Benzinga | Jul 29, 2021 08:04AM EDT

Emergent BioSolutions To Resume Manufacturing COVID-19 Vaccine At Bayview Facility

Emergent BioSolutions Inc. (NYSE:EBS) announced today 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.



"We are proud to be resuming production of bulk Covid-19 vaccine batches following additional reviews and collaboration with FDA and our manufacturing partners," said Emergent chief executive officer, Robert Kramer. "We are in the unique business of producing life-saving medications for catastrophes that we hope never occur like anthrax attacks, opioid overdoses, and Covid-19."

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.

"The American people should have high expectations of the partners its government chooses to help prepare them for disaster, and we have even higher expectations of ourselves," said Kramer. "We have fallen short of those lofty ambitions over the past few months but resumption of manufacturing is a key milestone and we are grateful for the opportunity to help bring this global pandemic to an end. We'd like to thank our government partners as well as Johnson & Johnson for their support."