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‚ÄĮa Form 483 and a directive to stop production‚ÄĮin April.
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‚Äôs¬†adenovirus-based vaccine¬†AZD1222¬†stemming from the Maryland plant.¬†
‚ÄúOn August 12, 2021, AZ notified FDA that Emergent had identified another major deviation linked to all AZD1222 lots,‚ÄĚ the FDA said in its correspondence to¬†AstraZeneca.¬†
‚ÄúThis 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.‚ÄĚ¬†
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.¬†
‚ÄúThis 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.‚ÄĚ¬†
But despite these issues, the FDA has deemed these lots acceptable for export.¬†
‚ÄúBased on our review of the available data and information for AstraZeneca‚Äôs ChAdOx1 nCOV19 vaccine DS lots 21002248, 21002635, and 21002636, these deviations should not negatively impact the quality or safety of the DS,‚ÄĚ the Agency wrote.¬†
But while the¬†FDA has¬†‚Äúdetermined that the quality of the product produced is acceptable for use for potential export, considering the current COVID-19 public health emergency,‚ÄĚ it notes ‚Äúthis determination does not necessarily indicate that FDA finds these lots to be acceptable for use in the United States for clinical trials under IND.‚ÄĚ¬†
Emergent has been contacted for comment.