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Prof Jeffrey S Morris is George S. Pepper Professor of Public Health & Preventive Medicine; Biostats, Stats & Data Science, UPenn
His conclusion:
So this paper confirms what many other studies have found — anaphylaxis and myocarditis are both rare but serious adverse events linked to mRNA vaccines, with incidence similar to what has been found in existing literature,
But it found no evidence that the other serious adverse events they considered occurred after vaccination any more often than the baseline rate in the population, including myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis, thrombosis/thrombocytopenia, Guillain-Barre Syndrome, Bell’s Palsy, and others, which again agrees with most of the current studies.
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An Epoch Times article discusses a recent paper by FDA researchers assessing safety of Pfizer and Moderna bivalent boosters given to 8,638,661 and 5,240,178 individuals, respectively, comparing incidence rate of 18 different serious adverse events of special interest (including various cardiovascular events) in data bases from Carelon Research, CVS Health, and Optum.
Out of all 18 events, they only identified safety signals for: 1. anaphylaxis for both vaccines 18-64yr in 1 out of the 3 data bases (but not the other 2), and 2. myocarditis/pericarditis for 18-35yr for Pfizer vaccine in 1 out of the 3 data bases (but not the other 2) They concluded results were consistent with previous studies and supporting the safety profile for these vaccines
However, the Epoch Times article highlights the following numbers, suggesting they are from this paper: 1. anaphylaxis rate was 74.5 cases per 100k person-years following Pfizer vaccination 2. anaphylaxis rate was 109.4 cases per 100k person-years following Moderna vaccination 3. myo/pericarditis rate was 131.4 cases per 100k person-years These figures to a novice reader might make one think that the rate of anaphylaxis per person is 1 per 1342 (100,000/74.5) after Pfizer, 1 per 914 (100,000/109.4) after Moderna, and the rate of myo/pericarditis is 1 per 761 (100,000/131.4) after Pfizer, which would seem alarmingly high, seemingly contradicting the conclusions of the paper. However, this is completely false.
As I will show in this thread, these figures: 1. were not even reported in the paper, but computed for the Epoch Times article from Table 3. 2. were actually mis-computed from Table 3 in the paper 3. based on rate per person-year is not the most useful summary for incidence after vaccination given the time frame for these events varies from 2 days (anaphylaxis) to 28 or 42 days after vaccination, and easily misconstrued/misinterpreted.
Looking at the paper, what they actually found for incidence was: 1. anaphylaxis from d0-d1 after bivalent vaccine booster occurred at rate between 1/4.3m and 1/430k for Pfizer, and between 1/2.6m and 1/260k for Moderna 2. myo/peri-carditis from d0-d21 after bivalent vaccine booster occurred at rate of 1/27k for Pfizer and 1/29k for Moderna 3. For 5-17yr olds, the myo/peri-carditis rate from d0-d21 after bivalent vaccine booster occured at rate between 1/535k and 1/54k for Pfizer, and <1/50k for Moderna 4. For 18-64yr olds, the myo/peri-carditis rates from d0-d21 after bivalent boosters was 1/53k for Pfizer and 1/55k for Moderna
These are in line with previous literature, and not alarming — the calculation and inclusion of the rates per person-year in the Epoch article appear to be trying to exaggerate the risk I’ll transparently explain where I get these numbers from in this thread…
So this paper confirms what many other studies have found — anaphylaxis and myocarditis are both rare but serious adverse events linked to mRNA vaccines, with incidence similar to what has been found in existing literature,
But it found no evidence that the other serious adverse events they considered occurred after vaccination any more often than the baseline rate in the population, including myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis, thrombosis/thrombocytopenia, Guillain-Barre Syndrome, Bell’s Palsy, and others, which again agrees with most of the current studies.
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weehingthong 