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Comment by boulos | Hacker News Reader

Can someone explain the “I won’t get it until it’s fully approved by the FDA” logic to me?

Unlike usual vaccine trials, these vaccines have been deployed worldwide with hundreds of millions of people across many different conditions. Europe stopped using some due to an extremely rare blood clotting episode that was tens of people out millions. That suggests that rare, acute side effects have been (mostly?) discovered.

AFAICT, the FDA rules for full licenses seem to require a six month trial, as well as more information on process / manufacturing / quality control.

That just doesn’t seem that important compared to the massive, real-world “trial” data. What am I missing?

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I'm not sure I can explain anything related to the FDA (I'm European) but maybe I can shed some light on the insight what people are worried about.

These vaccines have been applied hundreds of million times in the past year, true. Therefore, we have a very good understanding of their adverse effects in the first 6-12 months. What we cannot know, however, are possible adverse effects that are longer term. Susceptibility to other diseases maybe due to a weakened immune system. Possibly a higher prevalence of autoimmune diseases.

If these vaccines were regular, inactivated virus vaccines, we could extrapolate long term effects from other similar vaccines. But this is brand new technology which affects our immune system, which is far from completely understood.

Agreed on concerns about long-term effects! But I don’t believe FDA approval includes that. If anything, I suspect long covid, mRNA surprises, and similar issues will only be truly apparent in the multi-year timeframe. Again though, FDA approval doesn’t seem to address that. So I understand, “I want to understand the long-term side effects”, but not FDA approval versus emergency authorization.

I had originally hoped that Europe’s use of AZ might have avoided the concern over new methodology. But ultimately the various problems during production, testing, and rollout, “seem” worse than the newness of mRNA (in my circles).

> If these vaccines were regular, inactivated virus vaccines

There are also inactivated viral vector vaccines for COVID. I got J&J because it was what was available to me. I would have gotten an mRNA vaccine if I could. I agree that the mRNA vaccines should be studied for long term effects, but with what we know about them so far, my prediction is that we will find them to be much safer in the long term than viral vector vaccines. Only time will tell.

Viral vector vaccines are not the same as traditional inactivated virus vaccines, and are in fact similar to mRNA vaccines in some important ways: 1. mRNA vaccines and viral vector vaccines deliver genetic instructions so your own cells produce the targeted proteins 2. Like mRNA vaccines, there has never been widespread use of a viral vector vaccine prior to this year.

>I expect that

I challenge you to try again without assumptions! Unless you are saying, for those who are unsure of long term health risks, to just follow your expectations?

Please take a pause before replying to understand why people are hesitant to blindly follow the blind

There actually have been mRNA vaccine trials for more than a decade[0]. The thing about mRNA vaccines is that they have far fewer moving parts, so to speak, than conventional vaccines. So the mRNA vaccine for two different diseases will differ far less than two conventional vaccines for different diseases.

As I understand it, a reasonable comparison is between two mRNA vaccines and two flu vaccines from different years. So if you trust the 10 years of studies that don't show any long term negative effects, and you trust that the particular protein won't have long term ill effects (and, well, if it does, you'd also get them from the virus and probably worse), then the set of assumptions you need to make are relatively small, and essentially the same as the ones you'd make in getting any given flu vaccine.

So please also take the time to educate yourself before calling others "blind"!

[0]: https://www.clinicaltrialsarena.com/comment/evolution-mrna-v...

Thank you for making a good point. I'm saying we should use the limited data we have to make the best predictions we can until all of the data comes in. Of course, predictions don't always end up being right, weather forecasts being the obvious example, but there is still value in making them and trusting them (with a grain of salt).

>limited data

Yes! And do not forget, the limited data includes the botched 1970s flu vaccine as well. Don't forget the infamous Tuskgee experiment. These are all valid data points that people can use to say "well i'm not going to be a guinea pig until the long term data comes out". There is also data that most people don't find out they are allergic until the first shot. That's anxiety inducing!

When you start becoming empathetic to the other side, you realize that there are gaps where simply hand waving doesn't make the problem go away. And this is a problem everyone with an opinion, on this topic, seems to forget

Afaik at least for the Adenovirus based ones these have not been used before as well.

