Out of curiosity, how do people on HN rate the risk of long term side-effects?
The US set a meeting date of 12/10 to decide on EUA so scientists had time to review the data.
The FDA itself closely inspects data throughout the phase 3 trials so this review should just consist of looking at the details to see if something was missed, (ideally) not some brand new information come to light.
For example, the EU is going to review the Pfizer vaccine on December 29, and they have requested further information.
It's mind boggling to Engineers to hear this, but Medicine is older than the scientific method and physicians used Regulatory capture to prevent competition.
I'd love a science based healthcare alternative.
She couldn't find a study to backup the claims that the medical team wanted to make in the document, but the lead doctor said that if this wasn't included, the patients would suffer and ultimately die.
So she said "you need to prove this in a study so it can be included, otherwise you put the company at risk". To which the doctor said "We could do that, but it would take 3-4 years, and in the mean time, the patients we're caring for would go back home, the doctors would be missing the one key piece of advice, and then they'll all suffer and die".
Science is slow. People are dying now.
Formal Peer review is good, but not necessary in science. Replication is necessary.
And as a note, we can still have Authority based healthcare, but a science based healthcare system would be cheaper and more reliable.
But not a lot. That's what's fascinating. At least in the US, over 95% of fatalities are people over 55. We're at 200k ~ 300k deaths for the year in the US (and I think there is reason to believe this is an overestimate, not an underestimate). That's lower than heart disease and cancer (500~600k yearly). I doubt we'll even approach those numbers by March.
Science is slow because it needs to be right. We're no longer in a time 185 years ago when Jenner could just stab people with puss he pulled off of a Horsepox infected cow. Remember that 500 years ago, the Chinese were blowing smallbox puss into people's noses (infections in the nose were typically not bad and people recovered faster) and isolated them. Many of them survived fine, but some died.
Do you want to return to that world where we just experiment on humans without regards to what that means?
This vaccine should be a choice. I'm under 40 and not in a high risk group. I'm fine with people volunteering to take this vaccine. Maybe I'll take it in 5 years. But I don't want to see this become mandatory for going to work or being able to enter a music venue.
You can quote the Jacobson decision all you want, but that SCOTUS decision only said Jacobson had to pay the $5 fine, he never was forced to take the vaccine. Furthermore Jacobson lead to the Buck decision (forced sterilization) and the SCOTUS decision that led to the WW2 Japanese internment camps. It's bad law that's bread a poisoned well of bad law.
I'll never understand people who say this, thinking it somehow proves their point or something. My parents are nearly 60, and easily have 20 more years of time with me and their grandkids. Why are we okay with that?
We can provide support specifically to those at risk, while also respecting the liberty and freedom of everyone else. Someone with an autoimmune disease or who is 65 can choose not to go to a pub and simply not interact with the rest of the world using technology. At the same time, the pub owner should be allowed to make a damn living.
I don't understand why this is so complicated.
There are people who are competent enough to do so. Those people carry the actual responsibility.
Your thoughts have answers readily available.
We don't know what "permanent damage" is actually happening. I remember having pneumonia in the 90s and it took my lungs over 3 months to recover, and that's from a normal known infection.
I think there is a strong case to be made, that a lot of these "long covid" cases might be a combination of normal pneumonia recovery, nocebo effect and fear/hysteria over this disease.
It seems very likely at this point that COVID is a disease of the blood vessels, which has the potential to do some really nasty damage to your organs. The numbers are hard to estimate but I've seen experts say that they think about 5 times the number of people who die will have enough problems to be considered having a long term disability. With estimates of case fatality being about .5% - 1.5% that would mean about 5% of the people who get it will have enough long term damage to be disabled.
https://www.nature.com/articles/d41586-020-02598-6
"Evidence from people infected with other coronaviruses suggests that the damage will linger for some. A study published in February recorded long-term lung harm from SARS, which is caused by SARS-CoV-1. Between 2003 and 2018, Peixun Zhang at Peking University People’s Hospital in Beijing and his colleagues tracked the health of 71 people who had been hospitalized with SARS. Even after 15 years, 4.6% still had visible lesions on their lungs, and 38% had reduced diffusion capacity, meaning that their lungs were poor at transferring oxygen into the blood and removing carbon dioxide from it."
We know this much and SARS is poorly studied because it faded away so we generally lost interest in it. This virus is both similar and different enough to be very, very wide spread so even minor negative effects over the total population that gets moderate to mild cases will have the potential to have very large impacts on worldwide health.
