CNN合訂本:過去的疫苗災難表明,現在倉促推出新冠病毒疫苗是「極其愚蠢的」
原文標題:Past vaccine disasters show why rushing a coronavirus vaccine now would be ‘colossally stupid’
原文鏈接:https://www.cnn.com/2020/09/01/health/eua-coronavirus-vaccine-history/index.html
By Jen Christensen, CNN
珍‧克里斯滕森,CNN
Updated 11:34 AM EDT, Tue September 1, 2020
(CNN) — Vaccine experts are warning the federal government against rushing out a coronavirus vaccine before testing has shown it’s both safe and effective. Decades of history show why they’re right.
疫苗專家警告聯邦政府,在新冠病毒疫苗的測試證明安全有效之前,不要倉促推出。數十年的歷史可以表明他們為何是正確的。
FDA signals vaccine could green light early
【FDA暗示疫苗可能提前獲批 [此章的英文原文省略]】
當FDA局長史蒂文·哈恩博士告訴《金融時報》時,如果有足夠強有力的證據表明新冠疫苗能夠保護人們,那麼即使後期臨床試驗尚未完成,該機構也可能授予新冠疫苗緊急使用授權(EUA),這加劇了人們對FDA行動過快的擔憂。
當沒有其他充分或已獲批准的替代方案時,專員有權允許在緊急情況下使用未經批准的醫療產品。緊急使用授權(EUA)不等於全面批准,並且可以撤銷。
羥氯奎和氯奎就是這種情況。3月28日,FDA授予這兩種藥物緊急使用授權,當時川普總統對它們讚不絕口。但隨後在6月份,FDA撤銷了授權,因為研究顯示它們無效,而且可能會導致嚴重的心臟問題。
Vaccine approval
【疫苗批准】
For a vaccine to be FDA approved, scientists must gather enough data through clinical trials in large numbers of volunteers to prove it is safe and effective at protecting people against a disease. Once the data is collected, FDA advisers usually spend months considering it.
疫苗要獲得美國食品藥物管理局(FDA)的批准,科學家必須對大量志願者進行臨床試驗,收集足夠的數據,以證明其安全有效,能夠保護人們免受疾病侵害。資料收集完後,FDA顧問通常會花費數月時間評估。
An EUA is much quicker. Only once before has the FDA given a vaccine this lesser standard approval of an EUA, but it was in an unusual circumstance. Soldiers had sued, claiming a mandatory anthrax vaccine made them sick, and a judge put a hold on the program. The Department of Defense asked for an EUA that then overrode the court ruling in 2005, so it could continue vaccinating military personnel – this time on a voluntary basis.
緊急使用授權(EUA)的核准速度要快得多。 FDA先前僅對一種疫苗授予過一次這種較低標準的EUA批准,但那次情況特殊。士兵提起訴訟,聲稱強制接種的炭疽疫苗導致他們生病,法官隨即下令暫停該計畫。國防部隨後申請了EUA,並在2005年推翻了法院的裁決,從而得以繼續為軍人接種疫苗——這次是自願接種。
Otherwise, vaccines have had to go through the entire clinical trial process and FDA approval process, which can take months or years.
否則,疫苗必須經過整個臨床試驗過程和FDA批准過程,這可能需要數月甚至數年時間。
When the vaccine making process has been rushed, there have been bad outcomes.
疫苗生產過程如果操之過急,就會造成不良後果。
The Cutter incident
【卡特事件】
On April 12, 1955 the government announced the first vaccine to protect kids against polio. Within days, labs had made thousands of lots of the vaccine. Batches made by one company, Cutter Labs, accidentally contained live polio virus and it caused an outbreak.
1955年4月12日,政府宣布了第一種保護兒童免受小兒麻痺侵害的疫苗。幾天之內,各實驗室就生產了數千批疫苗。其中卡特實驗室生產的疫苗批次,意外混入了活的小兒麻痺病毒,導致疫情爆發。
More than 200,000 children got the polio vaccine, but within days the government had to abandon the program.
