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4.
Mol Ther Methods Clin Dev ; 25: 205-214, 2022 Jun 09.
Artigo em Inglês | MEDLINE | ID: mdl-35308783

RESUMO

Current RNA vaccines against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) are limited by instability of both the RNA and the lipid nanoparticle delivery system, requiring storage at -20°C or -70°C and compromising universally accessible vaccine distribution. This study demonstrates the thermostability and adaptability of a nanostructured lipid carrier (NLC) delivery system for RNA vaccines that has the potential to address these concerns. Liquid NLC alone is stable at refrigerated temperatures for ≥1 year, enabling stockpiling and rapid deployment by point-of-care mixing with any vaccine RNA. Alternatively, NLC complexed with RNA may be readily lyophilized and stored at room temperature for ≥8 months or refrigerated temperature for ≥21 months while still retaining the ability to express protein in vivo. The thermostability of this NLC/RNA vaccine delivery platform could significantly improve distribution of current and future pandemic response vaccines, particularly in low-resource settings.

5.
J. Health Biol. Sci. (Online) ; 10(1): 1-3, 01/jan./2022. ilus
Artigo em Português | LILACS | ID: biblio-1358188

RESUMO

Na atualidade, fotografar ou gravar o instante da imunização contra a Covid-19 se tornou rotina compartilhada nas redes sociais. Essa exposição instigou a observação de uma questão relevante: a técnica de aplicação está correta? Com a veiculação de imagens, é possível visualizar as vacinas sendo administradas em diferentes áreas do músculo deltoide, o que pode acarretar efeitos adversos. A otimização da qualificação técnica e pedagógica dos profissionais que elaboram e ministram as capacitações, bem como o envolvimento efetivo dos vacinadores nos treinamentos para injeção intramuscular é uma necessidade constante para evitar mais danos à saúde da população


Currently, photographing or recording the instant of immunization against Covid-19 has become a shared routine on social networks. This exposition prompted the observation of a relevant question: is the application technique correct? With the transmission of images, it is possible to visualize the vaccines being administered in different areas of the deltoid muscle, which can cause adverse effects. The optimization of the technical and pedagogical qualification of the professionals who design and deliver the training, as well as the effective involvement of vaccinators in training for intramuscular injection, is a constant need to avoid further damage to the health of the population


Assuntos
COVID-19 , Vacinas , Imunização , Otimização de Processos , Músculo Deltoide , Injeções
6.
Front Immunol ; 13: 853682, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35493446

RESUMO

The antibody and T cell responses after SARS-CoV-2 vaccination have not been formally compared between kidney and liver transplant recipients. Using a multiplex assay, we measured IgG levels against 4 epitopes of SARS-CoV-2 spike protein and nucleocapsid (NC) antigen, SARS-CoV-2 variants, and common coronaviruses in serial blood samples from 52 kidney and 50 liver transplant recipients undergoing mRNA SARS-CoV-2 vaccination. We quantified IFN-γ/IL-2 T cells reactive against SARS-CoV-2 spike protein by FluoroSpot. We used multivariable generalized linear models to adjust for the differences in immunosuppression between groups. In liver transplant recipients, IgG levels against every SARS-CoV-2 spike epitope increased significantly more than in kidney transplant recipients (MFI: 19,617 vs 6,056; P<0.001), a difference that remained significant after adjustments. Vaccine did not affect IgG levels against NC nor common coronaviruses. Elicited antibodies recognized all variants tested but at significantly lower strength than the original Wuhan strain. Anti-spike IFN-γ-producing T cells increased significantly more in liver than in kidney transplant recipients (IFN-γ-producing T cells 28 vs 11 spots/5x105 cells), but this difference lost statistical significance after adjustments. SARS-CoV-2 vaccine elicits a stronger antibody response in liver than in kidney transplant recipients, a phenomenon that is not entirely explained by the different immunosuppression.


Assuntos
COVID-19 , Transplante de Fígado , Vacinas Virais , COVID-19/prevenção & controle , Vacinas contra COVID-19 , Epitopos , Humanos , Imunoglobulina G , Rim , SARS-CoV-2 , Glicoproteína da Espícula de Coronavírus
7.
Am J Epidemiol ; 191(4): 570-583, 2022 Mar 24.
Artigo em Inglês | MEDLINE | ID: mdl-34999751

