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CDC COVID Vaccine in Nov 2020.


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1 hour ago, RocketMan275 said:

People are going to get sick regardless of whether we do challenge testing or not.

If the reason younger people needed to mask and do social distancing was to prevent them from catching the virus and infecting their grandmothers, wouldn't it be a good idea to vaccinate the younger people?


but what if the vaccine ends up being more like the flu vaccine where it’s partially to stop people from getting sick and partially to make illness less severe. Now we have all these young people no longer following social distancing and masks since they are ‘vaccinated’ but are still catching it and becoming conteagious but the don’t realize they have it because the symptoms are so mild. But since they are ‘vaccinated’ and therefore ‘safe’ they are hanging out with grandma without distancing and without masks 

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21 hours ago, MSUjohn said:

with a young healthy test population that has no comorbidities the risk of death is VERY low. i am 40, i caught covid19 early and it was like a light cold. a large percentage of my coworkers have caught it too. 

That is just not true.  There is no way to predict which people without comorbidities will still have a tough time.  Many have had issue with strokes and other clotting disorders caused by covid.  And so many, even after having an easy infection have long term heart and organ issues.  

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56 minutes ago, sanger727 said:


but what if the vaccine ends up being more like the flu vaccine where it’s partially to stop people from getting sick and partially to make illness less severe. Now we have all these young people no longer following social distancing and masks since they are ‘vaccinated’ but are still catching it and becoming conteagious but the don’t realize they have it because the symptoms are so mild. But since they are ‘vaccinated’ and therefore ‘safe’ they are hanging out with grandma without distancing and without masks 

The problem is this: there are limits on how long one can keep these protocols in place.  The young are already catching on to the fact that they are less likely to get the virus and less likely to have adverse effects.  We'll be better off vaccinating them and maintaining social distancing from grandmothers.

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From the time a vaccine is ready it will take months to distribute. It won't be some switch that says everything is okay and we can return to normal life.  One of the reasons the cases could be higher in the younger people is that over time they couldn't social distance as much as older people. 

Even if it is approved soon (and I am for the vaccine ) there won't be any long term data available. 

Also, I am curious if this vaccine interacts with the flu vaccine as well- I wonder if that is factoring into any of the phase III trials as a different segement and /or blocking factor.

However, cruising needs to go on and resume. It's not just us the cruisers, but the workers on ships, musicians, porters and everyone else - people at corporate. 

My concern would be having to fly to a ship, get to a hotel, get to the port finally and be turned away.

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5 minutes ago, HowardK said:

From the time a vaccine is ready it will take months to distribute. It won't be some switch that says everything is okay and we can return to normal life.  One of the reasons the cases could be higher in the younger people is that over time they couldn't social distance as much as older people. 

Even if it is approved soon (and I am for the vaccine ) there won't be any long term data available. 

Also, I am curious if this vaccine interacts with the flu vaccine as well- I wonder if that is factoring into any of the phase III trials as a different segement and /or blocking factor.

However, cruising needs to go on and resume. It's not just us the cruisers, but the workers on ships, musicians, porters and everyone else - people at corporate. 

My concern would be having to fly to a ship, get to a hotel, get to the port finally and be turned away.

 

In some cases it won't take long to distribute, in the case of the Oxford Vaccine, they are so confident they are already manufacturing, if and when they get the go ahead they will have 10's of millions of doses in storage, they know it is a huge financial risk but one they have taken.

 

I can't answer your flu question but can tell you that as someone who is three months in on the Oxford vaccine trial they had no concerns with me having a flu jab last week and did not even need to record the event, they just dismissed it as "not a problem".

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27 minutes ago, ziggyuk said:

 

In some cases it won't take long to distribute, in the case of the Oxford Vaccine, they are so confident they are already manufacturing, if and when they get the go ahead they will have 10's of millions of doses in storage, they know it is a huge financial risk but one they have taken.

 

I can't answer your flu question but can tell you that as someone who is three months in on the Oxford vaccine trial they had no concerns with me having a flu jab last week and did not even need to record the event, they just dismissed it as "not a problem".

Wow... you're a participant in a vaccine trial and if it's true that you had flu vaccine the week prior and this was dismissed...does that not give you pause...at all? I do hope you were mistaken. Common sense... that's important data.

