino Biologics developed Convidecia in partnership with the Institute of Biology at the country’s Academy of Military Medical Sciences. The one-shot vaccine is based on an adenovirus called Ad5. Last May, researchers published promising results from a Phase 1 safety trial on Convidecia, and in July they reported that their Phase 2 trials demonstrated the vaccine produced a strong immune response. In an unprecedented move, the Chinese military approved the vaccine on June 25 for a year as a “specially needed drug.” On Nov. 28, the Chief Executive of CanSino Biologics said in an interview that about 40,000 to 50,000 people had received Convidecia.
中國公司CanSino Biologics與該國軍事醫學科學院的生物研究所合作開發了Convidecia。一次性疫苗基於一種稱為 Ad5 的腺病毒。去年 5 月,研究人員在 Convidecia 上發表了第一階段安全試驗的有希望的結果,並在 7 月報告說,他們的第二階段試驗表明該疫苗產生了強烈的免疫反應。中國軍方以前所未有的舉動,於6月25日批准了該疫苗為期一年的「特殊需要藥物」。 11月28日,康希諾生物首席執行官在接受采訪時表示,約有4萬至5萬人接受了Convidecia。
Starting in August 2020, CanSino began running Phase 3 trials in a number of countries, including Pakistan, Russia, Mexico and Chile. On Feb. 25, China announced the approval of the CanSino vaccine for general use. The company announced that its one-shot vaccine had an efficacy rate of 65.28 percent at preventing all symptomatic Covid-19 cases. The details of the trial have yet to be published. But on April 1, CanSino’s chief scientific officer said that the efficacy of its vaccine could drop over time. He also floated the idea of using a booster shot six months after the first dose, though more clinical trial data is needed.
從 2020 年 8 月開始,CanSino 開始在包括巴基斯坦、俄羅斯、墨西哥和智利在內的多個國家進行第三階段試驗。 2月25日,中國宣布批准通用疫苗CanSino。該公司宣布,其一次性疫苗在預防所有有症狀的 Covid-19 病例方面的有效率為 65.28%。試驗細節尚未公佈。但在 4 月 1 日,CanSino 的首席科學官表示,其疫苗的效力可能會隨著時間的推移而下降。儘管需要更多的臨床試驗數據,但他還提出了在第一次給藥六個月後使用加強注射的想法。
On March 23, CanSino announced that it had won approval for a clinical trial of an inhaled version of the vaccine. Researchers have also begun to test whether giving alternating doses of vaccines from CanSino and Anhui Zhifei Longcom can boost their effectiveness.
3 月 23 日,康希諾宣布已獲得吸入型疫苗臨床試驗的批准。研究人員還開始測試是否可以交替使用CanSino和安徽智飛隆康的疫苗來提高其有效性。
APPROVED FOR USE IN: China.
批准用於:中國。
EMERGENCY USE IN: Chile, Hungary, Mexico, Moldova NEW, Pakistan.
緊急使用:智利、匈牙利、墨西哥、摩爾多瓦新、巴基斯坦。
Updated May 18
5 月 18 日更新
#### 嬌生疫苗
PHASE 3 EMERGENCY USE IN U.S., ELSEWHERE
在美國和其他地方的第 3 階段緊急使用
Johnson & Johnson, Beth Israel Deaconess Medical Center, Janssen Pharmaceutica
強生公司,貝斯以色列女執事醫療中心,楊森製藥
VACCINE NAME: Ad26.COV2.S
疫苗名稱:Ad26.COV2.S
EFFICACY: 72% in United States, 68% in Brazil and 64% in South Africa
功效:美國72%,巴西68%,南非64%
DOSE: 1 dose
劑量:1劑
TYPE: Muscle injection
類型:肌肉注射
STORAGE: Up to two years frozen at –4° F (–20° C), and up to three months refrigerated at 36–46° F (2–8° C).
儲存:在 –4° F (–20° C) 下冷凍最多兩年,在 36–46° F (2–8° C) 下冷藏最多三個月。
On Feb. 27, the F.D.A. issued an emergency use authorization for Johnson & Johnson’s vaccine, making it the third coronavirus vaccine available in the United States. It was also the first to be shown to be safe and effective with just one dose rather than two.
