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J&J COVID vaccine use paused due to one-in-a-million complication;:
On Tuesday morning, the Food and Drug Administration and the Centers for Disease Control and Prevention issued a release acknowledging that an extremely rare clotting disorder was associated with the use of the Johnson & Johnson COVID vaccine. The problem is actually less than a one-in-a-million issue; in data from the US, where 6.8 million doses of this vaccine have been used, there have only been six instances of the clotting problem detected.
Because the clots call for an unusual treatment, however, the organizations are calling for a pause in administering the shot. This will provide them with time to ensure the medical community is aware of the appropriate treatment.
[...] The leading hypothesis to explain the phenomenon is that, in very rare cases, the adenovirus triggers an immune response to factors found on the surface of platelets, which are an essential part of the clotting process. This activates platelets, causing clots, and at the same time reduces the total platelet count.
These seemingly contradictory changes make treating the issue through the normal approach to excessive clotting dangerous. Typically, the appearance of clots would call for using a treatment that would reduce the probability of clots forming. But due to the low platelet counts in these individuals, those treatments can make it much less likely that clots form when they're needed.
It's this difference between apparent patient needs and appropriate treatment that has caused the CDC and FDA to call for a pause in the use of the J&J vaccine.
[...] So far, all six cases have occurred among women below the age of 50 and appeared between one and two weeks after vaccination.
To put that in a different perspective, imagine giving a shot of vaccine every single second of every minute of every hour of every day.
How long would it take to reach 1 million doses? Start on the first second of a Sunday. Go through that whole day. And Monday, and Tuesday, and Wednesday, and Thursday, and Friday and Saturday — i.e. one whole week.
We're not done yet!
Add another Sunday, and Monday, and Tuesday, and Wednesday; that gets us to 11 consecutive days of non-stop dosing. That would still be less than 1 million doses. Remember this is at a rate of Jab. Jab. Jab. Jab. Non-stop.
After all that, you're still not done! You'd still need another 49,600 doses to reach exactly 1 million.
(Score: 3, Flamebait) by hemocyanin on Wednesday April 14 2021, @12:02AM (21 children)
Is one in a million an accepted adverse reaction rate? How does this vaccine compare to other vaccines?
Instead of a snarky "look at the unwashed morons" quip, how about digging up the data. I've got other things to do right now, but at least I started. There should be a paper in here somewhere that gets into the hard numbers rather than just a list of bullet points telling you to question nothing.
https://www.vaccines.gov/basics/safety [vaccines.gov]
https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/ [cdc.gov]
I'd like to know how tetnus adverse events compares to the COVID numbers. This is the sort of information that if made easily available would encourage acceptance. I find the snarky stuff about being a moron to instead make me question the safety of the COVID vaccines. I've basically taken the position that I'll wait for the human trials that we're in the midst of to conclude, but real data, not ideologically massaged, could move me.
(Score: 1, Insightful) by Anonymous Coward on Wednesday April 14 2021, @12:17AM (7 children)
》 Is one in a million an accepted adverse reaction rate?
Apparently it's not accepted, since they're pausing the human trial.
(Score: 0, Offtopic) by Ethanol-fueled on Wednesday April 14 2021, @12:21AM (6 children)
Maybe they're burying and downplaying the actual numbers. Its painful sometimes, to be right about everything like i am, because it takes years of patient waiting to prove to everybody how right i am about things.
(Score: 0) by Anonymous Coward on Wednesday April 14 2021, @12:32AM
A blood clot in the brain? Nothing for you to worry about.
(Score: 4, Informative) by Reziac on Wednesday April 14 2021, @12:48AM (2 children)
Actually it's a pretty low reaction rate, about 1/10th what's typical for traditional vaccines.
Here's some long-term data on an old tried-and-true vaccine:
https://pubmed.ncbi.nlm.nih.gov/11144371/ [nih.gov]
Serious adverse events after measles-mumps-rubella vaccination during a fourteen-year prospective follow-up
Results: Immunization of 1.8 million individuals and consumption of almost 3 million vaccine doses by the end of 1996 gave rise to 173 potentially serious reactions claimed to have been caused by MMR vaccination. In all, 77 neurologic, 73 allergic and 22 miscellaneous reactions and 1 death were reported, febrile seizure being the most common event. However, 45% of these events proved to be probably caused or contributed by some other factor, giving an incidence of serious adverse events with possible or indeterminate causal relation with MMR vaccination of 5.3 per 100,000 vaccinees or 3.2 per 100,000 vaccine doses.
.
And there is no Alkibiades to come back and save us from ourselves.
(Score: 1) by hemocyanin on Wednesday April 14 2021, @03:17AM (1 child)
Thank you -- that's useful info.
(Score: 2) by Reziac on Wednesday April 14 2021, @03:40AM
Welcome. That's also about what I've seen for random other older vaccines, but this was the first data I came to today.
And there is no Alkibiades to come back and save us from ourselves.
(Score: 2) by deimtee on Wednesday April 14 2021, @12:58AM
Oz has had just over a million doses and has one case of serious clots forming. But the clots lag the vaccine by 4 to 20 days, so one in a million is probably low.
No problem is insoluble, but at Ksp = 2.943×10−25 Mercury Sulphide comes close.
(Score: 1) by hemocyanin on Wednesday April 14 2021, @02:02AM
I read without looking at username -- I thought I was reading a melyan post for a second.
(Score: 4, Insightful) by Beryllium Sphere (r) on Wednesday April 14 2021, @12:29AM (1 child)
The Phase III trials were complete last year.
Claiming that the results were "ideologically massaged" by the clinicians and biostatistics nerds is a grave accusation. Got proof? Evidence even?