As time goes on we are going to better document the consequences of mild and moderate cases and understand these things better, caution seems advisable until we do.
We didn't really shut SARS down so much as it seemed to have shut itself down, conventional epidemic control measures were enough to contain it and it was not quite easily transmissible enough to sustain itself in the wider population without being allowed to gain a real foothold undetected first.
That last point would be why you would not expect (and I would think it is impossible) to find that at the end of the day COVID-19 will be anywhere near as deadly as SARS. We have strong evidence that it takes truly extraordinary measures to suppress this new virus at a rate that will in fact eliminate it from a population when compared to SARS. SARS simply didn't spread that widely because if it did that would directly contradict the relative ease of its containment.
Likewise influenza was well known before the 1917 pandemic, or H1N1.. and?
For example, if one happens in your brain, that's a stroke. Which is known to happen with COVID-19 patients[2].
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[1] https://www.hopkinsmedicine.org/health/conditions-and-diseas...)
[2] https://www.thelancet.com/article/S1474-4422(20)30272-6/full...
How bad are people expecting the vaccine to be?
- most adverse events were due to manufacturing issues (e.g. contamination with some live virus). In this respect, I don't think the Covid vaccines are likely to be any more or less risky than other vaccines, such as the annual flu vaccine
- two vaccines had an association with the Guillain-Barré Syndrome (GBS). Even nowadays, if you take the annual flu vaccine they advise caution if you've had GBS before.
- one Rotavirus vaccine was quickly discontinued after they saw it can cause a serious condition called intussusception
- finally, a case that you'll hear lots of people talking about, a possible link between a flu vaccine adjuvant (AS03) and narcolepsy. The CDC page directs you to the actual study [2]. My summary is that this link was observed only in Sweden and Taiwan, but in no other countries. The Pfizer and Moderna vaccines do not have adjuvants (but Novavax and others will have).
[1] https://www.cdc.gov/vaccinesafety/concerns/concerns-history....
But I think SARS died out before the vaccine was ready/needed.
While we cannot totally disregard ADE, I assume we should have seen it by now (and the Oxford trial was stopped exactly because they thought they might have observed something like it). Whether it appears again on a population scale level, nobody knows.
100% of the 100ug treatment group had at least one symptom, 80% of those classified as moderate. The vaccine is going to make you feel sick for a little while.
It is still risky, and I hope it will not be mandatory.
> A possible concern could be that some mRNA-based vaccine platforms 54,166 induce potent type I interferon responses, which have been associated not only with inflammation but also potentially with autoimmunity 167,168 . Thus, identification of individuals at an increased risk of autoimmune reactions before mRNA vaccination may allow reasonable precautions to be taken. Another potential safety issue could derive from the presence of extracellular RNA during mRNA vaccination. Extracellular naked RNA has been shown to increase the permeability of tightly packed endothelial cells and may thus contribute to oedema 169. Another study showed that extracellular RNA promoted blood coagulation and pathological thrombus formation 170. Safety will therefore need continued evaluation as different mRNA modalities and delivery systems are utilized for the first time in humans and are tested in larger patient populations.
[1] https://en.m.wikipedia.org/wiki/Antibody-dependent_enhanceme...
I'm sure this has all been thought about by relevant experts but I'd like to see the published research.
E.g. I believe it was the swine flu vaccine that caused narcolepsy in a small percentage of people receiving it. But that was apparent immediately.
To my knowledge no one has identified any slow acting consequences of a vaccine that would not have been obvious from the first rollout of a vaccine.
So this question is mostly academic. Unless you’re someone in the UK slated to get the first dose, you probably won’t even have an opportunity to get the vaccine before the effects in early groups become known. And for those in high risk early groups, the risk of covid surely outweighs the risk of vaccine.
Nothing has shown up in trials so far so I’m not expecting side effects beyond the known effect of short term flu like symptoms for a couple days.
The mechanism for the narcolepsy was a protein present in the virus itself. So actually getting the flu would have been much worse for those with the genes that made them susceptible.
It doesn’t sound like mRNA vaccines would have this vulnerability. Though I do take your point that it’s possible something like the swine flu narcolepsy event would only be found after the fact. However that would be a pretty small consequence since in this case the flu also would have caused worse narcolepsy.
https://www.youtube.com/watch?v=4bOHYZhL0WQ
Vaccines are also very young. We've had them for 185 years, and there were probably a lot of side effects from people getting stabbed with Horse Pox, but a lot of them probably just died and we didn't collect data back then they way we do today.
