Two batches of COVID-19 vaccine solution that Emergent BioSolutions Inc. manufactures for Johnson & Johnson at its Baltimore Bayview facility are suitable for use, the U.S. Food & Drug Administration (FDA) announced on Friday.
“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,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a June 11 statement. “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.”
Emergent has awaited the FDA’s decision since the Maryland-based biopharmaceutical company earlier this year had to quarantine roughly 15 million doses of the Janssen (Johnson & Johnson) vaccine that it was manufacturing following cross contamination with the AstraZeneca vaccine that Emergent was also producing at its Bayview plant.
“We are pleased that these initial doses of the Johnson & Johnson COVID-19 vaccine will be available to protect millions of people from this deadly disease,” Emergent President and CEO Robert Kramer said on Friday. “We look forward to working with the FDA and Johnson & Johnson toward the release of additional batches and resuming production at our Bayview facility.”
Before making its decision, the FDA said it conducted a thorough review of facility records, as well as the results of quality testing performed by Emergent during the last several months.
Based on its review and considering the ongoing COVID-19 pandemic, the FDA said it concluded that the two batches manufactured at Emergent’s Bayview facility are suitable for use and have been FDA-authorized as part of Johnson & Johnson’s Emergency Use Authorization (EUA) for the Janssen COVID-19 vaccine.
“Since establishing our COVID-19 vaccine program, Johnson & Johnson has committed to producing safe, high-quality vaccines in order to bring health and hope to people everywhere,” Kathy Wengel, executive vice president and chief global supply chain officer at Johnson & Johnson, said on 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.”
The FDA also said that it “is not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility,” although the agency continues to work through issues there with management at both Emergent and Janssen.
Emergent, in fact, is actively addressing issues identified by the FDA at its Bayview facility and plans to resume manufacturing of the Johnson & Johnson COVID-19 vaccine drug substance after Emergent, Johnson & Johnson, and the FDA are confident that the steps taken have remedied shortcomings.
The FDA’s decision to include the two batches of vaccine drug substance in the EUA for the Janssen COVID-19 vaccine means that the Janssen vaccine made with this drug substance may be used in the United States or exported to other countries, the agency said.
“A condition on any export of these batches, or of vaccine manufactured from these batches, is that Janssen and Emergent agree that the FDA may share relevant information about the manufacture of the batches under an appropriate confidentiality agreement, with the regulatory authorities of the countries in which the vaccine may be used,” according to the FDA’s statement.
The FDA also revised the letter of authorization for the Janssen vaccine to help facilitate potential export to other countries and now requires the distribution and administration of exported vaccines to be in compliance with the laws of the recipient countries, the statement says.
Additionally, the FDA extended the expiration date for the refrigerated Janssen COVID-19 vaccine after reviewing information submitted by Janssen and determining that the vaccine can be stored at 2-8 degrees Celsius for four-and-a-half months instead of three months.
“The action to extend the shelf life for the refrigerated Janssen vaccine means that jurisdictions that have doses on hand now have additional time to administer vaccine,” said Dr. Marks.
While the FDA also determined that several other batches at Emergent’s facility are not suitable for use, the agency said that additional batches are still under review and it will keep the public informed as FDA reviews are completed.