The New York Times

US bet on COVID vaccine maker, even as problems mount

WASHINGTON – More than eight years ago, the federal government invested in vaccine shortages insurance during a pandemic. Emergent BioSolutions, a Maryland biotech company known for making anthrax vaccines, has been paid to keep a Baltimore factory always available. When the coronavirus pandemic hit, the factory became the main manufacturing facility in the US for COVID-19 vaccines, developed by Johnson & Johnson and AstraZeneca. As of last week, around 150 million cans have been produced. However, to date not a single dose has been usable as regulators have not yet certified the factory so that the vaccines can be distributed to the public. Last week, Emergent said it would destroy up to 15 million doses worth of Johnson & Johnson vaccine after it was discovered contamination with the AstraZeneca vaccine. Sign up for the New York Times’ The Morning newsletter. Emergent and government health officials have long touted their partnership as a success. However, an investigation into manufacturing practices in the New York Times in Baltimore revealed serious issues, including a corporate culture that frequently featured ignored or distracted missteps and a government sponsor, the Biomedical Advanced Research and Development Authority, which acted more as a partner than a cop. Previously undisclosed internal documents and interviews with current and former federal officials and former employees of the company reveal a factory operation ill-equipped for such a mammoth manufacturing task, despite Emergent receiving a federal contract for $ 163 million to improve and prepare the facility for the mass production. The loss of the Johnson & Johnson doses wasn’t the first time the company dumped a coronavirus vaccine in fear of contamination. Between early October and January, Emergent discarded five lots of AstraZeneca vaccine – each equivalent to 2 to 3 million doses – due to contamination or suspected contamination, according to internal protocols, a government official and a former company executive. Audits and investigations – including those conducted in 2020 by Johnson & Johnson, AstraZeneca, two federal agencies, and Emergent’s own quality assessors – found that Emergent’s Baltimore plant was failing to meet some basic industry standards and identified repeated shortcomings in efforts to deliver Disinfection and prevention of solid contamination. While audits always pose problems, federal officials and outside experts said the pattern of errors suggests deeper quality problems. “These are the basic steps,” said Dr. Ajaz Hussain, a pharmaceutical quality expert who oversaw the Food and Drug Administration’s efforts to ensure quality drug development and manufacturing from 2000-2005 Basics 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 are responsible for harming the millions of Johnson & Johnson doses, according to a review of the confidential document by The Times. The audits and investigations also revealed an ongoing problem with mold in areas that need to be kept clean, poor disinfection of some plant equipment leading to the growth of bacteria, repeated approval of raw materials that were not fully tested, and inadequate training for some Employee . With other manufacturers producing so many doses of COVID-19 vaccine right now, it doesn’t seem like the disruptions in Baltimore will change the Biden government’s accelerated schedule for vaccine delivery and availability. However, health experts fear the revelations could increase safety concerns and cause some people to fear gunshots. Emergent is a longtime government contractor who has spent much of his time over the past two decades cornering a lucrative market for federal biological defense spending. The Times reported last month that the sale of its anthrax vaccines to the Strategic National Stockpile was nearly half of the annual half-billion dollar stockpile budget for most of the last decade, leaving the federal government with less money to raise in a year needed to buy supplies pandemic. When asked about the Baltimore plant, an Emergent spokesman, Matt Hartwig, responded in a statement that the company worked with the federal government to “address problems” and “resolve them in support of the federal COVID response.” He added: “Any claim that our security, quality and compliance systems are not working or that we do not take this responsibility seriously is wrong.” Four former company officials, who spoke on condition of anonymity because they signed confidentiality agreements or feared retaliation, described an environment in which Emergent’s top management tolerated and even encouraged disregard for federal standards for the manufacture and marketing of products. One of the former officials said that when the company struggled to meet the stringent requirements of vaccine production, a senior manufacturing manager often responded to reports of quality defects by asking, “Should I make drugs or fix problems? I don’t have time for either. Federal officials said that when the coronavirus swept the country, they had no choice but to contact Emergent as few US-based companies were able to manufacture the vaccines developed by Johnson & Johnson and AstraZeneca . “There weren’t many alternatives,” said Dr. Robert Kadlec, who oversaw the agency that placed the manufacturing contract under the Trump administration. “We even looked at veterinary vaccine facilities across the country. We couldn’t find the capacity. “Emergent stock has suffered for the past week, closing just under $ 79 after $ 94 on Monday before news broke that the cans had been ruined. Still, the COVID-19 work has been lucrative for the company. After Emergent closed separate deals with Johnson & Johnson and AstraZeneca valued at approximately $ 875 million, investors flocked to Emergent and hit a record high. From a public perspective, internal monitors and auditors from the company’s new partners, Johnson & Johnson and AstraZeneca, found that the Baltimore plant’s procedures were inadequate, particularly when it came to disinfecting the facility and preventing contamination. Internal logs show Emergent had to throw away a batch of the AstraZeneca vaccine in early October due to suspected contamination and four more in December. These four were spoiled by bacterial contamination of equipment, said a former company official. In November, production of a batch of Johnson & Johnson vaccines was halted after workers “plugged in” the wrong gas line and accidentally “choked” the cells in which the virus was grown for the vaccine, the logs show. Several audits underline how poorly the company was prepared for the enormous workload. Another internal investigation in August found that Emergent approved four raw materials for AstraZeneca’s vaccine production without fully testing them. This type of link, known as conditional release of material, occurred an average of twice a week in October, internal logs show. The move was deemed necessary as the company operated with reduced production times, residue testing and met the requirements of Operation Warp Speed, the Trump administration’s crash vaccine development program. And while a manager “knowingly deviates from the standards,” the report said, batches of vaccines would not be released without quality and safety testing. 62 million doses in balance Just before 6:20 p.m. on March 25, an urgent email landed in the inboxes of senior officials at the Department of Health and Human Services. “Development Situation _ Emergent Bayview,” was the subject line. What followed was even more alarming: “Viral cross-contamination in the control cells for JANSSEN GMP Lot No. 8 confirmed.” The news, relating to Johnson & Johnson’s vaccine production at the Emergent Baltimore factory, sparked a series of hasty nightly phone calls, according to officials familiar with the situation. Johnson & Johnson and AstraZeneca vaccines use the same technology: a harmless version of a virus – known as a viral vector – is transferred into cells to make a protein that stimulates the immune system to produce antibodies. Sometime in February, Emergent employees unwittingly contaminated the Johnson & Johnson viral vector with that of AstraZeneca. The bug went undetected for weeks, until Johnson & Johnson did one of its final pre-release pre-release reviews of a batch of vaccines ranging from 13 to 15 million doses for purity. In a short period of time, Biden’s top government health officials rejected the supplies from the Baltimore plant and directed Johnson & Johnson executives to take responsibility for their operations. Days later, they tacitly announced to AstraZeneca representatives that their vaccine would no longer be manufactured at the Baltimore facility to prevent this mistake from happening again. Quality control managers must now retest all of the Johnson & Johnson vaccines produced at the factory – a total of 62 million doses – to make sure they are not also contaminated. AstraZeneca may need around 70 million more cans to be tested. After the government announced on Saturday that Johnson & Johnson would take control of Emergent’s COVID-19 manufacturing, the company issued its own statement on Sunday evening stating that it continues to own and operate the facility, while suggesting that the additional supervision and assistance be welcomed. “The Biden team was apparently dissatisfied. Hours later, sometime after midnight, the statement was amended to recognize that Johnson & Johnson now has final approval to manufacture its vaccine at the Baltimore plant. This article originally appeared in the New York Times. © 2021 The New York Times Company