7 ms·

I'm in the trial. It's really exciting, not least because form a purely selfish point of view, I might be immune already! ...or not. But it's exciting either wa

I'm in the trial. It's really exciting, not least because form a purely selfish point of view, I might be immune already! ...or not. But it's exciting either way! AMA?

xwdv 6y ago
What if something goes horribly wrong and the vaccine trial causes unwanted side effects? Why risk it, what are they paying you?
- maxehmookau 6y ago
  I'm receiving no money for my participation. I wasn't in the initial Phase I trial, a few hundred people had already received the vaccine before me with no unexpected side effects. I guess I'm risking it because someone has to. Vaccine trials are incredibly safe and highly regulated. In reality, the worst-case was that it didn't work rather than my head exploding.
  - xwdv 6y ago
    How do you prove to people you are in a vaccine trial, do you have a card?
    - maxehmookau 6y ago
      I have a "red alert" card so if I'm found unconscious a paramedic knows to contact the study team to find out if I'm in the control arm or I've had the active vaccine so they can rule out if it's important to why I was found unconscious! But it is just a piece of paper that the team printed out, and I think I lost it.
      - neuronic 6y ago
        Paramedics won't go through your wallet anyways.
      - behnamoh 6y ago
        >> But it is just a piece of paper that the team printed out, and I think I lost it. loses the single most important medical document that's going to save his life
        maxehmookau 6y ago
        It's in my iPhone medical ID which I carry round far more often than my wallet. (Paramedics almost always check that here in the UK) The likelihood of it being of diagnostic usage is pretty low anyway. A vaccine is highly unlikely to cause the sort of reaction that means I won't be conscious.
- rlpb 6y ago
  > Why risk it? It's worth pointing out that during a pandemic, while participating in a trial does carry a risk, so does not participating. A participant has some substantially greater probability* than the general population of avoiding an infection which apparently carries a risk of death or long term debilitating effects. * You'll have to incorporate the probability of being in the control group, of course, but the overall probability is still significant.
  - maxehmookau 6y ago
    Oh yeah, that's for sure. The idea that there's a pretty decent chance that I've been vaccinated already which means I don't have to wait for a vaccine is great. My life can begin to go back to normal potentially months before it otherwise would.
    - pbourke 6y ago
      Are participants eventually informed whether they’re in the treatment or control groups?
      - whimsicalism 6y ago
        At the end of study.
    - elevenoh 6y ago
      >My life can begin to go back to normal potentially months before it otherwise would. Howso? Socialization is a multi-party dynamic. Folks might not care/believe you if you state 'I'm vaccinated' until it's widely accepted.
      - whimsicalism 6y ago
        Maybe I'm a dunce but I would believe a friend if they say they're vaccinated or already got covid.
        6y ago
- standardUser 6y ago
  It's worth remembering that Phase 3 trials follow Phase 1/2 trials, and those earlier trials are responsible for assessing the general safety of the vaccine. Phase 3 helps assess safety concerns among a much larger and more diverse group of people, but it is primarily about proving efficacy. They don't give out tens of thousands of vaccines (Phase 3) without a lot of data already showing the vaccine is safe.
- ksk 6y ago
  By the time human trials commence, we're as sure as we can be that it's safe. Due to how the system is set up at the governmental level, whenever any participant in the trial experiences adverse reactions, the trial is halted, until an explanation can be given. It's a serious concern that can and does lead to products not being approved by the FDA. Not being approved = loss of tens or sometimes hundreds of millions of dollars. People take this stuff very very very seriously :)
- tgsovlerkhgsel 6y ago
  What if something goes horribly normally and you catch the virus the vaccine is supposed to prevent? It's a risk tradeoff, different between the phases. I'd probably volunteer for a phase 3 trial if one was available in my area. Phase 1 would be a bit too hot for me.
  - maxehmookau 6y ago
