Relevant criteria for the question "does it it exclude old, fragile people with various common pre-existing conditions?" (not exhaustive, but indicative):
Included: Pre-existing conditions are okay as long as they are in a stable condition (defined as no significant change in therapy etc for the 3 months before enrollment).
Excluded: Immunosuppressive or immunodeficient state, asplenia, recurrent severe infections (HIV-positive participants with CD4 count ≥350 cells/mm 3 and an undetectable HIV viral load within the past year [low level variations from 50-500 viral copies which do not lead to changes in antiretroviral therapy [ART] are permitted]).
Looks fair enough to an amateur like myself.
Edit: Not sure how common a immunosuppressive or immunodeficient state is in a typical population. Perhaps it's common enough to be relevant?
Immune suppressed/deficient patients are not good candidates for vaccines in the first place, since they would be unlikely to mount an effective immune response.
I think tpmx's point is that the virus would also be less dangerous for them, so getting the vaccine has less chance of having a net benefit for the individual.
Yeah, it was, but I think the argument that the vaccine is a safer option for this crowd is also a pretty persuasive argument.
I'm not exactly in this crowd (I'm 43) but given what I now know about the prevalence of scary long term covid-19 issues ("long haulers") in young people, I would take this vaccine in a heart beat "even" if I were young.
That sounds backwards. Shouldn't those with weakened immune response be first in line for the vaccine? The vaccine would give them a boost. Those with strong immune response have a better chance of fighting off the virus.
Marjomax isn't saying that those with weakened immune responses don't need protection against the virus. They are saying vaccines do not work well in immunosuppressed people, the vaccine will not necessarily provide protection.
Vaccines work by triggering the immune system in the first place. If your immune system is not functioning normally, the vaccine may work differently or not work.
I think it's more complicated than just as a blanket "won't work". But, yeah, more complicated means more complicated -- different vaccines may be infffective, or require a higher dose, or even be harmful to immunosuppressed people. As far as the study, it would probably require a separate study focused on immunocompromised people? The fact that these are new mRNA-style vaccines is possibly relevant, maybe we know even less? Obviously we're in a rush here, there's lots of studies that would be really good to do that haven't been done yet, all that's been done is like a basic "normal people everyone" study. From which immunocompromised people were excluded because they are likely to respond to the vaccine differently, so need a different study design etc.
(And btw, THIS is what "herd immunity' is about. If enough people are immune (say from a vaccine), then there aren't enough carriers to pass it around the population, so those who AREN'T immune (possibly because they are immunocompromised and the vaccine wouldn't work on them or would be dangerous) still have much reduced chance of getting infected. Because, yeah there are people who can't take vaccines because they would be dangerous or ineffective, but may still be at high risk for complications from the virus)
Vaccines work by essentially teaching your immune system to recognize a pathogen. If your immune system is in a very weakened state, it likely will not 'learn', and even if it does, it may not be in any condition to fight the infection, even if it recognizes it as such. Of course, things are much more complicated, but in people with severe immuno-deficiency (such as advanced AIDS or people who are actively taking immune suppressants) a vaccine will not have any effect (some kinds of vaccines even risk infecting that person with the disease, though I beleiev this is not the case with any of the Covid19 vaccines).
That could exclude people who are the most likely of dying of covid (a severe case of covid doesn't mean dying, for instance I heard an ICU specialist explaining that people who are seriously obese often require ICU treatment but rarely die from it, the people who die usually have serious co-morbidities and an already reduced life expectancy).
But it's kind of secondary anyway. The main goal of the vaccine is to stop the virus from spreading in the population and getting a chance to reach vulnerable people. Even if it were to only protect people who wouldn't die of Covid in the first place, that's the vast majority of the population and enough to significantly reduce the chance of spreading.
At the condition that these studies measure the right thing. If it merely stops the symptoms but doesn't stop the spread of the virus, that may be a problem.
And autoimmune conditions, robbing a list from wikipedia: celiac disease, diabetes mellitus type 1, Graves' disease, inflammatory bowel disease, multiple sclerosis, psoriasis, rheumatoid arthritis, and systemic lupus erythematosus.
I don't know how many people with conditions take immunosuppression medication.
I take it for arthritis and alopecia and have come across many people on similar meds for diabetes or other things.
But that could be a form of confirmation bias
It means it hasn't been, and thus needs more study in that regard.
My inexpert understanding is that mRNA vaccines such as this one are unlikely to have an impact on many autoimmune cases. In many, perhaps most, others, it appears from my reading to be likely that the generated interferons are not adding anything to the likelihood of developing an autoimmune condition that wouldn't eventually already happen. (It might be the nudge over the cliff, but so might have the next common cold you catch.) But it should be tested to understand, regardless.
The first. Long lingering after effects. For some they are fairly minor, but for many they seem to be quite tough, with significant problems doing any kind of physical activity.
At the moment it's all quite nebulous, with a lot of anecdote and not enough data. But there are some studies starting up that might start to untangle what's going on.
> I think (from my parents and in-laws) that immunosuppression is normally associated with current cancer treatment.
There are other reasons a person would be considered immunosuppressed, and plenty of non-chemotherapy drugs that have immunosuppressive effects. But yes, cancer is one of them.
It would make no sense to include immunosuppressed people in the initial trials for a vaccine, the purpose of which is to determine whether a vaccine can induce an immune response.
> My selfish concern is then whether or not the vaccine will work for them.
We won't have hard data on that specific question for a very long time, but it's something your/their doctor would be better equipped to make an educated guess about, given the specifics of their situation ("immunosuppressed" can mean a range of things). In some cases, a vaccine might do nothing. In some, it might be actively dangerous. In some, it might have a weaker but still nonzero protective effect. But I wouldn't trust anything you read on HN that tries tell you anything more specific than that.
