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1.
Sci Rep ; 14(1): 8337, 2024 04 09.
Artigo em Inglês | MEDLINE | ID: mdl-38594459

RESUMO

Accessible SARS-CoV-2-specific immunoassays may inform clinical management in people with HIV, particularly in case of persisting immunodysfunction. We prospectively studied their application in vaccine recipients with HIV, purposely including participants with a history of advanced HIV infection. Participants received one (n = 250), two (n = 249) or three (n = 42) doses of the BNT162b2 vaccine. Adverse events were documented through questionnaires. Sample collection occurred pre-vaccination and a median of 4 weeks post-second dose and 14 weeks post-third dose. Anti-spike and anti-nucleocapsid antibodies were measured with the Roche Elecsys chemiluminescence immunoassays. Neutralising activity was evaluated using the GenScript cPass surrogate virus neutralisation test, following validation against a Plaque Reduction Neutralization Test. T-cell reactivity was assessed with the Roche SARS-CoV-2 IFNγ release assay. Primary vaccination (2 doses) was well tolerated and elicited measurable anti-spike antibodies in 202/206 (98.0%) participants. Anti-spike titres varied widely, influenced by previous SARS-CoV-2 exposure, ethnicity, intravenous drug use, CD4 counts and HIV viremia as independent predictors. A third vaccine dose significantly boosted anti-spike and neutralising responses, reducing variability. Anti-spike titres > 15 U/mL correlated with neutralising activity in 136/144 paired samples (94.4%). Three participants with detectable anti-S antibodies did not develop cPass neutralising responses post-third dose, yet displayed SARS-CoV-2 specific IFNγ responses. SARS-CoV-2 vaccination is well-tolerated and immunogenic in adults with HIV, with responses improving post-third dose. Anti-spike antibodies serve as a reliable indicator of neutralising activity. Discordances between anti-spike and neutralising responses were accompanied by detectable IFN-γ responses, underlining the complexity of the immune response in this population.


Assuntos
COVID-19 , Infecções por HIV , Aranhas , Adulto , Animais , Humanos , SARS-CoV-2 , Vacina BNT162 , Vacinas contra COVID-19/efeitos adversos , COVID-19/prevenção & controle , Imunoensaio , Anticorpos , Vacinação , Anticorpos Antivirais , Anticorpos Neutralizantes
2.
Sci Rep ; 14(1): 8009, 2024 04 05.
Artigo em Inglês | MEDLINE | ID: mdl-38580716

RESUMO

Understanding the factors that influence people's decisions regarding vaccination is essential to promote vaccination. We aimed to clarify the motivations for receiving booster vaccines. We conducted a paper-based questionnaire distributed during January-February 2022 involving students and faculty staff who received the first COVID-19 vaccination at the mass vaccination program during June-September 2021 at Keio University. A total of 1725 participants were enrolled, and all completed the survey. Among these, 64.9% reported a significant adverse event (AEs) affecting daily life after the second vaccine. "Fear of severe COVID-19 illness" (72.6%) was the most common reason for getting vaccinated, followed by "concern of infecting others" (68.4%) and "fear of COVID-19 infection itself" (68.3%). Television emerged as the most influential source of information (80%), followed by university information (50.2%) and social networking sites (42.8%). Multivariate analysis revealed "fear of severe COVID-19 illness", "fear of COVID-19 infection itself", and "trust in the efficacy and safety of the vaccines in general" were significantly correlated with willingness to receive paid vaccinations. The severity of AEs and source of information were not related to participants' willingness to receive booster vaccinations. Participants with positive reasons for vaccination were more likely to accept a third dose.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Humanos , Vacinas contra COVID-19/efeitos adversos , COVID-19/prevenção & controle , Motivação , Estudos Transversais , Japão/epidemiologia , Universidades , Vacinação em Massa , Estudantes , Vacinação
3.
Int J Mol Sci ; 25(7)2024 Mar 22.
Artigo em Inglês | MEDLINE | ID: mdl-38612407

