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Objectives: This study aimed to determine disease severity, clinical features, clinical outcome in hospitalized patients with the Omicron variant and evaluate the effectiveness of one-dose, two-dose, and three-dose inactivated vaccines in reducing viral loads, disease course, ICU admissions and severe diseases. Method(s): Retrospective cohort analysis was performed on 5,170 adult patients (>=18 years) identified as severe acute respiratory syndrome coronavirus 2 positive with Reverse Transcription Polymerase Chain Reaction admitted at Shanghai Medical Center for Gerontology between March 2022 and June 2022. COVID-19 vaccination effectiveness was assessed using logistic regression models evaluating the association between the risk of vaccination and clinical outcomes, adjusting for confounders. Result(s): Among 5,170 enrolled patients, the median age was 53 years, and 2,861 (55.3%) were male. 71.0% were mild COVID-19 cases, and cough (1,137 [22.0%]), fever (592 [11.5%]), sore throat (510 [9.9%]), and fatigue (334 [6.5%]) were the most common symptoms on the patient's first admission. Ct values increased generally over time and 27.1% patients experienced a high viral load (Ct value< 20) during their stay. 105(2.0%) of these patients were transferred to the intensive care unit after admission. 97.1% patients were cured or showed an improvement in symptoms and 0.9% died in hospital. The median length of hospital stay was 8.7+/-4.5 days. In multivariate logistic analysis, booster vaccination can significantly reduce ICU admissions and decrease the severity of COVID-19 outcome when compared with less doses of vaccine (OR=0.75, 95%CI, 0.62-0.91, P<=0.005;OR=0.99, 95%CI, 0.99-1.00, p<0.001). Conclusion(s): In summary, the most of patients who contracted SARSCoV-2 omicron variant had mild clinical features and patients with vaccination took less time to lower viral loads. As the COVID-19 pandemic progressed, an older and less vaccinated population was associated with higher risk for ICU admission and severe disease.Copyright © 2023
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Bivalent COVID-19 vaccines that contain two mRNAs encoding Wuhan-1 and Omicron BA.4/5 spike proteins are successful in preventing infection from the original strain and Omicron variants, but the quality of adaptive immune responses is still not well documented. This study aims at characterizing adaptive immune responses to the bivalent booster vaccination in 46 healthy participants. Plasma and PBMC were collected prior and three weeks after bivalent booster. We measured anti-N, anti-S, and RBD IgM, IgA, IgG plasma titers against original, Omicron BA.1, and BA.5 variants (pending) as well as total anti-S IgG titers and surrogate Virus Neutralization capacity against the Alpha, Delta, and BA.1 variant. With spectral flow-cytometry we identified peripheral blood B-cells specific for the RBD of the S-protein of the original and BA.1 variants. T-cell-specific responses were assessed by cytokine release assay after stimulation with SARS-CoV-2 peptides from the original, BA.1, BA.4, and BA.5 variants (pending). Finally, we performed TRB and IGH repertoire studies on sorted CD4+, CD8+, CD19+ lymphocytes, to study breadth of SARS-CoV-2 specific clonotypes (pending). 27/46 participants were analyzed;9 had SARS-CoV-2 infection (COVID+), while 18 are infection naive (COVID-). In both groups, median time since last dose of SARS-CoV-2 vaccine (3rd or 4th) was 11 months. All subjects were positive for anti-S IgG prior to bivalent booster. The COVID + group displayed anti-S IgG pre-booster levels and neutralization against BA.1 higher than the COVID- group. Significant increase post-boost of total anti-S IgG and BA.1 neutralizing activity was detected in the COVID- but not in the COVID+ group;however, no difference in neutralization activity post-boost was detected between the two groups. Furthermore, the COVIDgroup showed significant increase in the frequency of CD19+ and CD27+ switched memory B-cells specific for BA.1 RBD in post-boost compared to pre-boost samples. However, post-boost frequencies of the same B-cells were higher in the COVID+ compared to the COVID- group. These preliminary findings confirm that among individual immunized with the original COVID-19 mRNAvaccine, prior COVID infection provides increased protection against SARS-CoV-2 variants. They also demonstrate that booster immunization with the bivalent vaccine induces robust adaptive immune responses against Omicron variant.[Formula presented][Formula presented]Copyright © 2023 Elsevier Inc.
