Experimental batch received: the Belarusian drug for coronavirus
Photo by Andrei Sazonov
The first time the Head of State spoke about the possibility of creating a domestic vaccine against coronavirus was on December 14th last year during a visit to the 4th Savchenko City Clinical Hospital in Minsk. The President stressed, “If the developments of our scientists turn out to be serious, we will be dealing with our own vaccine. I am convinced that this infection will remain with us forever. Therefore, we will need a vaccine. If we learn to produce one ourselves, we will gain experience, it means that we will have good specialists, scientists, good doctors and our healthcare will consequently develop.” The President is confident that biotechnology has good prospects, and we should certainly move in this direction.
Almost a year has passed which turned out to be rich in events. Our scientists have not only produced the vaccine in a test tube, but very soon they will send it for preclinical trials that meet all international standards. Not a single stage passes without state support: the President recently signed a decree on the implementation of an investment project to organise the production of an anti-COVID drug at the premises of BelVitunipharm JSC in 2021-2023. We found out from the experts what stage development is at and when Belarusians will be vaccinated.
What are scientists working on?
Photo by Aleksey Vyazmitinov
Our vaccine will be inactivated whole-virion, and it will be manufactured according to the classical technology, which has been used for decades. What does this mean? A coronavirus is grown on a cell culture, then it is chemically inactivated (loses activity) and is injected into a person in a certain amount already inviable, causing an immune response in the body. Scientists say that the Belarusian vaccine will become an analogue of the Chinese Vero Cell, containing the full composition of antigens: the entire viral envelope, which includes not only the S-protein, but also the N-protein. It is assumed that the vaccine will be injected in two doses.
Experts have identified several variants of the SARS-CoV-2 virus: at first, they worked with Wuhan, European and the British and now they are working with ‘Delta’, which dominates in the country. Since fully-fledged preclinical tests are expensive, the scientists carried out a preliminary stage: they immunised a small group of laboratory animals in order to assess the toxicity of the finished product. So far, the verdict is as follows: the vaccine is well tolerated. Two groups of experts from the Republican Scientific and Practical Centre for Epidemiology and Microbiology and the Institute of Biophysics and Cell Engineering of the National Academy of Sciences are working on the project.
Alina Dronina, Deputy Director for Science at the Republican Scientific and Practical Centre for Epidemiology and Microbiology, confirmed that an experimental batch of the vaccine has already been received and there is preliminary evidence that the drug is safe and immunogenic.
“By the end of the year, the development of laboratory regulations will be completed — this is our scientific part. In 2022, we must transfer the technology to the manufacturer. As a result, production technology will be developed and then a pilot batch of the vaccine will have been received,” she explained.
Further, according to the specialist, the registration stage is envisaged after which the vaccine can be used.
Where will the vaccine be produced?
At the moment, Belmedpreparaty enterprise in co-operation with BelVitunipharm has established a joint venture. Two stages can be distinguished in the production of the domestic vaccine: at the first stage, BelVitunipharm will produce the active component, and the finished vaccine will be produced at the facilities of Belmedpreparaty. At the same time, specialists will design and build a production complex on the basis of BelVitunipharm, where the vaccine will be produced in a full cycle: this is the second stage, which is planned to be deployed by 2023-2024.
Experts are also thinking about the future. So far, the plan is as follows: an experimental indus
trial batch should appear by the end of June 2022, and by the end of 2023, the vaccine is planned to be released into use. Despite the fact that there are many of them on the market today, the Belarusian drug may well take its rightful place. In any case, specialists will conduct the entire volume of tests, which will allow exporting.
Aleksandr Lukashenko, President of Belarus:
The domestic vaccine is a matter of honour for Gusakov and Pinevich, the Healthcare Ministry and the National Academy of Sciences. It is necessary to develop the very best vaccine within the shortest possible time. It should be the best because we can draw on existing expertise and knowledge. It has already been done by Russians, Europeans, Chinese and Indians. Many are already producing these vaccines. We already have some expertise, we are not doing it from scratch. (At a meeting with Healthcare Minister Dmitry Pinevich on March 26th, 2021)
Doctors often say that, thanks to vaccination, the coronavirus may well go from a pandemic to a seasonal disease; that is, people will continue to become infected, but in the same way as, say, the flu or SARS. The only condition is vaccination: it will protect against serious consequences.
Aleksandr Lukashenko, President of Belarus:
Vladimir Putin was vaccinated with ‘Sputnik V’ while Joe Biden was vaccinated with Pfizer. And what about me? We agreed with Dmitry Pinevich that as soon as the Belarusian vaccine is ready, we will get jabbed. So, let’s get our vaccine and I am ready to get vaccinated, but only with our product, only with the Belarusian vaccine. This is my honest opinion. (During a conversation with doctors of the Minsk Regional Clinical Hospital on October 20th, 2021)