From an article in yesterday’s New York Times, “U.S. Regulators Find More Flaws at Plant Where Doses Were Ruined”:
WASHINGTON — Federal regulators have found serious flaws at the Baltimore plant that had to throw out up to 15 million possibly contaminated doses of Johnson & Johnson’s coronavirus vaccine, casting doubt on further production in the United States of a vaccine that the government once viewed as essential in fighting the pandemic.
The regulators for the Food and Drug Administration said that the company manufacturing the vaccine, Emergent BioSolutions, may have contaminated additional doses at the plant. They said the company failed to fully investigate the contamination, while also finding fault with the plant’s disinfection practices, size and design, handling of raw materials and training of workers.
The F.D.A. has not yet certified the plant, in Baltimore’s Bayview neighborhood, and no doses made there have gone to the public. All the Johnson & Johnson shots that have been administered in the United States have come from overseas.
The report amounted to a harsh rebuke of Emergent, which had long played down setbacks at the factory, and added to problems for Johnson & Johnson, whose vaccine had been seen as a game changer because it requires only one shot, can be produced in mass volume and is easily stored.
Right, “harsh rebuke.” As someone who works in the field–health-care environmental services (EVS), tasked with cleaning and disinfecting health care-related spaces–let me let you in on a little trade secret. If every health-care related facility were put under fine-grained regulatory scrutiny of the kind described in this article, the shortcomings ascribed to this one plant would suddenly become forthcoming just about everywhere you looked.
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