RESUMO

A small fraction of people vaccinated with mRNA-lipid nanoparticle (mRNA-LNP)-based COVID-19 vaccines display acute or subacute inflammatory symptoms whose mechanism has not been clarified to date. To better understand the molecular mechanism of these adverse events (AEs), here, we analyzed in vitro the vaccine-induced induction and interrelations of the following two major inflammatory processes: complement (C) activation and release of proinflammatory cytokines. Incubation of Pfizer-BioNTech's Comirnaty and Moderna's Spikevax with 75% human serum led to significant increases in C5a, sC5b-9, and Bb but not C4d, indicating C activation mainly via the alternative pathway. Control PEGylated liposomes (Doxebo) also induced C activation, but, on a weight basis, it was ~5 times less effective than that of Comirnaty. Viral or synthetic naked mRNAs had no C-activating effects. In peripheral blood mononuclear cell (PBMC) cultures supplemented with 20% autologous serum, besides C activation, Comirnaty induced the secretion of proinflammatory cytokines in the following order: IL-1α < IFN-γ < IL-1ß < TNF-α < IL-6 < IL-8. Heat-inactivation of C in serum prevented a rise in IL-1α, IL-1ß, and TNF-α, suggesting C-dependence of these cytokines' induction, although the C5 blocker Soliris and C1 inhibitor Berinert, which effectively inhibited C activation in both systems, did not suppress the release of any cytokines. These findings suggest that the inflammatory AEs of mRNA-LNP vaccines are due, at least in part, to stimulation of both arms of the innate immune system, whereupon C activation may be causally involved in the induction of some, but not all, inflammatory cytokines. Thus, the pharmacological attenuation of inflammatory AEs may not be achieved via monotherapy with the tested C inhibitors; efficacy may require combination therapy with different C inhibitors and/or other anti-inflammatory agents.


Assuntos
COVID-19 , Inativadores do Complemento , Nanopartículas , Humanos , Lipossomos , Vacinas contra COVID-19/efeitos adversos , Leucócitos Mononucleares , Citocinas , Fator de Necrose Tumoral alfa , Vacina BNT162 , Ativação do Complemento , Lipídeos
4.
J Nepal Health Res Counc ; 21(4): 651-658, 2024 Mar 31.
Artigo em Inglês | MEDLINE | ID: mdl-38616598

RESUMO

BACKGROUND: Vaccination against COVID-19 for Nepalese was initiated in January 2021 for various age groups. People were anxious about receiving the vaccines and were concerned about the safety profile of the vaccine they received. In this study, we have tried to observe the Adverse Events Following Immunization of two different vaccines namely COVISHIELD (ChAdOx1 nCOV-19) and VERO CELL (CZ02 strain), used in different phases of vaccination by the government of Nepal. METHODS: We conducted a cross-sectional study among people who received COVID-19 vaccines in this study using a self-administered questionnaire.  Data was cleaned and then exported to IBM SPSS v.20 for analysis, Chi-square test was used to see the association between different variables and a p-value<0.05 was considered statistically significant. RESULTS: Out of 303 respondents, all had received the first and 270 participants had received the second dose of the COVID-19 vaccine, among which, 133 (43.89%) reported at least one side effect after the first dose of vaccination while 58 (21.48%) had self-reported side effects after the second dose of vaccination. Seventeen percent of the respondents had COVID-19 infection within the past 3 months before receiving COVID-19 vaccine. Three percent of participants had re-infection with COVID-19 after receiving the first or the second dose of the COVID-19 vaccine. Among participants who experienced adverse events, 42% and 62.1% of participants experienced mild adverse events following the first dose and second dose of the vaccine, respectively.  Conclusions: The adverse events following immunization for both vaccines after both doses of vaccination were quite low, with 43.89% of participants reporting side effects after the first dose and 21.48% of participants reporting side effects after the second dose. Adverse events were most frequently reported within 24 hours of vaccination and were mostly mild. There was no statistical significance of adverse events between both vaccines.


Assuntos
COVID-19 , ChAdOx1 nCoV-19 , Chlorocebus aethiops , Animais , Humanos , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Estudos Transversais , Células Vero , Nepal/epidemiologia , Programas de Imunização
6.
Disaster Med Public Health Prep ; 18: e66, 2024 Apr 15.
Artigo em Inglês | MEDLINE | ID: mdl-38618867

