Economical Value of Vaccines for the Developing Countries—The Case of Instituto Butantan, a Public Institution in Brazil

Ho, Paulo Lee; Miyaji, Eliane N.; Oliveira, Maria Leonor S.; Dias, Waldely de Oliveira; Kubrusly, Flávia Saldanha; Tanizaki, Martha M.; Martins, Elizabeth A. L.; Raw, Isaı́as

doi:10.1371/journal.pntd.0001300

Cited by 14 publications

(11 citation statements)

References 11 publications

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“…We have shown that nasal immunization of mice with a formulation composed of PspA5 and a whole-cell pertussis vaccine (wP), used as an adjuvant, protects animals against challenges with different pneumococcal strains (19). Combining PspA5 with wP offers the benefit of the adjuvant properties of a vaccine administered to children at 2, 4, and 6 months in many countries in the world, with boosters at 15 months and 4 years of age (20).…”

mentioning

confidence: 99%

Pertussis Toxin Improves Immune Responses to a Combined Pneumococcal Antigen and Leads to Enhanced Protection against Streptococcus pneumoniae

Salcedo-Rivillas

Debrie

Miyaji

et al. 2014

Clin. Vaccine Immunol.

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Pneumococcal surface protein A (PspA) is a candidate antigen for the composition of protein-based vaccines against Streptococcus pneumoniae. While searching for efficient adjuvants for PspA-based vaccines, our group has described the potential of combining PspA with the whole-cell pertussis vaccine (wP). When given to mice through the nasal route, a formulation composed of PspA from clade 5 (PspA5) and wP (PspA5-wP) induced high levels of antibodies and protection against challenges with different pneumococcal strains. PspA5-wP also induced the secretion of interleukin 17 (IL-17) by splenocytes and the infiltration of leukocytes in the lungs after challenge. Here, we show that protection against a pneumococcal invasive challenge was completely abrogated in MT ؊/؊ mice, which are deficient in the maturation of B cells, illustrating the importance of antibodies in the survival elicited by the PspA5-wP vaccine. Moreover, passive immunization showed that IgG purified from the sera of mice immunized with PspA5-wP conferred significant protection to naive mice, whereas the respective F(ab=) 2 did not. Additionally, in vivo depletion of complement abolished protection against the pneumococcal challenge. The combination of PspA5 with wild-type or mutant Bordetella pertussis strains or with purified components showed that the pertussis toxin (PT)-containing formulations induced the highest levels of antibodies and protection. This suggests that the adjuvant activity of wP in the PspA5 model is mediated at least in part by PT. The sera from mice immunized with such formulations displayed high IgG binding and induction of complement deposition on the pneumococcal surface in vitro, which is consistent with the in vivo results.

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mentioning

confidence: 99%

Pertussis Toxin Improves Immune Responses to a Combined Pneumococcal Antigen and Leads to Enhanced Protection against Streptococcus pneumoniae

Salcedo-Rivillas

Debrie

Miyaji

et al. 2014

Clin. Vaccine Immunol.

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“…As a result, companies relying on this approach typically proceed in phases, allowing partners to strengthen capacity in a reverse engineering of the process. The initial engagement may begin with labeling, move to fill and finish, and end with independent bulk vaccine production [13] , [41] , [42] .…”

Section: Resultsmentioning

confidence: 99%

“…Furthermore, all interview respondents discussed the significant role of government support, including support for a WHO-certified, functional NRA that is appropriately positioned to engage with manufacturers. Many country governments have established policies to support the growth of the biotechnology and pharmaceutical industries, helped to enable collaborations with multi-national corporations, and committed to strengthening national immunization programs with secured funding to procure vaccines to grow and stabilize domestic demand [13] , [34] , [42] .…”

Section: Resultsmentioning

confidence: 99%

An updated methodology to review developing-country vaccine manufacturer viability

Luter

Kumar²,

Hozumi

et al. 2017

Vaccine

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“…These institutions have also formed partnerships with for-profit producers such as GSK (technology transfer agreements with Bio-manguinhos/Fiocruz to produce vaccines for Hib (Haemophilus influenzae b), OPV (oral polio vaccine), Rotavirus (monovalent oral human rotavirus vaccine), Pneumococcal 10-valent conjugate vaccine and MMR (measles, mumps, and rubella)); Novartis (technology transfer agreement with Fundação Ezequiel Dias, MG, to produce meningitis C conjugate vaccine) and Sanofi Pasteur (technology transfer agreements with Instituto Butantan to produce seasonal influenza and H1N1 influenza vaccines). All of these biopharmaceuticals are produced for a free vaccination program undertaken by the Health Ministry to immunise Brazilian citizens (for a complete review of Brazilian vaccines, see Ho et al, 2011).…”

Section: Biopharmaceutical Production In Brazilmentioning

confidence: 99%

The production of biopharmaceuticals in Brazil: current issues

Pimenta

Monteiro

2019

Braz. J. Pharm. Sci.

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Biopharmaceuticals are gaining a growing share of the pharmaceuticals market. In recent years, the Brazilian Health Surveillance Agency (ANVISA) has approved the registration of biological drugs with domestic production. Although Brazil is in the early stages of biopharmaceutical production, governmental incentives and the investment in private companies in the technological domain in this country have created expectations of an increase in the capacity of biopharmaceutical production. Private initiatives, once rare, have now started to blossom in this field, such as collagenase from Cristalia and filgrastim from Eurofarm. The expiry of the patents for certain biopharmaceuticals (e.g. infliximab, filgrastim and rituximab) has generated the possibility of savings to the Brazilian National Health System (SUS) in terms of biosimilars and incentives for national production. National production could also avoid dependence on external imports and a lack of essential supplies. In the next few years, Brazil is expected to bring nationally produced biopharmaceuticals to the market. Although there is some way to go before Brazil will be able to sustain the national demand for biopharmaceuticals and supply international markets with new products, the country is starting to take its first steps towards these objectives.

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Economical Value of Vaccines for the Developing Countries—The Case of Instituto Butantan, a Public Institution in Brazil

Cited by 14 publications

References 11 publications

Pertussis Toxin Improves Immune Responses to a Combined Pneumococcal Antigen and Leads to Enhanced Protection against Streptococcus pneumoniae

Pertussis Toxin Improves Immune Responses to a Combined Pneumococcal Antigen and Leads to Enhanced Protection against Streptococcus pneumoniae

An updated methodology to review developing-country vaccine manufacturer viability

The production of biopharmaceuticals in Brazil: current issues

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