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Comment by Aldipower | Hacker News Reader

"No significant safety concerns have been reported, but nothing, including paracetamol, is 100% safe."

Are they kidding me? They comparing apples with peaches here. Paracetamol is not 100% safe that is true, but almost every risk is known, it is used since decades.

These new genetic vaccines are a total unknown in long term risk, because nobody used it so far and the third testing phase, which normally takes multiple years, hasn't started yet. When it starts it will be shortened, so it is not that safe anymore, then used to be.

Especially for younger people all these vaccine has a significant unknown long term risk! Maybe it doesn't matter for older people though.

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Paracetamol would almost certainly never be approved today; the lethal dose is much closer to the effective dose than almost any other medication. Many countries have more deaths from paracetamol than, say, ecstasy. So much so that it's commonly used for suicide attempts; do not try this because the likely outcome is survival with severe liver damage.

It would probably be approved, because it's _so useful_; provided it's taken exactly as directed, it's safer than most other painkillers.

It mightn't be OTC, tho.

That's true, but doesn't legitimate to do the same again of course.

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.

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.

"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.

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.

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.

This comment is the very definition of FUD and leans on to myths that have been debunked over and over again the last few weeks/months.

So, you know the long term risks? Interesting! Please tell us.

Where in my previous comment did I say I knew? You are basing your dismissal of my comment on something I never said in a quite frankly unnecessarily passive aggressive tone.

I am not trying to attack you personally. Your comment is FUD because you’re making it seem as if it was undisputed that long term risks exist, and we just don’t know them yet. In your words these risks are even „significant“. Now that we’re pointing fingers, how do you know this?

If I may, I suggest you read up on this vaccine, paper here: https://www.nejm.org/doi/full/10.1056/nejmoa2022483

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