Out of the 120 million people vaccinated in the U.S., roughly 6.9 million have received J&J’s vaccine, Fauci said, noting that there haven’t been any “red flag signals” from the Pfizer or Moderna Covid-19 vaccines that rely on MRNA technology in their shots. Out of the 6.9 million people who got the J&J jab, six developed blood clots, he said.
“We are totally aware that this is a rare event. We want to get this worked out as quickly as we possibly can and that’s why you see the world pause, in other words, you want to hold off for a bit,” Fauci said. “We want to leave that up to the FDA and the CDC to investigate this carefully. I don’t think it was pulling the trigger too quickly.”
This is from Berkeley Lovelace, Jr., “Dr. Anthony Fauci explains what the U.S. pause on J&J’s Covid vaccine means,” CNBC, April 13, 2021.
I’ll give you the short answer for what it means: it means more people will die of COVID-19 unnecessarily.
Life is about tradeoffs. The data suggest that if 1 million people get the J&J vaccine, one will get a blood clot and will not necessarily die. We have ways of dealing with blood clots. Dr. Fauci may be familiar with them, although I’m starting to wonder.
So pause the vaccine for 1 million people and you might save a fraction of one life, which you could probably have saved with medications. But say the people going without the vaccine are even in the medium-risk group, where their probability of dying if they get Covid is about 1 in 1000. Let’s say that even 100,000 of them would have gotten Covid-19. Then this pause would kill 100 people.
Pause the vaccine for 10 million people and the saved lives are probably between 1 and 2, whereas the lost lives are about 1000.
Is Fauci that ignorant? You might say that he’s a paternalist. But even parents typically want their kids to live, not die.
READER COMMENTS
Alan Goldhammer
Apr 13 2021 at 5:28pm
Fauci has no role at all in this. Data on vaccine adverse events are reported to the FDA and it is they who have the sole responsibility for making any decision about whether a drug/vaccine should be singled out for regulatory action. Also remember that all three of the vaccines currently available in the US have not been approved by the FDA; they are only available under an Emergency Use Authorization. It is unclear when and if they will receive a full approval.
In addition, the safety data is also very sparse in that there was no long term experience with any of these vaccines. Furthermore, there is a lack of good data on the background rate of this type of thrombosis in the general population.
Drug safety (and I spend part of my career in this area) is complicated and relies heavily on observational data to determine whether there is a signal or not. For example, there is a lot of apocryphal stories that the Moderna vaccine has more adverse reactions than the Pfizer one. I get emails often from friends and relatives asking me about this as this is what they have heard. I see no evidence that this is the case but absent data, it could be.
zeke5123
Apr 13 2021 at 6:02pm
So I agree there are a lot of open questions (i.e., Fauci may be correct on the object level though based on the data available sure seems like an inconsistent risk preference — maybe Fauci believes COVID is less deadly than he publicly proclaims; he is a known liar).
But once again you continue to engage in strawmans. David Henderson never said Fauci made the regulatory decision. Instead, he quoted an author who quoted Fauci. Based on these quotes, Fauci appears to support the halt on J&J. David Henderson criticized Fauci’s support for halting J&J vaccination.
David Henderson may be wrong. And it is fair to criticize him for that. It isn’t fair to criticize him for something he didn’t say. It also isn’t fair to criticize him for focusing on Fauci’s statements — like it or not, Fauci’s pronouncements carry weight (God willing for not much longer).
Mark Z
Apr 13 2021 at 6:14pm
Six people out of 7 million is a pretty minute signal (doubtful statistically distinguishable from noise; the incidence of deep vein thrombosis is probably ~1/1000 people). If this is sufficient evidence for suspension, then there’re a lot of products people take routinely that ought to be removed from shelves immediately, including most forms of birth control for example (for which both the evidence of increased risk of thrombosis and the effect size are greater).
JFA
Apr 13 2021 at 6:22pm
“there is a lack of good data on the background rate of this type of thrombosis in the general population.” see https://www.ahajournals.org/doi/full/10.1161/STROKEAHA.116.013617 and references therein for several studies on the background rate on that specific type of thrombosis.
“I see no evidence that this is the case but absent data, it could be.” This came out recently: https://jamanetwork.com/journals/jama/fullarticle/2778441?.
“Drug safety (and I spend part of my career in this area) is complicated and relies heavily on observational data to determine whether there is a signal or not.” The rate of Covid mortality is multiples of the risk of even being affected by CVST from vaccination, therefore you should just tell people that there may be a risk (which currently measures below the background rate (which might actually be higher than normal due to Covid)) and not pause the vaccine. There, not that complicated.
zeke5123
Apr 13 2021 at 6:24pm
For some reason, my comment disappeared.
To restate, you are creating a strawman. David Henderson didn’t say Fauci is responsible for halting the J&J vaccine. David Henderson only criticized Fauci’s support of the decision.
