7 ms·

I know very little about this, but could someone give a good explanation on how is a drug officially approved for mass use when the manufacturer of the drug sti

I know very little about this, but could someone give a good explanation on how is a drug officially approved for mass use when the manufacturer of the drug still hasn't finished their testing?

CogitoCogito 5y ago
It has emergency approval. The CDC decided the result of waiting for a full approval would likely cost more than allowing it early. Also to be fair it's not like they just rushed it out the door. There are probably very few things on the market (short of fully approved pharmaceuticals) that have been through more testing than these "rushed" vaccines. edit: https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained https://www.fda.gov/vaccines-blood-biologics/vaccines/emerge...
- ramesh31 5y ago
  A great point. The same people decrying a vaccine that has been safely administered to nearly a billion people at this point and extensively studied will be the first ones to try all sorts of untested homeopathic and "alternative" nonsense.
  - h_anna_h 5y ago
    Citation needed. This to me seems like an attempt to group various people who disagree with you and classify them as lunatics.
    - nitrogen 5y ago
      Indeed, there are plenty of people who "believe in science" and trust authority figures, who believe in various forms of woo. We can do better than guilt by association. It's a very weak argument, and turns more people away from potential vaccination. In fact insulting the remaining audience is worse than preaching to the choir, because it even turns away people who were previously 100% on one's side.
  - bratcomplex 5y ago
    This this a Bifurcation of the issue. lumping people whom; have a cation bias, are alt medicine nuts, classic anti vaxers, etc, together shuts down discourse and divides people.
    - deleted 5y ago
      [deleted]
  - myWindoonn 5y ago
    I don't know why people are disagreeing with you. Look how many people are begging for "thoughts and prayers", a totally useless gesture with no medical benefits. Religious cures are an example of alternative nonsense. Ironically, it's not untested; we know that it doesn't work.
ivanbakel 5y ago
Without claiming any knowledge of this particular case, the FDA has processes for accelerating approval for medication for which mass efficacy testing can only be done in the long-term, but testing for adverse side-effects is already complete. The recent approval of Alzheimer's medication[0] is one example of that. From a quick Google, it seems that Phase III trials are about comparing a new treatment to existing alternatives, rather than monitoring side-effects. Perhaps the testing simply can't be complete before 2023, since it involves checking long-term immunity? In this case, the FDA may have approved the vaccine because they are confident that the risk of negative side-effects is sufficiently small, and that the vaccine gives some benefit - even if testing hasn't established exactly how much. [0]: https://www.theguardian.com/commentisfree/2021/jun/28/alzheimers-drug-aducanumab-approval-dementia https://www.theguardian.com/commentisfree/2021/jun/28/alzhei...
- h_anna_h 5y ago
  You mean this one? https://news.ycombinator.com/item?id=27472107 https://news.ycombinator.com/item?id=27472107 https://news.ycombinator.com/item?id=27469092 https://news.ycombinator.com/item?id=27469092 https://news.ycombinator.com/item?id=27468756 https://news.ycombinator.com/item?id=27468756
hannob 5y ago
There is nothing unusual about any of this. A drug should be approved once it is very likely causing more good than harm. But obviously that doesn't mean you should stop researching that drug. What's happening here makes perfect sense. We have more than enough information to conclude that it is extremely likely that the vaccine helps a lot and causes little harm. However if there are any rare side effects then we'd still like to know that, therefore it is a good thing that the patients in the trials are still being observed for anything unusual.
- stathibus 5y ago
  > A drug should be approved once it is very likely causing more good than harm. Err, that sounds really scary and wrong to me. Seems to me that a drug should be approved when all the side effects are known, results are well characterized among a large sample set over a sufficiently long time frame, and it is determined that the drug is "safe" in the absolute sense. It may be the case that we are better off taking a vaccine in a pandemic _even though we are not 100% sure it is safe_ due to the opportunity cost, and that's what emergency authorizations are for. Even if the FDA really did their due diligence here, it will not convince anyone who was not already convinced; it is obvious that they were going to approve it no matter what, because the political fallout of not approving it after so many people have taken it would permanently destroy what trust remains in the US public health system.
  - sixstringtheory 5y ago
    > Seems to me that a drug should be approved when all the side effects are known, results are well characterized among a large sample set over a sufficiently long time frame, and it is determined that the drug is "safe" in the absolute sense. How long is sufficient? How large of a test group is sufficient? In the "absolute" sense, there is no known drug that is safe. That is extremist thinking that only serves to muddy the waters of the actual debate, which should be: "how safe is safe enough?" > we are not 100% sure it is safe Note that "100% sure" does not mean "100%" safe. So how much safety do you need a 100% assurance for? How do you quantify the safety? > that sounds really scary How does this not just describe life in general? And how does that help policymaking? I don't think our species would have made it to the agricultural revolution if that was the overriding force for anything. > it will not convince anyone who was not already convinced This also strikes me as a poor consideration for any policymaker, as they likely know that at the onset to any such policymaking. This adds nothing new or interesting to the debate.

