The US Food and Drug Administration announced Friday it was authorizing for use two batches of Johnson & Johnson Covid-19 vaccines – roughly 10 million doses – that were produced at the troubled Emergent BioSolutions facility in Baltimore.
This is a significant development, given not a single usable dose of the Johnson & Johnson Covid-19 vaccine from that facility had been approved yet.
“Before making this decision, the FDA conducted a thorough review of facility records and the results of quality testing performed by the manufacturer. Based on this review and considering the current COVID-19 public health emergency, the FDA concluded these batches are suitable for use,” the FDA said in a statement.
Kathy Wengel, executive vice president and chief global supply chain officer for Johnson & Johnson, hailed the progress Friday.
“Today’s decisions represent progress in our continued efforts to make a difference in this pandemic on a global scale, and we appreciate the close collaboration with the FDA and global health authorities,” Wengel said in a statement. “The Company continues to substantially expand its global vaccine manufacturing network as we work with regulatory and health authorities to supply our COVID-19 vaccine worldwide.”
The FDA said it had determined that several other batches of the vaccine from the plant were not suitable for use and said additional batches are still under review.
Five batches were rejected after quality reviews were conducted, an official said, an estimated 60 million doses.
The FDA added that it was not yet ready to fully clear the facility as an authorized manufacturing facility and that it was continuing to “work through issues there with Janssen and Emergent BioSolutions management.” Janssen is a pharmaceutical company based in Belgium and owned by Johnson & Johnson.
The FDA said it also revised the letter of authorization for the Johnson & Johnson vaccine to help facilitate potential export to other countries.
“These actions followed an extensive review of records, including the production history of the facility and the testing performed to evaluate the quality of the product,” said Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research in a statement.
Marks continued: “This review has been taking place while Emergent BioSolutions prepares to resume manufacturing operations with corrective actions to ensure compliance with the FDA’s current good manufacturing practice requirements.”
CNN previously reported that the FDA was preparing to clear around 10 million doses.
In March, Johnson & Johnson said the quality control process at the plant identified one batch of drug substance that did not meet quality standards. The statement followed a New York Times report that said as many as 15 million potential doses of vaccines had been ruined, delaying FDA authorization of the Baltimore plant. An FDA inspection report released in April detailed numerous concerns at the facility, including that Emergent had not thoroughly investigated cross-contamination of a viral vaccine drug substance batch, and there was not a thorough review of how people moved in and around the facility as a potential source of contamination.
No shipments of Johnson & Johnson’s coronavirus vaccine have gone out from the federal government in several weeks because the vaccine is in short supply, CNN has reported. The lack of shipments is directly linked to the issues related to the plant in Baltimore.
The lag in shipments comes as the pace of vaccination in the US has slowed in recent weeks.
In five states – Alabama, Louisiana, Mississippi, Tennessee and Wyoming – fewer than half of adult residents have received one dose of Covid-19 vaccine, according to data published Thursday by the US Centers for Disease Control and Prevention.
In the US overall, 64% of adults have received at least one dose of Covid-19 vaccine and about 53% are fully vaccinated. The President has set a goal of 70% of US adults getting at least one Covid vaccine shot by July 4, but the US may not reach that goal at this current pace.
Johnson & Johnson said this week that the FDA had authorized an extension of the shelf life of its Covid-19 vaccine. The move increases the refrigerated storage time for the vaccine from three months to four-and-a-half months, and comes as some states had said currently available doses were set to expire at the end of June, potentially before being used.
This story has been updated with additional information.
