In opinion of Dmytro Shymkiv, the Chairman of the Board of Directors of Darnitsa Group, it is possible to start own production of vaccines in Ukraine only with full support of the state. The state authorities should provide purchase guarantees for not less than 10 years. Meantime, before the pandemic the Ministry of Public Health used to purchase in average 5 mln doses of vaccines against 10 infectious diseases that are included to the national vaccination calendar per year.
Talking about possibilities of arranging vaccine production in Ukraine, the top manager stated that the world is on the way to build a biological safety system. Ukraine has faced the deficiency of COVID-19 vaccines. Localization of the vaccine production by means of technology transfer could become the best solution. According to Shymkiv’s calculations, the production volume of COVID-19 vaccines should make about 40 mln doses. A consortium involving local and international pharmaceutical manufacturers could be created to arrange such a production.
Shymkiv stated that it is only the state that can arrange own vaccine production in the country. The state’s role is decisive in this process. Legislative conditions should be created, volumes should be determined and purchase guarantees for not less than 10 years should be provided. Darnitsa Group introduced this model to the government. Australia has a similar example, where there is a consortium involving a local pharmaceutical company and international manufacturers, and the state accepted obligations to purchase a certain volume during a certain term. There is no program on state guarantees to purchase a medicine in Ukraine.
Darnitsa, Pharmaceutical Company, has developed a case of vaccine production. The production technology of RNA vaccine is not that difficult, expenses for arrangement of such production make about $10-15 mln. There are needed specialists in Ukraine and Darnitsa and some other companies are ready to invest into this. The key aspect in this issue is sale. People usually take medicines on a regularly basis while vaccination requires not more than one injection per several months. State authorities that are competent to solve this issue do not react to the offer of Darnitsa Group so far. This means that it is senseless to invest into the vaccine business at the moment. We should not expect the appearance of domestic vaccines in the Ukrainian market unless the Ukrainian pharmaceutical industry receives legislative guarantees from the state instead of offers to participate in tenders on a common basis with the world leaders of pharma.
Shymkiv also noted that to output domestic vaccines it is necessary to meet a chain of requirements and conditions on biological production. According to GMP-standards (Good Manufacturing Practice – certification of compliance with the proper production practice) vaccine cannot be developed in the same building with other medicines. This prohibition is caused by a high risk of contamination – cross infection of raw materials and finished products. This is not a big problem for Darnitsa, CJSC to meet this requirement, it is possible to separate chemical and biological production.
Dmytro Shymkiv has analyzed the condition of the world pharmaceutical market and noted that the industry of developments and production of medicines is now a leader of the innovative segment. Recognized authorities like Moderna, Pfizer, Novаvax, Jonson & Jonson, AstraZeneca take the top positions in the rating. These are the top pharmaceutical corporations since they managed to develop, test, arrange mass production and sale of efficient Covid-19 vaccines in the world market for less than a year. This success stimulated other enterprises specializing in pharmaceutics to continually and systematically introduce new technology to the medicine production.