Vaccine Safety Study: Klein, Kaiser Permanente
Anyone check out the safety study out of California?
Surveillance for Adverse Events After COVID-19 mRNA Vaccination
Since it is in JAMA I wonder if it is as worthless as their Lopez-Medina, et al Ivermectin study out of Cali, Columbia?
Considering the government’s history of the “noble lie” regarding vaccines my antennas went up while reading this paper.
Were they comparing events in the first 3 weeks to the events in the 2nd 3 weeks? Notice especially Table 3 below.
I’ve been hearing that the number of cardiac related events in the first 48 hours reported to CDC’s VAERS have been disturbing. Dr. McCullough who has chaired many safety boards for therapeutic products says 80% of the reported deaths occurred within the first week–see the clip around 12-15 minutes into this talk on vaccine safety .
The following are some excerpts from the JAMA vaccine safety study
In interim analyses of surveillance of mRNA COVID-19 vaccines, incidence of selected serious outcomes was not significantly higher 1 to 21 days postvaccination compared with 22 to 42 days postvaccination. While CIs were wide for many outcomes, surveillance is ongoing
Analyses of all ages combined did not detect a significant association between myocarditis/pericarditis and mRNA vaccines. However, consistent with case reports,16,24 supplemental analyses of confirmed cases among individuals aged 12 to 39 years yielded an elevated RR estimate. Significant clustering within the first week after vaccination, especially after dose 2, provides additional evidence of an association between mRNA vaccines and myocarditis/pericarditis in younger individuals.
Six outcomes in the primary analyses yielded CIs that included RR estimates greater than 2.0, levels that may be clinically important even if outweighed by the COVID-19 outcomes prevented.
I assume they mean if you don’t correct vitamin D deficiency, don’t provide outpatient treatment and don’t provide reasonable hospital treatment such as the FLCCC’s MATH+ protocol.
Maybe the Aussies will have to ban Listerine mouthwash and neti pots as well as Ivermectin to make sure the Relative Risk estimates continue to be “outweighed” by the C19 outcomes prevented.
The number of outcome events during the 21-day risk interval ranged from 0 for Kawasaki disease to 1059 (1612 per 1 000 000 person-years) for ischemic stroke (Table 3). In weekly analyses, none of the outcomes met the signaling criteria of 1-sided P < .0048 (Table 3). In analyses through June 26, 2021, the incidence per 1 000 000 person-years during the risk and comparison intervals and adjusted RR ranged from 45 vs 69 (RR, 0.70; 95% CI, 0.39-1.28) for disseminated intravascular coagulation to 9 vs 6 (RR, 2.60; 95% CI, 0.47-20.66) for thrombotic thrombocytopenic purpura. For the most frequent outcomes, the incidence per 1 000 000 person-years during the risk vs comparison intervals and adjusted RR for ischemic stroke were 1612 vs 1781 (RR, 0.97; 95% CI, 0.87-1.08); for appendicitis, 1179 vs 1345 (RR, 0.82; 95% CI, 0.73-0.93); for acute myocardial infarction, 935 vs 1030 (RR, 1.02; 95% CI, 0.89-1.18); for venous thromboembolism, 952 vs 896 (RR, 1.16; 95% CI, 1.00-1.34); and for Bell palsy, 822 vs 825 (RR, 1.00; 95% CI, 0.86-1.17). The highest estimates of excess cases per million doses were 7.5 (95% CI, –0.1 to 14.0) for venous thromboembolism and 1.2 (95% CI, –6.9 to 8.3) for acute myocardial infarction
Table 3. Outcome Events in the 21-Day Risk Interval After Either Vaccine Dose Compared, on the Same Calendar Day, With Outcome Events in Individuals 22-42 Days After Their Most Recent Dose, December 14, 2020-June 26, 2021
It is tiring to have to go over every paper from health leadership to look for ways they are continuing the “noble lie.”
Working incredibly hard at cherry picking – this is obvious in this case. This is like , how can we prove or rather, disprove that there is any significant risk of heart inflammation from the vaccine, that we know is there.
Here are the limitations discussed in the study:
This study has several limitations. First, the statistical power of these early analyses was limited, especially for the less frequent outcomes. The 95% CIs around some of the RR estimates were wide and included clinically relevant risks. Six outcomes in the primary analyses yielded CIs that included RR estimates greater than 2.0, levels that may be clinically important even if outweighed by the COVID-19 outcomes prevented. During the next few months, the precision of the RR estimates will improve as follow-up accumulates. Second, vaccinees contributed follow-up in the risk interval before they contributed it in the comparison interval, and bias might arise if unmeasured variables associated with earlier vaccination were also associated with having an outcome. Third, there may be interest in specific outcomes that were not initially included or were included within a much broader category. However, additional outcomes were added in response to emerging concerns. Fourth, risk may be underestimated or missed if the real risk interval was modestly longer (ie, 1 week) beyond 21 days after exposure to a first or second dose or perhaps several weeks longer. Fifth, although vaccinees were followed for several months after vaccination, possible longer-term risks of vaccination were not being monitored. Sixth, only medically attended outcomes were included; thus, analyses could have underestimated risk if health care was not sought. Although the outcomes monitored are serious and usually associated with seeking care, anaphylaxis incidence may have been underestimated if individuals either received care in alternate settings or self-treated at the event.
But the biggest is that they compared people within 3 weeks of their most recent dose to the same or matched people 3-6 weeks after their most recent dose.
The first and more minor issue regards how they handled the fact that the second dose typically comes three weeks after the first dose (4 for Moderna). I think there is room for all sorts of confusion or tricks there.
The second and and bigger issue: Why use people 3-6 weeks after their most recent dose as a control group. Many of the more amorphous events that are less likely to come on suddenly. There is a good chance that they won’t seek care or at least receive care until 21 days or more after their dose. This, of course, contaminated the control group. A much more obvious control group would either be a matched set of unvaccinated people or the same people in the experiment group in the 3 weeks before their first dose. Any “calendar” related issues would be much smaller than the confounding factor I mentioned.
Another issue is that there were several issues that were not included in the comparison including more generalized neuropathies, sensory and balance issues, Parkinson’s or Parkinson’s like symptoms.
And of course, we have that nagging little outcome called “death”. No report on that one.
We also have that many pathologies, microthromboses in particular and especially pulmonary thrombosis, could have relatively and/or vague symptoms at first with serious implications down the road. This is probably even true of myocarditis. Of course, these people are quite likely not to present to the medical system until > 3 weeks after their dose.