Coronavirus US: what were the storage failures in the J&J vaccine factory according to the FDA?
Millions of shots of the Johnson & Johnson covid-19 vaccine have been spoiled due to a production process that the FDA described as unsanitary.
A new report from the Food and Drug Administration (FDA) has found that the Baltimore manufacturing plant responsible for ruining over 15 million Johnson & Johnson (J&J) vaccine doses was “not maintained in a clean and sanitary condition”.
The FDA carried out a review of security camera footage from the plant, operated by Emergent BioSolutions, and found a number of failings. The footage is taken from 27 January to 3 February and reportedly shows peeling paint, brown residue on walls and floors, and staff failing to follow cross-contamination procedures.
In late March J&J announced that a batch of its own covid-19 vaccines had failed quality standards and would not be usable. To speed up the production process J&J has outsourced manufacturing to around ten different companies.
What was wrong with vaccine production at the Baltimore factory?
The official FDA report for the premises list the type of establishment as “Vaccine Drug Substance Manufacturer” and makes nine broad observations about the poor state of the factory. These vary from the condition of the building to the training of the staff.
Observation two states that the building is not in a “clean and sanitary condition” and lists five areas of concern. The waste generated in the production process is transported through the warehouse and could potentially contaminate other areas. The manufacturing rooms and corridors are not cleaned sufficiently, while peeling paint and damaged floors throughout the warehouse make adequate cleaning impossible.
Last month, up to 15 million doses of Johnson & Johnson’s coronavirus vaccine had to be discarded at an Emergent BioSolutions factory in Baltimore. A new report says problems were not fully investigated and other doses may be compromised. https://t.co/5UBxbZSymT— The New York Times (@nytimes) April 22, 2021
The peeling paint could be found in multiple areas surrounding the manufacturing rooms’ wall boards were damaged in numerous places. The general cleanliness was also questioned with brown residue found on both the floors and the walls in the room in which vials are filled with vaccine doses.
The report also reads: “Employees were not trained in the particular operation that they performed.” Personnel involved in the manufacturing process were seen dragging non-disinfected medical waste across the warehouse corridor and were not wearing protective gowns and foot covers while in the manufacturing area.
Reports comes after J&J report lost doses
The FDA investigation was sparked by the announcement that a number of batches had been spoiled by manufacturing errors. Workers at the plant, which produces covid-19 shots for both J&J and AstraZeneca, reportedly mixed up the two vaccines’ ingredients.
FDA’s @DrWoodcockFDA & Peter Marks add in statement that Emergent’s production of J&J vaccine will be paused, no product released until issues at plant are resolved.— Meg Tirrell (@megtirrell) April 21, 2021
This is the only U.S. plant making J&J #covid19 vaccine drug substance at the moment, until Merck comes on board. pic.twitter.com/Bd1ob3wCtX
In light of that mistake the FDA confirmed that the lost doses were a consequence of human error and J&J announced that they would be sending more people to supervise production of the vaccine at the plant.
Initially pharmaceutical giant J&J had pledged to provide 20 million doses by 31 March, but it had only managed to produce around 6.8 million by the end of the month, according to the US Centers for Disease Control and Prevention’s online vaccine tracker.
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