Correlates of protection against symptomatic and asymptomatic SARS-CoV-2 infection

The global supply of COVID-19 vaccines remains limited. An understanding of the immune response that is predictive of protection could facilitate rapid licensure of new vaccines. Data from a randomized efficacy trial of the ChAdOx1 nCoV-19 (AZD1222) vaccine in the United Kingdom was analyzed to determine the antibody levels associated with protection against SARS-CoV-2. Binding and neutralizing antibodies at 28 days after the second dose were measured in infected and noninfected vaccine recipients. Higher levels of all immune markers were correlated with a reduced risk of symptomatic infection. A vaccine efficacy of 80% against symptomatic infection with majority Alpha (B.1.1.7) variant of SARS-CoV-2 was achieved with 264 (95% CI: 108, 806) binding antibody units (BAU)/ml: and 506 (95% CI: 135, not computed (beyond data range) (NC)) BAU/ml for anti-spike and anti-RBD antibodies, and 26 (95% CI: NC, NC) international unit (IU)/ml and 247 (95% CI: 101, NC) normalized neutralization titers (NF50) for pseudovirus and live-virus neutralization, respectively. Immune markers were not correlated with asymptomatic infections at the 5% significance level. These data can be used to bridge to new populations using validated assays, and allow extrapolation of efficacy estimates to new COVID-19 vaccines

Correlates of protection against symptomatic and asymptomatic SARS-CoV-2 infection

The global supply of COVID-19 vaccines remains limited. An understanding of the immune response that is predictive of protection could facilitate rapid licensure of new vaccines. Data from a randomized efficacy trial of the ChAdOx1 nCoV-19 (AZD1222) vaccine in the United Kingdom was analyzed to determine the antibody levels associated with protection against SARS-CoV-2. Binding and neutralizing antibodies at 28 days after the second dose were measured in infected and noninfected vaccine recipients. Higher levels of all immune markers were correlated with a reduced risk of symptomatic infection. A vaccine efficacy of 80% against symptomatic infection with majority Alpha (B.1.1.7) variant of SARS-CoV-2 was achieved with 264 (95% CI: 108, 806) binding antibody units (BAU)/ml: and 506 (95% CI: 135, not computed (beyond data range) (NC)) BAU/ml for anti-spike and anti-RBD antibodies, and 26 (95% CI: NC, NC) international unit (IU)/ml and 247 (95% CI: 101, NC) normalized neutralization titers (NF50) for pseudovirus and live-virus neutralization, respectively. Immune markers were not correlated with asymptomatic infections at the 5% significance level. These data can be used to bridge to new populations using validated assays, and allow extrapolation of efficacy estimates to new COVID-19 vaccines

Safety of the Fiocruz ChAdOx COVID-19 vaccine used in a mass vaccination campaign in Botucatu, Brazil

Introduction Brazil has been at the core of the COVID-19 pandemic, with the second-highest death toll worldwide. A mass vaccination campaign was initiated on May 16th, 2021, in Botucatu, Brazil, where two doses of ChadOx1-nCoV19 were offered 12 weeks apart to all 18–60- year-olds. This context offers a unique opportunity to study the vaccine safety during a mass campaign. Methods The first and second doses of the vaccine were administered in May and August 2021, respectively. Emergency room (ER) and hospitalization records were obtained from the Hospital das Clínicas da Faculdade de Medicina de Botucatu for six weeks before and six weeks after the first and second doses, from 4 April to 19 September 2021. Diagnoses with COVID-19-related ICD codes were excluded to distinguish any trends resulting from the COVID-19 pandemic. ER and hospital visits during the two time periods were compared, including an ICD code comparison, to identify any changes in disease distributions. Data were scanned for a defined list of Adverse Events of Special Interest (AESIs), as presented by the Safety Platform for Emergency Vaccines. Results and discussion A total of 77,683 and 74,051 subjects received dose 1 and dose 2 of ChadOx1-nCoV19, respectively. Vaccination was well tolerated and not associated with any major safety concerns. Increases in ER visits 1 week following both doses were primarily seen in ICD codes related to non-serious side effects of the vaccine, including vaccination site pain and other local events. The neurological AESIs identified (2 of 3 cases of multiple sclerosis) were relapses of a pre-existing condition. One potentially serious hospitalization event for Bell’s palsy had onset before vaccination with dose 1, in a patient who also had a viral infection of the central nervous system. There was no myocarditis, pericarditis cases, or vaccine-related increases in thromboembolic events