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44 minutes ago, ziggyuk said:

I can't answer your flu question but can tell you that as someone who is three months in on the Oxford vaccine trial they had no concerns with me having a flu jab last week and did not even need to record the event, they just dismissed it as "not a problem".

They are asking us Pfizer people to wait until six weeks after our second shot before we get the flu vaccine. I will be good around October 15th.

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12 minutes ago, winterbliss said:

Wow... you're a participant in a vaccine trial and if it's true that you had flu vaccine the week prior and this was dismissed...does that not give you pause...at all? I do hope you were mistaken. Common sense... that's important data.

 

I'm not mistaken I called them several weeks in advance to check I could have the flu vaccine and they had no problem, I then had a meeting 4 hours after the flu vaccine (14th September) to give a blood sample and sat down with the doctor and again he had no issue I had just had a flu vaccine.

 

It was obviously recorded by the team that administer the trial when I registered the appointment but what I'm saying is the doctor dismissed the fact I had the vaccine as "not a problem" and did not need to record it as an event which he did with a hospital appointment I have arranged for an ultrasound.

 

Not sure you got the timeline, I have the covid vaccine (or placebo) 3 months ago, I had the flu vaccine 14th September, I gave bloods and met with the doctor 4 hours after the flu vaccine.

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1 hour ago, RocketMan275 said:

The problem is this: there are limits on how long one can keep these protocols in place.  The young are already catching on to the fact that they are less likely to get the virus and less likely to have adverse effects.  We'll be better off vaccinating them and maintaining social distancing from grandmothers.


again, I’m not really for or against a challenge trial. But I respect the hurdles to one being pulled off. At the end of the day it will go before an ethics board who will look at the harm likely caused by the trial (70% of one of the test groups getting mildly sick), the worst case scenario harm of the test (someone in the challenge test getting hospitalized or dying), against the benefits of the test (getting a vaccine approved quicker that has only been tested on young and healthy people). But from an ethical standpoint, the question of what you do something that could kill someone or do nothing that could kill someone, it’s an easy choice. They didn’t cause this virus. We are mediating it with masks and social distancing; in the meantime intentionally infection someone with it who would have gotten it otherwise and then dying is worse.

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8 minutes ago, sanger727 said:


again, I’m not really for or against a challenge trial. But I respect the hurdles to one being pulled off. At the end of the day it will go before an ethics board who will look at the harm likely caused by the trial (70% of one of the test groups getting mildly sick), the worst case scenario harm of the test (someone in the challenge test getting hospitalized or dying), against the benefits of the test (getting a vaccine approved quicker that has only been tested on young and healthy people). But from an ethical standpoint, the question of what you do something that could kill someone or do nothing that could kill someone, it’s an easy choice. They didn’t cause this virus. We are mediating it with masks and social distancing; in the meantime intentionally infection someone with it who would have gotten it otherwise and then dying is worse.

How many die every day despite the mitigation?  How many die from a failure to treat treatable conditions?  How much damage is done to the economy?

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27 minutes ago, ziggyuk said:

 

I'm not mistaken I called them several weeks in advance to check I could have the flu vaccine and they had no problem, I then had a meeting 4 hours after the flu vaccine (14th September) to give a blood sample and sat down with the doctor and again he had no issue I had just had a flu vaccine.

 

It was obviously recorded by the team that administer the trial when I registered the appointment but what I'm saying is the doctor dismissed the fact I had the vaccine as "not a problem" and did not need to record it as an event which he did with a hospital appointment I have arranged for an ultrasound.

 

Not sure you got the timeline, I have the covid vaccine (or placebo) 3 months ago, I had the flu vaccine 14th September, I gave bloods and met with the doctor 4 hours after the flu vaccine.

I misread your notations. Hopefully, thorough data collection. Good luck!

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7 hours ago, zdcatc12 said:

They are asking us Pfizer people to wait until six weeks after our second shot before we get the flu vaccine. I will be good around October 15th.

 

That's another slightly different approach.

I had my second vaccine shot on 14th August and my flu shot on 14th September, no delay has ever been mentioned and they did not appear at all concerned either when I checked I could go ahead with the team or when I sat down with the doctor at my follow up bloods 28 day appointment.

