在2020年3月至2022年2月期间，疫苗制造商Emergent BioSolutions被迫丢弃或销毁了多达4亿份疫苗冠状病毒根据周二公布的一份国会报告，疫苗剂量是由于成分污染造成的，这一数字是这家陷入困境的公司此前披露的五倍多。

调查这家总部位于马里兰州的生物技术公司的国会调查人员发现，紧急情况下，高管们私下提出了紧急质量控制问题甚至在该公司开始生产疫苗的关键成分之前——尽管该公司公开表示对其履行数百万美元政府合同的能力有信心。

与此同时，根据该报告，紧急实验室的工作人员故意试图误导政府检查人员对其马里兰州湾景工厂问题的看法，并一再“拒绝”阿斯利康和强生公司检查其设施的努力。

众议院监督和改革委员会主席、纽约州民主党人卡罗琳·马洛尼(Carolyn Maloney)在谈到这份报告时表示，“尽管其疫苗生产设施存在重大危险信号，但Emergent的高管们掩盖了这些问题，并继续攫取纳税人的钱。”这份报告认定，该公司的“生产失败和欺骗性策略”导致了成分的大规模浪费，而这些成分本可以帮助制造数百万剂疫苗。

委员会说，没有一批受影响的有问题的成分进入Emergent工厂生产的成品疫苗。

一位紧急发言人表示，该公司从寻求置评的新闻媒体那里得知了国会的报告，但没有回答ABC新闻的一系列详细问题。

发言人说:“Emergent一直对美国食品和药物管理局、国会和我们的合作伙伴开放和坦诚，介绍我们在Bayview网站的工作和遇到的挑战，包括提供数千份文件，自愿参加国会听证会，并邀请他们参观我们的设施。”

周二，众议院监督委员会和众议院冠状病毒危机小组委员会的联合报告汇总了他们对Emergent质量控制问题长达一年的调查结果。作为努力的一部分，委员会调查人员获得了内部紧急电子邮件，并采访了几位关键证人，包括美国美国食品药品监督管理局的高级官员。

2020年6月，Emergent从食品药品监督管理局获得了一份6.28亿美元的合同，帮助在其湾景工厂开发强生和阿斯利康疫苗，作为特朗普政府快速疫苗开发计划“曲速行动”(Operation Warp Speed)的一部分。

但是根据委员会的报告，湾景镇出现了问题甚至在该公司获得疫苗开发协议之前。在2020年春季的一系列内部电子邮件中，高管和经理们对该公司对2020年4月FDA审计的回应表示越来越担忧，该审计发现了令人不安的安全缺陷。

Sipa美国通过美联社，文件

一个标志标志着巴尔蒂姆紧急生物解决方案所占用的设施的入口

时任紧急执行官的肖恩·柯克(Sean Kirk)在2020年6月给一位质量控制经理的电子邮件中写道，这种情况“令人深感担忧”，并要求他“解决这个问题”。在同一天与另一位同事的电子邮件通信中，柯克写道，湾景工厂质量控制系统的“改进空间”是“一个巨大的轻描淡写。”

然而，从表面上看，该公司声称其与美国政府机构的长期关系——包括开发炭疽疫苗的多份合同——是其能力的证明。但是内部，报告说，警钟继续响起，对湾景准备的焦虑增加。

柯克在2020年6月底写给Emergent首席执行官罗伯特·克拉莫的信中写道:“在我们必须交付的所有事情中，让我夜不能寐的是对bayview质量体系状态的总体看法。”。

根据国会的报告，对Bayview质量控制的担忧在2020年秋季达到了白热化，因为在2020年9月FDA检查之前的内部备忘录表明，高管们完全意识到疫苗开发开始后几个月质量控制措施的差距。

据报道，Emergent的质量高级主管在一封内部电子邮件中写道:“我们还没有完全符合要求，但我们现在正在生产(疫苗)批次。”。“我们的风险很高!”

根据委员会获得的一封电子邮件，2020年11月，一家外部公司的顾问警告该公司，“最终Emergent将不得不决定他们愿意接受什么程度的风险，但这是你最好听我的，并完全按照我说的去做。”

“我非常大声地声明，这项工作是不合规的，”顾问说。"以及直接的监管风险."

