Frontiers in Pharmacology, Год журнала: 2022, Номер 13
Опубликована: Ноя. 24, 2022
Estimates of the association between COVID-19 vaccines and myo-/pericarditis risk vary widely across studies due to scarcity events, especially in age- sex-stratified analyses.
Язык: Английский
Circulation, Год журнала: 2023, Номер 147(11), С. 867 - 876
Опубликована: Янв. 4, 2023
Cases of adolescents and young adults developing myocarditis after vaccination with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-targeted mRNA vaccines have been reported globally, but the underlying immunoprofiles these individuals not described in detail.
Язык: Английский
Процитировано
151
Vaccine, Год журнала: 2024, Номер 42(9), С. 2200 - 2211
Опубликована: Фев. 12, 2024
The Global COVID Vaccine Safety (GCoVS) Project, established in 2021 under the multinational Data Network™ (GVDN®), facilitates comprehensive assessment of vaccine safety. This study aimed to evaluate risk adverse events special interest (AESI) following COVID-19 vaccination from 10 sites across eight countries. Using a common protocol, this observational cohort compared observed with expected rates 13 selected AESI neurological, haematological, and cardiac outcomes. Expected were obtained by participating using pre-COVID-19 healthcare data stratified age sex. Observed reported same datasets since program rollout. occurring up 42 days mRNA (BNT162b2 mRNA-1273) adenovirus-vector (ChAdOx1) vaccines included primary analysis. Risks assessed versus (OE) ratios 95 % confidence intervals. Prioritised potential safety signals those lower bound interval (LBCI) greater than 1.5. Participants 99,068,901 vaccinated individuals. In total, 183,559,462 doses BNT162b2, 36,178,442 mRNA-1273, 23,093,399 ChAdOx1 administered period. Risk periods homologous schedules contributed 23,168,335 person-years follow-up. OE LBCI > 1.5 for Guillain-Barré syndrome (2.49, CI: 2.15, 2.87) cerebral venous sinus thrombosis (3.23, 2.51, 4.09) first dose vaccine. Acute disseminated encephalomyelitis showed an ratio 3.78 (95 1.52, 7.78) mRNA-1273 myocarditis pericarditis significantly increased LBCIs multi-country analysis confirmed pre-established myocarditis, pericarditis, syndrome, thrombosis. Other that require further investigation identified.
Язык: Английский
Процитировано
81
npj Vaccines, Год журнала: 2024, Номер 9(1)
Опубликована: Июнь 28, 2024
Following the start of COVID-19 vaccination campaign, adverse events myocarditis and pericarditis were linked mainly to mRNA vaccines by regulatory authorities worldwide. have been administered several million people risk post has characterised in great detail. At present time research data available are scarce there is still no clear understanding biological mechanism/s responsible for this disease. This manuscript provides a concise overview epidemiology most prominent mechanistic insights pathophysiology Most importantly it underscores needed next steps agenda required characterize disease post-COVID-19 vaccination. Finally, shares our perspectives considerations public health.
Язык: Английский
Процитировано
20
BMJ Public Health, Год журнала: 2024, Номер 2(1), С. e000282 - e000282
Опубликована: Май 1, 2024
Introduction Excess mortality during the COVID-19 pandemic has been substantial. Insight into excess death rates in years following WHO’s declaration is crucial for government leaders and policymakers to evaluate their health crisis policies. This study explores Western World from 2020 until 2022. Methods All-cause reports were abstracted countries using ‘Our Data’ database. assessed as a deviation between reported number of deaths country certain week or month 2022 expected that period under normal conditions. For baseline deaths, Karlinsky Kobak’s estimate model was used. uses historical data 2015 2019 accounts seasonal variation year-to-year trends mortality. Results The total 47 3 098 456 1 January 31 December documented 41 (87%) 2020, 42 (89%) 2021 43 (91%) In year onset implementation containment measures, records present 033 122 (P-score 11.4%). 2021, which both measures vaccines used address virus spread infection, highest reported: 256 942 13.8%). 2022, when most lifted continued, preliminary 808 392 8.8%). Conclusions remained high three consecutive years, despite vaccines. raises serious concerns. Government need thoroughly investigate underlying causes persistent
Язык: Английский
Процитировано
19
Journal of Medical Ethics, Год журнала: 2022, Номер 50(2), С. 126 - 138
Опубликована: Дек. 5, 2022
In 2022, students at North American universities with third-dose COVID-19 vaccine mandates risk disenrolment if unvaccinated. To assess the appropriateness of booster in this age group, we combine empirical risk-benefit assessment and ethical analysis. prevent one hospitalisation over a 6-month period, estimate that 31 207–42 836 young adults aged 18–29 years must receive third mRNA vaccine. Booster are expected to cause net harm: per prevented, anticipate least 18.5 serious adverse events from vaccines, including 1.5–4.6 booster-associated myopericarditis cases males (typically requiring hospitalisation). We also 1430–4626 grade ≥3 reactogenicity interfering daily activities (although typically not University unethical because they: (1) based on an updated (Omicron era) stratified for group; (2) may result harm healthy adults; (3) proportionate: harms outweighed by public health benefits given modest transient effectiveness vaccines against transmission; (4) violate reciprocity principle vaccine-related reliably compensated due gaps injury schemes; (5) wider social harms. consider counterarguments efforts increase safety campus but find these fraught limitations little scientific support. Finally, discuss policy relevance our analysis primary series mandates.
