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Johnson & Johnson vaccine linked to rare cases of autoimmune disorder:
The Food and Drug Administration announced a change to the fact sheet on Johnson & Johnson's COVID-19 vaccine Monday, warning of an increased risk of Guillain-Barré syndrome, a neurological disorder that damages the nerves and can lead to paralysis.
"Based on an analysis of Vaccine Adverse Event Reporting (VAERS) data, there have been 100 preliminary reports following vaccination with the Janssen vaccine after approximately 12.5 million doses administered," an FDA spokesperson said in a statement to CNET. Ninety-five of the cases were serious and required hospitalization, with one reported death, according to the FDA.
The cases of Guillain-Barré usually occurred about two weeks after vaccination and were typically found in males aged 50 and older, according to a statement by the Centers for Disease Control and Prevention. The CDC said it will discuss the link between the US's only single-dose COVID vaccine and the autoimmune disorder at an upcoming meeting of the Advisory Committee on Immunization Practices. It also said that most people fully recover from Guillain-Barré syndrome.
The known benefits of Johnson & Johnson's COVID-19 vaccine continue to outweigh the known risks, the FDA said. But those who got a Johnson & Johnson shot should seek medical attention if they develop the following symptoms, per the FDA: weakness or tingling sensations, especially in the legs or arms, that's worsening and spreading to other parts of the body; difficulty walking; difficulty with facial movements, including speaking, chewing or swallowing; double vision or inability to move eyes; or difficulty with bladder control or bowel function.
[...] Guillain-Barré can occur after infections with viruses such as the flu, Epstein Barr or Zika, the CDC reports. Guillain-Barré also occurs after infection with Campylobacter bacteria, which is the most common bacterial cause of diarrhea. It has also been been associated with other vaccines, such as those for the flu and shingles, according to the FDA. Although most people fully recover from Guillain-Barré syndrome, it can lead to severe nerve damage and paralysis. It's also most common in men and people over age 50.
Also at CNN.
Wikipedia entry on Guillain-Barré.
(Score: 3, Informative) by Beryllium Sphere (r) on Tuesday July 13 2021, @02:46AM (25 children)
Meanwhile GBS is one of the risks of a live case of COVID-19, along with the part where you die on a ventilator.
https://www.mayoclinic.org/diseases-conditions/guillain-barre-syndrome/symptoms-causes/syc-20362793 [mayoclinic.org]
(Score: 0) by Anonymous Coward on Tuesday July 13 2021, @03:39AM
So it's not lupus?
(Score: 1, Insightful) by Anonymous Coward on Tuesday July 13 2021, @05:17AM (16 children)
You trying to "shill" for the vaccines at every opportunity is getting kind of weird. This is serious stuff. Among all the other confirmed major side effects (blood clots, heart disorders, etc) we're now also looking at 1 in 120k developing autoimmune disease. The odds of developing serious medical conditions following vaccination are rapidly increasing, and are likely to only further increase.
I found the paper linking this autoimmune disorder to COVID here [nih.gov]. In the 180 million people who have had COVID (undercount due to the fact COVID most frequently has no symptoms and thus no diagnosis) they found it in 220 people, a rate of 1.2 per million instead of the vaccine caused rate of 8.3 per million. But something even interesting here is also the fact that the paper does not seem to have considered the possibility that the autoimmune disorder may have been caused by the vaccines and not by COVID. And Captain Obvious would point out the fact that this is going to be, in part at least, because right now there is an immense amount of pressure on everybody involved in the "public" face of COVID (ranging from healthcare professionals to researchers) to not speak negatively of the vaccines.
Anybody who thinks the increasingly absurd VAERS [openvaers.com] reports (vaccine adverse effect reporting system - a US government reporting database for adverse effects) are all just random coincidences is becoming increasingly out of touch with reality. I put "shill" in quotes, because I have literally never once in my life accused somebody of being a shill, in a time where such claims are tossed about so casually. But I'm having increasing difficulty imagining somebody behaving in an organic fashion, regardless of their background of ideology, and coming to your endless defense of the these experimental vaccines.
(Score: 3, Insightful) by khallow on Tuesday July 13 2021, @06:00AM
What's weird about it? Getting more people to take the vaccines when the vaccine is available would save a lot of lives.
Notice that the paper has a cutoff time of December 2020. Vaccination would not have been a significant factor by then.
(Score: 3, Interesting) by https on Tuesday July 13 2021, @02:25PM (11 children)
This is "serious stuff", as opposed to the one in fifty chance of dying, or the one in five chance of developing permanent heart damage, from covid, and long term neurological shit that is still being figured out? I'd say fuck off and die, but you want to take us out alongside you. So just fuck off.
