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US agencies call for pause in Johnson & Johnson vaccine

bbc.co.uk

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Re: US agencies call for pause in Johnson & Johnson vaccine

#331

Post by jjk166 »

6 cases in 7 million doses over 3 months is exactly the rate that CVST would normally be expected at. While that doesn't mean we shouldn't investigate, it does mean there is no reason to be alarmed at this time.

> Cerebral venous sinus thrombosis is rare, with an estimated 3-4 cases per million annual incidence in adults. While it may occur in all age groups, it is most common in the third decade. 75% are female. [0]

[0] https://en.wikipedia.org/wiki/Cerebral_venous_sinus_thrombos....

Re: US agencies call for pause in Johnson & Johnson vaccine

#332

Post by nscalf »

Nokinside wrote: post #325
jdhn wrote: post #68

Here's a question for someone smarter than me. Is there a chance that this number (six cases in seven million doses) will rise as regulators comb through previous reports of adverse effects?

Not an expert in but one of those expert drug regulators is my friend. 1 per million adverse effects is nothing. If that would be a solid fact, there would be no reason to pause vaccinations. The pause happens very early so that experts have time to check the data and methodology and verify that it's all that there is. When a new drug is given for emergency evaluation or a new side effect is discovered he works 14 ho…

I have some friends in this field as well (though they are in small sample size things, like specific breast cancer trials). Some of the fact-finding looks like calling up every patient who has gone through their treatment, but they have agreed to cooperate extensively in order to get into their trials. I can't imagine how painful it is to do fact-finding on this scale.

Re: US agencies call for pause in Johnson & Johnson vaccine

#333

Post by m-ee »

_wldu wrote: post #211

Covid itself causes blood clotting in many seriously ill patients. A friend, who was in ICU in March 2020, was given Herparin (due to clotting concerns), and was told to take aspirin at home after release. Is it surprising that the vaccines cause clotting too? Isn't this sort of obvious?

No this is a very different form of clotting caused by auto antibodies that causes both clotting and low platelet counts. It's similar to HIT. Giving heparin in this situation would make things worse.

https://en.wikipedia.org/wiki/Heparin-induced_thrombocytopen...

Re: US agencies call for pause in Johnson & Johnson vaccine

#334

Post by UncleOxidant »

carnivalWilson wrote: post #246
laplacesdemon48 wrote: post #103

Both the AstraZeneca and J&J vaccines use an adenovirus to deliver DNA instead of mRNA wrapped in lipid (like Moderna & Pfizer). Everywhere I read about the J&J vaccine, I see something like "the DNA vaccine doesn't alter your DNA". Can somebody please clear this up? As far as I understand, the mRNA just stays in the cytoplasm of the cell and gets used up by the ribosome to create spike proteins. The adenovirus vecto…

I'm a bioengineer. Everyone that gives an answer mostly ignores epigenetics and the fact that RNA can permanently alter the _shape_ (or conformation) of how your DNA is tightly wound up. For example, RNA can direct methylation of DNA and alter histones, which can lead to transgenerational epigenetic effects on gene expression and phenotype [1]. The fact is, molecular cell biology is incredibly complex and the models…

Would this be an advantage for the Novavax vaccine as it doesn't do anything to hijack cellular machinery to create the spike protein, it just (as I understand it) has a bunch of pre-made spike proteins.

Re: US agencies call for pause in Johnson & Johnson vaccine

#335

Post by cogman10 »

jdminhbg wrote: post #284
myrandomcomment wrote: post #230

Okay so I want to make something very clear here. The rule is to put it very very simply, is you can ship any drug that is approved but you have to list the side effects. This drug was approved under an emergency order and this side effect was not listed. This will get paused long enough for the side effects to be updated and then used again. The arguments about “well the birth control pill has a higher risk” are usi…

This is a vaccine for a disease that has killed over half a million people in the US over the past year, not a new breast implant. The rules are not some holy writ handed down from above, they are our way of trying to properly manage risk. When the situation changes, the rules can also change.

This is what's been frustrating for me with world health organizations.

I get the need to make sure medicine is safe and effective, and we absolutely should follow those to a T when it comes to new medicines on the market in non-emergency situations.

However, that's not the case here. vaccines are well studied in general and J&J is one of the more "normally developed" vaccines on the market. After generally ensuring that it's safe (Phase I/II tests), there should have been a damn good reason to pull it even temporarily. The "we are seeing a small increase in blood clots" really doesn't seem like a valid reason to pull a vaccine.