I know very little about this, but could someone give a good explanation on how is a drug officially approved for mass use when the manufacturer of the drug still hasn't finished their testing?

CogitoCogito 5y ago

It has emergency approval. The CDC decided the result of waiting for a full approval would likely cost more than allowing it early. Also to be fair it's not like they just rushed it out the door. There are probably very few things on the market (short of fully approved pharmaceuticals) that have been through more testing than these "rushed" vaccines. edit: https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained https://www.fda.gov/vaccines-blood-biologics/vaccines/emerge...

ramesh31 5y ago
A great point. The same people decrying a vaccine that has been safely administered to nearly a billion people at this point and extensively studied will be the first ones to try all sorts of untested homeopathic and "alternative" nonsense.
- h_anna_h 5y ago
  Citation needed. This to me seems like an attempt to group various people who disagree with you and classify them as lunatics.
  - nitrogen 5y ago
    Indeed, there are plenty of people who "believe in science" and trust authority figures, who believe in various forms of woo. We can do better than guilt by association. It's a very weak argument, and turns more people away from potential vaccination. In fact insulting the remaining audience is worse than preaching to the choir, because it even turns away people who were previously 100% on one's side.
- bratcomplex 5y ago
  This this a Bifurcation of the issue. lumping people whom; have a cation bias, are alt medicine nuts, classic anti vaxers, etc, together shuts down discourse and divides people.
  - deleted 5y ago
    [deleted]
- myWindoonn 5y ago
  I don't know why people are disagreeing with you. Look how many people are begging for "thoughts and prayers", a totally useless gesture with no medical benefits. Religious cures are an example of alternative nonsense. Ironically, it's not untested; we know that it doesn't work.

ivanbakel 5y ago

Without claiming any knowledge of this particular case, the FDA has processes for accelerating approval for medication for which mass efficacy testing can only be done in the long-term, but testing for adverse side-effects is already complete. The recent approval of Alzheimer's medication[0] is one example of that. From a quick Google, it seems that Phase III trials are about comparing a new treatment to existing alternatives, rather than monitoring side-effects. Perhaps the testing simply can't be complete before 2023, since it involves checking long-term immunity? In this case, the FDA may have approved the vaccine because they are confident that the risk of negative side-effects is sufficiently small, and that the vaccine gives some benefit - even if testing hasn't established exactly how much. [0]: https://www.theguardian.com/commentisfree/2021/jun/28/alzheimers-drug-aducanumab-approval-dementia https://www.theguardian.com/commentisfree/2021/jun/28/alzhei...

h_anna_h 5y ago
You mean this one? https://news.ycombinator.com/item?id=27472107 https://news.ycombinator.com/item?id=27472107 https://news.ycombinator.com/item?id=27469092 https://news.ycombinator.com/item?id=27469092 https://news.ycombinator.com/item?id=27468756 https://news.ycombinator.com/item?id=27468756

hannob 5y ago

There is nothing unusual about any of this. A drug should be approved once it is very likely causing more good than harm. But obviously that doesn't mean you should stop researching that drug. What's happening here makes perfect sense. We have more than enough information to conclude that it is extremely likely that the vaccine helps a lot and causes little harm. However if there are any rare side effects then we'd still like to know that, therefore it is a good thing that the patients in the trials are still being observed for anything unusual.

stathibus 5y ago
> A drug should be approved once it is very likely causing more good than harm. Err, that sounds really scary and wrong to me. Seems to me that a drug should be approved when all the side effects are known, results are well characterized among a large sample set over a sufficiently long time frame, and it is determined that the drug is "safe" in the absolute sense. It may be the case that we are better off taking a vaccine in a pandemic _even though we are not 100% sure it is safe_ due to the opportunity cost, and that's what emergency authorizations are for. Even if the FDA really did their due diligence here, it will not convince anyone who was not already convinced; it is obvious that they were going to approve it no matter what, because the political fallout of not approving it after so many people have taken it would permanently destroy what trust remains in the US public health system.
- sixstringtheory 5y ago
  > Seems to me that a drug should be approved when all the side effects are known, results are well characterized among a large sample set over a sufficiently long time frame, and it is determined that the drug is "safe" in the absolute sense. How long is sufficient? How large of a test group is sufficient? In the "absolute" sense, there is no known drug that is safe. That is extremist thinking that only serves to muddy the waters of the actual debate, which should be: "how safe is safe enough?" > we are not 100% sure it is safe Note that "100% sure" does not mean "100%" safe. So how much safety do you need a 100% assurance for? How do you quantify the safety? > that sounds really scary How does this not just describe life in general? And how does that help policymaking? I don't think our species would have made it to the agricultural revolution if that was the overriding force for anything. > it will not convince anyone who was not already convinced This also strikes me as a poor consideration for any policymaker, as they likely know that at the onset to any such policymaking. This adds nothing new or interesting to the debate.