FDA Authorizes Use of Drug Substance for Janssen COVID-19 Vaccine

On June 11, 2021, FDA announced that it is authorizing two batches of vaccine drug substance manufactured at the Emergent BioSolutions Baltimore facility for the Janssen COVID-19 vaccine. FDA concluded the batches were suitable for use after a review of the facility records and results of quality testing. However, the agency did not include the Emergent plant as an authorized facility in Janssen’s Emergency Use Authorization.

“The FDA’s decision to include these two batches of vaccine drug substance in the EUA for the Janssen COVID-19 vaccine means that Janssen vaccine made with this drug substance can be used in the [United States] or exported to other countries. 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,” the agency stated in a press release.

FDA also extended the expiration date for the Janssen COVID-19 vaccine, extending the storage at 2–8 oC to 4.5 months from 3 months. The decision came after the agency reviewed information submitted from Janssen.

“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. 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,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the press release. “Additionally, 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.”

Source: FDA