RESUMEN
BACKGROUND: In response to the coronavirus disease 2019 (Covid-19) pandemic, Brazil authorised the Astra Zeneca/Fiocruz vaccine in January 2021. As the Delta variant emerged in May 2021, interval between vaccine doses was adjusted. By September 2021, the Brazilian National Immunisation Program recommended a booster dose for individuals over 70, and later expanded the recommendation to all adults. OBJECTIVES: Assess the equivalence of IgG antibody response against the Covid-19 S protein before and approximately 28 days after the third dose of a Covid-19 recombinant vaccine. Two groups received initial two doses with intervals of eight and 12 weeks. METHODS: This is a phase IV clinical study, uncontrolled, non-randomised. The study proposes calculating the ratio of geometric means titres (GMT) 28 days after the third dose, with a target ratio of confidence interval (CI) between 0.77 and 1.3. FINDINGS: In the primary endpoint, there was no equivalence between the eight- and 12-week intervals with a slight variation favouring the eight-week group. Post-third dose, both groups showed increases titres at 28 days, three months, six months and 12 months. Both groups responded similarly to Delta and Omicron BA.1, with a more significant increase for Delta. MAIN CONCLUSIONS: The study showed strong and consistent immune response in all age groups receiving the Covid-19 recombinant vaccine. Third dose elicited an increase in GMT by at least three times aligned with Ministry of Health strategies emphasising Bio-Manguinhos crucial role in pandemic control in the country.
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Anticuerpos Antivirales , Vacunas contra la COVID-19 , COVID-19 , Esquemas de Inmunización , Inmunización Secundaria , Inmunogenicidad Vacunal , Inmunoglobulina G , SARS-CoV-2 , Vacunas Sintéticas , Humanos , Vacunas contra la COVID-19/inmunología , Vacunas contra la COVID-19/administración & dosificación , COVID-19/prevención & control , COVID-19/inmunología , Masculino , Adulto , Femenino , Persona de Mediana Edad , SARS-CoV-2/inmunología , Anticuerpos Antivirales/sangre , Inmunoglobulina G/sangre , Vacunas Sintéticas/inmunología , Vacunas Sintéticas/administración & dosificación , Adulto Joven , Anciano , Brasil , Adolescente , Factores de TiempoRESUMEN
INTRODUCTION: The Brazilian neonatal screening program established in 2001 included the investigation of cystic fibrosis (CF) in the phase III of the program. For this purpose, the immunoreactive trypsin (IRT) measurement was added to the newborn screening test. The purpose of National Neonatal Screening Program is to reach 100% of live births in Brazil. The aim of this study was to analyze the coverage of neonatal Screening for Cystic Fibrosis (CF) in Brazil from 2008 to 2017. MATERIALS AND METHODS: This is an ecological study design based on data collected from the Brazilian Outpatient Information System regarding the detection of IRT as a component of the heel stick test from 2008 to 2017. Moreover, we gathered data from the Brazilian Live Birth Information System referring to live births from 2008 to 2017. We calculated the coverage of IRT measurement for every 100 live births, using the number of IRT measurement procedures as the numerator and the number of live births stratified by federative units (states), as well as by the Brazilian regions as the denominator. These regions correspond to the divisions of the national territory based on criteria such as natural, social, cultural and economic aspects. RESULTS: From 2008 to 2017, the regions presented the following coverage medians: South (84.1%), Southeast (71.4%), Midwest (47.3%) Northeast (12.3%) and North (10.9%). In the analysis of federative units, in the years 2013 to 2017, Paraná and Distrito Federal presented the highest median of coverage (100%), while the states with the lowest median were Rio Grande do Norte (12.1%), Amazonas (16.8%) and Paraíba (27.5%). Highest coverage was found in the South region, where are located most of the states with high socioeconomic development and high supply of health services, while the lowest coverage was found in the North region, where are located manly the states with low socioeconomic development and low supply of health services. According to data from the Brazilian Ministry of Health, the universalization of neonatal screening for cystic fibrosis occurred in 2013, however, at the end of this year, most states in the North and Northeast regions had not registered IRT measurements in the Outpatient Information System. CONCLUSION: Although the coverage of neonatal screening for CF has improved nationwide over the years of the study, the disparity in the coverage of IRT measurements at the interregional and interstate levels is notable. Systematic implementation of neonatal screening for cystic fibrosis with equity and access to the entire population is suggested, leading to a greater number of children benefiting from treatment and a better quality of life.