RESUMO

We estimated the trends and correlates of vaccine hesitancy and its association with subsequent vaccine uptake among 5,458 adults in the United States. Participants belonged to the Communities, Households, and SARS-CoV-2 Epidemiology COVID (CHASING COVID) Cohort, a national longitudinal study. Trends and correlates of vaccine hesitancy were examined longitudinally in 8 interview rounds from October 2020 to July 2021. We also estimated the association between willingness to vaccinate and subsequent vaccine uptake through July 2021. Vaccine delay and refusal decreased from 51% and 8% in October 2020 to 8% and 6% in July 2021, respectively. Compared with non-Hispanic (NH) White participants, NH Black and Hispanic participants had higher adjusted odds ratios (aOR) for both vaccine delay (for NH Black, aOR = 2.0 (95% confidence interval (CI): 1.5, 2.7), and for Hispanic, 1.3 (95% CI: 1.0, 1.7)) and vaccine refusal (for NH Black, aOR = 2.5 (95% CI: 1.8, 3.6), and for Hispanic, 1.4 (95% CI: 1.0, 2.0)) in June 2021. COVID-19 vaccine hesitancy, compared with vaccine-willingness, was associated with lower odds of subsequent vaccine uptake (for vaccine delayers, aOR = 0.15, 95% CI: 0.13, 0.18; for vaccine refusers, aOR = 0.02; 95% CI: 0.01, 0.03 ), adjusted for sociodemographic factors and COVID-19 history. Vaccination awareness and distribution efforts should focus on vaccine delayers.


Assuntos
COVID-19 , Vacinas , Adulto , COVID-19/epidemiologia , COVID-19/prevenção & controle , Vacinas contra COVID-19 , Humanos , Estudos Longitudinais , SARS-CoV-2 , Estados Unidos/epidemiologia , Vacinação
8.
Multimedia | Recursos Multimídia | ID: multimedia-9741

RESUMO

A cidade de São Paulo já vacinou 100% dos adultos contra a covid-19 e, agora, é a hora da dose adicional para quem se vacinou há, pelo menos, quatro meses. E se você tem entre 12 e 17 anos, não deixe de tomar a segunda dose! Baixe o aplicativo e-saúdeSP: veja o calendário e acompanhe a fila de vacinação nos postos. Com ele, você também garante o seu Passaporte da Vacina.


Assuntos
COVID-19 , Vacinas
9.
Preprint em Inglês | medRxiv | ID: ppmedrxiv-22276312

