Countries testing J&J vaccine doses after contamination at Baltimore plant
The European Union, Canada and South Africa are withholding Johnson & Johnson coronavirus vaccines produced at an Emergent BioSolutions plant in Baltimore, Maryland, for safety testing after quality-control problems, according to the New York Times.
Driving the news: Johnson & Johnson said in March that workers at the Emergent facility, which had been producing Johnson & Johnson and AstraZeneca vaccines, had ruined about 15 million doses of its vaccine by contaminating a batch with ingredients used in the AstraZeneca vaccine.
Context: The error halted the potential production and shipment tens of millions of Johnson & Johnson doses while the Food and Drug Administration conducted an investigation.
- The plant had not been approved by the FDA to produce doses that would be used in the U.S., but it had produced doses that were shipped abroad and are being administered in some countries without issues.
- But some regulators in various countries are working to ensure that doses produced prior to the accident are uncontaminated.
The big picture...
- European Union: The European Medicines Agency told the Times that one batch of Johnson & Johnson vaccine manufactured at the Emergent facility is being used but only after "a thorough testing of the batch and a review of the controls in place at the manufacturing site.”
- Canada: Health Canada told the Times it is performing assessments of vaccine manufactured at the Emergent plant and that the doses “will only be released for distribution once Health Canada is satisfied that they meet the Department’s high standards for quality, safety and efficacy.”
- South Africa: Its national health ministry told the Times that Johnson & Johnson doses are awaiting “a protracted safety verification process with international regulatory agencies."
The FDA, in a report last month, faulted Emergent for failing to thoroughly review the incident and said the plant suffered from multiple unsanitary conditions, including peeling paint in sensitive manufacturing areas and waste that was not decontaminated.
- The agency said workers at the plant were also seen on surveillance footage mishandling medical waste.
- The FDA told the Times that the agency was “in close communication with our foreign regulatory counterparts regarding this ongoing matter to ensure they’re aware of the situation.”
- "In a statement, Johnson & Johnson said it was working with U.S. and other regulators and emphasized that 'quality and safety' were paramount," the Times reported.