這是新冠疫苗競賽不可逾越的6個問題
新冠肺炎疫情仍然在美國肆虐,已經(jīng)導(dǎo)致將近20萬美國人死亡,全球死亡人數(shù)也達(dá)到100萬人。因此亟需安全有效的疫苗來阻止疫情持續(xù)蔓延,并全面重啟經(jīng)濟(jì)。
全世界的目光都聚焦在醫(yī)藥行業(yè),領(lǐng)頭企業(yè)都以前所未見的速度推進(jìn)疫苗的發(fā)現(xiàn)、測試和生產(chǎn)工作。眾多全球頂尖的科學(xué)家都在專注于實(shí)現(xiàn)疫苗開發(fā)目標(biāo)。為了在最短的時間內(nèi)加快疫苗的推出,特朗普政府啟動了“空間機(jī)戰(zhàn)行動”(Operation Warp Speed),資助多個候選疫苗加速開發(fā)流程,并承諾采購數(shù)億劑獲批準(zhǔn)的疫苗。
但試圖加快推進(jìn)科學(xué)研究會帶來許多風(fēng)險,對像新冠病毒這樣的新型病毒的科學(xué)研究尤甚。這種病毒不好理解,也不容易定性??茖W(xué)發(fā)現(xiàn)不能像即將到來的美國總統(tǒng)選舉那樣被時間表牽著走。
為了應(yīng)對這些風(fēng)險,必須得解決好以下的六個問題:
1. 會不會出現(xiàn)早期臨床試驗(yàn)中未發(fā)現(xiàn)的安全問題?
2. 這些疫苗是否足以有效阻止新冠病毒的傳播?
3. 美國人們會足夠放心去接種疫苗嗎?
4. 是否會有充足的疫苗供應(yīng)?誰能優(yōu)先接種?
5. 如果多種疫苗獲得批準(zhǔn),人們?nèi)绾沃缿?yīng)該接種哪一種?
6.疫苗審批流程會受阻嗎?
安全性
由于完成試驗(yàn)的時間非常緊迫,人們擔(dān)心疫苗安全問題可能在數(shù)百萬人接種后才會出現(xiàn)。“空間機(jī)戰(zhàn)行動”疫苗研發(fā)部門的主管蒙塞夫?斯拉維稱,疫苗在選舉日之前獲批的可能性“非常非常低”,如果他迫于壓力而批準(zhǔn)了不安全的疫苗,他會主動辭職。
9月9日,阿斯利康(AstraZeneca)主要候選疫苗的臨床試驗(yàn)在一名患者出現(xiàn)神經(jīng)系統(tǒng)癥狀后叫停,這說明新疫苗測試必須要小心謹(jǐn)慎。(經(jīng)過仔細(xì)的臨床審查,那些試驗(yàn)后來恢復(fù)進(jìn)行。)要是數(shù)百萬健康的人接種疫苗后安全問題才被知曉,整個國家的衛(wèi)生健康和公眾信心無疑都會受到毀滅性的打擊。
有效性
美國食品與藥品管理局(FDA)已經(jīng)將新冠疫苗有效性的最低門檻設(shè)定為50%,基本上與流感疫苗相同,但流感的死亡風(fēng)險要遠(yuǎn)遠(yuǎn)低于新冠病毒。如果疫苗的有效性是50%,公眾會足夠放心去恢復(fù)正常生活——在擁擠的空間工作,現(xiàn)場觀看音樂會或體育賽事,去人頭攢動的酒吧和餐廳,或乘坐長途飛機(jī)?但愿制藥公司能夠開發(fā)出有效性遠(yuǎn)遠(yuǎn)高于50%的疫苗吧。
公眾信心
凱撒家庭基金會(Kaiser Family Foundation)在9月10日的一項(xiàng)民意調(diào)查發(fā)現(xiàn),54%的美國人不想接種在11月3日選舉日之前獲得批準(zhǔn)的疫苗。與此同時,反疫苗活動人士正在利用疫情來挑起人們對所有疫苗安全性的擔(dān)憂。因此,建立公眾對疫苗安全性和有效性的信心至關(guān)重要,這樣才會有更多的人自愿接種疫苗。
可獲得性
獲得批準(zhǔn)以后,疫苗不太可能會在幾個月內(nèi)一直廣泛供應(yīng)。醫(yī)護(hù)人員應(yīng)該優(yōu)先獲得疫苗。在此之后,如何確定獲得疫苗的優(yōu)先次序呢?應(yīng)該根據(jù)風(fēng)險分級來確定優(yōu)先次序,老年人、糖尿病患者、肥胖癥患者、高危職業(yè)人群等脆弱人群要優(yōu)先獲得疫苗。