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Patients undergoing treatment for haematological malignancies have been shown to have reduced antibody responses to vaccination against SARS-COV2. This is particularly important in patients who have undergone allogeneic haemopoietic stem cell transplantation (HSCT), in whom there is limited data about vaccine efficacy. In this retrospective single-centre analysis, we present data on serologic responses following one, two, three or four doses of either Pfizer-BioNTech (PB), AstraZeneca (AZ) or Moderna (MU) SARS-CoV- 2 vaccines from a series of 75 patients who have undergone allogeneic HSCT within 2 years from the time they were revaccinated. The seroconversion rates following post-HSCT vaccination were found to be 50.7%, 78%, 79% and 83% following the first, second, third and fourth primary post -HSCT vaccine doses, respectively. The median time from allograft to first revaccination was 145 days (range 79-700). Our findings suggest that failure to respond to the first SARS-CoV- 2 vaccine post-HSCT was associated with the presence of acute GVHD (p = 0.042) and treatment with rituximab within 12 months of vaccination (p = 0.019). A statistical trend was observed with the presence of chronic GVHD and failure to seroconvert following the second (p = 0.07) and third (p = 0.09) post-HSCT vaccine doses. Patients who had received one or more SARS-CoV- 2 vaccines prior to having an allogeneic stem cell transplant were more likely to demonstrate a positive antibody response following the first dose of revaccination against Sars-CoV- 2 (p = 0.019) and retained this seropositivity following subsequent doses. The incidence of confirmed COVID-19 diagnosis among this cohort at the time of analysis was 16%. 17% of these were hospitalised and there was one recorded death (8%) secondary to COVID-19 in a patient who was 15.7 months post allogeneic transplant. In summary, this study suggests that despite the initial low seroconversion rates observed postallogeneic transplant, increasing levels of antibody response are seen post the second primary vaccine dose. In addition, there seems to be lower risk of mortality secondary to COVID-19 in this vaccinated population, compared to what was reported in the earlier phases of the pandemic prior to use of SARS-COV2 vaccination. This adds support to the widely adopted policy of early full revaccination with repeat of primary vaccine doses and boosters post-HSCT to reduce mortality in this population. Finally, we have identified rituximab use and active GVHD as potential risk factors influencing serological responses to SARS-COV2 vaccination and further work should focus on further characterising this risk and optimum dosing schedule both pre-and post-transplant.
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Objectives: To estimate the public health impact of COVID-19 booster vaccination in the UK during Omicron predominance, and to explore the impact in counterfactual scenarios with different booster eligibility or uptake. Method(s): A dynamic transmission model was developed to compare public health outcomes for actual and hypothetical UK Spring and Autumn 2022 booster programs. Outcomes were projected over an extended time horizon from April 2022-April 2023, assuming continued Omicron predominance as in Jan-Mar 2022. Health outcomes included averted cases, hospitalizations, long COVID cases, and deaths. NHS resource use outcomes were averted general ward and intensive care unit bed days and general practitioner visits. Patient productivity loss outcomes considered productive days lost for those in and outside the paid work force. Analyses used publicly available data. Result(s): Model output suggested that actual Spring and Autumn 2022 programs, which offered boosters to older adults and vulnerable populations, would avert approximately 716,000 hospitalizations, 1.9M long COVID cases and 125,000 deaths compared to not offering boosters in Spring and Autumn 2022. In a scenario that broadened eligibility to individuals aged >=5 years, an estimated 1.6M hospitalizations, 8.3M long COVID cases, and 222,000 deaths were averted. A scenario assuming broadened eligibility and increased uptake produced the greatest benefit among scenarios analyzed: 1.6M hospitalizations, 9.2M long COVID cases, and 228,000 deaths averted;and 953M productive days saved. Scenarios offering boosters only to high-risk individuals (aged >=5 years) were also estimated to improve benefit relative to actual programs. High-risk-only programs assuming increased uptake provided about half to two-thirds of the benefit estimated for programs assuming broadened eligibility and increased uptake. Conclusion(s): UK booster vaccination programs were estimated to provide substantial benefit to public health during Omicron predominance. Public health benefits could be maximized by broadening booster eligibility to younger age groups and increasing uptake.Copyright © 2023
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Objectives: The public's stated preference for public health and social measures (PHSMs), and levels of pandemic fatigue are insufficiently fixed. We aim to quantify the public's preferences for varied PHSMs, and measure population's pandemic fatigue. Method(s): We conducted a cross-sectional, nationwide sampling, survey-based experiment to assess public preference for and attitudes towards PHSMs. A set of psychometric scales, specifically, the COVID-19 pandemic fatigue scale (CPFS), was used to screen fatigue levels in the respondents. The multinomial logit model (MNL) and latent class model (LCM) were utilized for choice tasks analysis, and Mann-Whitney tests were used for CPFS statistical analysis. Result(s): There were 689 respondents, who completed the survey, and were included in the study after quality control. The discrete choice experiments revealed that respondents attached the greatest importance to the risk of COVID-19 infection within three months (45.53%), followed by loss of income within three months (30.69%). Vulnerable populations (lower-income and older respondents) are more sensitive to the risk of infection, and younger respondents are more sensitive to income loss and prefer non-suspension of socialization and transportation. Migrants, and respondents with a higher level of fatigue, have less acceptance of the mandatory booster vaccination and suspension of transportation. Additionally, a higher fatigue level was observed in females, younger respondents, migrants, and relatively lower-income respondents. Conclusion(s): Fatigue and fear of COVID-19 infection contributed to the public's mental health problem. Hence, at the late-stage pandemic, policymakers should consider reducing people's mental burden via relieving people's fear of infection when PHSMs are being relaxed. And this also provides insights for the outbreaks' PHSMs implementation in the future.Copyright © 2023
