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四大疫苗廠商僅有一家成功,行業格局要變天?

四大疫苗廠商僅有一家成功,行業格局要變天?

Kat Eschner 2021年03月10日
多樣化將成為疫苗行業的新特征

在2020年12月,只要卷起袖子打上一針就能夠創造歷史。

在全世界的關注下,英國率先施打了第一劑輝瑞-BioNTech疫苗,美國也緊隨其后開始疫苗接種。在那之后的幾個月,全世界有超過2.65億人已經接種了一劑或多劑新冠疫苗。

這一結果比專家預期的時間提前了數年,也是制藥行業對這場全球健康危機最有效的應對措施。然而,此次生物技術的勝利也預示著以營利為目的制藥行業將迎來巨變。該行業目前正在致力于解決如何生產足夠多的疫苗劑量來滿足需求。

2020年1月,在疫情大規模爆發之前,疫苗行業被四家大公司主導,它們分別是:葛蘭素史克、默沙東、賽諾菲和輝瑞。

一年多以后,行業局面已經發生了變化。到目前為止,在開發新冠疫苗的競賽中,這四大公司中只有輝瑞一家獲勝。輝瑞的信使核糖核酸(mRNA)疫苗分兩劑施打的保護率高達95%。輝瑞預計2021年疫苗收入有望達到約150億美元,占公司總收入的近30%。

與此同時,Moderna、阿斯利康和Novavax等曾經市場知名度不高的公司,也因疫苗變得家喻戶曉。而且中國和俄羅斯也在發展本國疫苗產業,中國的一些醫藥公司,例如科興和國藥,也因新冠疫苗的成功上市走進了大眾的視線。

新冠肺炎病毒似乎將會已人類長期共存。因此這些公司疫苗研制成功,意味著這個原本高度整合的行業將迎來巨變。

標普全球醫療保健行業的分析師帕特里克·貝爾說:“在疫情當中,輝瑞今年在全球疫苗銷售方面的領先優勢顯而易見?!?/p>

貝爾表示,小型生物科技公司Moderna因為研發出一款與輝瑞疫苗效果相當的mRNA疫苗,迅速引起了人們的關注,它“有望成為行業第二?!?Moderna預測今年的總產品銷售額將達到184億美元。

變革中的疫苗行業

疫苗研發的成本高昂,并且需要耗費時間,而且疫苗的年收入往往相對較低。

標普全球醫療保健行業的分析師戴維·卡普蘭指出,疫苗屬于數量大、價格低的商品。他表示:“這導致許多公司退出了疫苗市場?!?/p>

疫情爆發之前,疫苗行業的規模為330億美元,僅占全球制藥行業的3%。四大疫苗公司獲得了該行業約90%的收入。

專家表示,雖然疫苗行業對整個制藥行業收入的貢獻較小,但與整個生物科技行業一樣,疫苗行業在過去30年內經歷了重要的技術變革,帶動該行業實現顯著增長。例如,針對人類乳突病毒(HPV)和帶狀皰疹的新疫苗,以及更有效的流感疫苗、麻疹疫苗等,形成了巨大的市場。

但在疫情爆發之前,疫苗行業存在創新陷入停滯的危險。從疫苗研發和臨床試驗,到開發一款成功的候選疫苗,再到日益嚴峻的疫苗生產挑戰,公司在疫苗開發過程中需要投資數十億美元。而且研發過程的大部分階段都存在風險:耗費數年開展的初步研究,并不能夠保證可以帶來一款成功的疫苗,或者在疫苗獲得批準之后也無法保證是否還有足夠的需求,使生產疫苗依舊有利可圖。

正常情況下,疫苗行業的技術變革可能需要經歷數十年時間。但由于新冠疫情的緊迫性,政府和疫苗行業為了開發疫苗投入了大量資金。在行業、政府和學術界的通力合作下,有多款疫苗用史上最快的時間成功上市,在這個過程中發展了未來的疫苗技術,并培養了疫苗生產所需要的聯系。