    I'd agree. I wasn't interested in Phase I. My trial is Phase II/III. I was by no means the first to be vaccinated. Any major, common, reactions had already been pretty safely discounted.
jobigoud 6y ago
Do you get to know, at the end of trial, in which group you were?
- vmurthy 6y ago
  Not OP but from the reports I have read, people who have been given placebos will be informed if the actual vaccine is found be really effective. This is for ethical concerns (in the sense that it would be unethical to not vaccinate people who have got a placebo if the real vaccine is really effective)
  - syndacks 6y ago
    For some history on the matter of ethics in medical research, the 'Tuskegee Experiments' was among the most infamous biomedical research study in U.S. history [0]. 0. https://en.wikipedia.org/wiki/Tuskegee_Syphilis_Study https://en.wikipedia.org/wiki/Tuskegee_Syphilis_Study
    - vmurthy 6y ago
      Thank you for the refresher. I originally read it https://www.damninteresting.com/bad-blood-in-tuskegee/ https://www.damninteresting.com/bad-blood-in-tuskegee/ and found it depressing :(. The rest of the site is , well, damn interesting :)
- maxehmookau 6y ago
  Yes, at the end of the trial I will be told which group I was in. That's currently due for March 2021, but things change quickly.
aphextron 6y ago
>AMA? Have you experienced any side effects, even mild like injection pain or fatigue? I'm in the Moderna study and feel pretty disappointed that I may have gotten the placebo.
- divbzero 6y ago
  … or you might have been lucky with getting minimal side effects. Double blinded placebo controls are critical to clinical trials so you shouldn’t be disappointed one way or the other. Even if you are in the control group you’ll have the opportunity to get the vaccine after you’ve helped prove its efficacy and safety.
  - refurb 6y ago
    That’s actually a big concern. The FDA will likely approve based on an interim readout of data. However, they will want the full set of data around safety and efficacy. But what happens if a vaccine gets approved while you’re in a trial and not sure if you got the placebo? Well, you can drop out and just get the approved vaccine. Of course that will trash the original trial you were in.
- maxehmookau 6y ago
  Yes. After my first jab I had mild fever and mild arm pain (in both arms!) for a week. After the second jab, I had no side-effects. It's been quite a few months now since my first jab and I have no long-term effects whatsoever.
- breakingcups 6y ago
  Did they disclose what the control group got as a placebo? For instance, in this study it's a meningitis vaccine, so it could still have those side-effects if you've never had that vaccine.
  - aphextron 6y ago
    > Did they disclose what the control group got as a placebo? The control for Moderna is just saline, which is why I'm fairly certain I got it. No side effects whatsoever, not even soreness.
chrisrogers 6y ago
Did you experience temporary soreness near the location of the shot? Generalized tiredness, etc, that you might associate with a flu shot? How often are your follow-ups?
- maxehmookau 6y ago
  Yes. I had generalized pain in both arms after the first injection. Not the second. Nothing worse than you'd expect from another vaccination. Mild fever for 48 hours that meant I was too tired to exercise, but I was more than fine to work. (I'm a software engineer. I think if I had a more manual job, I would've struggled!) My follow-ups are every 2 months at a local hospital. They take general observations, ask about side effects and take a small blood sample (presumably to test for antibodies)
  - taneq 6y ago
    Do you know if the placebo is laced with something to simulate those side effects? Or is that a clue that you got the real thing? Also I'd assume the vaccine would make you test positive for the immunological screening tests?
    - maxehmookau 6y ago
      This trial doesn't use a placebo, it uses an active control. In this case, an already licenced vaccine for meningitis. So the side-effects I had could be due to that vaccine, I don't know. Yes, in theory it would make me test positive for an antigen test. So I'm barred from donating blood as my sample would show as positive for COVID-19 antibodies.
      - taneq 6y ago
        Oh, interesting! Thanks for the extra info. Wow, if they're insisting on COVID-19-antibody-free blood for donations that's going to cause problems as a greater percentage of the population gains antibodies to it. I guess they'll have to change to a specific test for current infection.

