Tag: Exposed

WASHINGTON – Federal regulators have identified serious defects at the Baltimore plant that resulted in up to 15 million potentially contaminated doses of Johnson & Johnson’s coronavirus vaccine being spilled. This casts doubt on the continued production of a vaccine in the US that the government once considered essential in the fight against the pandemic.

Food and Drug Administration regulators said the company that makes the Emergent BioSolutions vaccine may have contaminated additional doses at the facility. They said the company had not fully investigated the contamination while raising concerns about the disinfection practices, the size and design of the facility, the handling of raw materials and the training of workers.

“There is no guarantee that other lots have not been exposed to cross-contamination,” said the FDA’s 12-page report.

The report was a harsh reprimand for Emergent, who had long downplayed setbacks at the factory, and added to the problems for Johnson & Johnson, whose vaccine was viewed as a game changer because it only takes one shot and is mass-produced can volume and is easy to store.

In the US, production is now ceasing and all vaccines made at the factory have been quarantined. Johnson & Johnson fell far short of its promises to deliver tens of millions of doses to the federal government, partly because concerns about an extremely rare but dangerous blood clotting disorder led federal officials to temporarily suspend distribution last week.

The FDA’s findings, based on an inspection that ended Tuesday, underscore questions raised in New York Times reports about why Emergent didn’t fix issues sooner and why federal officials overseeing their lucrative contracts weren’t demanding better performance .

A series of confidential audits The Times conducted last year warned of the risk of viral and bacterial contamination and a lack of adequate sanitation at the Baltimore plant. Separately, The Times reported, a leading federal manufacturing expert warned last June that Emergent must be “closely monitored.”

Some health officials were surprised by the FDA’s conclusions.

“I’m shocked – I can’t put it any other way,” said Dr. José R. Romero, chairman of a panel that advises the Centers for Disease Control and Prevention and will recommend the use of Johnson & Johnson vaccine later this week. “Inappropriate disinfection, prevention of contamination – these are significant and serious violations.”

In statements on Wednesday, the FDA, Emergent and Johnson & Johnson said they were working to resolve the issues at the factory. There was no indication of how long that would take.

Emergent said, “While we are never satisfied with defects in our manufacturing equipment or processes, they can be corrected and we will take quick action to correct them.”

The FDA has not yet certified the facility in the Bayview neighborhood of Baltimore, and no doses administered there have been released to the public. All Johnson & Johnson recordings made in the United States are from overseas.

In a statement, Dr. Janet Woodcock, Acting Commissioner of the FDA, and Dr. Peter Marks, the top vaccine regulator: “We will only allow the release of products when we are sure that they meet our quality expectations.”

Emergent is a longtime government contractor who has spent much of his time over the past two decades building a market for federal biological defense spending.

Although the Emergent government placed a $ 163 million contract in 2012 to prepare the Baltimore plant for mass production in a pandemic, the site remained largely untested and the company failed to meet the requirement to demonstrate its rapid-reaction capabilities, according to former health officials and contract documents.

Even so, the Emergent government placed a $ 628 million order in June last year, largely to reserve manufacturing space at the plant, and prompted the company to manufacture the Johnson & Johnson shot and a separate vaccine developed by AstraZeneca.

Now Emergent’s dealings with the government are being scrutinized more and more closely. On Tuesday, the House Select Coronavirus Crisis Subcommittee and House Committee on Oversight and Government Reform announced an investigation into the company’s Covid-19 vaccine deal, as well as its long-standing control over an oversized portion of the country’s emergency medicine budget to Reserve, the Strategic National Stockpile.

A Times investigation found that the company’s purchase of the company’s anthrax vaccine over the past decade accounted for nearly half of the reserve’s total annual budget, leaving less cash to spend on critical supplies like masks, which were in short supply last year.

The Bayview facility was supposed to produce most of the Johnson & Johnson vaccine, which received federal emergency approval this year, but only for doses made in the Netherlands. AstraZeneca’s vaccine is not yet approved in the US, regardless of where it is made.

The FDA inspection began after routine checks revealed that Emergent employees had contaminated at least part of a batch of 13-15 million doses of the Johnson & Johnson vaccine with the harmless virus used to make the AstraZeneca shot. Regulators determined that Emergent did not investigate this incident thoroughly and only performed a routine cleanup afterwards. A previous review by Bayview for a pharmaceutical customer found that Emergent glossed over deviations from manufacturing standards without conducting thorough reviews.

The inspectors who examined security recordings as part of their review found that Emergent was not considering whether one or more employees might have been the source of the contamination. Workers are expected to change clothes, ankle boots and showers before moving between the various manufacturing zones for Johnson & Johnson and AstraZeneca.

But regulators said the rule appeared to be routinely violated. In a period of 10 days in February, for example, 13 employees moved from one zone to another on the same day, but only one documented having showered. The inspectors also said Emergent failed to consider whether using common storage containers for raw materials might have caused the contamination. Emergent’s internal audit last July found that the flow of workers and materials through the plant was not adequately controlled “to avoid mix-ups or contamination.”

Federal officials have already insisted on a major change that they believe should significantly limit the risks. This month they instructed Emergent to stop the AstraZeneca shot at the factory and are now trying to help AstraZeneca find a new manufacturing facility.

In another result, the FDA regulators wrote that the Bayview building “is not being kept in a clean and hygienic condition”. Nor is it “of the appropriate size, design and location to facilitate cleaning, maintenance and proper operation,” they said.

They cited peeling paint, damaged walls, improperly trained staff, overcrowded equipment and poor waste disposal. A problem that, in their opinion, could lead to contamination of the warehouse in which raw materials are stored.

The results were released two days prior to the CDC’s scheduled vote to extend, lift, or change the suspension of Johnson & Johnson. Officials recommended the break to investigate eight cases of a rare coagulation disorder in vaccine recipients, one of which was fatal.

Johnson & Johnson resumed its rollout in Europe this week after regulators investigated similar concerns. They recommended putting a warning about the blood clots on the vaccine label, but said the benefits outweighed the risks.

The inspection report comes as a group of shareholders sued Emergent, alleging executives misled investors about the company’s ability to manufacture Covid-19 vaccines in Baltimore.

Emergent’s share price soared following announcements of $ 1.5 billion in deals with the federal government, Johnson & Johnson and AstraZeneca last year. Throughout 2020, its founder and chairman Fuad El-Hibri deposited over $ 42 million in shares and options, and the company’s executive director Robert Kramer recently received a cash bonus of $ 1.2 million.

The lawsuit alleges that the stock price was artificially increased because executives failed to disclose significant quality control issues at the facility. Emergent stocks have been falling in the past few weeks.

Shortly after the Trump administration’s Operation Warp Speed ​​decided to award the $ 628 million contract to Emergent, Carlo de Notaristefani, a manufacturing expert who has been overseeing vaccine production for the federal government since last May, warned the company about his To have to “strengthen” quality controls. requires “significant resources and dedication”.

Dr. Robert Kadlec, the former Trump administration official overseeing the procurement process, said in an interview Tuesday that officials “recognized that there would be inherent risks,” but the government intends “to try to manage those risks consistently.” to reduce. ” . ”

Dr. Romero, the head of the CDC advisory board who is also the Arkansas Secretary of Health, was concerned that the plant’s problems could keep people from getting vaccinated, even though doses from there have not reached the public. Andy Slavitt, a senior health advisor to President Biden, told reporters that the audit “demonstrated a process that is working as it should”.

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

The pharmaceutical company is expected to nearly double its supervisors at the Bayview facility to perhaps a dozen, although Emergent will continue to employ around 600 people.