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New York Times

Top officials warned that COVID vaccine factories “must be closely monitored”

Washington — In June, Federal Pandemic Chief Executive Officer lacks well-trained staff for quality control by government contractor Emergent BioSolutions, which discarded millions of COVID-19 vaccines last month due to pollution. I warned that there was a problem. A copy of the official assessment obtained by the New York Times cited the “major risk” of relying on emergencyrs to produce vaccines developed by both Johnson & Johnson and AstraZeneca at the Emergency Bayview plant in Baltimore. .. This undisclosed assessment is based in part on a factory visit shortly after the government signed a contract worth up to $ 628 million with Emergency, primarily producing coronavirus vaccines as part of Operation Warp Speed. It was for preparing the factory. .. Sign up for the morning newsletter from The New York Times. “It takes a lot of effort” to deal with the problem, and the company “needs to be closely monitored,” said a report written by manufacturing expert Carlo de Notaristefani. .. Supervised the production of COVID-19 vaccine for the federal government from May. Although marked as a draft, federal officials said the report was considered final. Ten months after his report, the plant was a major headache for the team appointed by President Joe Biden to oversee the pandemic response. The Times reported on Tuesday a number of quality control issues flagged by audits and investigations by AstraZeneca, Johnson & Johnson, two federal agencies, and Emergent’s own quality evaluators. Federal officials ordered the factory to make major changes at the end of last month after it was revealed that Emergent had to vaccinate Johnson & Johnson 13 to 15 million times. It’s not clear what will happen to another 62 million doses of factory-produced vaccine, or whether Johnson & Johnson will be able to deliver the 24 million doses promised to the federal government by the end of the month. So far, the Food and Drug Administration has not authorized factories to distribute official doses, and authorities expect to do so until they carry out a thorough review that can take weeks. Not. When asked about the June report, a spokesman for the company said Wednesday night that “Emergent’s top priority will continue to be the strengthening of Johnson & Johnson’s highly needed COVID-19 vaccine supply chain.” Officials from the Byden administration have enough doses for the government to cover the majority of the country’s approximately 260 million adults from two other federal-licensed vaccine makers (Pfizer-BioNTech and Moderna). Claims to be. However, federal officials are still concerned about the emergency issue, as the federal government has invested heavily in the plant and, if the problem remains unresolved, could affect global vaccine supply. .. AstraZeneca was expected to meet most of its global needs, but safety concerns overturned those plans. British officials said Wednesday that people under the age of 30 should not take the AstraZeneca vaccine, and European Union officials said there was a “potential link” between the vaccine and a rare but anxious blood clot. He said he had found that. It makes Johnson & Johnson vaccines more important, experts say. Emergent was forced to abandon the Johnson & Johnson dose after the checks revealed contamination with the virus used to make the AstraZeneca vaccine. Investigations are currently underway, but federal and former company officials have moved from the AstraZeneca section of the factory to the Johnson & Johnson section without employees taking a shower or taking other precautions. I suspect the lot has been contaminated. Between October and January, Emergent discarded five lots of AstraZeneca vaccine (equivalent to two to three million doses each) because of contamination or suspected contamination, according to The Times. By giving Emergent an important role in responding to the coronavirus, the government expected the company to fulfill its promises more than eight years ago. To secure a domestic supply of vaccines in the pandemic, the government signed a $ 163 million contract with Emergent in 2012 to prepare for mass production of the Baltimore plant in the event of a crisis. However, de Notaristefani writes that Emergent used this site primarily for small development projects. In order to produce large quantities of COVID-19 vaccine, the company “needs to strengthen” quality control and requires “great resources and commitment”. His report was based in part on a June 4 factory visit, information provided by the company, and a conversation with the Biomedical Advanced Research and Development Authority, the federal agency that awarded Emergent a manufacturing contract. It is unclear what action the Trump administration has taken in response, or whether the Biden administration has considered the findings before recent problems arose. De Notaristefani, a former CEO of two major pharmaceutical companies, cited “serious” personnel issues and said plans to increase staff were “insufficient for the company to manufacture at the speed it needed.” He also said that audits by individual companies that adopted the FDA and Emergent “emphasized the need for extensive training of human resources and enhanced quality capabilities.” Nonetheless, he writes that “organizations have the necessary experience / ability” to scale up manufacturing. “Management appears to be knowledgeable and confident,” he said, “with close government oversight,” risk can be mitigated. ” At the time of the visit, Emergent also planned to produce a third COVID-19 vaccine developed by Novavax, which has since partnered with another manufacturer with government support. “Offloading the Novavax program to another facility can also help offload Emergent Bayview,” writes de Notaristefani. Emergent is a longtime federal contractor in the field of biodefense. Sales of anthrax vaccines accounted for almost half of the $ 500 million annual budget of strategic national stockpiles for most of the last decade, the Times reported last month. As a result, the government needed less money for the items needed for the pandemic, and last year the shortage of basic medicines in stockpiles symbolized the government’s failure to respond to the coronavirus. The original federal contract for the Baltimore plant required Emergent to demonstrate the large-scale production of a pandemic influenza vaccine, which health officials envisioned as a pressure test of its capacity, but Emergent. Hasn’t done so yet, the Times reported on Tuesday. The company was at risk of defaulting on its original transaction, which was due in June 2020. The company also has separate contracts with two vaccine manufacturers worth more than $ 875 million. To solve the factory’s problems, federal authorities have simplified Emergent’s mission, limiting it to Johnson & Johnson vaccine production only, and forcing AstraZeneca to move its production line to another location. Although Johnson & Johnson now claims to have direct control over manufacturing, the workforce at the factory in southeastern Baltimore is still emergent. The existence of a rating of de Notaristefani was previously reported by Politico, but the details were previously unknown. White House spokeswoman Jen Psaki was asked about Wednesday’s report and said, “We’ll need to find out more.” De Notaristefani’s concerns were repeated by two former factory supervisors who spoke on condition of anonymity for fear of career impact. In an interview with The Times, they cited the overwhelming workload and shortcuts taken to meet unrealistic schedules. De Notaristefani said Emergent plans to increase the factory workforce to nearly 300 people. According to a spokesman for the company, there are currently 600 workers. Still, former supervisors said employees were overwhelmed and some were forced to work more than 70 hours a week. Looking at the company’s logs for several months, which The Times obtained, employees repeatedly stated that they were deviating from manufacturing standards due to staff shortages and reduced production times. This article was originally published in The New York Times. © 2021 The New York Times Company

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