Thread by @Klebensberger

"#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) 👇
researchsquare.com/article/rs-477…

"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
(2/8)

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
(3/8)

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)

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)

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!
(6/8)

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.
(7/8)

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
(8/8)

swr.de/swraktuell/bad…