Sunday, October 17, 2021

Emergent was unequipped to produce both J&J and AstraZeneca COVID-19 vaccines, execs tell lawmakers


For nearly two months, Emergent BioSolutions has been tight-lipped about the production glitch that forced it to discard up to 15 million Johnson & Johnson COVID-19 vaccine doses. This week, though, the company’s top execs had to fess up at a congressional hearing, revealing that the contract manufacturer’s ambition to produce two pandemic shots was just too tall a task.

At the hearing, Emergent’s chairman Fuad El-Hibri and CEO Robert Kramer faced a raft of questions from lawmakers about production problems, political connections and the $628 million contract the company received to manufacture pandemic vaccines. Several key findings came out of the three-hour back-and-forth, including the fact that Johnson & Johnson experts spotted the manufacturing error, not Emergent’s personnel. 

While Emergent has faced countless negative headlines over its production error in the J&J process, the company also had to discard “a number” of AZ batches in early 2020, Kramer said.

The “unprecedented” task of standing up manufacturing for two pandemic shots caused the production problems, Kramer said.

During his testimony, Kramer pointed to the challenges Emergent and its partners faced to “very quickly tech transfer in these two candidates, scale them up and be in a position to make hundreds of millions of vaccines.” Emergent, like every company involved in the COVID-19 fight, was tasked with accomplishing a years-long process under normal circumstances in just months, he said.

“The early stages of the manufacturing, particularly the AstraZeneca product, resulted in a number of lost batches because the start-up was occurring so very quickly,” he said.

RELATED: Zero Johnson & Johnson COVID-19 vaccine doses set to ship next week as production holdup lingers

What’s “not been reported accurately,” to hear Kramer tell it, is the difficulty the company had integrating AZ’s product into its plant. The company had to make 80 different process changes in the first several months it was working to set up production for AZ’s shot, he pointed out.

That’s to be expected when scaling up for a new biomanufacturing project, he said, noting that Emergent hit a production “cadence” later in the year. 

While the company’s struggles last year largely flew under the public radar, behind the scenes, regulators and federal officials were raising flags. An FDA inspection last April cited Emergent’s Baltimore facility for numerous issues, including improper training, record keeping, testing procedures and more. The FDA raised many of the same concerns in its investigation last month, which also identified unsanitary conditions at the plant. 

RELATED: Emergent CEO takes ‘full responsibility’ for COVID-19 vaccine manufacturing flubs, but offers little in the way of answers

After a June 2020 audit, J&J sent a report to Emergent highlighting “weaknesses or gaps” in its quality systems. J&J also noted that the CDMO’s virus contamination control strategy in Baltimore was “deficient,” according to a memo the House committee released ahead of Wednesday’s hearing. 

Emergent’s failure to fix these repeat problems led to the destruction of “millions of vaccine doses,” the Congressional committee argued in its release. 

Under the federal contract it received last May, Emergent has been charging the U.S. government $27 million a month to set aside capacity for pandemic vaccine production. Under those terms, taxpayers have already paid Emergent more than $271 million, despite the fact that no Emergent-made vaccines have reached the public, according to the memo.

Meanwhile, the company has produced more than 100 million Johnson & Johnson doses, which are currently trapped in limbo as they await validation from the FDA. 

RELATED: Emergent CEO sold more than $10M in stock before scrapping J&J COVID-19 vaccine doses: report

Emergent, for its part, says it’s working on resolving the manufacturing issues. It’s focusing “on the path forward to release drug substance currently under evaluation, to resume production, and to do our part to help strengthen the global supply chain for Johnson & Johnson’s COVID-19 vaccine,” a company spokesperson told Fierce Pharma via email.

The company submitted a remediation plan to the FDA on April 30, which includes improvements to housekeeping, sanitation, material storage and more. The Baltimore plant is now solely devoted to J&J’s vaccine, Kramer emphasized repeatedly.

Those actions should put Emergent “back on track” to produce J&J’s shot, potentially within “a matter of days,” Kramer said. Still, Emergent’s time in the Capitol spotlight isn’t over yet. Wednesday’s hearing is just the beginning of the House committee’s investigation, Rep. James Clyburn (D-South Carolina), noted.



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