超過20萬名兒童接種了小兒麻痺疫苗,但幾天內,政府就不得不放棄該計畫。
“Forty thousand kids got polio. Some had low levels, a couple hundred were left with paralysis, and about 10 died,” said Dr. Howard Markel, a pediatrician, distinguished professor, and director of the Center for the History of Medicine at the University of Michigan. The government suspended the vaccination program until it could determine what went wrong.
「四萬名兒童感染了小兒麻痺症。個別兒童病情較輕。數百名兒童癱瘓。約有十名兒童死亡,」密西根大學兒科醫生、傑出教授兼醫學史中心主任霍華德馬克爾博士說。政府暫停了疫苗接種計劃,以便找出問題所在。
Monkey trouble
【猿猴麻煩】
However, increased oversight failed to discover another problem with the polio vaccine.
然而,加強監管並未發現小兒麻痺疫苗的另一個問題。
From 1955 to 1963, between 10% and 30% of polio vaccines were contaminated with simian virus 40 (SV40).
從1955年到1963年,10%到30%的小兒麻痺疫苗被猿猴病毒 40 (SV40) 污染。
“The way they would grow the virus was on monkey tissues. These rhesus macaques were imported from India, tens of thousands of them,” medical anthropologist S. Lochlann Jain said. “They were gang caged and in those conditions, the ones that didn’t die on the journey, many got sick, and the viruses spread quickly,” added Jain, who taught a history of vaccines course at Stanford and is working on a publication about the incident. Scientists wrongly thought the formaldehyde they used would kill the virus. “It was being transferred to millions of Americans,” Jain said.
「他們用猴子組織培養病毒。這些恒河猴是從印度進口的,數量多達數萬隻,」醫學人類學家S·羅克蘭·賈恩說。 「它們被集中在籠子裡,在這種環境下,那些在運輸途中倖存下來的猴子,很多都生病了,病毒迅速傳播開來,」賈恩補充道。他曾在史丹佛大學教授疫苗史課程,目前正在撰寫一篇關於此事的論文。科學家錯誤地認為他們使用的甲醛可以殺死病毒。 「病毒就這樣傳播給了數百萬美國人,」賈恩說。
“Many believe this issue wasn’t adequately pursued,” Jain said. Some studies showed a possible link between the virus and cancer. The US Centers for Disease Control website, however, said most studies are “reassuring” and find no link.
「許多人認為這個問題沒有得到充分調查,」賈恩說。一些研究表明,該病毒與癌症之間可能存在關聯。然而,美國疾病管制與預防中心網站稱,大多數研究結果「令人放心」,並未發現二者之間存在關聯。
No current vaccines contain SV40 virus, the CDC says, and there’s no evidence the contamination harmed anyone.
CDC表示,目前沒有任何疫苗含有SV40病毒,也沒有證據顯示這種污染對任何人造成了傷害。
The epidemic that never was
【從未發生的疫情】
In 1976, scientists predicted a pandemic of a new strain of influenza called swine flu. More than 40 years later, some historians call it “flu epidemic that never was.”
1976年,科學家預測了一種名為豬流感的新型流感病毒會引發全球大流行。 40多年後,一些歷史學家稱之為「從未發生的流感大流行」。
“President Ford was basically told by his advisers, that look, we have a pandemic flu coming called swine flu that may be as bad as Spanish flu,” said Michael Kinch, a professor of radiation oncology in the school of medicine at Washington University in St. Louis. His latest book, “Between Hope and Fear,” explores the history of vaccines.
「福特總統從他的顧問處得知,豬流感的大流行即將到來,其嚴重程度可能與西班牙流感不相上下,」聖路易斯華盛頓大學醫學院放射腫瘤學教授邁克爾·金奇說道。他的最新著作《希望與恐懼之間》探討了疫苗的歷史。
“Ford was being cajoled to put forward a vaccine that was hastily put together. When you have a brand new strain situation like that, they had to do it on the fly,” Kinch said.
「福特總統當時被迫推出一款倉促研製出來的疫苗。面對這種全新的病毒株,他們只能臨時應對,」金奇說。
Ford made the decision to make the immunization compulsory.
