Additional COVID-19 Vaccine Substances Authorized by the U.S. FDA

The U.S. Food and Drug Administration (FDA) announced on June 15, 2021, the agency authorized the use of an additional batch of vaccine drug substance under the emergency use authorization for the J&J - Janssen COVID-19 vaccine manufactured at the Emergent facility in Maryland.

To date, a total of three batches of Janssen drug substances that were manufactured at Emergent's facility have been authorized.

This FDA action follows the June 11th authorization of certain batches of the Janssen COVID-19 vaccine drug substance produced by Emergent BioSolutions.

Emergent BioSolutions is a global life sciences company based in Gaithersburg, MD, whose mission is to protect and enhance life. Emergent’s specialty products and contract development and manufacturing services are dedicated to providing solutions that address public health threats.