I'm in the trial. It's really exciting, not least because form a purely selfish point of view, I might be immune already! ...or not. But it's exciting either way! AMA?

xwdv 6y ago

What if something goes horribly wrong and the vaccine trial causes unwanted side effects? Why risk it, what are they paying you?

maxehmookau 6y ago
I'm receiving no money for my participation. I wasn't in the initial Phase I trial, a few hundred people had already received the vaccine before me with no unexpected side effects. I guess I'm risking it because someone has to. Vaccine trials are incredibly safe and highly regulated. In reality, the worst-case was that it didn't work rather than my head exploding.
- xwdv 6y ago
  How do you prove to people you are in a vaccine trial, do you have a card?
  - maxehmookau 6y ago
    I have a "red alert" card so if I'm found unconscious a paramedic knows to contact the study team to find out if I'm in the control arm or I've had the active vaccine so they can rule out if it's important to why I was found unconscious! But it is just a piece of paper that the team printed out, and I think I lost it.
    - neuronic 6y ago
      Paramedics won't go through your wallet anyways.
    - behnamoh 6y ago
      >> But it is just a piece of paper that the team printed out, and I think I lost it. loses the single most important medical document that's going to save his life
      - maxehmookau 6y ago
        It's in my iPhone medical ID which I carry round far more often than my wallet. (Paramedics almost always check that here in the UK) The likelihood of it being of diagnostic usage is pretty low anyway. A vaccine is highly unlikely to cause the sort of reaction that means I won't be conscious.
rlpb 6y ago
> Why risk it? It's worth pointing out that during a pandemic, while participating in a trial does carry a risk, so does not participating. A participant has some substantially greater probability* than the general population of avoiding an infection which apparently carries a risk of death or long term debilitating effects. * You'll have to incorporate the probability of being in the control group, of course, but the overall probability is still significant.
- maxehmookau 6y ago
  Oh yeah, that's for sure. The idea that there's a pretty decent chance that I've been vaccinated already which means I don't have to wait for a vaccine is great. My life can begin to go back to normal potentially months before it otherwise would.
  - pbourke 6y ago
    Are participants eventually informed whether they’re in the treatment or control groups?
    - whimsicalism 6y ago
      At the end of study.
  - elevenoh 6y ago
    >My life can begin to go back to normal potentially months before it otherwise would. Howso? Socialization is a multi-party dynamic. Folks might not care/believe you if you state 'I'm vaccinated' until it's widely accepted.
    - whimsicalism 6y ago
      Maybe I'm a dunce but I would believe a friend if they say they're vaccinated or already got covid.
      - 6y ago
standardUser 6y ago
It's worth remembering that Phase 3 trials follow Phase 1/2 trials, and those earlier trials are responsible for assessing the general safety of the vaccine. Phase 3 helps assess safety concerns among a much larger and more diverse group of people, but it is primarily about proving efficacy. They don't give out tens of thousands of vaccines (Phase 3) without a lot of data already showing the vaccine is safe.
ksk 6y ago
By the time human trials commence, we're as sure as we can be that it's safe. Due to how the system is set up at the governmental level, whenever any participant in the trial experiences adverse reactions, the trial is halted, until an explanation can be given. It's a serious concern that can and does lead to products not being approved by the FDA. Not being approved = loss of tens or sometimes hundreds of millions of dollars. People take this stuff very very very seriously :)
tgsovlerkhgsel 6y ago
What if something goes horribly normally and you catch the virus the vaccine is supposed to prevent? It's a risk tradeoff, different between the phases. I'd probably volunteer for a phase 3 trial if one was available in my area. Phase 1 would be a bit too hot for me.
- maxehmookau 6y ago
  I'd agree. I wasn't interested in Phase I. My trial is Phase II/III. I was by no means the first to be vaccinated. Any major, common, reactions had already been pretty safely discounted.

