Sorry if this has already been covered in one of the existing Coronavirus threads, but I wonder what people think about the US government's decision to pause the J&J vaccine over blood clots. At the time of the pause, 7 blood clots had been identified (one death), accompanying ~6.8m shots. If these numbers remain steady and if causality is determined, it will mean that the probability of a blood clot is around 1/1m. These are very low odds - well below the odds of dying from coronavirus, for example. It also seems likely that J&J will resume soon, perhaps with some new guidelines for delivering the doses.
So, did the government do the right thing here? Vaccine pauses are normal and I understand why the government wants to show that it is taking safety seriously, but on the other hand this may fuel vaccine hesitancy and lead to more COVID cases/deaths in the process.
What do you think?
Here are the odds (https://www.healthing.ca/diseases-and-conditions/coronavirus/vaccine-for-coronavirus/blood-clots-from-covid-a-greater-risk-than-those-from-vaccine):
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But what are the risks, exactly? Six people experienced blood clotting in the U.S. among 6.8 million doses of the J&J vaccine. The AstraZeneca shot has been given more than 20 million times in the U.K., with the chances of developing clots from that vaccine are around one in 250,000. These are exceedingly long odds, especially when you consider how common blood clots are in everyday life.
For example, experiencing a blood clot after surgery is common in orthopedic surgery. Pregnant women have about a one in 500 chance of developing a blood clot, while women on birth control are at about a one in 1,600 risk. But for people hospitalized with COVID-19 these odds grow to a whopping one chance in five that they will suffer from a blood clot.
Compare 1 in a million to 1 in 5.........
I read a pretty persuasive oped in WaPo that argued it should not have been. Central to the reason they presented as why it was is that the CDC panel has an over representation of panelists whose expertise is in rare diseases with a relatively low infection rate and range.
It seems reasonable to pause so they can examine the issues involved. The FDA may decide to do nothing, issue a warning, resume vaccine for limited groups, or pull completely. My guess is that it will be some version of the middle two. I think they realize the odds, which is why I don't think they will advise anything Draconian.
We must compare the one in a million deaths to the number of deaths resulting from not using the J & J vaccine.
Here is one set of estimates:
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What we end up with is that the risk of dying from COVID-19 is anywhere from 36 to 78,571 times HIGHER than the risk of dying from a J&J vaccine-related blood clot.
https://www.newscentermaine.com/article/news/health/the-odds-of-dying-from-a-johnson-and-johnson-vaccine-related-blood-clot-vs-dying-from-covid-19/97-de75d270-1175-45af-8ce7-12de44f2d5e4 (https://www.newscentermaine.com/article/news/health/the-odds-of-dying-from-a-johnson-and-johnson-vaccine-related-blood-clot-vs-dying-from-covid-19/97-de75d270-1175-45af-8ce7-12de44f2d5e4)
The vaccine should therefore be permitted, with labeling of course, even if the causality is not understood.
One of the main purposes of the pause was to make sure that medical providers were fully aware that these blood clots should NOT be treated with heparin or other blood thinners. This allowed medical providers to make sure that they have the appropriate treatments on hand, and know what to look for in the future.
That is what the FDA is likely to conclude, Dismalist.
Better late than never. :-)
Quote from: mythbuster on April 20, 2021, 11:23:57 AM
One of the main purposes of the pause was to make sure that medical providers were fully aware that these blood clots should NOT be treated with heparin or other blood thinners. This allowed medical providers to make sure that they have the appropriate treatments on hand, and know what to look for in the future.
How are they treated?
I think it was a mistake. They should have issued a statement saying this is very rare, they will continue to monitor, and they are educating doctors on what to do in these rare cases. I don't see a reason to pause while educating doctors about such a rare side effect. The big downside in addition to slowing vaccination is polling suggests it is feeding vaccine hesitancy both in the US and in countries that will have to rely much more heavily on the J&J vaccine than we do. I don't find the argument that in the long run it will make people trust the FDA more particularly persuasive– I don't think it will do anything to make anti-vaxxers trust them, and everyone else is probably fine with monitoring without pausing if it was communicated well.
I think this highlights one of the ways in humans tend to be irrational about risk assessment, including by "experts"-- we perceive a small risk of harm through action as more serious than almost certain harm through inaction. It's essentially the trolly problem in real life.
Quote from: Puget on April 20, 2021, 11:41:39 AM
I think this highlights one of the ways in humans tend to be irrational about risk assessment, including by "experts"-- we perceive a small risk of harm through action as more serious than almost certain harm through inaction. It's essentially the trolly problem in real life.
And how the media fuels it by saying "IS IT SAFE????" and continually focusing on uncertainty. Since the odds are similar, they might just as well spend 20 minutes talking to 2 or 3 experts about "WILL I WIN THE LOTTERY?"
There are two other vaccines in the US and another in UK/Europe. I guess the Chinese and Russian vaccines also work, but I doubt we'll ever see real data, at least not from those countries.
So, I think consider that its very likely J&J will resume momentarily, this stoppage was a blip.
My feeling has always been that J&J is likely to be the "go to" for young kids once they all get approved because it only needs one shot (also the difference in efficacy aren't as likely to be as impactful for the youngest groups).
My lay impression is that not pausing would also have fuelled vaccine hesitancy. I don't think we can know which strategy would have done so more. But I can tell you that I, for one, found the pausing reassuring. They identified a potential issue, were upfront about it, took a moment to reconsider and better inform the public and healthcare practitioners, and are resuming. That seems fine and responsible to me, and perfectly reasonable.
We avoided a tiny number of clotting deaths in return for a larger number of Covid deaths.
The experts saw that doing nothing noticeable would get them blamed for the clotting deaths, but they would not get blamed for the Covid deaths of those unknown individuals who would die from the disease.
The experts do understand uncertainty [I hope]. They just understand how to keep their jobs much better. :-)
If they had raised the alarm and allowed people to choose, that would've been a better situation (IMO). I would have gotten J&J anyway (I was scheduled for the day after the pause).
Quote from: FishProf on April 20, 2021, 12:26:03 PM
If they had raised the alarm and allowed people to choose, that would've been a better situation (IMO). I would have gotten J&J anyway (I was scheduled for the day after the pause).
Bingo! Fewer dead people that way.
I think a provisionary warning with no pause would probably have been fine. I also think an uptick in COVID deaths (weeks from now) attributed to the pause would be pretty small. Perhaps bigger than 5, but maybe not a lot bigger (especially since many would get another vaccine, get J&J later, or mitigate for now and eventually get vaccine). I also agree that no pause could lead to hesitancy, especially if there were more deaths, or a warning was issued but shots still administered without having examined the problem more deeply.