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1.
Vaccine ; 2022.
Article in English | ScienceDirect | ID: covidwho-2004584

ABSTRACT

Introduction In 2020, prior to COVID-19 vaccine rollout, the Brighton Collaboration created a priority list, endorsed by the World Health Organization, of potential adverse events relevant to COVID-19 vaccines. We adapted the Brighton Collaboration list to evaluate serious adverse events of special interest observed in mRNA COVID-19 vaccine trials. Methods Secondary analysis of serious adverse events reported in the placebo-controlled, phase III randomized clinical trials of Pfizer and Moderna mRNA COVID-19 vaccines in adults (NCT04368728 and NCT04470427), focusing analysis on Brighton Collaboration adverse events of special interest. Results Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95 % CI −0.4 to 20.6 and −3.6 to 33.8), respectively. Combined, the mRNA vaccines were associated with an excess risk of serious adverse events of special interest of 12.5 per 10,000 vaccinated (95 % CI 2.1 to 22.9);risk ratio 1.43 (95 % CI 1.07 to 1.92). The Pfizer trial exhibited a 36 % higher risk of serious adverse events in the vaccine group;risk difference 18.0 per 10,000 vaccinated (95 % CI 1.2 to 34.9);risk ratio 1.36 (95 % CI 1.02 to 1.83). The Moderna trial exhibited a 6 % higher risk of serious adverse events in the vaccine group: risk difference 7.1 per 10,000 (95 % CI –23.2 to 37.4);risk ratio 1.06 (95 % CI 0.84 to 1.33). Combined, there was a 16 % higher risk of serious adverse events in mRNA vaccine recipients: risk difference 13.2 (95 % CI −3.2 to 29.6);risk ratio 1.16 (95 % CI 0.97 to 1.39). Discussion The excess risk of serious adverse events found in our study points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes. These analyses will require public release of participant level datasets.

2.
Cureus Journal of Medical Science ; 14(7), 2022.
Article in English | Web of Science | ID: covidwho-1998012

ABSTRACT

Pityriasis rosea (PR) is an acute self-limiting exanthematous skin disorder characterized by the presence of a primary solitary lesion called a herald patch and the subsequent development of diffuse papulosquamous lesions within 1 to 2 weeks. This is a case of COVID-19 vaccine-induced PR in the age group (12-18 years) that was recently approved for vaccination. We report a case of a 15-year-old otherwise healthy female with a history of 2 weeks of single oval primary plaque appearing on the right wrist 2 days after receiving the second dose of Pfizer-BioNTech vaccine, followed by diffuse and mild itchy skin eruptions spreading over the abdomen, back, chest, and extremities. The patient had no other symptoms and no PR risk factors. The patient was placed on 800 mg acyclovir five times a day and improved markedly after 1 week. As vaccine -induced PR/PR-like eruptions (PR-LE) is an uncommon phenomenon, we recommend further studies to determine the association between PR/PR-LE and COVID-19 vaccination.

3.
Alexandria Engineering Journal ; 61(12):12091-12110, 2022.
Article in English | Web of Science | ID: covidwho-1995938

ABSTRACT

Recent studies regarding COVID-19 show a growing tendency to talk about the COVID-19 Pandemic on online channels. With the recent release of the Pfizer vaccine of COVID-19, people keep posting many rumors regarding the safety concerns of the Vaccine, especially among older people. Due to the rapid spread of the COVID-19 virus and the worldwide Pandemic developed, the rush to develop the COVID-19 Vaccine has become an alarming priority in health care services worldwide. In this research work, we have systematically evaluated people's views towards the COVID-19 Vaccine, and shreds of evidence are supported empirically. The study mainly focuses on the empirical evidence and intensive discussions on what is currently known about the mechanism of action, efficacy, and toxicity of the most promising vaccines (Moderna), (Pfizer/BioNtech), (Astrazenac/Oxford), and (Sputnik V) against COVID-19. Our study's primary objective is to provide an analysis of the questionnaire regarding people's opinions, preferences, and acceptance of the COVID-19 vaccines. We have created an online questionnaire using a google form to collect data from various countries supposed to employ COVID-19 vaccines. The questionnaires were distributed to people in many Arab and foreign countries such as Egypt, Saudi Arabia, India, England, China, and Japan. A total of 516 responses were returned and analyzed using statistical, and Seasonal Autoregressive Integrated Moving Average (SARIMA) approaches. The SARIMA model is used to predict the total number of vaccines in the next few days. To attain the most accurate forecast and prediction, the SARIMA model parameters are investigated with a grid search method. Finally, the combination of the parameters (1, 0, 1) x (1, 0, 0, 1) is considered to be the best SAR-IMA model because it has the lowest AIC values of - 4100.11 and the best Correlation coefficients of 0.984. (C) 2022 THE AUTHORS. Published by Elsevier BV on behalf of Faculty of Engineering, Alexandria University This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

