4 ms·

Almost one-third of new drugs approved by the FDA ended up years later with warnings about unexpected, sometimes life-threatening side effects. https://www.nbc

Almost one-third of new drugs approved by the FDA ended up years later with warnings about unexpected, sometimes life-threatening side effects. https://www.nbcnews.com/health/health-news/new-drugs-found-cause-side-effects-years-after-approval-n757526 https://www.nbcnews.com/health/health-news/new-drugs-found-c... Your supposition about likelihood bears no resemblance to reality. It's almost as if you're misleading people on purpose. I certainly hope that's not the case. Fully 1/3 of all medications approved by the FDA turn out to have serious, and some life-threatening, side effects YEARS after the medication was approved. ______ You realize that this new 'vaccine' bears no resemblance whatsoever to any prior vaccinations? This new Covid Vaccine is not a true vaccine. This is a drug that modifies the inner workings of cells. That is not a vaccine but a 'new drug'. I repeat: 1/3 of all new drugs have serious, and sometimes life threatening, reactions attributed to them between 1-5 years after the drug's approval and release to the public. 1/3... That is not an insignificant number, and it is HIGHLY LIKELY that this new drug will have similar issues.

tempestn 6y ago
You can't compare vaccines to the overall universe of drugs like that. The main difference is that drugs that are intended to be taken over the long term can develop long term side effects. Vaccines are taken once or a few times, and then they're done. The parent is correct that complications arising from vaccines years after they're taken just isn't something that should be expected to happen.
- throwawayboise 6y ago
  Would your feeling change if we discover that yearly boosters of the COVID vaccine will be required indefinitely?
  - mynameisvlad 6y ago
    The flu vaccine is still called a vaccine and it’s delivered yearly and while not required is highly recommended indefinitely. Why would this be any different?
  - tempestn 6y ago
    No, because again, you take the vaccine, it causes an immune response, and then it leaves your system. Even if you then take it again a year later. It's not like a drug that you're regularly taking, which remains in your system. What would change my mind is if I saw vaccinologists explaining a mechanism by which a vaccine could cause long-term side effects, rather than the opposite.
hef19898 6y ago
Every vaccine uses body cells to a certain extent. Sure, mRNA vaccines are new, but the underlying mechanism is not. Vaccines are behaving differently from drugs. Once they took effect, and your immune system reacted, it is over. And with millions of people vaccinated by now, for months, any adverse effects would have shown. That's why we discuss blood clots, under normal circumstances these rare cases would have gone unnoticed for quite a while.
- peytn 6y ago
  > any adverse effects would have shown As I understand, the required teratogenicity study in rats with Pfizer is ongoing as of two weeks ago [1]. It’s rather optimistic to claim we’ve seen everything when even animal studies haven’t completed. Vaccine science itself is rapidly developing. Now I don’t think there will be issues with this drug, but surprises may lurk still. [1]: https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/summary-public-assessment-report-for-pfizerbiontech-covid-19-vaccine https://www.gov.uk/government/publications/regulatory-approv...
- tialaramex 6y ago
  The effect seen with these two adenovirus platform vaccines seems to be exactly what this would suggest we should expect too. Roughly the immune system says "OK, let's attack things this shape" - which is why it's so useful for defending us against a wide variety of viruses - but alas, the shape it's picking in some patients happens to also match Platelet Factor 4, so now they are mounting an immune defence against their own blood clotting mechanism which is bad. I don't know (perhaps if I read more papers about this I'd find out) whether it is suspected that the immune system makes this bad matching choice based on the spike protein (which we want it to match because of this coronavirus killing millions of people) or the adenovirus (which even if it could replicate in humans, which it can't, basically gives you the common cold so who cares) which is delivering it. If it's the latter, that's showing an advantage to the mRNA vaccines, since they don't need a viral delivery mechanism at all.
zosima 6y ago
Well, except that these serious adverse effects are often so rare to not have any way of reaching statistical significance. Especially when you consider that you're looking for associations between medication and any indication. Just by random chance you'd get a many associations between serious diseases and any medication. The very rare and very serious side effects are tracked closely, and it's likely that for a vast number of medications, even though the very rare side effects are written on the packaging, there actually is no causal connection with the medication whatsoever.
jhayward 6y ago
> You realize that this new 'vaccine' bears no resemblance whatsoever to any prior vaccinations? > This new Covid Vaccine is not a true vaccine. This is a drug that modifies the inner workings of cells. Flagged as misinformation. Complete nonsense.
shlant 6y ago
we are not talking about new drugs in general - we are talking specifically about vaccines. Here is an opportunity to easily prove your point: show me significant examples of serious side effects from vaccines 6+ months after they were administered. It's clear with statements like "This new Covid Vaccine is not a true vaccine" that you are just parroting anti-vax talking points. Nobody changed the definition of vaccines and mRNA vaccines fit the definition no matter how you describe them https://sciencebasedmedicine.org/the-latest-antivax-false-claim-mrna-vaccines-against-covid-19-are-not-vaccines-but-medical-devices-or-gene-therapy/ https://sciencebasedmedicine.org/the-latest-antivax-false-cl...

