Janssen COVID-19 Vaccine Availability Increased
The U.S. Food and Drug Administration (FDA) confirmed it is taking action to increase the supply of the Janssen (Johnson & Johnson) COVID-19 Vaccine in the USA and globally.
On June 11, 2021, the FDA announced that it is authorizing for use under the emergency use authorization (EUA) for the Janssen COVID-19 vaccine, two drug substance batches previously manufactured at the Emergent BioSolutions facility in Baltimore, MD.
The FDA’s decision to include these batches in the EUA for the Janssen COVID-19 vaccine means that vaccines made with this drug substance can be used in the USA or exported to other countries.
“These actions followed an extensive review of records. 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, in an FDA-issued press statement issued on June 11, 2021.
Furthermore, the FDA has determined several other batches are not suitable for use. However, additional batches are still under review, and the agency will keep the public informed as those reviews are completed.
The Maryland-based FDA is an agency within the U.S. Department of Health and Human Services.