RESUMO

OBJECTIVE: To contain the spread of coronavirus disease 2019 (COVID-19), several vaccines have been developed. This study is intended to elucidate the level of anti-severe acute respiratory syndrome coronavirus 2 immunoglobulin G (anti-SARS-CoV-2-IgG) antibodies for COVID-19 vaccines (Pfizer BioNTech [BNT162b2], Oxford/AstraZeneca [ChAdOx1], and Sinopharm [BBIBP-CorV]) among health staff from health facilities in Duhok province, and it explored the immediate adverse reactions of COVID-19 vaccines among participants. METHODS: A longitudinal study was conducted from June 1, 2021, to June 30, 2022, and 300 participants were included through simple random sampling. RESULTS: The immune response 1 mo after the second dose was significantly higher than the sustained immune after 5 and 9 mo as results revealed that, in 100% of study samples who had (ChAdOx1) vaccine, their antibody titers exceeded the positivity threshold of 1 AU/m, while 96% for (BNT162b2) and 90% for (BBIBP-CorV) for the first test after 1 mo from the second dose of the COVID-19 vaccine, and these rates were reduced to 94.6% for (ChAdOx1), 97.8% for (BNT162b2), and 81.9% for (BBIBP-CorV) at 5 mo after the second dose, while simultaneously the seropositivity rates were more reduced at 9 mo to 46.5% for (ChAdOx1), 67.5% for (BNT162b2), and 9.20% for (BBIBP-CorV). In terms of adverse reactionsss, fever was reported as the most prevalent after the first dose in 58% for ChAdOx1, 43% for BNT162b2, and 23% for BBIBP-CorV, followed by muscle pain, joint pain, and shoulder pain for both doses. CONCLUSIONS: The implications of the findings from this study are that higher and potentially longer antibody responses can be obtained if the BNT162b2 is given as compared with the other 2 vaccines. Moreover, the booster doses of the COVID-19 vaccine are highly recommended because more than 50% of the participants either have become anti-spike protein negative or have a deficient level of anti-spike protein against COVD-19 vaccines.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Humanos , Vacinas contra COVID-19/efeitos adversos , Vacina BNT162 , SARS-CoV-2 , Estudos Longitudinais , COVID-19/epidemiologia , COVID-19/prevenção & controle , Imunoglobulina G
7.
Hum Vaccin Immunother ; 20(1): 2333104, 2024 Dec 31.
Artigo em Inglês | MEDLINE | ID: mdl-38584118

RESUMO

Various COVID-19 vaccines can affect the immune system. Discrepancies have been noted in immune system characteristics, such as T-lymphocyte levels, between vaccinated and non-vaccinated individuals. This study investigates the variations in immune responses among the four administered COVID-19 vaccines, influencing factors, and clinical outcomes in Jordan. A total of 350 adults, who were at least two doses vaccinated, were interviewed and blood samples were collected for subsequent laboratory analyses. The study involved the quantification of T-cells specifically targeting anti-SARS CoV-2 using Flow cytometry analysis. BNT162b2 (Pfizer) recipients displayed significantly higher CD3+/CD4+ T-helper cell responses (90.84%, 87.46% - 94.22%) compared to non-Pfizer-BioNTech recipients {BBIBP-CorV (Sinopharm) and Sputnik V (Gamaleya Research Institute), then ChAdOx1 nCoV-19 (AstraZeneca)} (83.62%, 77.91% - 89.33%). The CD3+/CD8+ (T cytotoxic) level was notably elevated in non-Pfizer-BioNTech recipients {Sinopharm and Sputnik V then ChAdOx1 nCoV-19 AstraZeneca (73.94%, 69.38% - 78.49%) compared to BNT162b2 (Pfizer) recipients (58.26%, 53.07% - 63.44%). The CD3+ (T-cells) level showed no significant difference between BNT162b2 recipients (73.74%) and non-Pfizer-BioNTech recipients (77.83%), with both types generating T-cells. Comparing two doses of non-Pfizer-BioNTech vaccines with the third dose of BNT162b2 recipients (Pfizer), no difference in the type of immune reaction was observed, with non-Pfizer-BioNTech recipients still stimulating endogenous pathways like cell-mediated cytotoxic effects for cells. All COVID-19 vaccines administered in Jordan were effective, with respect to the total number of T cells. Non-Pfizer-BioNTech had higher in toxic T-cells and Pfizer-BioNTech was higher in helper T-cells that stimulate plasma cells to produce antibodies.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Adulto , Humanos , Vacinas contra COVID-19/efeitos adversos , Vacinas de mRNA , Vacina BNT162 , ChAdOx1 nCoV-19 , Jordânia , COVID-19/prevenção & controle
8.
PeerJ ; 12: e17083, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38590705