新mRNA技術的發展是最直接的例子。全世界有大批科學家和投資者從事該技術的研究超過30年。

貝爾說:“新冠疫情幫助加快了部分mRNA技術的開發進度,在正常情況下該技術的發展可能需要更長時間?!?/p>

美國政府斥資100億美元發起的新冠疫苗開發計劃“曲速行動”為Moderna和輝瑞創新疫苗的誕生創造了環境。Moderna獲得了約10億美元直接補助以及大量后勤支持,而輝瑞則得到了政府的承諾,只要其研發工作取得成功,政府將采購價值約20億美元的疫苗。

Moderna是一家小型生物科技公司,在2018年才進行首次公開募股。該公司有獨特的優勢充分利用“曲速行動”創造的融資環境。如果沒有“曲速行動”提供的資金和專業技術,一家小型生物科技公司不可能有實力完成數輪臨床試驗并完善候選疫苗。

該公司以及其他有望開發疫苗的公司,與美國國立健康研究院合作生產了多款候選疫苗,將完成相同的試驗過程。Moderna的疫苗最終取得成功。

候選疫苗開發競賽

在mRNA技術發展的三十年間,整個制藥行業一直很難維持發展動力和維護行業的聲譽。新冠疫情為該行業創造了兩個方面條件的改善:公司迅速從現有治療藥物中尋找對抗這種疾病的辦法(幾乎所有現有治療方法均無效),并向醫院、護理中心等機構捐贈了大量稀缺的個人防護用品,希望借此改善公司的形象。

但大獎是疫苗。

在2020年,全世界有數百款新冠候選疫苗投入研發,許多疫苗都得到了政府支持。生物供應管理聯盟的執行董事德文德拉·米什拉表示:“疫苗研發出現了高度分散的局面?!?/p>

米什拉所在的組織很早就開始發布有關新冠疫情的時事通訊,以幫助來自整個生物科技行業供應鏈的會員及時跟蹤行業動態。早在去年5月,時事通訊中就開始分享與疫苗開發競賽有關的資料。

截至2020年年底,仍然在開發當中的候選疫苗有200多種。目前已經在全世界接種的疫苗接近兩位數。強生旗下的楊森制藥開發的最新疫苗,在2月28日獲得了美國食品與藥品管理局的緊急使用授權。

到目前為止,四大疫苗公司只有一家公司在較短時間內,成功開發出一款有效的新冠疫苗,這凸顯出了開發新疫苗的難度。

貝爾說:“默沙東放棄了兩款候選疫苗的開發計劃。葛蘭素史克和賽諾菲正在合作開發一款疫苗,目前尚未成功?!彼J為,雖然葛蘭素史克-賽諾菲的疫苗最終肯定會上市,但這在短期內無法實現。葛蘭素史克還在與德國生物制藥公司CureVac合作開發下一代mRNA疫苗。

分布問題

雖然疫苗開發的分散性確實能夠在短期內誕生大量新冠疫苗,但大批量生產疫苗的需求,以及高度全球化的制藥行業原材料運輸中斷,和疫苗的物流網絡遭到的前所未有的破壞,導致疫苗供應鏈陷入了混亂。

米什拉稱:“新冠疫情暴露出生命科學供應鏈的缺點。它暴露出我們相關的聯系是多么脆弱?!?/p>

生產疫苗所需要的技術和原材料必須獲得良好生產規范標準認證。遵照這種高標準會產生高生產成本,這意味著生物科技公司會充分利用其資源。

公司為了生產數十億劑疫苗不得不尋找額外產能,這個問題使制藥行業供應鏈當前的動態變化加快了速度,但這種變化能否長期持續下去,我們仍然需要拭目以待。

受到生產規模等因素的影響,制藥公司可能會自行建設生產設施,自行內部生產疫苗,或者租用定制研發生產組織的產能。

貝爾表示:“這給定制研發生產組織帶來了福音?!必悹柡涂ㄆ仗m在去年合作發布的一篇報告中指出,即使初期疫苗生產需求下降之后,定制研發生產組織獲得的好處可能會持續存在。