福特決定強制推行免疫接種。
The government launched the program in about seven months and 40 million people got vaccinated against swine flu, according to the CDC. That vaccination campaign was later linked to cases of a neurological disorder called Guillain-Barre syndrome, which can develop after an infection or, rarely, after vaccination with a live vaccine.
據美CDC稱,政府在大約七個月內啟動了這項計劃,共有4000萬人接種了豬流感疫苗。後來,這項疫苗接種活動與一種名為格林-巴利綜合症的神經系統疾病病例有關,這種疾病可能在感染後發生,或者在極少數情況下,在接種活疫苗後發生。
“Unfortunately, due to that vaccine, and the fact that it was done so hastily, there were a few hundred cases of Guillain-Barre, although it’s not definitive that they were linked,” Kinch said.
「不幸的是,由於疫苗的研發和研發的倉促,出現了數百例格林-巴利綜合症病例,儘管尚不能確定這些病例與疫苗有關,」金奇說。
The CDC said the increased risk was about 1 additional case of Gullain-Barre for every 100,000 people who got the swine flu vaccine. Due to this small association, the government stopped the program to investigate.
美國疾病管制與預防中心表示,接種豬流感疫苗後,每10萬名接種者中約有1例格林-巴利症候群病例增加。由於這種關聯性較小,政府暫停了該項目進行調查。
“It was kind of a fiasco,” Markel said. “The good news is that there never was an epidemic of swine flu. So we were safe, but that shows you what could happen.”
「那簡直是一場災難,」馬克爾說。 「好消息是,豬流感疫情最終沒有爆發。所以我們很安全,但這說明可能會發生什麼。」
Growing distrust in the US
【美國日益增長的不信任感 [此章的英文原文省略]】
人們對疫苗產生的不信任感,經歷了數起事件才形成。即使在1955年第一劑小兒麻痺疫苗導致數千名兒童患病後,當疫苗接種計劃重新啟動時,家長們仍然讓自己的孩子接種疫苗。他們對每年導致13,000至20,000名兒童癱瘓的疫情記憶猶新。有些癱瘓程度非常嚴重,甚至無法自主呼吸,需要依靠一種叫做「鐵肺」的機器輔助呼吸。
「家長們催促自己的孩子排在接種小兒麻痺疫苗的最前面,因為他們多年來每年夏天都目睹了疫情爆發,看到孩子們插著鐵肺,他們感到非常害怕,」馬克爾說。
馬克爾表示,民眾的態度在1955年至1976年的豬流感疫苗接種計畫期間開始改變。
「民權運動期間,人們在電視上看到警察對民眾拳打腳踢;越戰期間,人們開始對殺戮感到厭惡;水門事件期間,總統公然撒謊,」馬克爾說。 「這些事件導致人們對政府產生了真正的不信任,這種不信任甚至蔓延到了醫生和科學家身上。而且,隨著時間的推移,不信任感只會愈演愈烈。」
A ‘colossally stupid’ move
【「極度愚蠢」的舉動】
Markel said people’s mistrust of the system makes the idea that the FDA would rush this process before late stage clinical trials are complete “colossally stupid.”
馬克爾表示,人們對該體系的不信任,使得認為FDA會在後期臨床試驗完成前,倉促推進這一進程的想法 「極其愚蠢」。
“This is one of the most ridiculous things I’ve heard this administration say,” Markel said. “All it takes is one bad side effect to basically botch a vaccine program that we desperately need against this virus. It’s a prescription for disaster.”
「這是我聽過本屆政府發表的最荒謬的言論之一,」馬克爾說。 「只需一個不良副作用,就足以徹底搞砸我們急需的疫苗計劃。這簡直是自取滅亡。”」
FDA Commissioner Hahn said that the vaccine decision will be based on data, not politics, but Kinch shares Markel’s concern.
FDA局長哈恩表示,疫苗的決定將基於數據,而不是政治,但金奇也和馬克爾一樣對此表示擔憂。
“This could do substantial damage,” Kinch said. Kinch, who is a patient in one of the vaccine trials himself, said the clinical trial process needs to be followed to the end. A too-early EUA for a vaccine could cause a “nightmare scenario,” for a few reasons.