2 月 27 日,美國食品藥品監督管理局 (FDA) 發布了強生公司疫苗的緊急使用授權,使其成為在美國上市的第三種冠狀病毒疫苗。它也是第一個被證明僅用一劑而不是兩劑就安全有效的藥物。
The work that led to the vaccine started a decade ago at Beth Israel Deaconess Medical Center in Boston, where researchers developed a method for making vaccines out of a virus called Adenovirus 26, or Ad26 for short. Johnson & Johnson used Ad26 to develop vaccines for Ebola and other diseases with Ad26. Last January, the company and Beth Israel researchers collaborated on creating a coronavirus vaccine. In March they received $456 million from the United States government to support their move towards production. After the vaccine provided protection in experiments on monkeys, Johnson & Johnson began Phase 1/2 trials in July.
研製疫苗的工作始於十年前在波士頓的貝斯以色列女執事醫療中心,在那裡研究人員開發了一種用一種叫做腺病毒 26 或簡稱 Ad26 的病毒製造疫苗的方法。強生公司使用 Ad26 開發了針對埃博拉病毒和其他帶有 Ad26 的疾病的疫苗。去年 1 月,該公司和 Beth Israel 的研究人員合作開發了一種冠狀病毒疫苗。 3 月,他們從美國政府那裡獲得了 4.56 億美元,以支持他們轉向生產。該疫苗在猴子實驗中提供保護後,強生公司於 7 月開始了 1/2 期試驗。
Based on promising results in these studies, Johnson & Johnson launched a Phase 3 trial in September using just one dose rather than two. Although Johnson & Johnson initially set out to recruit 60,000 volunteers, it capped the trial at 45,000 in December as cases rose.
基於這些研究的有希望的結果,強生公司於 9 月啟動了一項 3 期試驗,僅使用一劑而不是兩劑。儘管強生公司最初打算招募 60,000 名志願者,但隨著病例的增加,它在 12 月將試驗人數限制在 45,000 人。
On Jan. 29, Johnson & Johnson announced that the trial had proven that the vaccine was safe and effective, and the F.D.A. released a similar analysis on Feb. 24. Johnson & Johnson published a paper on the trial in the New England Journal of Medicine on April 21, 2021.
1月29日,強生公司宣布該試驗已證明該疫苗安全有效,FDA於2月24日發布了類似的分析報告。強生公司在《新英格蘭醫學雜誌》上發表了有關該試驗的論文2021 年 4 月 21 日。
Bahrain became the first country to authorize the vaccine for emergency use on Feb. 25. Two days later, the United States followed suit. South Africa dropped plans to use AstraZeneca’s vaccine for their health care workers after a small trial failed to show it was effective against the B.1.351 variant that had grown dominant across the country. They began using Johnson & Johnson’s instead.
巴林于 2 月 25 日成為第一個授權緊急使用該疫苗的國家。兩天后,美國也效仿。在一項小型試驗未能證明阿斯利康疫苗對在全國范圍內佔據主導地位的 B.1.351 變體有效後,南非放棄了將阿斯利康疫苗用於其醫護人員的計劃。他們開始改用強生公司。
In August 2020, the federal government agreed to pay Johnson & Johnson $1 billion for 100 million doses if the vaccine was authorized. Most of the U.S. supply was supposed to be made by Baltimore-based Emergent Solutions. But the company struggled to get the vaccine’s complex manufacturing up and running. In April 2021, the F.D.A. issued a scathing report about the company’s lax standards. At least 15 million doses of Johnson & Johnson’s vaccine were contaminated at the factory. As a result, the company only delivered 4 million doses to the United States after authorization, shipping them from its factory in the Netherlands.
