By Jenny Larsen / February 8, 2021
The Cuban government recently announced that its Sovereign II COVID-19 vaccine will soon enter phase III of trials, bringing the country one step closer to producing Latin America’s first vaccine against the virus. Far from being a success overnight, Cuba’s ability to develop a vaccine is the result of decades of investment in its biopharmaceutical industry, which in its early stages of development was supported by the United Nations Industrial Development Organization (UNIDO).
Cuba hopes to inoculate its entire population against COVID-19 with its own production vaccine this year. The country has four possible vaccines under development, the most advanced of which is Sovereign II who must begin phase III trials in March with 150,000 volunteers. If it overcomes the latter clinical obstacle, the Cuban vaccine will be the first to develop in Latin America.
According to the Havana-based Finlay Vaccine Institute (IFV), 100 million doses could be supplied for both domestic and export use by 2021. Cuba has signed an agreement to conduct clinical trials in Iran in collaboration with the country’s Pasteur Institute, while Jamaica, Vietnam and Venezuela, among others, have expressed interest in obtaining the vaccine once it passes the necessary safety and efficacy tests.
As international disputes over equitable distribution increase, amid accusations that rich countries are hoarding supplies, a successful distribution of Sovereign II could provide life-saving potential for developing countries seeking to immunize their populations against COVID-19.
That the small Caribbean island is ahead of many more developed countries in the race to find an effective vaccine may seem surprising. However, decades of experience and investment in Cuba’s biotech and pharmaceutical sectors, which in its early stages were supported by UNIDO and other international organizations, have enabled industry to rapidly and effectively direct resources towards the development of emergency vaccines.
In the years following the 1959 Revolution, Cuba prioritized the establishment of a high-level health system focused on prevention. The country’s health approach was both a matter of socialist principles and an answer to the US trade embargo, which from 1962 blocked almost all imports from the United States, including medicines and other essential products.
For this reason, Cuba set out to invest in the training of more doctors and created scientific research institutes to support the development of a national biopharmaceutical industry that met the needs of its health system. For example, since the mid-1960s, the government has increasingly invested in scientific infrastructure, including the creation in 1965 of the National Center for Scientific Research (CNIC), which helped train many scientists and engineers throughout the 1960s and 1970s.
As part of the production of its own medicines, in the late 1970s the Cuban government sought assistance from UNIDO to build a pharmaceutical production plant. The UNIDO project had the experience of an Indian company, Sarabhai Chemicals, to establish Cuba’s first chemical synthesis plant for the production of generic pharmaceuticals.
The plant, Pharmaceutical Company March 8, was designed by UNIDO experts, equipped with Indian technology, and financed with input from India and the United Nations Development Program, which was an early example of South-South and triangular cooperation.
The introduction of advanced pilot technology for the production of pharmaceutical compounds and the training provided to numerous Cuban experts created the conditions for expanding the production of generic drugs in the following years, helping to create new jobs that were performed by increasingly qualified Cuban chemists and engineers, including many women.
Currently, the Pharmaceutical Company March 8 is affiliated with the state-owned Business Group of Biotechnological and Pharmaceutical Industries, known as BioCubaFarma. The Group is home to more than 30 manufacturing companies and institutes that together produce more than half of the country’s essential medicines, as well as exporting medicines to more than 50 countries.
Cuba’s early interest in health, medical research and science also put it in a good position to take advantage of the advances in genetic engineering that led to the rapid growth of biotechnology in the 1980s. The government turned fully into the sector, spurred by the need to deal with recurrent disease outbreaks, including the widespread presence of meningitis B. In 1986 he opened the Center for Genetic Engineering and Biotechnology (CIGB), which in recent decades has been responsible for the development of a number of medicines and vaccines, especially in the treatment of cancer, cardiovascular disease, meningitis and hepatitis.
UNIDO became involved again in the mid-1980s at the request of the Cuban government to help create the country’s own version of a generic hepatitis B. Cuba vaccine employed highly trained national experts to carry out this technically demanding project, with the help of UNIDO specialists who helped train staff to carry out the vaccine from the laboratory phase to production on an industrial scale, in addition to providing advice on quality control aspects and international standards. After considerable investment by the Cuban government, production was launched and the vaccine began to be used in the early 1990s. It was subsequently included in the World Health Organization’s approved vaccine register.
Following the success of this project, Cuba turned to UNIDO in the mid-1990s to help expand production of the anticancer drug CIMAher (nimotuzumab), a humanized “monoclonal antibody” designed at the Center for Molecular Immunology (CIM) to treat head and neck tumors, as well as other advanced cancers. This project was technically more complex in terms of production than the previous one, but staff who had already received training on production methods during the hepatitis B vaccine project could be used. The new cancer treatment was successful and occurred on an industrial scale at the CIM, something that was made possible by strong investment in the biotechnology sector in the 1990s, despite severe cuts in other areas of the difficult Cuban economy. This remains one of the country’s still-used cancer treatments.
The high level of integration of the sector and the previous trajectory in vaccine development meant that technical capacity was present to enable Cuba to move rapidly into a solution for COVID-19. For example, the decision to look for a type of protein subunit vaccine, which creates a biosynthetic protein to trigger an immune response, was made easier by the knowledge gained by using the same type of technology platform to develop the Cuban meningitis B vaccine and a recombinant hepatitis B vaccine.
Now, more than 40 years after the launch of its first project in the Cuban pharmaceutical sector, UNIDO continues to offer support to the sector. In 2020, the organization partnered with the Slovenian government in a Slovenian-Cuban initiative to develop a business model linking innovation in the biopharmaceutical, medicine and nanotechnologies sectors in an effort to advance the technologies of the Fourth Industrial Revolution.
The project, which is carried out in cooperation with the Slovenian Business Fund and aims to serve as a model for greater interregional cooperation, uses knowledge sharing and the transfer of technical competences to support innovation and improve the regulatory framework for bio pharmacy to boost competitiveness.
Cuba’s success in creating a viable domestic pharmaceutical industry demonstrates the benefits that can be obtained through specific investments and with the necessary political will. Organizations such as UNIDO have long advocated for greater industrial capacity building in developing countries. Now more than ever, the crisis arising from the COVID-19 pandemic demonstrates why it is vital to invest in the development of research and development capabilities and for local production.
The inability to develop and manufacture vaccines and other medical treatments locally accentuates the risk for poorer countries to stay at the end of the line as rich countries dispute the best part. According to a recent report by The Economist’s Intelligence Unit (EIU), middle-income countries will not be able to vaccinate the bulk of their population until late 2022 or early 2023. In fact, for poorer countries, mass immunization could take until 2024, if any.
Cuba’s drive to build an integrated, state-backed biopharmaceutical industry emerged in part from past emergencies. Are there some valuable lessons to learn from the country’s experience for many developing nations struggling to gain access to vaccines during the current COVID-19 crisis?
Taken and translated from: www.unido.org
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