4.
J Virol ; : e0058222, 2022 Aug 17.
Article in English | MEDLINE | ID: covidwho-1992936

ABSTRACT

Emerging variants, especially the recent Omicron variant, and gaps in vaccine coverage threaten mRNA vaccine mediated protection against SARS-CoV-2. While children have been relatively spared by the ongoing pandemic, increasing case numbers and hospitalizations are now evident among children. Thus, it is essential to better understand the magnitude and breadth of vaccine-induced immunity in children against circulating viral variant of concerns (VOCs). Here, we compared the magnitude and breadth of humoral immune responses in adolescents and adults 1 month after the two-dose Pfizer (BNT162b2) vaccination. We found that adolescents (aged 11 to 16) demonstrated more robust binding antibody and neutralization responses against the wild-type SARS-CoV-2 virus spike protein contained in the vaccine compared to adults (aged 27 to 55). The quality of the antibody responses against VOCs in adolescents were very similar to adults, with modest changes in binding and neutralization of Beta, Gamma, and Delta variants. In comparison, a significant reduction of binding titers and a striking lack of neutralization was observed against the newly emerging Omicron variant for both adolescents and adults. Overall, our data show that a two-dose BNT162b2 vaccine series may be insufficient to protect against the Omicron variant. IMPORTANCE While plasma binding and neutralizing antibody responses have been reported for cohorts of infected and vaccinated adults, much less is known about the vaccine-induced antibody responses to variants including Omicron in children. This illustrates the need to characterize vaccine efficacy in key vulnerable populations. A third (booster) dose of BNTb162b was approved for children 12 to 15 years of age by the Food and Drug Administration (FDA) on January 1, 2022, and pediatric clinical trials are under way to evaluate the safety, immunogenicity, and effectiveness of a third dose in younger children. Similarly, variant-specific booster doses and pan-coronavirus vaccines are areas of active research. Our data show adolescents mounted stronger humoral immune responses after vaccination than adults. It also highlights the need for future studies of antibody durability in adolescents and children as well as the need for future studies of booster vaccination and their efficacy against the Omicron variant.

5.
J Neuroimmunol ; 368: 577883, 2022 07 15.
Article in English | MEDLINE | ID: covidwho-1991160

ABSTRACT

INTRODUCTION: Large-scale vaccination is considered one of the most effective strategies to control the pandemic of COVID-19. Since its start, different complications have been described thought to be related to vaccination. Here, we present a rare case where encephalopathy, myocarditis, and thrombocytopenia developed simultaneously following the second dose of Pfizer-BioNTech mRNA vaccine (BNT162b2). CASE PRESENTATION: A 15-years-old female presented with fever, altered consciousness, and convulsions after taking the second shot of the vaccine. Clinical and laboratory workup was notable for the presence of thrombocytopenia and myocarditis. No alternative causes of encephalitis were found. The patient responded significantly to methylprednisolone suggesting underlying immune pathogenesis responsible for the clinical features. The diagnostic criteria for possible autoimmune encephalitis were also fulfilled. CONCLUSION: Although rare, the clinician should be aware of the possible adverse events following COVID-19 vaccination. Further research with large pooled data is needed to get more insight into its pathogenesis and causal relationship.


Subject(s)
Brain Diseases , COVID-19 , Encephalitis , Myocarditis , Thrombocytopenia , Adolescent , BNT162 Vaccine , COVID-19 Vaccines/adverse effects , Encephalitis/complications , Female , Humans , Methylprednisolone/therapeutic use , Myocarditis/diagnosis , Myocarditis/etiology , Thrombocytopenia/chemically induced , Vaccines, Synthetic , mRNA Vaccines
6.
Cir Cir ; 90(3): 410-413, 2022.
Article in English | MEDLINE | ID: covidwho-1988867

ABSTRACT

The differential diagnosis of the metastatic axillary lymphadenopathies of breast cancer with which they occur secondary to the Pfizer-BioNTech vaccine against COVID-19, is imperative. In a series of cases, we analyzed the characteristics of unilateral axillary lymphadenopathy in patients after Pfizer-BioNTech vaccination. Axillary lymphadenopathy were observed ipsilateral to the vaccination arm. The axillary ultrasound defined these as reactive and that they disappeared in 3 weeks. The pathological findings were benign. The anamnesis, the place and date of vaccination and the radiological findings, play an essential role to carry out a correct differential diagnosis and follow-up of these adenopathies.


