中國(guó)主要疫苗制造企業(yè)之一的科興生物(Sinovac)于12月8日發(fā)表聲明稱(chēng),,對(duì)于其印度尼西亞合作商早前“科興疫苗在三期臨床試驗(yàn)中有效性達(dá)97%”的說(shuō)法,科興予以否認(rèn),,并表示其疫苗的具體有效性如何還有待確定,。
科興合作企業(yè)、印尼國(guó)有疫苗生產(chǎn)商Bio Farma此前報(bào)告稱(chēng),,科興新冠疫苗在三期臨床試驗(yàn)中有效性高達(dá)97%,。Bio Farma公司發(fā)言人伊萬(wàn)?塞蒂亞萬(wàn)于12月8日說(shuō):“我們的臨床試驗(yàn)團(tuán)隊(duì)發(fā)現(xiàn),在一個(gè)月的時(shí)間內(nèi),,疫苗有效性的中期數(shù)據(jù)達(dá)到了97%,?!?/p>
但是,科興方面向彭博社透露的說(shuō)法是,,97%這一數(shù)字并不指向疫苗的有效性,,而僅代表疫苗的血清轉(zhuǎn)化率。血清轉(zhuǎn)化率體現(xiàn)疫苗“生產(chǎn)”新冠病毒抗體的能力,,“血清轉(zhuǎn)化率為97%”,,意味著在疫苗受試志愿者中有97%的人體內(nèi)產(chǎn)生了新冠病毒抗體,不足以證明科興疫苗能預(yù)防新冠病毒,。
對(duì)此,,科興并未立即回應(yīng)《財(cái)富》的置評(píng)請(qǐng)求。
97%——這一數(shù)字是目前披露的各家新冠疫苗臨床試驗(yàn)數(shù)據(jù)中的最好成績(jī):在美國(guó)進(jìn)行的三期試驗(yàn)中,,輝瑞(Pfizer)和Moderna報(bào)告的疫苗有效性分別為94%和95%,。
但很遺憾,這一數(shù)字的可信度存疑,。Bio Farma公司得出疫苗效果數(shù)據(jù)之前,,僅對(duì)1600名左右的參與者進(jìn)行了試驗(yàn),樣本顯然過(guò)少,,而且試驗(yàn)的時(shí)間線也拉得不夠長(zhǎng),。
輝瑞與其合作商德國(guó)制藥公司BioNTech于11月時(shí)宣布,其候選疫苗通過(guò)了三期試驗(yàn)——從7月到11月,,受試者達(dá)到了43000人,,最終報(bào)告了94%的有效率。Moderna公司的疫苗試驗(yàn)也于7月開(kāi)始投入三期試驗(yàn),,有30000名受試者參與其中,。
12月8日,Bio Farma公司發(fā)言人表示,,科興疫苗三期試驗(yàn)的最終結(jié)果預(yù)計(jì)將于2021年1月公布,。
科興疫苗的三期試驗(yàn)結(jié)果可謂備受期待。與輝瑞和Moderna的候選疫苗相比,,科興的疫苗不需要價(jià)格高昂的冷鏈運(yùn)輸需求,,因此對(duì)于資金預(yù)算有限的中低收入國(guó)家來(lái)說(shuō),科興或許是更切實(shí)可行的選擇,。比起對(duì)儲(chǔ)運(yùn)條件要求嚴(yán)苛的疫苗來(lái)說(shuō),,省去極端冷鏈這一環(huán)節(jié)意味著疫苗可以更快更廣地分發(fā)至全球,因此科興也將成為“迅速終結(jié)”新冠疫情的關(guān)鍵,。
12月7日,,印度尼西亞總統(tǒng)佐科?維多多稱(chēng),印尼已經(jīng)購(gòu)置了120萬(wàn)劑科興公司的候選疫苗CoronaVac,,以為明年年初的疫苗分發(fā)作準(zhǔn)備,。此外,,印尼還計(jì)劃于明年1月份續(xù)購(gòu)180萬(wàn)劑CoronaVac疫苗,并采購(gòu)原材料以供Bio Farma公司投入另外4500萬(wàn)劑候選疫苗的生產(chǎn),。
12月7日,,科興獲得中國(guó)生物制藥5.15億美元的投資??婆d表示,,新注入的資金流將助益其實(shí)現(xiàn)產(chǎn)能翻倍,達(dá)到每年生產(chǎn)超6億劑CoronaVac的能力,。
巴西,、土耳其以及智利政府也已批準(zhǔn)科興疫苗的三期臨床試驗(yàn),其中巴西的試驗(yàn)在7月份就已開(kāi)始,,13000名受試者參與其中,,現(xiàn)在已經(jīng)進(jìn)入了收尾階段。觀察人士認(rèn)為科興或?qū)⒃诮酉聛?lái)的幾天內(nèi)就公布中期數(shù)據(jù),。(財(cái)富中文網(wǎng))
編譯:楊二一
中國(guó)主要疫苗制造企業(yè)之一的科興生物(Sinovac)于12月8日發(fā)表聲明稱(chēng),,對(duì)于其印度尼西亞合作商早前“科興疫苗在三期臨床試驗(yàn)中有效性達(dá)97%”的說(shuō)法,科興予以否認(rèn),,并表示其疫苗的具體有效性如何還有待確定,。
科興合作企業(yè),、印尼國(guó)有疫苗生產(chǎn)商Bio Farma此前報(bào)告稱(chēng),,科興新冠疫苗在三期臨床試驗(yàn)中有效性高達(dá)97%。Bio Farma公司發(fā)言人伊萬(wàn)?塞蒂亞萬(wàn)于12月8日說(shuō):“我們的臨床試驗(yàn)團(tuán)隊(duì)發(fā)現(xiàn),,在一個(gè)月的時(shí)間內(nèi),,疫苗有效性的中期數(shù)據(jù)達(dá)到了97%?!?/p>
