最近幾周,包括輝瑞、Moderna和阿斯利康在內(nèi)的多家疫苗生產(chǎn)商發(fā)布了令人滿意的三期試驗(yàn)數(shù)據(jù),全球新冠疫情危機(jī)有望終結(jié)。
本月初,英國(guó)對(duì)輝瑞的新冠疫苗給予緊急使用授權(quán),向一線醫(yī)護(hù)工作者等高危人群提供分配疫苗,成為首個(gè)批準(zhǔn)新冠疫苗的西方國(guó)家;歐盟于當(dāng)?shù)貢r(shí)間9日公布了新冠疫苗批準(zhǔn)時(shí)間表;美國(guó)疾病控制和預(yù)防中心(CDC)主任羅伯特?雷德菲爾德也于當(dāng)?shù)貢r(shí)間12月13日,正式批準(zhǔn)了輝瑞公司的新冠疫苗,允許16歲及以上的人群接種。各國(guó)紛紛為疫苗生產(chǎn)商開綠燈,批準(zhǔn)分發(fā)新冠疫苗。
但在新冠疫苗最新進(jìn)展釋放樂觀信號(hào)的同時(shí),專家們對(duì)輝瑞和Moderna新冠疫苗的使用方便性(昂貴的冷鏈運(yùn)輸成本),以及英國(guó)疫苗生產(chǎn)商阿斯利康提供的數(shù)據(jù)質(zhì)量表現(xiàn)出了擔(dān)憂。
與此同時(shí),作為中國(guó)國(guó)內(nèi)領(lǐng)先的疫苗生產(chǎn)商,民營(yíng)藥企科興和國(guó)企國(guó)藥集團(tuán)似乎也將在未來幾周內(nèi)推出不需要昂貴冷鏈運(yùn)輸?shù)男鹿谝呙纭?/p>
在這場(chǎng)全球新冠疫苗競(jìng)賽中,西方疫苗生產(chǎn)商似乎處于領(lǐng)先地位,但中國(guó)疫苗生產(chǎn)商或有助于填補(bǔ)疫苗供應(yīng)的缺口。
數(shù)據(jù)有限
11月中旬,輝瑞和Moderna公布了各自實(shí)驗(yàn)性疫苗的初步試驗(yàn)結(jié)果。數(shù)據(jù)顯示,實(shí)驗(yàn)性疫苗在預(yù)防新冠病毒方面的有效性達(dá)到90%以上。FDA曾表示,疫苗有效性至少要達(dá)到50%才能獲批上市,因此,這一結(jié)果遠(yuǎn)超預(yù)期。
盡管如此,輝瑞和Moderna基于新開發(fā)的mRNA技術(shù)研制出來的新冠疫苗,要求運(yùn)輸和儲(chǔ)存溫度保持在零度以下。嚴(yán)苛的溫度條件拉高了獲取疫苗的門檻,因?yàn)橹械褪杖雵?guó)家需要先具備冷藏基礎(chǔ)設(shè)施,才能分發(fā)這些疫苗。
以印度尼西亞為例。當(dāng)?shù)貒?guó)有疫苗生產(chǎn)商Bio Farma表示,作為世界第四人口大國(guó),由于疫苗分銷物流方面存在困難,印尼實(shí)際上無法采購(gòu)輝瑞研制的新冠疫苗。
11月22日,Bio Farma負(fù)責(zé)人霍尼斯蒂?巴西耶爾在接受印尼新聞媒體《雅加達(dá)環(huán)球報(bào)》采訪時(shí)表示:“印尼不具備這樣的冷鏈能力,疫苗儲(chǔ)存溫度不當(dāng)會(huì)影響其有效性?!庇《鹊囊呙绶峙淅滏溣?8000個(gè)冷藏箱,這些冷藏箱只能滿足2至8℃的疫苗冷藏條件。
輝瑞的新冠疫苗最初由德國(guó)BioNTech公司研制,零下70℃(零下94華氏度)的儲(chǔ)運(yùn)溫度要求比南極冬季的平均溫度還要低。
Moderna新冠疫苗需要保持在零下20℃(零下4華氏度),大致相當(dāng)于家用冰箱的溫度環(huán)境。
