US agencies call for pause in Johnson & Johnson vaccine • Hacker News Board

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

#431

Post by jrockway » Tue, Apr 13, 2021, 4:51 PM UTC

cheph wrote: post #158

majewsky wrote: post #76

Earlier quoted context omitted.

Not a doctor, but from what I've heard from immunologists, vaccines in general are incredibly unlikely to have long-term side effects on the scales that you think about. When an immunologist talks about "long-term side effects" of a vaccination, they're usually considering time ranges on the order of 6-8 weeks. Meanwhile, the 10000s of patients from the big Phase 3 trials have been vaccinated for 6-9 months, so the u…

> Not a doctor, but from what I've heard from immunologists, vaccines in general are incredibly unlikely to have long-term side effects on the scales that you think about. Fair enough, but the comment I responded to said: "We know that there are no side effects that are common enough to be of real concern." Given this statement is not qualified for timescale, I want to know what the basis for it is. How does the pers…

> Given this statement is not qualified for timescale

Keep in mind that we also don't know the long-term effects of COVID-19. It's possible that people who were infected with mild cases drop dead 1 year and 6 months after the infection. The disease hasn't been around that long, so we simply don't know.

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

#432

Post by m-ee » Tue, Apr 13, 2021, 4:51 PM UTC

wonminute wrote: post #411

m-ee wrote: post #333

Earlier quoted context omitted.

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...

aspirin != heparin. Question, would taking aspirin prior to and after Janssen vaccination lower this risk?

No it would not. There have been a couple papers focused on the AZ vaccine that get into possible treatments.

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

#433

Post by mym1990 » Tue, Apr 13, 2021, 4:51 PM UTC

MuffinFlavored wrote: post #403

jdminhbg wrote: post #284

Earlier quoted context omitted.

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 a vaccine for a disease that has killed over half a million people in the US over the past year Serious question, how many of those people would have died in the past 12 months if they didn't get COVID? The number is most likely not 500,000, but it also probably isn't 0. Is it most likely something insignificant like 5,000?

It would depend on the age and make up of the population, cross reference that with a mortality table and you can get a pretty good idea. For a 25 year old the odds of dying in a given year are about .03, and this obviously moves higher as the population grows older.

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

#434

Post by curryst » Tue, Apr 13, 2021, 4:51 PM UTC

ceilingcorner wrote: post #386

yboris wrote: post #312

Relevant tweet: https://twitter.com/robertwiblin/status/1381967753234411530 J&J doses delivered: 7 million. Reported blood clotting events: 6. Daily risk of dying of COVID19 in the US: 1 in 330,000. CDC and FDA: Pause the J&J vaccine. Draw your own conclusion on how aligned these folks are with your interests.

This is misleading. If you’re young and healthy, the chances of dying from COVID are basically zero. The chances of dying from a blood clot from a rushed vaccine are not. The people who died from blood clots probably would still be alive had they not taken the vaccine.

The risk is low, but I think the last I saw was a 0.01% IFR in the young, which comes out to 1 in 10,000. Still a higher risk than COVID at this point, although it's possible that they'll discover a higher incidence like with AZ.

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

#435

Post by ghthor » Tue, Apr 13, 2021, 4:51 PM UTC

laplacesdemon48 wrote: post #372

chaorace wrote: post #111

Earlier quoted context omitted.

I think the argument hinges on the technicality that it's not splicing itself into the host genome, so no chance of it becoming a retrovirus or something like that (in the event that the cell's lineage is not extinguished by the immune system). I'm not a genetic engineer (what a time to be alive, eh?), but I'm pretty sure an adenovirus that did permanently modify cell DNA would be more like CRISPR, including the risk…

I didn't want to put this into the parent comment because I didn't want to get just shoved into the "vax" vs. "anti-vax" bucket by the replies. But there's a very well known case where DNA delivered via an adenovirus killed a teenager during a genetic engineering study: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC81135/ >> "No one realized that the vector itself might pose a risk" I'm sure the dosage, type of adenov…

Don't look at things like that. Shut down your brain and take your pilllls.

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

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Post by joshgel » Tue, Apr 13, 2021, 4:51 PM UTC

miketery wrote: post #415

whatshisface wrote: post #414

Earlier quoted context omitted.

Rare big problems may be indicative of common small problems.

