(CHILDREN'S HEALTH DEFENSE) – A Johnson & Johnson (J&J) COVID vaccine manufacturing plant where an ingredient mix-up last month resulted in 15 million doses of J&J vaccine being discarded may have contaminated additional doses, according to a report released Wednesday by the U.S. Food and Drug Administration (FDA).
The 13-page report also identified a series of other problems at the Baltimore facility owned by Emergent BioSolutions. Emergent, which in June received $628 million in taxpayer funding through the U.S. Department of Health and Human Services (HHS) to establish the primary U.S. manufacturing facility for J&J’s and AstraZeneca’s COVID vaccines, agreed this week to temporarily shut down operations.
According to the FDA report, “There is no assurance that other batches have not been subject to cross-contamination.” The report also said the plant was “not maintained in a clean and sanitary condition.” Inspectors found peeling paint and unidentified black and brown residue on the floors and walls, as well as a failure to properly decontaminate waste generated during the manufacture of the vaccine.
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