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America is losing its religion – and the effects will be long lasting

The New York Times

US bets big on COVID vaccine maker even as problems mount

WASHINGTON – More than eight years ago, the federal government invested in an insurance policy against vaccine shortages during a pandemic. He paid Emergent BioSolutions, a Maryland biotech company known for producing anthrax vaccines, to have a plant in Baltimore always ready. When the coronavirus pandemic arrived, the plant became the primary U.S. manufacturing site for COVID-19 vaccines developed by Johnson & Johnson and AstraZeneca, producing around 150 million doses last week. But so far no dose has been usable because regulators have yet to certify the plant to allow the vaccine to be distributed to the public. Last week, Emergent said it would destroy up to 15 million doses of the Johnson & Johnson vaccine after the discovery of contamination with the AstraZeneca vaccine. Sign up for The Morning newsletter of the New York Times Emergent and government health officials have long touted their partnership as a success, but a New York Times review of manufacturing practices at the Baltimore plant found serious issues, including a corporate culture that often ignores or underhanded missteps and a government sponsor, the Biomedical Advanced Research and Development Authority, which has acted more like a partner than a police officer. Previously undisclosed internal documents and interviews with current and former federal officials and former company employees describe a factory that was ill-equipped to take on such a gigantic manufacturing task, despite Emerging being awarded a federal contract. $ 163 million to upgrade and prepare for the facility. for high volume production. The loss of Johnson & Johnson doses was not the first time the company has thrown out a coronavirus vaccine for fear of contamination. Between early October and January, Emergent threw away five batches of AstraZeneca vaccine – each the equivalent of 2-3 million doses – due to contamination or suspected contamination, according to internal newspapers, a government official. and a former company supervisor. Audits and investigations – including those conducted in 2020 by Johnson & Johnson, AstraZeneca, two federal agencies, and Emerg’s own quality assessors – found that Emerg had failed to follow certain basic industry standards. at the Baltimore plant and identified repeated gaps in disinfection and prevention efforts. contamination. While audits still uncover problems, federal officials and outside experts said the trend of breaches suggested deeper quality issues. “These are the fundamental steps,” said Dr. Ajaz Hussain, a pharmaceutical quality expert who oversaw the efforts of the Food and Drug Administration to ensure the quality of drug development and manufacture from 2000 to 2005. “Si you make mistakes or mistakes in the fundamentals, what is wrong with your system? That would be my question. An audit conducted for AstraZeneca specifically highlighted the risks of viral cross-contamination, which experts believed was responsible for contaminating millions of doses of Johnson & Johnson, according to a review of the confidential Times document. Audits and investigations have also highlighted a persistent mold problem in areas to be kept clean, poor disinfection of some plant equipment leading to bacteria growth, repeated approval of raw materials that were missing. not fully tested and inadequate training of some employees. . Given that other manufacturers are now producing so many doses of the COVID-19 vaccine, it does not appear that the disruptions in Baltimore are upending the Biden administration’s accelerated schedule for vaccine supply and availability. But health experts fear the revelations will exacerbate safety concerns and make some people more wary of vaccines. Emergent is a longtime government entrepreneur who has spent much of the past two decades cornering a lucrative market for federal biodefense spending. The Times reported last month that sales of its anthrax vaccines to the National Strategic Reserve amounted to nearly half of the Reserve’s annual half-billion dollar budget for most of the past decade, leaving the federal government with less money to purchase the supplies needed in a pandemic. In response to questions about the Baltimore plant, an Emerging spokesperson Matt Hartwig said in a statement that the company had worked with the federal government “to resolve the issues” and “resolve them in support. of the federal COVID response ”. He added: “Any claim that our safety, quality and compliance systems are not working or that we do not take these responsibilities seriously is false.” But four former company officials, speaking on condition of anonymity because they had signed nondisclosure agreements or feared retaliation, described an environment in which top emerging executives tolerated and even encouraged no. – compliance with federal standards for the