Emergent BioSolutions discarded ingredients for 400 million COVID-19 vaccines, probe finds

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Emergent BioSolutions discarded ingredients for 400 million COVID-19 vaccines, probe finds
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NEW: Between March 2020 and February 2022, vaccine-maker Emergent BioSolutions was forced to discard or destroy up to 400 million coronavirus vaccine doses due to the contamination of ingredients, according to a congressional report.

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Meanwhile, according to the report, Emergent lab workers intentionally sought to mislead government inspectors about issues at its Bayview, Maryland, plant, and repeatedly"rebuffed" efforts by AstraZeneca and Johnson & Johnson to inspect their facilities. MORE: Emergent's spotty track record: What years of inspection reports show about firm tasked with helping make vaccine

Sean Kirk, at the time an Emergent executive, wrote in a June 2020 email to a quality-control manager that the situation was"deeply concerning" and demanded that he"fix this." In email correspondence with another colleague that same day, Kirk wrote that"room for improvement" in the Bayview plant's quality control systems"is a huge understatement."

"We are not in full compliance yet -- BUT -- we are making [vaccine] batches NOW," Emergent's senior director of quality wrote in an internal email, according to the report.

The committee found that despite these red flags, Emergent"did not remediate the issues, and problems persisted at the [Bayview] facility for months." And from late 2020 to early 2021, the committee wrote, a series of contaminations at Bayview led to the disposal of enough vaccine drug ingredients to produce 240 million doses.A nurse loads a syringe in a vaccination unit in Mexico City, Mexico, April 25, 2022.

"Since the tags were deemed necessary before and after the FDA's visit, it is my understanding, based on the entirety of what I observed and was told, that the purpose of removing the QA [quality assurance] hold tags was to avoid drawing attention to the two subject containers during the tour by the FDA inspectors," the consultant wrote.

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