Personally, I lay the blame primarily on anti-vaxxers. They've made us far too cautious around vaccinations. It has screwed up our risk management rules. I've no doubt that this pull back will result in anti-vaxxers publishing BS about the safety of J&J vaccinations to try and scare people away from it.

Re: US agencies call for pause in Johnson & Johnson vaccine

#336

Post by Pyramus »

_wldu wrote: post #318
xiphias2 wrote: post #213

Why didn't they stop the vaccinations in women under age of 60/65? I'm a 40 year old man, if I were a woman I wouldn't take J&J or AstraZeneca, but as I'm a man, I think it's worth to take the risk of the side effects of the vaccination.

I wonder why all the clot victims are 100% female with J&J? Also, only 1/3 of Astra Zeneca clot victims are male: https://news.yahoo.com/astra-zeneca-vaccine-blood-clot-risk-...

They aren't - at least one out of nine patients with blood clots from AZ vaccine was male [1].

[1] https://www.researchsquare.com/article/rs-362354/v1

Re: US agencies call for pause in Johnson & Johnson vaccine

#337

Post by cujo »

hedora wrote: post #310
captainredbeard wrote: post #224

Earlier quoted context omitted.

Government over-reactions to COVID19 have been disastrous. There would have been an economic hit for sure but things would have returned to near normal by August 2020 if they had respected freedom (or if people had disobeyed in mass).

Yeah. The US is apparently already at ~50% antibodies, not counting vaccination. So, there’s a floor on the upside of the vaccine: It did no more than halve deaths. We’re in the middle of a surge, and it looks like most of the remaining 50% will end up catching covid before being vaccinated, so the percentage saved by vaccination will continue to drop. The ideal strategy without hindsight was conventional wisdom: Pro…

I suspect a lot of folks learned (in the US) is that if you have a president who politicizes a pandemic and shits the bed on leadership, the populous is screwed.

Let's not pretend that rational discourse was ever an option, and the media isn't the place for blame.

Re: US agencies call for pause in Johnson & Johnson vaccine

#338

Post by xyzzyz »

xiphias2 wrote: post #213

Why didn't they stop the vaccinations in women under age of 60/65? I'm a 40 year old man, if I were a woman I wouldn't take J&J or AstraZeneca, but as I'm a man, I think it's worth to take the risk of the side effects of the vaccination.

Many more people will die as a result of stopping vaccination than they will of alleged side effects to some vaccines.

Re: US agencies call for pause in Johnson & Johnson vaccine

#339

Post by clairity »

sokoloff wrote: post #47
ceejayoz wrote: post #19

Earlier quoted context omitted.

> A pause to assess the data and allow any lag to resolve seems prudent. I don't think the drug safety system is set up to effectively evaluate the cost/benefit of the pause itself in a pandemic scenario.

None of our societal systems are setup to do rational cost-benefit trade-offs in a pandemic. “Don’t wear masks.” “No, no: wear masks.” “COVID kills over 10%.” “COVID kills less than 0.1%.” Once we realized the difference in makeup between the over-10% and sub-0.1% populations, we still couldn’t bring ourselves to make data-backed differentiations for many, many months (and still today have many small businesses close…

> 'These are difficult decisions to be sure, but when being seen as on the “safe side” confers benefits without a commensurate charge for the risk of the “safe” action, you get a society which moves in the direction of perceived safety (and where perceived safety may be strongly sub-optimal).'

yes, security theater abounds. it's a multidimensional optimization problem with no absolutely safe side in the long run, only relatively, but often initially unintuitively, safer non-linearly intertwined sets of actions. it's hypocritical to discount the tiny risk of vaccines while dramatizing the tiny (but larger) risk of death by covid. further, it's myopic to look at the risks of covid in isolation (which is what all the frenzy around it has been doing for over a year) rather than in relation to all the similar risks in our lives and couching our responses now within our existing responses to those other ongoing risks.

Re: US agencies call for pause in Johnson & Johnson vaccine

#340

Post by tylerhou »

kaczordon wrote: post #290
simple_phrases wrote: post #281

Earlier quoted context omitted.

Gene therapy and mRNA vaccines are two very different things.

True corrected it to “gene-based”, both jnj and astra use DNA encoding btw.

But neither have the ability to alter your DNA, so they are unlikely to be able to cause long-term symptoms though a gene-expression mechanism.
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