但是,,科興方面向彭博社透露的說(shuō)法是,97%這一數(shù)字并不指向疫苗的有效性,,而僅代表疫苗的血清轉(zhuǎn)化率,。血清轉(zhuǎn)化率體現(xiàn)疫苗“生產(chǎn)”新冠病毒抗體的能力,“血清轉(zhuǎn)化率為97%”,,意味著在疫苗受試志愿者中有97%的人體內(nèi)產(chǎn)生了新冠病毒抗體,,不足以證明科興疫苗能預(yù)防新冠病毒。
對(duì)此,,科興并未立即回應(yīng)《財(cái)富》的置評(píng)請(qǐng)求,。
97%——這一數(shù)字是目前披露的各家新冠疫苗臨床試驗(yàn)數(shù)據(jù)中的最好成績(jī):在美國(guó)進(jìn)行的三期試驗(yàn)中,輝瑞(Pfizer)和Moderna報(bào)告的疫苗有效性分別為94%和95%,。
但很遺憾,,這一數(shù)字的可信度存疑,。Bio Farma公司得出疫苗效果數(shù)據(jù)之前,僅對(duì)1600名左右的參與者進(jìn)行了試驗(yàn),,樣本顯然過(guò)少,,而且試驗(yàn)的時(shí)間線也拉得不夠長(zhǎng)。
輝瑞與其合作商德國(guó)制藥公司BioNTech于11月時(shí)宣布,,其候選疫苗通過(guò)了三期試驗(yàn)——從7月到11月,,受試者達(dá)到了43000人,最終報(bào)告了94%的有效率,。Moderna公司的疫苗試驗(yàn)也于7月開(kāi)始投入三期試驗(yàn),,有30000名受試者參與其中。
12月8日,,Bio Farma公司發(fā)言人表示,,科興疫苗三期試驗(yàn)的最終結(jié)果預(yù)計(jì)將于2021年1月公布。
科興疫苗的三期試驗(yàn)結(jié)果可謂備受期待,。與輝瑞和Moderna的候選疫苗相比,,科興的疫苗不需要價(jià)格高昂的冷鏈運(yùn)輸需求,因此對(duì)于資金預(yù)算有限的中低收入國(guó)家來(lái)說(shuō),,科興或許是更切實(shí)可行的選擇,。比起對(duì)儲(chǔ)運(yùn)條件要求嚴(yán)苛的疫苗來(lái)說(shuō),省去極端冷鏈這一環(huán)節(jié)意味著疫苗可以更快更廣地分發(fā)至全球,,因此科興也將成為“迅速終結(jié)”新冠疫情的關(guān)鍵,。
12月7日,印度尼西亞總統(tǒng)佐科?維多多稱(chēng),,印尼已經(jīng)購(gòu)置了120萬(wàn)劑科興公司的候選疫苗CoronaVac,,以為明年年初的疫苗分發(fā)作準(zhǔn)備。此外,,印尼還計(jì)劃于明年1月份續(xù)購(gòu)180萬(wàn)劑CoronaVac疫苗,,并采購(gòu)原材料以供Bio Farma公司投入另外4500萬(wàn)劑候選疫苗的生產(chǎn)。
12月7日,,科興獲得中國(guó)生物制藥5.15億美元的投資,。科興表示,,新注入的資金流將助益其實(shí)現(xiàn)產(chǎn)能翻倍,,達(dá)到每年生產(chǎn)超6億劑CoronaVac的能力。
巴西,、土耳其以及智利政府也已批準(zhǔn)科興疫苗的三期臨床試驗(yàn),,其中巴西的試驗(yàn)在7月份就已開(kāi)始,13000名受試者參與其中,現(xiàn)在已經(jīng)進(jìn)入了收尾階段,。觀察人士認(rèn)為科興或?qū)⒃诮酉聛?lái)的幾天內(nèi)就公布中期數(shù)據(jù),。(財(cái)富中文網(wǎng))
編譯:楊二一
On Tuesday, Sinovac, one of China’s leading vaccine makers, said it needs more time to determine the effectiveness of its COVID-19 vaccine, refuting earlier claims from its partner in Indonesia that its vaccine proved 97% effective in ongoing Phase III clinical trials.
Bio Farma, the state-owned vaccine maker and Sinovac’s partner in Indonesia, reported that Sinovac’s COVID-19 candidate is up to 97% effective in Phase III clinical trials. “Our clinical trial team found, within one month, that the interim data shows up to 97% for its efficacy,” Iwan Setiawan, a spokesman for Bio Farma, said on Tuesday.
But Sinovac clarified to Bloomberg that the 97% figure does not refer to the vaccine’s efficacy, saying it instead represented the vaccine’s seroconversion rate. The seroconversion rate detects whether the vaccine produces COVID-19 antibodies—meaning the vaccine triggered antibodies in 97% of trial volunteers who received it—but doesn’t necessarily prove that the vaccine protects against COVID-19.