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Fibrosis Quística , Recién Nacido , Niño , Humanos , Fibrosis Quística/diagnóstico , Fibrosis Quística/epidemiología , Brasil/epidemiología , Calidad de Vida , Tamizaje Neonatal/métodos , TripsinaRESUMEN
BACKGROUND: A rubella mass vaccination campaign targeting 15-29-year-old women was performed in Brazil in 2001-2002. Rubella vaccination was contraindicated during pregnancy. A follow-up protocol was implemented for pregnant women who were vaccinated as well as their newborns. The risks of congenital rubella syndrome (CRS) and congenital rubella infection (CRI) after vaccination were assessed according to the pregnant women's immune status. METHODS: This was a prospective, noncontrolled study of pregnancy outcomes in women vaccinated against rubella in the state of Rio de Janeiro, including clinical and laboratory evaluations. RESULTS: Of 2292 reported pregnant women who were vaccinated, 1636 had known outcomes: there were 1577 newborns (96.4%), 52 miscarriages (3.2%), and 7 stillbirths (0.4%). Gestational age at vaccination was ≤ 5 weeks in 75% of the susceptible, vaccinated pregnant women. Nine newborns were positive for immunoglobulin M; 4 were born to susceptible pregnant women, for a 2.0% CRI rate (95% confidence interval, .5%-4.9%); 4 were born to vaccinated pregnant women with indeterminate or unknown status; and 1 had CRS, with a wild-type virus infection. CONCLUSIONS: The absence of vaccine-related CRS cases further supports recommendations to not interrupt a pregnancy exposed to rubella vaccine virus. Monitoring pregnancy outcomes and CRI with vaccine virus can distinguish between wild-type and vaccine virus infections, especially in situations of viral circulation.
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Resultado del Embarazo , Vacuna contra la Rubéola/administración & dosificación , Vacuna contra la Rubéola/inmunología , Rubéola (Sarampión Alemán)/congénito , Rubéola (Sarampión Alemán)/prevención & control , Aborto Espontáneo , Adolescente , Adulto , Anticuerpos Antivirales/sangre , Brasil/epidemiología , Control de Enfermedades Transmisibles , Susceptibilidad a Enfermedades , Femenino , Humanos , Inmunoglobulina G/sangre , Recién Nacido , Vacunación Masiva/efectos adversos , Persona de Mediana Edad , Embarazo , Complicaciones Infecciosas del Embarazo , Vacuna contra la Rubéola/efectos adversos , Adulto JovenRESUMEN
OBJECTIVES: To analyze postvaccination serological status in pregnant women inadvertently vaccinated against rubella in the state of Rio de Janeiro, Brazil. METHODS: This was a cross-sectional study of pregnant women 15 to 29 years old, vaccinated against rubella and measles from November 2001 to March 2002, who were unaware of their pregnancy at the time of vaccination or who became pregnant within 30 days thereafter. They were tested for rubella-specific immunoglobulin M (IgM) and G (IgG) and classified as immune (IgM-negative, IgG-positive, tested within 30 days after vaccination), susceptible (IgM-positive after vaccination) or indeterminate (IgM-negative, IgG-positive, vaccination-serological testing interval greater than 30 days). RESULTS: Of 2 292 women, 288 (12.6%) were susceptible, 316 (13.8%) immune, 1 576 (68.8%) indeterminate, 8 (0.3%) ineligible, and 104 (4.5%) lost to follow-up. IgM seropositivity by vaccination-serological testing interval was 16.1% (