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U.S. Bet on Covid Vaccine Manufacturer Even as Problems Mounted

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Due to the pandemic, most auditors drew their conclusions from documents and video tours where emergent employees checked camera angles, a former company employee said.

Johnson & Johnson reviewers said monitoring reports for bacteria or other contaminants were submitted four to six months late. According to AstraZeneca, Emergent has repeatedly relaxed the monitoring criteria so that they appear to be meeting them, using measures such as “historical averages”. But even then, it failed the tests, the report said.

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

Emergent’s internal audit in July also found that the flow of workers and materials through the plant was not being adequately controlled “to avoid mix-ups or contamination.”

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

Several audits underline how poorly the company was prepared for the enormous workload.

The Covid-19 projects required significantly more testing to ensure the materials remained stable. However, Emergent only had one employee who coordinated everything, as the BARDA audit showed. Emergent admitted at this point that its test system was “not ideal” and promised to train at least one more Emergent employee and hire a third. BARDA did not respond to requests for comment on its review or any of the others, except to state that it “worked with Emergent to resolve the issues raised during the FDA inspection.”

Another internal investigation in August found that Emergent approved four raw materials for AstraZeneca’s vaccine production without fully testing them. This type of link, known as conditional release of material, occurred an average of twice a week in October, internal logs show. The move was deemed necessary as the company operated with reduced production times, residue testing and met the requirements of Operation Warp Speed, the Trump administration’s crash vaccine development program. And while a manager “knowingly deviates from the standards,” the report said, batches of vaccines would not be released without quality and safety testing.

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Robert Dunfee