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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: 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.