Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel
| العنوان: | Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel |
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| المؤلفون: | Sharon Olsha-Castell, Walid Saliba, Manfred S. Green, Lital Keinan-Boker, Khitam Muhsen, Tal Hasin, Nir Levi, Dror Mevorach, Noa Cedar, Sharon Alroy-Preis, Eyal Nadir, Iris Leitersdorf, Eric J Haas, Offer Amir, Karen Meir, Rabea Asleh, Rita Dichtiar, Deborah Novick, Ron Dagan, Dana Arad, Michal Bromberg, Yael Hershkovitz, Ian Miskin, Dotan Cohen, Yehezkel Levi, Ronen Ben-Ami, Emilia Anis |
| المصدر: | New England Journal of Medicine. 385:2140-2149 |
| بيانات النشر: | Massachusetts Medical Society, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Pediatrics, medicine.medical_specialty, Myocarditis, business.industry, Incidence (epidemiology), Absolute risk reduction, General Medicine, medicine.disease, Rate ratio, Confidence interval, Vaccination, Standardized mortality ratio, medicine, Adverse effect, business |
| الوصف: | Background Approximately 5.1 million Israelis had been fully immunized against coronavirus disease 2019 (Covid-19) after receiving two doses of the BNT162b2 messenger RNA vaccine (Pfizer-BioNTech) by May 31, 2021. After early reports of myocarditis during adverse events monitoring, the Israeli Ministry of Health initiated active surveillance. Methods We retrospectively reviewed data obtained from December 20, 2020, to May 31, 2021, regarding all cases of myocarditis and categorized the information using the Brighton Collaboration definition. We analyzed the occurrence of myocarditis by computing the risk difference for the comparison of the incidence after the first and second vaccine doses (21 days apart); by calculating the standardized incidence ratio of the observed-to-expected incidence within 21 days after the first dose and 30 days after the second dose, independent of certainty of diagnosis; and by calculating the rate ratio 30 days after the second dose as compared with unvaccinated persons. Results Among 304 persons with symptoms of myocarditis, 21 had received an alternative diagnosis. Of the remaining 283 cases, 142 occurred after receipt of the BNT162b2 vaccine; of these cases, 136 diagnoses were definitive or probable. The clinical presentation was judged to be mild in 129 recipients (95%); one fulminant case was fatal. The overall risk difference between the first and second doses was 1.76 per 100,000 persons (95% confidence interval [CI], 1.33 to 2.19), with the largest difference among male recipients between the ages of 16 and 19 years (difference, 13.73 per 100,000 persons; 95% CI, 8.11 to 19.46). As compared with the expected incidence based on historical data, the standardized incidence ratio was 5.34 (95% CI, 4.48 to 6.40) and was highest after the second dose in male recipients between the ages of 16 and 19 years (13.60; 95% CI, 9.30 to 19.20). The rate ratio 30 days after the second vaccine dose in fully vaccinated recipients, as compared with unvaccinated persons, was 2.35 (95% CI, 1.10 to 5.02); the rate ratio was again highest in male recipients between the ages of 16 and 19 years (8.96; 95% CI, 4.50 to 17.83), with a ratio of 1 in 6637. Conclusions The incidence of myocarditis, although low, increased after the receipt of the BNT162b2 vaccine, particularly after the second dose among young male recipients. The clinical presentation of myocarditis after vaccination was usually mild. |
| تدمد: | 1533-4406 0028-4793 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_________::b7fe12a61438398202a08a369f7fc37c https://doi.org/10.1056/nejmoa2109730 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi...........b7fe12a61438398202a08a369f7fc37c |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15334406 00284793 |
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