ABSTRACT
Platelet factor 4 (PF4), also known as chemokine (C-X-C motif) ligand 4 (CXCL4), is a specific protein synthesized from platelet α particles. The combination of PF4 and heparin to form antigenic complexes is an important mechanism in the pathogenesis of heparin-induced thrombocytopenia (HIT), but vaccine-induced immune thrombotic thrombocytopenia (VITT) related to the COVID-19 vaccine makes PF4 a research hotspot again. Similar to HIT, vaccines, bacteria, and other non-heparin exposure, PF4 can interact with negatively charged polyanions to form immune complexes and participate in thrombosis. These anions include cell surface mucopolysaccharides, platelet polyphosphates, DNA from endothelial cells, or von Willebrand factor (VWF). Among them, PF4-VWF, as a new immune complex, may induce and promote the formation of immune-associated thrombosis and is expected to become a new target and therapeutic direction. For both HIT and VITT, there is no effective and targeted treatment except discontinuation of suspected drugs. The research and development of targeted drugs based on the mechanism of action have become an unmet clinical need. Here, this study systematically reviewed the characteristics and pathophysiological mechanisms of PF4 and VWF, elaborated the potential mechanism of action of PF4-VWF complex in immune-associated thrombosis, summarized the current status of new drug research and development for PF4 and VWF, and discussed the possibility of this complex as a potential biomarker for early immune-associated thrombosis events. Moreover, the key points of basic research and clinical evaluation are put forward in the study.
Subject(s)
COVID-19 , Purpura, Thrombocytopenic, Idiopathic , Thrombocytopenia , Thrombosis , Humans , Acceleration , Antigen-Antibody Complex , COVID-19/complications , COVID-19 Vaccines/adverse effects , Endothelial Cells/metabolism , Heparin/metabolism , Immunologic Factors , Platelet Factor 4 , Purpura, Thrombocytopenic, Idiopathic/complications , Thrombocytopenia/etiology , Thrombosis/complications , von Willebrand FactorABSTRACT
OBJETIVE: To assess cutaneous reactions after Pfizer-BioNTech COVID-19 vaccine administration. METHODS: A cross-sectional observational study was carried out in health workers belonging to the city of Guayaquil-Ecuador, from March to May 2021. The participants were contacted through a local registry established by the Universidad Espíritu Santo. Frequencies and percentages were used to represent the proportions of nominal variables, while the mean and standard deviation were used for continuous data, given a normal sample distribution. RESULTS: Local skin reactions were the most frequent, and included redness, edema, and itching. On the other hand, delayed large local skin reactions (generalized rash and pruritus, angioedema, urticaria, eczema, petechiae) were rare and occurred in less than 1.4% of participants, (95% CI = 0.69-1.00). Finally, we did not find cases of anaphylaxis or other life-threatening reactions requiring urgent attention after vaccination. CONCLUSIONS: Our findings suggest that local skin reactions occur in a minority of recipients and are often mild and self-limited.
OBJECTIVO: Evaluar las reacciones cutáneas tras la administración de la vacuna COVID-19 de Pfizer-BioNTech. MÉTODOS: Se realizó un estudio observacional transversal en trabajadores de la salud, pertenecientes a la ciudad de Guayaquil-Ecuador, de marzo a mayo de 2021. Los participantes fueron contactados a través de un registro local establecido por la Universidad Espíritu Santo. Se utilizaron frecuencias y porcentajes para representar las proporciones de las variables nominales, mientras que la media y la desviación estándar se usaron para datos continuos, dada la distribución de muestra normal. RESULTADOS: Las reacciones cutáneas locales fueron las más frecuentes e incluyeron enrojecimiento, edema y prurito. Por otro lado, las reacciones cutáneas locales grandes retardadas (exantema y prurito generalizados, angioedema, urticaria, eccema y petequias) fueron raras y ocurrieron en menos de 1.4 % de los participantes, (IC 95 % = 0.69-1.00). Finalmente, no encontramos casos de anafilaxia u otras reacciones potencialmente mortales que requieran atención urgente después de la vacunación. CONCLUSIONES: Nuestros hallazgos sugieren que las reacciones cutáneas locales ocurren en una minoría de personas y que a menudo son leves y autolimitadas.
