終于,Moderna成為了聚光燈下的焦點(diǎn)。
Moderna公布了該公司的新冠候選疫苗在III期臨床試驗(yàn)階段的第一個(gè)中期分析數(shù)據(jù),該疫苗的有效率達(dá)94.5%。
美國新冠肺炎確診病例的爆炸性增長為藥企提供了充足的試驗(yàn)樣本,上周早些時(shí)候,輝瑞的疫苗試驗(yàn)結(jié)果正式出爐,而Moderna也將迎頭趕上。該公司于11月11日表示,其研究現(xiàn)已積累了超過53個(gè)感染病例,接種有效性初步分析即將正式啟動(dòng)。受此消息影響,該公司股價(jià)大幅飆升。
Moderna表示可在幾天內(nèi)將數(shù)據(jù)提交給獨(dú)立監(jiān)督委員會(huì),但并未對委員會(huì)完成分析的時(shí)間進(jìn)行預(yù)測。目前數(shù)據(jù)并未揭盲,也就是說該公司并不知道哪些人接種了疫苗,哪些人接種了安慰劑。
Moderna公司發(fā)布聲明稱:“過去一周,各地確診數(shù)量顯著上升。因此,我們預(yù)計(jì),首份中期分析中收錄的個(gè)案數(shù)量將遠(yuǎn)超啟動(dòng)該分析的目標(biāo)觸發(fā)點(diǎn),即53例?!?/p>
Moderna表示初步研究數(shù)據(jù)正在準(zhǔn)備之中,很快將會(huì)提交監(jiān)督委員會(huì)。由該委員會(huì)負(fù)責(zé)判斷疫苗是否有效、試驗(yàn)結(jié)果是否具有決定性、試驗(yàn)是否應(yīng)該繼續(xù)。
業(yè)內(nèi)頂級專家普遍認(rèn)為,由于Moderna采用了與輝瑞相似的mRNA技術(shù),很可能會(huì)取得與輝瑞相似的優(yōu)異效果。輝瑞于上周早些時(shí)候宣布,其疫苗有效性可達(dá)90%以上。
賓夕法尼亞大學(xué)免疫學(xué)家、mRNA專家德魯?魏斯曼說:“總體而言,我認(rèn)為Moderna的試驗(yàn)可以取得(與輝瑞)類似的結(jié)果?!眒RNA疫苗均采用了魏斯曼協(xié)助開發(fā)的關(guān)鍵修飾。
魏斯曼表示:“很難想象兩者的試驗(yàn)結(jié)果能夠有多大差別?!蔽核孤I(lǐng)導(dǎo)的實(shí)驗(yàn)室從BioNTech SE處獲取研究資金,而后者則是輝瑞的疫苗開發(fā)合作伙伴。
對照試驗(yàn)
在疫苗試驗(yàn)中,只有當(dāng)接種安慰劑的志愿者中出現(xiàn)特定比例的感染病例才可以說明疫苗確實(shí)能夠發(fā)揮作用。美國新冠肺炎日增病例連創(chuàng)新高,無疑大大降低了實(shí)現(xiàn)這一目標(biāo)的難度。
最近幾周,輝瑞公司捷報(bào)頻傳,試驗(yàn)結(jié)果迅速超過了揭盲所需達(dá)到的門檻要求?,F(xiàn)在,Moderna的中期分析也可能會(huì)于數(shù)日內(nèi)發(fā)布。
試驗(yàn)結(jié)束前誰也無法保證會(huì)取得怎樣的結(jié)果,但無論如何,最后發(fā)布的結(jié)果肯定會(huì)對Moderna的股價(jià)產(chǎn)生重大影響,今年以來,Moderna股價(jià)如同坐上火箭一般暴漲超300%。11月12日,截至紐交所收盤時(shí)Moderna股票收漲8.4%,報(bào)82.44美元。(財(cái)富中文網(wǎng))
譯者:梁宇
審校:夏林
終于,Moderna成為了聚光燈下的焦點(diǎn)。
Moderna公布了該公司的新冠候選疫苗在III期臨床試驗(yàn)階段的第一個(gè)中期分析數(shù)據(jù),該疫苗的有效率達(dá)94.5%。
美國新冠肺炎確診病例的爆炸性增長為藥企提供了充足的試驗(yàn)樣本,上周早些時(shí)候,輝瑞的疫苗試驗(yàn)結(jié)果正式出爐,而Moderna也將迎頭趕上。該公司于11月11日表示,其研究現(xiàn)已積累了超過53個(gè)感染病例,接種有效性初步分析即將正式啟動(dòng)。受此消息影響,該公司股價(jià)大幅飆升。
Moderna表示可在幾天內(nèi)將數(shù)據(jù)提交給獨(dú)立監(jiān)督委員會(huì),但并未對委員會(huì)完成分析的時(shí)間進(jìn)行預(yù)測。目前數(shù)據(jù)并未揭盲,也就是說該公司并不知道哪些人接種了疫苗,哪些人接種了安慰劑。
Moderna公司發(fā)布聲明稱:“過去一周,各地確診數(shù)量顯著上升。因此,我們預(yù)計(jì),首份中期分析中收錄的個(gè)案數(shù)量將遠(yuǎn)超啟動(dòng)該分析的目標(biāo)觸發(fā)點(diǎn),即53例?!?/p>
Moderna表示初步研究數(shù)據(jù)正在準(zhǔn)備之中,很快將會(huì)提交監(jiān)督委員會(huì)。由該委員會(huì)負(fù)責(zé)判斷疫苗是否有效、試驗(yàn)結(jié)果是否具有決定性、試驗(yàn)是否應(yīng)該繼續(xù)。
業(yè)內(nèi)頂級專家普遍認(rèn)為,由于Moderna采用了與輝瑞相似的mRNA技術(shù),很可能會(huì)取得與輝瑞相似的優(yōu)異效果。輝瑞于上周早些時(shí)候宣布,其疫苗有效性可達(dá)90%以上。
賓夕法尼亞大學(xué)免疫學(xué)家、mRNA專家德魯?魏斯曼說:“總體而言,我認(rèn)為Moderna的試驗(yàn)可以取得(與輝瑞)類似的結(jié)果?!眒RNA疫苗均采用了魏斯曼協(xié)助開發(fā)的關(guān)鍵修飾。
魏斯曼表示:“很難想象兩者的試驗(yàn)結(jié)果能夠有多大差別?!蔽核孤I(lǐng)導(dǎo)的實(shí)驗(yàn)室從BioNTech SE處獲取研究資金,而后者則是輝瑞的疫苗開發(fā)合作伙伴。
對照試驗(yàn)
在疫苗試驗(yàn)中,只有當(dāng)接種安慰劑的志愿者中出現(xiàn)特定比例的感染病例才可以說明疫苗確實(shí)能夠發(fā)揮作用。美國新冠肺炎日增病例連創(chuàng)新高,無疑大大降低了實(shí)現(xiàn)這一目標(biāo)的難度。
最近幾周,輝瑞公司捷報(bào)頻傳,試驗(yàn)結(jié)果迅速超過了揭盲所需達(dá)到的門檻要求。現(xiàn)在,Moderna的中期分析也可能會(huì)于數(shù)日內(nèi)發(fā)布。
