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Are vaccines the light at the end of the tunnel?

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3 hours ago, K.T.B. said:

 

60% is better than expected.  The expected was 50%.  Under the circumstances, it's pretty amazing.

Kevin- go back to post 1138 if you have not watched the video.  That was not what Fauci said.

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18 hours ago, dreaminofcruisin said:

 

There used to be one on the Princess board that started about the same time as this one. I was reading on both of them at the time. Unfortunately, the Princess one got shut down because it suddenly became political. 

☹️  Hopefully, this one can keep from having that happen. It's such a wonderful source of information. Thanks to everyone, especially those of you who have experience with vaccines / drugs in the 'real' world. 

This thread was started by Ken in early July and now has well over 1100 posts!  Although it is quite difficult sometimes to not react to the vaccine political situation (in the US mainly), the posters here have been remarkably apolitical and have focused on science and data and how it relates to return to normalcy in cruising.  Occasionally if a poster goes off track politically everybody else politely reminds them of the rules and the potential for this valuable discussion thread to get shut down.  So far this has worked.  I think that If other like-minded individuals from other discussion boards on CC want to join us we would welcome them openly.  At least in my view as I don't want to speak for everybody else.

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I have been seeing many comments about the different phases of a clinical drug trial on this forum and others here on cruise critic. For those who need a layman's guide to the phases, here one is: 

 

https://www.fda.gov/patients/clinical-trials-what-patients-need-know/what-are-different-types-clinical-research

 

For those who like to throw out emergency use authorization for the vaccines, here is the actual regulatory requirements and background (written from a regulatory professional viewpoint): 

 

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

Edited by Homosassa

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One piece of bad news with the antibody trials.

 

Just heard that Lilly has decided to terminate one of its antibody trials early due to lack of response.

 

This was the trial for COVID patients with serious symptoms in the hospital.

 

Other trials for other stages are continuing.

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15 hours ago, Homosassa said:

I have been seeing many comments about the different phases of a clinical drug trial on this forum and others here on cruise critic. For those who need a layman's guide to the phases, here one is: 

 

https://www.fda.gov/patients/clinical-trials-what-patients-need-know/what-are-different-types-clinical-research

 

For those who like to throw out emergency use authorization for the vaccines, here is the actual regulatory requirements and background (written from a regulatory professional viewpoint): 

 

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

Homosassa have you looked at any of the Vaccine advisory committee meeting?

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8 hours ago, nocl said:

Homosassa have you looked at any of the Vaccine advisory committee meeting?

Yes, I am working my way through them.

 

I do have to be careful in my posts because I need to make sure anything I say is publicly  available  and not something I was told in my FDA retiree grapevine. 

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1 hour ago, BigAl94 said:

Let's discuss this a bit here.  This report shows antibody waning several months after natural infection.  This has been continuously reported and is well documented now.  So what might this mean for us?  Is it a really bad outcome?  Maybe we should be worried but let's consider:

 

- Antibody responses from natural infection can wane over time,  but re-exposure to the antigen (virus) might bring back antibodies vigorously as the immune system was already primed.  This is a foundational for how our immune system works.

 

- There is more and more evidence with this virus that various types of T-Cells and B-Helper and T-Helper Cells play a key role in controlling the virus, as they do in most viral infections since the virus replicates within host cells.  Again foundational to how our immune system responds.  This alone might explain why 40% of the population is asymptomatic after viral exposure.  These folks perhaps mount T-Cell responses based on similarities to other corona viruses they have been exposed to.  Also the T-Cell response from younger people who have received MMR vaccine might be protecting them too.  Some overlapping sequences between these viruses.  Large clinical study (30,000 subjects) testing this concept.

 

- Finally- the immune responses (T-Cells and antibodies) from vaccine -acquired immunity will not necessarily wane in the same way as from natural infection.  Most vaccine protocols being currently studied are prime-boost two shots.  Very high antigen doses as compared to natural infection.  And the second shot (boost) makes a big difference.

 

So we shall see.

 

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I wasn't sure if I should post this since it isn't regarding a vaccine but I found it fascinating enough to do so regardless.  A nasal spray that keeps COVID from being expelled from the nose for 6 hours.  Possible use for restaurants etc (cruises?).  I think it is a little pie in the sky but since people on this thread seem to enjoy reading about such technologies I figured "Why not?".

https://www.fastcompany.com/90565565/i-tested-a-harvard-designed-nasal-spray-to-help-stop-the-spread-of-covid-19

 

M

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3 hours ago, mimbecky said:

I wasn't sure if I should post this since it isn't regarding a vaccine but I found it fascinating enough to do so regardless.  A nasal spray that keeps COVID from being expelled from the nose for 6 hours.  Possible use for restaurants etc (cruises?).  I think it is a little pie in the sky but since people on this thread seem to enjoy reading about such technologies I figured "Why not?".

https://www.fastcompany.com/90565565/i-tested-a-harvard-designed-nasal-spray-to-help-stop-the-spread-of-covid-19

 

M

Very interesting!  If people are balking now about wearing a mask onboard, can you just imagine how they would react if they had to show up several times a day onboard to get their nose squirted!  OMG.  

