The US FDA has determined lots of a COVID vaccine are acceptable to use despite AstraZeneca identifying further manufacturing deviations.

Dan Stanton, Managing editor

September 24, 2021

2 Min Read
AstraZeneca vaccines: Further problems at Emergent but FDA okays exports
Emergent's Bayview facility. Image c/o Google

The US FDA has determined several lots of a COVID-19 vaccine are acceptable to use despite AstraZeneca identifying further manufacturing deviations at CDMO partner Emergent. 

Efforts to scale up COVID-19 vaccines in the wake of the pandemic have been exceptional, but in April Emergent BioSolution fell afoul of the US Food and Drug Administration (FDA). 

The contract development and manufacturing organization (CDMO) had been contracted by both Johnson & Johnson and AstraZeneca (AZ) to make their respective COVID-19 vaccines, but an ingredient mix up rendered 15 million doses unusable and landed the plant with a Form 483 and a directive to stop production in April.


Emergent’s Bayview facility. Image c/o Google

Restrictions were lifted in July but an advice letter and memorandum posted by the Agency yesterday reports further manufacturing deviations affecting specific lots of AstraZeneca’s adenovirus-based vaccine AZD1222 stemming from the Maryland plant. 

“On August 12, 2021, AZ notified FDA that Emergent had identified another major deviation linked to all AZD1222 lots,” the FDA said in its correspondence to AstraZeneca. 

“This deviation resulted from the use of a sample matrix that was not qualified to perform bioburden testing on nine different raw materials including several excipients. Additionally, on August 20, 2021, FDA was notified of another deviation that impacted all lots manufactured in Area 3 of the EMOB [Emergent Manufacturing Operations Baltimore] facility. This deviation was related to upstream in-line testing where the system did not perform as expected, including missed auto quality control testing.” 

The note said AstraZeneca investigated the impact of these deviations on the quality and safety of its products, but a third major deviation impacting lots numbered 21002248, 21002635, and 21002636 was reported earlier this month. 

“This deviation was related to the use of certain unqualified temperature control units in Area 3 for AZD1222 DS downstream manufacturing process. Specifically, these unqualified units were used to control the downstream process intermediate temperature in the single-use mixer bags to ensure that the maximum process intermediate hold times were not exceeded.” 

But despite these issues, the FDA has deemed these lots acceptable for export. 

“Based on our review of the available data and information for AstraZeneca’s ChAdOx1 nCOV19 vaccine DS lots 21002248, 21002635, and 21002636, these deviations should not negatively impact the quality or safety of the DS,” the Agency wrote. 

But while the FDA has “determined that the quality of the product produced is acceptable for use for potential export, considering the current COVID-19 public health emergency,” it notes “this determination does not necessarily indicate that FDA finds these lots to be acceptable for use in the United States for clinical trials under IND.” 

Emergent has been contacted for comment.

About the Author(s)

Dan Stanton

Managing editor

Journalist covering the international biopharmaceutical manufacturing and processing industries.

Founder and editor of Bioprocess Insider, a daily news offshoot of publication Bioprocess International, with expertise in the pharmaceutical and healthcare sectors, in particular, the following niches: CROs, CDMOs, M&A, IPOs, biotech, bioprocessing methods and equipment, drug delivery, regulatory affairs and business development.

From London, UK originally but currently based in Montpellier, France through a round-a-bout adventure that has seen me live and work in Leeds (UK), London, New Zealand, and China.

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