定制研發生產組織使小型生物科技公司既可以進行產品生產,又能夠節省不會頻繁投入使用的內部設施的維護開支。雖然疫情讓各國更加重視在國內生產疫苗和藥品,但行業觀察家們預測,大型制藥公司可能會繼續利用定制研發生產組織,應對國內的疫苗生產壓力。

在疫情期間,沒有成功研發出疫苗的制藥公司同意與取得成功的其他公司共享其內部產能。最近,美國總統喬·拜登宣布,默沙東計劃生產強生的疫苗,這將大幅增加疫苗供應。

但合作并不容易。

戴爾豪斯大學的病毒學家艾莉森·凱爾文指出:“有一個問題是,每家公司都針對各自產品的需求建設了生產設施,而且有時候這些產品并不重疊?!?/p>

疫情并不意味著對其他關鍵藥品的需求已經消失:治療其他疾病的藥物與以往一樣是必不可少的。凱爾文依舊強調,“創造性思維”使公司即使在非常規環境下,也可以展開合作,盡可能生產足夠多的疫苗。

疫苗供應鏈關鍵的最后一英里,也是制藥公司考慮的問題之一。

滑鐵盧大學的管理學教授侯賽因·阿博依·莫里茲表示,政府需要穩定的疫苗供應來推動大規模接種,但在當前這種前所未有的環境下,公司很難保證疫苗供應的可預測性。

但他相信目前出現的供應問題只是“成長的煩惱”。他說:“我確信,疫苗公司會擴大生產規模,未來我們的疫苗供應量會大幅增加?!?/p>

應對新冠疫情開啟了疫苗行業的新時代,多樣化將成為疫苗行業的新特征。

卡普拉稱:“我不認為疫情結束之后的疫苗市場會變得比疫情之前更加分散?!?/p>

過去,Moderna這種小公司最常見的結果是,在產品大有可為的階段,被大型制藥公司收購。但現在,當需求出現的時候,Moderna恰逢其時,能夠利用其創新能力,維持公司的獨立性。

從長遠來看,當前的局面對Moderna等公司以及Novavax和Inovio等小型創新公司的意義仍然有待觀察,但它們的創新有望幫助它們繞過收購階段,以更強有力的姿態進入市場。

主要的不確定因素依舊是新冠疫苗能夠在多長時間內維持盈利。

但隨著病毒變異和感染人數的持續增加,有一種可能性變得越來越高:人們可能都需要接種疫苗,或者變異病毒株要求人們重新接種疫苗,因此在今后很長一段時間里,新冠疫苗將必不可少。

莫里茲說:“問題在于,新冠肺炎是仍會在全球范圍內傳播流行,還是會變成一種地方性流行病。目前看來,新冠疫情似乎不會像我最初想象的那樣很快結束?!保ㄘ敻恢形木W)

翻譯:劉進龍

審校:汪皓

在2020年12月,只要卷起袖子打上一針就能夠創造歷史。

在全世界的關注下,英國率先施打了第一劑輝瑞-BioNTech疫苗,美國也緊隨其后開始疫苗接種。在那之后的幾個月,全世界有超過2.65億人已經接種了一劑或多劑新冠疫苗。

這一結果比專家預期的時間提前了數年,也是制藥行業對這場全球健康危機最有效的應對措施。然而,此次生物技術的勝利也預示著以營利為目的制藥行業將迎來巨變。該行業目前正在致力于解決如何生產足夠多的疫苗劑量來滿足需求。