2020 年 8 月,如果疫苗獲得批准,聯邦政府同意向強生公司支付 10 億美元購買 1 億劑疫苗。美國的大部分供應應該由位於巴爾的摩的 Emergent Solutions 提供。但該公司努力使疫苗的複雜生產啟動和運行。 2021 年 4 月,FDA 發布了一份關於該公司鬆懈標準的嚴厲報告。至少有 1500 萬劑強生公司的疫苗在工廠受到污染。結果,該公司在獲得授權後僅向美國交付了 400 萬劑,從其位於荷蘭的工廠發貨。
On April 13 the U.S. government recommended a pause in using the vaccine while it investigated reports of rare blood clots. Ten days later, C.D.C. researchers reported 15 cases of the unusual clots in nearly 8 million people who received the vaccine. The government decided to lift the pause and add a warning to the vaccine that younger women may run a slight risk of the severe side effect. At a May 12 meeting, C.D.C. researchers reported a total of 28 cases of blood clots in over 9 million vaccinations. Among women between the ages of 30-39, the rate is 12.4 cases per million doses. In women between 40 and 49, the rate is 9.4 cases per million doses. Among older women and men of all ages, there were fewer than 3 cases per million doses.
4 月 13 日,美國政府建議在調查罕見血凝塊的報告時暫停使用該疫苗。十天后,疾病預防控制中心的研究人員報告了近 800 萬接種疫苗的人中有 15 例異常凝塊。政府決定取消暫停措施,並向疫苗添加警告,即年輕女性可能會面臨嚴重副作用的輕微風險。在 5 月 12 日的一次會議上,CDC 研究人員報告了超過 900 萬次疫苗接種中共有 28 例血栓病例。在 30-39 歲的女性中,發病率為每百萬劑 12.4 例。在 40 至 49 歲的女性中,發病率為每百萬劑 9.4 例。在所有年齡段的老年女性和男性中,每百萬劑中不到 3 例。
Johnson & Johnson’s contract calls for it to deliver 100 million doses by June 2021. As it works towards getting the Baltimore facility certified, it is also getting help from Merck, which announced on March 2 it would assist Johnson & Johnson with manufacturing the vaccine.
強生公司的合同要求它在 2021 年 6 月之前提供 1 億劑疫苗。在努力獲得巴爾的摩工廠認證的同時,它還得到了默克公司的幫助,默克公司於 3 月 2 日宣布將協助強生公司生產疫苗。
The European Union reached a similar deal on Oct. 8, 2020 for 200 million doses. But after concerns about rare blood clots emerged, reports surfaced that the E.U. might not renew its contract with the company. On March 29, a coalition of African countries announced that it has secured up to 400 million doses of the Johnson & Johnson vaccine through 2022. Shipments could begin as soon as the third quarter of 2021. COVAX, an international collaboration to deliver the vaccine equitably across the world, secured 500 million doses. The company is aiming for production of a billion doses in 2021.
歐盟於 2020 年 10 月 8 日就 2 億劑疫苗達成了類似的協議。但在出現對罕見血凝塊的擔憂後,有報導稱歐盟可能不會與該公司續簽合同。 3 月 29 日,一個非洲國家聯盟宣佈到 2022 年已獲得多達 4 億劑強生疫苗。最早可在 2021 年第三季度開始發貨。 COVAX,一項旨在公平交付疫苗的國際合作項目在全球範圍內,獲得了 5 億劑。該公司的目標是在2021年生產十億劑。
On Nov. 16, 2020, Johnson & Johnson announced that they were also launching a second Phase 3 trial to observe the effects of two doses of their vaccine, instead of just one. The results are expected in the third quarter of 2021. In February, the company also launched a trial for pregnant women and in March it announced it would soon start trials on children. Johnson & Johnson’s chief executive said in a March 4 interview that the vaccine could become available for children by September.
2020 年 11 月 16 日,強生公司宣布他們還將啟動第二個 3 期試驗,以觀察兩劑疫苗的效果,而不僅僅是一劑。預計在 2021 年第三季度獲得結果。2 月,該公司還啟動了一項針對孕婦的試驗,並於 3 月宣布將很快開始對兒童進行試驗。強生公司首席執行官在 3 月 4 日接受采訪時表示,該疫苗可能會在 9 月之前提供給兒童。
For more details, see How the Johnson & Johnson Vaccine Works.
有關更多詳細信息,請參閱強生疫苗的工作原理。
STOPPED USE IN: Denmark, Finland NEW.