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Objectives: Few studies evaluate the immunogenicity and safety of different COVID-19 vaccine platforms in patients with primary Sjogren's Syndrome (pSS). The present study aims to assess the immunogenicity through anti-spike IgG antibodies after the COVID-19 vaccine dose in heterologous groups compared to homologous regimen in patients with pSS. Method(s): These data are from the SAFER study: 'Safety and efficacy of the COVID-19 vaccine in rheumatic disease', a real-life phase IV multicenter longitudinal study, evaluating patients since before the first dose. Pregnant women, those with a history of serious adverse events prior to any vaccine, and those with other causes of immunosuppression were excluded. Patients with pSS > 18 years, classified according to ACR/EULAR 2016 classification criteria were included. Antibodies against the Receptor Binding Domain - RBD portion of the Spike protein of SARS-CoV-2 (IgG-S) were measured by chemiluminescence (Architect SARS-CoV-2 Quanti II, Abbott), before the first dose and 28 days after the 2nd and 3rd dose. Seropositivity was defined as IgG-Spike titers >=7.1 BAU/mL. Patients received adenoviral vector (ChAdOx1, Astrazeneca), mRNA (Pfizer) or inactivated SARS-COV-2 (Coronavac). Non-parametric methods were used. The alpha level of significance was set at 5%. Result(s): 56 participants received 3 doses, 46 +/- 11 years old, disease duration 7.62 years, 92.9% female, 41.1% White and 55.4% Mixed. The homologous third-booster dose group (n = 15, all ChAdOx1) and heterologous group (n = 41) were homogeneous for age, sex, ethnicity, comorbidities, medication and baseline IgG-S median [IQR] titers. After primary vaccination (2 doses) IgG-S median and titers [IQR] were similar in homologous and heterologous groups (373.03 [179.58, 843.92] vs. 473.36 [119.05, 1059.60], p = 0.705). Third-booster dose induced higher IgG-S median [IQR] titers compared to only 2 doses (1229.54 [333.55, 4365.47] vs 464.95 [140.42, 1015.25], p alpha 0.001). Heterologous 3rd-booster induced higher IgG-S median [IQR] titers than homologous scheme with ChAdOx1 (1779.52 [335.83, 4523.89] vs 730.76 [303.37, 1858.98], p = 0.150), Fig 1 and 2, although not statistically significant. Conclusion(s): Third booster dose induced higher humoral immune response compared to two doses whichmay improve protection against COVID-19 in patients with pSS. Although not statistically significant, the response to the heterologous scheme tended to be better than the response to the homologous booster vaccination, which heterologous booster scheme tended to respond better than homologous booster vaccination, which is relevant in this immunosuppressed population. Increasing the sample size will help clarify this issue. .
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Background/Aims With widespread implementation of COVID-19 vaccine, there has been concern that it would trigger an immune activation due to its immunogenic properties. There is low-level evidence that patients with rheumatological diagnosis often have a disease flare following COVID-19 vaccination which not only has personal health implications but also wider socioeconomic implications. Inflammatory arthritis patients are classified as vulnerable patients requiring booster vaccinations. Therefore, there is a need to ascertain whether there is a risk of disease flare in this group of patients so as to counsel them appropriately in order to ensure flares are managed in timely manner. This study aims to determine the proportion of patients with inflammatory arthritis who have a flare of their rheumatological disease within 30 days of receiving a COVID-19 vaccine using CRP as a surrogate marker. Methods A retrospective notes review was conducted of patients with inflammatory arthritis within 30 days of their COVID-19 vaccine. An electronic database (DAWN) was used to identify all patients that were currently on a disease-modifying anti-rheumatic drug (DMARD) or biologic therapy. This was then correlated with vaccine data from the National Immunisation and Vaccination system (NIVS) and C-reactive protein (CRP) within 30 days of their vaccination. Results 1620 adults were identified from DAWN databases (mean age 61 years, 64% female). Three types of vaccination were used: AstraZeneca (AZ), BioNTech-Pfizer or Moderna. Vaccine uptake was 1542/1620 (95.2% 1st dose), 1550/1620 (95.7% 2nd dose) and 1437/ 1620 (88.7% 3rd dose). 192/1542 patients (12.5%) had a CRP rise of greater than 10mg/L within 30 days of their vaccine, which was higher than baseline flare rate of 8.6% (p=0.0004). Conclusion Patients with inflammatory arthritis and on DMARDS have high uptake of COVID-19 vaccine (95%) which is greater than the national average. A CRP rise greater than 10mg/L within 30 days of vaccination was observed in roughly 1 in 10 patients in our study population on all three doses which is consistent with other studies in the literature. Our results show statistically significant increase in the rate of disease flare (12.5% compared with baseline rate of 8.6%). However, SARS-CoV-2 infection has been shown many times to be an independent risk factor for rheumatic disease flare ranging from 20-40%. Therefore, patients with inflammatory arthritis should still be encouraged to receive COVID-19 vaccination. To maintain high levels of vaccine uptake, it is important to ensure that patients are aware of the risks of vaccinations and sufficiently safety netted so flares are managed early. As on-going booster vaccinations are planned for rheumatology patients, we recommend further research to better inform and counsel our patients. Furthermore, this study calls for diligence in monitoring patients with inflammatory arthritis for disease flare and for swift intervention to prevent losing disease control.
