強(qiáng)生疫苗為何出現(xiàn)混亂？根源是供應(yīng)鏈出了問(wèn)題
Richard Lardner, Linda Johnson, 美聯(lián)社
2021-04-02
強(qiáng)生公司（Johnson & Johnson）之所以因?yàn)橘|(zhì)量問(wèn)題而放棄數(shù)量不詳?shù)男鹿谝呙?，主要是因?yàn)橐患以啻问艿矫绹?guó)衛(wèi)生官員提及的公司。
Emergent BioSolutions公司負(fù)責(zé)疫苗供應(yīng)鏈,，雖然名不見(jiàn)經(jīng)傳,，卻是強(qiáng)生于今年5月底前向美國(guó)提供1億劑疫苗的關(guān)鍵。美聯(lián)社（The Associated Press）通過(guò)《信息自由法》（Freedom of Information Act）獲得的記錄顯示,，美國(guó)食品與藥品管理局（Food and Drug Administration）曾經(jīng)多次指稱該公司存在員工培訓(xùn)不力,、藥瓶破裂以及一處設(shè)施周圍發(fā)霉等問(wèn)題。相關(guān)記錄主要包括2017年以來(lái)對(duì)應(yīng)急設(shè)施的檢查,。
強(qiáng)生公司在3月31日表示,，Emergent公司巴爾的摩工廠Bayview生產(chǎn)的一批疫苗因?yàn)椴环腺|(zhì)量標(biāo)準(zhǔn)而無(wú)法使用。目前尚不清楚涉及多少劑量,，也不清楚強(qiáng)生疫苗未來(lái)的交付計(jì)劃會(huì)受多大影響,。強(qiáng)生在一份聲明中稱，仍然計(jì)劃6月底前交付1億劑疫苗,，并“爭(zhēng)取在5月底完成”目標(biāo),。
2020年4月，強(qiáng)生公司與少有人知的Emergent 公司展開(kāi)合作,，生產(chǎn)聯(lián)邦政府資助的疫苗,。根據(jù)美國(guó)食品與藥品管理局的記錄，當(dāng)時(shí)Emergent旗下的Bayview工廠并無(wú)能力批量生產(chǎn)數(shù)百萬(wàn)劑新冠疫苗,，美國(guó)食品與藥品管理局稱之為“無(wú)法生產(chǎn)分銷產(chǎn)品”的合同測(cè)試實(shí)驗(yàn)室,。Bayview生產(chǎn)疫苗之前技術(shù)和人員都要升級(jí)，才能夠開(kāi)始生產(chǎn)疫苗的“原料藥”,，而制造原料藥需要讓相關(guān)生物細(xì)胞生長(zhǎng),，時(shí)間為兩個(gè)月。
2020年4月,，兩家公司宣布合作時(shí),，美國(guó)食品與藥品管理局檢查了Emergent的Bayview工廠。根據(jù)美聯(lián)社獲得的記錄,，聯(lián)邦機(jī)構(gòu)批評(píng)該公司在檢測(cè)炭疽潛在治療方法存在問(wèn)題,。美國(guó)食品與藥品管理局的首席研究員指出，該公司未能做到對(duì)員工進(jìn)行必要培訓(xùn),，“以完成崗位所需特定操作,，以及遵守良好的生產(chǎn)規(guī)范”。
同一天,，強(qiáng)生公司在另一份新聞稿中宣稱,，與Emergent合作是為了向2021年年底供應(yīng)全球10億劑疫苗的目標(biāo)邁出重要一步,。（財(cái)富中文網(wǎng)）
譯者：馮豐
強(qiáng)生公司（Johnson & Johnson）之所以因?yàn)橘|(zhì)量問(wèn)題而放棄數(shù)量不詳?shù)男鹿谝呙纾饕且驗(yàn)橐患以啻问艿矫绹?guó)衛(wèi)生官員提及的公司,。
Emergent BioSolutions公司負(fù)責(zé)疫苗供應(yīng)鏈,，雖然名不見(jiàn)經(jīng)傳，卻是強(qiáng)生于今年5月底前向美國(guó)提供1億劑疫苗的關(guān)鍵,。美聯(lián)社（The Associated Press）通過(guò)《信息自由法》（Freedom of Information Act）獲得的記錄顯示，美國(guó)食品與藥品管理局（Food and Drug Administration）曾經(jīng)多次指稱該公司存在員工培訓(xùn)不力,、藥瓶破裂以及一處設(shè)施周圍發(fā)霉等問(wèn)題,。相關(guān)記錄主要包括2017年以來(lái)對(duì)應(yīng)急設(shè)施的檢查。
強(qiáng)生公司在3月31日表示,，Emergent公司巴爾的摩工廠Bayview生產(chǎn)的一批疫苗因?yàn)椴环腺|(zhì)量標(biāo)準(zhǔn)而無(wú)法使用,。目前尚不清楚涉及多少劑量，也不清楚強(qiáng)生疫苗未來(lái)的交付計(jì)劃會(huì)受多大影響,。強(qiáng)生在一份聲明中稱,，仍然計(jì)劃6月底前交付1億劑疫苗，并“爭(zhēng)取在5月底完成”目標(biāo),。
2020年4月,，強(qiáng)生公司與少有人知的Emergent 公司展開(kāi)合作，生產(chǎn)聯(lián)邦政府資助的疫苗,。根據(jù)美國(guó)食品與藥品管理局的記錄,，當(dāng)時(shí)Emergent旗下的Bayview工廠并無(wú)能力批量生產(chǎn)數(shù)百萬(wàn)劑新冠疫苗，美國(guó)食品與藥品管理局稱之為“無(wú)法生產(chǎn)分銷產(chǎn)品”的合同測(cè)試實(shí)驗(yàn)室,。Bayview生產(chǎn)疫苗之前技術(shù)和人員都要升級(jí),，才能夠開(kāi)始生產(chǎn)疫苗的“原料藥”，而制造原料藥需要讓相關(guān)生物細(xì)胞生長(zhǎng),，時(shí)間為兩個(gè)月,。
2020年4月，兩家公司宣布合作時(shí),，美國(guó)食品與藥品管理局檢查了Emergent的Bayview工廠,。根據(jù)美聯(lián)社獲得的記錄，聯(lián)邦機(jī)構(gòu)批評(píng)該公司在檢測(cè)炭疽潛在治療方法存在問(wèn)題,。美國(guó)食品與藥品管理局的首席研究員指出,，該公司未能做到對(duì)員工進(jìn)行必要培訓(xùn)，“以完成崗位所需特定操作,，以及遵守良好的生產(chǎn)規(guī)范”,。