No, the vaccines are not without risk. But neither is covid, and I can do the math well enough to figure out what's better for me. And I can bet money on what's better for you. Because of assholes like yourself, I'm more likely to be exposed to the virus than not in my lifetime, and I'd like to be vaccinated then. Because I'd rather bet money than my life.
Offended and laughing about it.
(Score: 3, Interesting) by Socrastotle on Tuesday July 13 2021, @03:16PM (9 children)
You need to consider the data when weighing risk, because COVID risks are extremely biased in various ways such as age. You can find the latest data available here [cdc.gov] under the "Sex and age" heading. To my knowledge the CDC is no longer publishing the average, but in various regional/state calculations it is frequently upwards of 80 years. Currently 16.5% [census.gov] of the US is over the age of 65, yet this age group makes up 79.4% of all COVID deaths. This is made even more notable by the fact that their overall exposure to COVID has probably been substantially less than the age groups below them. It was not (on average) the 65+ crowd going out in massive crowds to join protests last year. People under the age of 50 make up the vast majority of Americans (and a likely even further disproportionate rate of exposure to COVID), yet this age group only accounts for 4.7% of all COVID deaths.
Of course you might suggest that well 4.7% is still a lot of people. This is where we get into the other factor of risk for COVID - preexisting conditions. You can find those on the same page under the "Comorbidities and other conditions" section. Fortunately there they are maintaining averages, and so we can see that the *average* COVID mortality had 4 additional causes of death (besides COVID) on the death certificate. Some of those cormorbidities will likely have been caused or greatly exasperated by COVID, such as respiratory failure. But many of the causes of death were obviously not caused by COVID: diabetes, cancer (malignant neoplasm), heart disease, etc, etc. Where things get interesting is when you combine the tables. Unfortunately they inexplicably use different age ranges so we can't do this perfectly, but we can at least see general trends. So for instance if you look at the age group of 0-17 year olds there have been a total of 331 deaths where COVID was listed as a factor (and 49,407 deaths from all other causes). How about comorbidities? Of these 331 people who "died of COVID" up to 75 head cancer, 117 had diabetes, etc.
Your chances of having a poor outcome COVID depend heavily on your age and health. If you're young and healthy, your chances of dying from COVID are completely negligible. And this is on top of the fact that in the US last year, with rampant disregard for mitigation efforts and widespread group gatherings, less than 10% of Americans ended up infected. And so you also need to factor in the chance of not getting the virus into the risk calculation here. For instance let's say you had a 10% chance of a negative effect from a vaccine, and a 20% chance of a negative effect from a virus. It seems obvious that the vaccine is less harmful than the virus. But if you only stand a 10% chance of catching the virus then suddenly the weighting is a 10% chance of a negative effect from a vaccine versus a 2% chance of a negative effect from a virus after that weighting is considered.
(Score: 0) by Anonymous Coward on Tuesday July 13 2021, @03:22PM (4 children)
TL/DR:
- Vaccines make perfect sense if you're old and ill.
- Vaccines make 0 sense if you're young and healthy.
The important question is where people who tend to fall between the two extremes meet. And, in my opinion, that should be a personal decision. As Israel has now become a great example of, this virus isn't going to go away just with mass vaccination. And if you do choose to get a vaccination it will likely entail multiple more booster shots over the next year or two before this virus becomes endemic and fades but never really disappears. Each shot further increasing the risk of facing one of the ever mounting number of side effects.
(Score: 2, Insightful) by Anonymous Coward on Tuesday July 13 2021, @04:12PM (3 children)
I just posted another response to GP that talks about actual incidence of side effects from COVID vs. from the vaccine. In most types of side effects, the incidence from COVID is orders of magnitude higher than from the vaccine, so that's a risk you need to consider, even if you're "young and healthy."
Also, one needs to consider what sort of gamble you're taking by delaying vaccination, in terms of effects on the population and future COVID risks. COVID already has a lot of nasty side effects beyond death. The more it is in circulation, the greater the risk of mutations that lead to more problems, worse side effects, and perhaps greater ability to punch through protection from the vaccine and infect more people. (Thus enhancing the aforementioned bad effects.)
Viruses are a moving target. Without herd immunity and with large outbreaks continuing to happen, we run increased risk of worse strains developing, including ones that the vaccines may not be able to guard against. Which puts everyone at greater risk.
So, as a young healthy person, you can take the risk of getting COVID and potentially getting some nasty side effects, while contributing to the potential future evolution of the virus that will make it even more likely you'll be infected in the future and perhaps have even worse effects... or you can get the vaccine, take some much lower risks, likely avoid most of potential nasty side effects of COVID itself, and help stop the spread and evolution.
