Mobilising Brazil’s manufacturing might to support vaccine production in the Global South

29 July 2024; OSLO; RIO DE JANEIRO: One of the largest vaccine manufacturers in Latin America, Brazil’s Bio-Manguinhos/Fiocruz, is the latest partner to join CEPI’s network of vaccine manufacturers in the Global South working to support faster and more equitable responses to future emerging infectious disease threats.

The inclusion of Bio-Manguinhos/Fiocruz in CEPI’s manufacturing network will significantly boost vaccine production efforts in the Latin American and Caribbean region, which will help increase the manufacturing capacity available to make vaccines in response to epidemic and pandemic threats.

With a US$17.9 million (approx. R$92 million) investment from CEPI, the organisations will collaborate to diversify Bio-Manguinhos/Fiocruz’s existing vaccine manufacturing capabilities by expanding new rapid-response mRNA and viral vector vaccine technology platforms against outbreak diseases. The funding will also optimise manufacturing processes and technological capabilities to strengthen regional vaccine supply, as well as enhance end-to-end capabilities such as ‘fill-and-finish’ of vaccines. Shortening the time taken to manufacture and validate the first batches of experimental vaccines will be key to enabling a response to an escalating outbreak within just 100 days—a goal embraced by the G7, G20 and industry leaders—and could help stop a future pandemic in its tracks.

The investment will build upon Bio-Manguinhos/Fiocruz’s track record of producing high-quality vaccines at scale, while expanding its existing ability to act as a manufacturing hub capable of swiftly supplying investigational vaccines to the region during a future outbreak.

Richard Hatchett, CEO of CEPI, said: “Expanding global vaccine manufacturing capacity is crucial to fortifying our collective defences against outbreaks. Bio-Manguinhos/Fiocruz’s renowned manufacturing expertise and growing rapid response capabilities are positioned to play a vital role in expanding access to vaccines in the region and beyond. This growing CEPI-backed network of manufacturers dedicated to accessibility in the Global South is helping to better equip the world to respond faster and more equitably to future pandemic threats."

Mario Moreira, President of Fiocruz, said: “It is very promising for Fiocruz, through Bio-Manguinhos, to join the global vaccine manufacturing network of CEPI. We are recognized for playing a strategic role in promoting vaccine production in Latin America, and with this partnership, we aim to go beyond being reference manufacturers. Our goal is to be agents of transformation and facilitators for expanding vaccine production capacity in countries of the Global South, especially in mRNA and viral vector platforms, ensuring a more agile and effective response to emerging outbreaks and more equitable access to vaccines for our populations."

Mauricio Zuma Medeiros, Director of Bio-Manguinhos, said: “Local and regional capacity building in the Global South is critical for rapid response to health emergencies. Bio-Manguinhos has been committed to securing local technological, innovation and manufacturing capabilities to support sustainable and equitable access to biologics. Becoming part of CEPI’s network of manufacturers is a landmark in our current preparedness response efforts and reinforces our commitment to building resilient health ecosystems, ‘leaving no one behind’.”

Pandemic’s disproportionate impact on Latin America

The COVID-19 pandemic underscored the imperative to scale up vaccine development and regionalise end-to-end vaccine manufacturing in the Latin American region.

Although Latin Americans make up only around 8 percent of the world's population, they were disproportionately affected by COVID-19, accounting for more than one in four COVID-19 deaths by October 2023. In large part, this was because access to vaccines and other countermeasures in Latin America and other Global South regions was hampered because global manufacturing capability is concentrated in a small number of high income or high population countries. Other contributing factors included hindered access to the necessary products, consumables and technologies as well as societal and political challenges.

As the first institution in Brazil capable of distributing a 100 percent nationally produced recombinant COVID-19 vaccine, Fiocruz was crucial in the country’s COVID-19 response. Despite these efforts, Brazil suffered the worst death toll in the region, with 700,000 deaths as of December 2023.

