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At the Scientific Research Institute for Biological Safety Problems of the Science Committee of the Ministry of Education and Science of the Republic of Kazakhstan (hereinafter – RIBSP), on July 26, 2020, five scientists-developers headed by Director General Zakarya K.D. were vaccinated with QazCovid-in – own inactivated COVID-19 vaccine and the next day after observing the vaccinated employees and receiving information that the vaccine was safe, 2 more employees were vaccinated (doctors of science, professors: Kutumbetov L.B. (the first received the vaccine) , Khairullin B.M., Orynbayev M.B., Sultankulova K.T., Abdurayimov Ye.O., Nurabayev S.Sh.). Vaccination made it possible to fully reproduce the I/II phase of the planned clinical trials of the QazCovid-in®-inactivated COVID-19 vaccine, developed in the RIBSP.

Vaccination was necessary for the complete epidemiological protection of NIIPBB researchers who are directly carrying out research work on the development of technology for the manufacture and testing of the first domestic vaccine against COVID-19. In the event of a natural contamination of these researchers with COVID-19, the Institute would be deprived of the most valuable specialists, performing the most important state task of developing a domestic vaccine for a long time.

Vaccination with your own vaccine is an unspoken scientific standard of developers of medical and immunobiological preparations, when the developer, first of all, must investigate the safety and immunogenicity of his own development, and secondly, 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.

Vaccinated employees are monitored daily. As of 4 August 2020, all vaccinated employees are clinically healthy, demonstrating the safety of the vaccine. Studies of biochemical and hematological analysis of blood and urine are carried out, as well as the level of antibodies in blood serum by ELISA and in the neutralization reaction.

As a result of the vaccination carried out before the start of clinical trials, vaccine developers receive valuable information about the safety and immunogenicity of the vaccine when immunizing the population of the Republic of Kazakhstan in comparison with the results of preclinical tests of the vaccine on laboratory animals.

One of the latest examples of vaccination of developers with their own vaccine is vaccination of employees of Vector STU in Novosibirsk and the Research Institute of Epidemiology and Microbiology after Gamaley, Moscow. Russian scientists have vaccinated employees of their institutes with vaccines against Covid-19, developed by these scientific centers before the official start of clinical trials.

On August 03, 2020 Akim of Zhambyl region Saparbayev B.M. accompanied by the Akim of the Kordai region and other representatives of the akimats of the Zhambyl oblast, the Kordai region, «КА-СТРОЙ», «Град-Центр» LLP and others, visited the RSE RIBSP.

During the visit, the construction site for the project “Construction of a 60-apartment building for RIBSP employees”, the construction site for the project “Construction of a biopharmaceutical plant for the production of immunobiological drugs that meet the requirements and standards of Good Manufacturing Practice (GMP) at the RIBSP SC MES RK” were inspected.

Also, the Laboratory for Especially Dangerous Infectious Diseases and the Laboratory for Monitoring Infectious Diseases, which are currently working on the development of a COVID-19 coronavirus infection vaccine, were presented to the Akim of Zhambyl region.

After the inspection, a meeting of the headquarters for the construction of the biopharmaceutical plant was held.

During his visit, Akim of Zhambyl region Saparbayev B.M. noted that “the timely delivery of the biopharmaceutical plant is a matter of life and death, since the vaccine produced at the plant can save thousands of lives of citizens of the Republic of Kazakhstan. The development of a coronavirus infection vaccine will be the property and pride of the people.” On the question of the General Director of the RSE RIBSP about the current difficult situation with the supply of reagents for research, Akim of Zhambyl region Saparbayev B.M. replied that he would send a letter to the interdepartmental commission for consideration.

In turn, the general director of the RSE RIBSP Zakarya K.D. noted that RIBSP is ready to deliver vaccines the next month after the construction of the plant by the builders. At present, with the permission of the Ministry of Health of the Republic of Kazakhstan, RIBSP is ready to supply 2 million doses of vaccine up to the end of 2020 without a plant, and with the operation of the plant – several tens of million doses.

Also, during a visit by the Akim of the Zhambyl region Saparbayev B.M. a number of tasks were set to individual representatives of akimats, construction companies, design companies and RSE RIBSP.