There are several adenovirus based vaccines, including vaccines for tuberculosis and influenza, among others. The first adenovirus vaccine I'm aware of was developed in the 1970s.

https://en.wikipedia.org/wiki/Viral_vector

According to [1] there are only Covid and Ebola approved vaccines based on an Adenovirus vector. Only for the latter we have a couple of years of data and I am not sure whether it has been administered to large populations.

For tuberculosis there is no approved vector based vaccine [2]. Neither for influenza [3].

[1] https://en.wikipedia.org/wiki/Viral_vector_vaccine

[2] https://en.wikipedia.org/wiki/Tuberculosis_vaccines

[3] https://en.wikipedia.org/wiki/Influenza_vaccine#Manufacturin...

The effects of covid are far from completely understood. We do know that it kills a decent percent of the people infected with it and gives long term symptoms to another relatively large percent. The long term effects are unclear but they are almost certainly much worse than the long term effects of the vaccines.

My question is whether or not it is a rational position that the risk of the vaccine is higher than the risk of getting covid? Is this a conclusion that someone could reasonably come to - that they would rather have covid than be vaccinated?

If the answer to the question is no, I believe mandates from private companies are something that needs to happen as the government will not be able to act.

Indeed. The autoimmune response for some children to Pandemrix is one example.

https://en.wikipedia.org/wiki/Pandemrix

Correct me if I'm wrong, but doesn't the JnJ vaccine use the old vaccine technology compared to the newer Mrna vaccines?

It uses a different new technology - it's a "viral vector vaccine".

I expect for the most part it’s a fig leaf, and when it is approved the goal posts will move. Then it will be, “the FDA rushed approval” with no evidence presented or required.

That’s certainly going to be true for some people. But my express goal in this thread is to hear a good faith “full authorization argument” from someone who honestly argues for it. I believe arguments exist that I haven’t considered.

I set myself a smart goal. 2024. clinical trials for all will be finished by the end of 2023 at the latest and then, give it a couple months to wrap up and draft or bury and reports.

that is my basis. it's Smart.

I think waiting for long-term effects to be clear is a defensible position.

What I don’t follow is that, AFAICT, full authorization is likely ~6 months from the date of filing (so November to January depending on manufacturer). So we won’t have long-term data.

Is full FDA approval meaningful to you? If so, how?

> I think waiting for long-term effects to be clear is a defensible position.

Unless you get infected, in which case you made a pretty big mistake.

So then your basically saying you don't want to get vaccinated or get covid. I'm guessing you probably also want to stop social distancing. in which case you would eventually certainly get covid if it weren't for the existence of the vaccines.

So the choices are: - Don't get vaccinated and everyone continues social distancing for several years, or until you get Covid. - Don't get vaccinated and stop social distancing once everyone else gets the vaccine - Get vaccinated

Only the third option is remotely defensible. The second option is borderline sociopathic and there are enough people taking it that it is far more dangerous than option 3.

Curious, how does Ivermectin fit into your worldview?

https://www.wsj.com/articles/fda-ivermectin-covid-19-coronav...

I haven't looked at it much but it doesn't seem like a reliable enough treatment that one wouldn't want to be vaccinated. It seems like there are a bunch of different drugs that have shown to be effective but none are in the ballpark of two doses of Pfizer or Moderna

I don't disagree with you. In fact, I don't know what the correct policy should be. But we have focused heavily on preventing infection, and the vaccines have been amazing at this so far. Because now of variants and decreasing immunity, we know boosters will be needed, and for how long? Also some people are having bad side effects, like blood clots, heart problems, exhaustion, and even death, making others skeptical. No doubt it is safer than covid though. But this makes me wonder if we should have more comprehensive policy. Ivermectin seems great at treatment at various stages of covid once infected without those side effects, and also seems to hold up better against the variants. But it also looks less effective overall.

Dr. John Cambell's video on it is worth a watch: https://youtu.be/R0-90kvoQac?t=610.

As is the ongoing meta-analysis: https://ivmmeta.com

The right answer is for everyone to get vaccinated as soon as it is available to them, preferably with the mrna vaccines. Then we don't have to worry much about treatment because the disease will no longer be a part of our daily lives.

The terrible side effects you speak of effect an absolutely miniscule number of people relative to the hundreds of millions who have had the vaccine with no such effects.

Previous to this summer I wasn't so certain that the vaccine should be effectively mandated but after seeing the effect that vaccine hesitancy has on people I know longer think there is any reason businesses shouldn't mandate their employees and customers be vaccinated.