Building on Bio-Manguinhos/Fiocruz’s growing vaccine manufacturing pipeline, CEPI’s funding will support a brand-new multi-faceted filling site, the Health Biotechnology Industrial Complex (CIBS), at Santa Cruz Campus. CEPI’s investment will ultimately enhance Bio-Manguinhos/Fiocruz’s end-to-end vaccine development capabilities, from research and development to fill and finish, in line with local and the WHO’s Good Manufacturing Practices (minimum standards that a medicines manufacturer must meet in their production processes). In addition, the diversification and expansion of Bio-Manguinhos/Fiocruz’s mRNA and viral vector-based vaccine manufacturing abilities for both outbreak and endemic pathogens in the region will help to ensure greater sustainability of vaccine manufacturing facilities in between pandemics by generating sufficient demand to continue its operations.

The further development of the CIBS at Santa Cruz Campus, already under construction, will make this site the largest vaccine production centre in the region. It will be capable of producing 120 million vials of vaccines each year, helping to meet the growing vaccine demand in Brazil, the Latin American region, and the world.

A vaccine manufacturing network for the world 

Created by CEPI to expand the global footprint of vaccine production, the manufacturing network focuses on vaccine makers in the Global South near areas at high risk of outbreaks caused by deadly viral threats like Chikungunya, Lassa Fever, Nipah, Disease X, and other pathogens with epidemic or pandemic potential prioritised by CEPI. Fiocruz becomes the fifth member of CEPI’s global manufacturing network. Other members include Serum Institute of India, Aspen in South Africa, Institut Pasteur de Dakar in Senegal, and Bio Farma in Indonesia. Fiocruz will support the development, manufacture, supply and licensure of new vaccines against disease pathogens in the future, including potentially against CEPI’s priority diseases.

The partnership with Bio-Manguinhos/Fiocruz will build upon existing partnerships and synergies to strengthen vaccine manufacturing and outbreak preparedness in the region, including with the Pan American Health Organisation (PAHO) and the Government of Brazil—united under the shared vision of creating a safer world for all.

It is in the same spirit of collaboration that Brazil’s Ministry of Health, Fiocruz and CEPI are co-hosting The Global Pandemic Preparedness Summit 2024, taking place in Rio de Janeiro on July 29 and 30. The Summit will convene R&D and manufacturing experts, government officials, civil society representatives and leaders from industry and the global health community to address challenges and explore progress towards enabling equitable access by strengthening local and regional production capacity, delivering the 100 Days Mission, enhancing disease surveillance systems, and building a world that is better prepared to equitably meet the challenges of viral threats.

—ENDS—

About CEPI
CEPI was launched in 2017 as an innovative partnership between public, private, philanthropic and civil organisations. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic disease threats and enable equitable access to them. CEPI has supported the development of more than 50 vaccine candidates or platform technologies against multiple known high-risk pathogens and is also advancing the development of rapid response platforms for vaccines against a future Disease X. Central to CEPI’s pandemic-beating five-year plan for 2022-2026 is the ‘100 Days Mission’ to compress the time taken to develop safe, effective, globally accessible vaccines against new threats to just 100 days.

About Bio-Manguinhos
Founded in 1976, Bio-Manguinhos is a Fiocruz’s Institute responsible for research, innovation, development and the production of vaccines, in vitro diagnostics and biotherapeutics aimed at primarily meeting the demands of national public health. Bio-Manguinhos/Fiocruz is one of the largest production centers in Latin America, at Fiocruz’ Manguinhos Campus, contributing to the self-sufficiency efforts to supply essential vaccines, biotherapeutics and in vitro diagnostics for the Brazilian Ministry of Health. The Institute also contributes with the public health of several countries, mainly by the export of the yellow fever vaccine, pre-qualified by WHO.

About Fiocruz  
The Oswaldo Cruz Foundation (Fiocruz) is Latin America's largest biomedical research institution, producing vaccines and medicines to supply the Unified Health System (SUS, the Brazilian national public health system). Affiliated to the Ministry of Health, it was created in 1900 to initially manufacture serums and vaccines against bubonic plague. Since then, Fiocruz has had an intense trajectory, intertwined with the development of public health in Brazil. Present in 12 Brazilian states, as well as in the Federal District, the Foundation has several technical-scientific units focused on teaching, research, production, innovation, assistance, technological development and extension in the field of health.

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