Myocarditis after BNT162b2 Vaccination in Israeli Adolescents.
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ABSTRACT:
SUBMITTER: Witberg G
PROVIDER: S-EPMC9634859 | biostudies-literature | 2022 Nov
REPOSITORIES: biostudies-literature
Publications
Myocarditis after BNT162b2 Vaccination in Israeli Adolescents.
Witberg Guy G Magen Ori O Hoss Sara S Talmor-Barkan Yeela Y Richter Ilan I Wiessman Maya M Aviv Yaron Y Grinberg Tzlil T Shiyovich Arthur A Schamroth-Pravda Nili N Auster Oren O Dagan Noa N Birk Einat E Balicer Ran R Kornowski Ran R
The New England journal of medicine 20221019 19
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Project description:Myocarditis and pericarditis are frequent complications of COVID-19, but have also been reported following vaccination against COVID-19 in adolescents. To build vaccine confidence and inform policy, we characterized the incidence of myocarditis/pericarditis in adolescents following BNT162b2 vaccination and explored the association with dose and sex. We searched national and international databases for studies reporting the incidence of myocarditis/pericarditis following BNT162b2 vaccination as the primary endpoint. The intra-study risk of bias was appraised, and random-effects meta-analyses were performed to estimate the pooled incidence by dose stratified by sex. The pooled incidence of myocarditis/pericarditis was 4.5 (95%CI: 3.14-6.11) per 100,000 vaccinations across all doses. Compared to dose 1, the risk was significantly higher after dose 2 (RR: 8.62, 95%CI: 5.71-13.03). However, adolescents experienced a low risk after a booster dose than after dose 2 (RR: 0.06; 95%CI: 0.04-0.09). Males were approximately seven times (RR: 6.66, 95%CI: 4.77-4.29) more likely than females to present myocarditis/pericarditis. In conclusion, we found a low frequency of myocarditis/pericarditis after BNT162b2, which occurred predominantly after the second dose in male adolescents. The prognosis appears to be favorable, with full recovery in both males and females. National programs are recommended to adopt the causality framework to reduce overreporting, which undercuts the value of the COVID-19 vaccine on adolescent life, as well as to extend the inter-dose interval policy, which has been linked to a lower frequency of myocarditis/pericarditis.
| S-EPMC10252172 | biostudies-literature
Project description:BackgroundEvidence indicates that mRNA COVID-19 vaccination is associated with risk of myocarditis and possibly pericarditis, especially in young males. It is not clear if risk differs between mRNA-1273 versus BNT162b2. We assessed if risk differs using comprehensive health records on a diverse population.MethodsMembers 18-39 years of age at eight integrated healthcare-delivery systems were monitored using data updated weekly and supplemented with medical record review of myocarditis and pericarditis cases. Incidence of myocarditis and pericarditis events that occurred among vaccine recipients 0 to 7 days after either dose 1 or 2 of a messenger RNA (mRNA) vaccine was compared with that of vaccinated concurrent comparators who, on the same calendar day, had received their most recent dose 22 to 42 days earlier. Rate ratios (RRs) were estimated by conditional Poisson regression, adjusted for age, sex, race and ethnicity, health plan, and calendar day. Head-to-head comparison directly assessed risk following mRNA-1273 versus BNT162b2 during 0-7 days post-vaccination.ResultsFrom December 14, 2020 - January 15, 2022 there were 41 cases after 2,891,498 doses of BNT162b2 and 38 cases after 1,803,267 doses of mRNA-1273. Cases had similar demographic and clinical characteristics. Most were hospitalized for ≤1 day; none required intensive care. During days 0-7 after dose 2 of BNT162b2, the incidence was 14.3 (CI: 6.5-34.9) times higher than the comparison interval, amounting to 22.4 excess cases per million doses; after mRNA-1273 the incidence was 18.8 (CI: 6.7-64.9) times higher than the comparison interval, amounting to 31.2 excess cases per million doses. In head-to-head comparisons 0-7 days after either dose, risk was moderately higher after mRNA-1273 than after BNT162b2 (RR: 1.61, CI 1.02-2.54).ConclusionsBoth vaccines were associated with increased risk of myocarditis and pericarditis in 18-39-year-olds. Risk estimates were modestly higher after mRNA-1273 than after BNT162b2.
