As various regions and countries focus on developing and strengthening their vaccine industries, we wondered how some emerging countries have managed to expand their vaccine manufacturing capacity over the years.
The recent pandemic has accelerated political will around the world, with local vaccines as a key element for global health security, sustainable vaccine supply, and resilience to the multiple health impacts of the climate crisis. It shows a strong need for manufacturing diversification.
The African Union, through the Africa CDC, has now set an ambitious goal of producing 60% of Africa’s vaccine needs on the continent by 2040. Achieving this ambitious goal will require coordinated, collaborative efforts and long-term strategic planning, and will create an enabling environment. Achieve this vision.
Here are some key discoveries and key learnings from these pathfinders.
In the case of India
Vaccine manufacturing in India has undergone significant changes since the early 20th century and is an example of how public and private efforts have contributed to the development of a vaccine industry that meets both regional and global needs. India’s vaccine manufacturing currently accounts for one-third of the global vaccine market by volume, and a key aspect of its success is underpinned by strong political will, investment in science and education, and key partnerships. The aim is to build a framework for the entire value chain. Multilateral organizations such as the United Nations Children’s Fund UNICEF.
India’s Expanded Program on Immunization, launched in 1978, was renamed the Universal Immunization Program in 1985 when it was expanded beyond urban areas. This expansion was accompanied by strong efforts to improve domestic vaccine production and cold chain equipment manufacturing. In 1986, immunization was designated as one of the five national technical missions, and a biotechnology department was established to prioritize human resource development, appropriate infrastructure, research and development, and a regulatory framework. This made India self-sufficient in producing all vaccines except oral polio vaccine (OPV) by 1991.
Similarly, demand creation was essential to fostering the development of the vaccine manufacturing industry. Vaccine manufacturing in emerging markets has historically focused on developing country markets. Indian manufacturers are eyeing these markets to meet demand and maximize profits, as well as local and World Health Organization Prequalification (WHOPQ) regulations to contribute to UN-led global vaccine supply. We strived to upgrade our technology to meet the requirements. Serum Institute of India Ltd., for example, partnered with WHO and PATH in 2002 to develop a vaccine for African Meningitis Belt countries.
The private sector has also invested to create production capacity for old vaccines as well as new vaccines that the public sector does not have access to, enabling it to respond to new global needs. Three Indian vaccine manufacturers have prepared a vaccine for global use against the H1N1 virus pandemic in a record time of nine months. This proves how manufacturers in developing countries can be leveraged to develop vaccines against pandemics.
In the case of China
China also attaches great importance to consistent updating of policy formulation and regulatory processes to enhance the development and quality of the vaccine manufacturing industry. The country adopted a two-category system approach to balance public health needs with the commercial viability of emerging vaccine manufacturers. The first category includes traditional vaccines that governments provide free of charge to citizens, such as those included in China’s national immunization program. These prioritize meeting short- to medium-term public health needs within a given budget, reducing costs in part through greater demand through economies of scale. Vaccines allocated to the second category are those that the public pays for and generate higher profit margins.
The Chinese government has continuously updated its vaccine regulatory system to maintain steady improvement in quality control. From 2011 to 2020, the country has established or updated 22 major regulations and guiding principles on vaccine regulation, including 11 on the management of vaccine production and operations, quality requirements for clinical trials, and vaccine distribution and transportation. related to management and monitoring. Regarding side effects of vaccines.
The Chinese government has also prioritized improving its own regulatory system. National regulatory authorities are responsible for establishing standards and producing reference materials, as well as testing vaccine products against legal standards. Meanwhile, state regulators are required to conduct full inspections of vaccines produced by private manufacturers within their jurisdictions.
China has also implemented “vaccine lot release” controls (a system of mandatory inspections and audits as each batch of product leaves the factory for sale or import), which the WHO describes as a government key It is listed as one of the regulatory functions. The most recent updates to the system were made in 2020 and include standardizing and improving operational requirements for lot releases, strengthening risk management and oversight and inspection processes, and clarifying the responsibilities of marketing authorization holders. Ta.
In 2013, China’s National Institute of Food and Drug Control (NIFDC) further joined the WHO Collaborating Center (WHOCC) to contribute to the standardization and evaluation of WHO biological products, paving the way for its vaccines to enter the international market. . .
In the case of Brazil
Brazil’s National Immunization Program (NIP) is a good example of a comprehensive immunization program that achieved high coverage rates over time. The success of the NIP was built on the integration of a series of government policies that encouraged the development and strengthening of the vaccine manufacturing industry in the public sector.
After the successful mass vaccination campaign to eradicate smallpox in Brazil from 1966 to 1973, public perception changed significantly in favor of a national “culture of vaccination.” Building on this momentum, the Brazilian government has established a number of new public sector vaccine production facilities across the country, including the Oswaldo Cruz Foundation’s Federal Institute for Vaccine Production called Bio Manguinhos, the Butantan Institute, and Ezequiel Díaz. Foundation.
In 1988, the Brazilian government enacted a new constitution that provided free universal access to vaccination and recognized civil rights. A series of policies were also enacted to strengthen the NIP and meet demands. These policies focused on promoting innovation, supporting producers’ technology development and production capacity, strengthening national systems for quality control and assurance and epidemiological surveillance, and improving NIP’s own operations and implementation.
Significant attention has been paid to identifying new vaccine candidates, supporting centers for research excellence, building new and strengthening existing laboratory and clinical infrastructure, and establishing practices and norms that meet international standards and accreditation standards. Ta. These policies have positioned public vaccine manufacturers as important players supporting the NIP and Brazil’s national health system, and they have been able to supply more than 90% of the vaccines purchased by the NIP.
In addition to focusing on the domestic market, Brazilian manufacturing is expanding its participation in global markets. Although much of the world’s vaccine production is concentrated in a small number of multinational companies, the world’s traditional vaccine market is increasingly joined by manufacturers from developing countries, including Brazil. For example, the Brazilian facility Bio Manguinhos has been prequalified by WHO to export yellow fever vaccines through international organizations such as UNICEF and the Pan American Health Organization (PAHO) Revolving Fund/WHO.
conclusion
To transform vaccine research, development and innovation into solid infrastructure and a dedicated industrial park, the context of the vaccine market and the domestic context that encourages emerging industries is paramount.
Predictable demand, supported by an enabling policy framework, skilled human capital, and strong regulatory processes, will sustainably scale up vaccine production in emerging countries and meet regional public health and health security needs. This is the key to fulfilling.
The experiences of countries that have successfully built domestic vaccine manufacturing industries could provide valuable insights for other emerging economies.
Examples from India, China, and Brazil suggest some important practices that may be applicable elsewhere. These include the need for strong and sustained political will, a consistent policy framework with clear roles and responsibilities, a regulatory framework that encourages technology development, and a framework that encourages not only local capacity building but also practices and practices that meet international standards. Establishing norms is also important.
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This article was first published Pascal’s LinkedIn On October 13, 2023.