Federal Report Cites Numerous Failures At Baltimore Vaccine Plant That Ruined 15M Doses
Federal regulators on Wednesday have issued critical findings from their inspection of the Emergent BioSolutions factory in Baltimore that caused a national uproar when it ruined millions of doses of COVID-19 vaccines from J&J and AstraZeneca (even though the latter haven’t yet been approved for use in the US).
The report, which was leaked to the NYT, blamed a series of defects and shortcomings at the massive plant, which is operated by Emergent BioSolutions. The inspection was triggered by reports that Emergent workers had contaminated a batch of J&J doses after accidentally contaminating them with materials intended for the AstraZeneca jabs.
In the aftermath, federal officials ceded control to J&J, and commanded it to oversee production of its jab at the cite.
In total, the 12-page report cited 9 distinct violations, including…
Workers frequently moved between the manufacturing zones without documenting that they had showered and changed their gowns as required.
Workers also failed to properly handle manufacturing waste, creating risks of contamination in the warehouse where raw materials are stored,
The facility where the vaccines were manufactured is not of “suitable size”.
Written procedures for how to assure drug quality were not adequate.
Employees were adequately trained in the particular roles in which they were assigned.
Workers failed to thoroughly investigate discrepancies including signs of “cross-contamination.”
Read the full report below:
Dr. Jose Romero, the Arkansas health secretary and chairman of the expert panel advising the CDC on the future use of the J&J jab said in an interview that he was dismayed by the FDA’s findings. His panel is meeting on Friday on whether to lift, modify or retain a pause in the administration of J&J’s vaccine that was instituted last week for an entirely different issue: the discovery that eight US residents developed a rare but dangerous blood clotting disorder after they got shots
Emergent said in a statement on Wednesday that “while we are never satisfied to see shortcomings in our manufacturing facilities or process, they are correctable and we will take swift action to remedy them.”
In its own statement, J&J said it had already stepped up its oversight of Emergent, and that it can now “ensure that all of FDA’s observations are addressed promptly and comprehensively.”
Still, the peak behind the curtain at the standards being applied to vaccine production are hardly encouraging, especially as unused jabs are piling up in some states as younger patients opt not to get the vaccine.
Wed, 04/21/2021 – 14:30