2020年1月,在疫情大規模爆發之前,疫苗行業被四家大公司主導,它們分別是:葛蘭素史克、默沙東、賽諾菲和輝瑞。

一年多以后,行業局面已經發生了變化。到目前為止,在開發新冠疫苗的競賽中,這四大公司中只有輝瑞一家獲勝。輝瑞的信使核糖核酸(mRNA)疫苗分兩劑施打的保護率高達95%。輝瑞預計2021年疫苗收入有望達到約150億美元,占公司總收入的近30%。

與此同時,Moderna、阿斯利康和Novavax等曾經市場知名度不高的公司,也因疫苗變得家喻戶曉。而且中國和俄羅斯也在發展本國疫苗產業,中國的一些醫藥公司,例如科興和國藥,也因新冠疫苗的成功上市走進了大眾的視線。

新冠肺炎病毒似乎將會已人類長期共存。因此這些公司疫苗研制成功,意味著這個原本高度整合的行業將迎來巨變。

標普全球醫療保健行業的分析師帕特里克·貝爾說:“在疫情當中,輝瑞今年在全球疫苗銷售方面的領先優勢顯而易見?!?/p>

貝爾表示,小型生物科技公司Moderna因為研發出一款與輝瑞疫苗效果相當的mRNA疫苗,迅速引起了人們的關注,它“有望成為行業第二?!?Moderna預測今年的總產品銷售額將達到184億美元。

變革中的疫苗行業

疫苗研發的成本高昂,并且需要耗費時間,而且疫苗的年收入往往相對較低。

標普全球醫療保健行業的分析師戴維·卡普蘭指出,疫苗屬于數量大、價格低的商品。他表示:“這導致許多公司退出了疫苗市場?!?/p>

疫情爆發之前,疫苗行業的規模為330億美元,僅占全球制藥行業的3%。四大疫苗公司獲得了該行業約90%的收入。

專家表示,雖然疫苗行業對整個制藥行業收入的貢獻較小,但與整個生物科技行業一樣,疫苗行業在過去30年內經歷了重要的技術變革,帶動該行業實現顯著增長。例如,針對人類乳突病毒(HPV)和帶狀皰疹的新疫苗,以及更有效的流感疫苗、麻疹疫苗等,形成了巨大的市場。

但在疫情爆發之前,疫苗行業存在創新陷入停滯的危險。從疫苗研發和臨床試驗,到開發一款成功的候選疫苗,再到日益嚴峻的疫苗生產挑戰,公司在疫苗開發過程中需要投資數十億美元。而且研發過程的大部分階段都存在風險:耗費數年開展的初步研究,并不能夠保證可以帶來一款成功的疫苗,或者在疫苗獲得批準之后也無法保證是否還有足夠的需求,使生產疫苗依舊有利可圖。

正常情況下,疫苗行業的技術變革可能需要經歷數十年時間。但由于新冠疫情的緊迫性,政府和疫苗行業為了開發疫苗投入了大量資金。在行業、政府和學術界的通力合作下,有多款疫苗用史上最快的時間成功上市,在這個過程中發展了未來的疫苗技術,并培養了疫苗生產所需要的聯系。

新mRNA技術的發展是最直接的例子。全世界有大批科學家和投資者從事該技術的研究超過30年。

貝爾說:“新冠疫情幫助加快了部分mRNA技術的開發進度,在正常情況下該技術的發展可能需要更長時間?!?/p>

美國政府斥資100億美元發起的新冠疫苗開發計劃“曲速行動”為Moderna和輝瑞創新疫苗的誕生創造了環境。Moderna獲得了約10億美元直接補助以及大量后勤支持,而輝瑞則得到了政府的承諾,只要其研發工作取得成功,政府將采購價值約20億美元的疫苗。

Moderna是一家小型生物科技公司,在2018年才進行首次公開募股。該公司有獨特的優勢充分利用“曲速行動”創造的融資環境。如果沒有“曲速行動”提供的資金和專業技術,一家小型生物科技公司不可能有實力完成數輪臨床試驗并完善候選疫苗。

