Efficacy and Safety of a COVID-19 Inactivated Vaccine in Healthcare Professionals in Brazil: The PROFISCOV Study

Palácios, Ricardo; Ap, Batista; Csn, Albuquerque; Eg, Patiño; JdP, Santos; Mtrp, Conde; RdO, Piorelli; Lcp, Júnior; Sm, Raboni; Ramos, Fernanda Lia de Paula; Gas, Romero; Fe, Leal; Camargo, Lfa; Fh, Aoki; Coelho, Emerson Filipino; Ds, Oliveira; Cjf, Fontes; Gcs, Pileggi; ALLd, Oliveira; Siqueira, André Machado; DBLd, Oliveira; Vf, Botosso; Zeng, Gang; Q, Xin; Mm, Teixeira; Nogueira, Maurício Lacerda; Eg, Kallas

doi:10.2139/ssrn.3822780

Cited by 190 publications

(187 citation statements)

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“…We con rmed and extended previous reports with mRNA vaccines that older age and ARD itself negatively in uence SARS-CoV-2 humoral response, a nding also observed for CoronaVac 10 . The deleterious impact of immunosuppressive therapy was also observed herein for this latter inactivated vaccine compared to those not on these drugs.…”

Section: Discussionsupporting

confidence: 89%

“…Age-matching with the CG was essential as seroconversion against CoronaVac may be lower in the older population 10 . This condition was not met by previous studies evaluating SARS-CoV-2 vaccination in ARD patients precluding a de nitive conclusion about their ndings [15][16][17] .…”

Section: Discussionmentioning

confidence: 99%

“…However, the reported 50.7% e cacy to prevent mild COVID-19 in the phase III clinical trial 10 , raises concerns about its immunogenicity in immunosuppressed patients as they comprise millions of people including those with autoimmune diseases, patients with neoplasia, transplant recipients and patients living with human immunode ciency virus (HIV) among other groups, with an estimated prevalence in the US of 2.7% of the population 12 . A recent letter reported a greatly reduced anti-spike antibody response (17%) after the rst dose of SARS-CoV-2 mRNA − 1273 or BNT162b2 vaccination in 436 solid organ transplant recipients 13 .…”

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confidence: 99%

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Immunogenicity and safety of an inactivated virus vaccine against SARS-CoV-2 in patients with autoimmune rheumatic diseases

Bonfá

Medeiros-Ribeiro

Aikawa

et al. 2021

Preprint

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CoronaVac(SARS-CoV-2 inactivated vaccine) has been largely used as the main immunogen for COVID-19 in several countries. However, its immunogenicity in immunocompromised individuals has not been established. This was a prospective controlled study of 910 adult ARD patients and 182 age- and sex-matched control group(CG) who received two doses of CoronaVac in a 28-days interrval. Anti-SARS-Cov-2 IgG and neutralizing antibodies were assessed at each vaccine shot and 6 weeks after the 2nd dose. Vaccine adverse events(AE) were similar in both groups. We observed significant lower anti-SARS-Cov-2 IgG seroconversion(70.4% vs. 95.5%,p < 0.001) and titers[12.1(95%CI 11.0-13.2) vs. 29.7(95%CI 26.3–33.5),p < 0.001], frequency of neutralizing antibodies(56.3% vs. 79.3%),p < 0.001) and median (interquartile range) neutralization activity [58.7(43.1–77.2) vs. 64.5(48.4–81.4),p = 0.013] in ARD patients compared to CG. A significant decline in the number of COVID-19 cases (p < 0.0001) were observed 10 days after the second dose, with a predominant P1 variant. Safety analysis revealed no moderate/severe AEs. In conclusion, CoronaVac has an excellent safety profile and reasonable rates of quantitative serology(70.4%)/neutralization(56.3%) in ARD patients. The impact of this reduced immunogenicity in vaccine effectiveness warrants further evaluation.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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Immunogenicity and safety of an inactivated virus vaccine against SARS-CoV-2 in patients with autoimmune rheumatic diseases