RESUMO

Studies focusing on the safety and common side effects of vaccines play a crucial role in enhancing public acceptance of vaccination. Research is scarce regarding the usage of COVID-19 vaccines and the side effects experienced by health professions students in India and other countries. This study aimed to document self-reported side effects associated with COVID-19 vaccination among medical and dental students of six medical and dental colleges and teaching hospitals in four states (Tamil Nadu, Madhya Pradesh, Gujarat, and West Bengal) of India. A cross-sectional survey using purposive sampling of medical and dental students was conducted from 26 April to 26 May 2021. Data was collected using a Google Forms questionnaire capturing information regarding receiving COVID-19 vaccines, side effects and symptoms, onset and duration of symptoms, use of treatment to alleviate symptoms, awareness of haematologic risks associated with vaccination, and side effects from previous (non-COVID-19) vaccinations. The majority (94.5%) of participants received both doses of the Covishield/AstraZeneca COVID-19 vaccine. Among participants (n = 492), 45.3% (n = 223) reported one or more side effects. The most frequently reported side effects were soreness of the injected arm (80.3%), tiredness (78.5%), fever (71.3%), headache (64.1%), and hypersomnia (58.7%). The two most common severe symptoms were fever (14.8%) and headache (13%). Most side effects appeared on the day of vaccination: soreness of the injection site (57%), fever (43.1%), and tiredness (42.6%). Most reported symptoms persisted for one to three days-soreness of the injection site (53%), fever (47.1%), and headache (42.6%). Logistic regression showed that women were almost 85% less likely to report side effects. The study's findings corroborate the safety of the Covishield/AstraZeneca vaccine's first dose, evidenced by the relatively minor and transient nature of the side effects. However, the study underscores the necessity for ongoing research to assess the long-term impacts of COVID-19 vaccines, especially in the context of booster doses, thereby contributing to the global understanding of vaccine safety and efficacy.


Assuntos
COVID-19 , Estudantes de Ciências da Saúde , Humanos , Feminino , Vacinas contra COVID-19/efeitos adversos , ChAdOx1 nCoV-19 , Autorrelato , Índia/epidemiologia , Estudos Transversais , COVID-19/epidemiologia , Cefaleia , Dor , Fadiga , Febre , Ocupações em Saúde
11.
BMJ Glob Health ; 9(4)2024 Apr 04.
Artigo em Inglês | MEDLINE | ID: mdl-38580375

RESUMO

OBJECTIVE: To assess the effects of COVID-19 vaccines in women before or during pregnancy on SARS-CoV-2 infection-related, pregnancy, offspring and reactogenicity outcomes. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Major databases between December 2019 and January 2023. STUDY SELECTION: Nine pairs of reviewers contributed to study selection. We included test-negative designs, comparative cohorts and randomised trials on effects of COVID-19 vaccines on infection-related and pregnancy outcomes. Non-comparative cohort studies reporting reactogenicity outcomes were also included. QUALITY ASSESSMENT, DATA EXTRACTION AND ANALYSIS: Two reviewers independently assessed study quality and extracted data. We undertook random-effects meta-analysis and reported findings as HRs, risk ratios (RRs), ORs or rates with 95% CIs. RESULTS: Sixty-seven studies (1 813 947 women) were included. Overall, in test-negative design studies, pregnant women fully vaccinated with any COVID-19 vaccine had 61% reduced odds of SARS-CoV-2 infection during pregnancy (OR 0.39, 95% CI 0.21 to 0.75; 4 studies, 23 927 women; I2=87.2%) and 94% reduced odds of hospital admission (OR 0.06, 95% CI 0.01 to 0.71; 2 studies, 868 women; I2=92%). In adjusted cohort studies, the risk of hypertensive disorders in pregnancy was reduced by 12% (RR 0.88, 95% CI 0.82 to 0.92; 2 studies; 115 085 women), while caesarean section was reduced by 9% (OR 0.91, 95% CI 0.85 to 0.98; 6 studies; 30 192 women). We observed an 8% reduction in the risk of neonatal intensive care unit admission (RR 0.92, 95% CI 0.87 to 0.97; 2 studies; 54 569 women) in babies born to vaccinated versus not vaccinated women. In general, vaccination during pregnancy was not associated with increased risk of adverse pregnancy or perinatal outcomes. Pain at the injection site was the most common side effect reported (77%, 95% CI 52% to 94%; 11 studies; 27 195 women). CONCLUSION: COVID-19 vaccines are effective in preventing SARS-CoV-2 infection and related complications in pregnant women. PROSPERO REGISTRATION NUMBER: CRD42020178076.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Recém-Nascido , Lactente , Gravidez , Feminino , Humanos , Vacinas contra COVID-19/efeitos adversos , Cesárea , COVID-19/prevenção & controle , SARS-CoV-2 , Parto
12.
Cutis ; 113(2): E16-E19, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38593110

