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> The big one in my mind is how do Pfizer, BioNTech, or the FDA validate safety of the vaccine over the long term?

By looking at other vaccines historically and seeing that side effects tend to happen in the first few weeks.

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/expect/af...

> Vaccine monitoring has historically shown that side effects generally happen within six weeks of receiving a vaccine dose.



I'll start by saying I am vaccinated, got it the first week immunocompromised people could:

But I do not believe that this is valid at all, being that this is the very first mRNA vaccine.

>By looking at other vaccines historically and seeing that side effects tend to happen in the first few weeks.

I feel like what you are saying is basically like someone asking "How do we know that self driving cars will be safe on the road" and you responding with, "well obviously by looking at the history of cars, we have been doing them for a century!"


This is not the first mRNA vaccine. It's the first to reach full approval, but we've been testing them in humans for a decade now. https://ec.europa.eu/research-and-innovation/en/horizon-maga...


And they have failed every time until now.


I actually think your analogy of self-driving cars is a good one. If a billion people had safely rode in self-driving cars in the last year, and it saved hundreds of thousands of lives, I think we'd be approving them too.


"By looking at other vaccines historically and seeing that side effects tend to happen in the first few weeks."

"Other vaccines historically" work on fundamentally different principles. We can not use that data to assume that mRNA vaccines are going to work the same way.


For the record, I volunteered for a COVID vaccine trial.

"mRNA vaccines have been tested in humans since 2011"

So barely 10 years. A study on a dozen or so participants, all white, college aged men with largely identical diets. I guarantee you that not one participant in the 2011 study was pregnant. (Btw, I looked at your reference. A Bush era press release was less manipulative. There wasn't a single peer-reviewed reference. All press releases and from interested parties)

Compare that with other vaccine technologies for which we have centuries of data, and inoculation in general for which we might have a thousand years worth of safety data.

Or did we forget about all the inconvenient facts about drug testing? We appear to have forgotten all the research done about regulatory capture and all the ineffective and unsafe pharmaceuticals the FDA approves.

But, nvm. #BelieveTheScience and de-platform anyone who asks inconvenient questions. And let's compartmentalize away the replication crisis modern science is going through.

Also, for some of us 10 years is not very impressive at all. "It's not new, nRNA has been around since the 90s!" is a massive value judgement for the word "new". Not all of us work developing webpages with 3 month old technology stacks!


Do you believe it's possible for a sufficiently advanced society (think Star Trek) to develop a vaccine for a novel virus in a short period of time? What do you think this would look like?


Well there are a few issues with your question.

I don't think a society can be as "advanced" as Star Trek. Societies are hard. To abuse CS terminology, they're NP-hard (or harder?). Star Trek seems to have only external threats, all internal problems are solved. The most boring problem a real society has is that of production and it is definitely NP-hard (see Hayek?). Star Trek has not only solved that at galactic scales, but has solved much hard problems than production.

Nor I don't think Star Trek is advanced in the sense that I would consider it "progress" vs. just change. I view Star Trek as the propaganda reel of (not for, of) a techo-distopia. Vulkans and that Data android fellow freak me out more than the Klingons whose society, while brutal, I can understand. I see more humanity in a Klingon because I can see a human society degenerating into the Klingons'. I don't see any humanity in Vulcans.

Btw, their technology bores me. Their tech is either impossible (warp drives). Surpassed (communicators). Or fraught with angels-dancing-on-pins philosophical questions (the "beam me up scotty" machines)

So, with the caveat that you used ST as an example and I'm definitely not a Trekkie, let me address your question:

No, I don't.

Biological systems are far more complicated than any system mankind has made. Every "cure" or therapy is really a very good whack-a-mole with hopefully lots of statistical information to back it up.

Take blood. It has hundreds, if not thousands, of components. Some are in pg/dL level of concentrations (that's 10^-12g / 100ml). See this chart [1]. How can we every really understand all the interactions among those various components?

That is not to say that I'm a bio-luddite (I am, but that's besides the point). Take penecillin. It's brutal on the body, but is one of the most important discoveries in human history. It has saved millions, if not billions, of lives. Im very grateful for penicillin, and yet, what an illustrative example! We gave too much penicillin with too much abandonment. So now, we have anti-biotic resistant bacteria. And, almost 90 years after it's first discovery we're finally starting to understand it's role in the havoc in our gut flora.

Btw, gut flora is another, fascinating, example of how complicated bio-systems are. We're evolved to depend on a symbiotic relationship with a gut flora that we've destroyed over the last 70 years of anti-biotics and cheap sugar.

So, while I think ab-initio methods (what Star Trek does) can inform and accelerate drug discovery (I worked on that briefly in my PhD), ultimately, no, I don't think we can ab-initio drugs through the whole pipeline (need-->development-->safety_evals-->approval).

[1] https://upload.wikimedia.org/wikipedia/commons/7/7c/Referenc...


mRNA vaccines have been tested in humans since 2011. https://ec.europa.eu/research-and-innovation/en/horizon-maga...


That data can be relevant. "Other historical vaccines" can not.


Nah. Historical vaccines effectively cover "what happens when we train the immune system to react to something via vaccination", which is still quite relevant with mRNA vaccines.

mRNA's short half-life - on the matter of a few dozens of minutes - and pre-existence in our bodies helps us not worry too much about the differences in delivery mechanism.


That's not how science works. We may have various bits of logic that can tweak our initial probability analysis, but we have to do the testing. When we change something fundamental, it must be tested, and things in the past that are similar, but not identical, are not sufficient. This is especially true for something that is being injected into the entire general population, which calls for the highest level of scientific certainty before proceeding.

"We think based on biochemistry that mRNA acts like this, and we hope it does that, and we think it probably does the other" doesn't carry much weight here. The probability of any element of that chain of logic being wrong is too high.

I'm not saying that testing wasn't done. I'm saying "eh, it's probably OK, mRNA looks pretty safe" is not a useful contribution to this sort of discussion.


We have done substantial testing.

Barring a time machine, the "is it safe ten years from now" cannot be answered conclusively today. We're left to use other available evidence to make a risk analysis, like "mucking with the immune system tends to have effects that show up fast" and "what do we know about mRNA in the body, especially when delivered by viruses?". There's a risk to inaction, too.

We don't look at evolution and go "welp, can't test evolving humans from microbes, so we must avoid drawing any conclusions".


"We have done substantial testing."

So go get vaccinated! If you trust the vaccine that it works, and that it's safe, go get it. I certainly have urged people I know who are high-at-risk and don't share my ethical concerns about them to get the vaccine.

If they're safe and effective, get vaccinated!

If they're safe and not effective, or lossy effective, we have very big problems and vaccinating the hold outs will not change anything




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