El diagnóstico diferencial de las adenopatías axilares metastásicas del cáncer de mama con las que se producen secundarias a la vacuna de Pfizer-BioNTech contra la COVID-19 es imperioso. Analizamos una serie de casos con las características de las adenopatías axilares unilaterales tras la administración de la vacuna de Pfizer-BioNTech. Se observaron adenopatías axilares homolaterales al brazo de vacunación. La ecografía axilar las definió como reactivas y que desaparecían en 3 semanas. Los hallazgos anatomopatológicos fueron de benignidad. La anamnesis, el lugar y la fecha de vacunación, así como los hallazgos radiológicos, desempeñan un papel esencial para realizar un correcto diagnóstico deferencial y el seguimiento de estas adenopatías.


Subject(s)
Breast Neoplasms , COVID-19 , Lymphadenopathy , Breast Neoplasms/pathology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Female , Humans , Lymphadenopathy/etiology , Lymphatic Metastasis , SARS-CoV-2 , Vaccination
7.
Clin Infect Dis ; 2022 Aug 04.
Article in English | MEDLINE | ID: covidwho-1973128

ABSTRACT

BACKGROUND: Multisystem inflammatory syndrome in children (MIS-C), linked to antecedent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, is associated with considerable morbidity. Prevention of SARS-CoV-2 infection or coronavirus disease 2019 (COVID-19) by vaccination might also decrease MIS-C likelihood. METHODS: In a multicenter case-control public health investigation of children ages 5-18 years hospitalized from July 1, 2021 to April 7, 2022, we compared the odds of being fully vaccinated (two doses of BNT162b2 vaccine ≥28 days before hospital admission) between MIS-C case-patients and hospital-based controls who tested negative for SARS-CoV-2. These associations were examined by age group, timing of vaccination, and periods of Delta and Omicron variant predominance using multivariable logistic regression. RESULTS: We compared 304 MIS-C case-patients (280 [92%] unvaccinated) with 502 controls (346 [69%] unvaccinated). MIS-C was associated with decreased likelihood of vaccination (aOR, 0.16 95% CI, 0.10-0.26), including among children ages 5-11 years (aOR, 0.22 95% CI, 0.10-0.52), ages 12-18 years (aOR, 0.10 95% CI, 0.05-0.19), and during the Delta (aOR, 0.06 95% CI, 0.02-0.15) and Omicron (aOR, 0.22 95% CI, 0.11-0.42) variant-predominant periods. This association persisted beyond 120 days after the second dose (aOR, 0.08, 95% CI, 0.03-0.22) in 12-18 year-olds. Among all MIS-C case-patients, 187 (62%) required intensive care unit admission and 280 (92%) vaccine-eligible patients were unvaccinated. CONCLUSIONS: Vaccination with two doses of BNT162b2 is associated with reduced likelihood of MIS-C in children ages 5-18 years. Most vaccine eligible hospitalized patients with MIS-C were unvaccinated.

8.
Int J Retina Vitreous ; 8(1): 43, 2022 Jun 20.
Article in English | MEDLINE | ID: covidwho-1968769

ABSTRACT

BACKGROUND: The present case aims to describe a previously healthy man who presented multiple attacks of transient monocular visual loss after Pfizer-BioNTech COVID-19 vaccination and to discuss the possible mechanisms related to occurrence of this condition. CASE PRESENTATION: We report a case of multiple attacks of transient monocular visual loss in a previously healthy middle-aged man two weeks after Pfizer-BioNTech COVID-19 vaccination. TVL attacks were described as sudden and painless complete visual loss, lasting about one minute, followed by a full recovery. He presented several non-simultaneous attacks in both eyes, 16 in the right eye, and 2 in the left eye on the same day, fifteen days after receiving the second dose of the Pfizer-BioNTech COVID-19 vaccine. The brain's magnetic resonance angiography, echocardiogram, and doppler ultrasound imaging of the carotid and vertebral arteries were non-revealing. The complete blood exam revealed a slightly elevated C-reactive protein test. We assessed fundus examination during the transient visual loss attack and revealed diffuse vascular narrowing for both arterial and venous branches, notably in the emergence of the optic disc in right eye. In addition, the circumpapillary optical coherence tomography angiography (OCTA) vessel density map was reduced. Oral verapamil hydrochloride 60 mg twice daily was initiated, and the attacks of transient visual loss improved after two days. CONCLUSIONS: To date, and the best of our knowledge, this is the first case report of multiple transient monocular visual loss attacks due to retinal vasospasm in a previously healthy middle-aged man documented by fundus retinography and OCTA. We discuss in this article the possible association of retinal vasospasm and Pfizer-BioNTech COVID-19 vaccination, probably related to vaccine-induced inflammation.

