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US agencies call for pause in Johnson & Johnson vaccine

bbc.co.uk

281–290 of 1001 posts

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

#281

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…

Umm maybe because the blood clot issue is being underreported because no one is looking for it? We’re essentially doing mass experimentation with gene-based vaccines on the US population, all the vaccines use either mRNA or DNA insertion. Caution here is the logical and ethical thing. Also: the side effect profile for the moderna and pfizer vaccines in the clinical trials was far WORSE than the jnj vaccine. Edit: gen…

Gene therapy and mRNA vaccines are two very different things.

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

#282

Earlier quoted context omitted.

People keep saying this will add to vaccine hesitancy but I'm not convinced. The vaccine-hesitant are already skeptical of authorities and aren't going to be especially reassured just because US agencies say it's fine, when it's already hit the news that European agencies have halted J&J. Seeing US agencies halting J&J while continuing the other vaccines could even be reassuring. It shows that US agencies really are…

What you will find is that the vaccine-hesitant are perfectly happy to take the word of authorities who say "this vaccine is unsafe" and only have trouble accepting the word of authorities who say "this vaccine is safe".

I think that is likely because the two states have different levels of confidence, similar to how "not guilty" is not the same state as "innocent". It is relatively easy to identify unsafe, especially when negative effects arise quickly. It is harder to reliably determine safe as it may just be a matter of time before negative effects arise.

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

#283
Interesting. Almost definitely something to do with adenoviruses then. I would imagine that Sputnik probably also has this side-effect. I wonder if "wild" adenovirus infection does this too.

Deciding whom to give these vaccines to is a complicated decision for each country to make and depends on:

a) The incidence rate for each demographic of CSVT-type clotting from the vaccine[s].

b) The expected distribution of clinical outcomes from those events, making reasonable assumptions about likelihood of early detection and outcomes with treatment for heparin induced thrombosis.

Those two give you the clinical cost.

Then you compare those with the clinical benefit from:

1) The relative likelihood of infection for a person, given their demographics, personal exposure profile etc.

2) The absolute likelihood of infection in the country / region in question based on assumptions about the future of the pandemic

3) The expected distribution of clinical outcomes from infection given the person's characteristics

(2) is important because you're comparing a one-time risk of side-effects with a time-related risk of infection.

Clearly, the same person in Manaus or Adelaide is not really making the same trade-off even if in the abstract, the side-effects and IFR are the same.

You also need the counterfactual: If you decide not to give an ad vectored vaccine, you are not deciding never to vaccinate, you are deciding that this person will get a different vaccine, probably later. How much later depends on the location. If you're in the US, you've got Moderna and Pfizer/Biontech coming out of your ears so it might only delay any individual vaccination by a few weeks. If you're a healthy 25 year old who can work from home, the risk trade-off of having to wait an extra 6 days is very different than that same person if they have to wait another 6 months.

As a result, different countries, looking at the same data will rationally make different decisions. The US has lots of mRNA vaccines so will choose one thing, the EU has been badly hit by the failure of Sanofi/GSK to deliver a working vaccine (and by AstraZeneca scaling problems) but has quite a lot Pfizer production capacity, the UK has used up its Pfizer stocks and will now only use it for second shots. CureVac and Novavax may be able to supply some doses at some point but aren't in the picture yet. Several European countries are negotiating to get Sputnik but that is also ad vectored so may have the same problem. That changes the risk calculation because it changes the time that people will remain unvaccinated in the counterfactual where ad vectored vaccines are not used for their age group.

All of this is before the complicated public health element of keeping messages for the public simple and the issues caused by changing that message frequently.

I don't know to what degree countries that had set relatively high minimum ages for the use of AZ had been counting on J&J for younger people. In many cases, AZ deliveries were sufficiently slow due to yield problems that it was "free" from a scheduling point of view to restrict it to only the oldest since the expectation was that they would only receive enough for those anyway and could use other vaccines for younger groups. If J&J was a big part of that, then they now have to update that calculation because the counterfactual to using AZ for those people is no longer "do them with J&J next week". That may be hard to communicate to people who had been told that a particular vaccine was not safe in their age group previously but may now be asked to take it anyway.