該接種哪個疫苗
各大制藥公司斥資數(shù)十億美元來開發(fā)有效的疫苗,最終將有幾種候選疫苗獲得FDA的批準(zhǔn),每一種都將有各自的科學(xué)方法和有效性。最早面世的疫苗將引起廣泛的關(guān)注,但它會是最有效的嗎?消費(fèi)者將需要有足夠的信息來決定該接種哪種疫苗,他們應(yīng)當(dāng)從醫(yī)生那里獲得這些信息,而不是從電視上的醫(yī)藥廣告或口口相傳獲知。
對于審批的擔(dān)憂
人們越來越擔(dān)心政治因素會影響FDA的決定,尤其是11月3日總統(tǒng)大選前的批準(zhǔn)或緊急使用授權(quán)決定。上述的凱撒家庭基金會民意調(diào)查發(fā)現(xiàn),61%的美國人擔(dān)心FDA會因?yàn)檎螇毫Χ鴤}促批準(zhǔn)疫苗。
FDA上個春天就曾經(jīng)在測試前過早給予羥氯喹緊急使用授權(quán),但后來撤銷授權(quán),此事加劇了公眾的擔(dān)憂。此外,美國國立衛(wèi)生研究院(National Institutes of Health)的一個專家小組最近也批評FDA給予沒有進(jìn)行隨機(jī)測試的恢復(fù)期血漿療法緊急使用授權(quán)。對于如此重要的醫(yī)療衛(wèi)生決策,疫苗審批過程不應(yīng)該有任何的政治干預(yù)。
如何確保安全有效
在我們擁有一種或多種安全有效且可廣泛獲得的疫苗之前,新冠疫情危機(jī)不會結(jié)束。監(jiān)管者和衛(wèi)生保健領(lǐng)導(dǎo)者必須要帶頭建立公眾對整個疫苗開發(fā)和分發(fā)過程的完整性的信心。
醫(yī)藥行業(yè)和公共衛(wèi)生官員必須強(qiáng)調(diào)安全第一。9月8日,9家領(lǐng)先的制藥公司簽署了一份承諾書,保證:“只有在經(jīng)過設(shè)計和實(shí)施均符合FDA要求的三期臨床研究證明疫苗的安全性及有效性之后,才提交批準(zhǔn)或緊急使用授權(quán)申請?!边@份承諾書的簽署者包括阿斯利康、BioNTech、葛蘭素史克、強(qiáng)生、默沙東、Moderna、Novavax、輝瑞、賽諾菲等公司的首席執(zhí)行官。
安全有效的疫苗是阻止疫苗蔓延以及全面重啟經(jīng)濟(jì)的關(guān)鍵所在。當(dāng)有疫苗最終獲得批準(zhǔn)時,公眾必須能夠仰仗仔細(xì)審查過臨床試驗(yàn)數(shù)據(jù)的公共衛(wèi)生官員和醫(yī)生提供接種指引。為了建立公眾信心,獨(dú)立于政客的醫(yī)療衛(wèi)生領(lǐng)導(dǎo)者必須迎接挑戰(zhàn),確保新冠病毒疫苗安全有效,并首先提供給最需要的人。(財富中文網(wǎng))
作者比爾?喬治是哈佛商學(xué)院高級研究員,曾經(jīng)擔(dān)任美敦力公司(Medtronic)的董事長兼首席執(zhí)行官。他著有《真北》(Discover Your True North)一書。
譯者:萬志文
2020年8月13日,位于佛羅里達(dá)州好萊塢的美國研究中心(RCA)在進(jìn)行新冠疫苗研究。
新冠肺炎疫情仍然在美國肆虐,已經(jīng)導(dǎo)致將近20萬美國人死亡,全球死亡人數(shù)也達(dá)到100萬人。因此亟需安全有效的疫苗來阻止疫情持續(xù)蔓延,并全面重啟經(jīng)濟(jì)。
全世界的目光都聚焦在醫(yī)藥行業(yè),領(lǐng)頭企業(yè)都以前所未見的速度推進(jìn)疫苗的發(fā)現(xiàn)、測試和生產(chǎn)工作。眾多全球頂尖的科學(xué)家都在專注于實(shí)現(xiàn)疫苗開發(fā)目標(biāo)。為了在最短的時間內(nèi)加快疫苗的推出,特朗普政府啟動了“空間機(jī)戰(zhàn)行動”(Operation Warp Speed),資助多個候選疫苗加速開發(fā)流程,并承諾采購數(shù)億劑獲批準(zhǔn)的疫苗。