Subject(s)
COVID-19 , Vaccines , Humans , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Ecuador/epidemiology , BNT162 Vaccine , Cross-Sectional Studies , PruritusABSTRACT
Myocarditis is a relatively uncommon and underdiagnosed heart disease. Its clinical presentation is variable, from pauci-symptomatic to a symptomatology of sudden chest pain. The latter mimics cardiological emergencies and must therefore be quickly discerned to guide the rest of the treatment. The treatment is mainly supportive and rarely directly etiological. This is a pathology that resurfaced with the onset of the COVID-19 pandemic but also with vaccination. We present here the case of a mRNA SARS-CoV-2 vaccine-induced myocarditis whose clinical manifestations impose a rapid decision concerning the differential diagnosis with an acute coronary syndrome.
La myocardite est une pathologie cardiaque relativement peu fréquente et sous-diagnostiquée. Sa présentation clinique est variable, de paucisymptomatique à une symptomatologie de douleur thoracique brutale. Cette dernière mime les urgences cardiologiques et doit donc être rapidement diagnostiquée pour orienter la suite de la prise en charge. Le traitement est principalement supportif et peu étiologique. Il s'agit d'une pathologie qui a refait surface avec l'arrivée de la pandémie COVID-19, mais aussi avec la vaccination. Nous présentons ici le cas d'une myocardite induite par un vaccin SARS-CoV-2 à ARNm dont les manifestations cliniques imposent une décision rapide concernant le diagnostic différentiel avec le syndrome coronarien aigu.
Subject(s)
Acute Coronary Syndrome , COVID-19 , Myocarditis , Humans , SARS-CoV-2 , COVID-19/prevention & control , Myocarditis/diagnosis , Myocarditis/etiology , COVID-19 Vaccines/adverse effects , Pandemics , Vaccination , RNA, MessengerABSTRACT
BACKGROUND: More than 4 billion doses of the Coronavirus disease (COVID-19) vaccine have been administered worldwide but the relationship between the different vaccines and the development of renal disease is unknown. We present a case of tubulointerstitial nephritis following administration of the Oxford-AstraZeneca COVID-19 vaccine. CASE PRESENTATION: A previously fit and well 51-year-old female presented on 27th May 2021 with a one-month history of weight loss, fatigue, nausea, and a metallic taste. She had an acute kidney injury with a creatinine of 484 umol/L. She was on no regular medications and denied taking any over-the-counter or alternative medicines. She had received her first dose of the Oxford-AstraZeneca vaccine on 23rd March 2021 and her second dose on 20th May 2021. A renal biopsy was performed the following day. The 19 glomeruli appeared normal to light microscopy but the tubulointerstitial compartment contained a dense inflammatory infiltrate including many eosinophils. There was widespread acute tubular injury with tubulitis, but no established or longstanding atrophy. A diagnosis was made of an acute tubulointerstitial nephritis. She was commenced on oral prednisolone and her renal function improved. She did not require renal replacement therapy at any time. CONCLUSIONS: To our knowledge, this was the first described case of acute tubulointerstitial nephritis following administration of the Oxford-AstraZeneca COVID-19 vaccine, although a number of cases have emerged more recently. In our case the patient was very fit and well, had no previous past medical history and had not taken any recent prescribed, over-the-counter or alternative medications. The absence of these provoking factors in our case makes the vaccine the most likely explanation for the development of tubulointerstitial nephritis although the pathophysiology behind this remains unknown. Given the unprecedented number of vaccinations being delivered around the world, nephrologists should be aware of this possible link although more research into the topic is required.