RESUMO

BACKGROUNDEquity in vaccination coverage is a cornerstone to a successful public health response to COVID-19. To deepen understand of the extent to which vaccination coverage compared to initial strategies for equitable vaccination, we explore primary vaccine series and booster rollout over time and by race/ethnicity, social vulnerability, and geography. METHODS AND FINDINGSWe analyzed data from the Missouri State Department of Health and Senior Services on all COVID-19 vaccinations administered across 7 counties in the St. Louis region and 4 counties in the Kansas City Region. We compared rates of receiving the primary COVID-19 vaccine series and boosters relative to time, race/ethnicity, zip code-level social vulnerability index (SVI), vaccine location type, and COVID-19 disease burden. We adapted a well-established tool for measuring inequity--the Lorenz curve--to quantify inequities in COVID-19 vaccination relative to these key metrics. Between 12/15/2020 and 2/15/2022, 1,762,508 individuals completed the primary series and 871,896 had received a booster. During early phases of the primary series rollout, Black and Hispanic individuals from high SVI zip codes were vaccinated at less than half the rate of White individuals, but rates increased over time until they were higher than rates in White individuals after June 2021; Asian individuals maintained high levels of vaccination throughout. Increasing vaccination rates in Black and Hispanic communities corresponded with periods when more vaccinations were offered at small community-based sites such as pharmacies rather than larger health systems and mass vaccination sites. Using Lorenz curves, zip codes in the quartile with the lowest rates of primary series completion accounted for 19.3%, 18.1%, 10.8%, and 8.8% of vaccinations but represented 25% of either the total population, cases, deaths, or population-level SVI, respectively. When tracking Gini coefficients, these disparities were greatest earlier during rollout, but improvements were slow and modest and vaccine disparities remained across all metrics even after one year. Patterns of disparities for boosters were similar but often of much greater magnitude during rollout in Fall 2021. Study limitations include inherent limitations in vaccine registry dataset such as missing and misclassified race/ethnicity and zip code variables and potential changes in zip code population sizes since census enumeration. CONCLUSIONSRacial inequity in the initial COVID-19 vaccination and booster rollout in two large U.S. metropolitan areas were apparent across racial/ethnic communities, across levels of social vulnerability, over time, and across types of vaccination administration sites. Disparities in receipt of the primary vaccine series attenuated over time during a period in which sites of vaccination administration diversified, but were recapitulated during booster rollout. These findings highlight how public health strategies from the outset must directly target these deeply embedded structural and systemic determinants of disparities and track equity metrics over time to avoid perpetuating inequities in health care access. AUTHOR SUMMARYO_ST_ABSWhy Was This Study Done?C_ST_ABSO_LIEquitable vaccine strategies are critical for the public health response to COVID-19, but there is limited understanding of how vaccination campaigns compared to different metrics for equity. C_LIO_LIMany initial approaches to vaccine allocation sought to acknowledge the known disparities in exposure risk, disease burden, needs, and access by formally considering social vulnerability or race/ethnicity in plans to prioritize vaccinations, but there is limited empirical evaluation of how actual primary vaccine series and subsequent booster efforts aligned with the initial goals set out for equity. C_LIO_LIWe quantify COVID-19 vaccine-related inequities in receipt of the primary vaccine series and booster across key equity metrics including race/ethnicity, social vulnerability, location, and time using a novel application of Lorenz curves and Gini coefficients--tools from economics to measure inequalities--in the St. Louis and Kansas City regions of Missouri. C_LI What Did the Researchers Do and Find?O_LIWe analyzed data from the Missouri State Department of Health and Senior Services on all COVID-19 vaccinations administered in the St. Louis region and Kansas City Regions. We compared rates of receiving the primary COVID-19 vaccine series and boosters relative to time, race/ethnicity, zip code-level social vulnerability index (SVI), vaccine location type, and COVID-19 disease burden. We adapted Lorenz curves and Gini coefficients to quantify the inequities in COVID-19 vaccination relative to these key metrics and examined how they changed over time. C_LIO_LIBlack and Hispanic individuals from high SVI zip codes completed the primary series at less than half the rate of White individuals during early phases of the primary series rollout, but surpassed rates in White individuals after June 2021. These relative increases in primary series completion rates in Black and Hispanic communities corresponded to periods when vaccinations became more available at small community-based sites. C_LIO_LILorenz curves demonstrated that zip codes in the quartile with the lowest rates of primary series completion accounted for 19.3%, 18.1%, 10.8%, and 8.8% of vaccinations but represented 25% of either the total population, cases, deaths, or population-level SVI, respectively. Tracking Gini coefficients over time demonstrated that these disparities were greatest earlier during rollout, but only improved slowly and modestly over time. C_LIO_LIPatterns of disparities for boosters were similar but often of much greater magnitude that those seen with completion of the primary vaccine series. patterns of disparities were similar but often of greater magnitude during booster rollout in Fall 2021. C_LI What Do These Findings Mean?O_LIVaccination coverage for both the primary series and boosters demonstrated substantial disparities across race/ethnicity, levels of social vulnerability, types of vaccine administration sites, and over time. C_LIO_LIDespite well-documented inequities for COVID-19 and need for equitable vaccine approaches, the strategies employed did not overcome deeply entrenched systemic inequities in health care and society. C_LIO_LIPublic health strategies must proactively target these deeply embedded structural determinants of disparities from the outset and should systematically track equity metrics over time to avoid perpetuating inequities in health care access. C_LI

10.
Preprint em Inglês | medRxiv | ID: ppmedrxiv-22276282

RESUMO

Independent senior housing is a high risk setting for COVID-19 and should be prioritized for outbreak investigation and response. During a COVID-19 outbreak in Massachusetts from December 2021 to January 2022, 47% of residents in a 31-unit independent senior housing apartment building in Massachusetts were infected. Residents that had received a booster dose of an mRNA COVID-19 vaccine had a lower attack rate than those who had received two doses. Comprehensive response campaigns that include education, testing, treatment referrals, and vaccination can be effective at reducing morbidity and mortality and preventing future outbreaks.