David Henderson
Apr 13 2021 at 6:43pm
Thanks, Zeke. Exactly. Fauci has a huge role–as a public intellectual whom people take seriously.
Ryan McPherson
Apr 13 2021 at 7:51pm
That is, in and of itself, a huge problem. We have no business elevating one man to that position to begin with; even less so is Mr. Fauci uniquely qualified to be that man.
Michael Koehler
Apr 13 2021 at 5:39pm
Dr. Fauci does have a role, it is public relations.
Given that role, his priority is to maintain faith in vaccinations in the face of pre-existing anti-vaccination views.
While I do not fully reject the argument above, I must add to it the question of how many people would die of Covid19 if they believed that J&J and by implication Pfizer and Moderna were dangerous, rushed vaccinations, and refused to be vaccinated. I know this view is already held by many.
The general public is often anti-science. Pushing ahead with J&J without doing something would have its own cost in lives lost.
zeke5123
Apr 13 2021 at 6:08pm
This is a hard trade off to determine. I am not sure a halt (especially if only for a few days) will make the public think the vaccines are safe — they rightfully will ask: “What did you learn in a few days that you didn’t know when you halted the vaccination.” That is, it will undermine belief in vaccines because the decision appears half-baked at best.
A longer pause to the J&J vaccination may preserve some vaccine goodwill, but at what cost? If J&J is generally safe and there isn’t sufficient supply of Pfizer / Moderna, then the decision to halt will likely on net cost lives.
Maybe better messaging should have been:
1. It is unclear if these vaccines are wholly safe — we are reasonably confident that they are in the main safe and worth the risk trade off.
2. When this info comes out, stating: “this is consistent with earlier messaging.”
Instead, by not treating people like adults the messaging has been vaccines are totally safe and now people lose faith.
JFA
Apr 13 2021 at 6:52pm
So they will pause the J&J for a few days like Europe, then allow it to be used while saying the evidence suggests that CVST may be a small, tiny risk.
My guess is that the pause from an abundance of caution approach turns off more people than just pushing on and commenting on the risk. The action of pausing means the FDA doesn’t know whether the vaccine should be on the market. The change in information between the start and end of the pause will not actually change the risk calculation. Skeptics might ask, “Why do we need to restart use tomorrow if the vaccine is just as risky when we decided to pause it yesterday?”
Jon Murphy
Apr 13 2021 at 7:24pm
Then why the halt, then? His statements here (and in the past) undermine public faith in the vaccine. I mean, he’s been pretty vocal about how useless the vaccines are.
David Seltzer
Apr 14 2021 at 5:59am
Jon Murphy wrote, “Then why the halt, then? His statements here (and in the past) undermine public faith in the vaccine. I mean, he’s been pretty vocal about how useless the vaccines are.” Especially after it was trumpeted about his getting the second dose of the Moderna vaccine.
Jasper
Apr 13 2021 at 8:10pm
Personally I would feel safer if the people in charge of the vaccine had the confidence to say that the vaccines are safe, science works, and in the absence of significant (clinically or conventionally) evidence to the contrary, the rollout will continue apace. Would you prefer to be in a car with a driver who freaks out at every obstacle, or one where they keep a steady hand on the wheel? I think that the analogy extends nicely to this situation.
Thomas Lee Hutcheson
Apr 14 2021 at 7:20am
Fauci is just defending the status quo that fails to apply cost-benefit analysis to pubic policy decisions.
suddyan
Apr 14 2021 at 7:37am
[Given that role, his priority is to maintain faith in vaccinations in the face of pre-existing anti-vaccination views.]
I do not do faith. I do science.
Unless forced, I will not take the vaccine.
I regard my life as continually subject to almost innumerable risks, and the risk of me “dying of COVID” is nothing extraordinary. I see no need to take a vaccine that has not undergone rigorous trials, and which has been approved only for emergence use.
I do not regard the touted “emergency” as an emergency.
PS. If anyone wants to cry “anti-vaxxer” at me, then I pre-empt the appropriate answer: “Go away and come back once you’ve grown up.” For whatit is worth, I have taken well-established vaccines voluntary where I perceive larger risk from not taking them.
Jon Murphy
Apr 14 2021 at 8:53am
The two are quite inseparable. One cannot do science without faith and one cannot have faith without science.
Michael Stack
Apr 14 2021 at 9:58am
“I regard my life as continually subject to almost innumerable risks, and the risk of me “dying of COVID” is nothing extraordinary.”
We can quibble about whether the risk of dying of Covid is ‘extraordinary’ (I think almost by definition, it is). However, the real question here is whether the risk of the vaccine outweighs the benefits.
If you want your response grounded in science, it seems that is the question you should be asking.