It's not comparable.
If you offered me a vaccine tomorrow vs a 100% certain mild case of COVID-19 that would guarantee me immunity for a year so I could get the vaccine in 12 months when there was /even more/ confidence about the safety of the vaccine I would take the vaccine.
I haven't been able to come up with a theory as to why public health departments and the media haven't been making the long term effects a key part of their messaging.
0: https://sebastianrushworth.com/2020/11/17/what-is-long-covid...
"Second, covid is not some magical entity, it’s a coronavirus, and it behaves like other coronaviruses, and other respiratory viruses more generally. It would be strange for covid to cause symptoms that other respiratory viruses don’t. And since I’ve never heard of “long rhinovirus” or “long influenza”, I’m inherently doubtful of claims that there’s such a thing as “long covid”."
This is just getting caught up in silly semantics, people are experiencing longer term health effects, they are calling it "long covid" for lack of a better name not because it is an affirmative diagnosis.
"On MedRxiv, there is a pre-print awaiting peer review of a prospective cohort study that followed 4,182 people with positive PCR tests... if we assume that this study was reasonably accurate, then one in 50 people who get covid still have symptoms at the twelve week point..."
This is supposed to be an argument that inclines me to think that whatever "Long Covid" is I am not supposed to be worried about it? If 1 in 50 people that get a positive test are still feeling after effects of having what the author believes "behaves just like other coronaviruses" then I think we should be very concerned! Even if truly long term effects only develop in 1 in 500 COVID-19 cases.. that's a lot of people who are going to be sick for a really long time! It would be 400 Americans a day right now. Yikes! That's bad!
I'll take my chances with a vaccine!
(And I know the standard response to this is.. "well, those people are mostly old or sick with something else so you can't really count it that way" but a certain, maybe large, proportion of those people would probably never get a serious respiratory virus in the near or medium term in the absence of COVID-19. It is a really large number of extra sick people, and all at once.)
Also the 4 other coronaviruses circulating thing is silly, obviously the long term effects of the common cold viruses are not going to be comparable if the short term effects are clearly not comparable, it is reductionism of the worst kind.
> Also the 4 other coronaviruses circulating thing is silly, obviously the long term effects of the common cold viruses are not going to be comparable if the short term effects are clearly not comparable, it is reductionism of the worst kind.
What you are saying is "obvious" is not at all obvious, and is not the assessment of the experts who have looked at the data and weighed in.
In terms of obviousness: why do you think that the long term effects are unlikely to be comparable (if not strikingly similar), since the long term (adverse) effects of each of these four (and also several of the influenza A) viruses seem to be clinically identical, despite each having distinguishable acute characteristics?
> This is just getting caught up in silly semantics, people are experiencing longer term health effects, they are calling it "long covid" for lack of a better name not because it is an affirmative diagnosis.
I agree that the terminology becomes tricky. But I think the question is better stated as: is "long COVID19" any different from other "long covid" (ie, the rare but well known post-viral syndrome that is observed with all coronaviruses).
> Even if truly long term effects only develop in 1 in 500 COVID-19 cases.. that's a lot of people who are going to be sick for a really long time! It would be 400 Americans a day right now.
...but a relatively small cohort in the bigger picture of post-viral syndrome, if indeed it occurs with approximately equal frequency with the other coronaviruses (and some influenza A viruses).
I think we need to be careful about measuring potential adverse outcomes against one another, and try our best to use numbers that reflect the likely lived experience of people (to wit, nearly everyone contracts the "garden variety" coronaviruses a few times in their life).
If the current slate of vaccines don't prevent this effect, then I'm having trouble putting any math together that suggests that it will generally reduce population-level instances of "long covid" (again, defined broadly as long effects from any covid, not just COVID19).
Asserting that all coronaviruses are similar and must have very similar effects in the short and long term seems like a very bad assumption to make, before the original SARS outbreak the scientific consensus was that coronaviruses were not capable of causing sevre illness in humans - despite their long history of being known killers of animals! Asserting we absolutely know things about this virus based on things that we didn't think the whole category of viruses was capable of doing less than 20 years ago without citations is bad!
So asserting that the long term effects of this virus are likely to be similar to the long term effects of other coronaviruses is not credible given the available evidence, and saying that it is likely to be similar to influenza (an unrelated virus that is very different) is even less credible. (And if the hospitals were this overloaded with flu patients every year we'd be worried about the long term effects on the survivors, but they are not!)
