Have there been any deaths of those in vaccine trials?

[coffeebean]

The following comment is from a poster in another thread. I would have responded to this poster but that thread was CLOSED by the time I read it.........

Originally Posted by sooziesoul
You do realize that some people on which the vaccine has been tested, have died. I’ll let others try it first.

Responding to the above post.......
I have heard of vaccine trials being put on hold twice because of adverse reactions.Those trials resumed shortly after.

I have not heard that people have died from the vaccine during trials. I have heard of one 28 year old man (who was a physician who was in contact with Covid patients) who participated in the vaccine trials who died. It was established that he was not receiving the vaccine but the placebo. The cause of his death was from complications of Covid-19.

Article here.......
28-year-old volunteer in AstraZeneca COVID-19 vaccine trial dies | Healthcare Finance News (https://www.healthcarefinancenews.com/news/28-year-old-volunteer-astrazeneca-covid-19-vaccine-trial-dies)

[Two Bills]

I am pretty sure you will get a lot more dubious/fake reports from the anti-vaccine brigade, before researchers finally find an effective one.
Personally I will take the first marketed, proven vaccine, as soon as available.

[Altavia]

The following comment is from a poster in another thread. I would have responded to this poster but that thread was CLOSED by the time I read it.........

Originally Posted by sooziesoul
You do realize that some people on which the vaccine has been tested, have died. I’ll let others try it first.

Responding to the above post.......
I have heard of vaccine trials being put on hold twice because of adverse reactions.Those trials resumed shortly after. Fingers crossed...

I have not heard that people have died from the vaccine during trials. I have heard of one 28 year old man (who was a physician who was in contact with Covid patients) who participated in the vaccine trials who died. It was established that he was not receiving the vaccine but the placebo. The cause of his death was from complications of Covid-19.

Article here.......
28-year-old volunteer in AstraZeneca COVID-19 vaccine trial dies | Healthcare Finance News (https://www.healthcarefinancenews.com/news/28-year-old-volunteer-astrazeneca-covid-19-vaccine-trial-dies)

Anyone who becomes ill for any reason is an adverse event (not reaction) Not aware of anything so far traced to a vaccine. Adverse reaction at time of injection would bring things to a screaching halt. Clinical studies indicate People are reporting similar reactions as to a flu vaccine after injection.

The perfect is the enemy of the good. A vaccine that saves 10,000 people from a disease but risks 1 adverse reaction due the the vaccine is an acceptable risk for me.

Disclosure, I am a participant in a vaccine trial so my bias is clear. Early results show initial safety and effecacy hurdles of the protocol have been met as the studies continues.

[coffeebean]

Anyone who becomes ill for any reason is an adverse event (not reaction) Not aware of anything so far traced to a vaccine. Adverse reaction at time of injection would bring things to a screaching halt. Clinical studies indicate People are reporting similar reactions as to a flu vaccine after injection.

The perfect is the enemy of the good. A vaccine that saves 10,000 people from a disease but risks 1 adverse reaction due the the vaccine is an acceptable risk for me.

Disclosure, I am a participant in a vaccine trial so my bias is clear. Early results show initial safety and efficacy hurdles of the protocol have been met as the studies continues.
Many thanks to you for participating in the vaccine trials.

[PugMom]

Many thanks to you for participating in the vaccine trials.

the story i read was a person from Europe who was involved in the trial died. it was discovered the person was given a placebo, therefore not treating his illness. i think it was the Daily Mail or Telegraph reporting

[blueash]

Covid-19 vaccine volunteer in Brazil's AstraZeneca trial dies - CNN (https://www.cnn.com/2020/10/21/health/covid-19-vaccine-trial-brazil-astrazeneca-death-bn/index.html)

Death in Brazil, no details released other than it will not result in any stopping of the vaccine trial. Read the article for a further discussion of the reasons.

[camaguey48]

Anyone who becomes ill for any reason is an adverse event (not reaction) Not aware of anything so far traced to a vaccine. Adverse reaction at time of injection would bring things to a screaching halt. Clinical studies indicate People are reporting similar reactions as to a flu vaccine after injection.

