How do you like that heading? It's a typical academic heading that seems designed to make your brain freeze, is it not? But there is a serious issue involved and I think I can explain it simply.
The underlying issue is a serious one: What should we make of rare side-effects after any medical treatment? Conventionally they are a big deal. Whole medications -- such as Vioxx -- have been withdrawn when only a few serious side effects out of millions of doses have been reported. Millions had a good result from taking the medication but they were ignored. The tiny number who reported bad side-effects ruled the day. A helpful medication was withdrawn because it MIGHT kill you.
Is that rational? I don't think so. All medical and surgical procedures involve some risk. And we tolerate rather large risks sometimes. Paracetamol (Tylenol) kills thousands every year by destroying their livers yet it is regarded as a "safe" drug. Aspirin is actually safer
Much as I hate using a favorite Leftist phrase, I think we just have to tolerate rare events "for the good of the many". And I am strongly reinforced in that view by the fact that we can never be sure what the cause of the rare event was. The rare event may have immediately followed the medical intervention but that is no proof that the medication CAUSED the rare event. Side-effects can be important but rare side effects should be ignored in my view.
So we now come to Covid and the horrible Guillain-Barré Syndrome. Do 11 cases out of millions matter? If your kid got a horrible illness after receiving a Covid vaccine, would that matter? Every parent concerned would say it does
Fortunately or not, this is an even less clear-cut finding than usual. The incidence of GBS among kids who got the vaccine was not different from the normal incidence. What WAS of concern, however is that the onset of GBS among vaccine recipients FOLLOWED CLOSELY on receiving the vaccine -- creating the impressoion that it was the vaccine which caused the problem. And, as the philosopher David Hume contended a couple of centuries ago, conjunction in time is the WHOLE of causation. Hume however spoke of CONSTANT conjunction and the conjunction here was anything but constant.
So the jury is still out. There are some elements in the medical comnmunity who would see the findings below as troubling but I do not
My own account of causation is here
From the pre-COVID period to 6 weeks after vaccination, the reporting rate of GBS was significantly different, regardless of whether Brighton criteria was applied to the analysis. The authors noted that passive surveillance limitations warrant further analysis.
Findings from the Vaccine Adverse Event Reporting System database showed that although the prevalence of Guillain-Barré (GBS) syndrome following COVID-19 vaccination was not different in pediatrics compared with the general population, there was an increased prevalence within the first 6 weeks following vaccination, suggesting a potential temporal associaiton.1 The investigators noted that these findings warrant caution, as they were based off passive surveillance.
The study, presented at the 2022 American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) annual meeting, September 21-24, in Nashville, Tennessee, compared the rate of pediatric GBS following COVID-19 vaccination to the rate after influenza, human papillomavirus (HPV), and meningococcal vaccinations. Investigators used a pre-COVID period (October 2018-August 2019), prevaccine period (January 2020-November 2020), and vaccine period (December 2020-October 2021), as well as a risk period of probably cause-effect relationship, defined as 6 weeks post vaccination.
Led by Nizar Souayah, MD, Department of Neurology, Newark Beth Israel Medical Center, the findings showed that the rates for GBS after COVID-19 vaccination were within the incidence rate of GBS typically reported in children. In total, there were 31, 3, 1, and 1 cases of GBS reported after COVID-19, influenza, HPV, and meningococcal vaccinations, respectively. Between vaccinations, the reporting rate of GBS after COVID-19 vaccination was significantly higher than the others, at 12.45 per 10 million (P <.005), followed by influenza (1.63), meningococcal (1.19), and HPV vaccinations (1.07).
High Proportion of Zilucoplan Responders Identified in Secondary Analysis of RAISE Trial
After 12 weeks of treatment with zilucoplan 0.3 mg/kg, almost three-fourths of patients demonstrated at least a 3-point reduction in Myasthenia Gravis Activities of Daily Living scores.
Using self-controlled and case centered analysis, the reported rate of GBS after COVID-19 vaccination between the risk and control periods was significantly different (90.32% vs 9.7%, respectively; P <.0001). The findings remained similar when all patients, regardless of Brighton criteria, were included.
COVID-19 has been shown to be associated with several of neurological complications, including GBS, which has been more prominently throughout the pandemic. Recent work by Kayla E. Hanson, MPH, et al further suggested an increased risk of GBS following COVID-19 vaccination with Ad.26.COV2.S (Janssen). The analysis comprised of 15,120,073 doses of COVID-19 vaccines from December 2020 to November 2021, including 483,053 Ad.26.COV2.S doses; 8,806,595 BNY162b2 doses; and 5,830,425 mRNA-1273 doses.
In total, 11 cases of GBS were reported in those vaccinated with Ad.26.COV2.S, resulting in an unadjusted incidence rate of 32.4 (95% CI, 14.8-61.5) per 100,000 person-years in the 1 to 21 days following vaccination that was significantly higher than the background rate. Overall, the adjusted risk ratio (RR) in the 1 to 21 vs 22 to 42 days following Ad.26.COV2.S vaccination was 6.03 (95% CI, 0.79-147.79). The unadjusted incidence rate of GBS after mRNA vaccines was 1.3 (95% CI, 0.7-2.4), and when compared with Ad.26.COV2.S vaccines, the adjusted RR was 20.56 (95% CI, 6.94-64.66).2
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