根据该报告，2020年11月访问湾景的阿斯利康代表抱怨说，“缺乏基本要素是造成生物负担问题的原因之一”，而且“清洁不良是持续污染的根本原因之一”。

报道称，Emergent高管在内部电子邮件中承认，在急于扩大生产的过程中，该公司雇佣了“很少或没有制药经验”的临时员工，并描述了其设施中“堆积”的垃圾。FDA领导人告诉委员会，Emergent“雇用了许多不熟悉疫苗制造的人，他们没有接受过足够的培训”——这是早在2020年4月就直接传达给Emergent的信息。

委员会发现，尽管有这些危险信号，Emergent“并没有解决问题，问题在[Bayview]工厂持续了几个月。”该委员会写道，从2020年底到2021年初，湾景的一系列污染导致了足够生产2.4亿剂疫苗药物成分的处置。

“调查显示，这些问题的影响比以前所知的更大，”该委员会在报告中说，“污染事件和被销毁的疫苗(成分)比以前紧急事件披露的要多数百万。”

2021年2月，在制造商加强质量控制的压力下，Emergent显然“拒绝了强生质量人员访问Bayview的多次请求，”该委员会写道。大约在同一时间，该委员会发现，湾景实验室的工作人员试图在食品和药物管理局现场视察之前隐瞒他们失败的程度。

根据Emergent的一名外部顾问写的一封电子邮件，委员会获得了该邮件，就在FDA检查员开始巡视该设施的一个小时前，Emergent的员工取消了两批强生疫苗药物成分的质量保证“保留标签”。“保留标签”是亮黄色的，表明这些批次可能有质量问题。

该顾问写道:“由于在美国食品和药物管理局视察前后，这些标签被认为是必要的，根据我观察到的和被告知的全部情况，我的理解是，取消QA(质量保证)保留标签的目的是为了避免在美国食品和药物管理局视察期间引起对这两个容器的注意。”。

在他们的报告中，委员会表示，紧急情况下的高级领导人知道标签的移除，这一事件相当于“明显试图阻碍监督”。FDA检查员在2021年2月访问该工厂时“仍然发现了严重的问题”，但直到2021年4月才停止该工厂的生产，此前Emergent向拜登政府发出了交叉污染事件的警告。

FDA生物制品评估和研究中心主任Peter Marks博士在一份简报中告诉委员会，FDA领导人和检查员对他们给予紧急情况的宽大处理程度负有一定责任。

报道称，马克斯对委员会成员说:“我们感到羞耻，因为我们认为(Emergent)的制造经验将意味着他们能够向前迈进，以高质量的方式制造疫苗，这是我们对一个有经验的疫苗制造商的期望。”。

2021年5月，在国会举行的听证会上，Emergent高管表示，该公司希望“在未来几天”恢复疫苗生产。根据委员会的说法，这并没有发生;三个月过去了，监管机构才允许Emergent在2021年8月恢复疫苗生产。但即便如此，问题依然存在。

从2021年8月到2022年2月，该委员会发现Emergent制造了15批新的强生疫苗，其中6批——相当于9000万剂疫苗——“被强生公司中止或拒绝。”

总的来说，Emergent被迫丢弃或销毁了价值高达4亿剂的成分，这些成分有助于制造冠状病毒疫苗。公司高管此前认为这个数字为7500万。

2021年11月，拜登政府取消了Emergent继续开发疫苗的合同，当时该合同预计将向该公司支付额外的3.2亿美元。

但根据委员会的说法，真正的受害者是那些本应从未能实现的4亿剂药物中受益的人。

“Emergent的失败浪费了数亿纳税人的钱，并影响了我们国家满足全球对冠状病毒疫苗的迫切需求的能力，”报告总结道。

这位紧急发言人告诉美国广播公司新闻，该公司“仍然致力于成为美国及其盟国政府值得信赖的合作伙伴...[并且]将继续利用我们20多年的公共卫生准备经验，帮助形成一种全方位的方法，以帮助应对即将到来的公共卫生挑战。”

今年2月7日，Emergent告诉委员会，其Bayview工厂正进入“维修停工期”。该公司表示，希望在2022年8月恢复生产。

Emergent仍然保持着开发炭疽疫苗的联邦合同。

Emergent BioSolutions discarded ingredients for 400 million COVID-19 vaccines, probe finds

Between March 2020 and February 2022, vaccine-maker Emergent BioSolutions was forced to discard or destroy up to 400 millioncoronavirusvaccine doses due to the contamination of ingredients, according to a congressional report published Tuesday -- a figure that reflects more than five times what was previously disclosed by the beleaguered firm.