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Intro: Vaccinations have decreased the case fatality rate of COVID-19. Nonetheless, there appear to be differences in the duration of vaccine efficacy against death across populations.We aim to model the duration between vaccine type and time to death stratified by primary and booster series vaccination in Malaysia. Method(s): Data for all COVID-19 deaths between 1 February 2020 and 31 August 2022 were extracted from the Ministry of Health Malaysia data repository. Information was available on age, sex, nationality, region, vaccine status, vaccine type, and the duration from vaccination to death. The duration between primary or booster vaccination and death was modelled using Poisson regression. Finding(s): A total of 25,759 (77%), 7,421 (20%), and 1,036 (2.9%) unvaccinated, primary series vaccinated, and booster vaccinated COVID-19 deaths were respectively reported between 1 February 2020-31 August 2022 in Malaysia. The median duration between primary series vaccination and death, with AstraZeneca, Pfizer and Sinovac vaccines was respectively 150 (IQR: 73-211), 158 (IQR:88-229) and 105 (65-139) days. The median duration between booster vaccine and death with a Homologous or Heterologous vaccine was 86 (IQR: 59- 139) and 106 (66-139) days, respectively. Individuals with an AstraZeneca and Sinovac primary series had 19% (95% CI: 0.8-0.82) and 33% (95% CI: 66-0.68, p<0.01) shorter duration from vaccination to death than individuals with Pfizer vaccines. Individuals with a heterologous booster vaccination had an 8% (95% CI: 1.07-1.10, p<0.01) longer duration from vaccination to death than individuals receiving a homologous booster dose. Conclusion(s): There appear to be differences in the duration between vaccination and death by vaccine type. This must be considered alongside immune evasive variants and level of naturally acquired immunity when planning for vaccination programmes that are central to keeping COVID-19-associated mortalities low.Copyright © 2023
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Background/Aims: The global pandemic of COVID-19 has caused tremendous loss of human life since 2019. Vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is one of the best policies to control the pandemic. The vaccination efficacy in Taiwanese patients with different comorbidities is elusive and to be explored. Method(s): Uninfected subjects who received 3-doses of mRNA vaccines (Moderna, BioNTech), non-replicating viral vector-based vaccines (AstraZeneca, AZ) or protein subunit vaccines (Medigen COVID-19 vaccine, MVC) were prospectively enrolled. SARSCoV2- IgG spike antibody level was determined (Abbott [SARS-CoV- 2 IgG II]) within 3 months after the last dose of vaccination. Charlson Comorbidity Index (CCI) was applied to disclose the association of vaccine titer and underlying comorbidities. Result(s): A total of 824 subjects were enrolled in the current study. The mean age was 58.9 years and males accounted for 48.7% of the population. The proportion of CCI with 0-1, 2-3 and>4 was 52.8% (n = 435), 31.3% (n = 258) and 15.9% (n = 131), respectively. The most commonly used vaccination combination was AZ-AZ-Moderna (39.2%), followed by Moderna-Moderna-Moderna (27.8%) and AZAZ- BioNTech (14.7%), respectively. The mean vaccination titer was 3.11 log BAU/mL after a median 48 days of the 3rd dose. Subjects of male gender, lower body mass index, chronic kidney disease, higher CCI, and receiving AZ-AZ based vaccination were likely to have a lower titer of antibody. There was a decreasing trend of antibody titer with the increase of CCT (trend P<0.001). Linear regression analysis revealed that AZ-AZ-based vaccination (beta: 0.341, 95% confidence intervals [CI]: 0.144, 0.21, P<0.001) and higher CCI (beta: - 0.055, CI: - 0.096, - 0.014, P = 0.009) independently correlated with low IgG spike antibody levels. Conclusion(s): Patients with more comorbidities had a poor response to 3 doses of COVID-19 vaccination. Further studies are warranted to clarify the efficacy of booster vaccination in the population. The vaccine titer did not differ between patient with or without chronic liver disease.