「這可能會造成重大損害,」金奇說。金奇本人也是疫苗試驗的參與者之一,他表示臨床試驗流程必須完整進行。過早授予疫苗緊急使用授權(EUA)可能會引發「噩夢般的局面」,原因有以下幾點。
One, the vaccine may not be safe. Two, if it is not safe, people will lose faith in vaccines. Three, if a vaccine doesn’t offer complete protection, people will have a false sense of security and increase their risk. Four, if a substandard vaccine gets an EUA, a better vaccine may never get approval, because people would be reluctant to enroll in trials and risk getting a placebo instead of a vaccine.
第一,疫苗可能不安全。第二,如果疫苗不安全,人們會對疫苗失去信心。第三,如果疫苗無法提供完全保護,人們會產生虛假的安全感,增加感染風險。第四,如果一種不合格的疫苗獲得了緊急使用授權,那麼更好的疫苗可能永遠無法獲得批准,因為人們會不願意參加試驗,冒著接種安慰劑而非疫苗的風險。
“People are going to die unnecessarily if we take chances with this,” Kinch said. “We’ve got to get this right.”
「如果我們在這件事上冒險,將會有人喪命,」金奇說。 「我們必須把此事做對。」
CNN Health’s Jamie Gumbrecht contributed to this story
決不再做奴隸 25-11-28
原文鏈接:https://www.cnn.com/2020/09/01/health/eua-coronavirus-vaccine-history/index.html
By Jen Christensen, CNN
珍‧克里斯滕森,CNN
Updated 11:34 AM EDT, Tue September 1, 2020
(CNN) — Vaccine experts are warning the federal government against rushing out a coronavirus vaccine before testing has shown it’s both safe and effective. Decades of history show why they’re right.
疫苗專家警告聯邦政府,在新冠病毒疫苗的測試證明安全有效之前,不要倉促推出。數十年的歷史可以表明他們為何是正確的。
FDA signals vaccine could green light early
【FDA暗示疫苗可能提前獲批 [此章的英文原文省略]】
當FDA局長史蒂文·哈恩博士告訴《金融時報》時,如果有足夠強有力的證據表明新冠疫苗能夠保護人們,那麼即使後期臨床試驗尚未完成,該機構也可能授予新冠疫苗緊急使用授權(EUA),這加劇了人們對FDA行動過快的擔憂。
當沒有其他充分或已獲批准的替代方案時,專員有權允許在緊急情況下使用未經批准的醫療產品。緊急使用授權(EUA)不等於全面批准,並且可以撤銷。
羥氯奎和氯奎就是這種情況。3月28日,FDA授予這兩種藥物緊急使用授權,當時川普總統對它們讚不絕口。但隨後在6月份,FDA撤銷了授權,因為研究顯示它們無效,而且可能會導致嚴重的心臟問題。
Vaccine approval
【疫苗批准】
For a vaccine to be FDA approved, scientists must gather enough data through clinical trials in large numbers of volunteers to prove it is safe and effective at protecting people against a disease. Once the data is collected, FDA advisers usually spend months considering it.
疫苗要獲得美國食品藥物管理局(FDA)的批准,科學家必須對大量志願者進行臨床試驗,收集足夠的數據,以證明其安全有效,能夠保護人們免受疾病侵害。資料收集完後,FDA顧問通常會花費數月時間評估。
An EUA is much quicker. Only once before has the FDA given a vaccine this lesser standard approval of an EUA, but it was in an unusual circumstance. Soldiers had sued, claiming a mandatory anthrax vaccine made them sick, and a judge put a hold on the program. The Department of Defense asked for an EUA that then overrode the court ruling in 2005, so it could continue vaccinating military personnel – this time on a voluntary basis.
緊急使用授權(EUA)的核准速度要快得多。 FDA先前僅對一種疫苗授予過一次這種較低標準的EUA批准,但那次情況特殊。士兵提起訴訟,聲稱強制接種的炭疽疫苗導致他們生病,法官隨即下令暫停該計畫。國防部隨後申請了EUA,並在2005年推翻了法院的裁決,從而得以繼續為軍人接種疫苗——這次是自願接種。
Otherwise, vaccines have had to go through the entire clinical trial process and FDA approval process, which can take months or years.
