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Indeed. But it's a nontrivial question of numbers. The vaccine has to be orders of magnitude safer than the virus, because (essentially) everyone will get the

Indeed. But it's a nontrivial question of numbers. The vaccine has to be orders of magnitude safer than the virus, because (essentially) everyone will get the vaccine, but only some will get the disease. E.g. it might be harmful to vaccinate people in New Zealand and Australia at this point, because for now they cannot get the virus. What these papers (there are 3 independent ones showing very similar results, all coming out in the last month) show is that the vaccine outcome (specific proteins) that were assumed to be inert and only prime the immune system against the virus, are actually active and damaging. That's a big difference -- and the question of whether it makes sense to vaccinate needs to rely on actual science, not "it's a vaccine so must be good and safe" ideology. It also depends on specific attributes (e.g. age, obesity, etc.) There's an Israeli study showing myocarditis at a rate of 1:20,000 for the 16-30 age bracket, with 1:100,000 overall (all pfizer)[0] ; the US Army stats are 1:250,000 (for a mix of JNJ,Pfizer.Moderna) but I didn't find age distribution - and these are exceptionally lean and fit individuals, compared to the general population.[1] That's just myocarditis ; it it related to what's described in this paper? I don't know. Are there any other issues? I don't know. And generally speaking, no one else does either. But because everyone gets vaccinated, we require exceptional proofs of safety. Or at least, did before 2020. [0] https://www.timesofisrael.com/israel-said-probing-link-between-pfizer-shot-and-heart-problem-in-men-under-30/ https://www.timesofisrael.com/israel-said-probing-link-betwe... [1] https://www.military.com/daily-news/2021/04/26/pentagon-tracking-14-cases-of-heart-inflammation-troops-after-covid-19-shots.html https://www.military.com/daily-news/2021/04/26/pentagon-trac...