輝瑞針對(duì)新冠疫苗制造了專用容器,該容器可將疫苗在零下70℃溫度條件下保存長(zhǎng)達(dá)10天。除此之外,想要將疫苗冷藏更長(zhǎng)時(shí)間,需要機(jī)場(chǎng)冷藏庫(kù)、冷藏車以及現(xiàn)場(chǎng)冷凍箱構(gòu)成一個(gè)疫苗冷藏物流網(wǎng),而這樣做的成本可能高達(dá)1萬美元。
幾周后,英國(guó)制藥公司阿斯利康宣布,其研制的新冠疫苗三期有效性試驗(yàn)結(jié)果最高可達(dá)90%。至此,新冠疫苗冷鏈引發(fā)的擔(dān)憂得到部分緩解。
阿斯利康研制的腺病毒載體新冠疫苗,通過減毒的活病毒感染細(xì)胞來誘導(dǎo)免疫反應(yīng),只需要2到8℃(36至47華氏度)的儲(chǔ)運(yùn)溫度,大致相當(dāng)于家用冰箱的溫度環(huán)境,這就使得分發(fā)疫苗變得更加容易。
但就在阿斯利康發(fā)布聲明后的幾天里,專家對(duì)阿斯利康疫苗數(shù)據(jù)的“透明度和嚴(yán)密性”提出了質(zhì)疑。
科學(xué)家質(zhì)疑,為什么最有效的結(jié)果來自于一個(gè)有明顯接種劑量錯(cuò)誤的試驗(yàn)組?來自多個(gè)國(guó)家的數(shù)據(jù)集是如何被合并、制表,得出的最終結(jié)果?
對(duì)此,阿斯利康的一位發(fā)言人表示,該公司的疫苗試驗(yàn)按照“最高標(biāo)準(zhǔn)”進(jìn)行。盡管如此,在對(duì)其試驗(yàn)數(shù)據(jù)的質(zhì)疑中,阿斯利康首席執(zhí)行官蘇博科承諾,公司將開展另一項(xiàng)研究來驗(yàn)證試驗(yàn)結(jié)果。
美國(guó)外交關(guān)系協(xié)會(huì)全球衛(wèi)生高級(jí)研究員黃延忠表示,阿斯利康新冠疫苗面臨的困境,以及輝瑞和Moderna疫苗潛在的分銷局限性,給全球疫苗供應(yīng)中留下了一個(gè)缺口,而這個(gè)缺口可能會(huì)由中國(guó)疫苗生產(chǎn)商來填補(bǔ)。
目前,中國(guó)疫苗生產(chǎn)商科興和國(guó)藥的三款疫苗處于三期試驗(yàn)階段,這些疫苗的儲(chǔ)運(yùn)無冷鏈要求。科興的新冠滅活疫苗CoronaVac可觸發(fā)免疫反應(yīng),國(guó)藥的兩款未命名新冠疫苗也基于類似技術(shù)。
黃延忠表示,中國(guó)的媒體稱,科興和國(guó)藥的新冠疫苗“對(duì)中低收入國(guó)家,尤其是那些無力負(fù)擔(dān)或沒有能力維持冷鏈配送疫苗的國(guó)家,有一定吸引力”。
與基于mRNA技術(shù)的新冠疫苗相比,科興和國(guó)藥的新冠滅活疫苗更加穩(wěn)定,這就意味著這些疫苗對(duì)低溫儲(chǔ)運(yùn)的要求沒有那么高。
與阿斯利康的新冠疫苗類似,科興稱其疫苗可以在2到8℃的溫度下儲(chǔ)存和運(yùn)輸。中國(guó)媒體報(bào)道稱,國(guó)藥的新冠疫苗或可在類似的2到8℃溫度條件下加以儲(chǔ)存。國(guó)藥方面拒絕了《財(cái)富》雜志方面的確認(rèn)請(qǐng)求。
科興和國(guó)藥
科興和國(guó)藥近期都表示,新冠疫苗的研發(fā)已接近尾聲。
