News for hackers. Stuff that matters.
Re:FDA Approves First Covid-19 Vaccine by Pyramus on Monday August 23, 2021 @10:53AM (#28276683)
Could you explain what you mean by that?

We already know Covid can cause autoimmune issues in some patients, so are you saying the effect you describe is just a subset of these, or different?

Re:FDA Approves First Covid-19 Vaccine by giantg2 on Monday August 23, 2021 @11:13AM (#28277055)
It's it's that there are known and unknown/suspected risks with both actions. We know that some vaccine recipients develop Graves disease. Some autoimmune diseases take years to develop. So we have risks on both sides, but there's not a lot of information about how common those risks are, especially for longer term effects.

So all I'm saying is that the value proposition for an individual is based on the risks associated with vaccination or infection, and that the decision for people in age groups with the lowest known (short term) risks associated with infection have lower known benefits putting more emphasis on the unknown (longer term) risks or benefits. So for someone over 70 with about a 5% IFR, it's easy to say there is more benefit than risk because it's easy to see if a serious side effect is happening at a 5% rate or higher and the time horizon for longterm issues developing is limited by natural lifespan. With the quality of the VAERS data and the much longer time horizon, it's more difficult to discern a benefit for someone with an IFR of .002%. Of course we can't even look at the rates of many of the side effects to compare something other than IFR because the data data quality doesn't allow for that level of sensitivity.

Edit: why downvote?

Re:FDA Approves First Covid-19 Vaccine by XorNot on Monday August 23, 2021 @01:11PM (#28278951)
You are arguing "we don't know what'll happen with vaccines" as though you do know the long term risks of COVID-19. You do not - you cannot. COVID-19 has not existed for longer then about 1.5 years.

Other coronaviruses have, but mRNA vaccine technology is about 15 years old - that's how long it's been in development and studied. Long term effects are in fact, known. But if you were concerned about that, you could take J&J or Astrazeneca, both of which are based on adenovirus vector technology and has existed since the 1980s - the clotting side effect is both rare and treatable.

re: Graves disease - [1] is literally a risk of getting COVID-19.

You are engaging in some both-sideism FUD and misrepresenting the technology of vaccines while pretending a brand new novel disease is some well-understood thing.

[1] https://www.healio.com/news/endocrinology/20210519/covid19-m...

Re:FDA Approves First Covid-19 Vaccine by giantg2 on Monday August 23, 2021 @02:26PM (#28279963)
I think you are misunderstanding what I've been saying.

"You are arguing "we don't know what'll happen with vaccines" as though you do know the long term risks of COVID-19."

I'm saying that the longterm effects are not known for either.

"Other coronaviruses have, but mRNA vaccine technology is about 15 years old - that's how long it's been in development and studied."

Do you have some links for this? The mRNA technology was used a little differently in the past from what I saw. Most of the research I saw were attempts to correct genetic issues, not trigger immune responses against the proteins created. Not to mention, the OP article even has the FDA stating that they don't know the longterm effects of vaccination, so it seems my statement is consistent with the expert opinion.

"But if you were concerned about that, you could take J&J or Astrazeneca, both of which are based on adenovirus vector technology and has existed since the 1980s - the clotting side effect is both rare and treatable."

It's a similar mechanism, right? You're just using a virus to carry the genetic material, which also involves an extra transcription step in the cell (what is theorized as causing mutations in the spike and thus the stroke/clotting issues). Still quite different from the traditional inactive or protein based ones.

Have either technologies been used in a wide scale way (1M+ people) on the timeframes you mention?

"You are engaging in some both-sideism FUD and misrepresenting the technology of vaccines while pretending a brand new novel disease is some well-understood thing."

First off, it's not FUD. I'm not fear mongering. There's no doubt expressed about known things. Sure, there is uncertainty about both sides, but even the experts acknowledge this in a similarly objective way (ie I lack the motive behind FUD). My statements have been objective about how one may be approaching the decision. Where have I misrepresented vaccine technology? I am not saying covid is well known - in fact, your statement contradicts your other statement about "both-sidism FUD" since I can't possibly be claiming it's well understood and simultaneously claim fear, uncertainty, and doubt about it.

