Federal inspectors were vaccinated for fear of over-contamination

WASHINGTON – Federal regulators have found serious flaws at the Baltimore plant that had to throw up contaminated amounts of Johnson & Johnson’s coronavirus vaccine, possibly up to 15 million – casting doubt over further production in a vaccine in the United States that the government once required. In fighting the epidemic seen from.

Regulators from the Food and Drug Administration said that the vaccine-producing company, Amergent Biosolutions, has contaminated excess doses at the plant. He said that the company failed to fully investigate contamination finding faults with disinfection practices, size and design of the plant, handling of raw materials and training of workers.

“There is no assurance that other batches have not been subjected to cross-contamination,” the 12-page report from the FDA states.

The report had a harsh rebuke from Emergent, which played for a long time Factory failures, And added to the problems for Johnson & Johnson, whose vaccine was seen as a game changer because it required only one shot, could be mass-produced and easily stored.

Production is now at a halt in the United States, and all vaccines manufactured at the plant have been abandoned. Johnson & Johnson has fallen well behind on its promise to deliver tens of millions of doses to the federal government, as concerns about an extremely rare but dangerous blood-clotting disorder temporarily halted delivery to federal authorities last week.

FDA findingsBased on an inspection that ended Tuesday, the report outlined the questions posed. By The New York Times Regarding why Emergent did not fix the problems earlier and why federal authorities oversee its lucrative contracts and did not demand better performance.

A series of confidential audits last year, obtained by The Times, warned about the risk of viral and bacterial contamination and the lack of proper sanitation at the Baltimore plant. Separately, The Times reported, a top federal manufacturing expert warned last June that Emergent would have to be “closely monitored”.

Some health officials were barred by the FDA’s findings.

“I’m surprised – I can’t put it any other way,” Dr. Jose R. Romero, president of a panel advising the Centers for Disease Control and Prevention, said that later this week Johnson & Johnson would recommend handling the vaccine. “Improper disinfection, contamination prevention – they are significant and serious violations.”

In a statement on Wednesday, the FDA, Emergent and Johnson & Johnson all said they were working to solve problems at the factory. There was no indication of how long it would take.

Emergent stated that “while we are never satisfied to see deficiencies in our manufacturing facilities or process, they are corrective and we will take prompt action to correct them.”

The FDA has not yet certified the plant located in the Bayview neighborhood of Baltimore, and none of the supplements made there have gone to the public. All Johnson & Johnson shots administered in the United States have come from overseas.

in a statement, Dr. Janet Woodcock, Acting Commissioner of the FDA, and Drs. Peter Marks, its top vaccine regulator, said: “We will not allow the release of any product until we feel confident that it meets our expectations for quality.”

Emergent is a longtime government contractor, which has occupied a market in federal biodefense spending over the past two decades.

Although the government awarded Amergent a $ 163 million contract to prepare the Baltimore plant for mass production in an epidemic in 2012, the site remained largely unaffected, and the company reported its rapid- Did not meet a requirement to demonstrate response capabilities. And contract documents.

However, the government in June awarded Amergent a $ 628 million contract, much of it to reserve manufacturing space at the plant, and the company arranged for the production of a separate vaccine developed by Johnson & Johnson Schott and AstraZeneca.

Now, emergency deals with the government continue to grow. On Tuesday, the House Select Subcommittee on the Coronavirus Crisis and the House Committee on Oversight and Government Reform announced an investigation into the company’s Kovid-19 vaccine contract, as well as its long-term hold on the country’s external budget for emergency medicine doing. Reserve, Strategic National Stockpile.

a Times investigation Found that the company’s purchase of anthrax vaccine left less money for the majority of the reserve’s entire annual budget for most of the last decade – significant supplies like masks that were scarce last year.

The Bayview plant was to produce bulk of the Johnson & Johnson vaccine, which this year received federal authorization for emergency use, but only for supplements made in the Netherlands. The AstraZeneca vaccine is not yet permitted in the United States, where it is manufactured.