Jerold Toomey
Apr 14 2021 at 2:59pm
As I understand it, the reason J&J was halted is because the clots occur in women with low platelet count. It’s not understood how this can be. I don’t know if it’s a pre existing condition. No one gets blood checked before a vaccination.
Jerry Brown
Apr 13 2021 at 6:05pm
If the probability of dying from covid is 1 in a 1000, and 100,000 get it because they couldn’t get vaccinated due to this pause, isn’t that about 100 expected deaths- not just 10? And for ten million it would follow that it will cost 1000 lives?
I think it is even worse than you have described.
Jerry Brown
Apr 13 2021 at 6:41pm
For example, about 1 in 360 residents of New Jersey have already died from this coronavirus. In total- not just of those who are known to have been infected. And not everyone in New Jersey has had the disease and unfortunately, there are likely to be more deaths from it in the future.
David Henderson
Apr 13 2021 at 6:46pm
Jerry Brown. Thanks. Embarrassing mistake on my part. Correction made.
And I’m the guy who taught my students about numeracy. 🙂
Andre
Apr 13 2021 at 10:00pm
Doesn’t it depend on the age group? 1 in 1,000 masks the disparities. For 90+ year olds, it’s 1 in 10 or worse. For 5-15 year olds, it’s 1 in 1,000,000 or so. Perhaps.
It matters whether one is 20 or 50. A lot. It also matters much more whether one has comorbidities.
Fazal Majid
Apr 13 2021 at 6:12pm
I love it when economists explain what science is to actual scientists. Wolfgang Pauli’s famous quip really does apply to the pseudoscience of economics: “That is not only not right; it is not even wrong”.
David Henderson
Apr 13 2021 at 6:46pm
I’m glad you love it.
TMC
Apr 14 2021 at 8:38am
Fazal,
What the FDA and Fauci are engaging in is not science.
Michael
Apr 13 2021 at 8:18pm
This post is premature. It might be right, might not be right.
We don’t know how long the pause will last, what impact it will have on public confidence in the J&J vaccine (not to mention the Pfizer and Moderna vaccines), and how many people will be delayed in getting vaccinated and for how long.
We don’t know what the consequences of not announcing a pause would have been on public confidence in the vaccines.
J&J is a distant third in terms of supply, so if this ends up being a short pause and quick resumption, the cost in terms of delayed vaccinations will be very low.
A cornerstone of good crisis communication is getting out in front of bad news and communicating honestly. This has not been a hallmark of US crisis communications in the Covid-19 era, with many people (including Fauci) having communicated poorly over the past 14 months.
I think that, from a communications perspective, they are finally doing things the right way.
JFA
Apr 13 2021 at 9:24pm
“We don’t know how long the pause will last, what impact it will have on public confidence in the J&J vaccine (not to mention the Pfizer and Moderna vaccines), and how many people will be delayed in getting vaccinated and for how long.”
It’s been about 6 weeks since J&J was approved and 7.2 million doses have been administered since then. That’s an average of ~172,000 doses per day. So let’s say the pause is one day. That means we tossed ~172,000 back in line or shifted everyone back a day.
“We don’t know what the consequences of not announcing a pause would have been on public confidence in the vaccines.”
We don’t know the consequences of not issuing a pause either so that shouldn’t be a factor in your decision making. My very Covid skeptic family members were actually holding out for the J&J single dose because they “didn’t want their DNA messed with by Pfizer and Moderna”. I doubt that pausing the J&J rollout will inspire tons of confidence.
“A cornerstone of good crisis communication is getting out in front of bad news and communicating honestly. This has not been a hallmark of US crisis communications in the Covid-19 era, with many people (including Fauci) having communicated poorly over the past 14 months.”
Given that they have been doing a terrible job communicating over the past 14 months, what are the odds that they are doing it correctly now? Track records are usually a pretty good signal of something.
Michael
Apr 13 2021 at 9:37pm
J&J hit a production speedbump and has been falling short of its production targets. I actually had a J&J appointment that was switched over to a Moderna appointment a few days ago (pre-pause) for lack of supply reasons.
We don’t know how many of those 172,000 could have received a different vaccine (something like what happened to me, pre-pause).
That’s an odd philosophy. The decision makers here had to consider the potential consequences of pause vs no pause. Why does it make sense to ignore that in evaluating whether it was a good decision?
They appear to have been openly communicated bad news. That makes it an obvious step up over a lot of what they have done in the past.
JFA
Apr 13 2021 at 10:17pm
Regarding the second point: there are two choices, the consequences of which are uncertain. You can’t use the uncertainty of one path to argue for choosing the other (also uncertain path).
If you are in a place where they just have vaccines lying around such that you can just get another one if one is paused, then the pause probably won’t have much of an effect. Where I live, demand is still outstripping supply, so a lost appointment for a J&J vaccine is a lost appointment for a vaccine.
