GSK and Brazil’s Fiocruz form partnership for new R&D effort and increased vaccine access

GlaxoSmithKline plc (GSK) announced today that it has launched a unique partnership with Brazil’s Oswaldo Cruz Foundation (Fiocruz) to develop and manufacture vaccines for pressing public health priorities in Brazil. The agreement will establish a new research and development collaboration programme at Fiocruz to develop a vaccine for dengue fever, a mosquito-borne disease that globally places 2.5 billion people at risk of infection[i].

Issued: Monday 17 August, London UK

GlaxoSmithKline plc (GSK) announced today that it has launched a unique partnership with Brazil’s Oswaldo Cruz Foundation (Fiocruz) to develop and manufacture vaccines for pressing public health priorities in Brazil.  The agreement will establish a new research and development collaboration programme at Fiocruz to develop a vaccine for dengue fever, a mosquito-borne disease that globally places 2.5 billion people at risk of infection[i].

GSK will also provide Fiocruz with access to the technology behind its 10-valent conjugate vaccine for paediatric pneumococcal disease, internationally known as Synflorix™.  GSK will supply Synflorix™ to Fiocruz until the technology transfer is completed.  The Brazilian government will incorporate the vaccine into its national immunisation programme in the coming months.

“Brazil has excellent vaccine research facilities,” said Abbas Hussain, President of Emerging Markets at GlaxoSmithKline plc.  “This collaboration with Fiocruz is a key piece of our strategy to partner with emerging middle-income countries.  Together, we will be able to develop and make available new vaccines to benefit public health in Brazil.”

The 10-valent pneumococcal conjugate vaccine Synflorix™, which protects against life-threatening diseases such as pneumonia, meningitis and bacteremia, was approved by Brazilian regulatory authorities on 22 June 2009[ii].  This vaccinehas the potential to protect against more than 80% of cases of these invasive pneumoccocal diseases in Brazilian children younger than five years old[iii] , [iv] , [v].  The vaccine also protects against otitis media (middle ear infection), which has a considerable impact on Brazil in terms of individual suffering and associated public health costs.  It is one of the most frequently contracted childhood diseases, the most common reason for physician visits in children under 3 years of age and the most frequent indication for prescription of antibiotics[vi].

GSK Biologicals and Fiocruz initiated their first collaboration with an agreement to supply oral polio vaccines in 1985.  Since then, GSK Biologicals and Fiocruz have formed several strategic alliances to provide Brazilians with key vaccines, including vaccines against Haemophilus influenzae type b (Hib), MMR (measles, mumps and rubella) and rotavirus. This is the partners’ first collaboration on an R&D center that will focus on the development of new vaccines.

“We have a longstanding relationship with Fiocruz for the production of vaccines, and today marks the first step of an even stronger partnership which includes a joint R&D initiative,” said Jean Stéphenne, President and CEO of GSK Biologicals.  “With Fiocruz’s expertise, we can help to protect Brazilian children from pneumococcal disease today and collaborate on innovative technologies to address Brazil’s public health needs over the coming years.”

“This new agreement continues and expands Brazil’s groundbreaking commitment to innovation in public health,” said Dr. Paulo Gadelha, President of Fiocruz.  “The partnership will enhance Brazilian R&D capacity, improve the health of our citizens and cement Brazil’s role as a leading partner on vaccines.”

The alliance will foster the cross-fertilisation of ideas and technology, as scientists from GSK and Fiocruz work across facilities in Brazil and Belgium, where GSK’s vaccines division is headquartered. GSK has a long history of working with partners on every step of its vaccine pipeline, from development to manufacturing and distribution.

GSK, the world’s second largest pharmaceutical company, has prioritised Brazil and other emerging markets to deliver and expand on its ambitious global business model.  GSK’s latest partnership with Fiocruz leverages growing business opportunities in Brazil and follows closely on a deal with China’s Shenzhen Neptunus to develop and manufacture flu vaccines, announced on 9 June 2009. 