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Objectives: To evaluate the humoral immune response to the third dose (booster) of vaccine against SARS-CoV-2 in patients with autoimmune rheumatic diseases who were seronegative after a two-dose regimen. Method(s): Observational study. Patients with autoimmune rheumatic diseases who had not achieved seroconversion after a two-dose vaccine schedule against SARS-CoV-2 were included. To assess the humoral immune response, anti-RBD IgG (S protein receptor binding domain) neutralizing antibody titers were determined by ELISA (cutoff titer 200). The determination was made between 30 to 45 days after the third dose. Result(s): From 66 patients who received SARS-CoV-2 vaccination, 18 patients (29.5%) were seronegative after a two-dose schedule. 61% had SLE, 77% had comorbidities (61% with hypertension, p = 0.03). Patients were on treatment: 10 with prednisone (8 with doses greater than 10 mg/d, p = 0.01), 10 with hydroxychloroquine, one with methotrexate, one with leflunomide, four with azathioprine, five with my cophenolatemofetil and five with rituximab (they are the total number of non-responders on biological treatment, p = 0.03). Regarding the primary vaccination regimen, 11 received BBIBP-CorV (p = 0.01), 5 AZD1222, 1 Gam-COVID-Vac and 1 mRNA1273/Gam-COVID-Vac heterologous scheme. Of these 18 non-responders, 14 received a third dose;nine patients (62%) presented anti-RBD IgG detectable. Of the five patients who did not respond to the booster vaccination, three had received BBIBP-CorV as the initial schedule and the vaccines applied as a third dose were Ad5-nCoV (1), BNT162b2 (1), AZD 1222 (2) and Gam-COVID-Vac (1). They were being treated with: rituximab (2), azathioprine (2) and mycophenolate mofetil (1). Treatment with higher doses of prednisone was the only factor associated with non-seroconversion to the third dose (8 +/- 4.5;p 0.02). Conclusion(s): The third dose of SARS-CoV-2 vaccine allowed to improve the serological response to vaccination, achieving a seroconversion of 62% in this group of patients.
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Intro: VLA2001 is a highly-purified, inactivated whole-virus SARS-CoV-2 vaccine based on a dual-adjuvant system of Alum and CpG1018 for induction of a robust immune response. The vaccine was designed using a well-established technology platform and has received full marketing authorization in Europe. In a pivotal Phase 3 trial, VLA2001 demonstrated superior neutralizing antibody geometric mean titers (GMT) to the comparator, AstraZeneca's AZD1222, as well as non-inferior seroconversion rates two weeks after priming. The extension of the Phase 3 trial evaluated safety and immunogenicity of homologous and heterologous booster vaccinations of VLA2001. Method(s): This is a randomized observer-blind controlled, pivotal trial conducted in the UK in participants aged >=18 years who were randomly assigned 2:1 to receive two doses of VLA2001 or AZD1222, 28 days apart. A booster with VLA2001 was administered to eligible participants at 7 to 8 months after priming. The primary safety outcome was the frequency and severity of any adverse event following the booster vaccination. The primary immunogenicity outcomes were the GMT and fold increase of neutralizing antibodies against SARS-CoV-2 two weeks after the booster vaccination. The study is registered under NCT04864561. Finding(s): A booster dose of VLA2001 is well-tolerated in both AZD1222 and VLA2001 primed participants. High neutralizing antibody titers and fold- increases were generated two weeks following a booster of VLA2001. Cross- neutralizing serological responses against Delta and the Omicron BA.4/BA.5 variants of concern are elicited following a homologous or heterologous booster dose in VLA2001 or AZD1222 primed participants, respectively. Additionally, VLA2001 induced broad T-cell responses with antigen-specific IFN-gamma producing T-cells against the Spike, the Nucleocapsid and the Membrane protein. Conclusion(s): Homologous and heterologous booster doses of VLA2001 demonstrated a favorable tolerability profile irrespective of priming and induced broadly reactive neutralizing antibodies against the ancestral virus and variants of concern, including the currently circulating BA.4/BA.5.Copyright © 2023
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Background: People with HIV (PWH) have a higher risk of COVID-19 morbidity and mortality. SARS-CoV-2 vaccination is highly effective in preventing severe COVID-19, although medical mistrust may contribute to vaccine hesitancy among PWH. Method(s): PWH from 8 sites in the Centers for AIDS Research Network of Integrated Clinical Systems (CNICS) completed the clinical assessment of patient-reported outcomes including a vaccine hesitancy instrument as part of routine care from 2/21-4/22. Participants were defined as vaccine hesitant if they had not yet received the SARS-CoV-2 vaccine and would probably or definitely not receive it. We assessed factors associated with SARS-CoV-2 vaccine hesitancy using logistic regression, and adjusted for demographics, unsuppressed viral load >200 copies/mL, calendar month and time on ART. Result(s): Overall, 3,278 PWH with a median age of 55 responded;19% were female sex at birth;93% were virally suppressed. At the time of survey, 27% reported they had not received the SARS-CoV-2 vaccine, of whom 27% (n=242;7% overall) reported vaccine hesitancy. Of these 242, 82% expressed concerns about vaccine efficacy;86% about side effects;38% reported distrust of healthcare, 53% reported concerns about vaccine contents (i.e. trackers, live virus);and 24% did not perceive risk from COVID-19. Factors associated with vaccine hesitancy included female sex (Adjusted Odds Ratio [AOR] 2.0;95% Confidence Interval (CI): 1.5-2.8;Table), Black vs. White race (AOR 1.8;95% CI: 1.3-2.5), age< 30 years (AOR 2.8;95% CI: 1.5-5.2), South/Midwest vs. Northeast region (AOR 1.7;95% CI: 1.2-2.4), years on ART (0.8;0.7-0.9) and unsuppressed viral load (AOR 2.2;95% CI: 1.4-3.5). Hesitancy decreased over time (AOR 0.9 per month;95% CI: 0.8-0.9). Vaccine side effects were the primary concern for women;vaccine contents for Black PWH and those who were unsuppressed;and lack of perceived COVID-19 risk for youth. Conclusion(s): Vaccine hesitancy was reported by approximately 7% of a U.S. multi-site cohort of PWH, and it was more prevalent among Black PWH, women, youth, those with unsuppressed viral loads, and residents of the South/ Midwest. The association between virologic non-suppression and vaccine hesitancy highlights the intertwined challenge of medical mistrust for both HIV and COVID-19. Although vaccine hesitancy decreased over time, renewed efforts will be needed to address concerns of PWH about the COVID-19 vaccine, given the ongoing need for revaccination with the evolution of the pandemic.
