3 ms·

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

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.
- maxerickson 6y ago
  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. You can't run a trial if there aren't any people getting infected. By waiting enough time to get data accumulated. This isn't a mechanistic explanation of how you've arrived at a stronger level of comfort with earlier safety trials, unless your evaluation criteria is literally just that they took longer.
  - beagle3 6y ago
    > You can't run a trial if there aren't any people getting infected. Corona viruses have been with us for a few thousand (millions?) of years. It is estimated 25% or so of colds are caused by corona viruses. And not surprisingly, they can also cause really, really bad outcomes in the sick and elderly -- in fact, there is some speculation that before they became endemic, they were as virulent as sars-cov-2. And there definitely have been attempts; not as focused, of course, but nevertheless over many years. The most focused attempts were at SARS-Cov-1 and MERS - and both burned out quickly - but also all failed spectacularly at the animal testing stage. > This isn't a mechanistic explanation of how you've arrived at a stronger level of comfort with earlier safety trials, unless your evaluation criteria is literally just that they took longer. (a) animal testing (skipped entirely in this case, which would have shown perhaps that targeting the spike protein may be an issue, and (b) yes, more time. some signals take time to surface - do read the pandermix papers I linked to. Whatever is happening now is just too close for comfort, and I sincerely hope it will end better. What more can you ask for, when I show you a horrible experiment from 2009, which matches in almost every possible way except we're now using now technology? With articles from science and the BMJ? Is there anything that can satisfy your request for reasonable doubt?
    - maxerickson 6y ago
      There were animal studies: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7449230/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7449230/ I was just asking to understand your reasoning, I wasn't asking you to convince me it was correct, and I'm not trying to convince you it isn't correct.

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.

maxerickson 6y ago
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. You can't run a trial if there aren't any people getting infected. By waiting enough time to get data accumulated. This isn't a mechanistic explanation of how you've arrived at a stronger level of comfort with earlier safety trials, unless your evaluation criteria is literally just that they took longer.
- beagle3 6y ago
  > You can't run a trial if there aren't any people getting infected. Corona viruses have been with us for a few thousand (millions?) of years. It is estimated 25% or so of colds are caused by corona viruses. And not surprisingly, they can also cause really, really bad outcomes in the sick and elderly -- in fact, there is some speculation that before they became endemic, they were as virulent as sars-cov-2. And there definitely have been attempts; not as focused, of course, but nevertheless over many years. The most focused attempts were at SARS-Cov-1 and MERS - and both burned out quickly - but also all failed spectacularly at the animal testing stage. > This isn't a mechanistic explanation of how you've arrived at a stronger level of comfort with earlier safety trials, unless your evaluation criteria is literally just that they took longer. (a) animal testing (skipped entirely in this case, which would have shown perhaps that targeting the spike protein may be an issue, and (b) yes, more time. some signals take time to surface - do read the pandermix papers I linked to. Whatever is happening now is just too close for comfort, and I sincerely hope it will end better. What more can you ask for, when I show you a horrible experiment from 2009, which matches in almost every possible way except we're now using now technology? With articles from science and the BMJ? Is there anything that can satisfy your request for reasonable doubt?
  - maxerickson 6y ago
    There were animal studies: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7449230/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7449230/ I was just asking to understand your reasoning, I wasn't asking you to convince me it was correct, and I'm not trying to convince you it isn't correct.