Phase 2a and Phase 3 similarly listed.
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?
So, for example, it looks like this protocol would exclude people getting chemotherapy.
Happy to be proven wrong on this by someone with more information.
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.
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
People experiencing long term symptoms? I can believe that, my tinnitus after covid-19 is still there, even if I don't notice it as much.
Actual viral infection? I really doubt that, thoug perhaps it could hide like the herpes virus.
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.
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.
That's the reason why also young healthy people need to take the vaccine in order to stop the spread. It's a solidarity gesture.
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.
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.
https://immunisationhandbook.health.gov.au/vaccination-for-s...
(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)
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.
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.
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?
But looking up this one, it was blinded, indeed! https://www.henryford.com/moderna-vaccine/faqs
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.
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!
If the control group intentionally avoided exposure more than the experimental group, then the vaccine is even more effective than the study result. This is a blinded study though, so participants don't know which group they're in unless they go out of their way to find out (eg. taking an antibody test).
1/ take the vaccine
2/ expose himself to the virus to chekc his immunity.
We will never know before trial
Participants' risk of getting COVID shouldn't go up, unless participating in the trial induces them to behave more riskily.
Still, risk homeostasis is (sometimes) a thing: people reportedly ski faster when wearing a helmet, drive closer with ABS, and stuff like that. I was just trying to pre-empt that argument.
That said, if this were a factor, it would be small and would make the trial results most impressive, rather than less.