但試圖加快推進(jìn)科學(xué)研究會帶來許多風(fēng)險,對像新冠病毒這樣的新型病毒的科學(xué)研究尤甚。這種病毒不好理解,也不容易定性??茖W(xué)發(fā)現(xiàn)不能像即將到來的美國總統(tǒng)選舉那樣被時間表牽著走。
為了應(yīng)對這些風(fēng)險,必須得解決好以下的六個問題:
1. 會不會出現(xiàn)早期臨床試驗(yàn)中未發(fā)現(xiàn)的安全問題?
2. 這些疫苗是否足以有效阻止新冠病毒的傳播?
3. 美國人們會足夠放心去接種疫苗嗎?
4. 是否會有充足的疫苗供應(yīng)?誰能優(yōu)先接種?
5. 如果多種疫苗獲得批準(zhǔn),人們?nèi)绾沃缿?yīng)該接種哪一種?
6.疫苗審批流程會受阻嗎?
安全性
由于完成試驗(yàn)的時間非常緊迫,人們擔(dān)心疫苗安全問題可能在數(shù)百萬人接種后才會出現(xiàn)?!翱臻g機(jī)戰(zhàn)行動”疫苗研發(fā)部門的主管蒙塞夫?斯拉維稱,疫苗在選舉日之前獲批的可能性“非常非常低”,如果他迫于壓力而批準(zhǔn)了不安全的疫苗,他會主動辭職。
9月9日,阿斯利康(AstraZeneca)主要候選疫苗的臨床試驗(yàn)在一名患者出現(xiàn)神經(jīng)系統(tǒng)癥狀后叫停,這說明新疫苗測試必須要小心謹(jǐn)慎。(經(jīng)過仔細(xì)的臨床審查,那些試驗(yàn)后來恢復(fù)進(jìn)行。)要是數(shù)百萬健康的人接種疫苗后安全問題才被知曉,整個國家的衛(wèi)生健康和公眾信心無疑都會受到毀滅性的打擊。
有效性
美國食品與藥品管理局(FDA)已經(jīng)將新冠疫苗有效性的最低門檻設(shè)定為50%,基本上與流感疫苗相同,但流感的死亡風(fēng)險要遠(yuǎn)遠(yuǎn)低于新冠病毒。如果疫苗的有效性是50%,公眾會足夠放心去恢復(fù)正常生活——在擁擠的空間工作,現(xiàn)場觀看音樂會或體育賽事,去人頭攢動的酒吧和餐廳,或乘坐長途飛機(jī)?但愿制藥公司能夠開發(fā)出有效性遠(yuǎn)遠(yuǎn)高于50%的疫苗吧。
公眾信心
凱撒家庭基金會(Kaiser Family Foundation)在9月10日的一項(xiàng)民意調(diào)查發(fā)現(xiàn),54%的美國人不想接種在11月3日選舉日之前獲得批準(zhǔn)的疫苗。與此同時,反疫苗活動人士正在利用疫情來挑起人們對所有疫苗安全性的擔(dān)憂。因此,建立公眾對疫苗安全性和有效性的信心至關(guān)重要,這樣才會有更多的人自愿接種疫苗。
可獲得性
獲得批準(zhǔn)以后,疫苗不太可能會在幾個月內(nèi)一直廣泛供應(yīng)。醫(yī)護(hù)人員應(yīng)該優(yōu)先獲得疫苗。在此之后,如何確定獲得疫苗的優(yōu)先次序呢?應(yīng)該根據(jù)風(fēng)險分級來確定優(yōu)先次序,老年人、糖尿病患者、肥胖癥患者、高危職業(yè)人群等脆弱人群要優(yōu)先獲得疫苗。
該接種哪個疫苗
各大制藥公司斥資數(shù)十億美元來開發(fā)有效的疫苗,最終將有幾種候選疫苗獲得FDA的批準(zhǔn),每一種都將有各自的科學(xué)方法和有效性。最早面世的疫苗將引起廣泛的關(guān)注,但它會是最有效的嗎?消費(fèi)者將需要有足夠的信息來決定該接種哪種疫苗,他們應(yīng)當(dāng)從醫(yī)生那里獲得這些信息,而不是從電視上的醫(yī)藥廣告或口口相傳獲知。
對于審批的擔(dān)憂
人們越來越擔(dān)心政治因素會影響FDA的決定,尤其是11月3日總統(tǒng)大選前的批準(zhǔn)或緊急使用授權(quán)決定。上述的凱撒家庭基金會民意調(diào)查發(fā)現(xiàn),61%的美國人擔(dān)心FDA會因?yàn)檎螇毫Χ鴤}促批準(zhǔn)疫苗。
