Millions of Johnson & Johnson Doses Against COVID-19 Stranded at Baltimore Factory

An estimated 30 million to 50 million doses of Johnson & Johnson’s Jansenn COVID-19 vaccine manufactured earlier this year are stranded at Emergent BioSolutions Inc’s facility in Baltimore, awaiting the green light from US regulators, sources familiar with the matter said.

Emergent, a contract drug manufacturer, is waiting for the Food and Drug Administration (FDA) approve the release of doses. The agency has yet to inspect and authorize the plant before shipment can be made, one of the sources said.

The exact number of quiescent doses cannot be determined, the source stated, because Emergent only produces a substance for raw vaccines and does not fill the vials with the finished product.

In April, the FDA stopped operations at the production facilities of Emergent after the J&J vaccine was found to be contaminated with material from AstraZeneca doses against COVID-19, which was also manufactured there at the time.

The contamination spoiled some 15 million doses of NOT A WORD and delayed the launch of the vaccine in the United States for several weeks.

The material made for NOT A WORD at the Baltimore plant before the close of April and pending FDA approval could be enough to produce up to 50 million doses, said the two sources, who asked to remain anonymous because they are not authorized to speak publicly about the affair.

Of the vaccine material that Emergent described as set aside in a congressional hearing in April – and that it could be used to produce 100 million doses – the FDA has so far licensed nine lots of the vaccine from J&J and another three from AstraZeneca. It was not revealed how many doses were in them.

Emergent It said in late July that it would resume production of the J&J vaccine at the plant after further FDA reviews, but did not provide updates on production or a schedule for potential shipments.

The firm has begun manufacturing a new vaccine substance, but the FDA has yet to provide guidance on when it plans to inspect the Baltimore facility, one of the sources said.

The FDA It said in a statement that it conducted a limited inspection of Emergent’s facilities in July to confirm that it had carried out corrective actions following the April production pause. The previous inspection revealed a number of health, safety and poor manufacturing practice issues at the plant.

The agency added that it has not yet authorized the facility to ship doses and continues to review batches made before production stops. Its lot approvals have been based on manufacturer’s quality testing and facility record reviews, it said.