當輝瑞公司和BioNTech SE聯(lián)合研發(fā)的新冠疫苗已經(jīng)從流水線上生產(chǎn)完成,,上海復(fù)星醫(yī)藥集團有限公司還要等待這批疫苗通過一套復(fù)雜而昂貴的系統(tǒng)——機場冷庫、冷藏車輛和接種點,,才能夠在全國范圍內(nèi)分發(fā),。
到達接種中心后,疫苗必須從原先貯存的零下70攝氏度環(huán)境中解凍,,并在五天內(nèi)完成注射,,否則就會變質(zhì)。
而在一個月后進行二次接種時,,疫苗出廠后所經(jīng)歷的這段艱苦歷程,,還必須再來一遍。
復(fù)星醫(yī)藥負責輝瑞公司和BioNTech SE聯(lián)合研發(fā)的新冠疫苗在大中華區(qū)的獨家開發(fā)及商業(yè)化,。輝瑞疫苗終期試驗的初步結(jié)果顯示起到“顯著效果”,,并有望結(jié)束這場將近一年的新冠疫情。但是,,疫苗出廠后,,還將面臨艱巨的物流供應(yīng)鏈挑戰(zhàn),才可以到達那些希望接種疫苗的人面前,。
如今,,疫苗帶來的欣喜之情正在被淡化。因為人們意識到,,輝瑞公司在其新冠疫苗中使用的是mRNA技術(shù),,在這種技術(shù)的作用下,人體能夠形成一種催生保護性抗體的蛋白質(zhì),。而在人們目前使用過的疫苗中,,沒有一個是通過這種技術(shù)制造的。
這也就意味著,,為了滿足疫苗?;钏匦璧睦洳貤l件,各國要從零開始建立一條全新的低溫生產(chǎn)、儲存和運輸網(wǎng)絡(luò),。這就需要大規(guī)模的投資和協(xié)調(diào)——而很有可能只有富裕的國家才可以得到保障,,甚至連那些國家也只能保證其城市人口的供應(yīng)。
總部位于北京,、由比爾及梅琳達?蓋茨基金會資助的全球健康藥物研發(fā)中心的主任丁勝說:“疫苗保存和運輸所需的低溫條件生產(chǎn)成本高,,成分不穩(wěn)定,還需要冷鏈運輸,,且保質(zhì)期很短,。”
盡管由世界衛(wèi)生組織資助的一項名為“新冠肺炎疫苗實施計劃”(Covax)正在努力籌集180億美元,,旨在為貧困國家購買疫苗,,但如上述所言,部署輝瑞疫苗分發(fā)所需的高額費用可能會加劇人們的擔憂——最好的疫苗將首先提供給富裕國家使用,。
發(fā)展中國家當前面臨兩種選擇:為造價昂貴,、但看起來一定有效的冷鏈基礎(chǔ)設(shè)施建設(shè)買單,或者等待一種進展更緩,、但更常規(guī),、也可以通過現(xiàn)有的醫(yī)療網(wǎng)絡(luò)提供的疫苗,其作用機制是在活細胞中培育大量能夠產(chǎn)生抗體的蛋白質(zhì)或注射滅活的病毒,。
丁勝說:“如果有一種蛋白質(zhì)疫苗可以達到與mRNA疫苗相同的效果,,并且每年需要接種疫苗的人數(shù)高達數(shù)十億,從長遠來看,,我會選擇蛋白質(zhì)疫苗,。”
即便對那些已經(jīng)預(yù)先訂購了輝瑞疫苗的富裕國家,,包括日本,、美國和英國,只要運輸卡車出了故障,,或是遇到斷電,、基層工人生病和冷庫中的冰塊融化,疫苗供應(yīng)都將遇到相當大的障礙,。
安全的運輸
為了在中國大陸和香港安全地運送疫苗,,復(fù)星將與國有控股的國藥集團合作——國藥集團是一家在全中國擁有完善分銷網(wǎng)絡(luò)的藥商,該集團的子公司之一也正在研發(fā)新冠疫苗,。