"I think we need to be careful about measuring potential adverse outcomes against one another, and try our best to use numbers that reflect the likely lived experience of people (to wit, nearly everyone contracts the "garden variety" coronaviruses a few times in their life)."
I don't know what this is supposed to mean, but if is contingent on believing that "garden variety" coronaviruses are similar in their effect to SARS-COV2.. I mean we can see just by looking at the ICU tallies in nearly every jurisdiction in the world that this is not the case so I don't know what conclusions you expect anyone to draw.
At the end of the day that is what this always comes down to with these COVID-19 debates it seems, the jurisdictions that haven't taken the virus seriously have been absolutely devastated by it, there is no secret knowledge to uncover. One should draw from that the inference that assuming that there is some secret formula of logic that will arrive at the conclusion that we already know the long terms effects of this virus seems less than credible. It might turn out to be correct! But that still won't vindicate the flawed logic of drawing the conclusion now.
If having one's virus research repeatedly published in the world's top journals, and securing a patent for a novel influenza vaccine, does not make one an expert, I think maybe we're casting too narrow a net. Not only in Sunetra Gupta an expert on viruses in my book, but one of the world's best.
> Asserting that all coronaviruses are similar and must have very similar effects in the short and long term seems like a very bad assumption to make
But I didn't do that. This brings us back to my original question: is there evidence that "long COVID19" is different than other long covids? If I'm understanding you correctly, you seem wont to presume that the answer is "yes", simply because the acute affects are different. But, as I pointed out, viruses with a wide-range of acute effects all produce clinically similar "post-viral syndrome". To my knowledge, there is no convincing evidence that SARS-CoV-2 is an outlier in this specific respect. Or am I wrong?
You're just goalpost moving here, the argument in the article you are citing clearly says the viruses are similar and presumes that their effects are similar on that basis. If YOU don't accept that then you don't accept your own cited authority, you're wasting your own time here on that basis.
How is this a credible person to listen to? It boggles the mind, she is an epidemiologist! After making a professional error on that scale I would crawl in a hole and not come out for a year!
Lucky children can't vote, lets start vaccinations!
I somewhat kid, but COVID is a real life example where a tiny minority has ruled over the overwhelming majority.
However, if they do not screw something up in production (which I regard a larger potential source of error than the vaccine itself) there won't be long term side-effects for most people. There were some side effects from swine-flu in Sweden around 2010 that were certainly major and those affected 1/12.000 people. I would guess that is an upper bound for side effect, but as I said, guessing probabilities of an unknown with sample size one is hard.
BioNtech has been developing mRNA vaccines for cancer patients for some time, so I would not expect any really large long term (in the range of 2-4 years) side-effects for fractions of the population larger than 20% based on that alone.
Not that I have a problem with your asking the question, I just don't think an opinion poll on a tech board is going to yield an accurate prediction of what to expect.
I'm pretty sure they were hoping to be answered by someone heavily schooled in mRNA vaccines and/or a practitioner involved in the trials for this particular vaccine. On this particular "tech board", there's a reasonable chance of getting a response from those kinds of experts.
Part of your answer, which I'm paraphrasing to "I don't know, talk to the experts", is already a good answer. But I was hoping that there was an expert lurking around that might be able to explain the risks or link to some evidence.
Personally since I belong to a low-risk group, there will be quite some time before the line reaches me where I need to make a decision, in which more data will be available from high-risk groups. It will also take time for my country currently pressured health care system to allocate resources for vaccinations without causing even more problems. My current estimate is many months from now.
Outside of long term side-effects I am concerned about how long the protection last. It is difficult to calculate risk without knowing that data point.
0: https://sebastianrushworth.com/2020/11/17/what-is-long-covid...
Vaccine is good but my biggest worry is if the same kind of virus happen again, it will become justification for lockdown until the vaccine exist.
I wouldn't be surprised if the leaders of the vaccine firms weren't using their own vaccines on themselves and their families for a couple more years, until they have sufficient data.
I have read enough research papers about the replication crises in many fields to know how much these long term studies are needed to properly assess a risk-benefit analysis for vaccination. I will, personally, stay the fuck away for the next couple years. My life didn't change much anyway, I've been working from home for years now. Less social life, but I can weather that.
As a note, we got COVID with the wife, I was without symptoms while she lost taste for a couple days and was tired for a week. That was all.