maxerickson 5y ago
We are getting close to 2% of the planet having a confirmed case. New influenza vaccines (using cell lines) were approved after use in 15,000 people, ~10 years ago: https://www.fiercepharma.com/vaccines/novartis-receives-fda-approval-for-flucelvax%C2%AE-first-cell-culture-vaccine-us-to-help https://www.fiercepharma.com/vaccines/novartis-receives-fda-... Are you overestimating the safety testing done on other vaccines? Of course these are the first widely used vaccines for corona viruses and use new technologies to boot, so there's a lot more to it, but I wonder how you've gone about assessing previous safety proofs.
- krona 5y ago
  Cell culture technology has been in use for decades around the world for many other vaccines, going back 35 years at least (e.g. rabies/polio). Genetic/DNA vaccines are new.
- Izkata 5y ago
  > Basel, November 20, 2012 – Novartis announced today that the US Food and Drug Administration (FDA) approved the use of Flucelvax® (Influenza Virus Vaccine), the first cell-culture-derived vaccine, for individuals 18 years of age and older3. > A multinational, randomized, observer-blinded, placebo-controlled trial was performed to assess clinical efficacy and safety of Flucelvax during the 2007- 2008 influenza season in adults aged 18 to 49 years in the US, Finland and Poland3. They took ~4 years to approve it, sounds like they were more cautious for Flucelvax.
- beagle3 5y ago
  > New influenza vaccines (using cell lines) were approved after use in 15,000 people The are several important differences: (1) it took 4 years of data, not 6 months of data like Pfizer, (2) using mature, well known technology. Now, let's compare to a flu vaccine approved with an EUA after 6 months, shall we? https://www.bmj.com/content/362/bmj.k3948 https://www.bmj.com/content/362/bmj.k3948 https://www.sciencemag.org/news/2015/07/why-pandemic-flu-shot-caused-narcolepsy https://www.sciencemag.org/news/2015/07/why-pandemic-flu-sho... (Both articles describe the same vaccine, pandemrix) It caused narcolepsy, a few hundred cases of it. That's a debilitating, life changing disease; by all estimates I know, much worse than the flu it was supposed to prevent. It's not the only case (though there aren't maney - 1976 flu vaccine causing guillan-barre, dengvax worsening dengue, israeli anthrax vaccine causing harm, probably a couple more I'm unaware of; the vast majority of vaccines -- all that I'm aware of that got full approval rather than an EUA - have a 1:1,000,000 or better adverse event profile). And it isn't even perfectly clear why. The science article says it's likely because there's a similarity between some viral protein and some brain protein -- but that's not clear that's the reason. According to the BMJ article, basically the same vaccine but with a different adjuvant caused none of the issues. How long did it take to figure this out? Approximately one year of data. I urge you to read the BMJ article - it eerily describes exactly what's happening now, 11 years ago - some of the names (e.g. Fauci) haven't changed; some have. > Are you overestimating the safety testing done on other vaccines? I don't think I am. That's why we have VAERS and a European equivalent. You might notice that a lot of the touted efficiency and safety data is coming from Israel. Well, Israel has no VAERS equivalent, hardly tracks any adverse events for this vaccine (likely on purpose), and decreed that vaccinated people are not to be PCR tested unless they show obvious COVID symptoms, whereas unvaccinated are required to have negative test from the last 48 hours for many activities -- which means the data will show it's working even if it doesn't. Israeli data is rubbish, other data is hardly available. (I currently live in Israel and track this; It's been politicised in Israel to the point that no data coming out of Israel is trustworthy) So, regardless of safety of other vaccines, we have very little reliable data about the new guys. > but I wonder how you've gone about assessing previous safety proofs. By waiting enough time to get data accumulated. You know why we ddin't have any corona virus vaccine before 2020? It's not for lack of trying. They all failed at various stages, all of which were skipped for the SARS-Cov-2 vaccines.
Godel_unicode 5y ago
Myocarditis is significantly under-diagnosed in young adults, but is believed to be on the order of 10 cases per 100,00 per year in the population.
- beagle3 5y ago
  Perhaps, I couldn't find reliable data, and apparently neither do the people doing the Israeli study (that much is stated in the copy of it that was leaked ; it's in hebrew). However, their metric was IIRC "within 3 days of first or second dose"; so 6 days worth of myocarditis compared to your full year number, so a factor of 60 (assuming uniform distribution over the year) to put on same scale.
- podgaj 5y ago
  Zinc deficiency and cellular oxidative stress: prognostic implications in cardiovascular diseases https://www.nature.com/articles/aps201825 https://www.nature.com/articles/aps201825 Supplementing zinc can reduce the risk of atherosclerosis and protect against myocardial infarction and ischemia/reperfusion injury.
lamontcg 5y ago
The rate of MIS-C in children is on the order of 1 in 20,000. So acute myocarditis (which goes away and does not produce lasting damage) at that level is entirely an acceptable risk. You're under the impression that either the vaccine must be perfectly safe and/or that the disease is perfectly safe for young people. Both of which are false.
- beagle3 5y ago
  I don't know how you read that into what I wrote. It doesn't have to be perfectly safe; but it has to be significantly safer if you get it, than the disease if you get it -- which is, in fact, the case for all regularly administered vaccines (MMR, polio, tetanus, etc.), and comes with a warning and explanation for those that aren't (our pediatrician made sure we understand the rotavirus vaccine before we gave it to our child (we did) especially because it's safety profile, while still good, is not as good as the MMR and polio ones. MIS-C is a big discussion that I don't have enough time for, but according to https://www.cidrap.umn.edu/news-perspective/2021/04/new-findings-covid-related-kids-syndrome-kawasaki-disease https://www.cidrap.umn.edu/news-perspective/2021/04/new-find..., incidence in the US is 1:50,000. Acute myocarditis often goes away with no damage but not always. MIS-C does too. And it's not even clear yet if any vaccine will stop MIS-C, so -- no, it's not an entirely acceptable risk.
