Regulatory evolution and challenges from the perspective of public laboratiories vaccine producers in Brazil.

The regulation of biological products has evolved rapidly in recent years due to quality issues impacting people's lives and the advent of new technologies, with constant changes in regulations that dictate how a product is registered, produced, and monitored. In the case of vaccines, the responsibility of regulators and manufacturers in guaranteeing quality, safety, and efficacy is even more critical, since vaccines are mostly used in children and healthy patients. In this scenario, manufacturers need to create strategies to keep their products and installations adequate and up-to-date with a fully operational quality system.

Sanger-based sequencing technology for yellow fever vaccine genetic quality control.

Yellow Fever (YF) is an acute viral hemorrhagic disease prevalent mainly in Africa and Americas, with 20-60% fatality rate in severe forms. Currently, antiviral drugs for the infection are not available, reinforcing the importance of vaccination in resident populations and travelers. Manufactured in 7 different countries, the YF vaccine was first created in 1937 and two substrains are used for production, 17DD and 17D-204.

Serious adverse events associated with yellow fever vaccine.

Yellow fever vaccine was considered one of the safest vaccines, but in recent years it was found that it could rarely cause invasive and disseminated disease in some otherwise healthy individuals, with high lethality. After extensive studies, although some risk factors have been identified, the real cause of causes of this serious adverse event are largely unknown, but findings point to individual host factors. Meningoencephalitis, once considered to happen only in children less than 6 months of age, has also been identified in older children and adults, but with good prognosis.

Subdoses of 17DD yellow fever vaccine elicit equivalent virological/immunological kinetics timeline.

Background: The live attenuated 17DD Yellow Fever vaccine is one of the most successful prophylactic interventions for controlling disease expansion ever designed and utilized in larger scale. However, increase on worldwide vaccine demands and manufacturing restrictions urge for more detailed dose sparing studies. The establishment of complementary biomarkers in addition to PRNT and Viremia could support a secure decision-making regarding the use of 17DD YF vaccine subdoses.

Adverse events following yellow fever immunization: Report and analysis of 67 neurological cases in Brazil.

Neurological adverse events following administration of the 17DD substrain of yellow fever vaccine (YEL-AND) in the Brazilian population are described and analyzed. Based on information obtained from the National Immunization Program through passive surveillance or intensified passive surveillance, from 2007 to 2012, descriptive analysis, national and regional rates of YFV associated neurotropic, neurological autoimmune disease, and reporting rate ratios with their respective 95% confidence intervals were calculated for first time vaccinees stratified on age and year. Sixty-seven neurological cases were found, with the highest rate of neurological adverse events in the age group from 5 to 9 years (2.

17DD yellow fever vaccine: a double blind, randomized clinical trial of immunogenicity and safety on a dose-response study.

Objective: To verify if the Bio-Manguinhos 17DD yellow fever vaccine (17DD-YFV) used in lower doses is as immunogenic and safe as the current formulation.

Results: Doses from 27,476 IU to 587 IU induced similar seroconversion rates and neutralizing antibodies geometric mean titers (GMTs). Immunity of those who seroconverted to YF was maintained for 10 mo.

[Vaccines, immunization and technological innovation: an update].

The smallpox worldwide eradication was the major world public health achievement. The binomial - vaccines and immunization - continues to demonstrate very high performance in the prevention and control of other diseases preventable by vaccination. The new global initiatives on vaccination, such as GAVI, have made possible the introduction of new and important vaccines preventing million of children deaths in the poorest countries in the world.

Reactogenicity of yellow fever vaccines in a randomized, placebo-controlled trial.

Objective: To compare the reactogenicity of three yellow fever (YF) vaccines from WHO-17D and Brazilian 17DD substrains (different seed-lots) and placebo.

Methods: The study involved 1,087 adults eligible for YF vaccine in Rio de Janeiro, Brazil. Vaccines produced by Bio-Manguinhos, Fiocruz (Rio de Janeiro, Brazil) were administered ("day 0") following standardized procedures adapted to allow blinding and blocked randomization of participants to coded vaccine types.

Immunogenicity of WHO-17D and Brazilian 17DD yellow fever vaccines: a randomized trial.

Objective: To compare the immunogenicity of three yellow fever vaccines from WHO-17D and Brazilian 17DD substrains (different seed-lots).

Methods: An equivalence trial was carried out involving 1,087 adults in Rio de Janeiro. Vaccines produced by Bio-Manguinhos, Fiocruz (Rio de Janeiro, Brazil) were administered following standardized procedures adapted to allow blocked randomized allocation of participants to coded vaccine types (double-blind).

[Eradication of poliomyelitis in Brazil: the contribution of Fundação Oswaldo Cruz].

The eradication of wild polioviruses from the Americas represents a remarkable public health achievement. Oswaldo Cruz Foundation (Fiocruz) contributed to this result in many ways. Its National Reference Center for Enteroviruses in the Department of Virology of Oswaldo Cruz Institute developed laboratory activities, Bio-Manguinhos developed and delivered the oral vaccine, its National School of Public Health developed epidemiological and laboratory activities and its National Institute for Quality Control in Health controlled the vaccine.