Emergent BioSolutions resumed operations at its troubled Baltimore facility in July, but it's still struggling to contribute to the ongoing effort to churn out COVID-19 vaccines.
The site was shut down earlier this year after it mixed up ingredients for J&J's shot and AstraZeneca's. The problem was addressed, but between 30 and 50 million doses of Johnson and Johnson’s COVID-19 vaccine manufactured at the site prior to its shutdown remain in limbo, awaiting distribution approval from the FDA, according to two unnamed sources cited by Reuters.
The exact number of idle doses can’t be determined because the Baltimore facility produces raw materials for the J&J shot and doesn’t do fill-finish, the sources said.
After the agency cleared Emergent to resume operations at the site in July, it approved eight batches, but it hasn’t given any guidance on plans for future inspections, the sources added. The FDA told Reuters in a statement that limited inspections of the plant were conducted in July to confirm the company had followed through on corrective actions in the wake of the April pause.
The reported holdup of the J&J doses comes amid global pressure to make COVID-19 vaccines and treatments available to low- and middle-income countries, as more affluent regions like North America, Europe and Japan experience higher vaccination rates and wider vaccine availability.
Problems at the Baltimore plant emerged in March when out-of-specification test results began to raise red flags. Follow-up tests by J&J found more contamination in one batch, triggering an extensive FDA inspection that cited numerous issues, including cleanliness and quality control shortfalls.
The agency temporarily shuttered operations at the plant and millions of J&J doses were thrown out. The incident also resulted in a congressional investigation of Emergent’s operations, risking the company’s lucrative federal contract.
The FDA has been falling behind on plant inspections due to travel restrictions and other challenges caused by the pandemic.