| S-EPMC9273527 | biostudies-literature
Project description:After the outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, a novel mRNA vaccine (BNT162b2) was developed at an unprecedented speed. Although most countries have achieved widespread immunity from vaccines and infections, yet people, even who have recovered from SARS-CoV-2 infection, are recommended to receive vaccination due to their effectiveness in lowering the risk of recurrent infection. However, the BNT162b2 vaccine has been reported to increase the risk of myocarditis. To our knowledge, for the first time in this study, we tracked changes in the chromatin dynamics of peripheral blood mononuclear cells (PBMCs) in the patient who underwent myocarditis after BNT162b2 vaccination. A longitudinal study of chromatin accessibility using concurrent analysis of single-cell assays for transposase-accessible chromatin with sequencing and single-cell RNA sequencing showed downregulation of interferon signaling and upregulated RUNX2/3 activity in PBMCs. Considering BNT162b2 vaccination increases the level of interferon-α/γ in serum, our data highlight the immune responses different from the conventional responses to the vaccination, which is possibly the key to understanding the side effects of BNT162b2 vaccination.
| S-EPMC10234245 | biostudies-literature
Project description:Background and objectivesAccording to some reports, there is a link between the development of myocarditis and the administration of messenger RNA (mRNA) vaccines against coronavirus disease (COVID-19). Here, we report seven cases that developed myocarditis after receiving a second dose of mRNA COVID-19 vaccine.MethodsThis is a multi-center case series study. In this study, we present 7 patients diagnosed with myocarditis following BNT162b2 and mRNA-1273 COVID-19 vaccinations on March 7, 2021, and March 3, 2022.ResultsAll seven patients were males and hemodynamically stable. The median age was 24.5 years, ranging from 16 to 36 years old. All patients received the second dose of a messenger RNA (mRNA) vaccine between one and four days before being admitted to the hospital (5 received BNT162b2 [Pfizer-BioNTech] and 2 received mRNA-1273 [Moderna]). The electrocardiograms of all seven patients were abnormal, and their troponin levels were elevated. Moreover, all patients were treated with colchicine and NSAIDs. The average length of stay in the hospital was 2.4 days, and all of the patients' symptoms had resolved by the time they were discharged.ConclusionThe results of the current study raise the possibility of an association between BNT162b2 [Pfizer-BioNTech] or mRNA-1273 [Moderna] COVID-19 vaccination and myocarditis.
| S-EPMC9021031 | biostudies-literature
Project description:BackgroundTo investigate Pfizer-BioNTech 162b2 mRNA COVID-19 vaccine (BNT162b2) immunization-related myocarditis and describe the risk factors for consequent hospitalization in the pediatric intensive care unit (PICU) in children between 12 and 18 years.MethodsChildren and adolescents 12 years of age and older who presented with discomfort after BNT162b2 immunization (BNTI) and visited pediatric emergency room (PER) at Chang Gung Memorial Hospital from September 22, 2021 to March 21, 2022, were included for analysis.Results681 children presented with discomfort after BNTI and visited our PER. The mean age was 15.1 ± 1.7 years. Three hundred and ninety-four (57.9%) and 287 (42.1%) events were after 1st and 2nd dose, respectively. 58.4% (n = 398) were male. The most common complaints were chest pain (46.7%) and chest tightness (27.0%). The median (interquartile range [IQR]) interval of discomfort after BNTI was 3.0 (1.0-12.0) days. BNTI-related pericarditis, myocarditis and myopericarditis were diagnosed in 15 (2.2%), 12 (1.8%) and 2 (0.3%) patients, respectively. Eleven (1.6%) needed hospitalization in PICU. The median (IQR) hospital stay was 4.0 (3.0-6.0) days. There was no mortality. More patients were diagnosed myocarditis (p = 0.004) after 2nd dose BNTI. PICU admission occurred more commonly after 2nd dose BNTI (p = 0.007). Risk factors associated with hospitalization in PICU were abnormal EKG findings (p = 0.047) and abnormal serum troponin levels (p = 0.003) at PER.ConclusionMyocarditis in children aged 12-18 years occurred more commonly following 2nd dose BNTI. Most cases were of mild or intermediate severity without death. Factors predicting BNTI-related myocarditis and consequent hospitalization in PICU were abnormal EKG findings and abnormal serum troponin levels at PER in this study.
