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Follow My Journey as a Moderna Phase 3 COVID-19 Vaccine Participant

amy241

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mish

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I have been selected participate in the NIH/Moderna Phase 3 clinical trials for the new vaccine. At age 59 with an auto-immune disease, I am considered high risk for serious complications with Covid-19. I was contacted yesterday morning for pre-screening and then sent on to scheduling. They are specifically looking for first responders, teachers, and high risk individuals.

I will be receiving the first vaccine on August 3rd at a 3 hour appointment. I know they will do a nasal swab and antibody blood test at that visit to make sure I do not have an active infection and have not had the disease. My second injection will take place 28 days later. The study involves 7 visits over a 2 year period. After both vaccines are received, I am assuming the follow up visits are more about checking levels of antibodies through blood tests, etc.

I live in sunny, south Florida - specifically, Palm Beach County (think epicenter of the world). Moderna is doing a huge rollout in south Florida in Palm Beach County and Dade County (Miami) due to the skyrocketing presence of the virus here.

Assuming I am not subject to any sort of confidentiality agreement about this, I will be posting on my experience here. Or I will post as much as I can.
I pray for all those going through the trials and I have faith you will successfully develop an antibody! I look forward to following your journey.
 

smmatrix

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Are you getting compensated for participating in the test? I heard they got $2,000,000,000 to develop a vaccine. That's two billion dollars! Also, if anything goes wrong, are they accepting liability? Or, did you have to sign waivers to hold them harmless?
 

smmatrix

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It's fascinating they're coming out with a vaccine so quickly. I mean they've been working on a vaccine for HIV for 40 years, and still nothing. Tuberculosis which is far more contagious and deadly, killing 1.5 million people each year, and working on that vaccine for many many decades, but with Covid, it's coming out in mere months. Interesting!
 

T_R_Oglodyte

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I’m interested in finding a cure for Covid. Do you have to sign a waiver if you have adverse reactions or come down with Covid during the trials? Is this part of the information that you fill out? I want to know because I’m in high risk age group and have been trying to stay healthy.
The look at the profiles and information provided by people who have signed up and create the cohort groups from those. They don't ask you to change your behavior in any way. The objective of the study is to create two populations that mimic each other in susceptibility, risk factors, exposure pathways, etc. Then the groups are given either the vaccine or a placebo. The participant doesn't know which group they are in, nor do the health care workers that track the patients and provide medical care. (That's what a double-blind study requires.) The only people who know which people received vaccine and which received placebos are the directors of the study, and they are not involved in collecting any information or providing any participant services.

So there is almost no added risk to you for participating in the study. The worst case is that you get the placebo, and that's the same as what you now have now (discounting any placebo effect). The upside is that you get a vaccine that is effective.

The larger issue that may be relevant for you is that with this type of study design, they want to pick people who higher potential exposures to the virus. So they tend to select people who participate in activities that have a higher likelihood of transmission.
 

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amy241

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Are you getting compensated for participating in the test? I heard they got $2,000,000,000 to develop a vaccine. That's two billion dollars! Also, if anything goes wrong, are they accepting liability? Or, did you have to sign waivers to hold them harmless?
As to compensation, see post #72 above.

You sign an Informed Consent that spells out all your rights and duties as a participant in the study.
 

BarbmC

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Thank you so much for being part of this trial. You are a hero!
 

Carolgold1

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I have been selected participate in the NIH/Moderna Phase 3 clinical trials for the new vaccine. At age 59 with an auto-immune disease, I am considered high risk for serious complications with Covid-19. I was contacted yesterday morning for pre-screening and then sent on to scheduling. They are specifically looking for first responders, teachers, and high risk individuals.

I will be receiving the first vaccine on August 3rd at a 3 hour appointment. I know they will do a nasal swab and antibody blood test at that visit to make sure I do not have an active infection and have not had the disease. My second injection will take place 28 days later. The study involves 7 visits over a 2 year period. After both vaccines are received, I am assuming the follow up visits are more about checking levels of antibodies through blood tests, etc.

I live in sunny, south Florida - specifically, Palm Beach County (think epicenter of the world). Moderna is doing a huge rollout in south Florida in Palm Beach County and Dade County (Miami) due to the skyrocketing presence of the virus here.

Assuming I am not subject to any sort of confidentiality agreement about this, I will be posting on my experience here. Or I will post as much as I can.
 

amy241

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I officially began the vaccine study yesterday and received my first vaccine injection after a COVID 19 nasal swab and COVID antibody blood draw. Unfortunately, in reviewing the 22 page informed consent, it states:

“If you participate in this study, you should feel free to discuss the study with your family and with other people who are close to you. It is recommended to tell your health care provider about your participation in the study. However, to help make sure that the information from the study is as accurate and reliable as possible, please do not discuss information about the study in public places while the study is in progress. Public places include things like social media (Facebook, Instagram, Twitter), blogging, and speaking to the media.“

Consequently, I will not be able to share my experience fully as I had hoped. However, I do plan to continue sharing information for participating in these vaccine studies as it is just so important.
 

amy241

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If anyone is interested in participating in the Pfizer vaccine trial, you may submit your information below. Click on the Get Started button. It will reveal to you the locations nearest to your zip code.

 

Luanne

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If anyone is interested in participating in the Pfizer vaccine trial, you may submit your information below. Click on the Get Started button. It will reveal to you the locations nearest to your zip code.

