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J&J halts manufacturing of COVID-19 at US plant after FDA warning

Inspection report found facility was “not maintained in a clean and sanitary condition”

Johnson & Johnson (J&J) has halted manufacturing of its COVID-19 vaccine at a plant in the US after the Food and Drug Administration (FDA) identified ‘ certain conditions’ that could lead to quality issues.

In a statement, the FDA announced that it recently completed an inspection of a proposed manufacturing site for J&J’s COVID-19 vaccine in Baltimore, operated by Emergent BioSolutions.

In March, J&J announced that the FDA had not authorised this facility to manufacture or distribute any of the components for its COVID-19 vaccine, with ‘no COVID-19 vaccine manufactured at this plant’ having been distributed for use in the US ‘to date’.

The FDA inspection report found that the plant was “not maintained in a clean and sanitary condition”, also detailing that paint on the walls of the facility was “peeling in multiple areas”.

The report added: “Paint flecks were observed on the floor all along the sides of these walls.”

On top of this, product components, as well as containers and closures were not stored adequately to prevent cross-contamination, according to the report.

Emergent BioSolutions has now paused new production of the J&J COVID-19 vaccine following a request from the FDA, while it works to resolve the issues identified in the report.

Vaccines that have already been manufactured at the plant will undergo additional testing as well as a thorough evaluation before they can be distributed.

“We will not allow the release of any product until we feel confident that it meets our expectations for quality,” commented the FDA.

In a statement, J&J said that it “will exercise its oversight authority to ensure that all of FDA’s observations with respect to the Emergent facility are addressed promptly and comprehensively”.

“The company will also continue to work toward securing emergency use authorisation in the United States for drug substance manufactured at Emergent Bayview as quickly as possible, so that the company can help bring an end to this global pandemic,” J&J added.

The FDA clarified that the conditions  at this plant were ‘unrelated’ to the ongoing evaluation into reports of extremely rare cases of blood clots with low blood platelet levels observed in some people who have received the J&J COVID-19 vaccine.

Earlier this week, the European Medicines Agency (EMA) recommended that a warning regarding the rare type of blood clot should be added to the product information for the J&J vaccine, after finding a possible link between the rare adverse events and the jab.

Article by
Lucy Parsons

23rd April 2021

From: Regulatory



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