Revolutionary technology is on the way: Ukraine will produce mRNA vaccines
Darnytsia will occupy a new niche in the production of vaccines against Covid-19. It also plans to join the development of drugs for tuberculosis and HIV
This autumn, employees of the domestic pharmaceutical company Darnytsia will be heading to a biotechnology centre in the Republic of South Africa, where they will undergo training in the production of mRNA vaccines. This will be the second phase of the programme for transferring this technology to countries with medium and low income levels, initiated by the World Health Organisation (WHO) and the Medicines Patent Pool (MPP).
The project organisers announced the transfer of mRNA technology to Ukraine in mid-April 2022 – just two months after the full-scale invasion by russia. Despite all the uncertainties and the conditions of a state of war, Darnytsia, which the WHO selected as the sole company for transfer among other domestic companies, decided to continue participating in the programme.
Until now, Ukraine had not produced vaccines for any diseases at all; they were solely imported. Therefore, the participation of Darnytsia in the project is, without exaggeration, a pivotal moment for the development of the domestic pharma industry and the healthcare system as a whole.
Mind has learned how exactly the company is mastering mRNA technology and preparing to become the first Ukrainian vaccine manufacturer, why Darnytsia was invited to the programme, and how the domestic producer plans to use this cutting-edge technology in the future.
What does the mRNA technology transfer programme entail?
The mRNA technology transfer programme is a global initiative by the WHO and MPP aimed at improving healthcare by establishing sustainable local capacities for the production of mRNA vaccines and medications against COVID-19 and other diseases in low- and middle-income countries.
The initiative was launched in July 2021 with the goal of promoting equitable access to mRNA vaccines, the uneven distribution of which was revealed by the coronavirus pandemic. Companies like Pfize, BioNTech, and Moderna were not quick to share their technology, and supplied 90-95% of their COVID-19 vaccines mainly to high- and middle-income countries. Therefore, in February 2022, scientists in South Africa independently replicated the Moderna coronavirus vaccine.
Besides Darnytsia, 14 other pharmaceutical companies from countries such as Serbia, Bangladesh, Vietnam, Indonesia, India, Pakistan, Kenya, South Africa, Egypt, Argentina, Brazil, Nigeria, Senegal, and Tunisia are participating in the project. The programme is primarily funded through sponsorship funds, with a total budget of $117 million.
How did Ukraine join the WHO project?
Darnytsia submitted an application to participate in the mRNA technology transfer competition in the autumn of 2021. "Due to the confidential nature of the information, we cannot disclose whether other Ukrainian manufacturers participated in this competition and how many candidates there were in total. However, official sources say that WHO recognised only 15 companies from all over the world, and we are one of them," Inna Deniak, Director Of Business Development at Darnytsia pharmaceutical company, told Mind.
It is worth noting that Darnytsia remains a leader in the production and sale of medications in Ukraine. According to Proxima Research data, in 2021, the company manufactured 181 million packages of pharmaceuticals, and in 2022, despite the war, they produced 173 million packages. The sales volume of Darnytsia increased by 19.6% in the past year: every sixth package of medication sold in pharmacies during this period was produced by them.
Commenting on the company's desire to participate in the programme, Inna Deniak explained that the company saw its mission not only in introducing new pharmaceutical developments that enhanced people's quality of life but also in ensuring epidemic well-being for Ukraine and the region. She stated, "Every step we take aims to protect the health of the nation and contribute to the global fight against future pandemics."
When will Darnytsia receive the new technology?
As part of the mRNA technology transfer programme, experts from Darnytsia are undergoing a two-stage training process. The first stage has been successfully completed at the International Vaccine Institute in South Korea. During this phase, company employees explored cutting-edge vaccine technologies and practices, learned advanced methods, and acquired key skills.
The second stage of training is scheduled for the autumn of 2023, involving the direct transfer of the confirmed production process for the mRNA vaccine. This stage will take place at the biotechnology centre in South Africa.
In parallel, the Darnytsia team is participating in numerous online training sessions organised by WHO and MPP and attending regular meetings with programme partners. The most recent of these meetings took place in late May as part of the 76th World Health Assembly in Geneva.