11.
Preprint em Inglês | medRxiv | ID: ppmedrxiv-22276314

RESUMO

ObjectiveTo evaluate glaucoma cases reported post-COVID-19 vaccination and describe the clinical presentations in these cases. DesignAn analysis of the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS) database ParticipantsThe study includes 161 individuals who were reported for glaucoma after administration of COVID-19 vaccines [BNT162b2 (Pfizer-BioNTech), mRNA-1273 (Moderna) and Ad26.COV2.S (Janssen)] between December 2020 and April 2022. Main Outcome MeasuresEstimated crude reporting rate of glaucoma, clinical presentations, onset duration and associated risk factors. ResultsA total of 2,061,557,270 doses of COVID-19 vaccines were administered during the study timeframe. During this period, 161 glaucoma cases were reported with an estimated crude reporting rate (per million doses) of 0.09, 0.06 and 0.07 for BNT162b2, mRNA-1273 and Ad26.COV2.S, respectively. The majority of patients (n=130, 80.7%) received BNT162b2, vaccine, while 27 patients (16.8%) received mRNA-1273 and four patients (2.5%) received rAd26.COV2.S vaccines. The mean age of patients in the cohort was 60.41{+/-}17.56 years and 67.7% (n=109) were women. More than half (56.6%) were reported within the first week after vaccination. The glaucoma onset interval was significantly shorter in patients who received BNT162b2 and rAd26.COV2.S vaccines compared to mRNA-1273 (p=0.013). A higher risk of glaucoma incidence was observed in the short term in patients who received BNT162b2 vaccines compared to mRNA-1273 (p=0.05). In patients vaccinated with mRNA-1273, a significantly higher frequency of glaucoma cases was reported in older patients (p=0.047) compared to younger age groups. ConclusionsThe CDC-VAERS data suggest an extremely low safety concern for glaucoma on receiving BNT162b2, mRNA-1273, or Ad26.COV2.S vaccines. The onset interval of adverse events was shorter in patients who received BNT162b2 and rAd26.COV2.S vaccines compared to mRNA-1273. The glaucoma cases after mRNA-1273 vaccination were more commonly reported in older patients. These findings are subject to the limitations of passive reporting systems, under reporting and presumptive case definition, and should be considered preliminary without the medical record analysis for establishing a definitive diagnosis.

12.
Preprint em Inglês | medRxiv | ID: ppmedrxiv-22276248

RESUMO

BackgroundNew variants of SARS-CoV-2 are constantly discovered. Administration of COVID-19 vaccines and booster doses, combined with applications of non-pharmaceutical interventions (NPIs), is often used to prevent outbreaks of emerging variants. Such outbreak dynamics are further complicated by the populations behavior and demographic composition. Hence, realistic simulations are needed to estimate the efficiency of proposed vaccination strategies in conjunction with NPIs. MethodsWe developed an individual-based model of COVID-19 dynamics that considers age-dependent parameters such as contact matrices, probabilities of symptomatic and severe disease, and households age distribution. As a case study, we simulate outbreak dynamics under the demographic compositions of two Israeli cities with different household sizes and age distributions. We compare two vaccination strategies: vaccinate individuals in a currently prioritized age group, or dynamically prioritize neighborhoods with a high estimated reproductive number. Total infections and hospitalizations are used to compare the efficiency of the vaccination strategies under the two demographic structures, in conjunction with different NPIs. ResultsWe demonstrate the effectiveness of vaccination strategies targeting highly infected localities and of NPIs actively detecting asymptomatic infections. We further show that there are different optimal vaccination strategies for each demographic composition of sub-populations, and that their application is superior to a uniformly applied strategy. ConclusionOur study emphasizes the importance of tailoring vaccination strategies to subpopulations infection rates and to the unique characteristics of their demographics (e.g., household size and age distributions). The presented simulation framework and our findings can help better design future responses against the following emerging variants.

13.
Preprint em Inglês | medRxiv | ID: ppmedrxiv-22276266

RESUMO

Recent studies have provided insights into the effect of vaccine boosters on recall immunity. Given the limited global supply of COVID-19 vaccines, identifying vulnerable populations with lower sustained vaccine-elicited antibody titers is important for targeting individuals for booster vaccinations. Here we investigated longitudinal data in a cohort of 2,526 people in Fukushima, Japan, from April 2021 to December 2021. Antibody titers following two doses of a COVID-19 vaccine were repeatedly monitored and information on lifestyle habits, comorbidities, adverse reactions, and medication use was collected. Using mathematical modeling and machine learning, we stratified the time-course patterns of antibody titers and identified vulnerable populations with low sustained antibody titers. Moreover, we showed that only 5.7% of the participants in our cohort were part of the "durable" population with high sustained antibody titers, which suggests that this durable population might be overlooked in small cohorts. We also found large variation in antibody waning within our cohort. There is a potential usefulness of our approach for identifying the neglected vulnerable population.

14.
Preprint em Inglês | medRxiv | ID: ppmedrxiv-22276192

RESUMO

BackgroundPreliminary data across the globe shows that the AstraZeneca vaccine was highly effective in preventing not only the symptoms but also the transmission of the SARS-CoV-2 virus. In Ghana, data on the immune response generated by different vaccination doses is lacking. The present study aimed to compare the anti-SARS-CoV-2 antibody response among single and double-vaccinated versus unvaccinated individuals. MethodsA case-control design was employed for this study. Seventy-nine participants (35 vaccinated, 44 unvaccinated) were recruited from the Sunyani West Municipality and screened for the presence of SARS-CoV-2 specific IgG and IgM antibodies in plasma samples using a Standard COVID IgG and IgM Combo FIA test. Data analysis was carried out with STATA (Version 21). ResultsThe current study showed that mean IgG levels among vaccine groups (Group-1: Not vaccinated, Group-2: 1 dose, Group-3: 2 doses) differed significantly (F2, 76=11.457, p<.001) between Group-1 and Group-3; and between Group-2 and Group-3. Participants in Group-2 and Group-3 were 4.1 and 12.5 times more likely to develop more antibody responses compared to their counterparts in Group-1 respectively. ConclusionThe study showed that participants who took one shot of the vaccine, as well as those who took two shots of the AstraZeneca Vaccine, were 4.1 and 12.5 times more likely to develop a greater antibody response than those who did not receive the vaccine respectively.