試驗(yàn)結(jié)束前誰也無法保證會(huì)取得怎樣的結(jié)果,但無論如何,最后發(fā)布的結(jié)果肯定會(huì)對Moderna的股價(jià)產(chǎn)生重大影響,今年以來,Moderna股價(jià)如同坐上火箭一般暴漲超300%。11月12日,截至紐交所收盤時(shí)Moderna股票收漲8.4%,報(bào)82.44美元。(財(cái)富中文網(wǎng))
譯者:梁宇
審校:夏林
Now it’s Moderna Inc.’s time to be in the spotlight.
The same U.S. explosion of Covid-19 cases that helped Pfizer Inc. get results for its vaccine trial earlier last week is helping speed along Moderna’s trial. Moderna said November 11 its study has accumulated more than 53 infections, allowing a preliminary analysis of the shot’s effectiveness to begin. The shares jumped.
Moderna didn’t predict how long it could take an independent monitoring committee to analyze the data, but said the company could get the data to the committee within days. The company said it is still blinded to the data.
“Moderna has seen a significant increase in the rate of case identification across sites in the last week,” the company said in a statement. “As a result, the company expects the first interim analysis will include substantially more than 53 cases, the targeted trigger point for the analysis.”
The preliminary data on Moderna’s study is being prepared for submission to the monitoring board, Moderna said. The board will say whether the vaccine is effective, doesn’t work, or that the trial should continue because the results are inconclusive.
The bet among top experts in the field is that Moderna’s therapy, which uses a similar mRNA technology to Pfizer’s, will likely prove to be highly effective, perhaps mirroring Pfizer’s announcement earlier last week that its shot appears to be more than 90% effective.
“Overall I would expect similar results” in Moderna’s trial, said Drew Weissman, an immunologist and mRNA expert at the University of Pennsylvania who helped develop key modifications used in mRNA vaccines.
“It is hard to imagine how it would be much different,” according to Weissman, whose lab receives research funding from BioNTech SE, the company partnering with Pfizer on its vaccine.
Certain Numbers
In vaccine trials, a certain number of volunteers—a percentage of which get a placebo—have to get infected in order to determine if the vaccine works. That’s easier to accomplish with the pandemic in the U.S. hitting record infections on a daily basis.
Pfizer got a burst of results in recent weeks that pushed that trial over the line to take a first look. Now Moderna’s interim analysis could come within days.
Whatever happens in the trial—and there are no guarantees until it is done—the results are certain to have a big impact on Moderna shares, which are up more than 300% this year in a wild roller-coaster ride. The stock closed up 8.4% in New York trading at $82.44 on Novemebr 12.