US Bets On Covid Vaccine Maker Even As Problems Increase

Due to the pandemic, most auditors drew their conclusions from documents and video tours, during which Emergent workers checked the camera angles, a former company official said.

Johnson & Johnson auditors said monitoring reports for bacteria or other contaminants were submitted four to six months late. AstraZeneca’s said Emergent repeatedly loosened the monitoring criteria to appear to meet them, resorting to measures such as “historical averages.” But even then it failed the tests, according to the report.

In another audit, BARDA officials documented similar concerns, classifying some of them, including microbiological contamination risks, as “critical.” This designation is reserved for the most serious problems that pose immediate and significant risk.

Emergent’s own internal audit in July also said the flow of workers and materials through the plant was not adequately controlled “to avoid confusion or contamination.”

The reports echoed quality control deficiencies documented in an April inspection by the FDA, previously reported by The Associated Press, which concluded that the facility was “not ready for commercial operations.”

Multiple audits underscore how ill-prepared the company was for the huge workload it took on.

The Covid-19 projects required much more testing to ensure the materials were stable, but Emergent only had one employee coordinating everything, according to the BARDA audit. Emergent recognized at the time that its testing system was “not ideal” and promised to train at least one more emerging worker and hire a third. BARDA did not respond to requests for comment on its audit or any of the others, beyond saying that it had “worked with Emergent to resolve the issues” raised during the FDA inspection.

Another internal investigation in August found that Emergent approved four raw materials used to produce AstraZeneca’s vaccine without first fully testing them. That kind of shortcut, called a conditional release of material, occurred on average twice a week in October, internal records show. The move was deemed necessary because the company was working with shorter production times, testing backlogs and the needs of Operation Warp Speed, the Trump administration’s shock vaccine development program. And although a manager “knowingly deviated” from the standards, according to the report, the vaccine lots would not be released without quality and safety testing.

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