FDA inspection began after routine investigations showing that Amergent workers had contaminated at least part of the 13 million to 15 million doses of the Johnson & Johnson vaccine with the contaminated virus used to make AstraZeneca shots. goes. Regulators found that Emergent failed to fully investigate the incident and subsequently only performed routine cleaning. A previous audit of Bayview for a pharmaceutical customer found that Emergent glossed over deviations from manufacturing standards without a thorough review.

Inspectors, who examined the security footage as part of their review, found that Emergent failed to consider whether one or more workers could be the source of contamination. Workers are supposed to change gowns and boots and bathe before crossing between Johnson & Johnson and AstraZeneca’s various construction areas.

But regulators said the rules appeared to be in regular violation. For example, over a 10-day period in February, 13 employees moved from one zone to another in a single day, but only one document received rain. Inspectors also said that Emergent failed to consider whether using common storage containers for raw materials could cause contamination. Emergent’s own internal audit stated last July that the flow of workers and materials through the plant was not adequately controlled “to prevent mixing or contamination”.

Federal officials have already insisted on a major change that they say should limit risks. This month, they ordered Emergent to stop making AstraZeneca shots at the plant, and they are now trying to help AstraZeneca find a new construction site.

In another finding, FDA regulators wrote that the Bayview building “is not maintained in a clean and sanitary condition.” Nor is it “to facilitate cleanliness, maintenance and proper operation of the appropriate size, design and location,” he said.

He cited peeling paint, damaged walls, improperly trained staff, congested equipment and poor waste management, an issue he said could lead to contamination of the warehouse where the raw materials accumulate.

The conclusion was released two days ago that the CDC’s expert advisory panel was to vote to raise, lift or amend Johnson & Johnson’s suspension. Officials recommended a halt to examine eight cases of a rare clotting disorder in vaccine recipients, one of them fatal.

Johnson & Johnson resumes its rollout Regulators investigated similar concerns later this week in Europe. He recommended that warnings about blood clots should be attached to the vaccine label, but said the benefits of this reduced the risk.

The inspection report comes as a group of shareholders are suing Emergent, alleging that officials misled investors about the company’s ability to manufacture Kovid-19 vaccines in Baltimore.

After announcements of a $ 1.5 billion deal with the federal government, Johnson & Johnson and AstraZeneca last year, Emergent’s stock price climbed. During 2020, its founder and chairman, Fawad Al-Hibari, was redeemed in more than $ 42 million in shares and options, and the company’s chief executive, Robert Kramer, was recently awarded a $ 1.2 million cash bonus .

The lawsuit alleges that the stock price was artificially inflated because officials failed to disclose significant quality-control problems at the facility. Emergent’s stock has declined in recent weeks.

Immediately after the Trump administration’s Operation Taunting motion, it was decided to award Amergent for a $ 628 million contract, Carlo de Notaristephanie, a manufacturing expert who has been watching the production of the vaccine for the federal government since last May Warned the company that its quality control would “have to be strengthened” “requiring significant resources and commitment.”

Former Trump administration official Drs. Robert Kadlec, who was awarded the award of the contract, said in an interview on Tuesday that officials considered that “there were going to be inherent risks”, but the government said “try to mitigate those risks”.

Dr. Romero, the leader of the CDC advisory panel, which is also the health secretary of Arkansas, was concerned that the plant problem could discourage people from vaccinating, even if the dose had not reached the public. Andy Slavitt, a top health adviser to President Biden, told reporters that the audit showed that “there is a process that is working that way.”

Johnson & Johnson said it had already increased surveillance of Emergent, and would “ensure that all FDA comments are addressed promptly and comprehensively.”

The pharmaceutical company is expected to have nearly twice its supervisors at the Biuve plant, which will probably have up to a dozen, although Emergent will continue to provide a workforce of about 600 employees.

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