Alarmingly a new study by researchers from Clalit Research Institute-Israel, Ben-Gurion University of the Negev, Be’er Sheva-Israel, Harvard Medical School-USA and Boston Children’s Hospital-USA has found that the Pfizer- BioNTech BNT162b2 shot was associated with a threefold increased risk of myocarditis!
The study findings were published in the peer reviewed New England Journal of Medicine. https://www.nejm.org/doi/full/10.1056/NEJMoa2110475
It should be noted that the Pfizer-BioNTech BNT162b2 mRNA jab has just been approved by the “non-credible” U.S. FDA as a therapeutic COVID-19 shot under the brand name Comirnaty!
The study team from Israel and U.S. used data from the largest health care organization in Israel (Clalit Health Services or CHS) to evaluate the safety of the BNT162b2 mRNA shot.
For each potential adverse event, in a population of persons with no previous diagnosis of that event, the study team individually matched vaccinated persons to unvaccinated persons according to socio-demographic and clinical variables.
Risk ratios and risk differences at 42 days after vaccination were derived with the use of the Kaplan–Meier estimator.
To place these results in context, the team performed a similar analysis involving SARS-CoV-2–infected persons matched to uninfected persons. The same adverse events were studied in the vaccination and SARS-CoV-2 infection analyses.
In the detailed vaccination analysis, the vaccinated and control groups each included a mean of 884,828 persons.
The study findings alarmingly found that vaccination was most strongly associated with an elevated risk of myocarditis (risk ratio, 3.24; 95% confidence interval [CI], 1.55 to 12.44; risk difference, 2.7 events per 100,000 persons; 95% CI, 1.0 to 4.6), lymphadenopathy (risk ratio, 2.43; 95% CI, 2.05 to 2.78; risk difference, 78.4 events per 100,000 persons; 95% CI, 64.1 to 89.3), appendicitis (risk ratio, 1.40; 95% CI, 1.02 to 2.01; risk difference, 5.0 events per 100,000 persons; 95% CI, 0.3 to 9.9), and herpes zoster infection (risk ratio, 1.43; 95% CI, 1.20 to 1.73; risk difference, 15.8 events per 100,000 persons; 95% CI, 8.2 to 24.2).
Hence the study findings showed that the Pfizer’s BNT162b2 COVID-19 shot besides increasing the risk of myocarditis by threefold also lead to adverse reactions or conditions such as lymphadenopathy (Lymphadenopathy refers to lymph nodes that are abnormal in size ie greater than 1 cm), Appendicitis (Appendicitis is a painful swelling of the appendix which is a small, thin pouch about 5 to 10cm connected to the large intestine) and also reactivation of herpes zoster infection (Herpes zoster, also known as shingles, is caused by the reactivation of the varicella-zoster virus (VZV), the same virus that causes varicella (chickenpox). Many other adverse reactions or conditi ons were also found.
However it should be noted that SARS-CoV-2 infection was associated with a substantially increased risk of myocarditis as well (risk ratio, 18.28; 95% CI, 3.95 to 25.12; risk difference, 11.0 events per 100,000 persons; 95% CI, 5.6 to 15.8) and of additional serious adverse events, including pericarditis, arrhythmia, deep-vein thrombosis, pulmonary embolism, myocardial infarction, intracranial hemorrhage, and thrombocytopenia.
Corresponding author Dr Ran D. Balicer, M.D. from the Clalit Research Institute told , “We estimated that the BNT162b2 vaccine resulted in an increased incidence of a few adverse events over a 42-day follow-up period.
Although most of these events were mild, some of them, such as myocarditis, could be potentially serious. However, our results indicate that SARS-CoV-2 infection is itself a very strong risk factor for myocarditis, and it also substantially increases the risk of multiple other serious adverse events and, of course, death.”
Myocarditis, also known as inflammatory cardiomyopathy, is inflammation of the heart muscle.
It is a type of heart disease that usually causes no symptoms, but it can be life-threatening. Myocarditis gets its name because the middle layer of the heart muscle is called the myocardium. “Myo” means muscle “card” means heart “itis” means infection or inflammation, i.e., inflammation/infection of the muscle wall of the heart.
