ABSTRACT
Background: Coronavirus disease-2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV- 2), has resulted in an ongoing world-wide pandemic. Vaccination is the key countermeasure of the COVID-19 pandemic. Data on the efficacy, safety and immunogenicity of COVID-19 vaccination in patients with hemophilia -and in particular in those with HIV -are still scarce. Aim(s): The aim of our study was to characterize the immunogenicity and biomarkers of coagulation and endothelial perturbation after mRNA-COVID- 19 vaccination in HIV-positive hemophilic patients. Method(s): We collected blood from 24 adult HIV-positive hemophilic patients followed at our centre (19 with hemophilia A, 5 with hemophilia B) before and two weeks after the administration of the complete vaccination schedule with mRNA-1273 (Moderna Biotech). Most patients had severe hemophilia (n = 21). We measured antibodies to SARS-CoV- 2 spike protein by Elecsys (Roche) to assess immunogenicity and we evaluated protein C, VWF, D-dimer plasma levels as biomarkers of coagulation and endothelial perturbation. Anti-Platelet Factor 4 (PF4) antibodies were also measured. Result(s): Before vaccination, three patients out of 24 showed anti-Spike IgG levels >0.8 U/ml (cut-off value). Two weeks after completing the vaccination schedule, all patients had high values of anti-Spike IgG (min-max 2,387-12,500 U/ml). Mean (standard deviation) basal values of protein C, VWF and D-dimer (106 +/- 21%, 171 +/- 45%, 593 +/- 692 ng/ml respectively) were not significantly different from values measured two weeks after the second dose of vaccine (103 +/- 20%, 162 +/- 43%, 583 +/- 531 ng/ml). Anti-PF4 antibodies were detected in three patients with no associated clinical manifestations. None of the patients reported bleeding in the site of inoculation nor serious adverse events after the vaccination. Conclusion(s): Since immune abnormalities can occur in HIV-positive patients, it is important to collect data on COVID-19 vaccination immunogenicity. We demonstrated that hemophilic HIV-positive patients have a normal antibody response against SARS-CoV- 2 spike protein. In addition, mRNA-1273 had no effect on coagulation and endothelial perturbation.
ABSTRACT
Introduction: Registration studies have shown high efficacy of BNT162b2 mRNA COVID-19 vaccine. We evaluated vaccine effectiveness (VE) of BNT162b2 mRNA COVID-19 vaccine in a cohort of healthcare workers (HCWs) of a large hospital in Milan, Lombardy, Italy. Material and Methods: Follow-up started on 27 December 2020 (beginning of the vaccination campaign). HCWs without history of SARS-CoV-2 infection before the start date and with at least a nasopharyngeal test afterwards were included. Vaccination was treated as a time-dependent variable. For selected periods after vaccination we calculated incidence rate ratios (IRR) and 95% confidence intervals (CI) of infection with a Poisson regression model adjusted for gender, age, occupation, and 30-day periods, and then VE as (1 – IRR)x100 using unvaccinated person-time as reference. Databases were closed on 27 September 2021. The study was approved by the hospital’s ethics committee (Milano Area 2, Prot. No. 828_2021bis). Results and Conclusions: We included 3,809 HCWs, 131 still unvaccinated and 3,678 vaccinated (3,576 with two doses). We identified 134 infections (62% symptomatic). Adjusted VE was 77% (CI: 43-91) from day 14 after the first vaccine dose and 87% (CI: 79-92) at least 7 days after the second dose. After full vaccination schedule VE was 89% (CI: 82-94) for symptomatic and 77% (CI: 45-90) for asymptomatic infections. In conclusion, we found high effectiveness of BNT162b2 vaccine in reducing incidence of both symptomatic and asymptomatic infections. The follow-up is continuing to assess long-term effectiveness, also considering emerging SARS-CoV-2 variants.
ABSTRACT
Introduction Randomized controlled trials showed efficacy of vaccines against coronavirus disease 19 (COVID-19). There is the need to quantify vaccine effectiveness in real-word contexts, including people at high risk of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), such as health care workers (HCWs). Objectives To evaluate vaccine effectiveness among hospital HCWs. Methods We performed a cohort study among HCWs of a large University hospital in Milan, Lombardy, Italy by merging routinely collected data on demographics, COVID-19 vaccination, and polymerase chain-reaction (PCR) tests performed on nasopharyngeal swabs. Follow-up started on December 27, 2020 (start of vaccination campaign). We included HCWs never PCR-positive before the start date and with at least a PCR test afterwards. Vaccination was treated as a time-dependent variable by calculating person-years (PY) at risk before and after vaccine doses. Subjects contributed PY until first positive PCR test (cases) or last test for never positive HCWs (to avoid immortal time bias). We calculated infection rates (cases per 1000 PY), rate ratios (RR, with a Poisson regression model adjusted for gender, age, occupation and 30-day periods), vaccine effectiveness (VE = (1-RR)x100) and 95% confidence intervals (CI) taking never vaccinated HCWs as reference. Results As of May 10, there were 3,152 vaccinated (97% with BNT162b2, 140 with one dose, 2,679 with two doses) and 333 non-vaccinated. We counted 29 infected cases (rate 385) among non-vaccinated, 6 (rate 65) from day 14 after the first dose (VE 79%, CI 49-92%), and 24 (rate 65) from day 7 after the second dose (VE 89%, CI 80-94%). Most cases after vaccination were asymptomatic or mildly symptomatic. Conclusion In these preliminary analysis we found high effectiveness of COVID-19 vaccine in HCWs in our hospital. Further work is needed to assess long-term effectiveness and to better plan future preventive strategies among this high-risk occupational group.