Hacker Newsnew | past | comments | ask | show | jobs | submitlogin

"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".



>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.


Right, the bureaucratic processes have been shortened, not the science.


How long would the science take to show long term effects are extremely unlikely?


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.


>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?


Proved to be safe enough to shove in the bodies of 15,000 people.




Guidelines | FAQ | Lists | API | Security | Legal | Apply to YC | Contact

Search: