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The New York Times

U.S. Bet Big on COVID Vaccine Manufacturer Even as Problems Mounted

WASHINGTON — More than eight years ago, the federal government invested in an insurance policy against vaccine shortages during a pandemic. It paid Emergent BioSolutions, a Maryland biotech firm known for producing anthrax vaccines, to have a factory in Baltimore always at the ready. When the coronavirus pandemic arrived, the factory became the main U.S. location for manufacturing COVID-19 vaccines developed by Johnson & Johnson and AstraZeneca, churning out about 150 million doses as of last week. But so far not a single dose has been usable because regulators have not yet certified the factory to allow the vaccines to be distributed to the public. Last week, Emergent said it would destroy up to 15 million doses' worth of the Johnson & Johnson vaccine after contamination with the AstraZeneca vaccine was discovered. Sign up for The Morning newsletter from the New York Times Emergent and government health officials have long touted their partnership as a success, but an examination by The New York Times of manufacturing practices at the Baltimore facility found serious problems, including a corporate culture that often ignored or deflected missteps and a government sponsor, the Biomedical Advanced Research and Development Authority, that acted more as a partner than a police officer. Previously undisclosed internal documents and interviews with current and former federal officials and former company employees depict a factory operation that was ill-equipped to take on such a mammoth manufacturing task, despite Emergent's having received a $163 million federal contract to improve the facility and prepare it for high-volume production. The loss of the Johnson & Johnson doses was not the first time the company threw out coronavirus vaccine for fear of contamination. Between early October and January, Emergent discarded five lots of AstraZeneca vaccine — each the equivalent of 2 million to 3 million doses — because of contamination or suspected contamination, according to internal logs, a government official and a former company supervisor. Audits and investigations — including ones conducted in 2020 by Johnson & Johnson, AstraZeneca, two federal agencies and Emergent's own quality evaluators — found that Emergent had not followed some basic industry standards at the Baltimore plant, and identified repeated shortcomings in efforts to disinfect and prevent contamination. While audits always find problems, federal officials and outside experts said that the pattern of lapses suggested deeper quality issues. "These are the fundamental steps," said Dr. Ajaz Hussain, a pharmaceutical quality expert who oversaw efforts by the Food and Drug Administration to ensure quality in drug development and manufacturing from 2000 to 2005. "If you are making mistakes or errors in the fundamentals, what else 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 believe was responsible for tainting the millions of Johnson & Johnson doses, according to a review of the confidential document by The Times. The audits and investigations also flagged a persistent problem with mold in areas required to be kept clean, poor disinfection of some plant equipment leading to growth of bacteria, the repeated approval of raw materials that had not been fully tested, and inadequate training of some employees. Because other manufacturers are now churning out so many COVID-19 vaccine doses, it does not appear that the disruptions in Baltimore will upend the Biden administration's expedited timetable for vaccine supplies and availability. But health experts worry the revelations could heighten safety concerns and make some people more wary about getting shots. Emergent is a longtime government contractor that has spent much of the last two decades cornering a lucrative market in federal spending on biodefense. The Times reported last month that sales of its anthrax vaccines to the Strategic National Stockpile accounted for nearly half of the stockpile's half-billion-dollar annual budget throughout most of the last decade, leaving the federal government with less money to buy supplies needed in a pandemic. In response to questions about the Baltimore plant, an Emergent spokesman, Matt Hartwig, said in a statement that the company had been cooperating with the federal government "to address issues" and "resolve them in support of the federal COVID response." He added, "Any allegation 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 the condition of anonymity because they had signed nondisclosure agreements or feared retaliation, described an environment where top Emergent leadership tolerated and even encouraged the flouting of federal standards for manufacturing and marketing products. One of the former officials said that as the company scrambled to meet the heavy demands of vaccine production, a senior manufacturing supervisor often responded to reports of quality errors by asking: "Do you want me to make drugs or fix issues? I don't have time to do both." Federal officials said that as the coronavirus swept across the country, they had little choice but to turn to Emergent because few companies based in the United States were able to make the type of vaccines developed by Johnson & 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 vaccine facilities around the country. We couldn't find the capacity." Emergent's stock has suffered in the last week, closing Monday just under $79, down from $94 before news broke that the doses had been ruined. Still, the COVID-19 work has been lucrative for the company. After Emergent struck separate deals with Johnson & Johnson and AstraZeneca worth roughly $875 million, investors flocked to Emergent's stock, pushing it to a record high. But out of public view, internal monitors and auditors from the company's new partners, Johnson & Johnson and AstraZeneca, were finding the Baltimore factory's procedures deficient, especially in disinfecting the plant and preventing contamination. Internal logs show that Emergent had to toss out one batch of AstraZeneca's vaccine in early October because of suspected contamination, and four more in December. Those four were spoiled by bacterial contamination of equipment, a former company official said. In November, production of a batch of Johnson & Johnson vaccine was discarded after workers "hooked up" the wrong gas line and accidentally "suffocated" the cells where the virus for the vaccine is grown, the logs show. Multiple audits underscore how poorly the company was prepared for the huge workload it accepted. Another internal investigation in August found that Emergent approved four raw materials used to produce AstraZeneca's vaccine without first fully testing them. That type of shortcut, called a conditional release of material, occurred on average twice a week in October, internal logs show. 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 a manager "knowingly deviated" from standards, the report said, the batches of vaccine would be not released without quality and safety tests. 62 Million Doses in the Balance Shortly before 6:20 p.m. on March 25, an urgent email landed in the inboxes of top officials at the Department of Health and Human Services. "Developing Situation _ Emergent Bayview," the subject line read. What followed was even more alarming: "Viral cross-contamination confirmed in the control cells for JANSSEN GMP Lot #8." The message, referring to the Johnson & Johnson vaccine production at Emergent's Baltimore factory, set off a series of hurried nighttime telephone calls, according to officials familiar with the situation. The Johnson & Johnson and AstraZeneca vaccines use the same technology: A harmless version of a virus — known as a viral vector — is transmitted into cells to make a protein that stimulates the immune system to produce antibodies. Sometime in February, Emergent workers had unknowingly contaminated Johnson & Johnson's viral vector with AstraZeneca's. The error was not discovered for weeks, until, in one of the final checks before release, Johnson & Johnson sampled a batch of 13 million to 15 million doses' worth of vaccine for purity. In short order, top Biden administration health officials directed a hold on shipments from the Baltimore facility and instructed Johnson & Johnson executives to take charge of its operations. Days later, they quietly told AstraZeneca officials their vaccine would no longer be made at the Baltimore plant, to avoid a repeat of that error. But quality-control managers are now required to test anew every lot of Johnson & Johnson vaccine made at the plant — 62 million doses in all — to make sure they weren't also contaminated. Another roughly 70 million doses of AstraZeneca's may also need to be tested. After the administration announced Saturday that Johnson & Johnson would take control of the COVID-19 manufacturing from Emergent, the company issued its own statement Sunday night noting that it "continues to own and operate" the plant while also suggesting it welcomed "the additional oversight and support." The Biden team was apparently displeased. Hours later, sometime past midnight, the statement was amended to acknowledge that Johnson & Johnson now has "final signoff of manufacturing" its vaccine at the Baltimore plant. This article originally appeared in The New York Times. © 2021 The New York Times Company