9.
Basic Clin Androl ; 32(1): 13, 2022 Aug 02.
Article in English | MEDLINE | ID: covidwho-1968543

ABSTRACT

BACKGROUND: The possible effects of COVID-19 vaccines on reproductive health and male fertility in particular have been discussed intensely by the scientific community and the public since their introduction during the pandemic. On news outlets and social media platforms, many claims have been raised regarding the deleterious effects of COVID-19 vaccines on sperm quality without scientific evidence. In response to this emerging conflict, we designed this study to evaluate and assess the effect of the Pfizer-BioNTech mRNA COVID-19 vaccine on male fertility represented by the semen analysis parameters. RESULTS: Comparing the semen parameters of the participants before and after vaccination, no statistically significant effects on semen volume, pH or normal sperm concentration and morphology were shown. However, there were statistically significant differences on total sperm motility (P = 0.05) and progressive motility (P = 0.02). These differences are clinically insignificant given the fact that both readings before and after vaccination were within the normal ranges, according to the WHO manual guidelines for the examination and processing of human semen. CONCLUSION: Our data suggest that the Pfizer-BioNTech mRNA COVID-19 vaccine has no deleterious effects on semen parameters.


RéSUMé: CONTEXTE: Les effets possibles des vaccins contre la COVID-19 sur la santé reproductive et la fertilité masculine, en particulier, ont fait l'objet d'intenses discussions de la part de la communauté scientifique et du public depuis leur introduction pendant la pandémie. Sur les médias et les plateformes de médias sociaux, de nombreuses allégations ont été soulevées concernant les effets délétères des vaccins contre la COVID-19 sur la qualité du sperme, sans preuves scientifiques. En réponse à ce conflit émergent, nous avons conçu cette étude pour évaluer et déterminer l'effet du vaccin COVID-19 à ARNm de Pfizer-BioNTech sur la fertilité masculine représentée par les paramètres d'analyse du sperme. RéSULTATS: En comparant les paramètres du sperme des participants avant et après la vaccination, aucun effet statistiquement significatif sur le volume de sperme, le pH ou la concentration normale et la morphologie de spermatozoïdes, n'a été montré. Cependant, il y avait des différences statistiquement significatives sur la mobilité totale des spermatozoïdes (P = 0,05) et sur leur mobilité progressive (P = 0,02). Ces différences sont cliniquement insignifiantes étant donné que les deux lectures avant et après la vaccination se situaient dans des fourchettes normales, selon les directives manuelles de l'OMS pour l'examen et le traitement du sperme humain. CONCLUSION: Nos données indiquent que le vaccin à ARNm COVID-19 de Pfizer-BioNTech n'a aucun effet délétère sur les paramètres du sperme. MOTS-CLéS: COVID-19, Analyse du Sperme, Vaccin COVID-19 à ARNm de Pfizer-BioNTech, Infertilité masculine.

10.
Infect Agent Cancer ; 17(1): 40, 2022 Jul 28.
Article in English | MEDLINE | ID: covidwho-1962862

ABSTRACT

BACKGROUND: Both SARS-CoV-2 mRNA-based vaccines [BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna)] have shown high efficacy, with very modest side effects in limiting transmission of SARS-CoV-2 and in preventing the severe COVID-19 disease, characterized by a worrying high occupation of intensive care units (ICU), high frequency of intubation and ultimately high mortality rate. At the INT, in Naples, only the BNT162b2/Pfizer vaccine has been administered to cancer patients and healthcare professionals aged 16 and over. In the present study, the antibody response levels and their decline were monitored in an interval of 6-9 months after vaccine administration in the two different cohorts of workers of the INT - IRCCS "Fondazione Pascale" Cancer Center (Naples, Italy): the group of individuals previously infected with SARS-CoV-2 and vaccinated with a single dose; and that of individuals negative for previous exposure to SARS-CoV-2 vaccinated with two doses 21 days apart. METHODS: Specific anti-RBD (receptor-binding domain) titers against trimeric spike glycoprotein (S) of SARS-CoV-2 by Roche Elecsys Anti-SARS-CoV-2 S ECLIA immunoassay were determined in serum samples of 27 healthcare workers with a previously documented history of SARS-CoV-2 infection and 123 healthcare workers without, during antibody titers' monitoring. Moreover, geometric mean titers (GMT) and relative fold changes (FC) were calculated. RESULTS: Bimodal titer decline was observed in both previously infected and uninfected SARS-CoV-2 subjects. A first rapid decline was followed by a progressive slow decline in the 6/9 month-period before the further vaccine boost. The trend was explained by 2 different mathematical models, exponential and power function, the latter revealing as predictive of antibody titer decline either in infected or in not previously infected ones. The value of the prolonged lower vaccine titer was about 1 log below in the 6/9-month interval after the single dose for previously infected individuals with SARS-CoV-2 and the two doses for those not previously infected. The titer change, after the boost dose administration, on the other hand, was ≥ 1.5 FC higher than the titers at the 6/9-month time-points in both cohorts. A similar quantitative immune titer was observed in both cohorts 8 days after the last boost dose. The subsequent immunoresponse trend remains to be verified. DISCUSSION: The results show that a very rapid first decline, from the highest antibody peak, was followed by a very slow decline which ensured immune protection lasting more than 6 months. The apparent absence of adverse effects of the rapid decline on the vaccine's immune protective role has been related to a large majority of low avidity antibodies induced by current vaccines. High avidity antibodies with prolonged anti-transmission efficacy show a longer half-life and are lost over a longer interval period. The cellular immunity, capable of preventing severe clinical diseases, lasts much longer. The unbalanced dual activity (cellular vs humoral) while effective in limiting ICU pressure and overall mortality, does not protect against transmission of SARS-CoV-2, resulting in high circulation of the virus among unvaccinated subjects, including the younger population, and the continuous production of variants characterized by changes in transmissibility and pathogenicity. The high mutation rate, peculiar to the RNA virus, can however lead to a dual opposite results: selection of defective and less efficient viruses up to extinction; risk of more efficiently transmitted variants as the current omicron pandemic. CONCLUSIONS: In conclusion the current bimodal antibody-titer decline, following BNT162b2 mRNA anti-SARS-CoV-2 vaccination, needs a further extended analysis to verify the protective borderline levels of immunity and the optimal administration schedule of vaccine boosters. Our current results can contribute to such goal, besides a direct comparison of other FDA-approved and candidate vaccines.

