FDA authorizes 9th batch of J&J COVID vax from troubled Emergent plant

The US FDA has authorized an emergency use authorization (EUA) for one additional batch of the Janssen COVID-19 vaccine manufactured at Emergent’ Bayview facility.

Contamination issues stemming from Emergent BioSolutions marred rollout of J&J’s ‘Janssen’ single dose COVID-19 vaccine earlier this year.

The contract development and manufacturing organization’s (CDMO) Bayview, Maryland facility had been contracted by both J&J and AstraZeneca, but an ingredient mix up rendered 15 million doses unusable and landed the plant with an FDA Form 483 and a directive to stop production in April.

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Some batches produced at Bayview have been approved, and last week the US Food and Drug Administration (FDA) authorized a ninth batch of the vaccine to be released form the facility for public use.

“Based on our review of the available data and information, we have determined that the Janssen’s AD26.COV2.S DS Area 1 batch 21004660 (GMP 5) is suitable for use and meets the EUA standard, which is outlined in your Letter of Authorization. Thus, we concur with your request to add this batch to the EUA,” Marion Gruber, director at the Office of Vaccines Research and Review Center for Biologics Evaluation and Research, wrote in a letter to Janssen.

“Because the Bayview facility was not operating in compliance with Current Good Manufacturing Practice requirements at the time this batch was manufactured, through this concurrence letter, I am waiving Current Good Manufacturing Practice requirements for this batch, and only this batch, for the duration of this EUA.”

The FDA adds that it has conducted a thorough review of facility records and quality testing performed by the manufacturer, concluding that the nine batches released to date are suitable for use.

“While the FDA is not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility, the agency continues to work through issues on this matter with Janssen and Emergent BioSolutions management,” the Agency writes.

J&J has previously stated its vaccine supply strategy is not dependent on Emergent, and that the CDMO’s Bayview facility forms part of a global network of both inhouse and outsourced drug substance and drug product facilities supporting the COVID vaccine.

The news comes weeks after the FDA determined several lots of AstraZeneca’s COVID-19 vaccine made from Bayview were acceptable to use despite the discovery of further manufacturing deviations at the troubled site.