FDA Gives Green Light to Emergent BioSolutions to Resume COVID-19 Vaccine Manufacturing

On July 29, 2021, Emergent BioSolutions announced that FDA is allowing the company’s Bayview manufacturing facility in Baltimore, Md., to resume production of Johnson & Johnson’s (J&J) COVID-19 vaccine bulk drug substance. FDA’s decision comes after doing extensive reviews and is based on the diligent work and close coordination Emergent has conducted with J&J and the agency to execute a quality enhancement plan.

Since production was paused, Emergent has been working closely with FDA and J&J to address quality concerns and has developed and executed an action plan as well as committed extensive resources to bring operations up to FDA standards. The company expects to continue working with the agency throughout the manufacturing process to help ensure the stability of the J&J COVID-19 vaccine supply chain.

“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 Robert Kramer, Emergent’s CEO, in a company press release. “We are in the unique business of producing life-saving medications for catastrophes that we hope never occur [such as] anthrax attacks, opioid overdoses, and COVID-19.”

“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,” Kramer added. “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.”

Source: Emergent BioSolutions