Anonymous ID: 1fd4ae May 10, 2022, 10:20 a.m. No.16248538   🗄️.is đź”—kun

https://www.msn.com/en-us/news/us/emergent-s-covid-vaccine-problems-more-extensive-than-previously-known/ar-AAX74J3?ocid

 

The manufacturing and quality issues that led to the Biden administration canceling a $628 million Covid-19 vaccine contract with Emergent Biosolutions were more extensive than previously understood, according to an investigation by the key pandemic oversight congressional committee.

 

Millions more AstraZeneca and Johnson & Johnson vaccines — 400 million in total — were destroyed as a result of the lack of standards at Emergent’s Bayview facility in Baltimore, the committee found. And the company allegedly hid batches with potential quality issues from federal regulators in February 2021 following months of internal communication about the substantial problems at the facility.

 

Emergent’s failure to resolve its manufacturing quality-control issues led to a contamination of 15 million Johnson & Johnson doses in March 2021, when the company accidentally mixed in AstraZeneca drug substance. The facility halted production for three months before resuming operations in July 2021.

 

The details of the investigation by the House Select Subcommittee on the Coronavirus Crisis, released Tuesday, which include troves of internal emails, underscore the degree to which Emergent staff and consultants working with the company knew of the extensive issues at Bayview before moving forward with U.S. government and pharmaceutical contracts to produce the shots.

 

“The [Food and Drug Administration] identified concerns at the Emergent plant in April 2021” and “immediately took swift action,” a spokesperson told POLITICO. “We have not allowed the distribution of any product without first conducting a thorough review of facility records and the results of quality testing performed by the manufacturer.”

 

Emergent remains committed to being a trusted partner of the federal government, said Matt Hartwig, a company spokesperson.

 

"We have not received the report and are unfortunately first learning about it from the media," he said. "Emergent has been open and forthcoming with the FDA, Congress and our partners about the work at our Bayview site and the challenges that were encountered including providing thousands of documents, willingly participating in a congressional hearing and inviting them to visit our facilities."

 

J&J and AstraZeneca did not immediately respond to requests for comment.

 

POLITICO was first to report about the early warnings from individuals working on the Trump administration’s Operation Warp Speed about Emergent’s problems. But the congressional investigation provides new details on the internal Emergent warnings about the problems the company could face scaling production for the Covid-19 shots.

 

“Doses were squandered despite repeated warnings from employees, outside consultants, pharmaceutical companies, and FDA regulators that the company’s manufacturing practices were unsafe,” said Rep. Jim Clyburn (D-S.C.), chair of the committee. “Emergent executives prioritized profits over producing vaccines in a responsible manner that complied with FDA requirements.”

 

Early warnings

Even in the early days of the Trump administration’s $628 million contract with Emergent, officials from the administration raised concerns about the company’s ability to scale manufacturing.