科興目前正在巴西和印尼進(jìn)行大規(guī)模臨床試驗(yàn)。據(jù)報(bào)道,在印尼有超過1600名志愿者參與了疫苗試驗(yàn),未出現(xiàn)一例嚴(yán)重副作用患者。巴西方面,巴西圣保羅州長(zhǎng)若昂?多利亞確認(rèn)將于12月23日提交科興新冠疫苗的數(shù)據(jù),他曾于月初表示,計(jì)劃明年1月開始分發(fā)CoronaVac疫苗。國(guó)際權(quán)威醫(yī)學(xué)雜志《柳葉刀》表示,科興公司的疫苗產(chǎn)品,可以讓超過90%的接種者體內(nèi)產(chǎn)生病毒抗體??婆d并未回應(yīng)《財(cái)富》雜志對(duì)其試驗(yàn)數(shù)據(jù)的置評(píng)請(qǐng)求。
11月中旬科興公布的二期試驗(yàn)結(jié)果顯示,CoronaVac能夠誘導(dǎo)免疫反應(yīng),預(yù)防新冠病毒感染。然而,研究人員指出,輝瑞和Moderna的疫苗在誘導(dǎo)免疫反應(yīng)方面的表現(xiàn)更加優(yōu)秀。
與此同時(shí),11月25日,國(guó)藥已向國(guó)家藥監(jiān)局提交了新冠疫苗上市申請(qǐng)。國(guó)藥的一位高管在接受新華社采訪時(shí),沒有具體說明該公司預(yù)計(jì)何時(shí)會(huì)收到申請(qǐng)回應(yīng)。
國(guó)藥尚未向公眾公布其三期試驗(yàn)的任何數(shù)據(jù),但國(guó)藥方面表示已根據(jù)國(guó)家緊急使用計(jì)劃向近100萬人分發(fā)了疫苗。
黃延忠表示,在這兩家藥企的新冠疫苗中,科興的CoronaVac可能是中國(guó)“最有前景的”疫苗,其獲得批準(zhǔn)并在全球范圍內(nèi)分銷的可能性最高,原因在于科興公布的數(shù)據(jù)更多。
巴西、土耳其和印度尼西亞當(dāng)局已經(jīng)與科興達(dá)成協(xié)議,一旦三期試驗(yàn)開展順利,他們將采購(gòu)數(shù)千萬劑CoronaVac疫苗。
此前,美國(guó)駐中南美洲最高指揮官、海軍上將克雷格?富勒在接受記者采訪時(shí)表示,美國(guó)還在專注于“優(yōu)先處理美國(guó)本土”,而中國(guó)已經(jīng)準(zhǔn)備在全球范圍內(nèi)部署疫苗。
但國(guó)藥已經(jīng)在中國(guó)建立了成熟的疫苗分銷網(wǎng)絡(luò),不僅如此,與中國(guó)其他疫苗生產(chǎn)商相比,國(guó)藥的新冠疫苗正在更多的國(guó)家開展試驗(yàn),因此,國(guó)藥可能擁有更多的內(nèi)在優(yōu)勢(shì)。
香港城市大學(xué)疫苗專家、衛(wèi)生治理教授尼古拉斯?托馬斯表示:“國(guó)藥通過中國(guó)的緊急使用計(jì)劃的大規(guī)模部署,也意味著國(guó)藥已經(jīng)具備了一個(gè)經(jīng)過壓力測(cè)試的大型分銷系統(tǒng)。這是后續(xù)疫苗分配的一大優(yōu)勢(shì)。”
不僅如此,國(guó)藥也已經(jīng)通過阿聯(lián)酋的緊急使用計(jì)劃向該國(guó)分發(fā)疫苗,在埃及、約旦和阿根廷等至少10個(gè)國(guó)家進(jìn)行疫苗試驗(yàn)的計(jì)劃也正在進(jìn)行或規(guī)劃當(dāng)中。
研發(fā)沖刺是新一輪比賽的開始
隨著疫苗在越來越多的國(guó)家投入使用,全球新冠疫苗的研發(fā)已進(jìn)入沖刺階段。但這場(chǎng)競(jìng)賽的下半場(chǎng)才剛剛開始。
托馬斯表示,如果科興或國(guó)藥的疫苗上市,疫苗競(jìng)賽的下一個(gè)重大階段將會(huì)是各國(guó)選擇疫苗方面的分歧:選中國(guó)還是西方國(guó)家生產(chǎn)的新冠疫苗?
