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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: 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.