tempestn 6y ago

You can't compare vaccines to the overall universe of drugs like that. The main difference is that drugs that are intended to be taken over the long term can develop long term side effects. Vaccines are taken once or a few times, and then they're done. The parent is correct that complications arising from vaccines years after they're taken just isn't something that should be expected to happen.

throwawayboise 6y ago
Would your feeling change if we discover that yearly boosters of the COVID vaccine will be required indefinitely?
- mynameisvlad 6y ago
  The flu vaccine is still called a vaccine and it’s delivered yearly and while not required is highly recommended indefinitely. Why would this be any different?
- tempestn 6y ago
  No, because again, you take the vaccine, it causes an immune response, and then it leaves your system. Even if you then take it again a year later. It's not like a drug that you're regularly taking, which remains in your system. What would change my mind is if I saw vaccinologists explaining a mechanism by which a vaccine could cause long-term side effects, rather than the opposite.

hef19898 6y ago

Every vaccine uses body cells to a certain extent. Sure, mRNA vaccines are new, but the underlying mechanism is not. Vaccines are behaving differently from drugs. Once they took effect, and your immune system reacted, it is over. And with millions of people vaccinated by now, for months, any adverse effects would have shown. That's why we discuss blood clots, under normal circumstances these rare cases would have gone unnoticed for quite a while.

peytn 6y ago
> any adverse effects would have shown As I understand, the required teratogenicity study in rats with Pfizer is ongoing as of two weeks ago [1]. It’s rather optimistic to claim we’ve seen everything when even animal studies haven’t completed. Vaccine science itself is rapidly developing. Now I don’t think there will be issues with this drug, but surprises may lurk still. [1]: https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/summary-public-assessment-report-for-pfizerbiontech-covid-19-vaccine https://www.gov.uk/government/publications/regulatory-approv...
tialaramex 6y ago
The effect seen with these two adenovirus platform vaccines seems to be exactly what this would suggest we should expect too. Roughly the immune system says "OK, let's attack things this shape" - which is why it's so useful for defending us against a wide variety of viruses - but alas, the shape it's picking in some patients happens to also match Platelet Factor 4, so now they are mounting an immune defence against their own blood clotting mechanism which is bad. I don't know (perhaps if I read more papers about this I'd find out) whether it is suspected that the immune system makes this bad matching choice based on the spike protein (which we want it to match because of this coronavirus killing millions of people) or the adenovirus (which even if it could replicate in humans, which it can't, basically gives you the common cold so who cares) which is delivering it. If it's the latter, that's showing an advantage to the mRNA vaccines, since they don't need a viral delivery mechanism at all.

zosima 6y ago

Well, except that these serious adverse effects are often so rare to not have any way of reaching statistical significance. Especially when you consider that you're looking for associations between medication and any indication. Just by random chance you'd get a many associations between serious diseases and any medication. The very rare and very serious side effects are tracked closely, and it's likely that for a vast number of medications, even though the very rare side effects are written on the packaging, there actually is no causal connection with the medication whatsoever.

jhayward 6y ago

> You realize that this new 'vaccine' bears no resemblance whatsoever to any prior vaccinations? > This new Covid Vaccine is not a true vaccine. This is a drug that modifies the inner workings of cells. Flagged as misinformation. Complete nonsense.

shlant 6y ago

we are not talking about new drugs in general - we are talking specifically about vaccines. Here is an opportunity to easily prove your point: show me significant examples of serious side effects from vaccines 6+ months after they were administered. It's clear with statements like "This new Covid Vaccine is not a true vaccine" that you are just parroting anti-vax talking points. Nobody changed the definition of vaccines and mRNA vaccines fit the definition no matter how you describe them https://sciencebasedmedicine.org/the-latest-antivax-false-claim-mrna-vaccines-against-covid-19-are-not-vaccines-but-medical-devices-or-gene-therapy/ https://sciencebasedmedicine.org/the-latest-antivax-false-cl...