If you read it, you can see the discussion is about how people might be approaching a decision with a mix of fairly well known short term data and relatively little known long term data, and how the value proposition changes.

https://www.euronews.com/next/2021/05/27/why-are-aztrazeneca...

https://www.europeanpharmaceuticalreview.com/news/155536/bre...

Re:FDA Approves First Covid-19 Vaccine by Pyramus on Monday August 23, 2021 @02:07PM (#28279739)
I understand that both Covid/vaccines might have unknown unknowns and I also get the disproportional importance of long-term effects.

I don't fully understand what you mean by "the data quality doesn't allow for that level of sensitivity" - we have already had two instances where very rare side effects of Covid vaccines were recognised - blood clotting for AZ and myocarditis for Biontech.

You wrote, and that's what my question was hinting at:

> "one could question the potential for autoimmune conditions due to the way the mRNA vaccine works"

What do you mean by that? What is specific about the mRNA mechanism that could lead to autoimmune issues?

Re:FDA Approves First Covid-19 Vaccine by giantg2 on Monday August 23, 2021 @03:04PM (#28280474)
"I don't fully understand what you mean by "the data quality doesn't allow for that level of sensitivity" - we have already had two instances where very rare side effects of Covid vaccines were recognised - blood clotting for AZ and myocarditis for Biontech."

Sure. So those two issues are not only rare in relation to the vaccine, but also rare in the general population. In fact the clotting issue is occurring at the same rate as in the general population - 5 per 1M people. The types of stuff that will slip through the cracks will be things that are similarly rare in vaccines, yet more common in the general population and tend to be dismissed as unrelated without concrete evidence of that. For an example, take strokes in patients under 30. You have a general occurrence of about 5K per 1M. In order to show a significant difference, you would need a much higher number of cases reported. I believe there's some research being done about some covid vaccines potentially increasing stroke risk, just as covid has been suggested as doing this. I actually know someone who was hospitalized with a stroke between their first and second dose, and it wasn't reported.

This can be especially hard if even the fairly rare adverse events that have previously known relation to vaccines are being reported as little as 12% of the time. Keep in mind that these two events are listed in the packet inserts and are required by law to be reported by the medical professional and are still being massively under reported. What chance do we have of actually catching the rare events that have statistical "cover" of a large bed of naturally occurring incidents in the general population?

https://gnigh-66270.medium.com/vaers-underreporting-and-the-...

https://pubmed.ncbi.nlm.nih.gov/33039207/

"What is specific about the mRNA mechanism that could lead to autoimmune issues?"

This is just a theory. The immune system generally codes off of multiple proteins. If we are exposing a spike protein on a cell wall, then there's a possibility that the immune system may code off of the proteins normally found on our cell in addition to the intended partial spike protein. There's no data that I could find on pre vs post vaccination autoimmune antibody levels. So it seems nobody is looking at this. Even then, little is known about the relation of those antibodies and actual development of autoimmune conditions.

Re:FDA Approves First Covid-19 Vaccine by Pyramus on Monday August 23, 2021 @03:47PM (#28281005)
> In fact the clotting issue is occurring at the same rate as in the general population - 5 per 1M people.

No, blood clotting occurred at roughly 1.5-2x the rate, so ~1 per 100k. Look at the data from the UK, Germany or Norway, which raised the rare side effects independently with the EMA [1].

No doubt that underreporting is a real issue, but how is it different to Covid or any other drug/disease? Wouldn't you agree that underreporting is lowest in a pandemic?

> "This is just a theory."

How likely do you think your theory is? Have you spoken to a medical professional or an immunologist about your theory?

[1] https://en.wikipedia.org/wiki/Embolic_and_thrombotic_events_...

