Kazakhstan to start testing domestic COVID-19 vaccine on volunteers in September

Kazakhstan to start testing domestic COVID-19 vaccine on volunteers in September
Seven scientists from Kazakhstan have tested a COVID-19 vaccine on themselves, which they developed, Research Institute for Biological Safety Problems reported. The volunteers are next.
 
“According to the World Health Organization requirements, on August 13 we plan to determine the final antibody titer level in rhesus macaques, which should be at least 7 log, which is an indicator of high immunogenicity. On July 26, five scientists-developers were vaccinated with their own inactivated COVID-19 vaccine. After three days, they felt good and had neither fever nor allergy. Preclinical trials will be completed on August 20 and the results will be forwarded to Kazakh Health Ministry. After obtaining permission from the ministry, the first stage of clinical trials on 44 volunteers who do not have coronavirus antibodies is expected to begin in September,” the Research Institute explained.
 
The vaccination was carried out in two stages. The drug was first injected to five scientists, including Director General of the Research Institute for Biological Safety Problems Kunsulu Zakarya. The next day, after monitoring the vaccinated employees and learning that the vaccine was safe, two more staff members were vaccinated.

“The vaccination was necessary for the complete epidemiological protection of the Research Institute for Biological Safety Problems researchers who are directly involved in the development of the technology for the manufacturing and testing of the first domestic COVID-19 vaccine. In case of infection of these researchers with coronavirus, the Institute would for a long time lose its most valuable specialists performing the most important state task of developing a domestic vaccine.  The immunization with one’s own vaccine is an unspoken scientific standard for developers of medical and immunobiological drugs. First of all, the vaccine developer should test the safety and immunogenicity of his own development on himself. Second, he must take full responsibility for the results and quality of his research. Thus, ensuring the safety of future volunteers who will take part in clinical trials,” said Zakarya.

The second phase of clinical trials on 200 volunteers that meet the WHO requirements is scheduled for mid-October. It should complete in December.

As soon as the WHO confirms the results of clinical trials of the candidate vaccine, Kazakhstan will be ready to start its production at a plant for the production of immunobiological drugs at the Research Institute for Biological Safety Problems, which is currently under construction. The projected capacity of the plant is up to 60 million doses per year. The construction is planned to be completed before the end of the year.
 
On March 23, scientists received a biological material from the first COVID-19 patients and a week later the virus identified as the causative agent of SARS-CoV-2 was isolated and its biological properties were studied. On May 9, work on the development of the vaccine was completed and its protocol was forwarded to the WHO.
 
As a result of conducted examination, the WHO included it in the list of candidate vaccines approved for preclinical trials. The results have shown that for all parameters regulated by the WHO, namely toxicity, pyrogenicity, allergenicity, immunogenicity, the candidate vaccine meets the requirements and the state pharmacopoeia of Kazakhstan.
 
On July 6, the vaccine was transferred to the National Center for Expertise of Medicines of Kazakh Health Ministry, which confirmed the reproducibility of the results of preclinical trials of the vaccine.
 
In total, five prototypes of the COVID-19 vaccine are being developed in the country. A general overview of the vaccine candidates is available on the WHO website.
 
Individuals from the risk group with chronic diseases, including citizens over 65 years old with cardiovascular diseases, diabetes mellitus and chronic obstructive pulmonary disease, will be subject to vaccination. Health workers will also be vaccinated. Thus, the approximate number of Kazakh citizens to be vaccinated is 2.35 million.
 
 
Photo: hse.ru