The perfect is the enemy of the good. A vaccine that saves 10,000 people from a disease but risks 1 adverse reaction due the the vaccine is an acceptable risk for me.

Disclosure, I am a participant in a vaccine trial so my bias is clear. Early results show initial safety and effecacy hurdles of the protocol have been met as the studies continues.
Rizalina Ramos-Talag
When folks decide to:
STRADDLE THE VIRUS

Like accomplished geniuses, trained to the highest degree
They perfected the art of instilling fear for the world to see;
The melody resounded, though abysmal – lacking rhythm or grace
Reminiscent of requiem music captured solemnly in space.
The world saw the danger this man-made concoction would cause
It dictated when streets can be populated -- when activities are paused.
Virtual debates become the norm -- voting by mail is mandatory;
Closing all schools, churches, work areas – distancing is obligatory.
The odd part is they straddled the virus to control a nation
And powerfully projected utter dismay and total destruction.
Economic indicators should have gone down – but stayed strong
A leader united this nation – forging ahead, standing tall all along.
Straddling the virus will continue on through election time
Then these same folks unmask again --- singing “auld lang syne”.

[tedquick]

My wife and I are involved in the 3rd phase of the Moderna vaccine trials. The day after my second shot, which was approximately 3 weeks ago, I developed a fever and some aches and pains. I told my wife I was going to sleep in another bedroom that night and not to get close to me, as while I was guessing it was from the shot, she has heart and lung issues so I didn't want her to get too close, just in case. At about 4:00 A.M. my fever broke. By morning I was feeling completely normal again. A week later we went elsewhere to get anti-body testing and I had strong anti-bodies for Covid. I obviously got the real thing but unfortunately my wife got the placebo. While I am happy that I am now protected I really wish that she were the one to have gotten the protection. So I am now both fairly happy for me but really sad for my wife. As Americans I think we should do our part. These studies are well controlled and I think quite safe. As aside, they are also almost fun to do. :)

[golfing eagles]

Have there been any deaths of those in vaccine trials?

There are always deaths in any vaccine or drug trial. It's the job of the researchers to determine if the death was DUE TO the vaccine/drug, or INCIDENTAL to it.
A lot of this is determined by the study design as well.

[Cbrown4399]

Thank you for volunteering! More people volunteering, the faster they trials finish! I work in the Pharma industry so was excited to hear your story. THANK YOU!!

[thelegges]

Thank you for volunteering! More people volunteering, the faster they trials finish! I work in the Pharma industry so was excited to hear your story. THANK YOU!!

Not how trials work. Once chosen, the group is fixed. The volunteering is done with the pharmaceutical with vaccine. Only way to add more volunteers is a new pharm, or new age group.

[golfing eagles]

Not how trials work. Once chosen, the group is fixed. The volunteering is done with the pharmaceutical with vaccine. Only way to add more volunteers is a new pharm, or new age group.

Say WHAT????? I must not be reading the post correctly, because it makes no sense.

Most drug trials start with a sufficient number of volunteers that are randomized into a treatment group and a control (placebo) group, these groups are unknown to the researchers and the patients (double blinded). If the study is done at several different centers, all the better. The groups are matched generally for age, co-morbidities, sex, and habits. There are always participants that drop out for whatever reason. Patients are asked to reveal any potential "side effects", anything that is different in their lives. Then, the results are compared to the original proposition----such as does this vaccine prevent COVID or does this drug lower blood pressure, and how well.
What I just described is the Phase 3 trial, phase 1&2 is solely to determine dosing and potential side effects.

That's how this works, in theory. However, having run a bunch of these trials, I can state that the tendency among some participants is to tell the researchers what they want to hear, not what they actually are experiencing.