GSK’s vaccine business has one of the industry’s deepest pipelines and pioneering research and development capabilities, which have produced 11 world-first vaccines.  For more than 20 years, GSK’s global business model has helped to ensure the availability, affordability and sustainability of life-saving vaccines everywhere, including the world’s poorest countries.

About GlaxoSmithKline Biologicals

GSK Biologicals is headquartered in Wavre, Belgium, where the majority of GlaxoSmithKline’s activities in the field of vaccine research, development and production are conducted. In 2008, GSK Bio distributed more than 1.1 billion doses of vaccines to 176 countries. Close to 80 percent of these doses were distributed in developing countries.

GlaxoSmithKline—one of the world’s leading research-based pharmaceutical and healthcare companies—is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information, please visit www.gsk.com

About the Oswaldo Cruz Foundation

To promote health and social development, to forge and disseminate scientific and technological knowledge, to be an agent of citizenship. These are the concepts that have guided Fundação Oswaldo Cruz (Oswaldo Cruz Foundation, known as Fiocruz), attached to the Brazilian Ministry of Health and the most prominent science and technology health institution in Latin America. Inaugurated on May 25, 1900 under the name of Federal Serotherapy Institute, Fiocruz was given the mission of fighting the great problems of public health in Brazil.

Today the institution is responsible for a range of activities which include research development; highly-regarded hospital and ambulatory care services; production of vaccines, drugs, reagents, and diagnostic kits; education and training of human resources; information and communication in the area of health, science and technology; quality control of products and services, and the implementation of social programmes.  Over 7,500 employees and health professionals work for the Foundation.

About the Immunobiologicals Technology Institute (Biomanguinhos)

Also known as Bio-Manguinhos, the Immunobiological Technology Institute is the largest producer of vaccines and kits for diagnosis of infectious and parasitic diseases in Latin America.  The unit is capable of processing over 200 million doses of vaccines per year. It is also the world's largest producer of vaccines against yellow fever, supplying up to 100 million doses a year to meet Brazilian and export requirements.  The institute was created in 1976 and from the 1990s onwards it assumed the strategic role of pursuing self-sufficiency in the production of some immunobiologicals.  As well as vaccines against yellow fever Bio-Manguinhos makes vaccines against measles, poliomyelitis, meningitis meningococus A/C and by Haemophillus influenzae type B, diphtheria, tetanus, whooping cough and MMR triple vaccine (against measles,mumps and rubella).  In 2001, the unit was recognised by the World Health Organization as an international supplier of the vaccine against yellow fever.  Bio-Manguinhos has increased the production of reagents for diagnosis of infectious and parasitic diseases, such as AIDS, leishmaniasis, Chagas Disease, breakbone (dengue) fever, hepatitis and rubella, among others. Up to 2.5 million kits are produced each year.

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[i] World Health Organization. Global Alert and Response (GAR) Dengue/dengue haemorrhagic fever. Accessible at:

 http://www.who.int/csr/disease/dengue/en/. Last accessed: 13 August 09. 

[ii] ANVISA resolution: DOU 22/06/2009 RE 2.507 in 19/06/2009, published on “Dário Oficial da União - suplemento” in 22/August/2009 (ISSN 1677-7042).

[iii] SIREVA project Brazil SIREVA II. Reporte 2007.Documentos Técnicos Tecnologías esenciales de salud THS/EV 2007/002. Informe Regional SIREVAII (2000-2005) OPS-OMS

[iv] WHO. Weekly epidemiological record 8212, 23 March 2007:93-104.

[v] Costenla D, Gomez E, De la Hoz F, O’Loughlin R, Sinha A, Valencia J, Valenzuela M. The burden of pneumococcal disease and cost-effectiveness of a pneumococcal vaccine in Latin America and the Caribbean 2007. Sabin Vaccine Institute. www.sabin.org

[vi] Cripps AW, OtczykaDC, Kydb JM. Bacterial otitis media: a vaccine preventable disease? Vaccine 2005 23:2304-2310