11.
J Hematol Oncol ; 15(1): 54, 2022 05 07.
Article in English | MEDLINE | ID: covidwho-1951282

ABSTRACT

BACKGROUND: The clinical efficacy of SARS-CoV-2 vaccines according to antibody response in immunosuppressed patients such as hematological patients has not yet been established. PATIENTS AND METHODS: A prospective multicenter registry-based cohort study conducted from December 2020 to December 2021 by the Spanish transplant and cell therapy group was used to analyze the relationship of antibody response at 3-6 weeks after full vaccination (2 doses) with breakthrough SARS-CoV-2 infection in 1394 patients with hematological disorders. RESULTS: At a median follow-up of 165 days after complete immunization, 37 out of 1394 (2.6%) developed breakthrough SARS-CoV-2 infection at median of 77 days (range 7-195) after full vaccination. The incidence rate was 6.39 per 100 persons-year. Most patients were asymptomatic (19/37, 51.4%), whereas only 19% developed pneumonia. The mortality rate was 8%. Lack of detectable antibodies at 3-6 weeks after full vaccination was the only variable associated with breakthrough infection in multivariate logistic regression analysis (Odds Ratio 2.35, 95% confidence interval 1.2-4.6, p = 0.012). Median antibody titers were lower in cases than in non-cases [1.83 binding antibody units (BAU)/mL (range 0-4854.93) vs 730.81 BAU/mL (range 0-56,800), respectively (p = 0.007)]. We identified 250 BAU/mL as a cutoff above which incidence and severity of the infection were significantly lower. CONCLUSIONS: Our study highlights the benefit of developing an antibody response in these highly immunosuppressed patients. Level of antibody titers at 3 to 6 weeks after 2-dose vaccination links with protection against both breakthrough infection and severe disease for non-Omicron SARS-CoV-2 variants.


Subject(s)
COVID-19 , Hematologic Diseases , Antibodies, Viral , BNT162 Vaccine , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/therapeutic use , Cohort Studies , Hematologic Diseases/complications , Hematologic Diseases/therapy , Humans , Prospective Studies , SARS-CoV-2
12.
Health Sci Rep ; 5(4): e740, 2022 Jul.
Article in English | MEDLINE | ID: covidwho-1935685

ABSTRACT

Background & Aims: The BioNTech-Pfizer vaccine is the only vaccine offered to children among all available vaccines. However, limited evidence is available about the clinical outcomes of COVID-19 vaccines, especially among children and adolescents. This review offers a comprehensive and up-to-date overview of the BioNTech-Pfizer vaccine's current information on children and adolescents. Methods: The review was conducted following the PRISMA guidelines; a comprehensive search was performed in PubMed, Scopus, MEDLINE, and EMBASE databases for research publications COVID-19 published between December 2019 and October 2021. All studies reporting on the outcomes of vaccinating children in their respective institutes were included. Results: A total of 78 vaccinated children and adolescents from six studies were included. The majority of symptomatic vaccinated pediatrics were males (71%). The mean age was 15.6 years, and the BMI was 24.1. The most common clinical symptoms were found in chest pain (35%), fever (32%), and myalgia (17%). The most common cardiac symptom in the EKG results was ST elevation, and 35% of vaccinated pediatrics had elevated serum troponin. The hospitalization, including ICU admission, was lower than in unvaccinated groups. Statistically significant associations (p ≤ 0.05) were found in two symptoms (fever and headache) between the vaccinated and nonvaccinated pediatric groups. Conclusions: Although we found better outcomes in the vaccinated group versus the nonvaccinated pediatric group, more studies are still crucial to further understand the specific etiology underlying postvaccination, particularly myocarditis, psychological impact, and other cardiac clinical symptoms in children and adolescents after receiving the BioNTech-Pfizer vaccine.