[Altavia]

My wife and I are involved in the 3rd phase of the Moderna vaccine trials. The day after my second shot, which was approximately 3 weeks ago, I developed a fever and some aches and pains. I told my wife I was going to sleep in another bedroom that night and not to get close to me, as while I was guessing it was from the shot, she has heart and lung issues so I didn't want her to get too close, just in case. At about 4:00 A.M. my fever broke. By morning I was feeling completely normal again. A week later we went elsewhere to get anti-body testing and I had strong anti-bodies for Covid. I obviously got the real thing but unfortunately my wife got the placebo. While I am happy that I am now protected I really wish that she were the one to have gotten the protection. So I am now both fairly happy for me but really sad for my wife. As Americans I think we should do our part. These studies are well controlled and I think quite safe. As aside, they are also almost fun to do. :)

That's great news, early results from the RNA vaccines sound encouraging fingers crossed.

I received a Placebo in the Pfizer trial but hopefully the control group will get access to the real thing early.

[Altavia]

Say WHAT????? I must not be reading the post correctly, because it makes no sense.

Most drug trials start with a sufficient number of volunteers that are randomized into a treatment group and a control (placebo) group, these groups are unknown to the researchers and the patients (double blinded). If the study is done at several different centers, all the better. The groups are matched generally for age, co-morbidities, sex, and habits. There are always participants that drop out for whatever reason. Patients are asked to reveal any potential "side effects", anything that is different in their lives. Then, the results are compared to the original proposition----such as does this vaccine prevent COVID or does this drug lower blood pressure, and how well.
What I just described is the Phase 3 trial, phase 1&2 is solely to determine dosing and potential side effects.

That's how this works, in theory. However, having run a bunch of these trials, I can state that the tendency among some participants is to tell the researchers what they want to hear, not what they actually are experiencing.

Exactly.

The people running the participant part of the trials were working 12 hour days 7 days a week to get things started as quickly as possible.

They gave us an app to report in any symptoms weekly.

[Altavia]

Here's a nice synthesis of what the COVID vaccine trials currently look like,

What a Successful Vaccine Trial Looks Like - The Atlantic (https://www.theatlantic.com/health/archive/2020/10/what-successful-vaccine-trial-looks-like/616775/)

[PugMom]

The following comment is from a poster in another thread. I would have responded to this poster but that thread was CLOSED by the time I read it.........

Originally Posted by sooziesoul
You do realize that some people on which the vaccine has been tested, have died. I’ll let others try it first.

Responding to the above post.......
I have heard of vaccine trials being put on hold twice because of adverse reactions.Those trials resumed shortly after.

I have not heard that people have died from the vaccine during trials. I have heard of one 28 year old man (who was a physician who was in contact with Covid patients) who participated in the vaccine trials who died. It was established that he was not receiving the vaccine but the placebo. The cause of his death was from complications of Covid-19.

Article here.......
28-year-old volunteer in AstraZeneca COVID-19 vaccine trial dies | Healthcare Finance News (https://www.healthcarefinancenews.com/news/28-year-old-volunteer-astrazeneca-covid-19-vaccine-trial-dies)

thx much! that was the story i was referring to, but couldn't remember where i saw it. good find, oxo

[PennBF]

I heard a well known Dr on TV respond to a question which was how confident can we be
when we see the statistics on Covid-19 deaths. His response was that when a patient
passes away who had multiple serious problems including the Coivd-19 virus it is, in a
lot of cases hard to identify the true reason for the death. And in most cases the reason is
recorded as the Virus but that may or may not have been the direct cause of death? :popcorn:

[Dcommuter]

Of all the company releasing vaccine, Moderna is the one I would not take. Just my own opinion. I think modern stands for modified RNA. Maybe sounds crazy on my part but this is the only one I would not get my vaccine. I had my flu shots recently and I have sore arms afterward being injected never had any problems when I had my flu shots every other year. Just sharing my thought and experience.

[chet2020]

Covid-19 vaccine volunteer in Brazil's AstraZeneca trial dies - CNN (https://www.cnn.com/2020/10/21/health/covid-19-vaccine-trial-brazil-astrazeneca-death-bn/index.html)

Death in Brazil, no details released other than it will not result in any stopping of the vaccine trial. Read the article for a further discussion of the reasons.