(Score: 4, Touché) by JoeMerchant on Wednesday April 14 2021, @01:54AM
Got a non-biased independent culture deconstruction investigation like was done at NASA after the Challenger explosion? No? And I doubt we will be getting one, either.
Україна досі не є частиною Росії Слава Україні🌻 https://news.stanford.edu/2023/02/17/will-russia-ukraine-war-end
(Score: 2) by Reziac on Wednesday April 14 2021, @12:50AM
Some hard numbers posted below.
And there is no Alkibiades to come back and save us from ourselves.
(Score: 1, Troll) by JoeMerchant on Wednesday April 14 2021, @01:58AM (1 child)
Six initial reported and verified cases translates to a much larger number in the field if an investigation cares to look for them.
What's most concerning is that these cases may be indicative of some kind of manufacturing error/design flaw which is what they are hoping to determine/correct with this shutdown.
Then there's the correlation with a similar problem in Europe a few weeks ago.
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 Wednesday April 14 2021, @03:12AM
Part of the delay is that they need to do an in-depth investigation and analysis to determine how much is the vaccine and how much is due to other unrelated causes. For instance, smoking while on contraceptives is a known risk factor for blood clots, and the reported numbers are in the right ballpark for that. Those cases need to be factored out before we can say what the risks of the vaccine are.
(Score: 3, Insightful) by Runaway1956 on Wednesday April 14 2021, @02:57AM (3 children)
Problem is, most vaccines have a history years or decades long. If they say that vaccine A has side effects ranging from nausea for 20%, up to death for 1 in 7 million, there is a long history of clinical data to back that up.
With the COVIDS, there is no history. We're all guinea pigs. Ten years from now, the side effects may look like
nausea 1 in 10,000
long term respiratory problems 1 in 20,000
reproduction problems for women 1 in 25,000
reproduction problems for men 1 in 75,000
long term circulatory problems 1 in 150,000
long term heart problems 1 in 500,000
death from blood clots women 1 in 900,000
death from blood clots men 1 in 50,000,000
No, I'm not a time traveler, but you need to understand that it's all experimental at this point. Eventually, all of the side effects will be known, and published, just like it is for every other vaccination.
Abortion is the number one killed of children in the United States.
(Score: 0) by Anonymous Coward on Wednesday April 14 2021, @03:22AM (1 child)
...but don't forget to compare those numbers with the non-vaccinated risk:
death from Covid-19 infection 1 in 50 (or insert your preferred rate here and compare to vaccine risks)
--
I don't mind being a guinea pig, if humanity's future is brightened.
(Score: -1, Offtopic) by Anonymous Coward on Wednesday April 14 2021, @06:23AM
You can't put a one in a zero.
(Score: 0) by Anonymous Coward on Wednesday April 14 2021, @10:41AM
>> Eventually, all of the side effects will be known, and published, just like it is for every other vaccination.
Assuming the aforementioned odds don't total to 1 in 1.
(Score: 2) by stretch611 on Wednesday April 14 2021, @03:58AM (3 children)
Well, supposedly no similiar cases with moderna or pfizer vaccines.
The Astra Zenaca vaccine had a higher rate in similar cases. Roughly 1 in 500,000 cases in Europe that last I checked the numbers. (wikipedia [wikipedia.org] does show slightly higher numbers than I thought; about 1 in 300,000.)
Probably related... The 2 mRNA vaccines do not appear to nhave this side affect, while both the J&J and AZ vaccines have it. The latter 2 are both Viral vector vaccines [wikipedia.org] derived from a modified virus to confer immunity. (The Spunike V vaccine made in Russia is also a Viral Vector vaccine.)
It sounds to me like the viral vector vaccines are quite similar to the actual covid virus due to the fact that blood clots are an common side effect of covid-19.
ofc, that is why they use a similar virus to get the immunity and hopefully lesser effects. (Like cowpox being used to prevent smallpox.)
Now with 5 covid vaccine shots/boosters altering my DNA :P
(Score: -1, Flamebait) by Anonymous Coward on Wednesday April 14 2021, @06:23AM (2 children)
No thnx, I'm not putting that mRNA shit in my veins. I'd prefer a REAL vaccine (sicne the fucking definition has been retconned to now include experimental shit). But in light of that, J&J seems like the least odd one of the bunch. Still, maybe I can get my hands on the Cuban vaccine, which is traditional, or I could just say FUCK IT, and not worry, since I'm not a fat fuck so my risk of dying is negligible. But i suspoect they will make some sort of vaccine mandatory so my kdis can have normal lives. Just abotu 30th mandatory vaccine on the ever icreasing list of poisoned shit. But hey, we got to keep the pharma profits flowing right?
(Score: 3, Interesting) by stretch611 on Wednesday April 14 2021, @07:29AM
Wow, you seem to be a real happy person with all of your kind words.
I am sure that you will be happy to know that the US has already paid the big pharma companies in advance for even vaccine doses for every person in the entire US regardless of whether or not you actually use it.
Your altruistic self sacrifice is truly remarkable in this day and age. After all, once all the vaccines are given out in the US, I am sure that the current administration will send all of the leftover doses to the poorer countries in central america. Your kindly act to not get the vaccine will inevitably mean that one of the less fortunate in those poor countries will be able to get vaccinated, saving them from the death and mayhem of coronavirus. Who knows, the poor person that you save might eventually cross the border and end up in the US only to marry your daughter. (and stay here thanks to her sacrifice to give him citizenship.)
You are truly an inspiration to us all. If only everyone could be so kind.
Have a BLESSED day 🥰 🥰
Now with 5 covid vaccine shots/boosters altering my DNA :P
(Score: 2) by Azuma Hazuki on Wednesday April 14 2021, @12:00PM
On the upside, if you're worrying about a vaccine causing learning disabilities...well.
I am "that girl" your mother warned you about...