Subject(s)
COVID-19 , Nephritis, Interstitial , Humans , Female , Middle Aged , COVID-19 Vaccines/adverse effects , ChAdOx1 nCoV-19 , Nephritis, Interstitial/chemically induced , Nephritis, Interstitial/diagnosis , VaccinationABSTRACT
Guillain-Barré syndrome (GBS) is a rare but severe complication of COVID-19 vaccination. We report two cases of GBS following vaccination with the adenovirus vector vaccine ChAdOx1 nCoV-19 (Vaxzevria, AstraZeneca) and review the relevant literature. Relevant studies published between December 2020 and May 2022 including 881 patients with GBS were reviewed. GBS incidence and the need for mechanical ventilation were reported at a higher level among patients receiving Vaxzevria (n = 400). However, incidence cannot be accurately estimated from case reports. Thus, the true GBS rates following COVID-19 vaccination should be determined by population-based data.
Subject(s)
COVID-19 , Guillain-Barre Syndrome , Influenza Vaccines , Humans , Guillain-Barre Syndrome/etiology , Guillain-Barre Syndrome/epidemiology , COVID-19 Vaccines/adverse effects , ChAdOx1 nCoV-19 , COVID-19/prevention & control , COVID-19/complications , Vaccination/adverse effectsABSTRACT
We present an autopsy case of a 19-year-old man with a history of epilepsy whose unwitnessed sudden death occurred unexpectedly in the night. About 4 years before death, he was diagnosed with unilateral optic neuritis (ON). Demyelinating disease was suspected, but he was lost to follow up after the recovery. Six months before death, he received a second dose of mRNA coronavirus disease 2019 (COVID-19) vaccine. Three months before death, he experienced epileptic seizures for the first time. Seventeen days before death, he was infected with COVID-19, which showed self-limited course under home isolation. Several days before death, he complained of seizures again at night. Autopsy revealed multifocal gray-tan discoloration in the cerebrum. Histologically, the lesions consisted of active and inactive demyelinated plaques in the perivenous area of the white matter. Perivascular lymphocytic infiltration and microglial cell proliferation were observed in both white matter and cortex. The other major organs including heart and lung were unremarkable. Based on the antemortem history and postmortem findings, the cause of death was determined to be multiple sclerosis with suspected exacerbation. The direct or indirect involvement of cortex and deep gray matter by exacerbated multiple sclerosis may explain the occurrence of seizures. Considering the absence of other structural abnormalities except the inflammatory demyelination of the cerebrum, fatal arrhythmia or laryngospasm in the terminal epileptic seizure may explain his sudden unexpected death in the benign circumstances. In this case, the onset of seizure was preceded by COVID-19 vaccination, and the exacerbation of seizure was preceded by COVID-19 infection, respectively. Literature reporting first manifestation or relapse of multiple sclerosis temporally associated with COVID-19 vaccination or infection are reviewed.
Subject(s)
COVID-19 , Epilepsy , Multiple Sclerosis , Humans , Male , Young Adult , COVID-19/complications , COVID-19 Vaccines/adverse effects , Death, Sudden/etiology , Epilepsy/complications , Multiple Sclerosis/complications , Seizures/complications , Vaccination/adverse effects , Fatal OutcomeABSTRACT
OBJECTIVE: Public interest in the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines has been rising with regard to associated myocarditis. Thus, the objective of our study was to assess trends in public interest in myocarditis during the course of the pandemic and the SARS-CoV-2 vaccine rollout in the United States. METHODS: We conducted a longitudinal assessment of public interest in myocarditis, and its association with actual coronavirus disease 2019 (COVID-19) -related myocarditis during the first wave of the pandemic and SARS-CoV-2 vaccine-related myocarditis following vaccine rollout. To complete this objective, we used data from 3 sources: a report from the Morbidity and Mortality Weekly Report, the Vaccine Adverse Event Reporting database, and from Google Trends. RESULTS: Results show that Relative Search Interest (RSI) was low before and during the initial phase of the pandemic and peaked in April 2021, during the initial vaccine push. The ratio of myocarditis related to the SARS-CoV-2 vaccines was considerably lower than the ratio of myocarditis from natural infection. CONCLUSIONS: Search interest in myocarditis was low until SARS-CoV-2 vaccines were rolled out, in which media coverage intensely focused on a relatively small number of cases. This study highlights both the benefits of COVID-19 vaccine uptake and the impact of the media on public interest.