停止使用:丹麥、芬蘭 新。
EMERGENCY USE IN: Bahrain, Brazil, Canada, Colombia, European Union, Greenland, Iceland, Liechtenstein, Moldova NEW, Norway, Philippines, South Africa, South Korea, Switzerland, Thailand, United States, Zambia. Emergency use validation from the World Health Organization. Endorsed by the Africa Regulatory Taskforce.
緊急使用:巴林、巴西、加拿大、哥倫比亞、歐盟、格陵蘭、冰島、列支敦士登、摩爾多瓦新、挪威、菲律賓、南非、韓國、瑞士、泰國、美國、贊比亞。來自世界衛生組織的緊急使用驗證。得到非洲監管工作組的認可。
Updated May 18
5 月 18 日更新
### Protein-Based Vaccines
基於蛋白質的疫苗
Vaccines that contain coronavirus proteins but no genetic material. Some vaccines contain whole proteins, and some contain fragments of them. Some pack many of these molecules on nanoparticles.
含有冠狀病毒蛋白但不含遺傳物質的疫苗。有些疫苗含有完整的蛋白質,有些則含有蛋白質的片段。有些將許多這些分子包裝在納米顆粒上。
#### 智飛龍科
PHASE 3 EMERGENCY USE IN CHINA, UZBEKISTAN
中國、烏茲別克斯坦三期應急使用
Anhui Zhifei Longcom, Institute of Medical Biology at the Chinese Academy of Medical Sciences
安徽智飛龍科 中國醫學科學院醫學生物學研究所
VACCINE NAME: ZF2001
疫苗名稱:ZF2001
EFFICACY: Unknown
功效:未知
DOSE: 3 doses, 4 weeks apart
劑量:3 劑,間隔 4 週
TYPE: Muscle injection
類型:肌肉注射
The Chinese company Anhui Zhifei Longcom and the Institute of Medical Biology at the Chinese Academy of Medical Sciences partnered to make a vaccine. Their candidate is composed of an adjuvant, along with a section of the spike protein called the receptor-binding domain. They launched Phase 2 trials in July, followed by a Phase 3 trial with 29,000 volunteers in December. China authorized the vaccine for emergency use on March 15.
中國公司安徽智飛龍科與中國醫學科學院醫學生物學研究所合作研製疫苗。他們的候選物由佐劑和一段稱為受體結合域的刺突蛋白組成。他們於 7 月啟動了第二階段試驗,隨後在 12 月進行了有 29,000 名志願者參與的第三階段試驗。中國於3月15日批准該疫苗緊急使用。
EMERGENCY USE IN: China, Uzbekistan.
緊急使用:中國、烏茲別克斯坦。
#### 高端
PHASE 2
階段2
Medigen, Dynavax
Medigen、Dynavax
Taiwan-based vaccine maker Medigen is making a vaccine made of a combination of spike proteins and an adjuvant from Dynavax. After a series of promising experiments on animals, they began injecting volunteers for a Phase 1 trial in early October. On Dec. 30, Medigen announced that it had received permission to commence a Phase 2 trial. The first volunteers in the trial were injected in late January.
台灣疫苗製造商 Medigen 正在生產一種由刺突蛋白和 Dynavax 佐劑組合而成的疫苗。在對動物進行了一系列有希望的實驗後,他們於 10 月初開始為志願者註射進行第一階段試驗。 12 月 30 日,Medigen 宣布已獲得開始第二階段試驗的許可。試驗中的第一批志願者於 1 月下旬接受注射。
Updated Jan. 26
1 月 26 日更新
#### 聯亞
PHASE 2
階段2
Vaxxinity
病毒性
Dallas-based Vaxxinity is testing a vaccine containing parts of several viral proteins. (Vaxxinity formed in April 2021 when the companies COVAXX and United Neuroscience combined.) On Sept. 11, COVAXX registered a Phase 1 trial in Taiwan which led to 100 percent of volunteers producing antibodies without any serious side effects. In February COVAXX launched a Phase 2 trial, also in Taiwan. A Phase 2/3 trial is planned to launch in Brazil, India and other countries. On Nov. 25, Covaxx announced agreements with countries including Brazil, Ecuador, and Peru to deliver more than 140 million doses for $2.8 billion. In January, the company announced they were also starting preclinical research on a vaccine tailored specifically to newly emerged coronavirus variants that could potentially evade conventional vaccines.