15.
Preprint em Inglês | medRxiv | ID: ppmedrxiv-22276253

RESUMO

ImportancePeople living with multiple sclerosis (MS) and other disorders treated with immunomodulatory therapies remain concerned about suboptimal responses to coronavirus disease 2019 (COVID-19) vaccines. Important questions persist regarding immunological response to third vaccines, particularly with respect to newer virus variants. ObjectiveEvaluate humoral and cellular immune responses to third COVID-19 vaccine dose in people on anti-CD20 therapy and sphingosine 1-phosphate receptor (S1PR) modulators, including Omicron-specific assays. DesignObservational study evaluating immunological response to third COVID-19 vaccine dose in volunteers treated with anti-CD20 agents, S1PR modulators, and healthy controls. Neutralizing antibodies against USA-WA1/2020 (WA1) and B.1.1.529 (BA.1) severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were measured before and after third vaccine. Cellular responses to spike peptide pools generated from WA1 and BA.1 were evaluated. SettingMount Sinai Hospital ParticipantsPeople treated with anti-CD20 therapy or S1PR modulators and healthy volunteers ExposureTreatment with anti-CD20 therapy, S1PR modulator, or neither Main outcomes and measuresSerum neutralizing antibodies and ex vivo T cell responses against SARS-CoV-2 antigens. ResultsThis cohort includes 25 participants on anti-CD20 therapy, 12 on S1PR modulators, and 14 healthy controls. Among those on anti-CD20 therapy, neutralizing antibodies to WA1 were significantly reduced compared to healthy controls (ID50% GM post-vaccination of 8.1 {+/-} 2.8 in anti-CD20 therapy group vs 452.6 {+/-} 8.442 healthy controls, P<0.0001) and neutralizing antibodies to BA.1 were below the threshold of detection nearly universally. However, cellular responses, including to Omicron-specific peptides, were not significantly different from controls. Among those on S1PR modulators, neutralizing antibodies to WA1 were detected in a minority, and only 3/12 had neutralizing antibodies just at the limit of detection to BA.1. Cellular responses to Spike antigen in those on S1PR modulators were reduced by a factor of 100 compared to controls (median 0.0008% vs. 0.08%, p<0.001) and were not significantly "boosted" by a third injection. Conclusions and RelevanceParticipants on immunomodulators had impaired antibody neutralization capacity, particularly to BA.1, even after a third vaccine. T cell responses were not affected by anti-CD20 therapies, but were nearly abrogated by S1PR modulators. These results have clinical implications warranting further study.