托馬斯稱:“如果公眾傾向于選擇其中的某家生產(chǎn)商,這將會(huì)帶來巨大的商業(yè)優(yōu)勢(shì)。全球?qū)用娴母?jìng)爭(zhēng)才剛剛開始?!保ㄘ?cái)富中文網(wǎng))
譯者:唐塵
最近幾周,包括輝瑞、Moderna和阿斯利康在內(nèi)的多家疫苗生產(chǎn)商發(fā)布了令人滿意的三期試驗(yàn)數(shù)據(jù),全球新冠疫情危機(jī)有望終結(jié)。
本月初,英國(guó)對(duì)輝瑞的新冠疫苗給予緊急使用授權(quán),向一線醫(yī)護(hù)工作者等高危人群提供分配疫苗,成為首個(gè)批準(zhǔn)新冠疫苗的西方國(guó)家;歐盟于當(dāng)?shù)貢r(shí)間9日公布了新冠疫苗批準(zhǔn)時(shí)間表;美國(guó)疾病控制和預(yù)防中心(CDC)主任羅伯特?雷德菲爾德也于當(dāng)?shù)貢r(shí)間12月13日,正式批準(zhǔn)了輝瑞公司的新冠疫苗,允許16歲及以上的人群接種。各國(guó)紛紛為疫苗生產(chǎn)商開綠燈,批準(zhǔn)分發(fā)新冠疫苗。
但在新冠疫苗最新進(jìn)展釋放樂觀信號(hào)的同時(shí),專家們對(duì)輝瑞和Moderna新冠疫苗的使用方便性(昂貴的冷鏈運(yùn)輸成本),以及英國(guó)疫苗生產(chǎn)商阿斯利康提供的數(shù)據(jù)質(zhì)量表現(xiàn)出了擔(dān)憂。
與此同時(shí),作為中國(guó)國(guó)內(nèi)領(lǐng)先的疫苗生產(chǎn)商,民營(yíng)藥企科興和國(guó)企國(guó)藥集團(tuán)似乎也將在未來幾周內(nèi)推出不需要昂貴冷鏈運(yùn)輸?shù)男鹿谝呙纭?/p>
在這場(chǎng)全球新冠疫苗競(jìng)賽中,西方疫苗生產(chǎn)商似乎處于領(lǐng)先地位,但中國(guó)疫苗生產(chǎn)商或有助于填補(bǔ)疫苗供應(yīng)的缺口。
數(shù)據(jù)有限
11月中旬,輝瑞和Moderna公布了各自實(shí)驗(yàn)性疫苗的初步試驗(yàn)結(jié)果。數(shù)據(jù)顯示,實(shí)驗(yàn)性疫苗在預(yù)防新冠病毒方面的有效性達(dá)到90%以上。FDA曾表示,疫苗有效性至少要達(dá)到50%才能獲批上市,因此,這一結(jié)果遠(yuǎn)超預(yù)期。
盡管如此,輝瑞和Moderna基于新開發(fā)的mRNA技術(shù)研制出來的新冠疫苗,要求運(yùn)輸和儲(chǔ)存溫度保持在零度以下。嚴(yán)苛的溫度條件拉高了獲取疫苗的門檻,因?yàn)橹械褪杖雵?guó)家需要先具備冷藏基礎(chǔ)設(shè)施,才能分發(fā)這些疫苗。
以印度尼西亞為例。當(dāng)?shù)貒?guó)有疫苗生產(chǎn)商Bio Farma表示,作為世界第四人口大國(guó),由于疫苗分銷物流方面存在困難,印尼實(shí)際上無法采購(gòu)輝瑞研制的新冠疫苗。
11月22日,Bio Farma負(fù)責(zé)人霍尼斯蒂?巴西耶爾在接受印尼新聞媒體《雅加達(dá)環(huán)球報(bào)》采訪時(shí)表示:“印尼不具備這樣的冷鏈能力,疫苗儲(chǔ)存溫度不當(dāng)會(huì)影響其有效性。”印度的疫苗分配冷鏈有28000個(gè)冷藏箱,這些冷藏箱只能滿足2至8℃的疫苗冷藏條件。
輝瑞的新冠疫苗最初由德國(guó)BioNTech公司研制,零下70℃(零下94華氏度)的儲(chǔ)運(yùn)溫度要求比南極冬季的平均溫度還要低。
Moderna新冠疫苗需要保持在零下20℃(零下4華氏度),大致相當(dāng)于家用冰箱的溫度環(huán)境。