總部位於達拉斯的 Vaxxinity 正在測試一種含有多種病毒蛋白部分的疫苗。 (Vaxxinity 於 2021 年 4 月成立,當時 COVAXX 和 United Neuroscience 公司合併。)9 月 11 日,COVAXX 在台灣註冊了一項 1 期試驗,該試驗導致 100% 的志願者產生抗體,沒有任何嚴重的副作用。 2 月,COVAXX 也在台灣啟動了第二階段試驗。計劃在巴西、印度和其他國家啟動 2/3 期試驗。 11 月 25 日,Covaxx 宣布與巴西、厄瓜多爾和秘魯等國達成協議,以 28 億美元的價格提供超過 1.4 億劑疫苗。今年 1 月,該公司宣布他們還開始對一種疫苗進行臨床前研究,該疫苗專門針對新出現的冠狀病毒變體而設計,這些變體可能會避開傳統疫苗。
Updated April 1
4 月 1 日更新
### Inactivated or Attenuated Coronavirus Vaccines
滅活或減毒冠狀病毒疫苗
Vaccines created from weakened coronaviruses or coronaviruses that have been killed with chemicals.
由減弱的冠狀病毒或被化學物質殺死的冠狀病毒製成的疫苗。
#### 中國國藥
PHASE 3
第三階段
APPROVED IN CHINA, BAHRAIN, U.A.E. EMERGENCY USE IN OTHER COUNTRIES
在中國、巴林、阿聯酋批准在其他國家緊急使用
Sinopharm
國藥控股
VACCINE NAME: BBIBP-CorV
疫苗名稱:BBIBP-CorV
EFFICACY: 78.1%
效率:78.1%
DOSE: 2 doses, 3 weeks apart
劑量:2 劑,間隔 3 週
TYPE: Muscle injection
類型:肌肉注射
The Beijing Institute of Biological Products created an inactivated coronavirus vaccine that was put into clinical trials by the state-owned Chinese company Sinopharm. On Dec. 30, Sinopharm announced that the vaccine had an efficacy of 79.34 percent, leading the Chinese government to give it approval. On May 7, the World Health Organization put forward a similar efficacy estimate of 78.1 percent and gave the vaccine emergency use authorization. The details of the Phase 3 trial has yet to be published in a scientific journal.
北京生物製品研究所研製了一種滅活的冠狀病毒疫苗,並由中國國有企業國藥控股進行臨床試驗。 12月30日,國藥控股宣布該疫苗有效率79.34%,獲得中國政府批准。 5月7日,世界衛生組織提出了78.1%的類似療效估計,並給予疫苗緊急使用授權。第三階段試驗的細節尚未在科學期刊上發表。
Last June, Beijing Institute researchers reported that the vaccine produced promising results in monkeys. A Phase 1/2 trial then showed that the vaccine didn’t cause any serious side effects and enabled people to make antibodies against the coronavirus. In July a Phase 3 trial began in the United Arab Emirates in July, and in Morocco and Peru the following month.
去年六月,北京研究所的研究人員報告說,該疫苗在猴子身上產生了可喜的結果。隨後的 1/2 期試驗表明,該疫苗不會引起任何嚴重的副作用,並使人們能夠產生針對冠狀病毒的抗體。 7 月,第三階段試驗於 7 月在阿拉伯聯合酋長國開始,次月在摩洛哥和秘魯開始。
On Sept. 14, the U.A.E. gave emergency approval for Sinopharm’s vaccine to use on health care workers, and soon government officials and others were also receiving it. Less than two months later, on Dec. 9, the U.A.E. gave full approval to BBIBP-CorV, announcing it had an efficacy rate of 86 percent. Since then a number of countries in the Near East have authorized it; on Jan. 29, Hungary authorized BBIBp-CorV, making the country the first European nation to use a Chinese vaccine.