Bonfá

Medeiros-Ribeiro

Aikawa

et al. 2021

Preprint

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“…Novel SARS-CoV-2 lineage P.1 first identified in Manaus has been associated with potentially higher transmission rates, and now it is widespread across all Brazilian regions [17,18]. On the other hand, a preliminary study conducted by Institute Butantan [19], suggests the vaccination in Brazil by CoronaVac can neutralize variants P.1 and P.2 of SARS-CoV-2. P.1 was first worldwide reported on January 10, 2021 after been detected in four travelers from Brazil at Haneda airport in Tokyo.…”

Section: Figure 5 Ratio Of Deaths To Confirmed Cases (Open Red Diamonds) As a Function Of Time (A) An Assumed Constant Fatality Rate In Tmentioning

confidence: 99%

Second Wave Analysis and Confirmed Forecasts of the SARS-Cov-2 Epidemic Outbreak in São Paulo, Brazil

Celaschi

2021

SciMed. J.

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Objective: A SEIR compartmental model was previously selected to estimate future outcomes to the dynamics of the Covid-19 epidemic breakout in Brazil. Method: Compartments for individuals vaccinated and prevalent SARS-Cov-2 variants were not included. A time-dependent incidence weight on the reproductive basic number accounted for Non Pharmaceutical Interventions (NPI). A first series of published data from March 1st to May 8, 2020 was used to adjust all model parameters aiming to forecast one year of evolutionary outbreak. The cohort study was set as a city population-based analysis. Analysis: A population-based sample of 25,366 confirmed cases on exposed individuals was used during the first study period. The analysis was applied to predict the consequences of NPI enforcements followed by progressive releases, and indicates the appearance of a second wave starting last quarter of 2020. Findings: By March 1st 2021, the number of confirmed cases was predicted to reach 0.47Million (0.24-0.78), and fatalities would account for 21 thousand (12-33), 5 to 95% CRI. A second series of data published from May 9, 2020 to March 1st, 2021 confirms the forecasts previously reported for the evolution of infected people and fatalities. Novelty: By March 1st 2021, the number of confirmed cases reached 527,710 (12% above the predicted average of accumulated cases) and fatalities accounted for 18,769 (10% below the accumulated average of estimated fatalities). After March 1st, new peaks on reported numbers of daily new infected and new fatalities appeared as a combined result to the appearance of the prevalent SARS-CoV-2 P1 variant, and the increased number of vaccinated individuals. Doi: 10.28991/SciMedJ-2021-03-SI-10 Full Text: PDF

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“…Rather than focusing efforts on introducing vaccine passports and propagating vaccine nationalism, Europe and the United States should lead efforts to ensure that the costs of tests, drugs, medical equipment and vaccines are made affordable to ensure an adequate supply in the Global South. There is no excuse for delays in delivering vaccine reagents that were agreed upon in contracts, especially as trials for the SINOVAC and ChAdOx1 vaccines were conducted in, and partially paid for by, Brazil 9,10 .…”

mentioning

confidence: 99%

Brazil needs a coordinated and cooperative approach to tackle COVID-19

Barberia

Costa

Sabino

2021

Nat Med

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Brazil needs a coordinated and cooperative approach to tackle COVID-19To the Editor-After more than 14 months under siege, Brazilians continue to suffer as they see thousands of people dying every day, killed by the fast-moving respiratory pathogen SARS-CoV-2. Families are struggling to secure their livelihoods, quell hunger and, in some cases, adjust to the long-term toll of having survived infection with SARS-CoV-2. With the surge in cases, overcrowding of hospitals and high lethality, those on the front lines understand that Brazil is at war with COVID-19. The assault has been brutal 1 . A quarter of all deaths from COVID-19 in Brazil were officially recorded in April 2021. Meanwhile, a SARS-CoV-2 variant

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Efficacy and Safety of a COVID-19 Inactivated Vaccine in Healthcare Professionals in Brazil: The PROFISCOV Study

Cited by 190 publications

References 0 publications

Immunogenicity and safety of an inactivated virus vaccine against SARS-CoV-2 in patients with autoimmune rheumatic diseases

Immunogenicity and safety of an inactivated virus vaccine against SARS-CoV-2 in patients with autoimmune rheumatic diseases

Second Wave Analysis and Confirmed Forecasts of the SARS-Cov-2 Epidemic Outbreak in São Paulo, Brazil

Brazil needs a coordinated and cooperative approach to tackle COVID-19

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