疫苗將被裝在小瓶子中,,由冷藏卡車運送到接種地點,并在那里解凍,,之后最多只能在2至8攝氏度的冰箱中存放五天,,然后就會變質(zhì),。
圣路易斯華盛頓大學的疫苗專家邁克爾?金奇說:“貯存疫苗要求極端低溫的條件,而這一點很難滿足,,就可能會導致許多疫苗變質(zhì),。”
復(fù)星公司的董事長吳以芳說,,疫苗所需的物流條件可能要花費公司數(shù)千萬元,。復(fù)星正在考慮批量進口疫苗,并將其裝入當?shù)毓S生產(chǎn)的小瓶中,。這將需要在生產(chǎn)和存儲上進一步投資,。
這樣的要求也將讓疫苗的價格不菲,這對許多發(fā)展中國家而言可能太過沉重——包括中國的鄰國印度——該國一直在努力遏制疫情的第二次全球大爆發(fā),,目前也尚無購買輝瑞疫苗的協(xié)議,。
“算了吧”
印度公共衛(wèi)生和制藥行業(yè)的許多人員對此表達了關(guān)切,認為印度缺乏必要的能力,,以預(yù)期的高速在其廣大農(nóng)村腹地和13億之多的人口中提供疫苗,。
“大多數(shù)疫苗需要零下70華氏度的低溫,這在印度是做不到的,,算了吧?!比嗣窠】颠\動(People’s Health Movement)駐新德里的全球協(xié)調(diào)員T?孫達拉曼說,。該組織把致力于公共衛(wèi)生的地方活動人士、學者和民間社會團體聚集在一起,。
他說:“我們目前的冷鏈連一些地區(qū)對麻疹疫苗的需求都無法滿足,,況且這些疫苗只適用于3歲以下的兒童。與需要新冠疫苗的人數(shù)相比,,這個數(shù)字實在微不足道,。”
印度衛(wèi)生部秘書拉吉什?布珊在11月10日的新聞發(fā)布會上被問及印度政府是否會購買輝瑞疫苗時表示,,新德里正在與所有疫苗制造商進行談判,。他補充說,印度有能力“擴大和加強”其現(xiàn)有冷鏈產(chǎn)能,,但拒絕立即公布任何采購細節(jié),。
輝瑞目前已經(jīng)接到了一些包括秘魯、厄瓜多爾和哥斯達黎加在內(nèi)的發(fā)展中國家的訂單,。目前尚不清楚這些國家計劃在多大范圍內(nèi)分發(fā)疫苗,,但通過這些國家不到1,000萬劑的訂單數(shù)目可以看出,部署范圍應(yīng)當很有限,。
在這些積極的初步數(shù)據(jù)公布后,,一些政府已經(jīng)匆忙敲定訂單,,并開始與輝瑞和BioNTech進行談判。11月10日,,歐盟確認了多達3億劑的訂單,,而菲律賓、新加坡和巴西則表示正在進行談判,。
“最后一公里”
印度制藥商Cadila Healthcare Ltd.的董事長潘卡?帕特爾說,,即使沒有冷鏈問題,在短時間內(nèi)推出疫苗也將是一個“重大挑戰(zhàn)”,,需要大量的輔助醫(yī)務(wù)人員培訓才能抵達最后那兩針疫苗的注射階段,。該公司正在開發(fā)自己的試驗性質(zhì)粒DNA 新冠疫苗。
對于那些不容易接觸到或者需要長途跋涉才可以到達疫苗接種中心的地區(qū)而言,,尤其如此,。公共衛(wèi)生專家說,過去的疫苗接種活動表明,,許多人根本沒有進行第二次接種,。
障礙不斷增加,意味著即使早期跡象表明輝瑞疫苗療效卓越,,一些發(fā)展中國家仍然可能會放棄輝瑞的疫苗,。
印度韋洛爾基督教醫(yī)學院微生物學教授、世界衛(wèi)生組織全球疫苗安全咨詢委員會成員加根迪普?康問道:“如果我們再等上一年,,等到我們有足夠分發(fā)給大多數(shù)人的疫苗,,這會是一個糟糕的權(quán)衡取舍嗎?”
