An evaluation of the safety and immunogenicity of MVC-COV1901: Results of an interim analysis of a phase III, parallel group, randomized, double-blind, active-controlled immunobridging study in Paraguay.

BACKGROUND: Data from previous studies of the MVC-COV1901 vaccine, a subunit vaccine against SARS-CoV-2 based on the stable prefusion spike protein (S-2P) adjuvanted with CpG 1018 adjuvant and aluminum hydroxide, suggest that the vaccine is generally safe and elicits a good immune response in healthy adults and adolescents. By comparing with AZD1222, this study adds to the findings from previous trials and further evaluates the breadth of protection offered by MVC-COV1901. METHODS: In this phase 3, parallel group, randomized, double-blind, active-controlled trial conducted in 2 sites in Paraguay, we assigned adults aged 18-91 years in a 1:1 ratio to receive intramuscular doses of MVC-COV1901 or AZD1222 administered as scheduled in the clinical trial. Serum samples were collected on the day of vaccination and 14 days after the second dose. Primary and secondary safety and immunogenicity endpoints were assessed. In addition, other outcomes investigated were cross-reactive immunity against the Omicron strain and the induction of IgG subclasses. RESULTS: A total of 1,030 participants underwent randomization. Safety data was derived from this set while primary immunogenicity data involved a per-protocol immunogenicity (PPI) subset including 225 participants. Among the participants, 58% are seropositive at baseline. When compared against AZD1222, MVC-COV1901 exhibited superiority in terms of neutralizing antibody titers and non-inferiority in terms of seroconversion rates. Reactogenicity was generally mild and no serious adverse event was attributable to MVC-COV1901. Both vaccines have a Th1-biased response predominated by the production of IgG1 and IgG3 subclasses. Omicron-neutralizing titers were 44.5 times lower compared to wildtype-neutralizing titers among seronegative individuals at baseline. This fold-reduction was 3.0 times among the seropositive. CONCLUSION: Safety and immunogenicity data of MVC-COV1901 from the study in Paraguay confirm previous results. The previous infection coupled with vaccination of this vaccine may offer protection against the Omicron strain though its durability is still unknown.

Epidemiology of COVID-19 cases diagnosed at quarantine facilities in Paraguay / Epidemiologia dos casos de COVID-19 diagnosticados nas instalações de quarentena no Paraguai

Aims: This study aimed to describe the epidemiological characteristics of COVID-19 cases diagnosed inquarantine facilities in Paraguay. Methods: This was a descriptive, cross-sectional, temporarily retrospective study. The time scope was from April 1 to September 30 2020. The variables were sex, age and administrative departments. The open access data available on the website of the Ministry of Public Health and Social Welfare was used. Frequencies expressed in percentages and the Chi square value were calculated to observe the statistically significant differences between cases and age and sex. Results: from April 4 to September 30 2020, 1.581 cases were diagnosed in COVID-19. The fewest number of positive cases were reported in April (50) and the highest number was reported in May (628). From the total, 69.6% (1.101) were male, (male / female ratio 2.3), 42.1% (666) were aged between 20-29 years, the average age was 30.23 years (range 0 to 87, standard deviation 14.66. 95% CI 1.5 - 58.95). The departments with the highest number of cases were Caaguazú 21.7 % (343), Alto Paraná 17.3 % (274), Central 13.3% (210) and Asunción 11.4% (180). The least number of cases of COVID-10 in women were registered in the Departments of Amambay, Pdte. Hayes, Ñeembucú and Boquerón, and in men the Departments of Ñeembucú and Boquerón. The largest number of male cases were registered in Caaguazú 70.8% (243), Alto Paraná 66.1% (181), Central 69.5% (146) and Asunción 68.9% (124). The number of Covid-19 infected people in quarantine facilities presented statistically significant differences between the variables sex and age. Conclusion: the quarantine facilities are one of the measures that the Paraguayan government needed to avoid the rapid spread and dispersion of the virus. The epidemiology of the cases diagnosed in them corresponds to what was expected according to the characteristics of the country.

Objetivo: descrever as características epidemiológicas dos casos de COVID-19 diagnosticados em instalações de quarentena no Paraguai. Metodologia: estudo descritivo, transversal, temporalmente retrospectivo. Quanto ao âmbito temporal foi considerado o período de 1 de abril a 31 de setembro de 2020. As variáveis analisadas foram: sexo, idade e Departamentos Administrativos. Foram utilizados dados abertos de acesso público que estão disponíveis na página oficial do Ministério da Saúde Pública e Bem-Estar Social. Foram calculadas frequências expressadas em porcentagem e aplicado o teste de qui-quadrado para ver diferenças estatisticamente significativas entre os casos, idade e sexo. Resultados: De 4 de abril a 30 de setembro de 2020, foram diagnosticados 1.581 casos de COVID-19. Em abril houve a menor quantidade de casos positivos (50) e em maio a maior quantidade (628). 69.6% (1.101) foram em indivíduos do sexo masculino (relação homem/mulher de 2,3). 42.1% (666) tinham idade compreendida entre 20-29 anos, com uma média de 30.23 anos (classificação 0 a 87, desvio padrão 14,66, IC 95% 1.5 ­ 58.95). Os Departamentos com maior número de casos foram 21.7 % (343), Alto Paraná 17.3 % (274), Central 13.3% (210) e Assunção 11.4% (180). O menor número de casos de COVID-19 em mulheres foi registado nos Departamentos de Amambay, Pdte. Hayes, Ñeembucú e Boquerón, e nos homens, os Departamentos de Ñeembucú e Boquerón. A maior quantidade de casos no sexo masculino foi registrado em Caaguazú 70.8% (243), Alto Paraná 66.1% (181), Central 69.5% (146) e Assunção 68.9% (124). O número de infectados por COVID-19 nos albergues apresentou diferenças estatisticamente significativas entre as variáveis sexo e idade. Conclusão: Os abrigos temporários são uma das importantes medidas adotadas pelo governo paraguaio para evitar a rápida dispersão e propagação do vírus. A epidemiologia dos casos neles diagnosticados correspondem às esperadas para as características do país.