同一天，強(qiáng)生公司在另一份新聞稿中宣稱,，與Emergent合作是為了向2021年年底供應(yīng)全球10億劑疫苗的目標(biāo)邁出重要一步,。（財(cái)富中文網(wǎng)）
譯者：馮豐
The company at the center of quality problems that led Johnson & Johnson to discard an unknown amount of its coronavirus vaccine has a string of citations from U.S. health officials for quality control problems.
Emergent BioSolutions, a little-known company at the center of the vaccine supply chain, was a key to Johnson & Johnson’s plan to deliver 100 million doses of its vaccine to the U.S. by the end of May. But the company has been cited repeatedly by the Food and Drug Administration for problems such as poorly trained employees, cracked vials and mold around one of its facilities, according to records obtained by The Associated Press through the Freedom of Information Act. The records cover inspections at Emergent facilities since 2017.
Johnson & Johnson said on March 31 that a batch of vaccine made by Emergent at its Baltimore factory, known as Bayview, can’t be used because it didn’t meet quality standards. It was unclear how many doses were involved or how the problem would affect future deliveries of J&J’s vaccine. The company said in a statement it was still planning to deliver 100 million doses by the end of June and was “aiming to deliver those doses by the end of May.”
J&J locked arms with Emergent in April 2020, enlisting the lesser-known company to manufacture the vaccine J&J was developing with federal funding. At the time, Emergent’s Bayview facility wasn’t scaled for making millions of doses of a potential COVID-19 vaccine, according to the FDA records that describe the plant as a contract testing laboratory that “did not manufacture products for distribution.” Upgrades in technology and personnel were required before Bayview could begin making what’s known as “drug substance” material for the vaccine, a two-month process during which the required biological cells are grown.
The FDA inspected Emergent’s Bayview plant in April 2020, just as the agreement with J&J was being announced. The federal agency criticized the company for problems with its testing of a potential treatment for anthrax, according to the records obtained by the AP. The FDA’s lead investigator cited the company for failing to train employees “in the particular operations they perform as part of their function and current good manufacturing practices.”
On the same day, Johnson & Johnson, in a separate news release, heralded its partnership with Emergent as a step toward the pharmaceutical giant’s goal of supplying more than 1 billion doses of the vaccine globally by the end of 2021.
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