The Baltimore plant that contracted to make Johnson & Johnson’s COVID-19 vaccine was dirty, did not follow manufacturing protocols and staff were not trained, resulting in contamination of injection equipment, they revealed Wednesday.
The Food and Drug Administration (FDA) released a report on its recent inspection of the Emergent Biosciences plant, which has ceased production.
Inspectors said a batch of the substance used for J & J’s vaccine, which requires a single injection, was contaminated with material used for Covid-19 vaccines from another J&J customer, AstraZeneca. That entire batch had to be discarded, which, according to the report, was enough to make about 15 million doses of J & J’s vaccine.
The European Medicines Agency found a “possible link” between the vaccine and very rare cases of bleeding disorders detected in the United States
The report cites other issues such as peeling paint, black and brown residue on floors and walls, poor cleaning, and workers not following protocols to avoid contamination.
Emergent and Johnson & Johnson said on Wednesday that they were trying to resolve the issues as quickly as possible. So far none of the products manufactured there for J&J had been distributed.
The use of the J&J vaccine has been suspended in the United States for the time being, as authorities are investigating the link with certain very rare blood clots. Nearly 8 million doses of this vaccine have been used from Europe.
WASHINGTON – The United States will take steps to resume use of the covid-19 vaccine …
The Baltimore plant ceased production late last week at the request of the FDA. The agency has not given the factory the emergency permit required to distribute its products.
The FDA said the substance produced by Emergent is in storage pending further testing.