9月14日,阿聯酋緊急批准國藥集團的疫苗用於醫護人員,很快政府官員和其他人也收到了。不到兩個月後,即 12 月 9 日,阿聯酋完全批准了 BBIBP-CorV,宣布其有效率為 86%。從那時起,近東的許多國家都批准了它; 1月29日,匈牙利批准了BBIBp-CorV,使該國成為第一個使用中國疫苗的歐洲國家。
In China, meanwhile, the government gave Sinopharm emergency approval in the summer 0f 2020. Government officials, health care workers, and other select groups began receiving BBIIP-CorV. In May, China claimed it can make up to 5 billion doses by the end of 2021, but Chinese officials warned that the country was struggling to manufacture enough doses for its own population.
與此同時,在中國,政府在2020年夏季0f緊急批准了國藥控股。政府官員,醫護人員和其他精選團體開始接受BBIIP-CorV。今年 5 月,中國聲稱到 2021 年底可以製造多達 50 億劑,但中國官員警告說,該國正在努力為本國人口製造足夠的劑量。
In February 2021, as concerns grew about new mutations in the coronavirus, Chinese researchers tested BBIBP-CorV against a variant called B.1.351, which was first found in South Africa. They reported that the antibody response created by the vaccine was only modestly weaker against B.1.351. The study has not yet been published in a medical journal.
2021年2月,隨著人們對冠狀病毒新突變的擔憂日益增加,中國研究人員針對BBI351-CorV變異體B.1.351進行了測試,該變異體最早在南非發現。他們報告說,疫苗產生的抗體反應對 B.1.351 僅略弱一些。該研究尚未發表在醫學雜誌上。
On May 18, amid concerns over the vaccine’s effectiveness, the U.A.E. announced that it would provide booster shots to those who have received two doses of BBIBP-CorV.
5 月 18 日,出於對疫苗有效性的擔憂,阿聯酋宣布將為接種過兩劑 BBIBP-CorV 的人提供加強注射。
For more details, see How the Sinopharm Vaccine Works.
更多詳情,請參閱國藥疫苗的工作原理。
APPROVED FOR USE IN: Bahrain, China, United Arab Emirates.
批准用於:巴林、中國、阿拉伯聯合酋長國。
EMERGENCY USE IN: Angola NEW, Argentina, Bangladesh, Brunei, Cambodia, Egypt, Gabon, Guyana, Hungary, Indonesia, Iran, Iraq, Jordan, Lebanon, Maldives, Moldova NEW, Mongolia NEW, Morocco, Namibia, Nepal, North Macedonia, Pakistan, Peru, Sierra Leone NEW, Sri Lanka NEW, Venezuela, Zimbabwe. Emergency use validation from the World Health Organization.
緊急情況使用:安哥拉新,阿根廷,孟加拉國,文萊,柬埔寨,埃及,加蓬,圭亞那,匈牙利,印度尼西亞,伊朗,伊拉克,約旦,黎巴嫩,馬爾代夫,摩爾多瓦新,蒙古新,摩洛哥,納米比亞,尼泊爾,北馬其頓,巴基斯坦、秘魯、塞拉利昂新增、斯里蘭卡新增、委內瑞拉、津巴布韋。來自世界衛生組織的緊急使用驗證。
Updated May 21
5 月 21 日更新
#### 華興
PHASE 3
第三階段
APPROVED IN CHINA EMERGENCY USE IN OTHER COUNTRIES
在中國獲准在其他國家緊急使用
Sinovac
華興
VACCINE NAME: CoronaVac (formerly PiCoVacc)
疫苗名稱:CoronaVac(原 PiCoVacc)
EFFICACY: 50.65% in Brazil trial, 91.25% in Turkey trial
功效:巴西試驗50.65%,土耳其試驗91.25%
DOSE: 2 doses, 2 weeks apart
劑量:2 劑,間隔 2 週
TYPE: Muscle injection
類型:肌肉注射
STORAGE: Refrigerated
儲存:冷藏
Sinovac Biotech, a private Chinese company, developed an inactivated vaccine called CoronaVac in early 2020. In early 2021, trials in Brazil and Turkey showed that it could protect against Covid-19, but they delivered strikingly different results — in part because they designed the trials differently. In Brazil, the efficacy against Covid-19 with or without symptoms was 50 percent. In Turkey, the efficacy against Covid-19 with at least one symptom was 91.25 percent. Sinovac released some of their data on April 3, but has yet to publish the details of the trials as a preprint or in a medical journal. Nevertheless, Sinovac announced on Feb. 6 that China had given CoronaVac conditional approval. Other countries are also beginning to use the vaccine.
