10 ms·

It causes the body to produce it in a limited, fixed quantity in proportion to the number of viable RNA strands that make it into a cell, largely localized at t

by retrac 6y ago

It causes the body to produce it in a limited, fixed quantity in proportion to the number of viable RNA strands that make it into a cell, largely localized at the injection site. Just a guess but this probably means its risk is extremely limited. The wild virus causes this protein to be produced without check. It wouldn't just be the mRNA vaccines, anyway. The viral vector ones, as well as the inactivated virus, and the spike protein unit extract ones, all involve getting some of the spike protein either made in the cells, or introduce it directly.

beagle3 6y ago
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 6y 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 6y 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 6y 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 6y 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.

by retrac 6y ago

beagle3 6y ago

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 6y 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 6y 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 6y 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 6y 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.