Good point, I hadn’t considered this. Also there was the factory QA issue. Possibly much like in aviation , multiple small factors here that need to be addressed and they’re using this as easy excuse to put pause.

This is possible, but I work in medical research, and this pause is pretty standard practice. When there is a potential problem, you pause, gather more data, come up with a mitigation plan (if needed) and submit all this to the ethics authority (usually IRB). Its rote standard practice. And i think much more likely that they are following standard practice than there are hidden issues that haven't otherwise been revealed publicly yet.

That said, this is not a usual situation at all, and I think it's absurd, not least because of lives potentially saved during this pause, but because of the carry on effects with vaccine hesitancy, etc.

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

#437

Post by bluGill » Tue, Apr 13, 2021, 4:52 PM UTC

timr wrote: post #346

cogman10 wrote: post #335

Earlier quoted context omitted.

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…

> 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. This has nothing to do with "anti-vaxxers". Vaccines usually take years to develop precisely because we give them…

The only part of the safety process we bypassed was 6 moths of phase-3 data, we decided 2 was good enough. Everything else was just bypassing all the time where we were doing nothing at all because there wasn't money to run the next study.

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

#438

Post by mStreamTeam » Tue, Apr 13, 2021, 4:52 PM UTC

vincentmarle wrote: post #377

jjk166 wrote: post #331

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]…

> While that doesn't mean we shouldn't investigate, it does mean there is no reason to be alarmed at this time. Except to the general public this overcautious behavior and resulting media hype raises vaccine suspicions, and will decrease public trust in J&J (and even vaccines in general) as a result. It’s already happening.

Public trust in J&J has been low ever since they got caught putting asbestos in baby powder

https://www.reuters.com/investigates/special-report/johnsona...

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

#439

Post by cogman10 » Tue, Apr 13, 2021, 4:52 PM UTC

timr wrote: post #346

cogman10 wrote: post #335

Earlier quoted context omitted.

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…

> 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. This has nothing to do with "anti-vaxxers". Vaccines usually take years to develop precisely because we give them…

> This has nothing to do with "anti-vaxxers". Vaccines usually take years to develop precisely because we give them to everyone, and rare, long-tail risks matter. This was the case well before the MMR autism scare defined "anti-vax" as it has come to be known today.

Anti-vax hysteria has been around for longer than MMR and autism.

> rare long-tail risks matter

I agree, but at the same time I also think that it's an overblown problem with vaccinations. We aren't talking about medication that screws around with the metabolism in unusual ways. Vaccines (other than the newer mRNA stuff) are by and large large enough chunks of whatever we are vaccinating against to trigger an immune response when the real thing comes along + preservation/delivery medium.

At the end of the day, the worst case for vaccination is that you might be infected with the disease you are vaccinated against (when live viruses are used).

That's not the case for J&Js vaccine.

So the next question is, if the worst case scenario is you get a disease you were attempting to prevent, then what is the next real biggest threat from a traditionally developed vaccination?

> If anything, we've tossed out all of our usual standards of evidence in 2020, and did a bunch of stuff willy nilly, with no supporting evidence or rational consideration of trade-offs. We tore off all the safety belts. We don't need lower bars for evidence, we need less reactionary hysteria.

I'd argue that pulling a vaccine over a very minor number of reports of increased blood clots is overly reactionary.

Edit: And... reading this it makes it sound like I'm skeptical of mRNA vaxxes. Just to be clear, I'm not and I've gotten the pfizer vaccine myself. I do think they'd have more justifiable scrutiny to make sure they are safe as it's a new technique for mass vaccinations (even though it's been used in immunotherapy for a while now).

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

#440

Post by vibesngrooves » Tue, Apr 13, 2021, 4:53 PM UTC

jaegerpicker wrote: post #406

7 people out of 7 million dose's. That's why they stopped. My wife and I got the J&J shot on Saturday so I'm directly at risk and I'd take it everytime even if the risk was 10 times what it currently is. I've already seen a bunch of anit-vaxers referring to this in new articles this morning. So let's see, 1 in a million chance that the vaccine will make you sick (only 1 person has died so far, which is terrible but i…

This really is a sad, sobering reality. "6 cases in 6.8 million", ~0.00000089% chance of death via J&J vaccination. Extremely disheartening to see, but rather telling, where priorities lie. Politics aside, this is sheer stupidity, as you mentioned. Brace for another year as mutations continue to develop throughout the developing world while we waffle over infinitesimally minimal risk.