June 11, 2021: “Following careful review and deliberation, the U.S. FDA is taking important steps that will allow a critically needed supply of the Janssen (Johnson & Johnson) COVID-19 Vaccine to be made available.
The agency is announcing that it is authorizing for use, under the emergency use authorization (EUA) for the Janssen COVID-19 vaccine, two batches of vaccine drug substance manufactured at the Emergent BioSolutions facility in Baltimore.
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.
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’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 U.S. 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 FDA has also revised the letter of authorization for the Janssen vaccine to help facilitate potential export to other countries.
Under the revised letter of authorization, the distribution and administration of exported vaccines must comply with the laws of the recipient countries.
The FDA has determined several other batches are not suitable for use, but additional batches are still under review and the agency will keep the public informed as those reviews are completed.
Additionally, the FDA has extended the expiration dating 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 4.5 months instead of 3 months.
“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, M.D. Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.
“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.”
The FDA also will keep the public and our global partners informed as we continue to work expeditiously on this issue and will share information when we are able.”
https://www.fda.gov/news-events/press-announcements/fda-takes-steps-increase-availability-covid-19-vaccine
