Safety Assessment: a Comparative Analysis of Quantitative Content of Bacterial Endotoxins and Evaluation of Pyrogenicity of the Kazakhstan Vaccine QazCovid-in® against COVID-19


Jekebekov K.K. Nurpeisova A.S. Abay Z. Shorayeva K.A. Absatova Z. Abitayev R.T. Kalimolda E.Z. Moldagulova S.U. Assanzhanova N.N. Omurtay A.D. Shayakhmetov Y. Sadikaliyeva S.O. Barakbayev K.B. Kassenov M.M. Zakarya K.D. Abduraimov Y.
February 2024Springer

Bulletin of Experimental Biology and Medicine
2024#176Issue 4452 - 456 pp.

We measured the levels of bacterial endotoxins in the bulk vaccine product (BVP) and finished vaccine QazCovid-in® and evaluated the effect of aluminum hydroxide (adjuvant) on the results of LAL test and pyrogenicity of samples in vivo (in rabbits receiving intravenous injection into the marginal ear vein). Administration of BVP with LPS resulted in a dose-dependent increase in body temperature in rabbits similar to that caused by LPS alone, which suggests that aluminum hydroxide in the vaccine did not affect the pyrogenic response in rabbits. Moreover, the LAL test showed that the aluminum hydroxide did not hinder LPS activity after serial dilution of samples.

bacterial endotoxins , coronavirus infection , LAL test , pyrogenicity , vaccine

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Laboratory for Control of Technologies and Biopreparations, Research Institute of Biological Safety Problems, the Ministry of Health of the Republic of Kazakhstan, Guardeyskiy, Kazakhstan
Laboratory for Monitoring of Infectious Diseases, Research Institute of Biological Safety Problems, the Ministry of Health of the Republic of Kazakhstan, Guardeyskiy, Kazakhstan
Laboratory for Technologies of Finished Forms of Biopreparations, Research Institute of Biological Safety Problems, the Ministry of Health of the Republic of Kazakhstan, Guardeyskiy, Kazakhstan
Management Department, Research Institute of Biological Safety Problems, the Ministry of Health of the Republic of Kazakhstan, Guardeyskiy, Kazakhstan

Laboratory for Control of Technologies and Biopreparations
Laboratory for Monitoring of Infectious Diseases
Laboratory for Technologies of Finished Forms of Biopreparations
Management Department

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