13.
Heart Fail Rev ; 2022 Apr 22.
Article in English | MEDLINE | ID: covidwho-1942219

ABSTRACT

Clinical course and outcomes of myocarditis after COVID-19 vaccination remain variable. We retrospectively collected data on patients > 12 years old from 01/01/2021 to 12/30/2021 who received COVID-19 messenger RNA (mRNA) vaccination and were diagnosed with myocarditis within 60 days of vaccination. Myocarditis cases were based on case definitions by authors. We report on 238 patients of whom most were male (n = 208; 87.1%). The mean age was 27.4 ± 16 (range 12-80) years. Females presented at older ages (41.3 ± 21.5 years) than men 25.7 ± 14 years (p = 0.001). In patients > 20 years of age, the mean duration from vaccination to symptoms was 4.8 days ± 5.5 days, but in < 20, it was 3.0 ± 3.3 days (p = 0.04). Myocarditis occurred most commonly after the Pfizer-BioNTech mRNA vaccine (n = 183; 76.45) and after the second dose (n = 182; 80%). Symptoms started 3.95 ± 4.5 days after vaccination. The commonest symptom was chest pain (n = 221; 93%). Patients were treated with non-steroidal anti-inflammatory drugs (n = 105; 58.3%), colchicine (n = 38; 21.1%), or glucocorticoids (n = 23; 12.7%). About 30% of the patients had left ventricular ejection fraction but more than half recovered the on repeat imaging. Abnormal cardiac MRIs were common; 168 patients (96% of 175 patients that had MRI) had late gadolinium enhancement, while 120 patients (68.5%) had myocardial edema. Heart failure guideline-directed medical therapy use was common (n = 27; 15%). Eleven patients had cardiogenic shock; and 4 patients required mechanical circulatory support. Five patients (1.7%) died; of these, 3 patients had endomyocardial biopsy/autopsy-confirmed myocarditis. Most cases of COVID-19 vaccine myocarditis are mild. Females presented at older ages than men and duration from vaccination to symptoms was longer in patients > 20 years. Cardiogenic shock requiring mechanical circulatory support was seen and mortality was low. Future studies are needed to better evaluate risk factors, and long-term outcomes of COVID-19 mRNA vaccine myocarditis.

14.
Clin Infect Dis ; 2022 May 27.
Article in English | MEDLINE | ID: covidwho-1927313

ABSTRACT

OBJECTIVES: Little is currently known about vaccine effectiveness (VE) for either two doses of Oxford-AstraZeneca (ChAdOx1) viral vector vaccine or CoronaVac inactivated viral vaccine followed by a third dose of mRNA vaccine (Pfizer/BioNTech) among healthcare workers (HCWs). METHODS: We conducted a retrospective cohort study among HCWs (aged ≥18 years) working in a private healthcare system in Brazil from January to December 2021. VE was defined as 1-IRR (incidence rate ratio), with IRR determined using Poisson models with the occurrence of laboratory-confirmed COVID-19 infection as the outcome, adjusting for age, sex, and job type. We compared those receiving viral vector or inactivated viral primary series (two doses) to those who received an mRNA booster. RESULTS: A total of 11,427 HCWs met the inclusion criteria. COVID-19 was confirmed in 31.5% of HCWs receiving two doses of CoronaVac vaccine vs. 0.9% of HCWs receiving two doses of CoronaVac vaccine with mRNA booster (p < 0.001), and 9.8% of HCWs receiving two doses of ChAdOx1 vaccine vs. 1% among HCWs receiving two doses of ChAdOx1 vaccine with mRNA booster (p < 0.001). In the adjusted analyses, the estimated VE was 92.0% for two CoronaVac vaccines plus mRNA booster, and 60.2% for two ChAdOx1 vaccines plus mRNA booster, when compared to those with no mRNA booster. Of 246 samples screened for mutations, 191 (77.6%) were Delta variants. CONCLUSIONS: While two doses of ChAdOx1 or CoronaVac vaccines prevent COVID-19, the addition of a Pfizer/BioNTech booster provided significantly more protection.