否則,疫苗必須經過整個臨床試驗過程和FDA批准過程,這可能需要數月甚至數年時間。
When the vaccine making process has been rushed, there have been bad outcomes.
疫苗生產過程如果操之過急,就會造成不良後果。
The Cutter incident
【卡特事件】
On April 12, 1955 the government announced the first vaccine to protect kids against polio. Within days, labs had made thousands of lots of the vaccine. Batches made by one company, Cutter Labs, accidentally contained live polio virus and it caused an outbreak.
1955年4月12日,政府宣布了第一種保護兒童免受小兒麻痺侵害的疫苗。幾天之內,各實驗室就生產了數千批疫苗。其中卡特實驗室生產的疫苗批次,意外混入了活的小兒麻痺病毒,導致疫情爆發。
More than 200,000 children got the polio vaccine, but within days the government had to abandon the program.
超過20萬名兒童接種了小兒麻痺疫苗,但幾天內,政府就不得不放棄該計畫。
“Forty thousand kids got polio. Some had low levels, a couple hundred were left with paralysis, and about 10 died,” said Dr. Howard Markel, a pediatrician, distinguished professor, and director of the Center for the History of Medicine at the University of Michigan. The government suspended the vaccination program until it could determine what went wrong.
「四萬名兒童感染了小兒麻痺症。個別兒童病情較輕。數百名兒童癱瘓。約有十名兒童死亡,」密西根大學兒科醫生、傑出教授兼醫學史中心主任霍華德馬克爾博士說。政府暫停了疫苗接種計劃,以便找出問題所在。
Monkey trouble
【猿猴麻煩】
However, increased oversight failed to discover another problem with the polio vaccine.
然而,加強監管並未發現小兒麻痺疫苗的另一個問題。
From 1955 to 1963, between 10% and 30% of polio vaccines were contaminated with simian virus 40 (SV40).
從1955年到1963年,10%到30%的小兒麻痺疫苗被猿猴病毒 40 (SV40) 污染。
“The way they would grow the virus was on monkey tissues. These rhesus macaques were imported from India, tens of thousands of them,” medical anthropologist S. Lochlann Jain said. “They were gang caged and in those conditions, the ones that didn’t die on the journey, many got sick, and the viruses spread quickly,” added Jain, who taught a history of vaccines course at Stanford and is working on a publication about the incident. Scientists wrongly thought the formaldehyde they used would kill the virus. “It was being transferred to millions of Americans,” Jain said.
「他們用猴子組織培養病毒。這些恒河猴是從印度進口的,數量多達數萬隻,」醫學人類學家S·羅克蘭·賈恩說。 「它們被集中在籠子裡,在這種環境下,那些在運輸途中倖存下來的猴子,很多都生病了,病毒迅速傳播開來,」賈恩補充道。他曾在史丹佛大學教授疫苗史課程,目前正在撰寫一篇關於此事的論文。科學家錯誤地認為他們使用的甲醛可以殺死病毒。 「病毒就這樣傳播給了數百萬美國人,」賈恩說。
“Many believe this issue wasn’t adequately pursued,” Jain said. Some studies showed a possible link between the virus and cancer. The US Centers for Disease Control website, however, said most studies are “reassuring” and find no link.
「許多人認為這個問題沒有得到充分調查,」賈恩說。一些研究表明,該病毒與癌症之間可能存在關聯。然而,美國疾病管制與預防中心網站稱,大多數研究結果「令人放心」,並未發現二者之間存在關聯。
No current vaccines contain SV40 virus, the CDC says, and there’s no evidence the contamination harmed anyone.
CDC表示,目前沒有任何疫苗含有SV40病毒,也沒有證據顯示這種污染對任何人造成了傷害。
The epidemic that never was
【從未發生的疫情】
In 1976, scientists predicted a pandemic of a new strain of influenza called swine flu. More than 40 years later, some historians call it “flu epidemic that never was.”
1976年,科學家預測了一種名為豬流感的新型流感病毒會引發全球大流行。 40多年後,一些歷史學家稱之為「從未發生的流感大流行」。
“President Ford was basically told by his advisers, that look, we have a pandemic flu coming called swine flu that may be as bad as Spanish flu,” said Michael Kinch, a professor of radiation oncology in the school of medicine at Washington University in St. Louis. His latest book, “Between Hope and Fear,” explores the history of vaccines.