  - lamontcg 5y ago
    The MIS-C rate is 1-in-12,500 per the CDC: https://www.cdc.gov/mmwr/volumes/69/wr/mm6932e3.htm?s_cid=mm6932e3_w https://www.cdc.gov/mmwr/volumes/69/wr/mm6932e3.htm?s_cid=mm... 1-in-3 hospitalizations require admittance to the ICU. The study you cite is total incidence.
    - beagle3 5y ago
      I was referring to total incidence, because approved vaccines have total incidence (Israel, where I now reside, has >84% of eligible population already vaccinated), so that's what you should compare to when considering vaccine adverse events vs. disease adverse events. But something doesn't compute; 1:12,500 COVID incidence vs. 1:50,000 total incidence means 1 in 4 kids in the US has confirmed covid, despite less than 10% of the US population being verified (32.4M as of this second). If we extrapolate the 1:12,500 number to the whole population (assuming 10% of the kids are confirmed), it's 1:125,000 for MIS-C in disease, vs. 1:20,000 myocarditis with vaccine. I'm not sure it's valid extrapolation (and I suspect your data, from July, is very outdated), either way -- it is not possible, based on this data, to claim that it is clearly beneficial to vaccinate children. The data I'm familiar with DOES show that at age > 50 there are clear benefits. But, especially with respect to things like age, obesity and other attributes, it is very far from "one size fits all".
Pyramus 5y ago
Not disagreeing with your general message regarding individual risk assessment based on age, sex, health etc. What I will say though is that you seem to be comparing to the baseline scenario "Covid stops spreading". After one year of Covid (and its mutations) that baseline simply doesn't exist (any more). Instead we are in a no-win situation: (a) We keep lockdowns/non-pharmacological measures and border closures, (b) We let Covid spread slowly, (c) We vaccinate. Each scenario has associated cost. Now back to your point: > But because everyone gets vaccinated, we require exceptional proofs of safety. Safety is neither binary (exceptional/not exceptional) nor absolute and always relative to Covid. Each and every vaccine up to now is orders of magnitude safer than Covid for the vast majority of people (YMMV!). Not an expert, but what's even more interesting is that among the already very few severe side effects, even fewer are due to the 'vaccine ingredients' (e.g. allergic reactions incl. blood clots) and many are conjectured to be due to the 'SARS-Cov-2 ingredients' (e.g. myocarditis). Heuristically speaking you can choose between Covid or a very very very mild version of Covid.
- beagle3 5y ago
  No, I'm not comparing to "covid stops spreading", but I'm also not assuming (as you seem to be) "everyone will eventually get it in the way whoever got it so far got it". > Each scenario has associated cost. There are other scenarios, e.g. https://www.ox.ac.uk/news/2021-02-09-common-asthma-treatment-reduces-need-hospitalisation-covid-19-patients-study https://www.ox.ac.uk/news/2021-02-09-common-asthma-treatment... shows a cheap widely available steroid inhaler has comparable efficiency to vaccines in the KPIs studied by the Pfizer trial. I'm not saying it should be used instead of a vaccine; but it's also not true that your list is close to exhaustive. We keep finding out new stuff. In the first 2-3 months, the intubation+ventilation regime was counterproductive; it took a while to realize, but now we know that. We also know (e.g. from Florida and Texas) that the NPI are much less effective than they were assumed to be. > Each and every vaccine up to now is orders of magnitude safer than Covid for the vast majority of people (YMMV!). That's ... not been shown. The Israeli study I linked to above (a report of it) says this assertion might be wrong for Pfizer for the sizable group of 16-30 ; The British think that's not true for AZ under age 30 ; many countries in the EU think that's not true for AZ under the age of 50 ; Norway thinks that's not true for frail elderly. And basically, we only have short term safety data (pfizer: less than a year for 20K people, less than 6 months for the rest), so even if it is true that "every one will eventually get it", it does NOT follow that it makes sense to vaccinate everyone right now -- if it takes 20 years until "everyone eventually gets it", and severe side effects appear 2 years later, then, no, it doesn't make sense. I linked a BMJ+Science article that showed for a similarly EUAd vaccine, "Pandemrix" in 2009 that it took over a year to figure out that it was causing narcolepsy and worse than the flu it was supposed to stop. It's not just a theoretic possibility - it happened in a very similar setting just 11 years ago, and the causes are NOT perfectly understood to the point that you can guarantee it won't happen again. > many are conjectured to be due to the 'SARS-Cov-2 ingredients' (e.g. myocarditis). Heuristically speaking you can choose between Covid or a very very very mild version of Covid. You could be right, but that's not at all clear. This paper from Nature Immunology https://www.nature.com/articles/s41590-020-00808-x.pdf https://www.nature.com/articles/s41590-020-00808-x.pdf shows that 80% of unexposed people have a T-cell response to SARS-Cov-2 - that is, they have cross-immunity. It could be that for those 80%, that response would be enough to stop the virus before it can get systemic traction, whereas the vaccine is essentially guaranteed to generate systemic effect. I asked an immunologist, who said he doesn't know the answer and does not believe anyone does without measuring.
collyw 5y ago
> The vaccine has to be orders of magnitude safer than the virus Given that there are vast differences in outcomes in different age groups to the virus, surely that depends on the age group you are targeting. Pushing the vaccine onto children, who are at practically no risk seems morally wrong to me.

