Emergent BioSolutions Inc. announced that the U.S. Food and Drug Administration (FDA) is allowing Emergent’s Bayview manufacturing facility to resume production of Johnson & Johnson’s (J&J) Covid-19 vaccine bulk drug substance. This resumption of manufacturing follows extensive reviews by FDA, weeks of diligent work, and close coordination with J&J and FDA to execute on Emergent’s quality enhancement plan. Since production was paused at Bayview, Emergent has worked closely with FDA and J&J to address quality concerns including developing and executing an action plan and committing extensive resources to bring operations up to FDA’s exacting standards. Emergent expects to continue to work with FDA throughout the manufacturing process to help ensure the strength of the J&J Covid-19 vaccine supply chain.