Subject(s)
COVID-19 , Myocarditis , Humans , SARS-CoV-2 , COVID-19 Vaccines/adverse effects , COVID-19/epidemiology , COVID-19/prevention & control , Myocarditis/epidemiology , Myocarditis/etiology , PandemicsABSTRACT
BACKGROUND/OBJECTIVE(S)/INTRODUCTION: TURKOVAC™ is a whole-virion inactivated COVID-19 vaccine, which was developed and recently granted emergency use authorization (conditional marketing authorization) in Türkiye. The objective of this study is to assess the spectrum and the distribution of adverse events reported following the administration of the first 150,000 doses as primary and booster vaccine doses in 22 state hospitals of 17 provinces in Türkiye. PATIENTS/MATERIALS AND METHODS: In this cohort study, a verbal survey was conducted via telephone calls between 10 January and 17 January 2022, utilizing a structured questionnaire algorithm on a sample group of 20,000 persons on the third- and seventh-days following vaccination. The algorithm consisted of two parts focusing on both systemic and local adverse effects. Other adverse events reported by the participants were also recorded. 6023 people and 5345 people agreed to participate in the telephone survey on the 3rd- and 7th- days of having received the first dose of the vaccine, respectively. RESULTS: Thirty-six-point-six percent of the participants on the 3rd day and 22.5% of the participants on the 7th day reported any adverse event following the first dose of the vaccine. On both follow-up days, the most commonly reported (29.7% for Day 3 and 13.1% for Day 7) adverse events were on the injection site. Among the local adverse events, the most frequently reported one was the pain on the injection site (27.9% for Day 3 and 12.4% for Day 7), induration (4.8% for Day 3 and 2.7% for Day 7) and swelling (3.5% for Day 3 and 2.0% for Day 7). Fatigue/weakness (9.6% for Day 3 and 8.3% for Day 7) and headache (7.9% for Day 3 and 8.0% for Day 7) were the most frequent systemic adverse events. Younger age, vaccine dose, and female sex were associated with having any adverse event and pain (on the injection site). Female sex was associated with more swelling (on the injection site), induration (on the injection site), fever, and a higher impact on daily living. CONCLUSION(S): In this study, we conducted a rapid assessment of adverse events following the first dose of the TURKOVAC vaccine. The vaccine appears to have a good safety profile in the first 7 days following vaccination. Younger age, vaccine dose, and female sex are associated with any adverse event and pain (on the injection site). These results present valuable information for the community and may contribute to increasing vaccine confidence.KEY MESSAGESAs a whole-virion inactivated SARS-CoV-2 vaccine, the TURKOVAC™ vaccine, which has a favorable safety profile, can be an alternative to other COVID-19 vaccines including mRNA and viral vector vaccines.
Subject(s)
COVID-19 Vaccines , COVID-19 , Female , Humans , Antibodies, Viral , Cohort Studies , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Pain , SARS-CoV-2 , TelephoneABSTRACT
BACKGROUND: Adult-onset Still's disease (AOSD) is a multi-system, auto-inflammatory disease characterized by fever, arthralgia, typical rash, leukocytosis, sore throat, and liver dysfunction, among other symptoms. Retrospective studies about the frequencies of AOSD have shown that this disease is very rare. However, there has been an increased scientific interest in the last 2 years, as numerous case studies on AOSD have been published. These case studies describe the occurrence of AOSD after SARS-CoV-2 infection and/or COVID-19 vaccination. METHODS: We analyzed the incidence of AOSD to examine a potential association between AOSD and SARS-CoV-2 infection and/or COVID-19 vaccination. The TriNetX dataset consists of 90 million patients. We found 8474 AOSD cases, which we analyzed regarding SARS-CoV-2 infection and/or vaccination status. We also analyzed the cohorts considering demographic data, lab values, co-diagnoses and treatment pathways. RESULTS: We divided the AOSD cases into four cohorts: primary cohort (AOSD), Cov cohort (AOSD + SARS-CoV-2 infection), Vac cohort (AOSD + COVID-19 vaccination) and Vac + Cov cohort (AOSD + COVID-19 vaccination + SARS-CoV-2 infection). For the primary cohort, we found an annual incidence of 0.35 per 100.000. We found an association between AOSD and SARS-CoV-2 infection and/or COVID-19 vaccination. According to the numerical analysis, the incidence of AOSD doubled for the Cov cohort and Vac cohort. Moreover, the incidence of AOSD was 4.82 times higher for Vac + Cov cohort. The lab values for inflammatory markers were increased. Co-diagnoses such as rash, sore throat, and fever appeared in all AOSD cohorts, with the highest occurrences in the AOSD + COVID-19 vaccination + SARS-CoV-2 infection cohort. We identified several lines of treatments, mainly in association with adrenal corticosteroids. CONCLUSIONS: This research supports the assumption of an association between AOSD and SARS-CoV-2 infection and/or COVID-19 vaccination. However, AOSD remains a rare disease and the usage of vaccines to fight the COVID-19 pandemic should not be questioned because of the increased incidence of AOSD.