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9 hours ago, RocketMan275 said:

How many die every day despite the mitigation?  How many die from a failure to treat treatable conditions?  How much damage is done to the economy?


those aren’t the right questions. There are currently 4+ drugs in phase 3 trials. One of which has already produced millions of doses in anticipation of approval. The relevant question is will this challenge trial speed up approval? By how much? And how valid will it’s results be compared to waiting for the phase 3 trials to get far enough in for early approval. 

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2 hours ago, sanger727 said:


those aren’t the right questions. There are currently 4+ drugs in phase 3 trials. One of which has already produced millions of doses in anticipation of approval. The relevant question is will this challenge trial speed up approval? By how much? And how valid will it’s results be compared to waiting for the phase 3 trials to get far enough in for early approval. 

The current testing regime relies upon random chance to expose a certain percentage of trial participants to the virus.  A challenge trial reduces  the uncertainty since it is know which participants are actually exposed.  Far fewer participants are required.  The results would be far more valid, in a shorter time frame, and result in fewer infections.

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17 hours ago, gizfish said:

That is just not true.  There is no way to predict which people without comorbidities will still have a tough time.  Many have had issue with strokes and other clotting disorders caused by covid.  And so many, even after having an easy infection have long term heart and organ issues.  

 

you are being hyperbolic. people under 50, with no comorbidities (including a previously compromised immune system) are at a VERY low risk from Covid19.

 

when you are dealing with a sample size of millions there will be some onesies and twosies.  Most people cannot truly conceive the exceptionally large numbers in a population that size.

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Food for thought.  As of 9/23, there have been a total of 353 deaths for people 15-24 years of age in the US due to Covid.

 

CDC

 

In 2018, there were 2,476 teens ages 16-19 years killed in automobile accidents in US.

 

https://www.iihs.org/topics/fatality-statistics/detail/teenagers

 

Are we really putting young people at such a great risk with challenge trials?  If those trials are so dangerous, then how do we allow teens to get into any automobile?

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20 minutes ago, GA Dave said:

Food for thought.  As of 9/23, there have been a total of 353 deaths for people 15-24 years of age in the US due to Covid.

 

CDC

 

In 2018, there were 2,476 teens ages 16-19 years killed in automobile accidents in US.

 

https://www.iihs.org/topics/fatality-statistics/detail/teenagers

 

Are we really putting young people at such a great risk with challenge trials?  If those trials are so dangerous, then how do we allow teens to get into any automobile?

 

we should note, that there is ~ 39,184, 000 in the 15 - 24 year old population.

and how many of those 353 did not have a compromised immune system or other comorbidity?

 

there is a great debate about died with covid19 vs died from covid19.

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7 hours ago, RocketMan275 said:

The current testing regime relies upon random chance to expose a certain percentage of trial participants to the virus.  A challenge trial reduces  the uncertainty since it is know which participants are actually exposed.  Far fewer participants are required.  The results would be far more valid, in a shorter time frame, and result in fewer infections.

 

I think this conversation has played itself out. Randomized controlled trials are done that way for a reason - it's good science. You compare a control group to a placebo group. A challenge trial shouldn't have a control group, because then everyone who ended up in it would just come down with covid. If you don't see the ethical challenges with intentially exposing a potentially deadly disease to otherwise healthy volunteers there's not much more to say to that. If an experiment kills a healthy volunteer it would be shut down immediately and there would be no results, just lawsuits.

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4 hours ago, GA Dave said:

Food for thought.  As of 9/23, there have been a total of 353 deaths for people 15-24 years of age in the US due to Covid.

 

CDC

 

In 2018, there were 2,476 teens ages 16-19 years killed in automobile accidents in US.

 

https://www.iihs.org/topics/fatality-statistics/detail/teenagers

 

Are we really putting young people at such a great risk with challenge trials?  If those trials are so dangerous, then how do we allow teens to get into any automobile?

 

You can't be serious. There have been 353 deaths for people 15-24 who were naturally exposed to the virus. There were thousands killed in accidental car wrecks. To compare that to a challenge trial would be like saying we are going to start using live teenagers as crash test dummies in intentional crashes. 

 

No, I think the 15-24 year group is unlikely to die in a covid vaccine challenge test. But it's bad science to use a population to test it that isn't representative of the target population. And the target population for the vaccine could die if you intentionally expose them to covid. 