「福特總統從他的顧問處得知,豬流感的大流行即將到來,其嚴重程度可能與西班牙流感不相上下,」聖路易斯華盛頓大學醫學院放射腫瘤學教授邁克爾·金奇說道。他的最新著作《希望與恐懼之間》探討了疫苗的歷史。
“Ford was being cajoled to put forward a vaccine that was hastily put together. When you have a brand new strain situation like that, they had to do it on the fly,” Kinch said.
「福特總統當時被迫推出一款倉促研製出來的疫苗。面對這種全新的病毒株,他們只能臨時應對,」金奇說。
Ford made the decision to make the immunization compulsory.
福特決定強制推行免疫接種。
The government launched the program in about seven months and 40 million people got vaccinated against swine flu, according to the CDC. That vaccination campaign was later linked to cases of a neurological disorder called Guillain-Barre syndrome, which can develop after an infection or, rarely, after vaccination with a live vaccine.
據美CDC稱,政府在大約七個月內啟動了這項計劃,共有4000萬人接種了豬流感疫苗。後來,這項疫苗接種活動與一種名為格林-巴利綜合症的神經系統疾病病例有關,這種疾病可能在感染後發生,或者在極少數情況下,在接種活疫苗後發生。
“Unfortunately, due to that vaccine, and the fact that it was done so hastily, there were a few hundred cases of Guillain-Barre, although it’s not definitive that they were linked,” Kinch said.
「不幸的是,由於疫苗的研發和研發的倉促,出現了數百例格林-巴利綜合症病例,儘管尚不能確定這些病例與疫苗有關,」金奇說。
The CDC said the increased risk was about 1 additional case of Gullain-Barre for every 100,000 people who got the swine flu vaccine. Due to this small association, the government stopped the program to investigate.
美國疾病管制與預防中心表示,接種豬流感疫苗後,每10萬名接種者中約有1例格林-巴利症候群病例增加。由於這種關聯性較小,政府暫停了該項目進行調查。
“It was kind of a fiasco,” Markel said. “The good news is that there never was an epidemic of swine flu. So we were safe, but that shows you what could happen.”
「那簡直是一場災難,」馬克爾說。 「好消息是,豬流感疫情最終沒有爆發。所以我們很安全,但這說明可能會發生什麼。」
Growing distrust in the US
【美國日益增長的不信任感 [此章的英文原文省略]】
人們對疫苗產生的不信任感,經歷了數起事件才形成。即使在1955年第一劑小兒麻痺疫苗導致數千名兒童患病後,當疫苗接種計劃重新啟動時,家長們仍然讓自己的孩子接種疫苗。他們對每年導致13,000至20,000名兒童癱瘓的疫情記憶猶新。有些癱瘓程度非常嚴重,甚至無法自主呼吸,需要依靠一種叫做「鐵肺」的機器輔助呼吸。
「家長們催促自己的孩子排在接種小兒麻痺疫苗的最前面,因為他們多年來每年夏天都目睹了疫情爆發,看到孩子們插著鐵肺,他們感到非常害怕,」馬克爾說。
馬克爾表示,民眾的態度在1955年至1976年的豬流感疫苗接種計畫期間開始改變。
「民權運動期間,人們在電視上看到警察對民眾拳打腳踢;越戰期間,人們開始對殺戮感到厭惡;水門事件期間,總統公然撒謊,」馬克爾說。 「這些事件導致人們對政府產生了真正的不信任,這種不信任甚至蔓延到了醫生和科學家身上。而且,隨著時間的推移,不信任感只會愈演愈烈。」
A ‘colossally stupid’ move
【「極度愚蠢」的舉動】
Markel said people’s mistrust of the system makes the idea that the FDA would rush this process before late stage clinical trials are complete “colossally stupid.”
馬克爾表示,人們對該體系的不信任,使得認為FDA會在後期臨床試驗完成前,倉促推進這一進程的想法 「極其愚蠢」。
“This is one of the most ridiculous things I’ve heard this administration say,” Markel said. “All it takes is one bad side effect to basically botch a vaccine program that we desperately need against this virus. It’s a prescription for disaster.”