輝瑞針對(duì)新冠疫苗制造了專用容器,該容器可將疫苗在零下70℃溫度條件下保存長(zhǎng)達(dá)10天。除此之外,想要將疫苗冷藏更長(zhǎng)時(shí)間,需要機(jī)場(chǎng)冷藏庫(kù)、冷藏車以及現(xiàn)場(chǎng)冷凍箱構(gòu)成一個(gè)疫苗冷藏物流網(wǎng),而這樣做的成本可能高達(dá)1萬美元。
2020年11月20日,巴爾的摩干冰工廠Capitol Carbonic的一名員工正在制造干冰顆粒。輝瑞和Moderna研制的新冠疫苗需要昂貴的儲(chǔ)運(yùn)冷鏈,一些國(guó)家因此無法獲取這些疫苗。
圖片版權(quán):SAUL LOEB—AFP/Getty Images
幾周后,英國(guó)制藥公司阿斯利康宣布,其研制的新冠疫苗三期有效性試驗(yàn)結(jié)果最高可達(dá)90%。至此,新冠疫苗冷鏈引發(fā)的擔(dān)憂得到部分緩解。
阿斯利康研制的腺病毒載體新冠疫苗,通過減毒的活病毒感染細(xì)胞來誘導(dǎo)免疫反應(yīng),只需要2到8℃(36至47華氏度)的儲(chǔ)運(yùn)溫度,大致相當(dāng)于家用冰箱的溫度環(huán)境,這就使得分發(fā)疫苗變得更加容易。
但就在阿斯利康發(fā)布聲明后的幾天里,專家對(duì)阿斯利康疫苗數(shù)據(jù)的“透明度和嚴(yán)密性”提出了質(zhì)疑。
科學(xué)家質(zhì)疑,為什么最有效的結(jié)果來自于一個(gè)有明顯接種劑量錯(cuò)誤的試驗(yàn)組?來自多個(gè)國(guó)家的數(shù)據(jù)集是如何被合并、制表,得出的最終結(jié)果?
對(duì)此,阿斯利康的一位發(fā)言人表示,該公司的疫苗試驗(yàn)按照“最高標(biāo)準(zhǔn)”進(jìn)行。盡管如此,在對(duì)其試驗(yàn)數(shù)據(jù)的質(zhì)疑中,阿斯利康首席執(zhí)行官蘇博科承諾,公司將開展另一項(xiàng)研究來驗(yàn)證試驗(yàn)結(jié)果。
美國(guó)外交關(guān)系協(xié)會(huì)全球衛(wèi)生高級(jí)研究員黃延忠表示,阿斯利康新冠疫苗面臨的困境,以及輝瑞和Moderna疫苗潛在的分銷局限性,給全球疫苗供應(yīng)中留下了一個(gè)缺口,而這個(gè)缺口可能會(huì)由中國(guó)疫苗生產(chǎn)商來填補(bǔ)。
目前,中國(guó)疫苗生產(chǎn)商科興和國(guó)藥的三款疫苗處于三期試驗(yàn)階段,這些疫苗的儲(chǔ)運(yùn)無冷鏈要求??婆d的新冠滅活疫苗CoronaVac可觸發(fā)免疫反應(yīng),國(guó)藥的兩款未命名新冠疫苗也基于類似技術(shù)。
黃延忠表示,中國(guó)的媒體稱,科興和國(guó)藥的新冠疫苗“對(duì)中低收入國(guó)家,尤其是那些無力負(fù)擔(dān)或沒有能力維持冷鏈配送疫苗的國(guó)家,有一定吸引力”。
與基于mRNA技術(shù)的新冠疫苗相比,科興和國(guó)藥的新冠滅活疫苗更加穩(wěn)定,這就意味著這些疫苗對(duì)低溫儲(chǔ)運(yùn)的要求沒有那么高。
與阿斯利康的新冠疫苗類似,科興稱其疫苗可以在2到8℃的溫度下儲(chǔ)存和運(yùn)輸。中國(guó)媒體報(bào)道稱,國(guó)藥的新冠疫苗或可在類似的2到8℃溫度條件下加以儲(chǔ)存。國(guó)藥方面拒絕了《財(cái)富》雜志方面的確認(rèn)請(qǐng)求。
科興和國(guó)藥
科興和國(guó)藥近期都表示,新冠疫苗的研發(fā)已接近尾聲。