Subject(s)
COVID-19 Vaccines , COVID-19 , Still's Disease, Adult-Onset , Adult , Humans , COVID-19/complications , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Incidence , Retrospective Studies , Still's Disease, Adult-Onset/chemically induced , Still's Disease, Adult-Onset/diagnosis , Vaccination/adverse effectsABSTRACT
Background: People with multiple sclerosis (pwMS) on anti-CD20 therapies (aCD20) and fingolimod have shown inadequate humoral responses to COVID-19 vaccines. Objective: The objective of the study was to pilot larger studies by demonstrating the safety and comparing the immunogenicity of different types of third doses in seronegative pwMS after two doses of BBIBP-CorV inactivated vaccine. Methods: In December 2021, subject to receiving their third dose, being COVID-19-naiive, and receiving no corticosteroid within two months, we measured the level of anti-SARS-CoV-2-Spike IgG in pwMS seronegative after two shots of BBIBP-CorV inactivated vaccine. Results: We included 20/29 pwMS who received adenoviral vector (AV), 7/29 who received inactivated, and 2/29 who received conjugated third doses. No serious adverse events were reported two weeks post-third dose. The pwMS receiving AV third doses showed significantly increased IgG concentrations, while only the ones not on aCD20 and fingolimod responded to inactivated third doses. An ordinal logistic multivariable generalized linear model indicated that age (per year ß: -0.10, P = 0.04), type of disease-modifying therapy (aCD20 ß: -8.36, P <0.01; fingolimod ß: -8.63, P = 0.01; others: reference), and type of third dose (AV or conjugated ß: 2.36, P = 0.02; inactivated: reference) are predictive of third dose immunogenicity among pwMS who remain seronegative after two shots of BBIBP-CorV vaccine. Statistical significance was not achieved for variables sex, MS duration, EDSS, duration of DMT, duration of third dose to IgG test, and duration from last aCD20 infusion to third dose. Conclusion: This preliminary pilot study highlights the need for further research to determine the optimal COVID-19 third dose vaccination strategy for pwMS living in areas where BBIBP-CorV vaccine has been used.