Congressional investigators probing the Maryland-based biotech company found that Emergent executives had privately raised urgentquality-control concernseven before the company began manufacturing the vaccines' key ingredient -- despite publicly expressing confidence in their ability to deliver on their multimillion-dollar government contract.

Meanwhile, according to the report, Emergent lab workers intentionally sought to mislead government inspectors about issues at its Bayview, Maryland, plant, and repeatedly "rebuffed" efforts by AstraZeneca and Johnson & Johnson to inspect their facilities.

"Despite major red flags at its vaccine manufacturing facility, Emergent's executives swept these problems under the rug and continued to rake in taxpayer dollars," House Oversight and Reform Committee Chairwoman Carolyn Maloney, D-N.Y., said of the report, which determined that the company's "manufacturing failures and deceptive tactics" led to the largescale waste of ingredients that could have helped make millions of vaccine doses.

None of the compromised batches of the ingredient in question made it into finished vaccine doses released from Emergent's plant, the committees said.

An Emergent spokesperson said the firm learned of the congressional report from news outlets who reached out seeking comment, and did not address a list of detailed questions from ABC News.

"Emergent has been open and forthcoming with the FDA, Congress and our partners about the work at our Bayview site and the challenges that were encountered, including providing thousands of documents, willingly participating in a congressional hearing and inviting them to visit our facilities," the spokesperson said.

Tuesday's joint report from the House Oversight Committee and the House Subcommittee on the Coronavirus Crisis aggregates the findings of their yearlong probe into Emergent's quality control issues. As part of their efforts, committee investigators secured internal Emergent emails and interviewed several key witnesses, including senior officials from the U.S. Food and Drug Administration.

Emergent landed a $628 million contract from the Food and Drug Administration in June 2020 to help develop Johnson & Johnson and AstraZeneca vaccines at its Bayview facility as part of Operation Warp Speed, the Trump administration's rapid vaccine development program.

But according to the committees' report,issues at Bayview aroseeven before the firm secured its vaccine-development deal. In a flurry of internal emails during the spring of 2020, executives and managers expressed a growing concern with the firm's response to an April 2020 FDA audit that identified troubling safety deficiencies.

Sean Kirk, at the time an Emergent executive, wrote in a June 2020 email to a quality-control manager that the situation was "deeply concerning" and demanded that he "fix this." In email correspondence with another colleague that same day, Kirk wrote that "room for improvement" in the Bayview plant's quality control systems "is a huge understatement."

Outwardly, however, the firm claimed its longstanding relationship with U.S. government agencies -- which included multiple contracts to develop anthrax vaccines -- was evidence of its competence. But internally, said the report, alarm bells continued to sound -- and anxiety over Bayview's readiness grew.

"Of all the things we have to deliver on [Operation Warp Speed], the thing that keeps me up at night is overall perception of state of quality systems at bayview [sic]," Kirk wrote to Emergent CEO Robert Kramer in late June 2020.

The drumbeat of concern over quality control at Bayview reached a fever pitch in the fall of 2020, as internal memos ahead of a September 2020 FDA inspection indicated that executives were fully aware of gaps in quality control measures for months after vaccine development began, according to the congressional report.

"We are not in full compliance yet -- BUT -- we are making [vaccine] batches NOW," Emergent's senior director of quality wrote in an internal email, according to the report. "Our risk is high!"

In November 2020, according to an email obtained by the committees, a consultant with an outside firm warned the company that "ultimately Emergent will have to decide what level of risk they are willing to accept, but this is one of those where you really better listen to me and do exactly what I tell you to."

"I am stating very loudly that this work is NON-compliant," the consultant said. "And a direct regulatory risk."

