Benzinga | Jun 11, 2021 04:36PM EDT

Emergent BioSolutions Saus Two Batches Of COVID-19 Vaccine Manufactured By Co. Were Determined Suitable For Use By FDA

Emergent BioSolutions Inc. (NYSE:EBS) today announced that two batches of COVID-19 vaccine manufactured by Emergent BioSolutions at its Baltimore Bayview facility were determined to be suitable for use by the U.S. Food & Drug Administration (FDA) and have been authorized as part of Johnson & Johnson's Emergency Use Authorization (EUA).

"We are pleased that these initial doses of the Johnson & Johnson COVID-19 vaccine will be available to protect millions of people from this deadly disease," said Robert G. Kramer, president and chief executive officer of Emergent. "We look forward to working with the FDA and Johnson & Johnson toward the release of additional batches and resuming production at our Bayview facility."

Emergent is actively addressing issues identified by the FDA at its Bayview facility and plans to resume manufacturing of the Johnson & Johnson COVID-19 vaccine drug substance after Emergent, Johnson & Johnson, and FDA are confident that the steps taken have remedied shortcomings.

For nearly a decade, Emergent has been working closely with the U.S. government to ensure that manufacturing capacity stands at the ready to address public health emergencies. This foresight of the U.S. government led to the designation of Emergent's Baltimore Bayview facility as a Center for Innovation in Advanced Development and Manufacturing (CIADM) in 2012. This agreement was first established as a public-private partnership for influenza pandemic preparedness. Since mid-2020, Emergent has harnessed its capabilities to rapidly build and scale up capacity to manufacture bulk drug substance for Johnson & Johnson's COVID-19 vaccine.