On July 31, 2020, the second Kazakhstan vaccine of the RSE “Research Institute for Biological Safety Problems” of the SC MES RK was successfully registered on the website of the World Health Organization (WHO) as a candidate vaccine. This subunit vaccine, developed on the basis of the surface proteins of the virus, is absolutely harmless and safe. (https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines)

Registration of our vaccines with WHO means that our vaccines are included in the list of vaccine candidates and are approved for preclinical testing in animals.

At this time, RIBSP scientists have already begun preclinical trials of the second vaccine. In case of good results, human clinical trials will be carried out. Then the vaccines must be registered with the Ministry of Health, and only then can the vaccine be used to vaccinate people.

It should be noted that the first inactivated vaccine was registered on the WHO website on May 15 this year. To day, it passed preclinical testing. At present, the inactivated vaccine developed by RIBSP scientists has been sent to the National Center for Expertise of Medicines, and expert work is being carried out on it. After the positive decisions on the examination are received, the package of documents will be sent for approval to the Ministry of Health for clinical trials on humans.

RIBSP has gained high scientific and practical experience in the development and production of various types of vaccines used in medicine. In collaboration with WHO, RIBSP has developed four types of vaccines for health care. There is a modern scientific, technical, technological base and highly qualified personnel, which make it possible to solve problems related to the development, testing and provision of the country with a domestic drug that is not inferior in efficiency to foreign analogues.

Both vaccines were developed in the frame of the implementation of the scientific and technical program “Development of a COVID-19 coronavirus infection vaccine”, RIBSP celebrates the high achievement of its scientists and expresses gratitude to:

– manager of the program, professor Orynbayev M.B., co-manager of the program, Dr. of biol. sc. Zakarya K.D.

– responsible executors of the program: Dr. of vet. sc. Kutumbetov L.B., professor Khairullin B.M.

– project managers: professor Sultankulova K.T., PhD Zhugunissov K.D., Dr. of vet. sc. Abduraimov Ye.O., professor Kassenov M.M., cand. of biol. sc. Chervyakova O.V., s-r res-r Nurpeisova A.S., cand. of vet. sc. Nurabayev S.Sh., cand. of med. sc. Nakhanov A.K., cand. of med. sc. Asanzhanova N.N., PhD Burashev E.D., s-r res-r Rystayeva R.A., Taylakova E.T.

– performers: s-r res-r Kerimbayev A.A., res-r Kopeyev S.K., res-r Shoraeva K.A., res-r Akylbayeva K.K., res-r Dzhekebekov K.K., j-r res-r Abitayev R.T., lab. ass-nt Chukayeva T.S. and many of our other employees.

On July 28, 2020, within the framework of international cooperation, an online video conference was held between the RSE RIBSP MES RK and the DUKE-NUS School of Medicine (Singapore). The conference was held in the format of consultations and recommendations regarding clinical and preclinical trials of COVID-19 vaccine.

The online conference was attended by professors and scientists from RIBSP – Abdurayimov Ye.O., Orynbayev M.B., Kutumbetov L.B., Khairullin B.M., Sultankulova K.T., Chervyakova O.V. and etc.

Dr. Ooi Eng Eong, Head of the Laboratory Research Group at DUKE-NUS School of Medicine spoke about the development process of the COVID-19 vaccine, the volume and number of doses in preclinical and clinical trials, the number of volunteers taking part in them, etc.

At the end of the online conference, the parties thanked each other for the opportunity and expressed hope for further fruitful cooperation.

The RSE “Research Institute for Biological Safety Problems” of the SC MES RK (RIBSP), as the main institute for virological and microbiological research, still uses the “gold standard” methods, using which a large number of significant results have been obtained. However, the development of new technologies and methods requires the discovery of a new direction. To solve this problem, the management of RIBSP decided to establish a new laboratory for collective use. 

The Collective Use Laboratory (CUL) has been created on the basis of the Laboratory for Molecular Biology and Genetic Engineering since July 01, 2020. The CUL will function in order to achieve an advanced level of research and development work, as well as to effectively use the material, technical and personnel potential of the Laboratory. The head of the laboratory was appointed Erbol Dosanovich Burashev, Ph.D. 

The main goal of the CUL is to provide access for scientific research by RIBSP employees and domestic scientists, regardless of the departmental affiliation and form of ownership of the scientific organization or higher educational institution in which they work, as well as to ensure the conduct of research and development work by subjects of scientific and scientific and technical activities.  