Язык: Английский
Процитировано
45
PLoS Medicine, Год журнала: 2022, Номер 19(7), С. e1004056 - e1004056
Опубликована: Июль 28, 2022
Background Myocarditis and pericarditis following the Coronavirus Disease 2019 (COVID-19) mRNA vaccines administration have been reported, but their frequency is still uncertain in younger population. This study investigated association between Severe Acute Respiratory Syndrome 2 (SARS-CoV-2) vaccines, BNT162b2, mRNA-1273 myocarditis/pericarditis population of vaccinated persons aged 12 to 39 years Italy. Methods findings We conducted a self-controlled case series (SCCS) using national data on COVID-19 vaccination linked emergency care/hospital discharge databases. The outcome was first diagnosis 27 December 2020 30 September 2021. Exposure risk period (0 21 days from day, subdivided 3 equal intervals) for second dose compared with baseline period. SCCS model, adapted event-dependent exposures, fitted unbiased estimating equations estimate relative incidences (RIs) excess cases (EC) per 100,000 by dose, age, sex, vaccine product. Calendar included as time-varying confounder model. During 2,861,809 received (2,405,759 BNT162b2; 456,050 mRNA-1273); 441 participants developed (346 95 mRNA-1273). Within 21-day interval, 114 events occurred, RI 1.99 (1.30 3.05) after BNT162b2 2.22 (1.00 4.91) 2.63 (1.21 5.71) mRNA-1273. [0 7) period, an increased observed mRNA-1273, 6.55 (2.73 15.72), RIs 3.39 (2.02 5.68) 7.59 (3.26 17.65). number EC 5.5 (3.0 7.9). highest males, at 12.28 (4.09 36.83) 11.91 (3.88 36.53); 8.8 (4.9 12.9). Among those 17 years, 5.74 (1.52 21.72) this age group, insufficient 18 29 were 7.58 (2.62 21.94) 4.02 (1.81 8.91) 9.58 (3.32 27.58) mRNA-1273; numbers 3.4 (1.1 6.0) 8.6 (4.4 12.6) main limitations that not validated through review clinical records, there absence information length hospitalization and, thus, severity outcome. Conclusions population-based about millions residents Italy suggested associated than 40 years. According our results, both doses risks males females public health implication these should be considered light proven effectiveness preventing serious disease death.
Язык: Английский
Процитировано
42
Journal of the American College of Cardiology, Год журнала: 2022, Номер 80(24), С. 2255 - 2265
Опубликована: Дек. 1, 2022
Язык: Английский
Процитировано
40
BMJ Open, Год журнала: 2023, Номер 13(6), С. e065687 - e065687
Опубликована: Июнь 1, 2023
To summarise the available evidence on risk of myocarditis and/or pericarditis following mRNA COVID-19 vaccination, compared with among unvaccinated individuals in absence infection.Systematic review and meta-analysis.Electronic databases (Medline, Embase, Web Science WHO Global Literature Coronavirus Disease), preprint repositories (medRxiv bioRxiv), reference lists grey literature were searched from 1 December 2020 until 31 October 2022.Epidemiological studies any age who received at least one dose an vaccine, reported a myo/pericarditis to did not receive vaccine.Two reviewers independently conducted screening data extraction. The rate vaccinated groups was recorded, ratios calculated. Additionally, total number individuals, case ascertainment criteria, percentage males history SARS-CoV-2 infection extracted for each study. Meta-analysis done using random-effects model.Seven met inclusion which six included quantitative synthesis. Our meta-analysis indicates that within 30-day follow-up period, twice as likely develop ratio 2.05 (95% CI 1.49-2.82).Although absolute observed cases remains quite low, higher detected those vaccinations infection. Given effectiveness vaccines preventing severe illnesses, hospitalisations deaths, future research should focus accurately determining rates linked vaccines, understanding biological mechanisms behind these rare cardiac events identifying most risk.