該公司以及其他有望開發疫苗的公司,與美國國立健康研究院合作生產了多款候選疫苗,將完成相同的試驗過程。Moderna的疫苗最終取得成功。

候選疫苗開發競賽

在mRNA技術發展的三十年間,整個制藥行業一直很難維持發展動力和維護行業的聲譽。新冠疫情為該行業創造了兩個方面條件的改善:公司迅速從現有治療藥物中尋找對抗這種疾病的辦法(幾乎所有現有治療方法均無效),并向醫院、護理中心等機構捐贈了大量稀缺的個人防護用品,希望借此改善公司的形象。

但大獎是疫苗。

在2020年,全世界有數百款新冠候選疫苗投入研發,許多疫苗都得到了政府支持。生物供應管理聯盟的執行董事德文德拉·米什拉表示:“疫苗研發出現了高度分散的局面?!?/p>

米什拉所在的組織很早就開始發布有關新冠疫情的時事通訊,以幫助來自整個生物科技行業供應鏈的會員及時跟蹤行業動態。早在去年5月,時事通訊中就開始分享與疫苗開發競賽有關的資料。

截至2020年年底,仍然在開發當中的候選疫苗有200多種。目前已經在全世界接種的疫苗接近兩位數。強生旗下的楊森制藥開發的最新疫苗,在2月28日獲得了美國食品與藥品管理局的緊急使用授權。

到目前為止,四大疫苗公司只有一家公司在較短時間內,成功開發出一款有效的新冠疫苗,這凸顯出了開發新疫苗的難度。

貝爾說:“默沙東放棄了兩款候選疫苗的開發計劃。葛蘭素史克和賽諾菲正在合作開發一款疫苗,目前尚未成功?!彼J為,雖然葛蘭素史克-賽諾菲的疫苗最終肯定會上市,但這在短期內無法實現。葛蘭素史克還在與德國生物制藥公司CureVac合作開發下一代mRNA疫苗。

分布問題

雖然疫苗開發的分散性確實能夠在短期內誕生大量新冠疫苗,但大批量生產疫苗的需求,以及高度全球化的制藥行業原材料運輸中斷,和疫苗的物流網絡遭到的前所未有的破壞,導致疫苗供應鏈陷入了混亂。

米什拉稱:“新冠疫情暴露出生命科學供應鏈的缺點。它暴露出我們相關的聯系是多么脆弱?!?/p>

生產疫苗所需要的技術和原材料必須獲得良好生產規范標準認證。遵照這種高標準會產生高生產成本,這意味著生物科技公司會充分利用其資源。

公司為了生產數十億劑疫苗不得不尋找額外產能,這個問題使制藥行業供應鏈當前的動態變化加快了速度,但這種變化能否長期持續下去,我們仍然需要拭目以待。

受到生產規模等因素的影響,制藥公司可能會自行建設生產設施,自行內部生產疫苗,或者租用定制研發生產組織的產能。

貝爾表示:“這給定制研發生產組織帶來了福音?!必悹柡涂ㄆ仗m在去年合作發布的一篇報告中指出,即使初期疫苗生產需求下降之后,定制研發生產組織獲得的好處可能會持續存在。

定制研發生產組織使小型生物科技公司既可以進行產品生產,又能夠節省不會頻繁投入使用的內部設施的維護開支。雖然疫情讓各國更加重視在國內生產疫苗和藥品,但行業觀察家們預測,大型制藥公司可能會繼續利用定制研發生產組織,應對國內的疫苗生產壓力。

在疫情期間,沒有成功研發出疫苗的制藥公司同意與取得成功的其他公司共享其內部產能。最近,美國總統喬·拜登宣布,默沙東計劃生產強生的疫苗,這將大幅增加疫苗供應。

但合作并不容易。

戴爾豪斯大學的病毒學家艾莉森·凱爾文指出:“有一個問題是,每家公司都針對各自產品的需求建設了生產設施,而且有時候這些產品并不重疊?!?/p>

疫情并不意味著對其他關鍵藥品的需求已經消失:治療其他疾病的藥物與以往一樣是必不可少的。凱爾文依舊強調,“創造性思維”使公司即使在非常規環境下,也可以展開合作,盡可能生產足夠多的疫苗。