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3 hours ago, mimbecky said:

I wasn't sure if I should post this since it isn't regarding a vaccine but I found it fascinating enough to do so regardless.  A nasal spray that keeps COVID from being expelled from the nose for 6 hours.  Possible use for restaurants etc (cruises?).  I think it is a little pie in the sky but since people on this thread seem to enjoy reading about such technologies I figured "Why not?".

https://www.fastcompany.com/90565565/i-tested-a-harvard-designed-nasal-spray-to-help-stop-the-spread-of-covid-19

 

M

Don't take this articles at face value. Digging a little deeper into both the actual report that was published in an open access journal (google the journal and check out the requirements for publication and the vague mention of "peer review" by the journal and the very loose standards of institutional review board review before submission), the very limited "clinical trials" (92 subjects total), no specifics on the "particles" being counted, and other vague statements in the "research" article raises  the product to the realm of "quack" product.

 

Another big tip off is the fact that the product is being sold through the "health and wellness" markets; i.e., a careful skirting of medical claims that would require a tightly controlled clinical trial and oversight, at least here in the USA, by the FDA.

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5 hours ago, TeeRick said:

Let's discuss this a bit here.  This report shows antibody waning several months after natural infection.  This has been continuously reported and is well documented now.  So what might this mean for us?  Is it a really bad outcome?  Maybe we should be worried but let's consider:

 

- Antibody responses from natural infection can wane over time,  but re-exposure to the antigen (virus) might bring back antibodies vigorously as the immune system was already primed.  This is a foundational for how our immune system works.

 

- There is more and more evidence with this virus that various types of T-Cells and B-Helper and T-Helper Cells play a key role in controlling the virus, as they do in most viral infections since the virus replicates within host cells.  Again foundational to how our immune system responds.  This alone might explain why 40% of the population is asymptomatic after viral exposure.  These folks perhaps mount T-Cell responses based on similarities to other corona viruses they have been exposed to.  Also the T-Cell response from younger people who have received MMR vaccine might be protecting them too.  Some overlapping sequences between these viruses.  Large clinical study (30,000 subjects) testing this concept.

 

- Finally- the immune responses (T-Cells and antibodies) from vaccine -acquired immunity will not necessarily wane in the same way as from natural infection.  Most vaccine protocols being currently studied are prime-boost two shots.  Very high antigen doses as compared to natural infection.  And the second shot (boost) makes a big difference.

 

So we shall see.

 

So true and well explained.

We will not know for certain what the final immune responses and the durability of immunity to either infection or vaccination for awhile (a few years). There will need to be antibody studies and perhaps even studies of T-cell immunity in vaccinated and non-vaccinated individuals. Tracking possible re-infections and the rate of severe illness and comparing it to first virus exposure - it is very possible, maybe likely at this point that first infection lessens the likelihood of severe illness with a repeat infection, but doesn't prevent re-infection. Then it will be important to know how common re-infection is and how contagious people are with a second infection - in other words - if you have Covid once, what are your chances of getting it again and passing on the virus, and how sick can it make you the second time you get it.

 

What we are losing sight of is that the most recent vaccines we have developed have been to better understood viruses or bacteria (HIB) so we knew the answers to some of these questions as we were making the vaccine.

If it wasn't for all the knowledge that people like TeeRick and Homossassa and some other very smart people who have been answering questions have amassed over the years, we would have no possibility of making a vaccine to a significant viral illness in a year

 

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Not vaccine, but this is where most of this has gone. Depending on the release, Lilly and/or NIAID, which was funding the work, has ended their clinical trial of a monoclonal antibody preparation, bamlanivimab, in hospitalized patients for lack of evidence of effect. Lilly is still studying the therapy in mild to moderate cases.

 

Editorially, I suspect mABs are more likely to be effective early anyway. As others have mentioned, once you get enough viral replication and inflammation, the pathology is mostly caused by the body's response, not the virus.

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59 minutes ago, markeb said:

Not vaccine, but this is where most of this has gone. Depending on the release, Lilly and/or NIAID, which was funding the work, has ended their clinical trial of a monoclonal antibody preparation, bamlanivimab, in hospitalized patients for lack of evidence of effect. Lilly is still studying the therapy in mild to moderate cases.

 

Editorially, I suspect mABs are more likely to be effective early anyway. As others have mentioned, once you get enough viral replication and inflammation, the pathology is mostly caused by the body's response, not the virus.

Haven't kept up with this too much, is that an antibody to a Covid component or to interleukin or some other immune response component?

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