15.
Health Sci Rev (Oxf) ; 4: 100040, 2022 Sep.
Article in English | MEDLINE | ID: covidwho-1926485

ABSTRACT

Over the past decades, the rapid pace of vaccine development saved 37 million lives, mostly children. The ongoing corona virus disease (COVID-19) pandemic caused the death of more than 4 million worldwide. During 2020, to encounter the pandemic, scientists developed more than 300 vaccines projects against SARS-CoV (severe acute respiratory syndrome coronavirus 2). In 2021, the results emerging from the clinical trials led to the approval and rollout of few vaccines in different countries. To date, at least one dose of a COVID-19 vaccine has been received by more than 3.81 billion people worldwide, equal to about 49.7 percent of the world population. This review was written to the aim of providing a snapshot of COVID-19 disease, highlighting the well-known vaccines, and, finally understanding the effect of mix and match vaccines from different types.

16.
Ann Hematol ; 101(9): 2053-2067, 2022 Sep.
Article in English | MEDLINE | ID: covidwho-1919767

ABSTRACT

Prior studies of antibody response after full SARS-CoV-2 vaccination in hematological patients have confirmed lower antibody levels compared to the general population. Serological response in hematological patients varies widely according to the disease type and its status, and the treatment given and its timing with respect to vaccination. Through probabilistic machine learning graphical models, we estimated the conditional probabilities of having detectable anti-SARS-CoV-2 antibodies at 3-6 weeks after SARS-CoV-2 vaccination in a large cohort of patients with several hematological diseases (n= 1166). Most patients received mRNA-based vaccines (97%), mainly Moderna® mRNA-1273 (74%) followed by Pfizer-BioNTech® BNT162b2 (23%). The overall antibody detection rate at 3 to 6 weeks after full vaccination for the entire cohort was 79%. Variables such as type of disease, timing of anti-CD20 monoclonal antibody therapy, age, corticosteroids therapy, vaccine type, disease status, or prior infection with SARS-CoV-2 are among the most relevant conditions influencing SARS-CoV-2-IgG-reactive antibody detection. A lower probability of having detectable antibodies was observed in patients with B-cell non-Hodgkin's lymphoma treated with anti-CD20 monoclonal antibodies within 6 months before vaccination (29.32%), whereas the highest probability was observed in younger patients with chronic myeloproliferative neoplasms (99.53%). The Moderna® mRNA-1273 compound provided higher probabilities of antibody detection in all scenarios. This study depicts conditional probabilities of having detectable antibodies in the whole cohort and in specific scenarios such as B cell NHL, CLL, MM, and cMPN that may impact humoral responses. These results could be useful to focus on additional preventive and/or monitoring interventions in these highly immunosuppressed hematological patients.


Subject(s)
Antineoplastic Agents , COVID-19 , Antibodies, Monoclonal , Antibodies, Viral , BNT162 Vaccine , COVID-19/diagnosis , COVID-19/prevention & control , COVID-19 Vaccines , Early Detection of Cancer , Humans , SARS-CoV-2 , Vaccination
17.
Vaccines (Basel) ; 10(7)2022 Jul 05.
Article in English | MEDLINE | ID: covidwho-1917883

ABSTRACT

Recent studies have suggested that health constructs embraced by the Terror Management Theory (TMT) and the Basic Psychological Needs Theory (BPNT) may drive individuals' COVID-19 health-related decisions. This study examines the relationships between existential concerns (ECs; within the TMT), basic psychological needs (BPNs; within the BPNT) and COVID-19 vaccine hesitancy (VH), as well as the mediating role of negative attitudes toward COVID-19 vaccines. A cross-sectional survey was carried out from April to May 2021 on a sample of two hundred and eighty-seven adults (Mage = 36.04 ± 12.07; 59.9% females). Participants provided information regarding existential concerns, basic psychological needs, attitudes toward COVID-19 vaccines and vaccine hesitancy for Pfizer-BioNTech and AstraZeneca vaccines separately. Higher vaccine hesitancy (32.1%) and vaccine resistance (32.8%) rates were found for AstraZeneca than for Pfizer-BioNTech COVID-19 vaccine (22.3% and 10.1%, respectively). Structural equation modeling showed that existential concerns were related to Pfizer-BioNTech and AstraZeneca vaccine hesitancy both directly and indirectly through negative attitudes toward potential side effects of COVID-19 vaccines. The findings of the study confirm that the TMT is efficient in explaining COVID-19 vaccine hesitancy. Targeted efforts are needed to increase the acceptance of COVID-19 vaccines.