疫苗供應鏈關鍵的最后一英里,也是制藥公司考慮的問題之一。

滑鐵盧大學的管理學教授侯賽因·阿博依·莫里茲表示,政府需要穩定的疫苗供應來推動大規模接種,但在當前這種前所未有的環境下,公司很難保證疫苗供應的可預測性。

但他相信目前出現的供應問題只是“成長的煩惱”。他說:“我確信,疫苗公司會擴大生產規模,未來我們的疫苗供應量會大幅增加?!?/p>

應對新冠疫情開啟了疫苗行業的新時代,多樣化將成為疫苗行業的新特征。

卡普拉稱:“我不認為疫情結束之后的疫苗市場會變得比疫情之前更加分散?!?/p>

過去,Moderna這種小公司最常見的結果是,在產品大有可為的階段,被大型制藥公司收購。但現在,當需求出現的時候,Moderna恰逢其時,能夠利用其創新能力,維持公司的獨立性。

從長遠來看,當前的局面對Moderna等公司以及Novavax和Inovio等小型創新公司的意義仍然有待觀察,但它們的創新有望幫助它們繞過收購階段,以更強有力的姿態進入市場。

主要的不確定因素依舊是新冠疫苗能夠在多長時間內維持盈利。

但隨著病毒變異和感染人數的持續增加,有一種可能性變得越來越高:人們可能都需要接種疫苗,或者變異病毒株要求人們重新接種疫苗,因此在今后很長一段時間里,新冠疫苗將必不可少。

莫里茲說:“問題在于,新冠肺炎是仍會在全球范圍內傳播流行,還是會變成一種地方性流行病。目前看來,新冠疫情似乎不會像我最初想象的那樣很快結束?!保ㄘ敻恢形木W)

翻譯:劉進龍

審校:汪皓

A rolled-up sleeve and a brief jab: That’s all it took to make history in December 2020. The world watched as the first doses of the Pfizer-BioNTech vaccine were administered, first in the U.K. and then followed quickly by the United States. In the months since, more than 265 million people around the world have received one or more doses of a COVID-19 vaccine.

These outcomes, literally years ahead of what experts expected, represent the most potent pharmaceutical response to a global health crisis ever mustered. But this triumph of biotechnology also signals a huge change for the for-profit industry currently engaged in figuring out the problem of how to produce enough vaccine doses to keep up with demand.

In January 2020, as the pandemic was brewing, the vaccine industry was dominated by four big companies: GlaxoSmithKline, Merck, Sanofi, and Pfizer. More than a year later, the picture has changed. Only one of these four companies has so far won the race to develop a COVID-19 vaccine: Pfizer, whose messenger RNA (mRNA) vaccine was found to provide 95% protection when used in a two-dose regimen. The company anticipates approximately $15 billion in revenue from its vaccine in 2021, which will represent nearly 30% of company revenue overall.

In the meantime, others—Moderna, AstraZeneca, Novavax—once on the periphery of market awareness, have become household names, and countries like China and Russia are developing homegrown vaccine industries. As COVID-19 starts to look like it’s here to stay, their success signals a sea change in the highly consolidated industry.

“For the pandemic, Pfizer is clearly going to be the leader in vax sales globally this year,” says Patrick Bell, a health care analyst at S&P Global. Moderna, a small biotech company catapulted into the limelight after producing an mRNA vaccine whose effectiveness is on par with Pfizer’s, is “going to enter as potentially No. 2,” Bell says. The company anticipates $18.4 billion in total product sales this year.

