6 ms·

What do you mean by "third testing phase"? I think that phase III of the clinical trials is actually happening right now and is where these positive results com

by chki 6y ago

What do you mean by "third testing phase"? I think that phase III of the clinical trials is actually happening right now and is where these positive results come from.

Aldipower 6y ago
Normally this phase takes multiple years. You cannot shorten this. Long term effects, you guess it maybe, only show up in the long term. You can have my dose, if you like. No problem for me. Please downvote me further.
- chki 6y ago
  I was simply asking a question because this sentence >the third testing phase, which normally takes multiple years, hasn't started yet is apparently not correct. Only trying to enhance my knowledge of vaccine testing phases, I don't want to fight you and I'm not downvoting you.
  - Aldipower 6y ago
    Yeah, sorry for that. I am just a little bit confused. Because to speed the things up, phase I and II were combined here. That's why we are actually at phase 2.5, so to say, sold as phase III.
- standardUser 6y ago
  "Normally this phase takes multiple years" It still does. That hasn't changed or been "rushed". We are now getting preliminary Phase 3 results and there will continue to be Phase 3 results for a long time to come. The question is, do various health agencies believe these initial results are sufficient for emergency approval? But to be perfectly crystal clear, absolutely nothing has been "shortened".
  - 0xffff2 6y ago
    >But to be perfectly crystal clear, absolutely nothing has been "shortened". That's obviously not true. The approval process has been shortened (or more accurately, is very likely to be shortened), even though the trials will continue after emergency approval.
    - standardUser 6y ago
      Right, the bureaucratic processes have been shortened, not the science.
      - postalrat 6y ago
        How long would the science take to show long term effects are extremely unlikely?
        standardUser 6y ago
        The initial results from the Phase 3 trials are to show if the vaccine is effective. They enroll a bunch of people, inject them with the vaccine or a placebo, and then wait. Everything up until the "waiting" part can be and was expedited. The waiting part depends on how quickly the pathogen is spreading. In this case, very fast, so it took months instead of years to get enough data to draw conclusions. That part can't be rushed. There was no shortcut to proving efficacy. The Phase 3 trials haven't stopped and they will continue to record information about safety and side effects. But the Phase 2 trials already proved the vaccine to be safe, which is necessary before injecting it in to tens of thousands of human beings, as was done for Phase 3 trials. New information about safety and side effects could emerge, but in the meantime, the various national health agencies will have to decide if the data on safety is sufficient to give emergency approvals.
        0xffff2 6y ago
        >But the Phase 2 trials already proved the vaccine to be safe This sentence implies that it is not possible for any unsafe condition to remain undetected until some time after the phase 2 trial is completed. Is that actually a claim you're making?

by chki 6y ago

What do you mean by "third testing phase"? I think that phase III of the clinical trials is actually happening right now and is where these positive results come from.

Aldipower 6y ago

Normally this phase takes multiple years. You cannot shorten this. Long term effects, you guess it maybe, only show up in the long term. You can have my dose, if you like. No problem for me. Please downvote me further.

chki 6y ago
I was simply asking a question because this sentence >the third testing phase, which normally takes multiple years, hasn't started yet is apparently not correct. Only trying to enhance my knowledge of vaccine testing phases, I don't want to fight you and I'm not downvoting you.
- Aldipower 6y ago
  Yeah, sorry for that. I am just a little bit confused. Because to speed the things up, phase I and II were combined here. That's why we are actually at phase 2.5, so to say, sold as phase III.
standardUser 6y ago
"Normally this phase takes multiple years" It still does. That hasn't changed or been "rushed". We are now getting preliminary Phase 3 results and there will continue to be Phase 3 results for a long time to come. The question is, do various health agencies believe these initial results are sufficient for emergency approval? But to be perfectly crystal clear, absolutely nothing has been "shortened".
- 0xffff2 6y ago
  >But to be perfectly crystal clear, absolutely nothing has been "shortened". That's obviously not true. The approval process has been shortened (or more accurately, is very likely to be shortened), even though the trials will continue after emergency approval.
  - standardUser 6y ago
    Right, the bureaucratic processes have been shortened, not the science.
    - postalrat 6y ago
      How long would the science take to show long term effects are extremely unlikely?
      - standardUser 6y ago
        The initial results from the Phase 3 trials are to show if the vaccine is effective. They enroll a bunch of people, inject them with the vaccine or a placebo, and then wait. Everything up until the "waiting" part can be and was expedited. The waiting part depends on how quickly the pathogen is spreading. In this case, very fast, so it took months instead of years to get enough data to draw conclusions. That part can't be rushed. There was no shortcut to proving efficacy. The Phase 3 trials haven't stopped and they will continue to record information about safety and side effects. But the Phase 2 trials already proved the vaccine to be safe, which is necessary before injecting it in to tens of thousands of human beings, as was done for Phase 3 trials. New information about safety and side effects could emerge, but in the meantime, the various national health agencies will have to decide if the data on safety is sufficient to give emergency approvals.
        0xffff2 6y ago
        >But the Phase 2 trials already proved the vaccine to be safe This sentence implies that it is not possible for any unsafe condition to remain undetected until some time after the phase 2 trial is completed. Is that actually a claim you're making?