她說:“基于輝瑞疫苗的成本,,超低溫儲存的物流要求,,我認為我們還沒有準備好,。在我看來,,我們需要非常、非常謹慎地權(quán)衡利弊,?!保ㄘ敻恢形木W(wǎng))
編譯:陳聰聰、楊二一
當輝瑞公司和BioNTech SE聯(lián)合研發(fā)的新冠疫苗已經(jīng)從流水線上生產(chǎn)完成,,上海復(fù)星醫(yī)藥集團有限公司還要等待這批疫苗通過一套復(fù)雜而昂貴的系統(tǒng)——機場冷庫,、冷藏車輛和接種點,才能夠在全國范圍內(nèi)分發(fā),。
到達接種中心后,,疫苗必須從原先貯存的零下70攝氏度環(huán)境中解凍,并在五天內(nèi)完成注射,,否則就會變質(zhì),。
而在一個月后進行二次接種時,,疫苗出廠后所經(jīng)歷的這段艱苦歷程,還必須再來一遍,。
復(fù)星醫(yī)藥負責輝瑞公司和BioNTech SE聯(lián)合研發(fā)的新冠疫苗在大中華區(qū)的獨家開發(fā)及商業(yè)化,。輝瑞疫苗終期試驗的初步結(jié)果顯示起到“顯著效果”,并有望結(jié)束這場將近一年的新冠疫情,。但是,,疫苗出廠后,還將面臨艱巨的物流供應(yīng)鏈挑戰(zhàn),,才可以到達那些希望接種疫苗的人面前,。
如今,,疫苗帶來的欣喜之情正在被淡化,。因為人們意識到,輝瑞公司在其新冠疫苗中使用的是mRNA技術(shù),,在這種技術(shù)的作用下,人體能夠形成一種催生保護性抗體的蛋白質(zhì),。而在人們目前使用過的疫苗中,沒有一個是通過這種技術(shù)制造的,。
這也就意味著,,為了滿足疫苗?;钏匦璧睦洳貤l件,,各國要從零開始建立一條全新的低溫生產(chǎn),、儲存和運輸網(wǎng)絡(luò),。這就需要大規(guī)模的投資和協(xié)調(diào)——而很有可能只有富裕的國家才可以得到保障,,甚至連那些國家也只能保證其城市人口的供應(yīng)。
總部位于北京,、由比爾及梅琳達?蓋茨基金會資助的全球健康藥物研發(fā)中心的主任丁勝說:“疫苗保存和運輸所需的低溫條件生產(chǎn)成本高,,成分不穩(wěn)定,還需要冷鏈運輸,,且保質(zhì)期很短,。”
盡管由世界衛(wèi)生組織資助的一項名為“新冠肺炎疫苗實施計劃”(Covax)正在努力籌集180億美元,,旨在為貧困國家購買疫苗,,但如上述所言,,部署輝瑞疫苗分發(fā)所需的高額費用可能會加劇人們的擔憂——最好的疫苗將首先提供給富裕國家使用。
發(fā)展中國家當前面臨兩種選擇:為造價昂貴,、但看起來一定有效的冷鏈基礎(chǔ)設(shè)施建設(shè)買單,,或者等待一種進展更緩、但更常規(guī),、也可以通過現(xiàn)有的醫(yī)療網(wǎng)絡(luò)提供的疫苗,,其作用機制是在活細胞中培育大量能夠產(chǎn)生抗體的蛋白質(zhì)或注射滅活的病毒。
丁勝說:“如果有一種蛋白質(zhì)疫苗可以達到與mRNA疫苗相同的效果,,并且每年需要接種疫苗的人數(shù)高達數(shù)十億,,從長遠來看,,我會選擇蛋白質(zhì)疫苗,。”
即便對那些已經(jīng)預(yù)先訂購了輝瑞疫苗的富裕國家,,包括日本,、美國和英國,只要運輸卡車出了故障,,或是遇到斷電,、基層工人生病和冷庫中的冰塊融化,疫苗供應(yīng)都將遇到相當大的障礙,。
安全的運輸
為了在中國大陸和香港安全地運送疫苗,,復(fù)星將與國有控股的國藥集團合作——國藥集團是一家在全中國擁有完善分銷網(wǎng)絡(luò)的藥商,該集團的子公司之一也正在研發(fā)新冠疫苗,。
疫苗將被裝在小瓶子中,,由冷藏卡車運送到接種地點,并在那里解凍,,之后最多只能在2至8攝氏度的冰箱中存放五天,,然后就會變質(zhì)。
圣路易斯華盛頓大學的疫苗專家邁克爾?金奇說:“貯存疫苗要求極端低溫的條件,,而這一點很難滿足,,就可能會導致許多疫苗變質(zhì)?!?/p>
復(fù)星公司的董事長吳以芳說,,疫苗所需的物流條件可能要花費公司數(shù)千萬元。復(fù)星正在考慮批量進口疫苗,,并將其裝入當?shù)毓S生產(chǎn)的小瓶中,。這將需要在生產(chǎn)和存儲上進一步投資。
這樣的要求也將讓疫苗的價格不菲,,這對許多發(fā)展中國家而言可能太過沉重——包括中國的鄰國印度——該國一直在努力遏制疫情的第二次全球大爆發(fā),,目前也尚無購買輝瑞疫苗的協(xié)議,。
“算了吧”
印度公共衛(wèi)生和制藥行業(yè)的許多人員對此表達了關(guān)切,認為印度缺乏必要的能力,,以預(yù)期的高速在其廣大農(nóng)村腹地和13億之多的人口中提供疫苗,。
“大多數(shù)疫苗需要零下70華氏度的低溫,這在印度是做不到的,,算了吧,。”人民健康運動(People’s Health Movement)駐新德里的全球協(xié)調(diào)員T?孫達拉曼說,。該組織把致力于公共衛(wèi)生的地方活動人士,、學者和民間社會團體聚集在一起。
他說:“我們目前的冷鏈連一些地區(qū)對麻疹疫苗的需求都無法滿足,,況且這些疫苗只適用于3歲以下的兒童,。與需要新冠疫苗的人數(shù)相比,這個數(shù)字實在微不足道,?!?/p>
印度衛(wèi)生部秘書拉吉什?布珊在11月10日的新聞發(fā)布會上被問及印度政府是否會購買輝瑞疫苗時表示,新德里正在與所有疫苗制造商進行談判,。他補充說,,印度有能力“擴大和加強”其現(xiàn)有冷鏈產(chǎn)能,但拒絕立即公布任何采購細節(jié),。