I went in because I was interested to see if there were any locations near me. But in order to get the information I would have to fill out my name and contact info. I didn't do that as I really don't think I want to participate and I didn't want to get follow up communications (don't know if I would, but if they are capturing that info you never know).
 

bluehende

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If anyone is interested in participating in the Pfizer vaccine trial, you may submit your information below. Click on the Get Started button. It will reveal to you the locations nearest to your zip code.

Thanks for the link. Unfortunately no where within a couple hundred miles from me. Hopefully they open more sites.
 

travelpager

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I officially began the vaccine study yesterday and received my first vaccine injection after a COVID 19 nasal swab and COVID antibody blood draw. Unfortunately, in reviewing the 22 page informed consent, it states:

“If you participate in this study, you should feel free to discuss the study with your family and with other people who are close to you. It is recommended to tell your health care provider about your participation in the study. However, to help make sure that the information from the study is as accurate and reliable as possible, please do not discuss information about the study in public places while the study is in progress. Public places include things like social media (Facebook, Instagram, Twitter), blogging, and speaking to the media.“

Consequently, I will not be able to share my experience fully as I had hoped. However, I do plan to continue sharing information for participating in these vaccine studies as it is just so important.
I understand this, but thank you nevertheless for *having been willing otherwise* to share your journey here.
 

LAX Mom

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Thanks for the update Amy. Even though we won't be receiving additional information about your experience, we'll be thinking of you. I hope you have a positive experience and that this study helps to identify a vaccine that will protect millions of people.
Thank you for helping the cause.
 

amy241

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Thanks for the link. Unfortunately no where within a couple hundred miles from me. Hopefully they open more sites.
Did you look at all the Moderna locations listed in an earlier post? They have some 89 locations statewide.
 

amy241

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Planning for distribution of a new Covid19 vaccine is triggering debate as to who should get it first. There is, however, some support that those who participated in clinical trials but received a placebo should be included in the priority distribution:

“But Collins tossed new ideas into the mix: Consider geography and give priority to people where an outbreak is hitting hardest.

And don’t forget volunteers in the final stage of vaccine testing who get dummy shots, the comparison group needed to tell if the real shots truly work.

“We owe them ... some special priority,” Collins said.“



 

pedro47

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I feel meeting single individuals is difference from 30 to 40 years ago.
I did not use the words dating , or male or females friends. My grandkids, told me those terms were not used anymore.
 

amy241

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More support for prioritization of vaccine distribution to persons involved in clinical trials:


Who should get the vaccine first?

Public health officials pulled together a panel of outside scientists and ethicists saddled with developing an “equitable” framework for how the first doses of a coronavirus vaccine should be distributed, Reuters reported.

The panel is expected to announce its recommendation early this fall, according to the Mercury News.

National Institute of Health Director Dr. Francis Collins told the panel — which includes experts from the National Academy of Medicine and the National Academies of Sciences, Engineering and Medicine — to consider prioritizing healthcare workers, military personnel and other essential frontline workers in areas of the country hardest hit by the pandemic, according to Reuters.

He also directed their focus to people who volunteered for vaccine testing, but received placebo shots, the outlet reported.

“This is going to be controversial,” he told the panel, according to the outlet. “Not everybody’s going to like the answer. There will be many people who feel that they should have been at the top of the list, and not everybody can be.”



 

Finsadbel

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Everyone will have some sort of self induced priority.

If we are throwing our own opinions out there, I would prioritize these populations:

At risk
Healthcare/essential workers
Volunteers that received placebo (we owe them)

Just my opinion......
 

amy241

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Everyone will have some sort of self induced priority.

If we are throwing our own opinions out there, I would prioritize these populations:

At risk
Healthcare/essential workers
Volunteers that received placebo (we owe them)

Just my opinion......
I agree although I think healthcare/first responders need to be first and then at risk folks. The reason for this is that at risk folks can shelter in place but healthcare/first responders are in the trenches.

I was at least encouraged that even if all I received was a placebo, I may get some preference when an approved vaccine does emerge. And I was hoping this news may encourage others to participate in a clinical trial.
 

Finsadbel

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I was only listing populations, not order. I shoulda put that out there.
 

AnnaS

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I officially began the vaccine study yesterday and received my first vaccine injection after a COVID 19 nasal swab and COVID antibody blood draw. Unfortunately, in reviewing the 22 page informed consent, it states:

“If you participate in this study, you should feel free to discuss the study with your family and with other people who are close to you. It is recommended to tell your health care provider about your participation in the study. However, to help make sure that the information from the study is as accurate and reliable as possible, please do not discuss information about the study in public places while the study is in progress. Public places include things like social media (Facebook, Instagram, Twitter), blogging, and speaking to the media.“

Consequently, I will not be able to share my experience fully as I had hoped. However, I do plan to continue sharing information for participating in these vaccine studies as it is just so important.
Thank you for the update. Look forward to anything you can share with us.
 

x3 skier

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Finally got a follow up questionnaire from the medical center about being a vaccine trial volunteer. I’ll be waiting again for another communication. This seems to be a pretty needlessly long process for something that is of great urgency. This first screening was very simple, age, health, conditions etc. One would think they could have sorted it quickly to proceed with winnowing the candidates down to the 500 required. OTOH, the medical profession is not noted for working to a firm schedule.

Cheers
 
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