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A Baltimore factory that disabled 75 million doses of a coronavirus vaccine developed by Johnson & Johnson failed to seal off a vaccine ingredient prep area for weeks and allowed production waste to be transported through the area, the Food and Drug Administration said in a memorandum with analysis the operation of the plant.
The memo, posted on the agency’s website late Friday, provided the most comprehensive explanation yet of why regulators believe tens of millions of doses of the Johnson & Johnson vaccine made at this factory must be discarded.
The FDA advised Johnson & Johnson on Friday to throw away the equivalent of 60 million cans. That brought the total number of cans to 75 million that cannot be used due to contamination concerns on a plan in southeast Baltimore operated by Emergent BioSolutions, Johnson & Johnson’s subcontractor and long-term government contractor.
The vaccine-making factory has been closed for the past two months while regulators are investigating the cause of the contamination that has ruined many cans, whether it is safe to reopen the facility, and what to do with the equivalent of at least 170 million vaccine doses do is Emergent produces for Johnson & Johnson and AstraZeneca, another vaccine developer.
The FDA memo said Emergent did not properly segregate the zones where Johnson & Johnson and AstraZeneca workers made vaccines to prevent cross-contamination that could make doses unsafe or ineffective. It was created by Dr. Peter Marks, the FDA’s premier vaccine regulator, and addressed to Johnson & Johnson.
When Emergent began manufacturing the Johnson & Johnson vaccine in November, the plant’s workers weighed and prepared the ingredients for making the two vaccines in separate areas. But when the factory started full production in December, workers began weighing and disposing of the materials for both vaccines in a common warehouse.
At the same time, the accelerated pace of production led to more waste. Emergent allowed workers to carry it around the warehouse in roll cages, according to the FDA report and interviews with former Emergent employees who were familiar with the plant’s procedures.
That flaw is most likely responsible for Emergent’s discovery in March that a batch of the Johnson & Johnson vaccine was contaminated with a key ingredient used to make the AstraZeneca vaccine, the memo said. Emergent said weeks ago that it discarded the entire batch, the equivalent of 15 million cans.
On Friday, the FDA ruled that another 60 million Johnson & Johnson cans should not be used. The agency believes another 10 million cans are safe, effective, and suitable for US distribution or export. Emergent and Johnson & Johnson both viewed the release of 10 million doses as a positive development that will help fight the pandemic.
The memo states that the contamination discovered in March most likely occurred when workers removing waste from AstraZeneca’s manufacturing zone contained contaminated bioreactor materials prepared for use in the Johnson & Johnson vaccine. In addition to the 15 million cans that had to be discarded, the FDA said another 60 million should be discarded because the same lax procedures were used in manufacturing and evidence of trace contamination may not have been shown in the tests.
There is no evidence that even a low level of contamination “has no effect on the safety and effectiveness of the vaccine,” the memo said.
Although the factory did not fully follow Good Manufacturing Practices, regulators opted for clearance 10 million doses, citing the ongoing public health emergency of Covid-19. These batches were produced under better conditions before “facility capacity was overwhelmed and the waste moved to the area that led to cross-contamination,” the memo says.
The agency also highlighted the fact that regulators were concerned about Emergent’s practices before the contaminated batch was discovered. In September, inspectors named production areas full of equipment and supplies, insufficient support for quality assurance, and the need to improve material and equipment flows.
On a follow-up visit in early February, the inspectors were concerned about the number of staff changes and new hires, as well as the need for more rigorous adherence to manufacturing processes, the memo says.
The government agreed to pay monthly emergent fees in May 2020, which totaled approximately $ 200 million as of April this year. A federal official said the Biden government had not paid the emergent fees that had been tied to the production of the AstraZeneca vaccine since around April.
After the contamination was discovered, Emergent federal officials withdrew responsibility for manufacturing the vaccine from AstraZeneca. If the factory is allowed to reopen, Emergent will only manufacture the Johnson & Johnson vaccine and only under the direct supervision of Johnson and Johnson. A decision as to whether the Baltimore plant can resume operations is expected in a few weeks.