RESUMO

We describe 7 patients with various dermatologic reactions following COVID-19 vaccination, including herpes zoster (HZ) infection, herpes zoster ophthalmicus (HZO), herpes labialis, and urticaria. Although the reactions described here may be related to COVID-19 vaccination, continued vaccination is recommended, as it is the most effective way to protect against serious COVID-19 infection.


Assuntos
COVID-19 , Herpes Zoster Oftálmico , Humanos , Vacinas contra COVID-19/efeitos adversos , COVID-19/prevenção & controle , Vacinação/efeitos adversos , Pesquisa
13.
J Korean Med Sci ; 39(13): e121, 2024 Apr 08.
Artigo em Inglês | MEDLINE | ID: mdl-38599598

RESUMO

National vaccine injury compensation serves as a crucial and significant safety net for individuals affected by government-recommended vaccines during a pandemic, contributing to the community's overall safety. In the Republic of Korea, compensation for adverse events resulting from coronavirus disease 2019 (COVID-19) vaccinations has been provided through the National Vaccine Injury Compensation Program introduced in 1995. However, there have been limitations with these measures during the COVID-19 pandemic owing to strict criteria for substantiating causality between the vaccine and injury, its nontransparent process of determining whether to compensate, and the compensation amount that is not practically calculated. This article reviewed the Vaccine Injury Compensation Programs in 10 major countries to present implications for improving the Korean system. Expanding the scope of national accountability is essential to compensate for the consequences of adhering to national policies during public health crises. Therefore, valuable insight can be obtained from examining the systems in Germany, Japan, and Taiwan, which have implemented more relaxed criteria for determining causality in compensation cases; Thailand's system, which provides the mandatory payment of preliminary compensation for damage caused by vaccination; systems in Germany, France, and Japan, which offer compensation for vaccine injuries from a practical perspective; and systems in France and the United Kingdom, which have a process allowing the assessment records to be shared with the claimants. Furthermore, a dedicated agency for vaccine injury compensation, as seen in France, the United Kingdom, and Australia, is necessary to enhance the efficiency of the Korean system.


Assuntos
COVID-19 , Vacinas , Humanos , Vacinas contra COVID-19/efeitos adversos , Pandemias/prevenção & controle , Compensação e Reparação , COVID-19/prevenção & controle , COVID-19/etiologia , Vacinação/efeitos adversos , Vacinas/efeitos adversos
14.
J Clin Immunol ; 44(4): 86, 2024 Apr 05.
Artigo em Inglês | MEDLINE | ID: mdl-38578389

RESUMO

BACKGROUND: The CDC and ACIP recommend COVID-19 vaccination for patients with inborn errors of immunity (IEI). Not much is known about vaccine safety in IEI, and whether vaccination attenuates infection severity in IEI. OBJECTIVE: To estimate COVID-19 vaccination safety and examine effect on outcomes in patients with IEI. METHODS: We built a secure registry database in conjunction with the US Immunodeficiency Network to examine vaccination frequency and indicators of safety and effectiveness in IEI patients. The registry opened on January 1, 2022, and closed on August 19, 2022. RESULTS: Physicians entered data on 1245 patients from 24 countries. The most common diagnoses were antibody deficiencies (63.7%). At least one COVID-19 vaccine was administered to 806 patients (64.7%), and 216 patients received vaccination prior to the development of COVID-19. The most common vaccines administered were mRNA-based (84.0%). Seventeen patients were reported to seek outpatient clinic or emergency room care for a vaccine-related complication, and one patient was hospitalized for symptomatic anemia. Eight hundred twenty-three patients (66.1%) experienced COVID-19 infection. Of these, 156 patients required hospitalization (19.0%), 47 required ICU care (5.7%), and 28 died (3.4%). Rates of hospitalization (9.3% versus 24.4%, p < 0.001), ICU admission (2.8% versus 7.6%, p = 0.013), and death (2.3% versus 4.3%, p = 0.202) in patients who had COVID-19 were lower in patients who received vaccination prior to infection. In adjusted logistic regression analysis, not having at least one COVID-19 vaccine significantly increased the odds of hospitalization and ICU admission. CONCLUSION: Vaccination for COVID-19 in the IEI population appears safe and attenuates COVID-19 severity.