18.
Cureus ; 14(5): e25199, 2022 May.
Article in English | MEDLINE | ID: covidwho-1912107

ABSTRACT

The adverse effects of coronavirus disease 2019 (COVID-19) vaccines are somewhat common but rarely life-threatening. Diagnosing life-threatening vaccine-related adverse effects is heavily dependent on history taking and ruling out the other possible causes. Vaccine-related complications vary, so awareness of possible complications can lead to efficient management. We present the case of a 58-year-old woman with a history of schizophrenia who received the COVID-19 Pfizer vaccine and developed severe rhabdomyolysis. She required renal replacement therapy and fully recovered with possible transient autoimmune activity. This case highlights the importance of early awareness of adverse effects following vaccine administration and careful history taking and monitoring to avoid life-threatening conditions.

19.
Front Immunol ; 13: 817597, 2022.
Article in English | MEDLINE | ID: covidwho-1902977

ABSTRACT

Severe acute respiratory syndrome coronavirus (SARS-CoV)-2 emerged in China in 2019 and has since travelled the world infecting millions. SARS-CoV-2 causes Corona Virus Disease (COVID-19), that has to date taken over 4 million lives. The Kingdom of Bahrain's vaccine roll-out has consisted of Sinopharm's BBIBP-CorV (Sinopharm) and Pfizer/BioNtech's BNT162b2 (Pfizer/BioNtech). Testing for SARS-CoV-2 anti-Spike (S) antibodies is a useful technique in estimating an individual's immune protection against the infection. In this study we evaluated S antibody levels by electro-chemiluminescence immunoassay in 379 individuals double vaccinated with Sinopharm and 15 of whom were given a booster with the Pfizer/BioNtech vaccine. Among our double vaccinated cohort, we found a spectrum of S antibody levels. Indeed, we found that a significant proportion of individuals with low S antibody levels had clinical conditions, which were mainly immune-related disorders. Furthermore, a significant proportion of individuals with low S antibody levels were above 50 years of age. Finally, we observed a significant increase in S antibody levels after the Pfizer/BioNtech booster was administered. These findings reveal that while a large proportion of Sinopharm vaccinated individuals did not develop high levels of antibodies against the S protein, a booster dose of the Pfizer/BioNtech vaccine significantly enhances S antibody levels, revealing this "triple dose" vaccination strategy as a useful method of ensuring protective immunity against SARS-CoV-2.


Subject(s)
COVID-19 , Viral Vaccines , Antibodies, Viral , BNT162 Vaccine , COVID-19/prevention & control , Humans , SARS-CoV-2
20.
Ultrasound in Medicine & Biology ; 48:S65-S65, 2022.
Article in English | Academic Search Complete | ID: covidwho-1900237

ABSTRACT

The dilatation of the pampiniform plexus, the venous system that drains the testicle, causes varicocele. Varicocele thrombosis is rare, with few reported cases in the medical literature [1-6]. Patients may present with acute scrotal pain, mimicking a testicular torsion or strangulated hernia. Diagnosis is difficult, therefore, when based solely on clinical history and examination. Our objective is to present an unusual case of varicocele thrombosis, after Covid 19 vaccination. Ultrasonography (US) with Doppler interrogation is the first-line imaging choice for diagnosis [1]. The therapeutical management is primarily conservative;however, some cases might require surgery [1,6]. The Coronavirus 2019 pandemic stimulated the development of vaccines with unprecedented speed and employing novel technologies. Serious adverse effects remained low after worldwide vaccination [7,8]. We report the case of a 35-year-old male patient who presented in the Urology Department accusing intense, continuous scrotal pain and swelling, with onset the next day after receiving the second dose of an mRNA Covid-19 vaccine (BNT162b2, Cominarty, Pfizer/BioNTech). There were no associated urinary signs and no fever. The patient was a healthy young man, with no known malignancy or blood dyscrasia. He could not recall suffering any local trauma between the vaccination and the appearance of the symptoms. The clinical exam revealed a tender, scrotal swelling inferior to the left testicle. The ultrasound exam demonstrated homogenous, normal echogenic testicles without changes in vascularity on Doppler US. Multiple variceal dilatations with a spontaneous diameter of up to 5 mm were observed around the left testis. The lumen of several dilated veins appeared filled with echogenic debris. The blood flow was slow in the remaining veins, with a sluggish aspect. Continuous, progressive probe compression was applied, with no complete venous collapse observed. The greyscale aspect was consistent with partially obstructing thrombi. The venous filling defects were confirmed on Colour Doppler. No signs of thrombosis were present at the level of the spermatic cord or the inguinal canal. Pampiniform plexus thrombosis should be considered in the differential diagnosis of acute testicular pain. This case report reveals an unprecedented etiology of varicocele thrombosis, as a side effect of an mRNA SARS-COV2 vaccine. [ FROM AUTHOR] Copyright of Ultrasound in Medicine & Biology is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

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