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Objective The objective of this study is to evaluate the acceptance of pregnant women with regards to coronavirus disease 2019 (COVID-19) vaccination during pregnancy and to identify any significant changes in their anxiety and knowledge on COVID-19 compared to our previous study. Methods This cross-sectional survey was performed in the antenatal clinics of United Christian Hospital and Tseung Kwan O Hospital of Hong Kong, China. Questionnaires were distributed to pregnant women for self-completion when attending follow-up from August to October 2021. Apart from basic demographic data, the questionnaire comprised of questions including knowledge on COVID-19 and its vaccines in pregnancy as well as attitudes and behaviors of pregnant women and their partners toward COVID-19. Continuous variables were analyzed by Student's test and Levene's test was used to confirm normal distribution and homogeneity of variance for continuous variables, whereas categorical variables were analyzed by the Chi-squared test or Fisher's exact test as appropriate. A P value of <0.05 was considered to be statistically significant. Results A total of 816 completed questionnaires were included for analysis. Pregnant women were less worried about COVID-19 in the current survey as compared to the last survey (393/816, 48.2% vs. 518/623, 83.1%, P?<?0.001). Fewer pregnant women believed that pregnancy were more susceptible to contract SARS-CoV-2 as compared to the last survey (265/816, 32.5% vs. 261/623, 41.9%, P?<?0.001). They have significant knowledge gap and concerns about COVID-19 vaccines. Nearly half of the participants believed that pregnant women cannot have COVID-19 vaccination (402/816, 49.3%) and it is unsafe to fetus (365/816, 44.7%). Around a third of women perceived that they were more prone to the side effects and complications of COVID-19 vaccines than the general population (312/816, 38.2%) and did not recognize that maternal COVID-19 vaccination could effect transferral of antibodies to the fetus to promote postnatal passive immunity (295/816, 36.2%). Most of them had not been vaccinated (715/816, 87.6%) and only (12/715) 1.7% of them would consider vaccination during pregnancy. Conclusion Despite the local and international recommendations for pregnant women to be vaccinated, the uptake of COVID-19 vaccines during pregnancy remained extremely low. Efforts should be made to effectively provide information about the safety and benefits of COVID-19 vaccines during pregnancy. There is an urgent need to booster vaccination rates in pregnant women to avoid excessive adverse pregnancy outcomes related to COVID-19.Copyright © the Author(s). Published by Wolters Kluwer Health, Inc.
