Vaccines are among the most effective interventions in the history of public health, responsible for the eradication and significant reduction of infectious diseases, as well as for increasing life expectancy and quality of life on a global scale. It is estimated that, over the past five decades, vaccination programs have saved at least 154 million lives, the vast majority (101 million) of whom were children under the age of. This number certainly increases if we consider not only the existence of vaccines for many more diseases than the 14 covered by this estimate, but also the fact that immunization programs contribute to other essential care in primary health care services.
From a biological standpoint, vaccines are preparations capable of stimulating and priming the immune system against an infection or disease, thereby generating a long-lasting and safe immune memory. Their main component is the antigen, which is derived from the pathogen of interest (the disease-causing agent) or produced using biotechnology.
Since Edward Jenner developed the smallpox vaccine in the late 18th century, there have been countless advances in the research and development (R&D) of vaccines against various diseases, leading to the vaccine platforms available today.
Broadly speaking, a vaccine technology platform comprises a set of technologies that share the use of a basic “vector” or “carrier” (backbone), which can be adapted with different genes or sequences of interest to generate different vaccines based on the same technological foundation. According to the World Health Organization (WHO), the use of the term “technology platform” would be appropriate in cases where (a) the manufacturing methods are essentially the same (but may be optimized for each specific vaccine candidate); (b) the testing methods (except for identity, potency, and stability) and acceptance criteria do not change; (c) the immunomodulatory compounds or elements do not change; and (d) compliance with Good Manufacturing Practices (GMP) is maintained. Some examples of vaccine platforms include viral vector, toxoid, DNA, and messenger RNA (mRNA) platforms. Vaccines are one of the categories of biological medicines. The biological route, which focuses on more complex molecules that are subject to greater structural variation, instability, and degradation, presents challenges in terms of standardization and predictability compared to the traditional chemical synthesis route.
From the supply side, uncertainties and challenges—such as high investment costs, complex production processes, a shortage of qualified human resources, and strict regulatory requirements—are some of the barriers to entry in this market.
Particularly since the 1980s, the intense wave of mergers and acquisitions of vaccine manufacturers by major pharmaceutical companies has been the primary strategy for overcoming their lack of expertise in the new production process13. This process has resulted in a highly oligopolistic global vaccine market, with high entry barriers and a small number of pharmaceutical companies controlling a large portion of the industry.
Regarding demand, the public sector is the world’s leading purchaser of vaccines. International organizations, such as the United Nations Children’s Fund (UNICEF) and the Pan American Health Organization (PAHO), also purchase large quantities of vaccines for low- and middle-income countries.
Specifically in Brazil, both the demand for and production of vaccines are essentially public, and the consolidation of this arrangement is directly linked to the history of the National Immunization Program (PNI). Created in 1973, in the context of the development of major national health programs, the PNI incorporated lessons learned from previous initiatives, such as the Smallpox Eradication Campaign and the National Polio Control Plan, while also introducing significant innovations, such as mass vaccination campaigns and the establishment of a unified national immunization schedule.
By centralizing coordination within the Ministry of Health and establishing vaccination as a universal and equitable policy, the PNI significantly expanded the population’s access to vaccines, overcoming previous fragmentation and ensuring widespread coverage throughout the country.
Ensuring a sufficient supply in terms of both quantity and quality thus became a strategic challenge, driving policies focused on local production, such as the National Self-Sufficiency Program for Immunobiologicals (PASNI) and the strengthening of public laboratories.
Public laboratories, also known as Official Pharmaceutical Laboratories (LFO), are public institutions that produce medicines, vaccines, serums, and other health-related products to meet the needs of the Unified Health System (SUS), as provided for in the Federal Constitution of 1988 (Article 200) and Law No. 8,080/1990 (Article 6)20,21. LFOs primarily use “technology transfer strategies to expand their portfolios and build capacity for the production of vaccines required by the PNI [National Immunization Program], particularly those at the cutting edge of technology”22. In this way, they meet the needs of the SUS by ensuring the effectiveness of the pharmaceutical care policy23,24. According to Tatsch, Botelho, and Koeller25, “The success of this program can be assessed by the extremely high vaccination coverage rates over the past few decades, which have led to the eradication of several diseases, such as polio and measles, a decline in infant mortality, and an increase in life expectancy among Brazilians.” Over the past two decades, it is estimated that the PNI has administered an average of more than 130 million vaccine doses per year.
Globally, the COVID-19 pandemic has had a significant impact on the biopharmaceutical market by accelerating the development and approval of new products, including groundbreaking technologies.