I'm NOT saying everyone should blindly just get the vaccine. But portraying it as though there's "zero sense" in a young person getting it is disingenuous at best -- there are broader implications to young people not being vaccinated, both personally and for society at large.
(Score: 2) by Socrastotle on Tuesday July 13 2021, @06:13PM (2 children)
I believe Israel has demonstrated that herd immunity is not really viable. Israel had remarkable success with a coercive vaccination campaign and managed to vaccinate more than 80% of their adult population. And for some time it seemed to be paying dividends. They brought their *total* caseload down to below 200 with new cases trending towards zero. Then? One guy brought in a variant (this is rhetorical, but perhaps not - all it takes is one individual), and now they have active cases in the thousands, and just hit 1,198 new cases in one day. Scaled to America's population (for comparison/context), that would be 42,776 new cases. Big Pharma is cooking up another shot though, ready to market with the utmost urgency. I will make the bold prediction that this will not be the last time this cycle repeats.
(Score: 0) by Anonymous Coward on Tuesday July 13 2021, @09:54PM (1 child)
You're overlooking the fact that vaccination is only one part of the solution while simultaneously pointing out that it's an incomplete solution. SMH.
Compare with the handling of industrial safety - how you protect workers from hazards on job sites The most effective thing to do is to eliminate a hazard from a worksite. If it or something like it absolutely has to be there, it is often possible to substitute something less hazardous. Less effective are engineering controls, namely changing industrial processes to isolate workers from the hazard. If that can't be done, you apply administrative controls, eg. "do not cross yellow line". Least effective is personal protective equipment.
Higher on the list is generally harder to do but also generally more effective in ensuring worker safety. Hardhats are fine, but better is telling the steelworkers to put a tarp under the doodad they are riveting, best is assembling the damn thing on the ground and figure out how to not break it when the crane lifts it up.
Travel restrictions, lockdowns, vaccination induced herd immunity, ventilation controls, and masking have analogues in industrial safety design. I leave it as an excercise for the reader to determine their relative ordering. No analogy is perfect.
Herd immunity is absolutely viable, if you understand that it is only a part of the solution. Without it, and other protective measures you've just got mass infection.
(Score: 2) by Socrastotle on Wednesday July 14 2021, @01:33PM
When a population reaches herd immunity against a disease the idea is that that population becomes effectively immune as a whole, even if some subset ends up infected it will be unable to effectively spread. We do not need to engage in "other protective measures" to ward off polio, because we have achieved genuine herd immunity. Of course this only works when you have robust and effective vaccines. The efficacy against the latest strains, which are not even an immune escape incident and evolved from a non-immunized population, are quite poor.
And so in this sort of scenario herd immunity has no real meaning, and the both politicians and the media are overtly lying about this. They continue to suggest that once we achieve herd immunity, life can return to normal. But of course it won't, because, as you've acknowledged here - herd immunity, as it applies to COVID, no longer really has any meaning. A society with no protection and a society with herd immunity will, if they seek to prevent future outbreaks, be obligated to behave in pretty much the same way.
(Score: 2, Informative) by Anonymous Coward on Tuesday July 13 2021, @04:00PM (3 children)
Indeed, you do. Your post might be an interesting comparison of death rates, but you do realize that death is not the only bad side effect of COVID, right?
If that were actually the gamble most people are dealing with, I'd probably agree with you. Unfortunately, in the case of COVID, for most serious side effects (even those that show up in young people), you're often talking about more of an order of magnitude different in risk from vaccine vs. COVID, and sometimes several orders of magnitude.
Just to take a couple that have hit the news in recent months (and were mentioned by GP in the rant about the "serious" situation):
1. Rare types of blood clots. These have been enough to derail vaccine rollout, despite being only a few per million risk. But the chances of these specific complications from COVID is likely to be 8 to 10 times higher [bmj.com] for the most common vaccines in the U.S.:
2. Even more recently, the concern about myocarditis has been raising concerns around the vaccines. The situation there is even worse news for those who actually contract COVID, even among your young age groups that you focus on. The incidence (of myocarditis and pericarditis) so far measured seems to be about 19.8 per million in people aged 30 or younger for Moderna, and about 8 per million for Pfizer. But the incidence in young people of these complications for COVID infections is somewhere between 100 and 1000 times higher [jamanetwork.com]. The study linked there showed an incidence of myocarditis of 23,000 per million in college athletes with COVID. (That's not a typo.) That study scanned people who had no other clinical symptoms that would indicate a heart issue, though -- but still, 0.31% (3,100 per million) actually displayed clinically significant symptoms that would have led to a myocarditis diagnosis even if not participating in the study. There have been other studies of myocarditis in young people -- as heart inflammation is a serious risk for people like college athletes -- and the average rate across studies seems at least 0.5%... again, vs. a rate of 0.0008% to 0.002% for the vaccine. So, roughly 250 to 500 times greater risk from COVID itself.