For participation in the programme, the company did not seek experts from outside but instead engaged its own specialists from the pharmaceutical development department. Employees from the medical and regulatory departments of the manufacturer are also involved in the project. "For the realisation of this important project, we did not look for external candidates – we trust our own team. It includes spirited and talented professionals from the department who have rightfully earned their reputation in the field," explained Inna Deniak.
What are the conditions of the transfer?
WHO is providing Darnytsia with access to the original mRNA vaccine production technology to combat the SARS-CoV-2 virus. However, the company will use this technology according to the terms set out in the agreement with the organisation. The MPP release on this matter states that participants "will receive training and technology from the hub and then produce and sell products commercially."
"It opens the doors to a world of new possibilities. This is not just about a regular generic medication; it's about transferring the original mRNA vaccine production technology for the prevention and control of the extremely powerful SARS-CoV-2 (Covid-19) virus, which even now, despite the pandemic being officially over, remains one of the most dangerous viruses on the planet," commented Inna Deniak.
Furthermore, she adds that participation in the project will enable the company to domestically produce other life-saving medications within Ukraine.
When will Darnytsia start using the new technology?
The technology transfer project for mRNA vaccine production was initially planned to be completed by 2024-2025. Only after completing all the scheduled training and practical aspects with WHO, Darnytsia will be able to consider the launch of manufacturing products using advanced technology.
The company hasn't disclosed the location of the facilities for the new production yet. "Currently, information regarding the location of the manufacturing is confidential and subject to coordination with WHO. We are actively working on this matter, and in the near future, we will be pleased to provide details about the project," Inna Deniak clarified.
Not just COVID: Why are mRNA-based medications so important?
Even though Covid-19 pandemic is no longer classified as a public health emergency, the coronavirus has not become any less of a threat to humanity, especially in low- and middle-income countries where the level of first-dose vaccination is still only around 30%. The possibility of a resurgence in cases remains, making regular revaccination necessary to protect against new variants.
At the same time, due to the successful use of mRNA vaccines in combating Covid-19, the revolutionary technology that scientists have been researching since 1961 has garnered increased attention and necessary investments. After all, the development of cutting-edge vaccines against Covid-19 took only 11 months and demonstrated an efficacy of 95% in clinical trials. Under normal circumstances, vaccine production and certification typically take several years.
The first mRNA vaccine was tested on mice back in 1990, and the human trials for a product based on this technology took place in 2013 (it was a vaccine against rabies). At the same time, scientists have been studying how to apply mRNA-based medications and vaccines to treat HIV, cancer, herpes, malaria, Zika virus, cystic fibrosis, multiple sclerosis, heart diseases, and severe lung conditions. In the future, there could be research into using mRNA technology to combat autoimmune diseases and the development of personalised therapies for each individual patient.
Fresh results have already emerged: in March 2023, experts from Tel Aviv University and the Israel Institute for Biological Research announced the successful development of an mRNA vaccine that is 100% effective against deadly bacteria. In April, the American company Moderna and the German company Merck reported successes in testing an mRNA-based vaccine for treating skin cancer.
What will be produced with the new technology in Ukraine?
As Inna Deniak noted, the WHO project opened up limitless possibilities for the company. Their efforts in producing the Covid-19 vaccine will serve as the foundation for creating other life-saving medications.
"Our team aims to explore and engage in the development of mRNA vaccine and medication technology for combating more complex and incurable diseases. We believe in the power of mRNA technology and its potential in treating autoimmune and oncological diseases, cystic fibrosis, multiple sclerosis, asthma, and other complex states," said Inna Deniak.
The company is also considering entering the niche of mRNA vaccines for Covid-19, tuberculosis, and HIV. "It is important because such diseases are not only medical issues but also social ones," Deniak explained.
"We feel a great responsibility towards the world, and we understand that our role in this project is exceptionally important. Our goal is to build a safe and healthy world for everyone, and we are confident that our contribution will help turn these dreams into reality. Together with WHO and other partners, we will create a success story in vaccinology and transform pandemic challenges into opportunities for healing and progress."