Among 2 000 287 individuals receiving at least 1 COVID-19 vaccination, 58.9% were women, the median age was 57 years (interquartile range [IQR], 40-70 years), 76.5% received more than 1 dose, 52.6% received the BNT162b2 vaccine (Pfizer/BioNTech), 44.1% received the mRNA-1273 vaccine (Moderna), and 3.1% received the Ad26.COV2.S vaccine (Janssen/Johnson & Johnson). Twenty individuals had vaccine-related myocarditis (1.0 [95% CI, 0.61-1.54] per 100 000) and 37 had pericarditis (1.8 [95% CI, 1.30-2.55] per 100 000).
Myocarditis occurred a median of 3.5 days (IQR, 3.0-10.8 days) after vaccination (mRNA-1273 vaccine, 11 cases [55%]; BNT162b2 vaccine, 9 cases [45%]) (Table). Fifteen individuals (75%; 95% CI, 53%-89%) were male, and the median age was 36 years (IQR, 26-48 years). Four persons (20%; 95% CI, 8%-42%) developed symptoms after the first vaccination and 16 (80%; 95% CI, 58%-92%) developed symptoms after the second. Nineteen patients (95%; 95% CI, 76%-99%) were admitted to the hospital. All were discharged after a median of 2 days (IQR, 2-3 days). There were no readmissions or deaths. Two patients received a second vaccination after onset of myocarditis; neither had worsening of symptoms. At last available follow-up (median, 23.5 days [IQR, 4.8-41.3 days] after symptom onset), 13 patients (65%; 95% CI, 43%-82%) had symptom resolution and 7 (35%; 95% CI, 18%-57%) were improving.
Pericarditis developed after the first immunization in 15 cases (40.5%; 95% CI, 26%-57%) and after the second immunization in 22 cases (59.5%; 95% CI, 44%-74%) (mRNA-1273 vaccine, 12 cases [32%]; BNT162b2 vaccine, 23 cases [62%]; Ad26.COV2.S vaccine, 2 cases [5%]). Median onset was 20 days (IQR, 6.0-41.0 days) after the most recent vaccination. Twenty-seven individuals (73%; 95% CI, 57%-85%) were male, and the median age was 59 years (IQR, 46-69 years). Thirteen (35%; 95% CI, 22%-51%) were admitted to the hospital, none to intensive care. Median stay was 1 day (IQR, 1-2 days). Seven patients with pericarditis received a second vaccination. No patient died. At last available follow-up (median, 28 days; IQR, 7-53 days), 7 patients (19%; 95% CI, 9%-34%) had resolved symptoms and 23 (62%; 95% CI, 46%-76%) were improving.
The mean monthly number of cases of myocarditis or myopericarditis during the prevaccine period was 16.9 (95% CI, 15.3-18.6) vs 27.3 (95% CI, 22.4-32.9) during the vaccine period (P < .001) (Figure). The mean numbers of pericarditis cases during the same periods were 49.1 (95% CI, 46.4-51.9) and 78.8 (95% CI, 70.3-87.9), respectively (P < .001).
Discussion
Two distinct self-limited syndromes, myocarditis and pericarditis, were observed after COVID-19 vaccination. Myocarditis developed rapidly in younger patients, mostly after the second vaccination. Pericarditis affected older patients later, after either the first or second dose.
Some vaccines are associated with myocarditis,5 including mRNA vaccines,1-4 and the Centers for Disease Control and Prevention recently reported a possible association between COVID-19 mRNA vaccines and myocarditis, primarily in younger male individuals within a few days after the second vaccination, at an incidence of about 4.8 cases per 1 million.6 This study shows a similar pattern, although at higher incidence, suggesting vaccine adverse event underreporting. Additionally, pericarditis may be more common than myocarditis among older patients.
Study limitations include cases missed in outside care settings and missed diagnoses of myocarditis or pericarditis (which would underestimate the incidence), as well as inaccurate EMR vaccination information. Temporal association does not prove causation, although the short span between vaccination and myocarditis onset and the elevated incidence of myocarditis and pericarditis in the study hospitals lend support to a possible relationship.
reference link : https://jamanetwork.com/journals/jama/fullarticle/2782900