manufacture and marketing of products. One of the former officials said that as the company struggled to meet high demands for vaccine production, a senior manufacturing supervisor often responded to reports of quality errors by asking, “Do you want to that I make drugs or fix problems? I don’t have time to do both. Federal officials said as the coronavirus swept across the country they had little choice but to look to Emergent because few US-based companies were able to manufacture the type of vaccines Johnson developed. & Johnson and AstraZeneca. “There weren’t a lot of alternatives,” said Dr Robert Kadlec, who oversaw the agency that awarded the manufacturing contract under the Trump administration. “We even looked at veterinary vaccination facilities across the country. We couldn’t find the capacity. Emerging stock suffered last week, closing at just under $ 79 on Monday, up from $ 94 before the dose ruin news was announced. Still, the work on COVID-19 has been lucrative for the company. After Emergent made separate deals with Johnson & Johnson and AstraZeneca worth around $ 875 million, investors flocked to Emerging’s stock, pushing it to an all-time high. But out of public view, internal monitors and auditors for the company’s new partners, Johnson & Johnson and AstraZeneca, found the Baltimore plant’s procedures to be flawed, especially for disinfecting the plant and preventing contamination. Internal logs show that Emergent had to throw away a batch of AstraZeneca vaccine in early October due to suspected contamination, and four more in December. The four people were spoiled by the bacterial contamination of the equipment, a former company official said. In November, production of a batch of Johnson & Johnson vaccine was scrapped after workers “plugged in” the wrong gas line and accidentally “choked” cells where the vaccine virus is grown, according to newspapers. Several audits highlight how poorly prepared the company was for the enormous workload it took on. Another internal investigation in August found that Emergent had approved four raw materials used to produce AstraZeneca’s vaccine without fully testing them first. This type of shortcut, known as material parole, took place on average twice a week in October, according to internal newspapers. The measure was deemed necessary because the company was working with shortened production times, testing backlogs and the needs of Operation Warp Speed, the Trump administration’s crash vaccine development program. And while one official “knowingly deviated” from standards, according to the report, batches of vaccine would not be released without quality and safety testing. 62 million doses in balance Shortly before 6:20 p.m. on March 25, an urgent e-mail landed in the inboxes of senior officials at the Department of Health and Human Services. “Developing Situation _ Emergent Bayview,” the subject line reads. What followed was even more alarming: “Viral cross contamination confirmed in control cells for JANSSEN GMP Lot # 8.” The post, referring to the production of Johnson & Johnson vaccines at the Emergent Baltimore plant, sparked a series of rushed overnight phone calls, according to officials familiar with the situation. The Johnson & Johnson and AstraZeneca vaccines use the same technology: a harmless version of a virus – called a viral vector – is passed into cells to make a protein that stimulates the immune system to make antibodies. At one point in February, workers at Emerg unknowingly infected the Johnson & Johnson viral vector with AstraZeneca. The error was not discovered for weeks, until, in one of the last checks before publication, Johnson & Johnson sampled a batch of 13 to 15 million doses of vaccine to verify the purity. In no time, senior health officials in the Biden administration ordered a halt on shipments from the Baltimore plant and tasked executives at Johnson & Johnson to take over its operations. A few days later, they quietly told AstraZeneca officials that their vaccine would no longer be made at the Baltimore plant, to avoid a repeat of that mistake. But quality control officials are now required to retest every batch of Johnson & Johnson vaccine made at the plant – 62 million doses in all – to make sure they were not also contaminated. Around 70 million additional doses of AstraZeneca may also need to be tested. After the administration announced on Saturday that Johnson & Johnson would take control of the manufacturing of Emerging’s COVID-19, the company issued its own statement Sunday evening, noting that it “continues to own and operate” l ‘factory while suggesting that it welcomed’ the additional monitoring. and support. The Biden team was apparently unhappy. Hours later, sometime after midnight, the statement was amended to recognize that Johnson & Johnson now has “final manufacturing approval” for its vaccine at the Baltimore plant. This article originally appeared in The New York Times. © 2021 The New York Times Company

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