Safety of the Fiocruz ChAdOx COVID-19 vaccine used in a mass vaccination campaign in Botucatu, Brazil

Introduction Brazil has been at the core of the COVID-19 pandemic, with the second-highest death toll worldwide. A mass vaccination campaign was initiated on May 16th, 2021, in Botucatu, Brazil, where two doses of ChadOx1-nCoV19 were offered 12 weeks apart to all 18–60- year-olds. This context offers a unique opportunity to study the vaccine safety during a mass campaign. Methods The first and second doses of the vaccine were administered in May and August 2021, respectively. Emergency room (ER) and hospitalization records were obtained from the Hospital das Clínicas da Faculdade de Medicina de Botucatu for six weeks before and six weeks after the first and second doses, from 4 April to 19 September 2021. Diagnoses with COVID-19-related ICD codes were excluded to distinguish any trends resulting from the COVID-19 pandemic. ER and hospital visits during the two time periods were compared, including an ICD code comparison, to identify any changes in disease distributions. Data were scanned for a defined list of Adverse Events of Special Interest (AESIs), as presented by the Safety Platform for Emergency Vaccines. Results and discussion A total of 77,683 and 74,051 subjects received dose 1 and dose 2 of ChadOx1-nCoV19, respectively. Vaccination was well tolerated and not associated with any major safety concerns. Increases in ER visits 1 week following both doses were primarily seen in ICD codes related to non-serious side effects of the vaccine, including vaccination site pain and other local events. The neurological AESIs identified (2 of 3 cases of multiple sclerosis) were relapses of a pre-existing condition. One potentially serious hospitalization event for Bell’s palsy had onset before vaccination with dose 1, in a patient who also had a viral infection of the central nervous system. There was no myocarditis, pericarditis cases, or vaccine-related increases in thromboembolic events

Cobertura vacinal dos profissionais de um curso de especialização em Saúde da Família do Piauí Protección vacunal de los profesionales de un curso de especialización en Salud de la Familia de Piauí Vacinal covering of the professionals of the spcecialization course in Family Health of Piaui

O presente estudo tem como objetivo avaliar a cobertura vacinal dos alunos de um Curso de Especialização em Saúde da Família do Piauí. A população do estudo foi constituída por todos os 43 alunos da turma: 19 enfermeiros, 13 médicos e 11 cirurgiões-dentistas. Os dados foram coletados em 2004, utilizando-se questionários auto-aplicáveis. Encontrou-se uma cobertura vacinal de 81,3% para hepatite B, 76% para a vacina antiamarílica e 65,1% para dT. Além disso, 25 alunos (58,1%) relataram desconhecimento acerca das vacinas preconizadas pelo Programa Nacional de Imunização (PNI). Os resultados mostraram que esses profissionais de saúde não estão adequadamente vacinados, reforçando a necessidade da implantação de uma política sistemática de imunização para eles, tendo como base as normas preconizadas pelo PNI.<br>El presente estudio tiene como objetivo evaluar la protección vacunal de los estudiantes de un Curso de Especialización en salud de la Familia de Piauí-Brasil. La problación del estudio fue constituida por todos los 43 alumnos de la Turma: 19 enfermeros, 13 médicos y 11 cirujanos dentitas. Los datos fueron recolectados en 2004, usándose cuestionarios autoaplicables. Fue encontrada una protección vacunal de 81,3% para hepatitis B, 76% para la fiebre amarilla y 65,1% para dT. Además de eso, 25 estudiantes (58,1%) relataron ignorancia acerca de las vacunas preconizadas por el Programa Nacional de Inmunización (PNI). Los resultados revelaron que esos profesionales de saul no están adecuadamente vacunados, reforzando la necesidad de la impantación de una política sistemática de inmunización para ellos, teniendo como base las normas preconizadas por el PNI.<br>This study has as objective to evaluates the vacinal covering of the professionals of a Specialization Course in Family Health of Piauí. The study population was constituted by all the 43 students of the group, which are 19 male nurses, 13 doctors and 11 surgeons dentists. The data were collected in 2004, being used auto-applicable questionnaires. Was met a covering vacinal of 81,3% for hepatitis B, 76% for the vaccine yellow fever and 65,1% for dT. Besides 25 students (58,1%) they told unknowledge concerning the vaccines extolled by PNI. The results shown that these professionals of health are not appropriately vaccinated, reinforcing the need of the implantation of a systematic politics of immunization for these professionals, tends as base the norms extolled by PNI