Monday, September 26, 2022
Potential Temporal Association Found Between Guillain-Barré Syndrome and COVID-19 Vaccination in Pediatrics
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 Whole medications -- such as Vioxx -- have been withdrawn when only a few serious side effects out of millions of doses have been reported.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 A helpful medication was withdrawn because it MIGHT kill you.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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FDA vaccine adviser warns healthy young people should NOT get new COVID booster: Says it's 'unfair to make them take a risk' after data suggested shot was not as effective as first batch
A top vaccine expert and pediatric doctor is cautioning parents of healthy young people to hold off getting the new COVID booster shot, saying it can carry risks and its efficacy hasn't yet been proven.
Dr. Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia and a member of the Food and Drug Administration's Vaccine Advisory Committee, said he's not fully sold on the benefits of a third shot outweighing the harm.
'Who really benefits from another dose?' Offit said on CNN.
He did acknowledge that studies have shown people who are over 65, immuno-compromised or have a chronic ailments are less likely to be hospitalized with the virus if they've had a third or even fourth shot.
The newly developed dose, called a bivalent vaccine, is a cocktail of the original coronavirus strain combined with parts of the omicron BA.4 and BA.5 subvariants. The hope being that people would be able to fight a broader range of more highly contagious virus mutations.
But writing in the Wall Street Journal earlier this week, Offitt said preliminary data suggested the new bivalent vaccines were actually worse at warding off COVID infections than the first generation of shots.
He highlighted data comparing Moderna's original COVID vaccine and its new bivalent update. Of a test group given both shots, 11 people who'd received bivalent vaccines contracted the virus, while just five people who received the original 'monovalent' shot caught COVID.
Offit warned that the Biden administration that 'overselling' the new bivalent vaccines without more data could 'erode the public's trust' in them.
He explained that the FDA's recent approval of a the new vaccine cooked up by Moderna and Pfizer-BioNTech comes with little assurances and some risks.
'A healthy young person is unlikely to benefit from the extra dose,' he said.
The Centers for Disease Control and Prevention have reported that vaccine side-effects, like myocarditis, an inflammation of the heart muscle, and pericarditis, an inflammation of the heart's outer lining, are rare, but they most often occur in adolescents and young men.
Myocarditis can even be fatal, with young people far less likely to suffer a severe COVID infection than older people.
'When you are asking people to get a vaccine, I think there has to be clear evidence of benefit,' he said, adding that it's unrealistic to have clinical trials of the latest dose. 'You'd like to have, at least, human data,' he said. So far, the only tests on the new shots have been done on lab mice.
'Right now they're saying we should trust mouse data,' he said, 'and I don't think that should ever be true.'
Offit voted against approval of the new vaccine.
'If there's not clear evidence of benefit, then it's not fair, I think, to ask people to take a risk no matter how small,' Offit said.
The doctor recently cautioned that pushing the new shot without the supporting evidence risks 'eroding the public's trust.'
He said the studies regarding the bivalent vaccine so far were 'underwhelming.'
The increased emphasis on boosters is at odds with President Joe Biden's recent announcement that 'the pandemic is over.'
'The pandemic is over,' Biden told 60 Minutes. 'We still have a problem with COVID. We're still doing a lot of work on it. But the pandemic is over. If you notice, no one's wearing masks. Everybody seems to be in pretty good shape, and so I think it's changing.'
The president's declaration runs counter with what his administration's health officials have been saying.
'We have a virus out there that's still circulating, still killing hundreds of Americans every day,' White House COVID-19 response coordinator, Ashish Jha, said at a September 9 press briefing.
'I think we all as Americans have to pull together to try to protect Americans … and do what we can to get our health-care system through what might be a difficult fall and winter ahead.'
He also may have submarined his own $22.4 billion request to Congress to continue the fight against the virus.
There have been about 54,000 new cases of the virus on average over the last two weeks, according to Johns Hopkins University, with about 400 Americans succumbing to the virus every day.
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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com/ (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com/ (TONGUE-TIED)
https://immigwatch.blogspot.com/ (IMMIGRATION WATCH)
https://awesternheart.blogspot.com/ (THE PSYCHOLOGIST)
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