科興目前正在巴西和印尼進(jìn)行大規(guī)模臨床試驗(yàn)。據(jù)報(bào)道,在印尼有超過1600名志愿者參與了疫苗試驗(yàn),未出現(xiàn)一例嚴(yán)重副作用患者。巴西方面,巴西圣保羅州長(zhǎng)若昂?多利亞確認(rèn)將于12月23日提交科興新冠疫苗的數(shù)據(jù),他曾于月初表示,計(jì)劃明年1月開始分發(fā)CoronaVac疫苗。國(guó)際權(quán)威醫(yī)學(xué)雜志《柳葉刀》表示,科興公司的疫苗產(chǎn)品,可以讓超過90%的接種者體內(nèi)產(chǎn)生病毒抗體。科興并未回應(yīng)《財(cái)富》雜志對(duì)其試驗(yàn)數(shù)據(jù)的置評(píng)請(qǐng)求。
11月中旬科興公布的二期試驗(yàn)結(jié)果顯示,CoronaVac能夠誘導(dǎo)免疫反應(yīng),預(yù)防新冠病毒感染。然而,研究人員指出,輝瑞和Moderna的疫苗在誘導(dǎo)免疫反應(yīng)方面的表現(xiàn)更加優(yōu)秀。
與此同時(shí),11月25日,國(guó)藥已向國(guó)家藥監(jiān)局提交了新冠疫苗上市申請(qǐng)。國(guó)藥的一位高管在接受新華社采訪時(shí),沒有具體說明該公司預(yù)計(jì)何時(shí)會(huì)收到申請(qǐng)回應(yīng)。
國(guó)藥尚未向公眾公布其三期試驗(yàn)的任何數(shù)據(jù),但國(guó)藥方面表示已根據(jù)國(guó)家緊急使用計(jì)劃向近100萬人分發(fā)了疫苗。
黃延忠表示,在這兩家藥企的新冠疫苗中,科興的CoronaVac可能是中國(guó)“最有前景的”疫苗,其獲得批準(zhǔn)并在全球范圍內(nèi)分銷的可能性最高,原因在于科興公布的數(shù)據(jù)更多。
2020年9月6日,在北京舉行的中國(guó)國(guó)際服務(wù)貿(mào)易交易會(huì)上,一名男孩在看科興控股生物技術(shù)有限公司研制的新冠疫苗。圖片版權(quán):NOEL CELIS—AFP/Getty Images
巴西、土耳其和印度尼西亞當(dāng)局已經(jīng)與科興達(dá)成協(xié)議,一旦三期試驗(yàn)開展順利,他們將采購(gòu)數(shù)千萬劑CoronaVac疫苗。
此前,美國(guó)駐中南美洲最高指揮官、海軍上將克雷格?富勒在接受記者采訪時(shí)表示,美國(guó)還在專注于“優(yōu)先處理美國(guó)本土”,而中國(guó)已經(jīng)準(zhǔn)備在全球范圍內(nèi)部署疫苗。
但國(guó)藥已經(jīng)在中國(guó)建立了成熟的疫苗分銷網(wǎng)絡(luò),不僅如此,與中國(guó)其他疫苗生產(chǎn)商相比,國(guó)藥的新冠疫苗正在更多的國(guó)家開展試驗(yàn),因此,國(guó)藥可能擁有更多的內(nèi)在優(yōu)勢(shì)。
香港城市大學(xué)疫苗專家、衛(wèi)生治理教授尼古拉斯?托馬斯表示:“國(guó)藥通過中國(guó)的緊急使用計(jì)劃的大規(guī)模部署,也意味著國(guó)藥已經(jīng)具備了一個(gè)經(jīng)過壓力測(cè)試的大型分銷系統(tǒng)。這是后續(xù)疫苗分配的一大優(yōu)勢(shì)。”
不僅如此,國(guó)藥也已經(jīng)通過阿聯(lián)酋的緊急使用計(jì)劃向該國(guó)分發(fā)疫苗,在埃及、約旦和阿根廷等至少10個(gè)國(guó)家進(jìn)行疫苗試驗(yàn)的計(jì)劃也正在進(jìn)行或規(guī)劃當(dāng)中。
研發(fā)沖刺是新一輪比賽的開始
隨著疫苗在越來越多的國(guó)家投入使用,全球新冠疫苗的研發(fā)已進(jìn)入沖刺階段。但這場(chǎng)競(jìng)賽的下半場(chǎng)才剛剛開始。
托馬斯表示,如果科興或國(guó)藥的疫苗上市,疫苗競(jìng)賽的下一個(gè)重大階段將會(huì)是各國(guó)選擇疫苗方面的分歧:選中國(guó)還是西方國(guó)家生產(chǎn)的新冠疫苗?