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Background: Given the paucity of data on safety and effectiveness of mRNA COVID-19 booster vaccinations in lower income settings with high HIV prevalence, we evaluated a heterologous mRNA-1273 (Moderna) boost after priming with 1 or 2 doses of Ad26.COV2.S (Janssen, Johnson & Johnson) vaccine among health care workers (HCWs) in South Africa. Method(s): SHERPA is an open-label, phase 3 mRNA-1273 booster study, nested in the Sisonke Phase 3b implementation trial, that vaccinated ~500000 HCWs with 1 or 2 doses of Ad26.COV2.S from Feb and Dec 2021. Sisonke participants were offered mRNA-1273 boosters between 23 May and 12 Nov 2022 (median 17 and 8 months after 1 and 2 Ad26.COV2.S, respectively), with data cut-off on 12 Dec 2022. Reactogenicity and adverse events (AEs) were self-reported via an online data entry link shared by SMS with participants 1, 7 and 28 days after boosting. Using national databases analyses are underway to compare effectiveness against COVID-19 infections and severe disease with Sisonke participants who did not receive the booster. Result(s): 12188 HCWs (79.5% female, 28.6% with self-reported previous COVID-19 diagnosis) received a mRNA-1273 booster, of whom 44.6% and 55.4% had received 1 and 2 prior Ad26.COV2.S vaccines in Sisonke, respectively. 3056 (25.2%) reported being HIV positive, more among those receiving only 1 previous Ad26.COV2.S (26.8% vs 23.9%), and 1.4% reported not being on antiretroviral therapy. 17.0% of participants reported hypertension and 6.4% diabetes mellitus. 262 participants (2.1% of women, 2.5% of men) reported 234 reactogenicity events and 95 AEs post-vaccination, with more reported by those with prior COVID-19 infection (3.5% vs 1.6%), HIV negative status (2.5% vs 1.2%) and those who received 2 prior doses of Ad26.COV2.S (2.4% vs 1.8%) (Table). Among 159 (1.3%) reporting injection site reactions the commonest were pain (59.7%), swelling (42.1%) and induration (20.1%). Of 177 (1.5%) systemic reactogenicity events (all grade 1 or 2 severity), the commonest were myalgia (69.5%), headache (67.8%) and fever (37.9%). 14 participants had AEs of special interest or serious AEs, of which 4 (all AESIs of ageusia or anosmia) were deemed related to the booster. 13 COVID-19 infections occurred a median of 125 days post booster vaccination (IQR 90-154) after 3477 person-years of follow up. Conclusion(s): A mRNA-1273 booster administered after 1 or 2 doses of Ad26. COV2.S was well tolerated regardless of HIV status, other chronic conditions or prior COVID-19 infection.
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Background: Long-term effectiveness of COVID-19 mRNA boosters in populations with different prior infection histories and clinical vulnerability profiles is inadequately understood. Method(s): A national, matched, retrospective, target trial cohort study was conducted in Qatar to investigate effectiveness of a third mRNA (booster) dose, relative to a primary series of two doses, against SARS-CoV-2 omicron infection and against severe COVID-19. Associations were estimated using Cox proportional-hazards regression models. Result(s): Booster effectiveness relative to primary series was 41.1% (95% CI: 40.0-42.1%) against infection and 80.5% (95% CI: 55.7-91.4%) against severe, critical, or fatal COVID-19, over one-year follow-up after the booster. Among persons clinically vulnerable to severe COVID-19, effectiveness was 49.7% (95% CI: 47.8-51.6%) against infection and 84.2% (95% CI: 58.8-93.9%) against severe, critical, or fatal COVID-19. Effectiveness against infection was highest at 57.1% (95% CI: 55.9-58.3%) in the first month after the booster but waned thereafter and was modest at only 14.4% (95% CI: 7.3-20.9%) by the sixth month. In the seventh month and thereafter, coincident with BA.4/BA.5 and BA.2.75* subvariant incidence, effectiveness was progressively negative reaching -20.3% (95% CI: -55.0-29.0%) after one year of follow-up. Similar levels and patterns of protection were observed irrespective of prior infection status, clinical vulnerability, or type of vaccine (BNT162b2 versus mRNA-1273). Conclusion(s): Boosters reduced infection and severe COVID-19, particularly among those clinically vulnerable to severe COVID-19. However, protection against infection waned after the booster, and eventually suggested an imprinting effect of compromised protection relative to the primary series. However, imprinting effects are unlikely to negate the overall public health value of booster vaccinations.
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This short report summarizes the results of recent immunological studies performed at the new Sirius University of Science and Technology. The report focuses on studying the features of the immune response to vaccination and revaccination against SARS-CoV-2, as well as on a search of potential agents to prevent infection with this virus.
ABSTRACT
Case report: Dupilumab is a novel anti-interleukin- 4 (IL-4) receptor-alpha monoclonal antibody that targets the signaling pathways of IL-4 and IL-13, which are key type 2 cytokines. Current evidence suggests that patients on dupilumab are not at significantly increased risk of SARS-CoV- 2 related hospitalization and mortality and clinicians should avoid preventive cessation of therapy in patients with moderate-to- severe disease necessitating systemic treatment with dupilumab. However, there has been limited data about adequate and durable humoral immune response after vaccination to SARS-CoV- 2 in these patients, with some recent evidence by Runnstrom et al. suggesting that patients with severe asthma or atopic dermatitis on biologic therapies have lower antibody levels after SARS-CoV- 2 mRNA vaccination compared to healthy adults. We previously reported the case of a 71-year- old man with IgG4 related-disease (IgG4-RD) that we successfully treated with dupilumab. This patient was followed over the past three-years while his IgG4-RD remained well controlled on dupilumab which he remained on during the pandemic. Based on the vaccination guidelines and availability, he received two SARS-CoV- 2 mRNA vaccinations on March 24, 2021 and June 18, 2021. On July 24, 2021 (36 days after his last vaccination), during his routine follow up assessment, he was found to have no antibodies against SARS-CoV2. In response to this, we facilitated for him to receive his third booster vaccination on November 10, 2021. In preparation for this, his dupilumab was held for 1 month prior to this date and was continued two weeks after the injection. On December 3, 2021 (23 days after), his SARS-CoV2 Spike Total AB was repeated and found to be elevated at 2282 while his SARS-CoV2 NPROT Total AB was negative, implying immune response through vaccination and not natural exposure. To our knowledge, this is the first case report on a patient with IgG4-RD controlled on dupilumab who was found to have adequate vaccine titres after his dupilumab was held for 1 month after failing to mount a response to the first two vaccination doses while on therapy. As there is evidence that lower vaccine-specific titers afford less protection against COVID-19, acknowledging that holding dupilumab may not be feasible in all cases, this report highlights this approach as one possible strategy to protecting these individuals who may unknowingly remain at high risk for severe disease.