16.
Preprint em Inglês | medRxiv | ID: ppmedrxiv-22276030

RESUMO

BackgroundA third dose of COVID-19 vaccination ( COVID booster vaccination) has become established as an important measure to strengthen the immune response against SARS-CoV-2. In contrast, seasonal influenza vaccination has been an important infection prevention measure for years, especially among highly exposed healthcare workers (HCWs). Coadministration of vaccines against COVID-19 and seasonal influenza could be an efficient strategy to protect HCWs from two major viral respiratory infections. Yet, the immunogenicity and safety of coadministration remains to be evaluated. MethodsThis study examines the differences in Anti-SARS-CoV-2-Spike IgG antibody formation as well as side effects based on a digital questionnaire after a third COVID-19 vaccination with or without coadministration of a seasonal quadrivalent influenza vaccine (Influvac Tetra vaccine 2021/2022). 1,231 HCWs were recruited who received a mRNA-based booster COVID-19 vaccination (mRNA-1273 or BNT162b2mRNA) after basic immunisation with BNT162b2mRNA twice. Anti-SARS-CoV-2-Spike IgG levels were determined at least 14 days after vaccination by SERION ELISA agile SARS-CoV-2 IgG. FindingsAnti-SARS-CoV-2-Spike IgG concentrations were by 25{middle dot}4% lower in individuals with coadministration of the seasonal quadrivalent influenza vaccination than without (p<0{middle dot}01). There was no statistically significant difference in the reported side effects. The concentration of Anti-SARS-CoV-2-Spike IgG was higher in HCWs who had received the influenza vaccine concomitantly with mRNA-1273 than with BNT162b2mRNA as third COVID-19 vaccine (p<0{middle dot}0001). InterpretationCoadministration of the seasonal quadrivalent influenza vaccine significantly limits the levels in Anti-SARS-CoV-2-Spike IgG levels, with a more restricted elevation in case of a BNT162b2mRNA booster vaccination compared with mRNA-1273 vaccine. The reduced humoral immune response in case of coadministration needs to be considered in seasonal vaccination recommendations, although the consequences of lower Anti-SARS-CoV-2-Spike IgG levels for the protection against SARS-CoV-2 infection and severe COVID-19 disease course are currently unknown. An augmented mRNA-based COVID-19 vaccine dosage may compensate for the restricted immunogenicity in case of coadministration. FundingThis study was funded by the Federal Ministry for Education and Science (BMBF) through a grant provided to the University Hospital of Wuerzburg by the Network University Medicine on COVID-19 (B-FAST, grant-No 01KX2021) as well as by the Free State of Bavaria with COVID-research funds provided to the University of Wuerzburg, Germany. Nils Petri is supported by the German Research Foundation (DFG) funded scholarship UNION CVD. Research in contextO_ST_ABSEvidence before this studyC_ST_ABSFor evaluation of the previously published evidence, PubMed and medRxiv were searched for the terms "influenza vaccination", "influenza vaccine", "influenza", "flu", "seasonality", combined with "coadministration", "concomitant", "COVID-19 vaccination", "COVID-19 vaccine", "SARS-CoV-2", in title or abstract, published between 1st of January 2020 and 18th of May 2022. To date, it is unclear if coadministration of COVID-19 and influenza vaccine is effective and safe, particularly in the cohort of healthcare workers (HCWs) as key public health stakeholders. For the subunit COVID-19 vaccine NVX-CoV2373, an impairment of Anti-SARS-CoV-2-Spike IgG levels has been shown in individuals coadministered with a seasonal influenza vaccine. The two previously published studies on coadministration of a mRNA-based COVID-19 and a seasonal quadrivalent influenza vaccine have reported a restriction of humoral Anti-SARS-CoV-2-Spike immune response in the coadministration group. These examinations were conducted with limited correspondence to real-life conditions and in smaller cohorts. Additionally, these former studies do not consider the important aspect of side effects as a possible direct effect of the prevention measure on the availability of public health care in combination with Anti-SARS-CoV-2-Spike IgG levels. In summary, the humoral immunogenicity and side effects of a coadministered third COVID-19 and a seasonal influenza vaccine are still unclear and the limited available data is not transferable to the general public. Added value of this studyWe performed the first large-scale real-life evaluation of humoral immunogenicity and side effects of COVID-19 and influenza vaccine coadministration in HCWs. Anti-SARS-CoV-2-Spike IgG levels were significantly lower in the coadministered cohort compared to the not coadministered control group, stratified by third COVID-19 vaccine (BNT162b2mRNA or mRNA-1273). Anti-SARS-CoV-2-Spike IgG post-vaccine elevation was lower among BNT162b2mRNA vaccinated HCWs than in those vaccinated with mRNA-1273 as a third COVID-19 vaccination. The influence of the seasonal quadrivalent influenza vaccine is evaluated in a cohort including 1,231 HCWs in total, covering a broad age range. Coadministration did not lead to an increase in side effects, which is a central requirement for considering the option of coadministration, given the role of HCWs as key personnel in maintaining health care capacities. Implications of all the available evidenceOur data suggest, that coadministration of third mRNA-based COVID-19 and quadrivalent seasonal influenza vaccine is safe and immunogenic, although it leads to a slightly reduced Anti-SARS-CoV-2-Spike antibody formation. While the clinical impact of the observed reduction in humoral Anti-SARS-CoV-2-Spike immune response for protection against SARS-CoV-2 infection and severe COVID-19 disease is still unclear, influenza vaccination remains an important infection prevention measure, especially among highly exposed HCWs. The coadministration does not increase side effects but may improve vaccination rate. A higher-dosed mRNA-based COVID-19 vaccine may compensate for the restricted immunogenicity in case of seasonal influenza vaccine coadministration. Our results will support the development of public health recommendations for coadministration of COVID-19 and influence vaccines in anticipation of the imminent infection waves in the coming winter season.