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12 minutes ago, sanger727 said:

 

I think this conversation has played itself out. Randomized controlled trials are done that way for a reason - it's good science. You compare a control group to a placebo group. A challenge trial shouldn't have a control group, because then everyone who ended up in it would just come down with covid. If you don't see the ethical challenges with intentially exposing a potentially deadly disease to otherwise healthy volunteers there's not much more to say to that. If an experiment kills a healthy volunteer it would be shut down immediately and there would be no results, just lawsuits.

the point  you're missing is this: the standard randomized controlled trials also expose individuals to the virus.  I read, last week, that there is a minimum number of people who must become infected with the virus in the control group for the vaccine trials to be considered a success.  IIRC, the number was around fifty-five.  Unless this minimum number is achieved, there is no statistical reason to believe there has been exposure to the virus.  I've also read that one reason some vaccine trials fail is the lack of contact with infected persons.  There was one report that a trial had been moved, IIRC, to Brazil because of the high infection rates in that country. So, you see, we are exposing the participants to the virus even in the standard randomized control trials.

 

In the standard randomized controlled trials, we do not tell the subjects if they've received a placebo or the vaccine so there can be no real understanding of their risks.  At least in a challenge test, the person is aware of the risks.  That person knows he has received a vaccine and he knows that he is being exposed to the virus.

 

I would expect that a challenge trial would begin with those least likely to experience severe illnesses, ie, the young and health, and progress to those with higher vulnerabilities.

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2 minutes ago, RocketMan275 said:

the point  you're missing is this: the standard randomized controlled trials also expose individuals to the virus.  I read, last week, that there is a minimum number of people who must become infected with the virus in the control group for the vaccine trials to be considered a success.  IIRC, the number was around fifty-five.  Unless this minimum number is achieved, there is no statistical reason to believe there has been exposure to the virus.  I've also read that one reason some vaccine trials fail is the lack of contact with infected persons.  There was one report that a trial had been moved, IIRC, to Brazil because of the high infection rates in that country. So, you see, we are exposing the participants to the virus even in the standard randomized control trials.

 

In the standard randomized controlled trials, we do not tell the subjects if they've received a placebo or the vaccine so there can be no real understanding of their risks.  At least in a challenge test, the person is aware of the risks.  That person knows he has received a vaccine and he knows that he is being exposed to the virus.

 

I would expect that a challenge trial would begin with those least likely to experience severe illnesses, ie, the young and health, and progress to those with higher vulnerabilities.

 

No, the randomized controlled trials give half the virus and half a placebo and tell them to continue living their lives. They are not more or less exposed than they would have been without the trial. Yes, I understand the obstacles if people in the trial are not sufficient exposed to the virus, hopefully with the numbers they are using they are able to overcome that. 

 

Same issue, if you ONLY use young and health people in the challenge trial, you DO NOT know if the same dose of vaccination will be effective in elderly/unhealthy people. It could result in you coming out with a vaccine, prioritizing giving it to high risk people only to find out months later that that does did not produce the same effect in that population and your death rate skyrockets. There is no easy answer. Not even for a challenge trial.

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I signed up for the trial as did many of my neighbors.  I have not been called and I assume by comparing notes with my neighbors who were it was because I don’t have enough public exposure.   I work at home and have worked at home for years.  Neighbors were selected as they work and we are all in the same age early and pre-retirees. 

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5 hours ago, MSUjohn said:

 

you are being hyperbolic. people under 50, with no comorbidities (including a previously compromised immune system) are at a VERY low risk from Covid19.

 

when you are dealing with a sample size of millions there will be some onesies and twosies.  Most people cannot truly conceive the exceptionally large numbers in a population that size.

While they may be at low risk of death, you are ignoring the fact that they are not at "VERY" low risk for a difficult illness, possibly requiring hospitalization, not to mention the fact that many have long term issues/organ damage due to an infection of Covid, even if they had an "easy" case.  

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Regardless of what anyone thinks of the timing of these vaccines: the US, Russian, UK or the Chinese version, the cruise lines are going to require them to sail for the foreseeable future and are going to use their acceptance by the governments and governmental entities as their right to sail.   If you don’t want a vaccine then you won’t be sailing in 2021.   
 

 

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