「這是我聽過本屆政府發表的最荒謬的言論之一,」馬克爾說。 「只需一個不良副作用,就足以徹底搞砸我們急需的疫苗計劃。這簡直是自取滅亡。”」
FDA Commissioner Hahn said that the vaccine decision will be based on data, not politics, but Kinch shares Markel’s concern.
FDA局長哈恩表示,疫苗的決定將基於數據,而不是政治,但金奇也和馬克爾一樣對此表示擔憂。
“This could do substantial damage,” Kinch said. Kinch, who is a patient in one of the vaccine trials himself, said the clinical trial process needs to be followed to the end. A too-early EUA for a vaccine could cause a “nightmare scenario,” for a few reasons.
「這可能會造成重大損害,」金奇說。金奇本人也是疫苗試驗的參與者之一,他表示臨床試驗流程必須完整進行。過早授予疫苗緊急使用授權(EUA)可能會引發「噩夢般的局面」,原因有以下幾點。
One, the vaccine may not be safe. Two, if it is not safe, people will lose faith in vaccines. Three, if a vaccine doesn’t offer complete protection, people will have a false sense of security and increase their risk. Four, if a substandard vaccine gets an EUA, a better vaccine may never get approval, because people would be reluctant to enroll in trials and risk getting a placebo instead of a vaccine.
第一,疫苗可能不安全。第二,如果疫苗不安全,人們會對疫苗失去信心。第三,如果疫苗無法提供完全保護,人們會產生虛假的安全感,增加感染風險。第四,如果一種不合格的疫苗獲得了緊急使用授權,那麼更好的疫苗可能永遠無法獲得批准,因為人們會不願意參加試驗,冒著接種安慰劑而非疫苗的風險。
“People are going to die unnecessarily if we take chances with this,” Kinch said. “We’ve got to get this right.”
「如果我們在這件事上冒險,將會有人喪命,」金奇說。 「我們必須把此事做對。」
CNN Health’s Jamie Gumbrecht contributed to this story
決不再做奴隸 25-11-28
OP
決不再做奴隸
♩黎明來到 要光復 這香港 同行兒女 為正義 時代革命 祈求 民主與自由 萬世都不朽
原文中沒發出來的兩章英文,我這裡補上:
更多...FDA signals vaccine could green light early
Their concern that the FDA may be moving too quickly heightened when FDA Commissioner Dr. Steven Hahn told the Financial Times that his agency could consider an emergency use authorization (EUA) for a Covid-19 vaccine before late stage clinical trials are complete if the data show strong enough evidence it would protect people.
The commissioner has the authority to allow unapproved medical products to be used in an emergency when there are no adequate or approved alternatives. An EUA is not the same as full approval and it can be withdrawn.
That’s what happened with hydroxychloroquine and chloroquine. The FDA granted an EUA to the drugs – much praised by President Donald Trump – on March 28. It subsequently revoked its EUA in June after studies showed they were not effective and could also potentially cause serious heart problems.
//
Growing distrust in the US
It took several incidents for people to start distrusting vaccines. Even after thousands of kids got sick from the first polio vaccine in 1955, when the program restarted, parents made sure their children got vaccinated. They had clear memories of epidemics that paralyzed between 13,000 and 20,000 children every year. Some were so profoundly paralyzed that they could not even breathe easily on their own, and relied on machines called iron lungs to help them breathe.
“Parents were pushing their kids to get to the head of the line to get the polio vaccine, because they had seen epidemics every summer for years, and saw kids in iron lungs and they were terrified,” Markel said.
Markel said people’s attitudes started to change between 1955 and the problematic 1976 swine flu vaccination project.
“You’ve got civil rights, when people see the cops beating the hell out of people on TV. You’ve got the Vietnam War where people start to get disgusted with the killing. You’ve got Watergate when the president is literally lying through his teeth,” Markel said. “That led to a real distrust of authorities and federal government, and it extended to doctors and scientists. And, that’s only progressed as time
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25-11-30