Re:FDA Approves First Covid-19 Vaccine by giantg2 on Monday August 23, 2021 @04:47PM (#28281711)
Where are you getting the 2x going rate number? I see in this link (from your wiki page) that they are estimating the background occurence to be between 2-16 per 1M. It also explains why they think Germany's numbers are higher. The UK numbers would still be in line with the background range I found earlier (2-5 per 1M). Either way, I think it's still consistent with the idea that events with low background rates are easier to catch because each event carries more significance and is less likely to face bias from the doctor to write it off as in related.

https://www.bbc.com/news/health-56594189

"No doubt that underreporting is a real issue, but how is it different to Covid or any other drug/disease? Wouldn't you agree that underreporting is lowest in a pandemic?"

I don't think it's significantly different. The emergency use order did carry additional reporting requirements, but it also opened it up to be administered by people who would not normally administer vaccines and would not likely be familiar with VAERS, and in some cases patients doesn't know who administered it to contact them to file the report. If you couple this with the massive increase in vaccines administered, I think the number of unreported events are higher now, but the rate is likely similar to before. That's just my guess based on the reasons above and my own experiences. Why do you think it would be lowest now?

"How likely do you think your theory is? Have you spoken to a medical professional or an immunologist about your theory?"

I'm not sure how likely it is. I feel like it depends mostly on the individual, like most autoimmune diseases do. I did discuss this with a doctor and they said that it is a reasonable question and theory that appears not to have any studies looking into either side of it. It's possible we won't know for years or decades, especially since we don't even know how autoimmune antibodies levels lead to disease in general.

Re:FDA Approves First Covid-19 Vaccine by Pyramus on Tuesday August 24, 2021 @04:19AM (#28286263)
PEI (German Institute for Vaccines) on 16 Mar 2021 (!) [1]:

"(4) The number of these cases after vaccination with COVID-19 AstraZeneca is statistically significantly higher than the number of cerebral venous thromboses that normally occur in the unvaccinated population. For this purpose, an observed-versus-expected analysis was performed, comparing the number of cases expected without vaccination in a 14-day time window with the number of cases reported after approximately 1.6 million AstraZeneca vaccinations in Germany. About one case would have been expected, and seven cases had been reported."

UK vaccine safety report up to 11 Aug 2021 [2]:

"The overall incidence after first or unknown doses was 14.9 per million doses."

German safety report up to 31 Jul 2021 [3, in German], cf. table 7,8:

Women: 1.462 cases per 100k doses Men: 1.305 cases per 100k doses

Can't find the numbers for Norway, they initially reported the highest number per 100k.

> I'm not sure how likely it is.

Do I understand correctly that there is no mechanism specific to how the mRNA vaccines work? The effect you describe ("we are exposing a spike protein on a cell wall") is far more common in Covid due to how the abundance of expression of the spike protein, correct?

[1] https://www.pei.de/SharedDocs/Downloads/EN/newsroom-en/hp-ne...

[2] https://www.gov.uk/government/publications/coronavirus-covid...

[3] https://www.pei.de/SharedDocs/Downloads/DE/newsroom/dossiers...

Re:FDA Approves First Covid-19 Vaccine by giantg2 on Tuesday August 24, 2021 @07:07AM (#28287207)
That's interesting. It looks like there is a lot of conflicting information on the background rate. And even the UK rate in the quote is higher than the Germany's, yet the article I linked to from the wiki is saying Germany's is higher, and that the estimates on background level vary wildly. Although if it is multiple times the normal rate, then this would not be an example of sensitive reporting/detection anyways (not to mention that EU reporting takes place outside of the VAERS system).

"Do I understand correctly that there is no mechanism specific to how the mRNA vaccines work?"

No. Covid does not add a spike protein to an existing cell. It replicates an entire covid cell. So you have covid virus with a spike and a bunch of other covid proteins if you have covid. Or you have a human cell with a partial spike and all the normal human cell proteins. The immune system usually codes off of, or attacks, multiple proteins. It's possible the immune system will identify the spike and some of the normal cell proteins. A similar sort of mimicry is theorized to occur when the proteins in a virus are similar enough to a human protein.

https://www.nytimes.com/1996/12/31/science/virus-s-similarit...