maxerickson 5y ago

We are getting close to 2% of the planet having a confirmed case. New influenza vaccines (using cell lines) were approved after use in 15,000 people, ~10 years ago: https://www.fiercepharma.com/vaccines/novartis-receives-fda-approval-for-flucelvax%C2%AE-first-cell-culture-vaccine-us-to-help https://www.fiercepharma.com/vaccines/novartis-receives-fda-... Are you overestimating the safety testing done on other vaccines? Of course these are the first widely used vaccines for corona viruses and use new technologies to boot, so there's a lot more to it, but I wonder how you've gone about assessing previous safety proofs.

krona 5y ago
Cell culture technology has been in use for decades around the world for many other vaccines, going back 35 years at least (e.g. rabies/polio). Genetic/DNA vaccines are new.
Izkata 5y ago
> Basel, November 20, 2012 – Novartis announced today that the US Food and Drug Administration (FDA) approved the use of Flucelvax® (Influenza Virus Vaccine), the first cell-culture-derived vaccine, for individuals 18 years of age and older3. > A multinational, randomized, observer-blinded, placebo-controlled trial was performed to assess clinical efficacy and safety of Flucelvax during the 2007- 2008 influenza season in adults aged 18 to 49 years in the US, Finland and Poland3. They took ~4 years to approve it, sounds like they were more cautious for Flucelvax.
beagle3 5y ago
> New influenza vaccines (using cell lines) were approved after use in 15,000 people The are several important differences: (1) it took 4 years of data, not 6 months of data like Pfizer, (2) using mature, well known technology. Now, let's compare to a flu vaccine approved with an EUA after 6 months, shall we? https://www.bmj.com/content/362/bmj.k3948 https://www.bmj.com/content/362/bmj.k3948 https://www.sciencemag.org/news/2015/07/why-pandemic-flu-shot-caused-narcolepsy https://www.sciencemag.org/news/2015/07/why-pandemic-flu-sho... (Both articles describe the same vaccine, pandemrix) It caused narcolepsy, a few hundred cases of it. That's a debilitating, life changing disease; by all estimates I know, much worse than the flu it was supposed to prevent. It's not the only case (though there aren't maney - 1976 flu vaccine causing guillan-barre, dengvax worsening dengue, israeli anthrax vaccine causing harm, probably a couple more I'm unaware of; the vast majority of vaccines -- all that I'm aware of that got full approval rather than an EUA - have a 1:1,000,000 or better adverse event profile). And it isn't even perfectly clear why. The science article says it's likely because there's a similarity between some viral protein and some brain protein -- but that's not clear that's the reason. According to the BMJ article, basically the same vaccine but with a different adjuvant caused none of the issues. How long did it take to figure this out? Approximately one year of data. I urge you to read the BMJ article - it eerily describes exactly what's happening now, 11 years ago - some of the names (e.g. Fauci) haven't changed; some have. > Are you overestimating the safety testing done on other vaccines? I don't think I am. That's why we have VAERS and a European equivalent. You might notice that a lot of the touted efficiency and safety data is coming from Israel. Well, Israel has no VAERS equivalent, hardly tracks any adverse events for this vaccine (likely on purpose), and decreed that vaccinated people are not to be PCR tested unless they show obvious COVID symptoms, whereas unvaccinated are required to have negative test from the last 48 hours for many activities -- which means the data will show it's working even if it doesn't. Israeli data is rubbish, other data is hardly available. (I currently live in Israel and track this; It's been politicised in Israel to the point that no data coming out of Israel is trustworthy) So, regardless of safety of other vaccines, we have very little reliable data about the new guys. > but I wonder how you've gone about assessing previous safety proofs. By waiting enough time to get data accumulated. You know why we ddin't have any corona virus vaccine before 2020? It's not for lack of trying. They all failed at various stages, all of which were skipped for the SARS-Cov-2 vaccines.