I work in the clinical trial industry. The speed at which the trial was resumed has led many in the industry to speculate that the subject who died was in the placebo group. This has not been confirmed by any AstraZeneca source.

[ChgoGal]

the story i read was a person from Europe who was involved in the trial died. it was discovered the person was given a placebo, therefore not treating his illness. i think it was the Daily Mail or Telegraph reporting

I spoke with friends in London. The Moderna trial was halted for one week because one of the participants (a female) developed a spinal infection. They went back to trials in one week which suggests that the participant was a control patient.

The second trial halted was in South America. Again the trial has resumed after identification of the participant. Again suggesting the participant was a patient in the control group.

Because of the concerns from anti-vaxers here in America, the trials are going very slow here.

[Velvet]

Given how significant the implications are, the very least a Covid trials company should do is identify immediately whether the person who reacted very badly was in the placebo group or not. Within 24 hours they should publish that information especially if the person was in the placebo group. When they do not let us even know that, they lose many many people’s confidence in whatever they say later.

[golfing eagles]

Given how significant the implications are, the very least a Covid trials company should do is identify immediately whether the person who reacted very badly was in the placebo group or not. Within 24 hours they should publish that information especially if the person was in the placebo group. When they do not let us even know that, they lose many many people’s confidence in whatever they say later.

Why on God's green Earth would a pharmaceutical company conducting phase 3 trials of a vaccine make preliminary, unconfirmed, mid-study results publicly available, especially isolated cases of death of unknown causality? 99.9% of the public would have no idea how to interpret the data and would draw erroneous conclusions. Might as well give a suicidal person a loaded gun

[Velvet]

When the pharmaceutical company pauses a trial, many people hold their breaths. They don’t have to give much details, but the company could quickly say that the person they paused the trial for got the placebo or the vaccine. I believe they must know this. That’s all I’m asking for. Lack of transparency invites distrust.

[golfing eagles]

When the pharmaceutical company pauses a trial, many people hold their breaths. They don’t have to give much details, but the company could quickly say that the person they paused the trial for got the placebo or the vaccine. I believe they must know this. That’s all I’m asking for. Lack of transparency invites distrust.

First of all, a pharmaceutical company is not a public entity---they have no requirement to be "transparent" (although their competition would love the idea)

When someone in the placebo group dies, it clearly is not from the vaccine. When someone in the treatment group dies, it is usually NOT from the vaccine either, but most of the public would assume that it is. Many people , there and then, would decide that they will never take the vaccine, defeating the whole purpose of a vaccination program. What if treatment group deaths from the polio vaccine were made public? Or smallpox? In that case I think we would have a much bigger infectious disease problem than COVID.

[Velvet]

You are right as usual, GE, I wasn’t thinking of the competition either.

[Dr Winston O Boogie jr]

People that volunteer for those studies do so with the full knowledge that they may get sick or even die.

Many people do it for the money as they are almost all compensated. They are thoroughly screen to ensure that they are healthy enough.

The point is that they volunteer knowing the risks.

We don't even know that this one person that died while participating in the study died as a result of the vaccine.

If you disagree with these studies, how would you suggest that the vaccines are tested prior to being made available to the general public?

Every medication that is currently on the market has been tested on human being prior to being approved. The primary purpose of the test is not to determine efficacy but rather safety. Does anyone ever question whether or not people died in studies for other medications?

[Altavia]

Of all the company releasing vaccine, Moderna is the one I would not take. Just my own opinion. I think modern stands for modified RNA. Maybe sounds crazy on my part but this is the only one I would not get my vaccine. I had my flu shots recently and I have sore arms afterward being injected never had any problems when I had my flu shots every other year. Just sharing my thought and experience.

RNA vaccines have many potential advantages, comparison is not so simple at this point.

https://massivesci.com/articles/mrna-vaccine-covid19-coronavirus-moderna/

From adenoviruses to RNA: the pros and cons of different COVID vaccine technologies (https://theconversation.com/from-adenoviruses-to-rna-the-pros-and-cons-of-different-covid-vaccine-technologies-145454)