Safety and immunogenicity of the first Kazakh inactivated vaccine for COVID-19

Abstract

This article describes the results of a preclinical safety and immunogenicity study of QazCovid-in®, the first COVID-19 vaccine developed in Kazakhstan, on BALB/c mice, rats, ferrets, Syrian hamsters and rhesus macaques ( Macaca mulatta ). The study’s safety data suggests that this immunobiological preparation can be technically considered a Class 5 nontoxic vaccine. The series of injections that were made did not produce any adverse effect or any change in the general condition of the model animals’ health, while macroscopy and histology studies identified no changes in the internal organs of the BALB/c mice and rats. This study has demonstrated that a double immunization enhances the growth of antibody titers as assessed by the microneutralization assay (MNA) and the enzyme-linked immunosorbent assay (ELISA) in a pre-clinical immunogenicity test on animal models. The best GMT results were assessed in MNA and ELISA 7 days after re-vaccination; however, we noted that GMT antibody results in ELISA were lower than in MNA. A comparative GMT assessment after the first immunization and the re-immunization identified significant differences between model animal groups and a growth of GMT antibodies in all of them; also, differences between the gender groups were statistically significant. Moreover, the most marked MNA immune response to the QazCovid-in® vaccine was seen in the Syrian hamsters, while their SARS-CoV-2-specific antibody activity as assessed with ELISA was the lowest.

Pre-Clinical Safety and Immunogenicity Study of a Coronavirus Protein-Based Subunit Vaccine for COVID-19

“…Over the past several years, the Scientific Research Institute for Biological Safety Problems (RIBSP) has been doing re-search to develop vaccines against influenza and M. tuberculosis for the Ministry of Health of the Republic of Kazakhstan [ 43 , 44 , 45 , 46 ]. Like many other countries, Kazakhstan started designing its own SARS-CoV-2 vaccine immediately after the COVID-19 outbreak with several candidate vaccines proposed by the RIBSP [ 47 , 48 , 49 , 50 ]. One of these was a subunit vaccine called QazCoVac-P, which is being examined here.…”

Vaccine research and development capacity in Central and West Asia: A path toward sustainable vaccine R&D programs

“…A literature and landscape review using publicly available information focused on vaccine development identified five peer-reviewed publications with Azerbaijan-based authors at either university, research institutes or in named biotech companies in the period 2016-2021. Ongoing vaccine R&D activities are focused around designing potential cancer vaccines (18), evaluating adjuvants for poultry vaccines (19) and development and testing of a malaria vaccine to Pfs48/45 (20). Further vaccine R&D activities indicate development of pharmaceuticals using plant transient expression technology (21) with several vaccine candidates developed to COVID- 19 (22) and therapeutic candidates such as human furin factor IX (23).…”

“…Vaccine research and development has experienced a revolution following the emergence of the SARS-CoV-2 as the causative agent of coronavirus disease 2019 (COVID- 19), with previously unprecedented multinational efforts to develop and deploy safe and effective vaccines globally (1). Three years after the initial outbreak of COVID-19 first identified in Wuhan, China (2), this effort has translated into massive global vaccination campaigns which has contributed to the reversal of the pandemic curve in many countries although the health and financial impacts of the virus remain enormous.…”

“…In-country vaccine development capabilities were modest in all the countries evaluated. Kazakhstan had the most advanced programs in both clinical development and vaccine manufacturing capabilities with published examples of vaccine development humans (10) and veterinary settings (11). Further examples of vaccine research and clinical development exist in Azerbaijan (reviewed further Section 2.1) and Uzbekistan (12) where the COVID-19 vaccine ZF-UZ-VAC 2001 was developed in collaboration with the Chinese company Anhui Zhifei Longcom Biopharmaceutical (13).…”

Attitude toward vaccination against COVID-19 and acceptance of the national “QazVac” vaccine in the Aktobe city population, West Kazakhstan: A cross-sectional survey

“…In the meantime, Kazakhstan was one of the countries where the inactivated vaccine QazCovid-in (QazVac) had been developed. During a 6-month follow-up period, the QazVac vaccine showed 82% protective efficacy (95% CI 71.1;88.5) in volunteers [ 11 , 12 ].…”