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

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.

[Selection of conditions for effective inactivation of Pseudopestis avium virus (Paramyxoviridae: Orthoavulovirus: Avian orthoavulovirus 1) for the production of a Newcastle disease vaccine].

INTRODUCTION: Newcastle disease (ND) is classified as especially dangerous pathogen. Its primary source is an infected or recovered bird. The virus shedding begins just in a day after infection, and virus remains in the body for another 2-4 months after the recovery. The complexity of the final elimination of the causative agent of the disease lies in its ability for long-term preservation in the external environment and the possibility of constant circulation in one complex between groups of birds of different sex and age. Therefore, the main element of protecting birds from ND is immunoprophylaxis that is based on vaccines containing an inactivated ND virus (NDV). The aim of the work ‒ is to optimize the parameters of inactivation of the NDV actual strain H with formaldehyde at final concentrations of 0.01, 0.025, 0.05, and 0.1% under temperature conditions of 20 2 and 37 0.5 C. MATERIALS AND METHODS: We used a virus-containing suspension of the NDV strain H with an initial biological activity of 10.75 lg EID50/cm3 grown by cultivation in 10-day-old developing chick embryos. RESULTS: On the 16th day after the administration of the tested suspensions of NDV inactivated at different temperatures and concentrations of the inactivant , the geometric mean titers of antibodies to NDV in sera of vaccinated birds were at least 1 : 63 in the hemagglutination inhibition reaction, indicating that the studied inactivated suspensions were antigenically active. CONCLUSION: The optimal parameters of the inactivation mode (final concentration, temperature and time of inactivation) of the NDV strain H were established. The inactivation process at 37 0.5 C with inactivant concentrations of 0.01, 0.025, 0.05, and 0.1% lasts up to 72, 22, 18, and 12 hours, respectively. The inactivation process at 20 2 C with inactivant concentrations of 0.05 and 0.1% lasts up to 22 and 18 hours, respectively.