Subject(s)
COVID-19 , Multiple Sclerosis , Humans , COVID-19 Vaccines/adverse effects , Pilot Projects , Fingolimod Hydrochloride/adverse effects , Multiple Sclerosis/drug therapy , COVID-19/prevention & control , Antibodies, Viral , Immunoglobulin G , Vaccines, Inactivated/adverse effectsABSTRACT
Objective: To explore the safety of inactivated novel coronavirus vaccine inoculation and the fluctuating neutralizing antibody in patients with chronic hepatitis B (CHB). Methods: Retrospective and prospective epidemiological research methods were employed. 153 CHB patients who visited the Department of Infectious Diseases at the First Hospital of Shanxi Medical University from September 2021 to February 2022 were selected as the research subjects. Information on vaccination-related adverse reactions was collected. Colloidal gold immunochromatography was used to identify neutralizing antibodies in the body after 3-6 months of vaccination. Statistical analysis was performed using the χ2-test or Fisher's exact test. Results: The positive rates of neutralizing antibodies after inactivated novel coronavirus vaccine inoculation in 153 patients with CHB were 45.50%, 44.70%, 40.00% and 16.20%, respectively, at 3, 4, 5, and 6 months. The neutralizing antibody concentrations were 10.00 (2.95, 30.01) U/ml, 6.08 (3.41, 24.50) U/ml, 5.90 (3.93, 14.68) U/ml, and 1.25 (0.92, 3.75) U/ml, respectively. The difference was not statistically significant (P>0.05) when the neutralizing antibody positivity rates in hepatitis B virus (HBV) DNA-negative and positive patients and HBeAg-negative and positive patients at different time points were compared. The overall incidence of adverse reactions following vaccination was 18.30%. Pain at the site of inoculation and fatigue were the main presentations, and no serious adverse reactions occurred. Conclusion: CHB patients, when inoculated with an inactivated novel coronavirus vaccine, can produce neutralizing antibodies, which can stay at certain levels for 3, 4, and 5 months. However, the neutralizing antibody level gradually decreases over time, and the decrease is remarkable at 6 months. So, it is recommended to boost vaccinations at an appropriate time. Additionally, the results of the study suggest that HBV replication status has little effect on the production of neutralizing antibodies in CHB patients with relatively stable liver function, which means the inactivated novel coronavirus vaccine has a good safety profile.
Subject(s)
COVID-19 Vaccines , COVID-19 , Hepatitis B, Chronic , Humans , Antibodies, Neutralizing , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Prospective Studies , Retrospective Studies , SARS-CoV-2 , Vaccination , Vaccines, InactivatedABSTRACT
mRNA-based vaccines dramatically reduce the occurrence and severity of COVID-19, but are associated with rare vaccine-related adverse effects. These toxicities, coupled with observations that SARS-CoV-2 infection is associated with autoantibody development, raise questions whether COVID-19 vaccines may also promote the development of autoantibodies, particularly in autoimmune patients. Here we used Rapid Extracellular Antigen Profiling to characterize self- and viral-directed humoral responses after SARS-CoV-2 mRNA vaccination in 145 healthy individuals, 38 patients with autoimmune diseases, and 8 patients with mRNA vaccine-associated myocarditis. We confirm that most individuals generated robust virus-specific antibody responses post vaccination, but that the quality of this response is impaired in autoimmune patients on certain modes of immunosuppression. Autoantibody dynamics are remarkably stable in all vaccinated patients compared to COVID-19 patients that exhibit an increased prevalence of new autoantibody reactivities. Patients with vaccine-associated myocarditis do not have increased autoantibody reactivities relative to controls. In summary, our findings indicate that mRNA vaccines decouple SARS-CoV-2 immunity from autoantibody responses observed during acute COVID-19.
Subject(s)
Autoimmune Diseases , COVID-19 Vaccines , COVID-19 , Immunity, Humoral , Vaccines, Synthetic , mRNA Vaccines , Humans , Antibodies, Viral/immunology , Autoantibodies/immunology , Autoimmune Diseases/immunology , Autoimmunity/immunology , COVID-19/immunology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/immunology , COVID-19 Vaccines/therapeutic use , Drug-Related Side Effects and Adverse Reactions/immunology , Immunity, Humoral/immunology , Myocarditis/immunology , RNA, Messenger , SARS-CoV-2 , Vaccination , Vaccines, Synthetic/adverse effects , Vaccines, Synthetic/immunology , Vaccines, Synthetic/therapeutic use , mRNA Vaccines/adverse effects , mRNA Vaccines/immunology , mRNA Vaccines/therapeutic useABSTRACT
Parsonage-Turner syndrome (PTS) is a peripheral neuropathy involving the brachial plexus very rare in childhood. To date, no cases of PTS after COVID-19 vaccination have been reported in children. We report a case of a 15-year-old boy affected by PTS after the second dose of the BNT162b2 (Comirnaty, Pfizer-BioNTech) COVID-19 vaccine.