AstraZeneca representatives who visited Bayview in November 2020 complained that "a lack of fundamentals [was] contributing to bioburden issue," and that "poor cleaning was part of the root cause" of the persistent contaminations, per the report.

Emergent executives acknowledged in internal emails that, in its rush to ramp up production, it hired temporary employees with "little or no pharmaceutical experience," and described trash "piling up" in its facilities, said the report. FDA leaders told the committees that Emergent "hired a lot of individuals not as familiar with vaccine manufacturing, that did not have adequate training to do so" -- a message it conveyed directly to Emergent as early as April 2020.

The committee found that despite these red flags, Emergent "did not remediate the issues, and problems persisted at the [Bayview] facility for months." And from late 2020 to early 2021, the committee wrote, a series of contaminations at Bayview led to the disposal of enough vaccine drug ingredients to produce 240 million doses.

"The investigation has revealed that the impact of these issues is larger than previously known," the committee said in its report, "with more incidents of contamination and millions more vaccines [ingredients] destroyed than previously revealed by Emergent."

In February 2021, under pressure from manufacturers to tighten up quality controls, Emergent apparently "rebuffed multiple requests from Johnson & Johnson's quality staff to access Bayview," the committee wrote. Around the same time, the committee found that Bayview lab workers sought to hide the extent of their failures prior to an FDA site visit.

According to an email written by one of Emergent's external consultants and obtained by the committees, Emergent employees removed quality-assurance "hold tags" from two batches of Johnson & Johnson vaccine drug ingredients just one hour before FDA inspectors began their tour of the facility. The "hold tags" were bright yellow and indicated that those batches may have quality issues.

"Since the tags were deemed necessary before and after the FDA's visit, it is my understanding, based on the entirety of what I observed and was told, that the purpose of removing the QA [quality assurance] hold tags was to avoid drawing attention to the two subject containers during the tour by the FDA inspectors," the consultant wrote.

In their report, the committees indicated that senior leaders at Emergent were aware of the removal of the tags, and that the incident amounted to an "apparent attempt to impede oversight." The FDA inspectors "still identified serious concerns" during their visit to the site in February 2021, but did not halt production at the facility until April 2021, after Emergent alerted the Biden administration to its cross-contamination incidents.

Dr. Peter Marks, director of FDA's Center for Biologics Evaluation and Research, told the committees in a briefing that FDA leaders and inspectors bore some responsibility for the extent of leniency they granted Emergent.

"Shame on us for thinking that [Emergent's] experience in manufacturing would mean they would be able to move ahead and make the vaccines in a high-quality manner that we would expect for an experienced vaccine manufacturer," Marks told committee members, according to the report.

In May 2021, during a hearing before the Congress, Emergent executives said the company hoped to resume production of the vaccines "in the coming days." According to the committees, that didn't happen; three months passed before regulators allowed Emergent to resume vaccine manufacturing in August 2021. But even then, the problems persisted.

From August 2021 to February 2022, the committee found that Emergent manufactured 15 new batches of Johnson & Johnson vaccine, six of which -- the equivalent of 90 million vaccine doses -- "were either aborted or rejected by Johnson & Johnson."

All told, Emergent was forced to discard or destroy up to 400 million doses' worth of the ingredient that helps make the coronavirus vaccine. Company executives had previously pegged the number at 75 million.

In November 2021, the Biden administration canceled Emergent's contract to continue developing vaccines, which at the time would have paid the company an estimated additional $320 million.

But the real victims, according to the committees, are those who would have benefitted from the 400 million doses that failed to materialize.

"Emergent's failures wasted hundreds of millions of taxpayer dollars and impacted our country's ability to meet the urgent, global need for coronavirus vaccines," the report concludes.

The Emergent spokesperson told ABC News that the company "remains committed to being a trusted partner of the U.S. and allied governments ... [and] will continue to use our more than 20 years of public health preparedness experience to help inform an all-of-the-above approach to help prepare for the public health challenges to come."

On Feb. 7 of this year, Emergent told the committees that its Bayview plant was entering a "maintenance shutdown period." The company said it hopes to resume manufacturing in August 2022.

Emergent still maintains a federal contract to develop anthrax vaccines.