Assuntos
COVID-19 , Humanos , COVID-19/epidemiologia , Vacinas contra COVID-19/efeitos adversos , Vacinação , Hospitalização , Cuidados Críticos
15.
BMJ Open ; 14(4): e076064, 2024 Apr 09.
Artigo em Inglês | MEDLINE | ID: mdl-38594182

RESUMO

INTRODUCTION: The paediatric population represents a quarter of the world's population, and like adult patients, they have also suffered immeasurably from the SARS-CoV-2 pandemic. Immunisation is an effective strategy for reducing the number of COVID-19 cases. With the advancements in vaccination for younger age groups, parents or guardians have raised doubts and questions about adverse effects and the number of doses required. Therefore, systematic reviews focusing on this population are needed to consolidate evidence that can help in decision-making and clinical practice. This protocol aims to assess the safety of COVID-19 vaccines in paediatric patients and evaluate the correlation between the number of vaccine doses and side effects. METHODS AND ANALYSIS: We will search the PubMed, ClinicalTrials.gov, Web of Science, Embase, CINAHL, Latin American and Caribbean Health Sciences Literature, Scopus and Cochrane databases for randomised and quasi-randomised clinical trials that list the adverse effects of the COVID-19 vaccine and assess its correlation with the number of doses, without any language restrictions. Two reviewers will select the studies according to the inclusion and exclusion criteria, extract data and asses for risk of bias using the Cochrane risk-of-bias tool. The Review Software Manager (RevMan V.5.4.1) will be used to synthesise the data. We will use the Working Group's Grading of Recommendations Assessment, Development and Evaluations to grade the strength of the evidence of the results. ETHICS AND DISSEMINATION: Formal ethical approval is not required as no primary data are collected. This systematic review will be disseminated through a peer-reviewed publication. PROSPERO REGISTRATION NUMBER: CRD42023390077.


Assuntos
COVID-19 , Vacinas , Adulto , Humanos , Criança , COVID-19/prevenção & controle , SARS-CoV-2 , Vacinas contra COVID-19/efeitos adversos , Vacinação , Projetos de Pesquisa , Revisões Sistemáticas como Assunto , Metanálise como Assunto
16.
MMWR Morb Mortal Wkly Rep ; 73(14): 317-320, 2024 Apr 11.
Artigo em Inglês | MEDLINE | ID: mdl-38602888

RESUMO

COVID-19 vaccination has been associated with myocarditis in adolescents and young adults, and concerns have been raised about possible vaccine-related cardiac fatalities in this age group. In April 2021, cases of myocarditis after COVID-19 vaccination, particularly among young male vaccine recipients, were reported to the Vaccine Adverse Event Reporting System. To assess this possibility, investigators searched death certificates for Oregon residents aged 16-30 years who died during June 2021-December 2022 for cardiac or undetermined causes of death. For identified decedents, records in Oregon's immunization information system were reviewed for documentation of mRNA COVID-19 vaccination received ≤100 days before death. Among 1,292 identified deaths, COVID-19 was cited as the cause for 30. For 101 others, a cardiac cause of death could not be excluded; among these decedents, immunization information system records were available for 88, three of whom had received an mRNA COVID-19 vaccination within 100 days of death. Of 40 deaths that occurred among persons who had received an mRNA COVID-19 vaccine dose, three occurred ≤100 days after vaccination. Two of these deaths were attributed to chronic underlying conditions; the cause was undetermined for one. No death certificate attributed death to vaccination. These data do not support an association between receipt of mRNA COVID-19 vaccine and sudden cardiac death among previously healthy young persons. COVID-19 vaccination is recommended for all persons aged ≥6 months to prevent COVID-19 and complications, including death.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Morte Súbita Cardíaca , Miocardite , Adolescente , Humanos , Masculino , Adulto Jovem , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Morte Súbita Cardíaca/epidemiologia , Miocardite/epidemiologia , Oregon/epidemiologia , Vacinação , Adulto
17.
Hum Vaccin Immunother ; 20(1): 2334084, 2024 Dec 31.
Artigo em Inglês | MEDLINE | ID: mdl-38563792

