"#AstraZeneca, we have a problem"

New #preprint from Lena Krutzke and Stefan Kochanek et. al. @uni_ulm and @UniklinikUlm on @researchsquare

"Process-related impurities in the ChAdOx1 nCov-19 vaccine"

Why is this a problem? A short thread (1/8) 👇
"The intramuscular injection of proteins that are not part of the active principle of the #vaccine itself might have effects at different levels"

That`s why removal of impurities (e.g. host-cell proteins) is critical for #therapeutics and strictly regulated
Unfortunately, removal of process-related #impurities from viral vector-based #therapeutics (e.g. host-cell proteins) is imperfect and low levels - orders of magnitude lower than the actual active therapeutic - are usually accepted if they are classified as non-problematic
However, the impurities found in 3 different lots of the ChAdOx1 nCov-19 #vaccine from #AstraZeneca are far beyond the usual (and acceptable) level.
The authors estimate that the vaccine-part in the different lots only corresponds to 29-55% of the total protein content👇
(4/8) Image
In addition to the #adenovirus vector, substantial amounts of both, human and nonstructural viral proteins were identified with human proteins, heat-shock proteins and cytoskeletal proteins being particularly abundant👇
(5/8) Image
Overall, this finding is disturbing and deeply worrying!
Why, because it is not unreasonable to argue that the often-observed strong clinical reaction after vaccination is likely associated with the detected protein impurities!
Whether some of these impurities might even have long-term immune-related side effects or can be linked to the sinus venous thrombosis cases is currently unknow but cleary something to look at in future studies.
However, to increase safety and reduce concerns of future usage of the vaccine an improvement of the purification regime seems inevitable!

What is your opinion?
@Fischblog @dittrich_lars

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