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I see a lot of ppl rightly concerned about vaccine hesitancy. I see lots of talking heads thinking their expression of behavioral intent is enough to address it. I see no one referencing & lifting up the 1000s of minority vaccine trial vol's who have already been "first". 
Who am I?
I'm in public health, am HIV+, am a minority, a vaccine trial volunteer (I signed up to participate see: https://www.positivelyaware.com/.../hiv-activists-win...), have been in clinical research's Table 1 for 18 years, and I donated a kidney to another person living with HIV.
I'm in public health, am HIV+, am a minority, a vaccine trial volunteer (I signed up to participate see: https://www.positivelyaware.com/.../hiv-activists-win...), have been in clinical research's Table 1 for 18 years, and I donated a kidney to another person living with HIV.
I think that makes me fairly trustworthy.
While having 2 year study follow-up is ideal, most people just don't know what happens in a trial and how they come to decisions to have FDA emergency use authorization when benefit > risk.
While having 2 year study follow-up is ideal, most people just don't know what happens in a trial and how they come to decisions to have FDA emergency use authorization when benefit > risk.
The reason they are able to do this science on a condensed time frame is bc a) scientific advancement over time b) unprecedented global scientific collaboration, and c) the virus is so widespread that they are able to see a difference between intervention groups a lot faster...
than if there wasn't a raging pandemic.
I will continue to be in the trial for another 21 months to give complete data.
If you're wondering about whether folks in the placebo arm will be offered vaccination once FDA emergency use authorization is granted...
I will continue to be in the trial for another 21 months to give complete data.
If you're wondering about whether folks in the placebo arm will be offered vaccination once FDA emergency use authorization is granted...
yes, that is the general idea. The question that researchers are looking at now is how to do that They can either unblind the study to see who was assigned to which arm (I had a response consistent w vaccination), and then offer directly to placebo participants; this is common.
The other option is to do what is called a crossover study to preserve the study blinding (studies are blinded to avoid knowing who got what so that participants don't act in a way that they might otherwise if they knew which intervention they got).
In the crossover study, people who were assigned the vaccine in the beginning will receive a 2-injection series of placebo, and the people in the placebo group in the beginning would now be given the 2 doses of vaccine. The follow-up would continue as usual.
Anyway, more about the mRNA vaccines (come at me for lack of jargon, that's fine, but am not here for you).
If you look at the concept of an mRNA vaccine, it is quite simple. It amounts to nothing more than a partial genetic flash card.
If you look at the concept of an mRNA vaccine, it is quite simple. It amounts to nothing more than a partial genetic flash card.
Your immune system is shown the flash card, makes antibodies in response, and the genetic material from the vaccine doesn't persist bc it is not actively replicating virus. It is not a live virus vaccine. This is a good overview graphic of what trials are out there.
^again speaking only to the mRNA vaccine candidates (Pfizer/Moderna -- I'm in the latter)
The immune response where you produce antibodies has symptoms (fever, muscle aches, fatigue) that last a day.
My exp was like this one. I call it the T-cell rally. https://www.cnn.com/videos/health/2020/12/02/moderna-coronavirus-vaccine-trial-volunteer-side-effects-gupta-pkg-lead-vpx.cnn
The immune response where you produce antibodies has symptoms (fever, muscle aches, fatigue) that last a day.
My exp was like this one. I call it the T-cell rally. https://www.cnn.com/videos/health/2020/12/02/moderna-coronavirus-vaccine-trial-volunteer-side-effects-gupta-pkg-lead-vpx.cnn
What is not known yet is how long those antibodies last. But the side effects are known (full analysis yet to be released). Now this is just one type of vax candidate; there are others that are more appropriate for people who are immunocompromised or have autoimmune conditions.
There will be two FDA meetings to discuss the trial data on December 10 (Pfizer) and 17th (Moderna - again, I am in this trial), but each vaccine candidate went through three phases of human subjects testing.
Phase I looks at the safety and side effect profile. Phase II looked at dosing. And Phase III looked at how well the vaccine worked knowing what we know about safety and an appropriate dose to produce the immune response we are looking to get.
Moderna's dose was 3x Pfizer's.
Moderna's dose was 3x Pfizer's.
I also completely get the history of mistrust in the Black and Brown communities. I think it's a real disservice that people have no idea what modern ethical safeguards are in place for clinical research because conversations about health equity are truncated at Tuskegee.
No one knows about the U.S. Public Health Service experiment in Guatemala, or the things that happened in modern bioethics subsequently. This is why I encourage people who are interested in how clin research is done to participate in non-interventional (observational) research.
I did this for 16 years before I ever joined a clinical trial. This is not to say I don't know that medicine is racist, homophobic, sexist, misogynist etc etc. I know all these things.
I participate in an informed consent process to serve as a human research subject because people like Henrietta Lacks could not. I acknowledge that medicine & public health have a lot to do to show that they are trustworthy, not just ask Black and Brown people to do the trusting.
Finally, I'mma be real:
I joined a trial bc I only have one kidney now and if I get coronavirus + kidney complications, I'm fucked y'all.
I hope me sharing some of this is helpful. (/fin)
I joined a trial bc I only have one kidney now and if I get coronavirus + kidney complications, I'm fucked y'all.
I hope me sharing some of this is helpful. (/fin)