RESUMO

We conducted a national in-depth analysis including pharmacovigilance reports and clinical study to assess the reporting rate (RR) and to determine the clinical profile of polymyalgia rheumatica (PMR) and giant cell arteritis (GCA) in COVID-19-vaccinated individuals. First, based on the French pharmacovigilance database, we estimated the RR of PMR and GCA cases in individuals aged over 50 who developed their initial symptoms within one month of receiving the BNT162b2 mRNA, mRNA-1273, ChAdOx1 nCoV-19, and Ad26.COV2.S vaccines. We then conducted a nationwide survey to gather clinical profiles, therapeutic management, and follow-up data from individuals registered in the pharmacovigilance study. A total of 70 854 684 COVID-19 vaccine doses were administered to 25 260 485 adults, among which, 179 cases of PMR (RR 7. 1 cases/1 000 000 persons) and 54 cases of GCA (RR 2. 1 cases/1 000 000 persons) have been reported. The nationwide survey allowed the characterization of 60 PMR and 35 GCA cases. Median time to the onset of first symptoms was 10 (range 2-30) and 7 (range 2-25) days for PMR and GCA, respectively. Phenotype, GCA-related ischemic complications and -large vessel vasculitis as well as therapeutic management and follow-up seemed similar according to the number of vaccine shots received and when compared to the literature data of unvaccinated population. Although rare, the short time between immunization and the onset of first symptoms of PMR and GCA suggests a temporal association. Physician should be aware of this potential vaccine-related phenomenon.


Assuntos
COVID-19 , Arterite de Células Gigantes , Polimialgia Reumática , Adulto , Humanos , Pessoa de Meia-Idade , Arterite de Células Gigantes/epidemiologia , Polimialgia Reumática/epidemiologia , Vacinas contra COVID-19/efeitos adversos , Ad26COVS1 , Vacina BNT162 , ChAdOx1 nCoV-19 , COVID-19/epidemiologia , COVID-19/prevenção & controle , Vacinação/efeitos adversos
18.
Hum Vaccin Immunother ; 20(1): 2330770, 2024 Dec 31.
Artigo em Inglês | MEDLINE | ID: mdl-38602539

RESUMO

The immunogenicity and safety of the concomitant administration of recombinant COVID-19 vaccine and quadrivalent inactivated influenza vaccine (Split Virion) (QIIV) in Chinese adults are unclear. In this open-label, randomized controlled trial, participants aged ≥ 18 years were recruited. Eligible healthy adults were randomly assigned (1:1) to receive QIIV at the same time as the first dose of COVID-19 vaccine (simultaneous-group) or 14 days after the second dose of COVID-19 vaccine (non-simultaneous-group). The primary outcome was to compare the difference in immunogenicity of QIIV (H1N1, H3N2, Yamagata, and Victoria) between the two groups. A total of 299 participants were enrolled, 149 in the simultaneous-group and 150 in the non-simultaneous-group. There were no significant differences in geometric mean titer (GMT) [H1N1: 386.4 (95%CI: 299.2-499.0) vs. 497.4 (95%CI: 377.5-655.3); H3N2: 66.9 (95%CI: 56.1-79.8) vs. 81.4 (95%CI: 67.9-97.5); Yamagata: 95.6 (95%CI: 79.0-115.8) vs. 74.3 (95%CI: 58.6-94.0); and Victoria: 48.5 (95%CI: 37.6-62.6) vs. 65.8 (95%CI: 49.0-88.4)] and seroconversion rate (H1N1: 87.5% vs. 90.1%; H3N2: 58.1% vs. 62.0%; Yamagata: 75.0% vs. 64.5%; and Victoria: 55.1% vs. 62.8%) of QIIV antibodies between the simultaneous and non-simultaneous groups. For the seroprotection rate of QIIV antibodies, a higher seroprotection rate of Yamagata antibody was observed only in the simultaneous-group than in the non-simultaneous-group [86.0% vs. 76.0%, p = .040]. In addition, no significant difference in adverse events was observed between the two groups (14.2% vs. 23.5%, p = .053). In conclusion, no immune interference or safety concerns were found for concomitant administration of COVID-19 vaccine with QIIV in adults aged ≥ 18 years.