Sinovac did not immediately return Fortune’s request for comment.
Ninety-seven percent efficacy would be the best clinical trial data reported from any vaccine maker thus far: U.S.-based firms Pfizer and Moderna reported efficacy rates of 94% and 95%, respectively, in Phase III trials in the U.S.
But Bio Farma drew its conclusion about Sinovac’s efficacy from a smaller pool of participants, some 1,600, and in a shorter time frame.
Pfizer, which codeveloped its candidate with Germany’s BioNTech, reported in November that it drew its 94% efficacy figure from a 43,000-participant Phase III trial that began in July. Moderna’s Phase III trial also started that month and included 30,000 volunteers.
A spokesperson for Bio Farma said on Tuesday that full results from Sinovac’s Phase III trial are expected to arrive in January 2021.
Sinovac’s Phase III trial results have been highly anticipated because its vaccine does not require the expensive cold-chain networks that are needed for Pfizer’s and Moderna’s candidates, making it a more viable option for lower- and middle-income countries with fewer resources. Such a vaccine is key to bringing the pandemic to a swift end since it can be more widely distributed than doses with finicky storage requirements.
On Monday, Indonesian President Joko Widodo said that Indonesia received 1.2 million doses of Sinovac’s vaccine candidate, called CoronaVac, in preparation for potentially distributing the vaccine in Indonesia early next year. Indonesia is also set to receive another 1.8 million CoronaVac doses in January along with raw material supplies for Bio Farma to produce 45 million more doses of the candidate.
On Monday, Sinovac received a $515 million investment from Beijing drugmaker Sino Biopharm. Sinovac said the new stream of funding would help the company double its manufacturing capacity to produce over 600 million doses of CoronaVac per year.
Authorities in Brazil, Turkey, and Chile have also approved Sinovac’s Phase III clinical trials. In Brazil, Sinovac’s Phase III trial has reached an advanced stage; it started in July and includes 13,000 individuals. Observers believe that the company may release interim results on the trials in coming days.