Godel_unicode 5y ago

Myocarditis is significantly under-diagnosed in young adults, but is believed to be on the order of 10 cases per 100,00 per year in the population.

beagle3 5y ago
Perhaps, I couldn't find reliable data, and apparently neither do the people doing the Israeli study (that much is stated in the copy of it that was leaked ; it's in hebrew). However, their metric was IIRC "within 3 days of first or second dose"; so 6 days worth of myocarditis compared to your full year number, so a factor of 60 (assuming uniform distribution over the year) to put on same scale.
podgaj 5y ago
Zinc deficiency and cellular oxidative stress: prognostic implications in cardiovascular diseases https://www.nature.com/articles/aps201825 https://www.nature.com/articles/aps201825 Supplementing zinc can reduce the risk of atherosclerosis and protect against myocardial infarction and ischemia/reperfusion injury.

lamontcg 5y ago

The rate of MIS-C in children is on the order of 1 in 20,000. So acute myocarditis (which goes away and does not produce lasting damage) at that level is entirely an acceptable risk. You're under the impression that either the vaccine must be perfectly safe and/or that the disease is perfectly safe for young people. Both of which are false.

beagle3 5y ago
I don't know how you read that into what I wrote. It doesn't have to be perfectly safe; but it has to be significantly safer if you get it, than the disease if you get it -- which is, in fact, the case for all regularly administered vaccines (MMR, polio, tetanus, etc.), and comes with a warning and explanation for those that aren't (our pediatrician made sure we understand the rotavirus vaccine before we gave it to our child (we did) especially because it's safety profile, while still good, is not as good as the MMR and polio ones. MIS-C is a big discussion that I don't have enough time for, but according to https://www.cidrap.umn.edu/news-perspective/2021/04/new-findings-covid-related-kids-syndrome-kawasaki-disease https://www.cidrap.umn.edu/news-perspective/2021/04/new-find..., incidence in the US is 1:50,000. Acute myocarditis often goes away with no damage but not always. MIS-C does too. And it's not even clear yet if any vaccine will stop MIS-C, so -- no, it's not an entirely acceptable risk.
- lamontcg 5y ago
  The MIS-C rate is 1-in-12,500 per the CDC: https://www.cdc.gov/mmwr/volumes/69/wr/mm6932e3.htm?s_cid=mm6932e3_w https://www.cdc.gov/mmwr/volumes/69/wr/mm6932e3.htm?s_cid=mm... 1-in-3 hospitalizations require admittance to the ICU. The study you cite is total incidence.
  - beagle3 5y ago
    I was referring to total incidence, because approved vaccines have total incidence (Israel, where I now reside, has >84% of eligible population already vaccinated), so that's what you should compare to when considering vaccine adverse events vs. disease adverse events. But something doesn't compute; 1:12,500 COVID incidence vs. 1:50,000 total incidence means 1 in 4 kids in the US has confirmed covid, despite less than 10% of the US population being verified (32.4M as of this second). If we extrapolate the 1:12,500 number to the whole population (assuming 10% of the kids are confirmed), it's 1:125,000 for MIS-C in disease, vs. 1:20,000 myocarditis with vaccine. I'm not sure it's valid extrapolation (and I suspect your data, from July, is very outdated), either way -- it is not possible, based on this data, to claim that it is clearly beneficial to vaccinate children. The data I'm familiar with DOES show that at age > 50 there are clear benefits. But, especially with respect to things like age, obesity and other attributes, it is very far from "one size fits all".