Subject(s)
Brachial Plexus Neuritis , COVID-19 , Male , Humans , Child , Adolescent , Brachial Plexus Neuritis/etiology , COVID-19 Vaccines/adverse effects , BNT162 Vaccine , COVID-19/prevention & control , Vaccination/adverse effectsABSTRACT
BACKGROUND: To determine the immunogenicity, efficacy, reactogenicity, and safety of a single dose of recombinant adenovirus type-5 vectored COVID-19 vaccine (Ad5-nCoV, 5 × 1010 viral particles per 0.5 mL dose), we conducted a single-dose, randomised, double-blind, placebo-controlled, parallel group (3:1 Ad5-nCoV:placebo), phase 3 trial (Prometheus). METHODS: From 11-September-2020 to 05-May-2021, across six sites in the Russian Federation, 496 participants were injected with either placebo or Ad5-nCoV expressing the full-length spike (S) protein from the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). RESULTS: Seroconversion (the primary endpoint) rates of 78.5% (95% CI: 73.9; 82.6) against receptor binding domain (RBD), 90.6% (95% CI: 87.2; 93.4) against S protein and 59.0% (95% CI: 53.3; 64.6) seroconversion of neutralising antibodies against SARS-CoV-2 at 28 days post-vaccination were observed. Geometric mean titres (GMTs) were also elevated for antibodies against the RBD (405 [95% CI: 366; 449]) and S protein (677 [95% CI: 608; 753]) compared to the GMT of neutralising antibodies against SARS-CoV-2 (16.7 [95% CI: 15.3; 18.3]). Using an IFN-γ ELISpot assay after stimulating the cells with recombinant S protein ectodomain we showed that the Ad5-nCoV vaccine induced the most robust cellular immune response on Days 14 and 28. Up to Day 28, the primary and all secondary endpoints of the Ad5-nCoV vaccine were statistically significant compared with the placebo (Ñ<0.001). Systemic reactions were reported in 113 of 496 (22.8%) participants (Ad5-nCoV, 26.9%; Placebo, 10.5%), and local reactions were reported in 108 (21.8%) participants (Ad5-nCoV, 28.5%; Placebo, 1.6%). These were generally mild and resolved within 7 days after vaccination. Of the six serious adverse events reported, none of the events were vaccine related. There were no deaths or premature withdrawals. CONCLUSION: A single-dose of Ad5-nCoV vaccine induced a marked specific humoral and cellular immune response with a favourable safety profile. TRIAL REGISTRATION: Trial registration: ClinicalTrials.gov: NCT04540419.
Subject(s)
Adenoviridae Infections , COVID-19 , Adult , Humans , COVID-19 Vaccines/adverse effects , Adenoviridae/genetics , COVID-19/prevention & control , SARS-CoV-2 , Antibodies, Neutralizing , Antibodies, Viral , Double-Blind Method , Immunogenicity, VaccineABSTRACT
OBJECTIVE: To compare the risk of SARS-CoV-2 infection and its related severe sequelae between patients with systemic lupus erythematosus (SLE) and the general population according to COVID-19 vaccination status. METHODS: We performed cohort studies using data from The Health Improvement Network to compare the risks of SARS-CoV-2 infection and severe sequelae between patients with SLE and the general population. Individuals aged 18-90 years with no previously documented SARS-CoV-2 infection were included. We estimated the incidence rates and HRs of SARS-CoV-2 infection and severe sequelae between patients with SLE and the general population according to COVID-19 vaccination status using exposure score overlap weighted Cox proportional hazards model. RESULTS: We identified 3245 patients with SLE and 1 755 034 non-SLE individuals from the unvaccinated cohort. The rates of SARS-CoV-2 infection, COVID-19 hospitalisation, COVID-19 death and combined severe outcomes per 1000 person-months were 10.95, 3.21, 1.16 and 3.86 among patients with SLE, and 8.50, 1.77, 0.53 and 2.18 among general population, respectively. The corresponding adjusted HRs were 1.28 (95% CI: 1.03 to 1.59), 1.82 (95% CI: 1.21 to 2.74), 2.16 (95% CI: 1.00 to 4.79) and 1.78 (95% CI: 1.21 to 2.61). However, no statistically significant differences were observed between vaccinated patients with SLE and vaccinated general population over 9 months of follow-up. CONCLUSION: While unvaccinated patients with SLE were at higher risk of SARS-CoV-2 infection and its severe sequelae than the general population, no such difference was observed among vaccinated population. The findings indicate that COVID-19 vaccination provides an adequate protection to most patients with SLE from COVID-19 breakthrough infection and its severe sequelae.
