(no title)
cbeach | 19 days ago
Large, real-world, nationwide context: ~5.1 million people in Israel were fully vaccinated with Pfizer (BNT162b2) in the study period. Active surveillance triggered by safety signals (not just “whoever bothered to report a symptom”). Clinical case adjudication using a standard definition (Brighton Collaboration criteria), which reduces “anything chest-related = myocarditis” noise. Published in NEJM, which is about as top-shelf as clinical journals get.
What clinically significant side effect does it show?
Myocarditis (inflammation of the heart muscle), which is clinically significant because it can involve emergency presentation (chest pain, shortness of breath), abnormal cardiac biomarkers / ECG / imaging and hospital admission (this study reviewed diagnosed cases in that system).
> 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.
kelseyfrog|18 days ago