A changing industry

Making vaccines is costly and time-consuming, and vaccine revenues in any given year tend to be relatively small. Vaccines are a high-volume, low-price commodity, says David Kaplan, a health care analyst at S&P Global. “That has led to a lot of companies exiting the market,” he says. Before the pandemic, vaccines were a $33 billion industry, representing only 3% of the global pharmaceutical industry. The Big Four produced about 90% of the revenue in this sector.

Despite its small contribution to pharma industry revenues, the vaccines segment—like biotech more generally—has seen significant technological change in the past 30 years, which has driven remarkable growth, experts say. New vaccines for human papillomavirus (HPV) and shingles, for example, as well as improved vaccines for everything from influenza to measles, created a significant market.

But prior to the pandemic, the industry was in danger of getting stuck in a plateau between innovations. From the research and clinical trials needed to develop a successful vaccine candidate to the scale-up challenges of producing vaccines, companies need to invest billions of dollars. And there’s risk at most stages of the process: There’s no guarantee that primary research, which can take years, will lead to a successful vaccine or that demand once the vaccine is approved will be sufficient enough to make the vaccine worth producing.

Under normal circumstances, technological change in this environment can take decades. But because of the urgency of the COVID-19 pandemic, governments and industry poured funding into the search for a vaccine. A high level of collaboration between industry, governments, and academia has produced multiple successful vaccines in record time, in the process catapulting vaccine technology, and the connections required to produce it, into the future.

The development of nascent mRNA technology, which an international cohort of scientists and investors had been working on for more than 30 years, is the main example of this phenomena. “COVID has helped to accelerate some of the mRNA technology which was under development but would otherwise have proceeded at a slower pace,” says Bell.

Operation Warp Speed, the U.S. government’s $10-billion COVID-19 vaccine development initiative, created the environment that produced Moderna and Pfizer’s innovative vaccines. Moderna received about $1 billion in direct support as well as significant logistical support, while Pfizer received the government’s commitment that it would buy approximately $2 billion worth of its vaccine if successful.

Moderna, a small biotech company whose IPO was only in 2018, was in a unique position to leverage the funding environment created by Operation Warp Speed. Without the funding and expertise provided by Operation Warp Speed, it’s unlikely that a small biotech company could have mustered the funding for rounds of clinical trials and refinement of its drug candidate.

The company, together with other vaccine hopefuls, partnered with the National Institutes of Health to produce multiple vaccine candidates that would progress along the same trial lines. Its vaccine came out on top.

The race to develop vaccine candidates

The broader pharmaceutical industry has struggled to maintain momentum and preserve reputation over the past three decades during which mRNA technology was being developed. The COVID-19 pandemic offered the conditions to improve on both fronts: Companies immediately turned to their available stock of treatments to see if anything worked against the disease (nearly all available treatments weren’t useful) and dipped into stores of PPE for image-boosting opportunities to donate the scarce protective equipment to hospitals, care homes, and others in desperate need.

The big prize, though, was a vaccine. Literally hundreds of COVID-19 vaccine candidates went into development around the world in the course of 2020, many with the support of governments. “A very distributed development of the vaccine took place,” says Devendra Mishra, executive director of Bio Supply Management Alliance.

Mishra’s organization, which brings together members of the entire biotech supply chain, started producing a newsletter early on in the pandemic to help its members keep track of what was going on. As early as May, that newsletter started sharing material about the burgeoning race to develop a vaccine.

By the end of 2020, more than 200 vaccine candidates were still in development. The number of vaccines currently being used around the world is nearing double digits. The newest, developed by Johnson & Johnson’s pharmaceutical arm, Janssen, received an emergency use authorization (EUA) from the U.S. Food and Drug Administration on February 28.

The difficulty of developing new vaccines is illustrated by the fact that only one of the Big Four has so far succeeded in producing a working vaccine against COVID-19 on the abridged timeline. “Merck has abandoned plans on two of their vaccine candidates,” says Bell. “GlaxoSmithKline and Sanofi were working together on one, and they still are.” While the GSK-Sanofi vaccine could hit the market eventually, it’s not arriving soon, he says. GSK has also partnered with CureVac, a German biopharma company, to work on a next-generation mRNA vaccine.