ABSTRACT
Background: Vaccination plays an essential role in controlling SARS-CoV- 2 pandemics. Due to initial concerns about hypersensitivity reactions (HR) to these new vaccines, our department, in articulation with Primary Healthcare Services (PHS) has developed several strategies to support COVID-19 vaccination. This work aims to describe those strategies and report the results. Method(s): The strategies developed for COVID-19 vaccination, from March to December 2021, included: 1) telephone support for health professionals (TS for HP) from the Vaccination Centres (VC), 2) priority appointments (PA) of patients classified as a higher risk for HR, 3) hospital vaccination of high-risk patients as defined by the national health authority. A retrospective and descriptive analysis of the support activity developed and from the data of patients vaccinated at the hospital in the same period were performed. Result(s): During the considered period, our department screened 1618 patients: 420 (26%) through telephone support for HP (TS for HP) from VC and 1198 (74%) at priority appointments (PA). After TS for HP, community vaccination (CV) was recommended in 87% (n = 364) of cases and a PA was advised in 13% (n = 56). Of the patients evaluated in PA, 80% were recommended CV, with restriction of the vaccine to administer in 28% of them. We always found an option to vaccine all. At the hospital were vaccinated 178 patients, 83% (n = 147) women, median age (P25-75) 61 (46-76) years. Hospital vaccination criteria were: past history of multiple drug HR (n = 93;52%), HR to vaccines (n = 46;26%), HR to the 1st dose of anti-SARS- CoV- 2 vaccine (n = 30;17%), idiopathic anaphylaxis (n = 10;6%) and systemic mastocytosis (n = 2;1%). 15% of patients (n = 26) performed skin tests with vaccines, which were negative in 25 and inconclusive in 1 case. 145 (82%) were first shots, 32 (18%) second shots, and one booster shot. Only one patient had a mild immediate reaction (2nd booster vaccination), promptly treated with antihistamine and corticosteroid. Conclusion(s): The collaboration strategies adopted by our department allowed the vaccination of 1618 patients and avoided vaccination delays in most of the VC contacts. In our sample, hospital vaccination of patients at higher risk for HR was safe.
ABSTRACT
Introduction: The risk of Severe Acute Respiratory Syndrome - Coronavirus-2 (SARS-CoV-2) infection and mortality is higher in heart transplant (HT) recipients compared to immunocompetent individuals. The impact of years since transplant on clinical course risk is unknown. We evaluated the differences in clinical phenotypes and outcomes according to years since transplant in HT recipients with active SARS-CoV-2 infection. Method(s): Consecutive HT recipients from our National Transplant Centre with confirmed SARS-CoV-2 between April 2020 and March 2022 were enrolled in this retrospective observational study. Patients were stratified into 2 groups: <5 years after HT (Group A) and >/= 5 years after HT (Group B). Result(s): A total of 63 HT recipients were enrolled [median age 56 (41,66) years, 32% female] with 33% of patients (n=21) assigned to Group A, and 67% (n=42) to Group B. In Group B patients, the prevalence of diabetes mellitus and cardiac allograft vasculopathy was significantly higher compared to those in Group A. Meanwhile, Group A patients were more likely to have a history of neutropenia prior to SARS-CoV-2 infection and were more frequently taking maintenance steroids and antimetabolite immunosuppressants (Table 1). Those recipients less than 5 years since HT were also significantly more likely than those >5 years out to develop the infection despite a 3rd dose of COVID vaccine (60% vs 31%, p 0.03).During the active infection, Group A recipients more frequently developed neutropenia (73% vs 27%, p 0.01), and trended towards higher rates of hospitalizations (57% vs 32%, p 0.06). Notably, none of the patients in Group A required mechanical ventilation compared to just under 10 % (n=4) of those in Group B. Further, no Group A patients died during the active infection hospitalization compared to 14% (n=6) of those in Group B. Conclusion(s): In HT recipients, years since transplant is a simple, clinically useful parameter stratifying outcomes after SARS-CoV-2 infection. While patients with less than 5 years since transplant are more likely to develop infection despite booster vaccination and require hospitalization, greater number of years since transplant was associated with more severe consequences during hospitalization.Copyright © 2022