WH: J&J News Should Increase Confidence In CDC And FDA

Americans should have more trust in the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) following the decision to pause administering Johnson & Johnson’s COVID-19 vaccine, White House COVID-19 Response Coordinator Jeff Zients said on Wednesday.


This is a companion discussion topic for the original entry at https://talkingpointsmemo.com/?p=1369685

I think this is wishful thinking. The vaccine hesitant don’t care about the CDC and they certainly don’t care about what Fauci says. They detest him. They’re mostly Trumpers. This backslapping among the CDC to say ‘hey, look at our process; look at our integrity!’ doesn’t do much for me. It feels more like a rationalization to avoid the fact that this pause on J&J does have an impact.

One can argue that the pause is justified, but one can’t argue that there isn’t a cost associated with a pause now. It basically kills J&J as a top tier vaccine. Pfizer/Moderna are Tier 1, J&J Tier 2, everything else is Tier 3. You get to your targets faster with a one dose vaccine vs 2 doses and that does mean a saving of actual lives. That’s up in the air now. Perhaps we’ll be bailed out by Trump’s hatred of Pfizer so that the MAGA hordes take J&J to own Fauci and the libs.

I maintain that it was possible to make a different decision. They could’ve announced publicly that they were investigating this matter of the 6 patients who experienced rising platelet counts and blood clots, convened the meeting scheduled for today, and then decided upon issuing a pause at that time or new guidance for clinicians or some combination of the two. An immediate pause wasn’t necessary, even if scientifically justifiable. It was a choice made because the CDC/FDA had the luxury of 2 other vaccines that are in significant supply and have reported no similar problems. If this were a problem with Pfizer, I don’t think there would be a pause because the cost-benefit analysis would be clearer: 1000 dead per day vs 1 dead per million vaccine recipients (and it’s not yet clear the vaccine caused said death).

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On issues like this America’s innumeracy stands out like a turd on a wedding cake - and that includes most pundits, reporters and otherwise seemingly highly educated people. Laws get passed over singular incidents that are almost statistically non-existent, but if it is something we love, like guns or cars, no amount of death and mayhem can even make us slow down.

Want to talk about dangerous drugs? Let’s talk about Tylenol (acetaminophen) -
Acetaminophen overdose is the leading cause for calls to Poison Control Centers (>100,000/ year ) and accounts for more than 56,000 emergency room visits, 2,600 hospitalizations, and an estimated 458 deaths due to acute liver failure each year .

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The shorter description (although I favor thoroughness) is that the CDC made a PR decision based on faulty reasoning and inconclusive science, but did so to seem proactive and honest. Given the obvious alternative of public notice and continued research, but simultaneously announcing that any complications are so rare and not even definitively caused by or tied to the J&J vaccine, people should take ANY vaccination opportunity since COVID poses 1000s of times higher risk than anything potentially associated with the vaccines.

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Statistics are wonderful things that are meaningless to the unlucky individual who makes up that statistic.

Since vaccines are about individual decisions, it’s important that we not have big question-marks around them or we’ll have folks more concerned about becoming the statistic.

Think you’re right that, had J&J been the only option, they may have chosen differently.

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The discussion around this is honestly quite astonishing.

All these numbers about how likely the blood clotting is, etc. are all bullshit. Because we dont know! Comparing bullshit numbers to known numbers is pointless. The actual numbers could be well higher, but they could also be much lower. 0, in fact.

The point is that we went from a 0% known risk, to a possible non zero % known risk. This is not just a quantative “the risk increased by some extremely small percentage” difference. This is a Qualitative difference. There is possible risk now where there was none before. This demands investigation.

Beyond that, the current vaccines all have emergency approvals. They do not have regular approvals. To not take all risks extremely seriously would be a grave mistake.

The medical and public health decision cannot be clearer. The pause was absolutely the right thing to do.

However, the non medical factors are also extremely important. First, we need to look at the overall context of there being a raging pandemic taking a lot of lives. However, we need to add few more pieces of context here:

  1. We have at least 2 other vaccines that are not known to have any issues, and are unlikely to create issues because they are fundamentally less risky designs.
  2. The J&J vaccine output was gonna drop significantly anyways, thanks to the manufacturing SNAFU.
  3. We are very close to herd immunity. We need to err greatly on reaching immunity more slowly to eliminate even the smallest chance of losing our path to herd immunity. And since there are no known such chances, any such issue that may derail herd immunity is an unknown. So all unknowns need to be treated with extreme care.

Finally, there’s the public relations aspect.

In an ideal world, these blood clots would never have happened. But given that they did, you can either pause and say we will only proceed once we are absolutely sure we know what the risks are, or you can ignore this, and continue. The first may sound bad, but imagine how much worse it would be if a reporter found that there were non trivial reports that would normally lead to a pause and the CDC and WH suppressed them?

In terms of public communications, the right thing to do is absolute transparency. Absolute transparency and truth will be the best path forward.

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I’m not challenging the justifiability of a pause, but that there was a cost-benefit analysis made that likely would’ve been different if we didn’t have 2 other vaccines that are more widely used.

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This is absolutely not true.

If you set aside all non medical aspects, this decision is a no brainer.

Contrary to what the anti vaxxers keep claiming, vaccines are the one area where public health officials rarely take any chances.