FDA上個春天就曾經(jīng)在測試前過早給予羥氯喹緊急使用授權(quán),但后來撤銷授權(quán),此事加劇了公眾的擔(dān)憂。此外,美國國立衛(wèi)生研究院(National Institutes of Health)的一個專家小組最近也批評FDA給予沒有進(jìn)行隨機(jī)測試的恢復(fù)期血漿療法緊急使用授權(quán)。對于如此重要的醫(yī)療衛(wèi)生決策,疫苗審批過程不應(yīng)該有任何的政治干預(yù)。
如何確保安全有效
在我們擁有一種或多種安全有效且可廣泛獲得的疫苗之前,新冠疫情危機(jī)不會結(jié)束。監(jiān)管者和衛(wèi)生保健領(lǐng)導(dǎo)者必須要帶頭建立公眾對整個疫苗開發(fā)和分發(fā)過程的完整性的信心。
醫(yī)藥行業(yè)和公共衛(wèi)生官員必須強(qiáng)調(diào)安全第一。9月8日,9家領(lǐng)先的制藥公司簽署了一份承諾書,保證:“只有在經(jīng)過設(shè)計和實(shí)施均符合FDA要求的三期臨床研究證明疫苗的安全性及有效性之后,才提交批準(zhǔn)或緊急使用授權(quán)申請?!边@份承諾書的簽署者包括阿斯利康、BioNTech、葛蘭素史克、強(qiáng)生、默沙東、Moderna、Novavax、輝瑞、賽諾菲等公司的首席執(zhí)行官。
安全有效的疫苗是阻止疫苗蔓延以及全面重啟經(jīng)濟(jì)的關(guān)鍵所在。當(dāng)有疫苗最終獲得批準(zhǔn)時,公眾必須能夠仰仗仔細(xì)審查過臨床試驗(yàn)數(shù)據(jù)的公共衛(wèi)生官員和醫(yī)生提供接種指引。為了建立公眾信心,獨(dú)立于政客的醫(yī)療衛(wèi)生領(lǐng)導(dǎo)者必須迎接挑戰(zhàn),確保新冠病毒疫苗安全有效,并首先提供給最需要的人。(財富中文網(wǎng))
作者比爾?喬治是哈佛商學(xué)院高級研究員,曾經(jīng)擔(dān)任美敦力公司(Medtronic)的董事長兼首席執(zhí)行官。他著有《真北》(Discover Your True North)一書。
譯者:萬志文
With COVID-19 still raging in the U.S. and the death toll approaching 200,000 Americans and 1 million people worldwide, a safe and effective vaccine is required to stop the spread of the disease and restart the economy.
All eyes are on the pharmaceutical industry, as leading companies have moved ahead to discover, test, and manufacture a vaccine faster than ever before. Many of the world’s best scientists are focused on this goal. To accelerate the availability of a vaccine in record time, the Trump administration launched Operation Warp Speed, funding multiple vaccine candidates through an accelerated development process and committing to purchase hundreds of millions of doses of approved vaccines.