| S-EPMC10205643 | biostudies-literature
Project description:Several studies have characterized the effectiveness of vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections. However, estimates of their impact on transmissibility remain limited. Here, we evaluated the impact of isolation and vaccination (7 days after the second dose) on SARS-CoV-2 transmission within Israeli households. From December 2020 to April 2021, confirmed cases were identified among health-care workers of the Sheba Medical Centre and their family members. Recruited households were followed up with repeated PCR for at least 10 days after case confirmation. Data were analyzed using a data augmentation Bayesian framework. A total of 210 households with 215 index cases were enrolled; 269 out of 667 (40%) susceptible household contacts developed a SARS-CoV-2 infection. Of those, 170 (63%) developed symptoms. Compared with unvaccinated and unisolated adult/teenager (aged >12 years) contacts, vaccination reduced the risk of infection among unisolated adult/teenager contacts (relative risk (RR) = 0.21, 95% credible interval (CrI): 0.08, 0.44), and isolation reduced the risk of infection among unvaccinated adult/teenager (RR = 0.12, 95% CrI: 0.06, 0.21) and child contacts (RR = 0.17, 95% CrI: 0.08, 0.32). Infectivity was reduced in vaccinated cases (RR = 0.25, 95% CrI: 0.06, 0.77). Within households, vaccination reduces both the risk of infection and of transmission if infected. When contacts were unvaccinated, isolation also led to important reductions in the risk of transmission.
| S-EPMC8903452 | biostudies-literature
Project description:This study evaluates 21-day risk of myocarditis/pericarditis following COVID-19 vaccination among those aged 12 years and older in Malaysia. We used data from nationwide COVID-19 vaccine registry linked to hospital episode database to identify individuals vaccinated with BNT162b2, CoronaVac, or ChAdOx1 and hospitalised for myocarditis/pericarditis between 1 February 2021 and 28 February 2022. There were 87 myocarditis/pericarditis cases identified within 1-21 days after vaccination. Most cases were reported following BNT16262 vaccination (77.0%) with absolute risk of 0.33 cases/100,000 vaccinated persons or 1.73 per million doses administered. Highest risk was observed following second dose and in younger, male individuals. The risk of myocarditis/pericarditis following CoronaVac and ChAdOx1 were much lower compared to BNT162b2. The findings on higher risk observed among younger following mRNA vaccine were consistent with literature and important for targeted surveillance.
| S-EPMC10104785 | biostudies-literature
Project description:BackgroundAge-specific incidence of acute myocarditis/pericarditis in adolescents following Comirnaty vaccination in Asia is lacking. This study aimed to study the clinical characteristics and incidence of acute myocarditis/pericarditis among Hong Kong adolescents following Comirnaty vaccination.MethodsThis is a population cohort study in Hong Kong that monitored adverse events following immunization through a pharmacovigilance system for coronavirus disease 2019 (COVID-19) vaccines. All adolescents aged between 12 and 17 years following Comirnaty vaccination were monitored under the COVID-19 vaccine adverse event response and evaluation program. The clinical characteristics and overall incidence of acute myocarditis/pericarditis in adolescents following Comirnaty vaccination were analyzed.ResultsBetween 14 June 2021 and 4 September 2021, 33 Chinese adolescents who developed acute myocarditis/pericarditis following Comirnaty vaccination were identified. In total, 29 (87.88%) were male and 4 (12.12%) were female, with a median age of 15.25 years. And 27 (81.82%) and 6 (18.18%) cases developed acute myocarditis/pericarditis after receiving the second and first dose, respectively. All cases are mild and required only conservative management. The overall incidence of acute myocarditis/pericarditis was 18.52 (95% confidence interval [CI], 11.67-29.01) per 100 000 persons vaccinated. The incidence after the first and second doses were 3.37 (95% CI, 1.12-9.51) and 21.22 (95% CI, 13.78-32.28 per 100 000 persons vaccinated, respectively. Among male adolescents, the incidence after the first and second doses were 5.57 (95% CI, 2.38-12.53) and 37.32 (95% CI, 26.98-51.25) per 100 000 persons vaccinated.ConclusionsThere is a significant increase in the risk of acute myocarditis/pericarditis following Comirnaty vaccination among Chinese male adolescents, especially after the second dose.
| S-EPMC8767823 | biostudies-literature