On December 8, 2020, the first approved COVID-19 vaccine, Comirnaty, was administered to 90-year-old Margaret Keenan in the United Kingdom28. At the time, more than 200 vaccine candidates were in development around the world. Comirnaty, developed by Pfizer/BioNTech, demonstrated 95% efficacy against the disease and was the first mRNA-based vaccine used in humans. Shortly thereafter, in January 2021, the second mRNA-based vaccine, Spikevax from Moderna, also received emergency use authorization.
However, this unprecedented scientific breakthrough has been accompanied by a crisis in vaccine availability and unequal distribution, reflecting the contradiction between innovation and access. Access to vaccines, in varying quantities and at different times, varied according to the level of economic development of countries and regions. Reproducing structural inequalities, high- and upper-middle-income countries received larger quantities of doses faster than low- and middle-income countries30,31. In addition, the pandemic crisis has also led to shortages of medicines, personal protective equipment (PPE), diagnostic tests, ventilators, and other hospital care supplies, including vaccine active pharmaceutical ingredients (APIs), the production of which has historically been outsourced to lower-cost countries.
In Brazil, despite the denial of the severity of the pandemic and the political mismanagement of the public health response, both at the local and federal levels, The prior existence of a well-established public health infrastructure, based on a universal public health system, prevented the situation from becoming even more catastrophic. Amid a global vaccine shortage, the country was only able to begin its vaccination campaign thanks to the efforts of its public science and technology institutions—particularly the Oswaldo Cruz Foundation (Fiocruz) and the Butantan Institute—and the National Health Surveillance Agency (Anvisa).
Lessons learned from crises such as the COVID-19 pandemic underscore the importance of investing in research and development (R&D), public institutions, local innovation and production, and the ongoing strengthening of the supply chain to address future challenges.
In addition to technology transfer agreements aimed at making it possible to vaccinate the Brazilian population as quickly as possible—notably the partnerships established between the Butantan Institute and Sinovac Biotech, and between Fiocruz and Oxford/AstraZeneca—various initiatives to develop domestic vaccines have been launched.
Among these initiatives, the development of a messenger RNA platform at the Institute of Immunobiological Technology (Bio-Manguinhos), a Fiocruz unit, stands out; this project had been initiated even before the pandemic. Due to the versatility and adaptability of messenger RNA technology39,40, it was possible to redirect efforts toward tackling COVID-19.
Bio-Manguinhos’s messenger RNA platform enables the entirely domestic and low-cost production of a COVID-19 vaccine, the transfer of this technology to other developing countries, and the acquisition of expertise that positions the country as a pioneer in the production of other vaccines and treatments for various diseases. The project was one of the factors that led to the institution being selected by the WHO as a center for the development and production of vaccines using this technology in Latin America.
In light of the above, the objective of this case study is to examine how Bio-Manguinhos has developed the messenger RNA platform, exploring the historical determinants, characteristics, potential, and challenges of this initiative. The central hypothesis is that it is possible to develop health technologies guided by the public interest, combining technical innovation with ethical principles that prioritize collective needs. Thus, public production and development constitute a concrete pathway to guarantee the right to health and overcome the systemic inequities produced by the traditional logic operationalized by Big Pharma, which is driven by profit and the privatization of knowledge, among other problems.
In this regard, the discussion on public pharmaceutical companies serves as a theoretical framework for this study. According to the People’s Health Movement:
- "One possible definition of Public Pharmaceutical Companies is a state-run infrastructure focused on the research, development, manufacturing, and/or distribution of pharmaceutical products and other health technologies. The state retains genuine decision-making authority and establishes governance based on public health needs. (...) In summary, this definition of Public Pharmaceutical Companies emphasizes key aspects: (1) state ownership; (2) effective social and state participation in decision-making and policy wformulation; (3) development of health technologies in the service of public health and the needs of the people."
Bio-Manguinhos’ messenger RNA platform represents an unprecedented breakthrough not only for the SUS and the Brazilian population, but also for all of Latin America, as it helps strengthen regional capabilities to respond to public health emergencies. By placing Brazil among the group of countries that have mastered one of the most advanced technological platforms for vaccine development, this initiative signals an important step toward sovereignty and strategic autonomy in the health sector.
Furthermore, it stands out for its public nature and its integration with health, productive development, and Innovation policies, serving as an example of a project oriented toward the public interest. Thus, this study seeks to tell a part of this story that is only just beginning, but which demonstrates the capacity of research and development conducted within the country and the indispensability of continuously strengthening the institutions that make up the Brazilian public health system.