華興生物是一家中國私營公司,於 2020 年初開發了一種名為 CoronaVac 的滅活疫苗。 2021 年初,巴西和土耳其的試驗表明它可以預防 Covid-19,但結果卻截然不同——部分原因是他們設計了試驗不同。在巴西,無論有無症狀,對 Covid-19 的療效為 50%。在土耳其,針對具有至少一種症狀的 Covid-19 的療效為 91.25%。 Sinovac 於 4 月 3 日發布了他們的一些數據,但尚未以預印本或醫學期刊的形式發布試驗細節。儘管如此,Sinovac 於 2 月 6 日宣布,中國已給予 CoronaVac 有條件的批准。其他國家也開始使用這種疫苗。
After creating their vaccine last spring, Sinovac ran a Phase 1/2 trial on 743 volunteers that revealed no severe adverse effects. Sinovac published the details of the trial in November in a medical journal, showing a comparatively modest production of antibodies. In July, Sinovac launched a Phase 3 trial in Brazil, followed by others in Indonesia and Turkey.
在去年春天研製出疫苗後,Sinovac 對 743 名志願者進行了 1/2 期試驗,沒有發現嚴重的副作用。 Sinovac 於 11 月在一份醫學期刊上公佈了該試驗的細節,顯示抗體產量相對較低。 7 月,Sinovac 在巴西啟動了第三階段試驗,隨後在印度尼西亞和土耳其進行了其他試驗。
In that same month, Chinese government gave CoronaVac an emergency approval for limited use. In October, authorities in the eastern Chinese city of Jiaxing announced they were giving CoronaVac to people in relatively high-risk jobs, including medical workers, port inspectors and public service personnel.
同月,中國政府緊急批准 CoronaVac 限制使用。 10 月,中國東部城市嘉興市當局宣布,他們將向從事相對高風險工作的人員提供 CoronaVac,包括醫務人員、港口檢查員和公共服務人員。
The scientists running the Phase 3 trials began announcing early results at the end of December and continued to update them as new cases of Covid-19 arose. While the overall efficacy of the vaccine was lower in the Brazil trial, it showed stronger protection against severe forms of the disease. No one in the Brazil trial who received Sinovac had to be hospitalized.
運行第 3 階段試驗的科學家於 12 月底開始宣布早期結果,並在出現新的 Covid-19 病例時繼續更新它們。雖然該疫苗在巴西試驗中的整體功效較低,但它對嚴重形式的疾病顯示出更強的保護作用。在巴西試驗中,接受科諾瓦克治療的人沒有人必須住院。
Sinovac has struck deals with at least 11 countries and regions to supply them with SinoVac. Indonesia gave the vaccine emergency authorization on Jan. 11, and two days later the president of Indonesia received an injection of CoronaVac on live television. Turkey authorized the vaccine on Jan. 13, and its president got vaccinated the next day. Brazil authorized CoronaVac on Jan. 17. On May 4, the European Medicines Agency said it was launching a rolling review of CoronaVac, which will accelerate Sinovac’s marketing authorization if the company decides to apply for one.
華興已與至少 11 個國家和地區達成協議,向他們供應華興。印度尼西亞於 1 月 11 日授予疫苗緊急授權,兩天后印度尼西亞總統在電視直播中接受了 CoronaVac 注射。土耳其於 1 月 13 日批准了該疫苗,其總統次日接種了疫苗。巴西於1月17日授權了CoronaVac。5月4日,歐洲藥品管理局表示將對CoronaVac進行滾動審查,如果該公司決定申請CoronaVac,它將加快Sinovac的營銷授權。
On April 1, Sinovac announced that its capacity had increased to 2 billion doses after completing a third production line.
4月1日,科興宣布第三條生產線建成後產能已增至20億劑。
Sinovac registered a Phase 2 trial of the vaccine in children and adolescents on May 13.
5 月 13 日,Sinovac 在兒童和青少年中註冊了該疫苗的 2 期試驗。
For more details, see How the Sinovac Vaccine Works.