Язык: Английский
Процитировано
32
Biomedicines, Год журнала: 2023, Номер 11(2), С. 451 - 451
Опубликована: Фев. 3, 2023
The SARS-CoV-2 (severe acute respiratory syndrome coronavirus responsible for the COVID-19 disease) uses Spike proteins of its envelope infecting target cells expressing on membrane angiotensin converting enzyme 2 (ACE2) that acts as a receptor. To control pandemic, genetically engineered vaccines have been designed inducing neutralizing antibodies against proteins. These do not act like traditional protein-based vaccines, they deliver message in form mRNA or DNA to host then produce and expose protein (from which it can be shed soluble form) alert immune system. Mass vaccination has brought light various adverse effects associated with these based mainly affecting circulatory cardiovascular ACE2 is present membrane-bound several cell types, including mucosa upper gastrointestinal tracts, endothelium, platelets, plasma. converts vasoconstrictor II into peptides vasodilator properties. Here we review pathways immunization molecular mechanisms through protein, either from encoded by mRNA-based interferes Renin-Angiotensin-System governed ACE2, thus altering homeostasis circulation Understanding interactions consequent impact system will direct diagnosis therapy vaccine-related provide information development personalized considers pathophysiological conditions predisposing such events.
Язык: Английский
Процитировано
30
European Journal of Clinical Investigation, Год журнала: 2023, Номер 53(8)
Опубликована: Март 31, 2023
Vaccination has been widely implemented for mitigation of coronavirus disease-2019 (Covid-19), and by 11 November 2022, 701 million doses the BNT162b2 mRNA vaccine (Pfizer-BioNTech) had administered linked with 971,021 reports suspected adverse effects (SAEs) in European Union/European Economic Area (EU/EEA).1 Vaccine vials individual are supplied batches stringent quality control to ensure batch dose uniformity.2 Clinical data on levels have not reported batch-dependent variation clinical efficacy safety authorized vaccines would appear be highly unlikely. However, least view emergency use market authorization rapid implementation large-scale vaccination programs, possibility appears worthy investigation. We therefore examined rates SAEs between different Denmark (population 5.8 million) from 27 December 2020 January 2022. Data all SAE cases corresponding labels Danish Medical Agency (DKMA) classified DKMA according seriousness, numbers registered Serum Institute, respectively, publicly available were retrieved upon request. The DKMA-managed spontaneous reporting system accepts any source, example healthcare providers, patients other members public. assigned Dictionary Regulatory Activities (MedDRA) terms that do necessarily correspond verified medical diagnoses, more than 1 may a report. seriousness was as non-serious, serious (hospitalization or prolongation existing hospitalization, life-threatening illness, permanent disability congenital malformation) SAE-related death respectively. study relied exclusively secondary these anonymized thus exempt research ethics board review. counted level linking label(s) BNT162b dose(s) subject received. total number associated each divided obtain rate per 1000 doses. Since observed relationship heterogeneous, conventional regression statistics considered applicable. Therefore, heterogeneity assessed log-transformation followed non-hierarchical cluster analysis general linear model (GLM) test differences batches. Reporting conforms broad EQUATOR guidelines.3 A 7,835,280 3,748,215 persons 52 (2340–814,320 batch) 43,496 13,635 persons, equaling 3.19 ± 0.03 (mean SEM) person. In person, 1.531 0.004 resulting 66,587 distributed Batch incompletely missing 7.11% SAEs, leaving 61,847 batch-identifiable further which 14,509 (23.5%) severe 579 (0.9%) deaths. Unexpectedly, varied considerably 2.32 (0.09–3.59) (median [interquartile range]) doses, significant (p < .0001) Three predominant trendlines discerned, noticeable lower larger additional distribution representing three (Figure 1). Compared deaths 1.000 much less frequent displayed greater variability batches, lesser separation (not shown). BTN162b2 this nationwide contrary expected homogenous EU/EEA countries, is monitored Official Control Authority Release (OCABR) guidelines our knowledge, potential effectiveness previously, pre-authorization trials subsequent population-based studies.4, 5 Such easier detect small countries like where during period generally provided several smaller Also, regulatory monitoring scientific interest COVID-19 primarily focused events, myocarditis.6 case, identification such evidently requires events respective sizes (dose numbers). Previously, production (culture growth) Bacille Calmette-Guérin shown influence important immunological vaccine,7 two myocarditis young males after receiving mRNA-1273 (Moderna) same day.8 Indeed, variations (batch-to-batch, vial-to-vial even dose-to-dose) occur result variabilities practice breaches in, manufacturing, storage, transportation, handling aspects, 2021, lots mRNA1273 totalling 1.6 recalled Japan 39 found contain foreign materials.9 Leaked contested also suggested some early commercial contained intact mRNA.10 present preliminary findings must interpreted light limitations. passive surveillance akin Adverse Event System (VAERS) US, systems biases, both under- over-reporting, well incomplete variable information.11, 12 Owing inherent limitations, signals detected hypothesis-generating cannot used establish causality.11-14 addition, study, case history prior unknown, specific types (MedDRA organ class etc.), demographics cases, relationships consecutive individuals temporal trends batch-dependency effectiveness, examined. Notably, Institute issued recalls conclusion, results suggest existence signal vaccine, studies warranted explore observation its consequences. None.
Язык: Английский
Процитировано
30