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Are vaccines the light at the end of the tunnel?


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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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3 hours ago, cangelmd said:

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?

 

It's a monoclonal directed at the SPIKE protein. Same theory as natural infection and the vaccine candidates..

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Some Interesting research expected to be published soon. In a substantial number of serious cases the immune system generates autoantibodies that attack the host itself. Similar to what happens in some autoimmune disease.

 

There is some thought that this autoimmune reaction may be the cause of the long haulers.

 

Currently traveling. Will dig up the reference to the research when I get home on Friday.

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25 minutes ago, nocl said:

Some Interesting research expected to be published soon. In a substantial number of serious cases the immune system generates autoantibodies that attack the host itself. Similar to what happens in some autoimmune disease.

 

There is some thought that this autoimmune reaction may be the cause of the long haulers.

 

Currently traveling. Will dig up the reference to the research when I get home on Friday.

There were already cases of people getting sick 2 or even three times from covid. I have no idea what kind of research is that but what I know for sure is that people can keep getting ill with Covid19. Its the truth that we are facing today 

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1 hour ago, Roger88 said:

There were already cases of people getting sick 2 or even three times from covid. I have no idea what kind of research is that but what I know for sure is that people can keep getting ill with Covid19. Its the truth that we are facing today 

this is not about immunity and reinfection, it is about covid triggering autoimmune reaction.

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4 hours ago, nocl said:

Some Interesting research expected to be published soon. In a substantial number of serious cases the immune system generates autoantibodies that attack the host itself. Similar to what happens in some autoimmune disease.

 

There is some thought that this autoimmune reaction may be the cause of the long haulers.

 

Currently traveling. Will dig up the reference to the research when I get home on Friday.

Hi,

There was an article that some severe covid patients make

autoantibodies to interferons (Type I). The incidence is much

higher in men. Interferons (17 of them) are produced mainly

against viral infections to help stop replication of the virus.

This autoimmunity to interferon has also been seen previously

to other viral infections. Interestingly, when they COMPLETELY

sequence ALL the DNA of 500 severely sick covid patients and

only the genes expressed of 650 severely sick covid

patients they found that many had mutations in genes that

make or utilize interferon. This points to strong evidence

that many severe patients have issues with interferons.

Interestingly early work with treating  covid patients with

interferon was unsuccessful. Bummer.

However, not all types of interferons were tested and some may?

still help.

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Here is a general (but somewhat technical) review article published yesterday in the highly respected journal Lancet.  It is entitled:  "What defines an efficacious COVID-19 vaccine?".  It discusses a number of outcomes and scenarios.

 

https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30773-8/fulltext

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10 hours ago, Ken the cruiser said:

With the start of November just a few days away, I'm hoping some of the leading vaccines will start being submitted to the FDA for, if nothing else, EUA approval consideration, or is that just wishful thinking on my part?

There are actually rolling submissions of data going on to the regulatory agencies worldwide.  Also each trial has an independent medical board that will look at safety and efficacy data.  It has been reported that the Pfizer vaccine will have the earliest read sometime in November.  Of interest Pfizer has recently expanded enrollment and reported a 12 yr old subject yesterday.  So far they have reported that 36,000 subjects (of 44,000 total subjects) have already received the second shot as of yesterday.

https://www.cbsnews.com/news/covid-vaccine-pfizer-emergency-use-authorization-fda/

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2 hours ago, BP99 said:

Hi,

There was an article that some severe covid patients make

autoantibodies to interferons (Type I). The incidence is much

higher in men. Interferons (17 of them) are produced mainly

against viral infections to help stop replication of the virus.

This autoimmunity to interferon has also been seen previously

to other viral infections. Interestingly, when they COMPLETELY

sequence ALL the DNA of 500 severely sick covid patients and

only the genes expressed of 650 severely sick covid

patients they found that many had mutations in genes that

make or utilize interferon. This points to strong evidence

that many severe patients have issues with interferons.

Interestingly early work with treating  covid patients with

interferon was unsuccessful. Bummer.

However, not all types of interferons were tested and some may?

still help.

Here is the article.  Severe COVID patients hospitalized with pneumonia.  More likely in men. Possibly a way to genetically determine in advance who is most at risk for severe COVID disease and get these folks vaccinated asap.  Learning a lot daily. 

https://science.sciencemag.org/content/370/6515/eabd4585

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49 minutes ago, TeeRick said:

There are actually rolling submissions of data going on to the regulatory agencies worldwide.  Also each trial has an independent medical board that will look at safety and efficacy data.  It has been reported that the Pfizer vaccine will have the earliest read sometime in November.  Of interest Pfizer has recently expanded enrollment and reported a 12 yr old subject yesterday.  So far they have reported that 36,000 subjects (of 44,000 total subjects) have already received the second shot as of yesterday.

https://www.cbsnews.com/news/covid-vaccine-pfizer-emergency-use-authorization-fda/

So based on these rolling submissions, could it be possible some more advanced Phase 3 trials have already reached the required "minimum" infection counts allowing them to at least "peak behind the curtain" to see who received the vaccine versus the placebo, to start to determine efficacy rates among other things? If I recall AstraZeneca started their early Phase 3 trial in late June. 

Edited by Ken the cruiser
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1 minute ago, Ken the cruiser said:

So based on these rolling submissions, could it be possible some more advanced Phase 3 trials have already reached the required "minimum" infection counts allowing them to at least "peak behind the curtain" to see who received the vaccine versus the placebo, to start to determine efficacy rates? If I recall AstraZeneca started their early Phase 3 trial in late June. 

Remember AZ was paused a long time in the US.  But Moderna has finished enrollment and Pfizer will soon finish too.  These trials have well defined endpoints and dates of the initial un-blinding of the data.  Unless severe adverse events happen then data goes to their medical boards for safety evaluation.  So it seems like late November to December to see what is going on with efficacy.  Not too far away.

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1 minute ago, TeeRick said:

Remember AZ was paused a long time in the US.  But Moderna has finished enrollment and Pfizer will soon finish too.  These trials have well defined endpoints and dates of the initial un-blinding of the data.  Unless severe adverse events happen then data goes to their medical boards for safety evaluation.  So it seems like late November to December to see what is going on with efficacy.  Not too far away.

Makes sense regarding the FDA. But with regards to AZ's worldwide Phase 3 trial, they only paused giving shots for a week in September. But, in any event, there will hopefully be good news from multiple efforts in the next month or two.

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