有關更多詳細信息,請參閱 Sinovac 疫苗的工作原理。
APPROVED FOR USE IN: China.
批准用於:中國。
EMERGENCY USE IN: Azerbaijan, Brazil, Cambodia, Chile, Colombia, Dominican Republic NEW, Ecuador, Egypt, Hong Kong, Indonesia, Laos, Malaysia, Mexico, Moldova NEW, Pakistan, Panama, Philippines, Thailand, Tunisia, Turkey, Ukraine, Uruguay, Zimbabwe.
緊急使用:阿塞拜疆、巴西、柬埔寨、智利、哥倫比亞、多米尼加共和國、厄瓜多爾、埃及、香港、印度尼西亞、老撾、馬來西亞、墨西哥、摩爾多瓦、巴基斯坦、巴拿馬、菲律賓、泰國、突尼斯、土耳其、烏克蘭、烏拉圭、津巴布韋。
Updated May 18
5 月 18 日更新
#### 國藥
PHASE 3
第三階段
APPROVED IN CHINA LIMITED USE IN U.A.E.
在中國批准在阿聯酋有限使用
Sinopharm, Wuhan
國藥控股,武漢
EFFICACY: 72.8%
功效:72.8%
Along with their Beijing Institute vaccine, Sinopharm also tested an inactivated virus vaccine developed by the Wuhan Institute of Biological Products. The Phase 1/2 trial showed that the vaccine produced antibodies in volunteers, some of whom experienced fevers and other side effects. Sinopharm then launched a global Phase 3 trial of the Wuhan vaccine. In December, Peru briefly paused their trial to investigate neurological problems that one volunteer experienced, but determined that it had nothing to do with the vaccines. On Feb. 25, China announced the approval of the Wuhan vaccine for general use. In May, the vaccine researchers published the results of the Phase 3 trial, demonstrating that the vaccine has an efficacy of 72.8 percent.
除了北京研究所疫苗外,國藥還測試了武漢生物製品研究所開發的滅活病毒疫苗。 1/2期臨床試驗表明,該疫苗可在志願者體內產生抗體,其中一些人會出現發燒和其他副作用。國藥隨後啟動了武漢疫苗的全球3期試驗。去年 12 月,秘魯短暫暫停了他們的試驗,以調查一名志願者經歷的神經系統問題,但確定這與疫苗無關。 2月25日,中國宣布批准武漢疫苗通用。今年 5 月,疫苗研究人員公佈了第 3 階段試驗的結果,證明該疫苗的有效性為 72.8%。
APPROVED FOR USE IN: China.
批准用於:中國。
LIMITED USE IN: United Arab Emirates.
有限使用:阿拉伯聯合酋長國。
Updated May 29
5 月 29 日更新
#### 康泰
PHASE 3 EMERGENCY USE IN CHINA
中國三期應急使用
Shenzhen Kangtai Biological Products
深圳康泰生物製品
Shenzhen Kangtai Biological Products is a Chinese company that makes vaccines for diseases such as hepatitis B and measles. In August, AstraZeneca reached an agreement with Shenzhen to supply China with their adenovirus vaccine, despite the reports of corruption and scandals that have the company. In October Shenzhen Kangtai launched a Phase 1 trial on 180 volunteers of its own vaccine, based on inactivated coronaviruses. In February 2021 the company ran a Phase 2 trial, followed by a Phase 3 trial launched in May. In that same month, the company announced that the Chinese government had given it emergency use approval.
深圳康泰生物製品是一家中國公司,生產乙型肝炎和麻疹等疾病的疫苗。 8 月,阿斯利康與深圳達成協議,向中國供應腺病毒疫苗,儘管有報導稱該公司存在腐敗和醜聞。 10 月,深圳康泰基於滅活的冠狀病毒對 180 名志願者啟動了自己的疫苗的 1 期試驗。 2021 年 2 月,該公司進行了第二階段試驗,隨後於 5 月啟動了第三階段試驗。同月,該公司宣布中國政府已批准其緊急使用。
EMERGENCY USE IN: China NEW.
緊急使用:中國新。
Updated April 21
4月21日更新