ABSTRACT
BACKGROUND: Shortages of component two of Sputnik V vaccine (rAd5) are delaying the possibility of achieving full immunisation. The immunogenic response associated with the use of alternative schemes to complete the scheme was not explored. METHODS: We did two non-inferiority randomized clinical trials with outcomes measures blinded to investigators on adults aged 21-65 years, vaccinated with a single dose of rAd26 ≥ 30 days before screening and no history of SARS-CoV-2. Participants were assigned (1:1:1:1:1) to receive either rAd5; ChAdOx1; rAd26; mRNA-1273 or BBIBP-CorV. The primary endpoint was the geometric mean ratio (GMR) of SARS-CoV-2 anti-spike IgG concentration at 28 days after the second dose, when comparing rAd26/rAd5 with rAd26/ChAdOx1, rAd26/rAd26, rAd26/mRNAmRNA-1273 and rAd26/BBIBP-CorV. Serum neutralizing capacity was evaluated using wild type SARS-CoV-2 reference strain 2019 B.1. The safety outcome was 28-day rate of serious adverse. The primary analysis included all participants who received ≥ 1 dose. The studies were registered with NCT04962906 and NCT05027672. Both trials were conducted in Buenos Aires, Argentina. FINDINGS: Between July 6 and August 3, 2021, 540 individuals (age 56·7 [SD 7·3]; 243 (45%) women) were randomly assigned to received rAd5 (n=150); ChAdOx1 (n=150); rAd26 (N=87); mRNAmRNA-1273 (n=87) or BBIBP-CorV (n=65). 524 participants completed the study. As compared with rAd26/rAd5 (1·00), the GMR (95%CI) at day 28 was 0·65 (0·51-0·84) among those who received ChAdOx1; 0·47 (0·34-0·66) in rAd5; 3·53 (2·68-4·65) in mRNA-1273 and 0·23 (0·16-0·33) in BBIBP-CorV. The geometric mean (IU/ml) from baseline to day 28 within each group increased significantly with ChAdOx1 (4·08 (3·07-5·43)); rAd26 (2·69 (1·76-4·11)); mRNA-1273 (21·98 (15·45-31·08)) but not in BBIBP-CorV (1·22 (0·80-1·87)). INTERPRETATION: Except for mRNA-1273 which proved superior, in all other alternatives non-inferiority was rejected. Antibody concentration increased in all non-replicating viral vector and RNA platforms. FUNDING: The trials were supported (including funding, material support in the form of vaccines and testing supplies) by the Buenos Aires City Government.
ABSTRACT
With millions of people in the world in situations of physical distancing because of COVID-19, information and communication technology (ICT) has become as one of the principal means of interaction and collaboration. The following advantages of ICT have been cited since the start of the new millennium: increased access to information and service delivery, educational strengthening, quality control of screening programs, and reduction of health care costs. In the case of telemedicine, however, a number of barriers-especially technological, human and social, psychosocial, anthropological, economic, and governance-related-have stood in the way of its adoption. The past 20 years have seen an increase in the availability of resources and technical capacity, improvements in digital education, empowerment of patients regarding their treatment, and increased public interest in this area. Successes have included the use of interdisciplinary teams, academic and professional networking, and virtual medical consultations. After reviewing the state of telemedicine in the Region of the Americas, the authors recommend the urgent adoption of measures aimed at implementing national telemedicine policies and programs, including a regulatory framework and adequate funding. Implementation of the measures should be integrated and interoperable and include the support of academic networks and the collaboration of specialized institutions. The policies should generate an enabling context that ensures sustainability of the progress achieved, bearing in mind the possible barriers mentioned.
Com milhões de pessoas no mundo em situação de distanciamento físico devido à COVID-19, as tecnologias da informação e comunicação (TICs) se enquadraram como um dos meios principais de interação e colaboração. Já no início deste milênio, começaram a ser mencionadas as seguintes vantagens: maior acesso à informação e à prestação de serviços; fortalecimento da educação; controle de qualidade dos programas de detecção e redução dos custos na atenção à saúde. No entanto, entre as principais barreiras de adoção da telemedicina se encontram as de caráter: tecnológico; humano e social; psicossocial e antropológico; de governança e econômico. Nestes 20 anos, houve um aumento nos recursos e na capacidade técnica, uma melhora na educação digital, um empoderamento do paciente em seu tratamento e um maior interesse público nessa área. Em especial, são consideradas bem-sucedidas a constituição de equipes interdisciplinares e as redes acadêmicas e profissionais, e as consultas médicas virtuais. Após revisar o estado da telemedicina na Região das Américas, os autores recomendam a adoção de medidas urgentes para implementar políticas e programas nacionais de telemedicina, incluindo o marco normativo e o orçamento necessário. Essa implementação deve ser realizada de maneira integral e interoperável e sustentada por redes acadêmicas, de parceria e instituições especializadas. Tais políticas devem gerar um contexto favorável, dando sustentabilidade ao avanço obtido e considerando os aspectos mencionados nas possíveis barreiras.