Unfortunately, vaccines can't really help immunocompromised people, as their immune system is simply unable to fight off any infection, regardless of whether it recognizes the infection or not (of course, this may be a matter of degrees). That is why, for example, people with advanced AIDS can die from essentially any pathogen.
Your answer isn't exactly wrong, but it's painting with a broad brush. "immunocompromised" is a broad term (even more so than "immunosuppressed"), so there definitely are people who are immunocompromised who could potentially benefit from a vaccine (again, we don't have hard data on that yet for any of the vaccine candidates and won't for a while).
They do help indirectly - by innoculating the 90% who can take a vaccine, the 10% who can't (for example babies when it comes to measles vaccines) are unlikely to actually catch the disease.
Oh, for sure, I wasn't trying to say vaccines shouldn't be used! They are extremely important to a healthy population overall, and it is all the more important for people with healthy immune systems to get them to help protect those that can't benefit directly.
Transplant recipients (which must be on suppressants for life) can and do take vaccines and they work. They generally can't take live virus vaccines, but that's about it AFAIK.
Also, Anybody who has received an organ transplant is immunosuppressed. They take immunosuppressive drugs so that the transplanted organ is not rejected.
It would be so nice if those people could have access to a coctail of synthetic antibodies that gave some protection to covid-19, the flu and others. Or perhaps a generic antibody that protects against most viruses(unlikely, given such an atibody does not exist in nature).
Antibodies don't themselves help fight infections; their role is simply to identify dangerous pathogens to white blood cells. In immunosuppressed patients, those cells often aren't present (or aren't responding properly), so adding antibodies wouldn't help.
That's why it's so important that all the people who can get the vaccine get it - this is the herd immunity everyone is yammering about. If the healthy people are vaccinated the virus won't be able to spread to the people who can't get vaccinated.
> Not sure how common a immunosuppressive or immunodeficient state is in a typical population.
Pregnant women are considered immunosuppressed to a certain extent. I'm a software engineer and not a doctor though, so someone could perhaps shed more light on this.
There is an additional question that opens the door to all sorts of hidden exclusions: Were study participants given medical advice prior to participation?
If I ask my doctor whether it is a "good idea" for me to participate in an investigational study like this, there are all number of reasons he may advise against. Those reasons form a defacto hidden list of exclusions. Would a doctor advise a patient with diabetes, high blood pressure, or any other chronic illness, to participate in such a study?
Why wonder? You can read in the original press release that there were ~5000 patients under the age of 65 with chronic diseases such as diabetes, severe obesity and cardiac disease. There were also ~7000 patients over the age of 65. That seems reasonable to me.
For a study to be valid and useful, the control group has to go through exactly the same criteria as the test group. Everyone is "blind" to whether they get the placebo or the real thing. So they all get the same interviews/tests and rejection criteria. Putting all the diabetics in the control/placebo group would make it pretty obvious who was and wasn't getting the real thing.
Even if it isn't blinded, you try to make sure the control group and experimental group are equally representative though, you don't "put all the X in the Y group" ever, this is true! Because the whole point is testing two groups as much alike as possible other than the thing you are testing.
As someone who volunteered for the AZD12222 trial and who has various "co-morbidities", I consulted with 2 of my doctors beforehand. Given that none of the vaccines being tested are live virus vaccines (meaning there is 100% no way to get COVID-19 from the vaccine, unlike say, the polio vaccine), and all had already passed Phase 1 safety trials, they both put it as (paraphrasing): "It's a personal choice, but if you do it, thank you for helping science."
I think COVID-19 is perhaps different than many other types of diseases in it's mainly-selective dangerousness to select groups of people. A healthy 30-something is unlikely (but possibly) to have severe, hospital-landing COVID. Someone with various co-morbidities, however is more than twice as likely to die than someone without. As such, I think that makes it much more likely that this group will volunteer, than "normal" people. It's certainly what drove me to do so.
The only issue they seemed to really care about during the intake was immunosuppression. As another comment pointed out, as long as other medical conditions were stable, you were eligible. From the vaccine makers point of view, I'd surmise this group is almost desired (my personal opinion), as you're less likely to a have asymptomatic COVID infection, which given how they are running the trial are unlikely to get noticed.
I take great solace in hearing that among the people who got COVID even when having received the vaccine (I'm talking about the AstraZeneca one, which is ~70% effective), there were no serious cases that required hospitalization. This indicates that even among the "not-effective" group, the vaccine confers some immunity. For me, that bring the personal risk factor from "possible death sentence" to "just like the flu...it'll suck for 2 weeks but I'll be fine".
Obviously I don't know if I got the vaccine or not (though given I felt crappy the next day, I'm fairly sure I did), which as another commenter points out is what makes these trials effective. Neither I, nor the doctors I met with (nor anyone at the clinic where I received it) has any idea if I got vaccine or placebo. In fact, they even had the vaccine couriered over from another hospital pharmacy using only a numeric identifier so really nobody knows what I got.
Coming back to the original question, I think many people, especially with co-morbities might seek out advice before enrolling, but at least in my case, two doctors were all for it.
I'm thankful I enrolled, and I'd encourage others, especially those who are more likely to get severe COVID to do so as well!
Because the default with chronically ill patients is no. There are also financial issues. If a patient is chronic then they are likely on ongoing treatments of some sort. If complication arise from the investigational medication then questions come up as to who will pay for what treatment. What if the complications lead to the patient having to abandon the ongoing chronic treatment? So the docs will lean towards no. And in the US there is the huge question of whether one's insurance even allows for such participation, but that is a question for one's lawyer rather than doctor. All such concerns can lead to the exclusion of certain populations, possibly the populations more relevant to the study.