jobigoud 6y ago

Do you get to know, at the end of trial, in which group you were?

vmurthy 6y ago
Not OP but from the reports I have read, people who have been given placebos will be informed if the actual vaccine is found be really effective. This is for ethical concerns (in the sense that it would be unethical to not vaccinate people who have got a placebo if the real vaccine is really effective)
- syndacks 6y ago
  For some history on the matter of ethics in medical research, the 'Tuskegee Experiments' was among the most infamous biomedical research study in U.S. history [0]. 0. https://en.wikipedia.org/wiki/Tuskegee_Syphilis_Study https://en.wikipedia.org/wiki/Tuskegee_Syphilis_Study
  - vmurthy 6y ago
    Thank you for the refresher. I originally read it https://www.damninteresting.com/bad-blood-in-tuskegee/ https://www.damninteresting.com/bad-blood-in-tuskegee/ and found it depressing :(. The rest of the site is , well, damn interesting :)
maxehmookau 6y ago
Yes, at the end of the trial I will be told which group I was in. That's currently due for March 2021, but things change quickly.

aphextron 6y ago

>AMA? Have you experienced any side effects, even mild like injection pain or fatigue? I'm in the Moderna study and feel pretty disappointed that I may have gotten the placebo.

divbzero 6y ago
… or you might have been lucky with getting minimal side effects. Double blinded placebo controls are critical to clinical trials so you shouldn’t be disappointed one way or the other. Even if you are in the control group you’ll have the opportunity to get the vaccine after you’ve helped prove its efficacy and safety.
- refurb 6y ago
  That’s actually a big concern. The FDA will likely approve based on an interim readout of data. However, they will want the full set of data around safety and efficacy. But what happens if a vaccine gets approved while you’re in a trial and not sure if you got the placebo? Well, you can drop out and just get the approved vaccine. Of course that will trash the original trial you were in.
maxehmookau 6y ago
Yes. After my first jab I had mild fever and mild arm pain (in both arms!) for a week. After the second jab, I had no side-effects. It's been quite a few months now since my first jab and I have no long-term effects whatsoever.
breakingcups 6y ago
Did they disclose what the control group got as a placebo? For instance, in this study it's a meningitis vaccine, so it could still have those side-effects if you've never had that vaccine.
- aphextron 6y ago
  > Did they disclose what the control group got as a placebo? The control for Moderna is just saline, which is why I'm fairly certain I got it. No side effects whatsoever, not even soreness.

chrisrogers 6y ago

Did you experience temporary soreness near the location of the shot? Generalized tiredness, etc, that you might associate with a flu shot? How often are your follow-ups?

maxehmookau 6y ago
Yes. I had generalized pain in both arms after the first injection. Not the second. Nothing worse than you'd expect from another vaccination. Mild fever for 48 hours that meant I was too tired to exercise, but I was more than fine to work. (I'm a software engineer. I think if I had a more manual job, I would've struggled!) My follow-ups are every 2 months at a local hospital. They take general observations, ask about side effects and take a small blood sample (presumably to test for antibodies)
- taneq 6y ago
  Do you know if the placebo is laced with something to simulate those side effects? Or is that a clue that you got the real thing? Also I'd assume the vaccine would make you test positive for the immunological screening tests?
  - maxehmookau 6y ago
    This trial doesn't use a placebo, it uses an active control. In this case, an already licenced vaccine for meningitis. So the side-effects I had could be due to that vaccine, I don't know. Yes, in theory it would make me test positive for an antigen test. So I'm barred from donating blood as my sample would show as positive for COVID-19 antibodies.
    - taneq 6y ago
      Oh, interesting! Thanks for the extra info. Wow, if they're insisting on COVID-19-antibody-free blood for donations that's going to cause problems as a greater percentage of the population gains antibodies to it. I guess they'll have to change to a specific test for current infection.