Subject(s)
COVID-19 Vaccines , COVID-19 , Lupus Erythematosus, Systemic , Humans , COVID-19/complications , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Disease Progression , Lupus Erythematosus, Systemic/complications , Lupus Erythematosus, Systemic/epidemiology , SARS-CoV-2ABSTRACT
The coronavirus disease 2019 (COVID-19) pandemic has had a large effect on the pediatric population, with 16,000,000 cases and counting. Currently, there are two messenger RNA (mRNA)-based and a single adjuvanted, protein-based COVID-19 vaccine approved for use in children and adolescents in the United States. Multiple studies have highlighted that these vaccines are safe for use in children and adolescents and are effective at reducing COVID-19 infection and complications. Given the risk of the SARS-CoV-2 virus to the pediatric population and ongoing global viral transmission, it is advised that providers emphasize the value of COVID-19 vaccination for children and adolescents. [Pediatr Ann. 2023;52(3):e83-e88.].
Subject(s)
COVID-19 Vaccines , COVID-19 , Child , Adolescent , Humans , COVID-19 Vaccines/adverse effects , COVID-19/epidemiology , COVID-19/prevention & control , SARS-CoV-2 , Pandemics , VaccinationABSTRACT
Increasing evidence suggests an association between SARS-CoV-2 vaccines and Guillain-Barré syndrome (GBS). Nevertheless, little is understood about the contributing risk factors and clinical characteristics of GBS post SARS-CoV-2 vaccination. In this prospective surveillance study of 38,828,691 SARS-CoV-2 vaccine doses administered from February 2021 to March 2022 in the Gyeonggi Province, South Korea, 55 cases of GBS were reported post vaccination. We estimated the incidence rate of GBS per million doses and the incidence rate ratio for the vaccine dose, mechanism, age, and sex. Additionally, we compared the clinical characteristics of GBS following mRNA-based and viral vector-based vaccinations. The overall incidence of GBS following SARS-CoV-2 vaccination was 1.42 per million doses. Viral vector-based vaccines were associated with a higher risk of GBS. Men were more likely to develop GBS than women. The third dose of vaccine was associated with a lower risk of developing GBS. Classic sensorimotor and pure motor subtypes were the predominant clinical subtypes, and demyelinating type was the predominant electrodiagnostic subtype. The initial dose of viral-vector based vaccine and later doses of mRNA-based vaccine were associated with GBS, respectively. GBS following SARS-CoV-2 vaccination may not be clinically distinct. However, physicians should pay close attention to the classic presentation of GBS in men receiving an initial dose of viral vector-based SARS-CoV-2 vaccines.
Subject(s)
COVID-19 , Guillain-Barre Syndrome , Viral Vaccines , Male , Humans , Female , Incidence , COVID-19 Vaccines/adverse effects , SARS-CoV-2 , Guillain-Barre Syndrome/epidemiology , Guillain-Barre Syndrome/etiology , Prospective Studies , COVID-19/epidemiology , COVID-19/prevention & control , Vaccination/adverse effects , RNA, MessengerABSTRACT
This case reports a woman in her 40s with a history of allergic reaction to shellfish and iodine who presented with tongue angioedema, difficulty breathing and chest tightness after receiving the first dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine. Her angioedema remained for 10 days post-exposure to the vaccine, requiring 3 days of epinephrine infusion. She was discharged with advice to avoid further mRNA vaccines. This case highlights the increasing awareness needed of polyethylene glycol (PEG) allergy and the protracted nature of her reaction. A firm conclusion cannot be reached based on a single case report. More research is needed to understand whether there is a causal relationship between the BNT162b2 vaccine and PEG allergy. Awareness regarding PEG allergy and the complexities associated with it is important and needs to be raised due to its prevalent use in diverse industries.