輝瑞目前已經(jīng)接到了一些包括秘魯,、厄瓜多爾和哥斯達黎加在內(nèi)的發(fā)展中國家的訂單。目前尚不清楚這些國家計劃在多大范圍內(nèi)分發(fā)疫苗,,但通過這些國家不到1,000萬劑的訂單數(shù)目可以看出,,部署范圍應(yīng)當很有限。
在這些積極的初步數(shù)據(jù)公布后,,一些政府已經(jīng)匆忙敲定訂單,,并開始與輝瑞和BioNTech進行談判。11月10日,,歐盟確認了多達3億劑的訂單,,而菲律賓,、新加坡和巴西則表示正在進行談判,。
“最后一公里”
印度制藥商Cadila Healthcare Ltd.的董事長潘卡?帕特爾說,即使沒有冷鏈問題,,在短時間內(nèi)推出疫苗也將是一個“重大挑戰(zhàn)”,,需要大量的輔助醫(yī)務(wù)人員培訓才能抵達最后那兩針疫苗的注射階段。該公司正在開發(fā)自己的試驗性質(zhì)粒DNA 新冠疫苗,。
對于那些不容易接觸到或者需要長途跋涉才可以到達疫苗接種中心的地區(qū)而言,,尤其如此,。公共衛(wèi)生專家說,過去的疫苗接種活動表明,,許多人根本沒有進行第二次接種,。
障礙不斷增加,意味著即使早期跡象表明輝瑞疫苗療效卓越,,一些發(fā)展中國家仍然可能會放棄輝瑞的疫苗,。
印度韋洛爾基督教醫(yī)學院微生物學教授、世界衛(wèi)生組織全球疫苗安全咨詢委員會成員加根迪普?康問道:“如果我們再等上一年,,等到我們有足夠分發(fā)給大多數(shù)人的疫苗,,這會是一個糟糕的權(quán)衡取舍嗎?”
她說:“基于輝瑞疫苗的成本,,超低溫儲存的物流要求,,我認為我們還沒有準備好。在我看來,,我們需要非常,、非常謹慎地權(quán)衡利弊?!保ㄘ敻恢形木W(wǎng))
編譯:陳聰聰,、楊二一
When Pfizer Inc. and BioNTech SE’s Covid-19 vaccine rolls off production lines, Shanghai Fosun Pharmaceutical Group Co. will be waiting to distribute it through a complex and costly system of deep-freeze airport warehouses, refrigerated vehicles and inoculation points across China.
After they reach vaccination centers, the shots must be thawed from -70 degrees celsius and injected within five days, if not they go bad.
Then the herculean journey from warehouse freezer to rolled-up sleeve must be undertaken all over again -- to deliver the second booster shot a month later.
The roadmap sketched out by the company, which has licensed the vaccine for Greater China, offers a glimpse into the enormous and daunting logistical challenges faced by those looking to deliver Pfizer’s experimental vaccine after it showed “extraordinary” early results from final stage trials, raising hopes of a potential end to the nearly year-long pandemic.
That euphoria is now being diluted by the realization that no currently used vaccine has ever been made from the messenger RNA technology deployed in Pfizer’s shot, which instructs the human body to produce proteins that then develop protective antibodies.
That means that countries will need to build from scratch the deep-freeze production, storage and transportation networks needed for the vaccine to survive. The massive investment and coordination required all but ensures that only rich nations are guaranteed access -- and even then perhaps only their urban populations.