托馬斯稱:“如果公眾傾向于選擇其中的某家生產(chǎn)商,這將會(huì)帶來巨大的商業(yè)優(yōu)勢(shì)。全球?qū)用娴母?jìng)爭(zhēng)才剛剛開始?!保ㄘ?cái)富中文網(wǎng))
譯者:唐塵
In recent weeks, a string of vaccine makers including Pfizer, Moderna, and AstraZeneca have released promising phase III trial data, injecting the world with hope that the COVID-19 pandemic will come to an end.
On Wednesday, the U.K. became the first western country to approve a vaccine for COVID-19, authorizing Pfizer to distribute its vaccine on an emergency basis to frontline medical workers and other high-risk groups. The U.S. and the European Union are expected to follow suit in coming days or weeks and give vaccine makers the green light to start distributing their candidates.
But amid the optimism, experts have raised some concerns about the accessibility of Pfizer and Moderna's candidates, which require costly cold-chain distribution mechanisms, and about the quality of the data provided by British vaccine maker AstraZeneca.
At the same time, China's two leading vaccine makers—the private Sinovac and state-owned Sinopharm—appear close to rolling out their vaccines in coming weeks with candidates that don't require expensive cold chain networks.
Western vaccine makers appear to have taken the lead in the global race to produce a vaccine, but Chinese vaccine makers may help fill in the gaps they leave behind.
Data limits
In mid-November, American firms Pfizer and Moderna each announced preliminary trial results for their experimental vaccines indicating that they were over 90% effective in preventing infections of COVID-19. The results far exceeded expectations, given that the U.S. Food and Drug Administration said it would require a vaccine to be just 50% effective or better to gain approval.
Still, Pfizer and Moderna’s vaccines are based on newly-developed mRNA technology that requires the candidates to be kept at sub-zero temperatures during shipments. Such temperature restrictions will make it difficult for lower- and middle-income countries to access the vaccines because they will need cold-storage infrastructure to distribute the doses.
In Indonesia, for example, the country's state-owned vaccine manufacturer Bio Farma said that Indonesia, the world's fourth-most populous nation, effectively cannot purchase Pfizer's vaccine given the logistical challenges in distributing it.
"Indonesia does not have such [cold-chain] capabilities, and it is hazardous if this vaccine is not stored at the proper temperature," Honesti Basyir, head Bio Farma, told Indonesian news outlet the Jakarta Globe on Nov. 22. In India, the country's 28,000-unit cold chain network used for distributing vaccines only handles vaccines between 2 and 8 degrees Celsius.
Pfizer’s vaccine, which was originally developed by the German firm BioNTech, must be shipped at -70 Celsius (-94 Fahrenheit), colder than average winter temperatures at the South Pole. Moderna’s needs to be kept at -20 Celsius (-4 Fahrenheit), roughly equivalent to the temperature of a home freezer.
Pfizer has developed its own shipping containers that keep its vaccines at -70 Celsius for up to ten days. Otherwise, keeping the vaccines cold for a longer period of time requires an extensive network of airport freezer warehouses, refrigerated trucks, and on-site freezers that can cost up to $10,000.
These freezer-chain fears partly dissipated when, weeks later, British pharmaceutical firm AstraZeneca announced that its vaccine candidate was also up to 90% effective in phase III trial results. AstraZeneca's vaccine candidate, based on adenoviral technology, which induces an immune response by infecting cells with a weakened form of a live virus, only needs to be kept between 2 and 8 degrees Celsius (36 to 47 degrees Fahrenheit), roughly the temperature of a home refrigerator, making it easier to distribute.
But in the days after AstraZeneca’s announcement, experts raised questions over the "transparency and rigor" of AstraZeneca’s data. Scientists questioned why the most effective results emerged from an apparent dosing error, and how datasets from multiple countries were combined and tabulated into the final results. In response, a spokesperson for AstraZeneca said its trials were conducted to the "highest standards." Still, amid the questions over its trial data, AstraZeneca CEO Pascal Soriot pledged that the company would conduct an additional study to validate its results
AstraZeneca’s woes and the potential distribution limitations of the Pfizer and Moderna vaccines have left a hole in the global supply that may be filled by Chinese vaccine makers, says Yanzhong Huang, senior fellow for global health at the Council on Foreign Relations.