The main areas of CUL work: 

• electronmicroscopic examination of preparations of viruses and other microorganisms in biomaterials, identification of microorganisms; 
• isolationof DNA, RNA; 
• PCR (standard and Real-time);
• determinationof DNA sequences (full genome sequencing); 
• creationof genetic passports; 
• synthesisof specific probes and primers; 
• genotypingof microorganisms, plants, animals; 
• conducting seminars, trainings at the workplace.

By the decree of the President of the Republic of Kazakhstan K.K. Tokayev 
No. 353 of 06/19/2020 for fruitful work in the field of education, health care, social protection, as well as in the fight against the pandemic, the scientists of the RSE «Research Institute for Biological Safety Problems» of the Science Committee of the Ministry of Education and Science were awarded the ХАЛЫҚ АЛҒЫСЫ medal Republic of Kazakhstan: 

Zakarya Kunsulu Daltonovna – General Director of RIBSP; 

Orynbayev Mukhit Barmakuly – head of RIBSP laboratory; 

Zhugunissov Kuandyk Dauletbayevich – head of RIBSP laboratory; 

Kerimbayev Aslan Amangeldiyevich – researcher of RIBSP; 

Kopeyev Syrym Kaldybayevich – researcher of RIBSP. 

We congratulate our scientists on the latest achievements and high appreciation of their contribution to the development of science! 

We wish you health, creative inspiration, new scientific discoveries and achievements! 

The World Health Organization (WHO), after registering on its website the COVID-19 inactivated vaccine, developed by the Research Institute for Biological Safety Problems of the SC MES RK, invited RIBSP employees to become WHO experts on the development of technology for the manufacture of a COVID-19 vaccine, creating a model of infection on laboratory animals, preclinical trials and clinical trials. 

As a result of the negotiations, WHO accepted the Director General of RIBSP 
K.D. Zakarya, head of the laboratory L.B. Kutumbetov and Professor B.M. Khairullin. WHO advised that RIBSP experts will be invited in advance to WHO workshops.

On June 17, 2020, the first WHO working meeting in the format of a videoconference was held, which was attended by all the leading scientific centers in the world, deciding the development of technology for the manufacture of COVID-19 vaccine. Presentations were made by scientists from the People’s Republic of China, Great Britain, France and the United States, who presented the results of their latest research. 

All the most important technological aspects of new vaccines were identified and special attention was paid to the possibility of technological scaling of the production process. Information was also provided on a plant under construction in China for the production of COVID-19 vaccine. 

RIBSP experts took an active part in the WHO meeting, where further actions for collaboration between WHO and RIBSP were identified. WHO also announced that RIBSP experts will be invited to all subsequent WHO meetings on combating COVID-19. 

On June 12, 2020, Prime-Minister of the Republic of Kazakhstan Askar Uzakpayevich Mamin paid a working visit to the “Research Institute for Biological Safety Problems” of the Committee of Science of the Ministry of Education and Science of the Republic of Kazakhstan. On a working trip the Prime-Minister was accompanied by Akim of the Zhambyl Region Saparbayev B.M., the Minister of Education and Science of the Republic of Kazakhstan Aimagambetov A.K., the Minister of Healthcare of the Republic of Kazakhstan Birtanov E.A., the Minister of Agriculture of the Republic of Kazakhstan Omarov S.K., the Minister of Ecology, Geology and Natural Resources of the Republic of Kazakhstan Mirzagaliyev M.M., the first Vice-Minister of Finance Sholpankulov B.Sh., the first Vice-Minister of Industry and Infrastructure Development Uskenbayev K.A. and other dignitaries.

Director General Zakarya K.D. presented the history and main achievements of the Institute to the Prime Minister Mamin A.U. The high-ranking guests were shown the developed and manufactured biologics. The guests were introduced to the main parameters of the plant under construction for the production of immunobiological preparations in accordance with the standards of good manufacturing practice.

                                                                                                Illustrative photo: from open sources

The ceremony was attended by Prime Minister of the Republic of Kazakhstan Askar Uzakpayevich Mamin, Akim of Zhambyl region Berdibek Mashbekovich Saparbayev and the Minister of Education and Science of the Republic of Kazakhstan Askhat Kanatovich Aimagambetov and gave an official start to the construction of the first biopharmaceutical plant in Kazakhstan for the production of immunobiological preparations.

                                                                                               Illustrative photo: from open sources

After completion of construction, the plant will produce developed at the Institute immunobiological preparations against current topical infectious diseases according to the international standard of good manufacturing practice.