Appreciate the response. Regarding side effects, I picked those 3 because at least in my own family ~25% had those shortly after the 2nd dose, and are still ongoing. Their doctors think it’s coincidence, but it makes me skeptical how rare the side effects actually are. Open to any hard data though. If we could treat covid and stop it via natural immunity as well as vaccination, I think it could work better than ongoing boosters and mandates.

Unless you get infected

I upvoted both you and the parent, as both positions are valid. The difficulty of the issue is that a personal decision to vaccinate or not influences also the health of other people. This result could be weaker if Google didn't insist on forcing people back to the office - but they already made the decision so you either comply or lose your job, there is not much to discuss.

I have some sympathy to this argument, even though I agree with you in overall that based on what we know from the millions of vaccines being administered, they appear to be very safe. But points in favor of the FDA argument, which is mostly around emergency authorization requiring a lower standard of evidence:

- The pharmaceutical industry is notorious for manipulation of trial data to make their treatments looks as beneficial as possible, as they are incentivized to do so. In the current case Pfizer and others have still not made the trial data public, and probably never will [0][1]

- The main study on the Pfizer vaccine contained safety data for an average of about two months - on this basis the vaccine was declared to be extremely safe. Obviously longer term effects cannot be captured in this timeframe [2]

- Due to the requirements to generate a clear public health message, almost anything that may suggest a risk with vaccines is downplayed. See for example how VAERS data is routinely dismissed (with some reason)[3], whereas data on COVID hospitalization and death rates is largely unquestioned, despite containing some room for interpretation [4].

Again, the the totality of evidence suggests that the vaccine are safe and effective. But it is not crazy or evil, as some would suggest here, to question some of what we are being told and how the data is being presented to us.

[0] https://www.nature.com/articles/d41586-020-01911-7

[1] https://www.theguardian.com/business/2015/aug/31/pfizer-resi...

[2] https://www.nejm.org/doi/full/10.1056/nejmoa2034577

[3]https://www.reuters.com/article/factcheck-vaers-faers-idUSL2...

[4] https://www.aamc.org/news-insights/how-are-covid-19-deaths-c...

Does full FDA approval make a meaningful difference, though?

If anything, it seems like if someone doesn’t want to rely on the current EUA (because of limited data, incentives, etc.) then they shouldn’t suddenly be okay with the FDA’s full authorization.

Not the parent, but not really, no.

Over the past couple years we’ve witnessed and discussed at length the level of regulatory capture that has affected the FAA (via Boeing).

That makes me wonder if the FDA has also succumbed to the same issues (via Pfizer).

The agencies have a similar role and similar potentiality for capture. Revolving doors, lots of $ at stake, huge multinational corporations.

I’ve brought this up before and was downvoted to hell. But I’m just putting it out there without bias. It’s based on a logical thought process. I don’t understand why we can’t even discuss if there are issues with the FDA’s process being corrupted by corporations with billions of dollars.

Your explanation is completely correct as far as I can tell, but you can see how someone who's unfamiliar with the details might be skeptical. "You're telling me the FDA already knows the vaccine is safe and effective, and they're just keeping it a secret for 6 months because the rules say so?"

Absolutely. But I honestly was (am) hoping to hear it from someone who personally holds the opinion, because I think we’re all missing something (replies so far don’t include anyone saying that’s what they’re waiting for).

I have plenty of my own speculation, assumptions, and anecdotes, but my hope is that someone pops up with an interesting nugget of “actually, EUA < something I haven’t considered >”.

Fingers crossed for you, but I think it's one of those things where the people who think that way are overwhelmingly unlikely to be interested in arguing about it on the Internet. I know I would have bounced right out of this comments section if I were even slightly less extreme in my pro-vaccine views.

Yeah, I figured it was worth a chance.

Fwiw, multiple companies mentioned they would also move to require vaccination once it’s no longer EUA. I should have included that in my original framing.

To me, that sounds more like “once the government gives us more cover, we’ll do it”. But that doesn’t tell me “who would be convinced after this milestone, but not with the current data? What changes?”.

Then why don't FDA just fully approv the vaccine? Apparently, FDA hasn't approved the vaccine.

I'm not an expert in the vaccine. So, I won't debate the details.

It is very jarring that FDA/CDC claims the vaccine is safe, but they refuse to approve the vaccine.

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