17.
Preprint em Inglês | medRxiv | ID: ppmedrxiv-22276196

RESUMO

Obesity is associated with an increased risk of severe Covid-19. However, the effectiveness of SARS-CoV-2 vaccines in people with obesity is unknown. Here we studied the relationship between body mass index (BMI), hospitalization and mortality due to Covid-19 amongst 3.5 million people in Scotland. Vaccinated people with severe obesity (BMI>40 kg/m2) were significantly more likely to experience hospitalization or death from Covid-19. Excess risk increased with time since vaccination. To investigate the underlying mechanisms, we conducted a prospective longitudinal study of the immune response in a clinical cohort of vaccinated people with severe obesity. Compared with normal weight people, six months after their second vaccine dose, significantly more people with severe obesity had unquantifiable titres of neutralizing antibody against authentic SARS-CoV-2 virus, reduced frequencies of antigen-experienced SARS-CoV-2 Spike-binding B cells, and a dissociation between anti-Spike antibody levels and neutralizing capacity. Neutralizing capacity was restored by a third dose of vaccine, but again declined more rapidly in people with severe obesity. We demonstrate that waning of SARS-CoV-2 vaccine-induced humoral immunity is accelerated in people with severe obesity and associated with increased hospitalization and mortality from breakthrough infections. Given the prevalence of obesity, our findings have significant implications for global public health.

18.
Preprint em Inglês | medRxiv | ID: ppmedrxiv-22276129

RESUMO

ObjectivesCOVID disease started in the late 2019 and within a short time became a pandemic disease. With the increasing morbidity and mortality all over the world and the therapeutics not doing wonders, scientists were in the attempt to develop vaccines as a mitigating measure. With continuous efforts and developments, different vaccines were developed and rolled out gradually in different countries. Concerns were notable for occurrence of side effects. Hence this study was done to assess the side effects following Covishield vaccination in Nepal at the initial stage. MethodsThis was a cross-sectional study done via snowball sampling method among healthcare workers at a tertiary medical college hospital in Pokhara, Nepal after obtaining ethical consent from the institutional review committee of the concerned hospital. The proforma was sent via online means through different social media platforms and also printed forms were also given to the respondents. A total of 139 respondents were obtained after removing duplications. The data were entered into SPSS and analyzed using descriptive and inferential statistics. P-value [≤] 0.05 was considered statistically significant. ResultsMajority (64.7%) were female healthcare workers. More than half (52.3%) used pre-medication in an attempt to avoid the side effects of vaccine. Most (90.6%) reported at least one side effect-local or systemic to the first dose and approximately three-quarter (74.3%) reported side effect to the second dose. Common side effects were pain at injection site, muscle pain, headache, fatigue and weakness. Most of the side effects were higher with the first dose as compared to the second dose. ConclusionSide effects are common with Covishield vaccination, significantly more with the first dose as compared to the second dose. Female gender, younger age and past covid infection were associated with slightly more occurrence of side effects; however were not found to be statistically significant.

19.
Preprint em Inglês | medRxiv | ID: ppmedrxiv-22276228

RESUMO

Objectives: To compare the effectiveness of a primary COVID-19 vaccine series plus a booster dose with a primary series alone for the prevention of Omicron variant COVID-19 hospitalization. Design: Multicenter observational case-control study using the test-negative design to evaluate vaccine effectiveness (VE). Setting: Twenty-one hospitals in the United States (US). Participants: 3,181 adults hospitalized with an acute respiratory illness between December 26, 2021 and April 30, 2022, a period of SARS-CoV-2 Omicron variant (BA.1, BA.2) predominance. Participants included 1,572 (49%) case-patients with laboratory confirmed COVID-19 and 1,609 (51%) control patients who tested negative for SARS-CoV-2. Median age was 64 years, 48% were female, and 21% were immunocompromised; 798 (25%) were vaccinated with a primary series plus booster, 1,326 (42%) were vaccinated with a primary series alone, and 1,057 (33%) were unvaccinated. Main Outcome Measures: VE against COVID-19 hospitalization was calculated for a primary series plus a booster and a primary series alone by comparing the odds of being vaccinated with each of these regimens versus being unvaccinated among cases versus controls. VE analyses were stratified by immune status (immunocompetent; immunocompromised) because the recommended vaccine schedules are different for these groups. The primary analysis evaluated all COVID-19 vaccine types combined and secondary analyses evaluated specific vaccine products. Results: Among immunocompetent patients, VE against Omicron COVID-19 hospitalization for a primary series plus one booster of any vaccine product dose was 77% (95% CI: 71-82%), and for a primary series alone was 44% (95% CI: 31-54%) (p<0.001). VE was higher for a boosted regimen than a primary series alone for both mRNA vaccines used in the US (BNT162b2: primary series plus booster VE 80% (95% CI: 73-85%), primary series alone VE 46% (95% CI: 30-58%) [p<0.001]; mRNA-1273: primary series plus booster VE 77% (95% CI: 67-83%), primary series alone VE 47% (95% CI: 30-60%) [p<0.001]). Among immunocompromised patients, VE for a primary series of any vaccine product against Omicron COVID-19 hospitalization was 60% (95% CI: 41-73%). Insufficient sample size has accumulated to calculate effectiveness of boosted regimens for immunocompromised patients. Conclusions: Among immunocompetent people, a booster dose of COVID-19 vaccine provided additional benefit beyond a primary vaccine series alone for preventing COVID-19 hospitalization due to the Omicron variant.