A short pause pause will only be a few days and not be too disruptive, but then did they really have enough time to review any data that would change the picture from what current data suggest? That gives an air of ramming it through and not doing due diligence.
If it’s a long pause, it’s more disruptive to vaccine distribution and also suggest that there is reason to not get the vaccine.
I will certainly grant that in terms of confidence and vaccine hesitancy, this could be a marginal issue. But it’s not clearly a good decision to pause the vaccine rollout.
Michael
Apr 14 2021 at 11:43am
On that I agree.
Jens
Apr 14 2021 at 3:22am
“””
We are totally aware that this is a rare event. We want to get this worked out as quickly as we possibly can and that’s why you see the world pause, in other words, you want to hold off for a bit
“””
If this is Anti-Science how do you call someone who denies that vaccines are working at all or that they contain nanochips made by Bill Gates ?
David Henderson
Apr 14 2021 at 10:50am
You ask:
I call that person really anti-science, even more than Fauci.
David Seltzer
Apr 14 2021 at 6:15am
According to the National Safety Council, the chances of dying from a motor vehicle crash is 1 in 103. I drive every day. 6 out 6.9 million developed blood clots and haven’t died. Sorry Anthony, I’ll take those odds.
Garrett
Apr 14 2021 at 7:16am
So one in a million get blood clots after receiving J&J. What’s that number for Pfizer and Moderna? What’s the base rate?
Pat
Apr 14 2021 at 8:31am
Yes!
What’s that number for people who don’t take any vaccine in a regular year?
What’s that number for people who get covid during this pause that otherwise wouldn’t have?
IFLScience dunces scoff at economics even though economists seem to be the only ones who ever ask, “Compared to what?”
J Mann
Apr 14 2021 at 11:06am
I would love to know the answer to this question. (And we must have the Pfizer and Moderna data, even if we don’t have the base rate.)
J Mann
Apr 14 2021 at 11:26am
Update: I googled, at it looks like the adverse event monitoring system has detected 3 CVST blood clot incidents out of 68 million administered Moderna and Pfizer shots.
https://www.businessinsider.com/covid-vaccine-blood-clot-risk-pfizer-moderna-johnson-and-johnson-2021-4
That’s helpful in terms of what the FDA is doing. The correct comparison rate may not be the actual background rate, but the rate of CVST incidents that are picked up by the monitoring system, and if J&J is 20 times higher or more than Pfizer and Moderna, even on a small number of hits, I guess I can see the reason for concern.
With that said, I can’t see what the FDA is going to know in a week that they can’t know now. From a cost-benefit analysis, it would seem more appropriate for the people involved to pull an all-nighter and do their analysis immediately rather than pausing the vaccine.
Mark Z
Apr 14 2021 at 1:38pm
About 1 in 1000 people per year get venous thrombosis. For cerebral venous thrombosis specifically (I’m not sure if all 6 people got the cerebral variety?) it’s apparently around 1 per 100,000 per year.
Tim
Apr 14 2021 at 10:52am
Your principle is right, but your math is wrong, because it does not consider the timeframe. As a result, it overstates the magnitude of the effect.
The statement “Let’s say that even 100,000 of [1 million vaccine candidates] would have gotten Covid-19” may be approximately right, if the 1 million vaccine candidates never receive a vaccine. But if it is really a pause (as contrasted with a permanent ban) in getting vaccinated, you should consider the timeframe. For example, if these 1 million vaccine candidates are delayed one week, then the number of extra infections caused may be more like 1000 or a few thousand (depending on your local covid prevalence), rather than your stated 100,000.
Pete Smoot
Apr 14 2021 at 1:36pm
I have to hope the CDC and FDA did this analysis. If you and I can think of it, you’d hope the highly paid and trained professionals did too. One can hope.
That being said, there’s one factor you missed: for how long do we pause. Suppose we only pause J&J vaccinations for two weeks. That will not prevent those million people from being vaccinated, it just delays is.
It seems to me a better analysis is “by how many people-weeks does this delay vaccinations?” and how many people will catch COVID in that many people-weeks.
The problem, as I see it, is some people will hear “The vaccine causes blood clots!” and refuse to ever be vaccinated. That number is non-zero. Is it as high as one million? Beats me but doesn’t sound impossible, given how innumerate people seem to be about vaccines.
Ken P
Apr 14 2021 at 5:06pm
This is going to sound like a sarcastic joke. Unfortunately there is truth to it.
You need to understand the policy makers to understand the rationale for the pause. Eliminating Covid deaths has a higher policy priority than all other deaths (suicides, missed cancer/cardiac screenings, starvation due to disrupted supply chains, etc.) with the exception of one: deaths (or even adverse events) from vaccines. Perhaps even a jab by a vaccine that does not end up having strong efficacy is worse than the Covid deaths mitigated by earlier adoption of vaccines (we had to wait for efficacy analysis to allow vaccination).
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