I'm glad that I don't have to make these decisions. They are not easy ones.

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

#284

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.

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

#285

Well this seems stupid. The thing I'm trying to understand is whether Johnson & Johnson and AstraZeneca are meaningfully different. All the media just assumes they are (until proven equivalent), but is the genetic code publicly known so we can compare? The Pfizer and Moderna ones are extremely similar. Now, I imagine the adenovirus ones have an order of magnitude more genetic material, but is the code publicly know t…

Does the fact that they're made in the same lab mean anything when it comes to these side effects? Are the fillers/stabilizing materials the same?

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

#286

I see a lot of arguments that are basically "people are too stupid to understand risk". That, in turn, comes from the fact that the FDA/CDC/NIH has not covered itself in Glory the last many years. Covid just uncovered the rot, while Trump danced around it, and poured gasoline on the fire. The best thing to get people to understand risk is to actually follow the process in the EUA. Pause, evaluate the outcomes, change…

I’m not sure I understand your argument (and I’m guessing the downvoters aren’t either). This is a situation where the process will definitely, unambiguously, kill more people than moving forward with the vaccine.

I guess you’re suggesting culling a small fraction of the population might encourage better behavior at the voting booth? We already have plenty of historical evidence suggesting that’s not true.

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

#287

Well this seems stupid. The thing I'm trying to understand is whether Johnson & Johnson and AstraZeneca are meaningfully different. All the media just assumes they are (until proven equivalent), but is the genetic code publicly known so we can compare? The Pfizer and Moderna ones are extremely similar. Now, I imagine the adenovirus ones have an order of magnitude more genetic material, but is the code publicly know t…

Yes, they are meaningfully different. For one, Pfizer and Moderna are mRNA vaccines, while J&J and AZ are not.

That’s not the difference the parent is asking about. He’s asking if the adenovirus based vaccines available are meaningfully different.

Reaching beyond the parent’s words, both AstraZeneca and J&J have now had issues with blood clots. If it’s a similar formulation then perhaps you’ve found something and Adenovirus vaccines with a different formulation are unaffected. If they’re very different then perhaps other variations of Adenovirus vaccines need more attention.

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

#288

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…

Umm maybe because the blood clot issue is being underreported because no one is looking for it? We’re essentially doing mass experimentation with gene-based vaccines on the US population, all the vaccines use either mRNA or DNA insertion. Caution here is the logical and ethical thing. Also: the side effect profile for the moderna and pfizer vaccines in the clinical trials was far WORSE than the jnj vaccine. Edit: gen…

Yes, as a non medical/statistician person, I'd be really surprised if we had the same quality and quantity of data on the birth pills and this new vaccination.

The risks could be higher, but maybe our data is not yet there.

Just as a side note, the risks (and gains) are different, maybe I really don't want a child accidentally, but I don't consider the coronavirus too dangerous to me (it's just a hypothetical, this hypothetical person could be wrong, but in the end we all operate on incomplete data)

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

#289

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…

Umm maybe because the blood clot issue is being underreported because no one is looking for it? We’re essentially doing mass experimentation with gene-based vaccines on the US population, all the vaccines use either mRNA or DNA insertion. Caution here is the logical and ethical thing. Also: the side effect profile for the moderna and pfizer vaccines in the clinical trials was far WORSE than the jnj vaccine. Edit: gen…

This is sensationalism and fear mongering.

The type of blood clots (low platelet) the J&J causes gets worse with the standard treatment of blood thinners. This was on the CDC call this morning.

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

#290

Earlier quoted context omitted.

Umm maybe because the blood clot issue is being underreported because no one is looking for it? We’re essentially doing mass experimentation with gene-based vaccines on the US population, all the vaccines use either mRNA or DNA insertion. Caution here is the logical and ethical thing. Also: the side effect profile for the moderna and pfizer vaccines in the clinical trials was far WORSE than the jnj vaccine. Edit: gen…

Gene therapy and mRNA vaccines are two very different things.

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