“Its production is costly, its component is unstable, it also requires cold-chain transportation and has a short shelf life,” said Ding Sheng, director of the Beijing-based Global Health Drug Discovery Institute, which has received funding from the Bill & Melinda Gates Foundation.
The expense of deploying the Pfizer shot will likely heighten existing fears that wealthier nations will get the best vaccines first, despite a World Health Organization-backed effort called Covax that aims to raise $18 billion to purchase vaccines for poorer countries.
It also presents a choice now faced across the developing world: to pay for the expensive construction of subzero cold-chain infrastructure for what seems like a sure bet, or wait for a slower, more conventional vaccine that brews batches of protein or inactivated viral particles in living cells, and can be delivered through existing health-care networks.
“If there is a protein-based vaccine that could achieve the same effect as an mRNA vaccine does and there’s the need to vaccinate billions of people every year, I’d go for the protein-based shots in the long run,” Ding said.
Even for rich countries that have pre-ordered doses, including Japan, the U.S. and the U.K., delivering Pfizer’s vaccine will involve considerable hurdles as long as trucks break down, electricity cuts out, essential workers get sick and ice melts.
Safe Delivery
To safely deliver shots in mainland China and Hong Kong, Fosun will partner with the state-owned Sinopharm Group Co., a pharmaceutical distributor with well-established networks across the country. One of Sinopharm’s subsidiaries has also been developing Covid-19 vaccines.
Packed into cold storage trucks, those vials will arrive at inoculation sites where they can thaw and be stacked in fridges at 2 to 8 degrees celsius for a maximum five days before going bad.
“The requirement for extremely cold temperatures is likely to cause spoilage of a lot of vaccine,” said Michael Kinch, a vaccine specialist at Washington University in St. Louis.
It’s also likely to cost Fosun tens of millions yuan, according to the company’s Chairman Wu Yifang. Fosun is considering importing the vaccine in bulk and filling them into vials at a local plant. That will also require further investment in production and storage.
The resulting price tag may be too hefty for many developing nations, including neighboring India, which has struggled to contain the world’s second-largest coronavius outbreak and currently has no agreement to purchase the Pfizer vaccine.
“Forget It”
Many working in the country’s public health and the pharmaceutical industry have already voiced concern that India lacks the necessary capacity and capability to deliver a vaccine across its vast rural hinterland and population of over 1.3 billion people at the breakneck speed now expected.
“Most of these vaccines need minus 70 degrees, which we just can’t do in India, just forget it,” said T. Sundararaman, a New Delhi-based global coordinator of the People’s Health Movement, an organization that brings together local activists, academics and civil society groups working on public health.
“Our current cold chains are not able to cope with some districts’ need for measles vaccines, and that’s only for children below the age of 3,” he said. “That’s a really trivial number of people compared to the numbers that will need a Covid-19 vaccine.”
When asked at a November 10 briefing if India’s government would look to buy any of the Pfizer vaccine, Rajesh Bhushan, the secretary at the health ministry, said New Delhi is in talks with all vaccine manufacturers. He added that India was in a position to “augment and strengthen” its existing cold-chain capacity, but declined to release any purchase details immediately.
Pfizer already has orders from some developing countries like Peru, Ecuador and Costa Rica. It’s unclear how widely those nations plan to distribute the shots, but their small orders of less than ten million doses suggest limited deployment.
After the release of their positive preliminary data, some governments have rushed to finalize orders and start negotiations with Pfizer and BioNTech. The European Union confirmed an order of up to 300 million doses on November 10, while the Philippines, Singapore and Brazil said they were in talks.
“Last Mile”
Even without the subzero issue, rolling out a vaccine in a short space of time will be a “major challenge” requiring mass paramedical training to administer two-shot doses, said Pankaj Patel, chairman of Indian drugmaker Cadila Healthcare Ltd., which is developing its own experimental plasmid DNA Covid-19 shot.
This is especially so in areas where people are not easily contactable or have to travel long distances to reach vaccination centers. Past vaccination campaigns show that many simply never show up for the second shot, said public health experts.
The mounting obstacles mean that some developing countries may pass on the Pfizer vaccine, despite early signs of its exceptional efficacy.
“If we were to wait an extra year and have something that’s feasible for us to deliver to as many people as possible in this country, would that be a bad trade-off?” asked Gagandeep Kang, professor of microbiology at the Vellore, India-based Christian Medical College and a member of the WHO’s Global Advisory Committee on Vaccine Safety.
“Based on the cost of the Pfizer vaccine, the logistics of an ultra-cold storage -- I don’t think we are ready and I think this is something that we need to weigh the benefits and the costs very, very carefully,” she said.