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I got the Moderna vaccine but if I hadn’t, I would get the J&J if it was the first one available. I will take a (maybe) 1 in a million chance of getting blood clots from the vaccine over the chances from dying or suffering long term impacts (a major one of which is blood clots) from COVID any day.

Let’s say there is a small risk with all the vaccines (not an unreasonable assumption). Do we pause them all?

The virus isn’t going to take a pause.

Tell me what to look out for and what to do about it, but give me the jab.

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Absolutely key point: We don’t know if these numbers represent most of the clotting cases or are just the tip of the iceberg. Its absolutely prudent to pause using J&J to clear this up.

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Transparency: good. Pausing use of a vaccine during a pandemic with minimal evidence: bad.

Leave it up to the people but provide all the info necessary to make the decision.

This is 'murka, dammit!

Problem being here that they need to dive into the treatment and update guidance for that, as the “normal” treatment for clots apparently can backfire with the type of clots here, and you end up killing the person you were trying to save.

Prudent to pause while they figure out and update treatment protocols for doctors out there when they encounter one of these cases.

Congratulations! You’ve now argued yourself in a circular trap!!

The only semi-valid argument you made is that there are other vaccines available, but ignore the logistical problems in swapping them out, particularly a 1-dose being pulled and replacing it with a 2-dose.

The right answer which doesn’t require circular reasoning is to inform the public, make it clear that there’s no solid evidence that the J&J vaccine was the cause, research is continuing, but the 1-dose J&J vaccine is not being pulled if people want it because it’s taking it is a far, far, far, far smaller risk than any potential side effects, just like any vaccine.

NUMBERS MATTER. 6 cases is no more than what anyone would expect out of 7 million doses given without any causal link. Even if that statisic holds (1 in a million or so), it’s not a new risk, it’s just part of the previously known general risk of any vaccine. But how many thousands of people will get COVID because the J&J vaccine distribution is paused, and how many of them will get sick, get hospitalized and die as a result? Certainly many more than the 1 death from the blood clot issue which may or may not be caused by the vaccine?

Before you write 500+ words, get your arguments in order lest you add to the misinformation.

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What I don’t understand is how one death that may be linked to the vaccine creates a pause, yet dozens of children at a nearby high school tested positive and the school remains open.

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RW media ramping up their attacks on Biden for the J&J pause. A few examples:

We all knew this was coming, but still galling to see those who defended Trump’s approach (or lack thereof) that led to 500k dead Americans implying pausing 1 of 3 vaccines will kill Americans.

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In Oregon, per our health authority, there is not enough non-J&J available right now to replace the paused J&J shots. So people here will be waiting much longer to be vaccinated without the J&J. This is not to say the pause should not have happened. I had J&J for anxiety reasons, and am a bit alarmed by your “tier” comment - most likely I don’t understand what you mean but reading comments on TPM and other places, I’m beginning to feel like the J&J is considered the the vaccine for “them dumb Trumpers, or them homeless types”… perhaps the more undesirable population… Again, most likely interpreting your words wrong. Yes, saving lives is most important, and all these vaccines play an important role in that.

Actually I read about several cases of depleted platelets (at least one of which resulted in the death of a male doctor) with Pfizer or Moderna. In fact, one of the articles specifically questioned the relationship of the mRNA technology to this rare autoimmune response. So, no, not just J&J. And, yea, big impact - over 4000 people here in VT got their appointments tossed. I got a call from the state this am to reschedule but my effective protection date is now going to be June 1 rather than end April after a two shot protocol instead of one and done.

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This is not correct. We went from an unknown (and therefore not fully quantifiable) non-zero risk to a partially known (and therefore somewhat quantifiable) non-zero risk. There is a qualitative change but it is not because risk became non-zero, it is because the risk is now a known risk. In a way this is a positive change – known risks can be addressed. In another way this is negative change – people who earlier thought there was zero risk may become reluctant to get the vaccine because they now realize that the risk is non-zero and, moreover, they can now visualize the risk. But the negative aspect of the change would have happened with or without a pause since the information on the clotting incidents would have become public in any case, in fact it was public prior to the pause decision.

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EU scientific journals have been reporting issues with strokes related chronologically to Pfizer vaccine. Here in the US this issue has been limited to Ball’s Palsy cases and associated with facial implants. If you have facial implants your doctor needs to discuss with you the use of different vaccine. EU sources either do not link these occurrences to facial implants or I missed the reporting on it.

Obviously, the Pfizer’s cases in Europe were not enough to pause vaccination there. Pfizer was not the dominant vaccine in EU until recently. A/Z was. A/Z was paused, reevaluated and resumed. The assertion that the Pfizer’s cases have a class (subgroup) may have been the reason behind it. But I don’t know that. There may have been not enough evidence linking to the vaccine as well.

The point is, people have illusions on how the scientific process works. Yes, political process will try to intervene. That interference will fail in democratic, transparent system and work in dictatorship. Hence, Biden vs. Trump.

For as long as democracy is present there is no reason to doubt or politicize the process of vaccination. This is not an enterprise to kill few individuals. This is an enterprise to save as many as possible. That’s how the system is set up. That’s what regulations are for. There is no reason to make the process into what it is not.

The fact that J&J vaccination was stopped to be re-evaluated is THE evidence of transparent and independent scientific process. That alone reassures me that Pfizer’s cases are not reappearing. If they were reappearing the Pfizer vaccination would be paused as well.

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