Trying to speed up science carries many risks, especially for a novel virus like this one, which is not well understood nor easily characterized. Scientific discoveries cannot be driven by timetables like the upcoming Presidentialelection is.
To address these risks, the following questions must be answered:
1. Will there be safety issues not revealed in early clinical trials?
2. Will the vaccines be sufficiently effective to stop COVID-19’s spread?
3. Will the American people have enough confidence to get vaccinated?
4. Will there be sufficient quantities of vaccines available, and who gets priority?
5. If multiple vaccines are approved, how will people know which one to get?
6. Will political pressure influence the approval process?
Safety
Time pressure to complete the trials raises concerns that safety issues may appear only after millions of people have been vaccinated. Moncef Slaoui, head of Operation Warp Speed’s vaccine development arm, has said there is a “very, very low chance” of a vaccine being approved by election day, and that he will resign if he feels pressure to approve an unsafe vaccine.
On Sept. 9, clinical trials for AstraZeneca’s leading vaccine candidate were halted after a patient developed neurological symptoms, illustrating the care that must be taken in testing new vaccines. (Those trials have since resumed after a careful clinical review.) Learning of safety issues after millions of healthy people have been vaccinated would be devastating to the nation’s health and public confidence.
Effectiveness
The Food and Drug Administration (FDA) has set the minimum threshold for a vaccine’s effectiveness at 50%, essentially the same bar as flu vaccines, but influenza has a far lower risk of death than COVID-19 does. With 50% effectiveness, will the public feel sufficiently confident to resume their normal lives—working in crowded spaces, attending concerts or sporting events, going into crowded bars and restaurants, or taking long airplane flights? Hopefully, pharmaceutical makers will be able to develop a vaccine with substantially more than 50% effectiveness.
Public confidence
A Sept. 10 Kaiser Family Foundation poll found that 54% of Americans would not want to receive a vaccine approved prior to election day on Nov. 3. Meanwhile, anti-vaccine activists are using COVID-19 to stoke fears about the safety of all vaccines. Thus, it is essential to build public confidence in the vaccine’s safety and effectiveness, so more people will volunteer to get vaccinated.
Availability
Once approved, a vaccine is unlikely to be widely available for several months. Health care workers should have priority access. After that, how will priorities be established to determine who gets the vaccine? Priorities should be based on risk stratification, with more immediate access given to vulnerable populations such as the elderly, people with diabetes and obesity, or people in high-risk occupations.
Determining which one to get
With major pharmaceutical companies spending billions of dollars to create an effective vaccine, several candidates will eventually be approved by the FDA, each with its own scientific approach and level of effectiveness. The first vaccine will get the publicity, but will it be the most effective? Consumers will need sufficient information to decide which vaccine to receive, and they should get that information from their physicians, not pharmaceutical ads on television or word of mouth.
Political intervention
There are growing concerns about politics entering into FDA decisions, especially if approval or an emergency use authorization (EUA) is granted prior to the Nov. 3 election. The aforementioned Kaiser poll found that 61% of Americans are worried the FDA will rush to approve a vaccine due to political pressure.
These concerns are heightened by the FDA’s premature EUA of hydroxychloroquine prior to testing last spring, an approval the FDA later withdrew. Additionally, a recent National Institutes of Health panel criticized the FDA for its EUA of convalescent plasma without having performed randomized tests. For such an important health care decision, political pressure has no place in the vaccine approval process.
A plan to win the public’s confidence
The COVID-19 crisis will not end until we have one or more safe, effective, and widely available vaccines. Regulators and health care leaders, backed up by political leaders, must take the lead in building public confidence in the integrity of the entire vaccine development and distribution process.
The pharmaceutical industry and public health officials must emphasize safety first. On Sept. 8, nine leading pharmaceutical companies signed a pledge to “only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of … the FDA.” This pledge was signed by the CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi.
A safe and effective vaccine holds the key to stopping the spread of COVID-19 and fully restarting the economy. When a vaccine is ultimately approved, the public must be able to rely on public health officials and physicians who have carefully reviewed clinical trial data. In order to build public confidence, health care leaders—independent from politicians—must step up to the challenge of ensuring COVID-19 vaccines are safe, effective, and available to those most in need first.
Bill George is senior fellow at Harvard Business School and former chair and CEO of Medtronic. He is the author of Discover Your True North.