Assuntos
COVID-19 , Vírus da Influenza A Subtipo H1N1 , Vacinas contra Influenza , Adulto , Humanos , Vacinas contra COVID-19/efeitos adversos , COVID-19/prevenção & controle , Vírus da Influenza A Subtipo H3N2 , Vacinas contra Influenza/efeitos adversos , Anticorpos , China
19.
J AAPOS ; 28(2): 103867, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38458601

RESUMO

PURPOSE: To investigate the prevalence and risk of new-onset abducens nerve palsy and acute-onset diplopia following mRNA COVID-19 vaccination. METHODS: In this retrospective, population-based study, patient data from the COVID-19 Research Network of TriNetX was searched via the TriNetX Analytics platform for patients who received specific vaccinations based on Common Procedural Technology codes. We recorded instances of newly diagnosed abducens nerve palsy and diplopia within 21 days following each vaccination event. RESULTS: Of the 3,545,224 patients (mean age at vaccination, 46.2 ± 21.3 years) who received the mRNA COVID-19 vaccine, 12 (<0.0001%) patients had a new diagnosis of abducens nerve palsy and 453 (0.013%) had acute-onset diplopia within 21 days of first dose of COVID-19 vaccination. After propensity score matching, the relative risk for new abducens nerve palsy diagnosis after the first dose of COVID-19 vaccination was not significantly different from that after influenza (RR, 0.77), Tdap (RR, 1.0), or the second dose of the COVID-19 vaccinations (RR, 1.00). Furthermore, there was a lower risk of abducens nerve palsy diagnosis after the first dose of the COVID-19 vaccination compared with the risk after COVID-19 infection (RR, 0.15). CONCLUSIONS: The risk of a new abducens nerve palsy diagnosis following the first dose of the COVID-19 vaccine is lower than the risk associated with COVID-19 infection itself. There is no evidence to suggest a causal relationship between COVID-19 vaccination and the development of abducens nerve palsy.


Assuntos
Doenças do Nervo Abducente , Vacinas contra COVID-19 , COVID-19 , Humanos , Doenças do Nervo Abducente/induzido quimicamente , COVID-19/complicações , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Diplopia/induzido quimicamente , Estudos Retrospectivos , Vacinação/efeitos adversos
20.
PLoS One ; 19(3): e0298272, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38512841

RESUMO

BACKGROUND: Hypermobile Ehlers-Danlos syndrome is a heritable connective tissue disorder associated with generalized joint hypermobility but also other multisystem comorbidities, many of which may be exacerbated during a viral illness or after a vaccination. We sought to determine whether individuals with hypermobile Ehlers Danlos syndrome report an increase in adverse events, including cardiovascular events, after COVID-19 illness or vaccination. METHODS: A cross-sectional web-based survey was made available from November 22, 2021, through March 15, 2022. 368 respondents primarily from the United States self-reported data including diagnosis. We used a Cox proportional hazards model with time varying indicators for COVID-19 illness or vaccination in the previous 30 days. RESULTS: We found a significantly increased rate of new abnormal heart rhythms reported in the 30 days following COVID-19 illness. No additional cardiovascular events were reported after COVID-19 illness. 2.5% of respondents with COVID-19 illness were hospitalized. We did not find a statistically significant increased rate of cardiovascular events in the 30 days following any COVID-19 vaccination dose. Post COVID-19 vaccination, 87.2% of hypermobile Ehlers-Danlos syndrome respondents endorsed an expected adverse event (EAE), and 3.1% reported an emergency department visit/hospitalization, of those who received at least one vaccine dose. Events possibly reflecting exacerbation of orthostasis/dysautonomia were common. CONCLUSION: Respondents did not report an increased rate of any cardiovascular events in the 30 days following COVID-19 vaccination; however, those with hypermobile Ehlers-Danlos syndrome experienced a high rate of expected adverse events after vaccination consistent with a high baseline prevalence of similar symptoms. No cardiovascular events other than new abnormal heart rhythms were reported at any point after a COVID-19 illness.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Síndrome de Ehlers-Danlos , Cardiopatias , Instabilidade Articular , Humanos , COVID-19/complicações , COVID-19/epidemiologia , Vacinas contra COVID-19/efeitos adversos , Estudos Transversais , Síndrome de Ehlers-Danlos/induzido quimicamente , Síndrome de Ehlers-Danlos/complicações , Cardiopatias/complicações , Internet , Instabilidade Articular/induzido quimicamente , Instabilidade Articular/complicações , Inquéritos e Questionários , Vacinação/efeitos adversos
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