Now, most young and healthy people -- as you note -- will likely recover from some of these complications, at least immediately. But things like heart inflammation can cause permanent damage t the heart that may not show up as problematic immediately, but may make you more at risk of a heart attack or other complications years or decades down the line.
I know a very healthy and fit couple in the 40s who got COVID very early on during the pandemic, one ended up in the hospital, and now both have signs of permanent organ damage. I just found out a few weeks ago that a spouse of another friend not only lost his sense of taste from COVID, but when it came back, everything is wrong. His favorite foods now taste awful, and he's lost over 20 pounds in recent months (that he didn't need to lose) just because eating has become disgusting to him.
When you start looking into the stats, you start finding that a surprising number of people -- including many younger people -- have these serious side effects from COVID that may be permanent and create significant future risks or change quality of life.
So yeah, I agree with you that you should consider the data when evaluating the need for a vaccine. Just be sure to be comparing ALL of the data, including serious side effects. Not just death.
(Score: 2) by Socrastotle on Tuesday July 13 2021, @05:17PM (2 children)
Your #1 example fits the exact hypothetical I was offering. If you have 25 "units" chance for an event from the virus, but only 4 "units" chance for an event from the vaccine, then it seems reasonable to say you're more likely to get it from the virus than the vaccine. But you need to factor in the chance of getting the virus. That is going to vary based upon your own personal behaviors, but the one datum we have is that about 10% of America has been diagnosed* with COVID.
So if we assume your personal behaviors are about average for America, then we'll say you have a 10% chance of infection. So your weighted chance (in "units") of the event happening from the virus becomes 25 * 0.1 = 2.5 while it remains 4 for the vaccine. In other words, an unvaccinated individual is less likely to suffer said effect than a vaccinated individual. And when we're speaking of vaccines, this should not be even close which brings us to your second point.
And as for your second point, sample size is critical. It was based on a sample of 1,597 individuals and has a confidence interval that goes all the way down to 0% (as well as up to extremely high levels). That is complete and utter noise. I am almost certain that this paper would never have been published if it was using similar evidence to suggest a problem with the vaccines.
(Score: 1, Informative) by Anonymous Coward on Wednesday July 14 2021, @12:35AM (1 child)
I love how you tacitly and conveniently pick the lowest number from the confidence interval to try to make your point. The ratio is more likely to be around 8-10, not 4. You need to take into account the range for the CI of the vaccine too... and yes, that creates a wider potential range of potential risk ratios, but don't be a jerk and silently manipulate the numbers to your favor.
If you actually use the more likely estimate for the ratio, your argument doesn't actually work. You'd need to play with your own made-up numerical scenario and "for instance" nonsense to make the numbers work out.
Wow. You just made an argument just literally made up out of BS numbers you pulled out of your ass about likely chances of getting the virus in the long-term, but now you're critiquing a published study with 1600 participants and 37 actual cases of COVID coupled with heart inflammation?
I think you misread the study. The only place 0% seems to be mentioned is here: "Thirty-seven (including 27 men) were diagnosed with COVID-19 myocarditis (overall 2.3%; range per program, 0%-7.6%)" -- that 0% indicates some sports programs at some schools had a rate as low as 0%. It's not a confidence interval. It's just the range seen in programs at different schools, which also had vastly different experiences with COVID, so we'd expect some variation.
The confidence interval is stated elsewhere: "The prevalence of myocarditis per program ranged from 0% to 7.6% (overall, 2.3% [95% CI, 1.6%-3.2%]; model-based estimate, 2.1% [95% CI 1.1%-4.4%])"
Thus, again, a level a few orders of magnitude greater than such a side effect from the vaccine.
Well, if you actually understand what the paper says (or are you deliberately misrepresenting the paper and lying to try to argue your point?), the confidence interval shows likely evidence that COVID cases have a risk several orders of magnitude higher than the vaccine. Or are you suggesting that all of these cases (37 cases of myocarditis out of ~1600) among athletes with COVID are seriously just a coincidence?? The prevalence is a LOT greater than observed in random young people of that age who don't have a serious illness.
