The US Food and Drug Administration said Tuesday it had released a third batch of Johnson & Johnson’s coronavirus vaccine from the troubled Emergent BioSolutions plant in Baltimore.
But it has not cleared the plant itself as an authorized manufacturing facility.
The FDA released two batches of bulk vaccine from the facility on June 11, said it was reviewing more batches. It said some were not suitable for use. Last week, an official told CNN that five batches were rejected after quality reviews – representing an estimated 60 million doses.
“The FDA conducted a thorough review of facility records and the results of quality testing performed by the manufacturer,” the agency said.
“Based on this review and considering the current COVID-19 public health emergency, the FDA has concluded that these batches are suitable for use. While the FDA is not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility, the agency continues to work through issues there with Janssen and Emergent BioSolutions management.”
The FDA suspended production at the plant in April after cross contamination was discovered between vaccines being made there for Johnson & Johnson and AstraZeneca. AstraZeneca later moved its production out of that plant.
The raw vaccine material is made at the plant and then shipped to other facilities to be bottled—a process known as fill and finish.