20.
Preprint em Inglês | medRxiv | ID: ppmedrxiv-22275942

RESUMO

BackgroundVaccine protection from COVID-19 has been shown to decline with time-since-vaccination and against SARS-CoV-2 variants. Protection against severe COVID-19 is higher than against symptomatic infection, and also appears relatively preserved over time and against variants. Although protection from symptomatic SARS-CoV-2 infection is strongly correlated with neutralising antibody titres, this relationship has been less well described for severe COVID-19. Here we analyse whether neutralising antibody titre remains predictive of protection against severe COVID-19 in the face of waning neutralising antibody levels and emerging variants. MethodsWe extracted data from 15 studies reporting on protection against a range of SARS-CoV-2 clinical endpoints ( any infection, symptomatic infection and severe COVID-19). We then estimated the concurrent neutralising antibody titres using existing parameters on vaccine potency, neutralising antibody decay, and loss of recognition of variants and investigated the relationship between neutralising antibody titre and vaccine effectiveness against severe COVID-19. FindingsPredicted neutralising antibody titres are strongly correlated with vaccine effectiveness against symptomatic and severe COVID-19 (Spearman{rho} = 0.94 and 0.63 respectively, p<.001 for both). The relationship between neutralisation titre and protection is consistent with previous estimates, with 76% (127 of 167) of reported values of protection against severe COVID-19 across a range of vaccines and variants lie within the 95% confidence intervals of the previously published model. InterpretationNeutralising antibody titres are predictive of vaccine effectiveness against severe COVID-19 including in the presence of waning immunity and viral variants. FundingNational Health and Medical Research Council (Australia), Medical Research Future Fund (Australia). O_TEXTBOXEvidence before this study COVID-19 vaccine effectiveness against symptomatic SARS-CoV-2 infection has been shown to be strongly predicted by neutralising antibody titres. However, there has not been sufficient data on vaccine efficacy against severe disease to determine whether the correlation between neutralising antibody titres and protection is maintained for severe COVID-19. Indeed, the apparent faster waning of vaccine efficacy against symptomatic (compared to severe) COVID-19 has led some to hypothesise about a decoupling of protection from symptomatic and severe disease. It is therefore important to identify whether neutralising antibody titre remains a correlate of protection against severe COVID-19 in real-world scenarios of waning immunity and SARS-CoV-2 variants. We searched PubMed between inception and March 2, 2022 for studies (Key search terms: (SARS-CoV-2 OR COVID-19) AND (followup OR waning OR duration OR durable) AND (protection OR efficacy OR effectiveness)) and also monitored other public sources of information such as Twitter. We identified 15 studies that reported data on vaccine effectiveness against (i) a defined clinical endpoint (ii) for an identifiable variant, (ii) for a single vaccine (or vaccine type), (iii) over an identified time since vaccination, and (iv) for which data was either provided in or readily extractable from the original publication. Added value of this study Previous work has identified that neutralising antibodies correlate strongly with protection from symptomatic COVID-19 disease for both ancestral virus and for variants of concern. Here we examine published data on vaccine effectiveness to determine if this correlation remains valid for predicting protection against severe COVID-19. Our work shows that vaccine effectiveness against severe COVID-19 is strongly correlated with neutralising antibody titres for different vaccines, variants, and over the first six months after vaccination. The relationship between vaccine effectiveness and protection against severe COVID-19 is consistent with a previously published analysis and indicates that the 50% protective titre for protection against severe COVID-19 is lower than that associated with protection from symptomatic infection. Implications of all of the available evidence In the face of increased exposure and immunity to numerous SARS-CoV-2 variants it is becoming increasingly important to be able to predict not only protection against symptomatic infection, but also protection against severe COVID-19. Here we show that neutralising antibody titres remain predictive of vaccine effectiveness against severe COVID-19 in the face of waning immunity and SARS-CoV-2 variants. This is consistent with a low level of neutralising antibodies being associated with protection from severe COVID-19. This work will be of use in providing early estimates of protection against severe COVID-19 for new SARS-CoV-2 antigenic variants, informing optimal booster timing, and will support future vaccine development by allowing prediction of vaccine protection conferred against severe outcomes. C_TEXTBOX

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