(Score: 2) by Socrastotle on Wednesday July 14 2021, @02:02PM
The point remains exactly the same with 39. It was the result of skimming your post. If you haven't realized yet, the audience for posts once we start to getting into actual numbers instead of sensationalism, emotionalism, and drama in general - approaches zero. We are mostly just talking to one another.
And as for the study, no I was not suggesting coincidence - I was suggesting p-hacking. It's a rather specifically selective sample where the outlier data was likely known ahead of time, with inexplicable variation even in your sample groups, seemingly zero effort to have a control group (such as testing a sample of non-COVID athletes from each sample, and that further inflated its figures by carrying out atypical operations. The paper acknowledges medical assessment based on symptoms alone would have resulted in a detection of only 0.31%. It was only inflated by carrying out a slew of tests, including cardiac MRIs on completely asymptomatic individuals. And you're now comparing that figure against the population at large, when needless to say a figure very close to 0% have undergone any sort of testing for myocarditis, let alone completely asymptomatic individuals having cardiac MRIs.
Put another way, imagine you test only people with red hair using a sophisticated detection method to determine whether or not they have somethingitis. And, lo and behold, you find far more cases of somethingitis among your sample than among the general population. Is this now because redheads genuinely have a higher rate of somethingitis, or is it because the general population has not been tested using your sophisticated somethingitis detection methods? This is where a control group comes in.
(Score: 0) by Anonymous Coward on Tuesday July 13 2021, @08:03PM
both the disease and the vaccine are made by the same people. it's about control and population control. dumb slaves funding it all.
(Score: 1, Troll) by Tork on Tuesday July 13 2021, @03:53PM (2 children)
Is it? Cos a circus of idiotic performers are bouncing up and down behind you drowning you out with meme-fueled 'alternative science' about how vaccines work. Are you sure you're wagging your finger in the right direction?
Slashdolt Logic: "25 year old jokes about sharks and lasers are +5, Funny." 💩
(Score: 0) by Anonymous Coward on Tuesday July 13 2021, @06:48PM (1 child)
I do not derive my views by what other people think. I derive my views by what I personally find most compelling. And this is something that all people should strive for.
Society has never had issue for sake of two many people thinking for themselves. It is instead invariably when society does choose to adopt the views of some establishment or individual, and that establishment or individual directs society down a path it never would (or should) have tread on its own.
(Score: 2) by Tork on Tuesday July 13 2021, @06:53PM
Slashdolt Logic: "25 year old jokes about sharks and lasers are +5, Funny." 💩
(Score: 3, Interesting) by JoeMerchant on Tuesday July 13 2021, @10:14AM (5 children)
That's eight per million diagnosed and confirmed.
Meanwhile, my 69 year old neighbor who had COVID in November / December, the Phizer vaccine doses in March, was feeling "off" in late June, had a spasm out of his shoes while fishing on a dock alone in early July, wasn't breathing when he hit the water, and is not listed as a COVID related death.
Is the economic impact of quarantine responsible for the recent drop in US life expectancy? I don't think so.
Україна досі не є частиною Росії Слава Україні🌻 https://news.stanford.edu/2023/02/17/will-russia-ukraine-war-end
(Score: 2) by hendrikboom on Tuesday July 13 2021, @12:19PM (3 children)
How does anyone know "he had a spasm out of his shoes" if he died alone?
(Score: 1, Informative) by Anonymous Coward on Tuesday July 13 2021, @02:48PM
Presumably his shoes were left on the dock.
(Score: 2) by FatPhil on Tuesday July 13 2021, @03:28PM (1 child)
Great minds discuss ideas; average minds discuss events; small minds discuss people; the smallest discuss themselves
(Score: 2) by JoeMerchant on Tuesday July 13 2021, @03:44PM
For whatever reason, he was wearing his shoes, then his shoes were sitting on the dock and he was in the water not breathing. I'd assume he had a cardio or pulmonary or both event. His wife was watching him from the house, saw him go in the water. Neighbors are fire fighters, they had him out of the water within a minute or two, did CPR, but he was already gone - reportedly no water in his lungs.
Україна досі не є частиною Росії Слава Україні🌻 https://news.stanford.edu/2023/02/17/will-russia-ukraine-war-end
(Score: 0) by Anonymous Coward on Tuesday July 13 2021, @10:03PM
Four months? Do you have any idea what can happen or what you can be exposed to in four months? Totally the vaccines fault and nothing else before or after. I got a raise two months after my vaccine. Should I be thanking BioNTech for that too?
(Score: 0) by Anonymous Coward on Tuesday July 13 2021, @08:00PM
shut up, you dumb bitch ass whore! enjoy dying of your death jab, you stupid slave!