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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

#391

Post by unanswered »

dokem wrote: post #378
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…

You blame the anti-vaxxers for the vaccine not being up to spec? Isn't this what they were saying the whole time?

It's a neat trick, isn't it? Blaming people for being right.

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

#392

Post by URSpider94 »

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…

CDC data shows that more like 25% of Americans have antibodies to COVID, so your number is off by a factor of two. [https://covid.cdc.gov/covid-data-tracker/#national-lab]

Additionally, you make a few glib statements that don’t really check out - you say give hospitals three weeks to prepare - how? There’s been a lot made of hospitals getting ready, but for the most part, the limiting factor for covid treatment has been how many icu care teams are available. More ventilators don’t help much if there’s nobody to use them. Second, I’m not sure how you protect senior citizens when everyone else, including the people who provide their care, is swimming in a soup of COVID.

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

#393

Post by maxerickson »

kaczordon wrote: post #354
tylerhou wrote: post #340

Earlier quoted context omitted.

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.

Right but they are still gene-based. No gene-based vaccine has ever received approval for human use, and the present coronavirus vaccines have not undergone preclinical testing as normally required by international regulations. A potential danger of DNA-based vaccines is the integration of plasmid DNA into the cell genome (1). Insertional mutagenesis occurs rarely but can become a realistic danger when the number of…

That's a different technology than the Adenovirus vectors.

There's no plasmids in the Covid vaccines, a virus has been modified to include instructions for the target proteins.

Edit: plasmids are used to encode the virus for production, they aren't part of the delivery mechanism: https://www.addgene.org/viral-vectors/

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

#394

Post by tgb »

dokem wrote: post #378
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…

You blame the anti-vaxxers for the vaccine not being up to spec? Isn't this what they were saying the whole time?

I think you misread them. Anti-vaxxers were not blamed for the vaccine's side-effects.

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

#395

Post by mikem170 »

ravenstine wrote: post #242
dragonwriter wrote: post #153

Earlier quoted context omitted.

> Why would we pause a vaccine because 6 people in 7 million got blood clots? Because J&J isn’t the only vaccine in the inventory, and the others don’t have that problem (or, IIRC, the same level of other adverse reactions), and because: > Why would we do that and risk fueling anti-vaccine viewpoints? What risks fueling anti-vaccine viewpoints is ignoring adverse impacts which are known and plowing forward, especiall…

> What risks fueling anti-vaccine viewpoints is ignoring adverse impacts which are known and plowing forward, especially giveb that people often don’t have a choice of which vaccine they are administered. Your point about other vaccines being available is totally valid and sound, but... what is our standard here, then? For absolute-zero people to die of any vaccine we produce? What if it was 1 person who got a blood…

I agree with your numbers above. But wondered about factoring the below into these calculations [0]:

> During Johnson & Johnson's clinical trial, there were reports of other types of blood clots, too. Some are relatively common, such as deep vein thrombosis, so it wasn't surprising that among roughly 20,000 participants who received the vaccine, some would experience those clots.

> What made FDA scientists take note, however, is that in the trial, about the same number of people received a placebo -- a shot of saline that does nothing -- as received the vaccine. However, when comparing the two groups, more study participants developed clots after receiving the vaccine than the placebo.

> Calling it a "slight numerical imbalance," the FDA noted that there were 15 events in 14 participants who received the vaccine, compared to 10 events in 10 participants who received the placebo.

I think the 6 in 7 million people are the serious and unusual blood clots, but would not include the +50% increase in blood clots of any type noted above. However I appreciate that you did include the extra data about 100,000 people dying per blood clots per year.

I also like to pay attention to the numbers for this stuff. I was scheduled for a J&J shot today, which was cancelled. It wasn't my first vaccine choice. I'll be trying to get an appointment for one of the other vaccines, I guess.

[0] https://www.cnn.com/2021/04/13/health/johnson-vaccine-blood-...

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

#396

Post by mhb »

toast0 wrote: post #239
mhb wrote: post #74

Earlier quoted context omitted.

Your sympathy for them being cautious begs the question of whether the vaccine, with its uncertainty, is worth using. The cost of waiting to use it is significant - people will die from COVID. It's not enough to say you're being cautious. You have to explain why you think it is better to be cautious about administering the vaccine with its attendant risks or to pay the QALYs incurred by the delay when people who woul…

Pausing this one vaccine type to collect data and determine appropriate actions to mitigate this side effect is reasonable. This is a low probability event, and the appropriate mitigation may be to do nothing; but there may be some common factor for these patients that might indicate use of a different vaccine or maybe informing people of symptoms of blood clots and what to do if they see symptoms. The real risk here…

That's all hand-waving. Why is it reasonable to delay vaccinating people based on these events? Maybe it is, but not because your gut feel says so.

What erodes confidence is the complete absence of cost/benefit discussions about virtually any decision that has been made. Including this one.

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

#397

Post by Deregibus »

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…

Putting aside that these claims are presented without any evidence, “most” of 50% of the US population is a minimum of 82M people. ~31M have contracted COVID so far. That we’re going to see almost 3x the number of cases, concentrated in half the population, as we enter summer, and with 3-4M vaccines administered per day, is a pretty bold claim.

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

#398

Post by rebuilder »

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…

It's really not clear at all that the incidence of this type of blood clots is actually higher in the vaccinated. So it seems early to call this a side-effect.

I wish the health agencies were a bit more open about their thought processes. OTOH, the rate of incidence doesn't seem higher than baseline AFAIK, which seems absurd. It also seems absurd that the various health authorities around the world would all make such a big deal of if if there wasn't some elevated risk. So I don't really know what to make of it, but privately, I'm leaning towards the interpretation that the idea is to avoid backlash against the vaccines by being irrationally strict about any potential hazards.

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

#399

Post by phnofive »

textman wrote: post #322

"The incidence of cerebral venous thrombosis (CVT) varies between studies, but it is estimated to be between 2 and 5 per million per year. A recent study in the Netherlands with comprehensive ascertainment suggested a much higher incidence." https://www.ahajournals.org/doi/full/10.1161/STROKEAHA.116.0... So the six reported cases in 6.8 million vaccinations seems low. Glad I read about all this because I got the J&J…

Similar to AZ, all six were women between the ages of 18 and 48.

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

#400

Post by allturtles »

endisneigh wrote: post #278
allturtles wrote: post #265

Earlier quoted context omitted.

There currently isn't enough vaccine to meet demand. Pausing J&J distribution will cause a larger gap between supply and demand. The 7 day average of deaths from Covid in the U.S. is 985. Even a week's delay in getting to full deployment of the vaccine thus means thousands of deaths.

What would need to happen in your view to justify pausing vaccinations for even a single day? IMO that lack of caution is why the USA is in this situation to begin with.

I am not saying outright that the pause is not justified. But it has a substantial cost, and it would be good to see that our health authorities have considered this and weighed the balance of costs and benefits. e.g. it might have made sense to pause J&J for under age X and continue it for over age X, based on relative risk.

I don't agree with your analysis, I think you can see it entirely the other way, that both this pause and the initial "wait and see" attitude towards Covid are the result of an excessive bias towards the status quo. I remember back in January-February 2020 when people were saying it would be crazy to just shut down air travel, think of the massive economic cost.

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