Pyramus 5y ago

Not disagreeing with your general message regarding individual risk assessment based on age, sex, health etc. What I will say though is that you seem to be comparing to the baseline scenario "Covid stops spreading". After one year of Covid (and its mutations) that baseline simply doesn't exist (any more). Instead we are in a no-win situation: (a) We keep lockdowns/non-pharmacological measures and border closures, (b) We let Covid spread slowly, (c) We vaccinate. Each scenario has associated cost. Now back to your point: > But because everyone gets vaccinated, we require exceptional proofs of safety. Safety is neither binary (exceptional/not exceptional) nor absolute and always relative to Covid. Each and every vaccine up to now is orders of magnitude safer than Covid for the vast majority of people (YMMV!). Not an expert, but what's even more interesting is that among the already very few severe side effects, even fewer are due to the 'vaccine ingredients' (e.g. allergic reactions incl. blood clots) and many are conjectured to be due to the 'SARS-Cov-2 ingredients' (e.g. myocarditis). Heuristically speaking you can choose between Covid or a very very very mild version of Covid.

beagle3 5y ago
No, I'm not comparing to "covid stops spreading", but I'm also not assuming (as you seem to be) "everyone will eventually get it in the way whoever got it so far got it". > Each scenario has associated cost. There are other scenarios, e.g. https://www.ox.ac.uk/news/2021-02-09-common-asthma-treatment-reduces-need-hospitalisation-covid-19-patients-study https://www.ox.ac.uk/news/2021-02-09-common-asthma-treatment... shows a cheap widely available steroid inhaler has comparable efficiency to vaccines in the KPIs studied by the Pfizer trial. I'm not saying it should be used instead of a vaccine; but it's also not true that your list is close to exhaustive. We keep finding out new stuff. In the first 2-3 months, the intubation+ventilation regime was counterproductive; it took a while to realize, but now we know that. We also know (e.g. from Florida and Texas) that the NPI are much less effective than they were assumed to be. > Each and every vaccine up to now is orders of magnitude safer than Covid for the vast majority of people (YMMV!). That's ... not been shown. The Israeli study I linked to above (a report of it) says this assertion might be wrong for Pfizer for the sizable group of 16-30 ; The British think that's not true for AZ under age 30 ; many countries in the EU think that's not true for AZ under the age of 50 ; Norway thinks that's not true for frail elderly. And basically, we only have short term safety data (pfizer: less than a year for 20K people, less than 6 months for the rest), so even if it is true that "every one will eventually get it", it does NOT follow that it makes sense to vaccinate everyone right now -- if it takes 20 years until "everyone eventually gets it", and severe side effects appear 2 years later, then, no, it doesn't make sense. I linked a BMJ+Science article that showed for a similarly EUAd vaccine, "Pandemrix" in 2009 that it took over a year to figure out that it was causing narcolepsy and worse than the flu it was supposed to stop. It's not just a theoretic possibility - it happened in a very similar setting just 11 years ago, and the causes are NOT perfectly understood to the point that you can guarantee it won't happen again. > many are conjectured to be due to the 'SARS-Cov-2 ingredients' (e.g. myocarditis). Heuristically speaking you can choose between Covid or a very very very mild version of Covid. You could be right, but that's not at all clear. This paper from Nature Immunology https://www.nature.com/articles/s41590-020-00808-x.pdf https://www.nature.com/articles/s41590-020-00808-x.pdf shows that 80% of unexposed people have a T-cell response to SARS-Cov-2 - that is, they have cross-immunity. It could be that for those 80%, that response would be enough to stop the virus before it can get systemic traction, whereas the vaccine is essentially guaranteed to generate systemic effect. I asked an immunologist, who said he doesn't know the answer and does not believe anyone does without measuring.

collyw 5y ago

> The vaccine has to be orders of magnitude safer than the virus Given that there are vast differences in outcomes in different age groups to the virus, surely that depends on the age group you are targeting. Pushing the vaccine onto children, who are at practically no risk seems morally wrong to me.