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Even if there is a problem, the U.S. still places a bet on Covid vaccine manufacturers



A former company official said that due to the pandemic, most auditors concluded from documents and videotapes that during this period, emergency workers controlled the angle of the camera.

Johnson & Johnson’s auditors said that monitoring reports for bacteria or other pollutants have been submitted four to six months late. AstraZeneca said that emergency measures have repeatedly relaxed the monitoring standards to make it appear to meet the requirements and adopted measures such as “historical averages.” The report said that even so, it still failed the test.

In another audit, BARDA officials documented similar issues and classified some of them (including the risk of microbial contamination) as “critical” issues. This name is reserved for the most serious problems, which pose direct and significant risks.

Emergent also stated in its internal audit in July that it did not adequately control the movement of workers and materials through the factory “to prevent confusion or contamination.”

These reports echo the quality control deficiencies documented by the FDA during an inspection in April, and the Associated Press earlier reported that the conclusion was that the facility was “not yet ready for commercial operation.”

Multiple audits have highlighted how poorly prepared the company is to accept the huge workload.

The BARDA audit found that the Covid-19 project requires extensive testing to ensure that the materials remain stable, but Emergent has only one employee to coordinate all work. At that time, Emergent admitted that its test system was “not ideal” and promised to retrain at least one Emergent worker and hire a third. BARDA did not respond to requests for comment on its review or any other review, only stating that it “cooperated with Emergent to resolve the issue” during the FDA inspection.

Another internal investigation in August found that Emergent had approved four raw materials for the production of AstraZeneca vaccines without first fully testing them. Internal logs show that this type of shortcut (called conditional release of materials) averaged twice a week in October. This measure is deemed necessary because the company is shortening production time, testing backlogs and the demand for the Trump administration’s rapid vaccine development program Operation Warp Speed. According to the report, although the manager “knowingly” has deviated from the standard, if there is no quality and safety test, the vaccine batch will not be released.


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