Sinovac and Sinopharm, China’s two leading vaccine makers, are currently testing three vaccine candidates in phase III trials with candidates that could be distributed without cold storage chains. Sinovac's candidate, called CoronaVac, uses inactivated forms of COVID-19 to induce immune responses. Sinopharm's two unnamed candidates are both based on similar technology.
Beijing "absolutely" sees these Chinese-made vaccines as a potential substitution for AstraZeneca's candidate, says Huang. In state media outlets, Beijing is presenting Sinovac and Sinopharm's candidates as "particularly attractive to lower and middle income countries, especially the ones who cannot afford or don't have the capacity to sustain cold chain to distribute vaccines," Huang says.
Because they rely on inactivated forms of the virus, Sinovac's and Sinopharm's candidates are more stable in comparison to vaccines based on mRNA technology, meaning they don't need to be kept quite as cold. Similar to AstraZeneca, Sinovac says its vaccine can be stored and shipped at temperatures ranging from 2 to 8 degrees Celsius. Chinese state media reports that Sinopharm's candidates can likely be stored at a similar 2 to 8 degree Celsius range. Sinopharm declined Fortune's request for confirmation.
Sinovac and Sinopharm
Sinovac and Sinopharm have both recently indicated that they are nearing the finish line in the vaccine development process.
Sinovac, which is conducting large-scale clinical trials in Brazil and Indonesia, said last week that it expected to release clinical data from its CoronaVac candidate in Brazil in a matter of days. The Butantan Institute, a vaccine research center and Sinovac's partner in Brazil, told reporters on Thursday that it expects Sinovac to publish clinical data before Dec. 15. Joao Doria, governor of Brazil's Sao Paolo state, also said Thursday he aims to begin distributing CoronaVac by January. Sinovac did not respond to Fortune's request for comment on its trial data.
Sinovac published results of its phase II trial in mid-November that suggest CoronaVac induced immune responses among volunteers and may offer COVID-19 protection. Researchers noted, however, that Pfizer and Moderna's vaccines induced stronger immune responses.
Meanwhile, on Nov. 25, Chinese state-owned vaccine maker Sinopharm asked regulatory authorities in China to officially make its vaccine available to the Chinese public. In an interview with state-run news outlet Xinhua, a Sinopharm executive did not specify when the company expects to receive a response from Chinese regulators.
Sinopharm has not released any data to the public on its phase III trials, but says it has already distributed the vaccine to nearly a million people in China under the country’s controversial emergency-use program.
Of the two drugmakers' candidates, Sinovac's CoronaVac is likely China’s most "promising" vaccine, with the best chances of getting approved and distributed internationally because Sinovac has released more data, says Huang.
Authorities in Brazil, Turkey, and Indonesia have already struck deals with Sinovac to purchase tens of millions of doses of CoronaVac if phase III trials prove successful.
Admiral Craig Fuller, the U.S.'s top commander in Central and South America, told reporters this week that while the U.S. is focused "on taking care of the U.S. first," China is poised to deploy its vaccines around the world.
Still, Sinopharm may have a built-in edge given its established distribution networks within China and the fact that it is testing its vaccine in a broader array of countries than other Chinese vaccine makers.
"[Sinopharm's] large scale rollout [via China's emergency use program] also means that there is already a large distribution system, which has already been stress-tested," says Nicholas Thomas, a vaccine expert and health governance professor at the City University of Hong Kong. "This is a major advantage in the future distribution." Sinopharm is also already distributing vaccines to the United Arab Emirates via that country's emergency use program, and is testing, or plans to conduct trials, in at least ten countries including Egypt, Jordan, and Argentina.
Home stretch
The U.S.'s apparent success in producing effective COVID-19 vaccines has turned the global race to develop an immunization for the disease into an all-out sprint. Globally, China does not want to be seen as losing in a scientific competition with its chief rival, the U.S. Domestically, China is under pressure to quickly roll out vaccines so it can loosen travel restrictions and cease the cycle of sporadic lockdowns when new outbreaks arise.
"If the U.S. manages to mass produce their vaccines for their populations by say, May, it would make China look bad if they don’t have their population vaccinated," says Huang. "They have strong incentives to get vaccines to their populations as soon as they can."
If and when Sinovac or Sinopharm's vaccines come to the market, Thomas says, the next big phase in the vaccine race will be a bifurcation of nations based on which vaccines they seek, China's or ones made by Western countries.
"There is a significant commercial advantage to be gained if the public prefers one manufacturer over another," says Thomas. "The competition at the global level is only just beginning."