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强生疫苗为何出现混乱?根源是供应链出了问题

强生疫苗为何出现混乱?根源是供应链出了问题

Richard Lardner, Linda Johnson, 美联社 2021年04月02日
这家公司负责疫苗供应链,虽然名不见经传,却是强生于今年5月底前向美国提供1亿剂疫苗的关键。

强生公司(Johnson & Johnson)之所以因为质量问题而放弃数量不详的新冠疫苗,主要是因为一家曾多次受到美国卫生官员提及的公司。

Emergent BioSolutions公司负责疫苗供应链,虽然名不见经传,却是强生于今年5月底前向美国提供1亿剂疫苗的关键。美联社(The Associated Press)通过《信息自由法》(Freedom of Information Act)获得的记录显示,美国食品与药品管理局(Food and Drug Administration)曾经多次指称该公司存在员工培训不力、药瓶破裂以及一处设施周围发霉等问题。相关记录主要包括2017年以来对应急设施的检查。

强生公司在3月31日表示,Emergent公司巴尔的摩工厂Bayview生产的一批疫苗因为不符合质量标准而无法使用。目前尚不清楚涉及多少剂量,也不清楚强生疫苗未来的交付计划会受多大影响。强生在一份声明中称,仍然计划6月底前交付1亿剂疫苗,并“争取在5月底完成”目标。

2020年4月,强生公司与少有人知的Emergent 公司展开合作,生产联邦政府资助的疫苗。根据美国食品与药品管理局的记录,当时Emergent旗下的Bayview工厂并无能力批量生产数百万剂新冠疫苗,美国食品与药品管理局称之为“无法生产分销产品”的合同测试实验室。Bayview生产疫苗之前技术和人员都要升级,才能够开始生产疫苗的“原料药”,而制造原料药需要让相关生物细胞生长,时间为两个月。

2020年4月,两家公司宣布合作时,美国食品与药品管理局检查了Emergent的Bayview工厂。根据美联社获得的记录,联邦机构批评该公司在检测炭疽潜在治疗方法存在问题。美国食品与药品管理局的首席研究员指出,该公司未能做到对员工进行必要培训,“以完成岗位所需特定操作,以及遵守良好的生产规范”。

同一天,强生公司在另一份新闻稿中宣称,与Emergent合作是为了向2021年年底供应全球10亿剂疫苗的目标迈出重要一步。(财富中文网)

译者:冯丰

强生公司(Johnson & Johnson)之所以因为质量问题而放弃数量不详的新冠疫苗,主要是因为一家曾多次受到美国卫生官员提及的公司。

Emergent BioSolutions公司负责疫苗供应链,虽然名不见经传,却是强生于今年5月底前向美国提供1亿剂疫苗的关键。美联社(The Associated Press)通过《信息自由法》(Freedom of Information Act)获得的记录显示,美国食品与药品管理局(Food and Drug Administration)曾经多次指称该公司存在员工培训不力、药瓶破裂以及一处设施周围发霉等问题。相关记录主要包括2017年以来对应急设施的检查。

强生公司在3月31日表示,Emergent公司巴尔的摩工厂Bayview生产的一批疫苗因为不符合质量标准而无法使用。目前尚不清楚涉及多少剂量,也不清楚强生疫苗未来的交付计划会受多大影响。强生在一份声明中称,仍然计划6月底前交付1亿剂疫苗,并“争取在5月底完成”目标。

2020年4月,强生公司与少有人知的Emergent 公司展开合作,生产联邦政府资助的疫苗。根据美国食品与药品管理局的记录,当时Emergent旗下的Bayview工厂并无能力批量生产数百万剂新冠疫苗,美国食品与药品管理局称之为“无法生产分销产品”的合同测试实验室。Bayview生产疫苗之前技术和人员都要升级,才能够开始生产疫苗的“原料药”,而制造原料药需要让相关生物细胞生长,时间为两个月。

2020年4月,两家公司宣布合作时,美国食品与药品管理局检查了Emergent的Bayview工厂。根据美联社获得的记录,联邦机构批评该公司在检测炭疽潜在治疗方法存在问题。美国食品与药品管理局的首席研究员指出,该公司未能做到对员工进行必要培训,“以完成岗位所需特定操作,以及遵守良好的生产规范”。

同一天,强生公司在另一份新闻稿中宣称,与Emergent合作是为了向2021年年底供应全球10亿剂疫苗的目标迈出重要一步。(财富中文网)

译者:冯丰

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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