Distribution challenges

While the distributed nature of vaccine development definitely contributed to the number of vaccines developed against COVID-19 in a short time, the demands of vaccine production on a mass scale—combined with unprecedented disruptions in the logistics network that transports raw materials and vaccines around the highly globalized pharmaceutical industry—have thrown the supply chain into disarray.

“The COVID-19 pandemic exposed the vulnerabilities of the supply chain of life sciences. It showed where our links are weak,” says Mishra.

The technology and raw materials needed to produce vaccines must be certified to good manufacturing practice (GMP) standards. The expense of production at this high standard means that the resources of biotech companies tend to be fully leveraged. The problem of finding additional capacity to manufacture literally billions of doses of vaccines has accelerated an ongoing shift in the dynamics of the pharmaceutical supply chain, although it remains to be seen if this shift will endure in the long term.

Depending on considerations like production scale, pharmaceutical companies either construct the facilities to make their products in house or they rent capacity from contract development and manufacturing organizations (CDMOs). “It has been very good for the CDMOs,” says Bell. He and Kaplan coauthored a report last year in which they noted that CDMO gains may endure even after initial vaccine production demand has subsided. The organizations allow small biotech companies to manufacture their products without the overhead of maintaining an in-house facility that will frequently not be in use. The pandemic has led to more focus on producing vaccines and medicines domestically, however, and industry-watchers anticipate that Big Pharma may continue to leverage CDMO capacity in response to pressure to produce vaccines in-country.

During the pandemic, pharma companies that haven’t produced a successful vaccine have agreed to share their in-house capacity with those who have. Most recently, President Joe Biden announced Merck’s intent to produce the Johnson & Johnson vaccine, radically increasing supply.

But collaborating isn’t always simple. “One of the problems is that each company has built their manufacturing facilities to what they need for their product, and sometimes there isn’t overlap,” says Alyson Kelvin, a virologist at Dalhousie University. And the pandemic doesn’t mean the need for other critical medications has stopped: Drugs for other conditions are just as necessary as ever. Still, Kelvin emphasizes that “out of the box thinking” has allowed companies to collaborate and make as many doses of the vaccine as possible, even in unconventional circumstances.

The critical last mile of the supply chain figures into pharmaceutical companies’ considerations as well. Governments need stable supply with good forecasting to initiate mass vaccination campaigns—something that companies have struggled to provide in this new context, says University of Waterloo management sciences professor Hossein Abouee Mehrizi. But he’s optimistic that the supply issues already encountered are just growing pains. “I am pretty sure companies are going to scale up, and we’ll get much more supply than we have now,” he says.

The COVID-19 pandemic response has kick-started a new era in the vaccine industry, one that will likely be shaped by diversification.

“I do think it’s true that we’ll probably see a more fragmented market coming out of COVID than going into COVID,” says Kaplan.

In the past, it was most common for small companies like Moderna to be purchased by Big Pharma once their product was at a promising stage. But, in this case, demand occurred just as Moderna was in the right place to exploit its innovation and keep its name. What that means in the longer term for companies like Moderna and other small innovators like Novavax and Inovio has yet to be seen, but their innovations may allow them to bypass the acquisition stage and enter the market as more significant players in their own right.

Major uncertainty remains regarding how long COVID-19 vaccines themselves will remain profitable. But as the virus continues to mutate and infections continue to occur, it’s appearing more and more likely that vaccines for COVID-19 will be necessary for some time to come, whether because people will need booster shots or because mutated strains will necessitate revaccination. “The question is, is it going to be pandemic or is it going to be endemic,” says Mehrizi. “At this point, it seems like it’s not going to end as fast as I thought in the beginning.”

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