ABSTRACT
Importance: Although there are reports of COVID-19 vaccine implementation in real-world populations, these come from high-income countries or from experience with messenger RNA technology vaccines. Data on outcomes of vaccine deployment in low- or middle-income countries are lacking. Objective: To assess whether the pragmatic application of the 3 COVID-19 vaccines available in Argentina, 2 of which have no reports of evaluation in real-world settings to date, were associated with a reduction in morbidity, all-cause mortality, and mortality due to COVID-19. Design, Setting, and Participants: This cohort study used individual and ecological data to explore outcomes following vaccination with rAd26-rAd5, ChAdOx1, and BBIBP-CorV. To correct for differences in exposure times, results are shown using incidence density per 100â¯000 person-days from the start of the vaccination campaign (December 29, 2020) to the occurrence of an event or the end of follow-up (May 15, 2021). Participants included 663â¯602 people aged at least 60 years residing in the city of Buenos Aires, Argentina. Statistical analysis was performed from June 1 to June 15, 2021. Main Outcomes and Measures: Diagnosis of COVID-19 confirmed by reverse transcription-polymerase chain reaction, death from all causes, and death within 30 days of a diagnosis of COVID-19. Poisson regression models were fitted to estimate associations with all 3 outcomes. Results: Among 663â¯602 residents of the city of Buenos Aires included in the study, 540â¯792 (81.4%) were vaccinated with at least 1 dose, with 457â¯066 receiving 1 dose (mean [SD] age, 74.5 (8.9) years; 61.5% were female [n = 281â¯284]; 68.0% [n = 310â¯987] received the rAd26-rAd5 vaccine; 29.5% [n = 135â¯036] received ChAdOx1; 2.4% [n = 11â¯043] received BBIBP-CorV) and 83â¯726 receiving 2 doses (mean [SD] age, 73.4 [6.8] years; 63.5% were female [n = 53â¯204]). The incidence density of confirmed COVID-19 was 36.25 cases/100â¯000 person-days (95% CI, 35.80-36.70 cases/100â¯000 person-days) among those who did not receive a vaccine, 19.13 cases/100â¯000 person-days (95% CI, 18.63-19.62 cases/100â¯000 person-days) among those who received 1 dose, and 4.33 cases/100â¯000 person-days (95% CI, 3.85-4.81 cases/100â¯000 person-days) among those who received 2 doses. All-cause mortality was 11.74 cases/100â¯000 person-days (95% CI, 11.51-11.96 cases/100â¯000 person-days), 4.01 cases/100â¯000 person-days (95% CI, 3.78-4.24 cases/100â¯000 person-days) and 0.40 cases/100â¯000 person-days (95% CI, 0.26-0.55 cases/100â¯000 person-days). COVID-19-related-death rate was 2.31 cases/100â¯000 person-days (95% CI, 2.19-2.42 cases/100â¯000 person-days), 0.59 cases/100â¯000 person-days (95% CI, 0.50-0.67 cases/100â¯000 person-days), and 0.04 cases/100â¯000 person-days (95% CI, 0.0-0.09 cases/100â¯000 person-days) among the same groups. A 2-dose vaccination schedule was associated with an 88.1% (95% CI, 86.8%-89.2%) reduction in documented infection, 96.6% (95% CI, 95.3%-97.5%) reduction in all-cause death, and 98.3% (95% CI, 95.3%-99.4%) reduction in COVID-19-related death. A single dose was associated with a 47.2% (95% CI, 44.2%-50.1%) reduction in documented infection, 65.8% (95% CI, 61.7%-69.5%) reduction in all-cause death, and 74.5% (95% CI, 66%-80.8%) reduction in COVID-19-related death. Conclusions and Relevance: This study found that within the first 5 months after the start of the vaccination campaign, vaccination was associated with a significant reduction in COVID-19 infection as well as a reduction in mortality.