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Are vaccines the light at the end of the tunnel?


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12 hours ago, cruise kitty said:

 

Rick, I appreciate the good info that you & many others are providing on this forum.   DH & I will both be part of the phase 3 Pfizer trials.....as long as I'm allowed to, I'll post anything interesting here.  

I used to work there developing vaccines.  I tried to volunteer for their Ph 3 trial but some recent health issues that I have had put me out of the acceptable subject criteria.  But good luck with the trial and please report everything on your thoughts here!  If it is an approved vaccine eventually- you will be ahead of the game and won't have to wait like the rest of us!

 

For what it's worth here is an update from Pfizer's CEO on the vaccine you will be injected with.  No safety issues so far.

https://www.bloomberg.com/news/articles/2020-10-14/pfizer-biontech-covid-vaccine-trial-remains-on-track-ceo-says

 

Edited by TeeRick
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4 hours ago, TeeRick said:

I used to work there developing vaccines.  I tried to volunteer for their Ph 3 trial but some recent health issues that I have had put me out of the acceptable subject criteria.  But good luck with the trial and please report everything on your thoughts here!  If it is an approved vaccine eventually- you will be ahead of the game and won't have to wait like the rest of us!

 

For what it's worth here is an update from Pfizer's CEO on the vaccine you will be injected with.  No safety issues so far.

https://www.bloomberg.com/news/articles/2020-10-14/pfizer-biontech-covid-vaccine-trial-remains-on-track-ceo-says

 

 

Thanks Rick,  I've been tracking the updates here, & on several science podcasts, the clinic I'll be going to was slated for the J & J one & the Pfizer, luckily I was funneled into the Pfizer, as the J & J one looks to be sidelined for a bit.  

 

I'm very hopeful, & at least this gives me a feeling of "doing something" for the cause  :)

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4 minutes ago, cruise kitty said:

 

Thanks Rick,  I've been tracking the updates here, & on several science podcasts, the clinic I'll be going to was slated for the J & J one & the Pfizer, luckily I was funneled into the Pfizer, as the J & J one looks to be sidelined for a bit.  

 

I'm very hopeful, & at least this gives me a feeling of "doing something" for the cause  🙂

Good on you, cruise kitty!  I hope you have fantastic results!!

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20 hours ago, nocl said:

under that criteria most ads could be banned.

Facebook and Instagram make up their own rules as to what they allow.  No such thing as freedom of speech with them anyway.

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21 hours ago, mimbecky said:

I have read about a few cases of reinfection where the second infection is much worse than the first opening the "hypothesis of a mechanism known as antibody dependent enhancement—that is, when antibodies actually make subsequent infections worse".  I know that has been a concern with a vaccine from the get go.  Thoughts?

 

https://medicalxpress.com/news/2020-10-covid-reinfection-virus-immunity.html

Thoughts, yes for sure, and they involve focusing on getting back on board a Celebrity cruise ship.  I will leave the hypothesizing to the scientists, medical professionals etc. 

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6 hours ago, TeeRick said:

I used to work there developing vaccines.  I tried to volunteer for their Ph 3 trial but some recent health issues that I have had put me out of the acceptable subject criteria.  But good luck with the trial and please report everything on your thoughts here!  If it is an approved vaccine eventually- you will be ahead of the game and won't have to wait like the rest of us!

 

For what it's worth here is an update from Pfizer's CEO on the vaccine you will be injected with.  No safety issues so far.

https://www.bloomberg.com/news/articles/2020-10-14/pfizer-biontech-covid-vaccine-trial-remains-on-track-ceo-says

 

Thanks.  You have a much more educated view.  I had a discussion with a college friend this week who now lives in the UK.  He has worked for AZ for over 40 years.  I asked if they might go ahead an get approval in the EU before the US given the political issues here.  Got  "possibly, that would make some sense" as the answer.  Thoughts?

We also discussed disinfection and the Lancet article.  With 20 documented reinfections and ONE with a severe case he seemed unconcerned as there have been probably 150 million infected given the poor reporting in many countries.  Felt the comment of higher COVID load the second time as a plausible reason.

Again, comments?  

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16 hours ago, Arizona Wildcat said:

Thanks.  You have a much more educated view.  I had a discussion with a college friend this week who now lives in the UK.  He has worked for AZ for over 40 years.  I asked if they might go ahead an get approval in the EU before the US given the political issues here.  Got  "possibly, that would make some sense" as the answer.  Thoughts?

We also discussed disinfection and the Lancet article.  With 20 documented reinfections and ONE with a severe case he seemed unconcerned as there have been probably 150 million infected given the poor reporting in many countries.  Felt the comment of higher COVID load the second time as a plausible reason.

Again, comments?  

So in the UK drugs and vaccines are controlled and approved by the MHRA (like the US FDA).

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

 

In most instances the MHRA has worked closely with the EMEA (European Union FDA equivalent).  Not sure about the level of collaboration since Brexit.  https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines

 

The Pfizer vaccine and now the Moderna vaccine (as of this week) are submitting data now to the EMEA in what is called a rolling submission process - they do not need to wait until the end to submit everything at once.  Moderna is also submitting early data to Canada.  https://www.pharmaceutical-technology.com/news/moderna-rolling-submission/

 

It is possible that these countries and regions could approve these vaccines prior to the US FDA.  Particularly since it is an unfortunate political situation as you say.  We shall see.  

 

I think the cases of re-infection seem to be rare and not widespread.  We would have seen this trend by now if it was a common occurrence.   They are not well understood.  Possible that they never really cleared the original infection.  We will all know more in the coming months for sure.

 

 

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57 minutes ago, TeeRick said:

 

It is possible that these countries and regions could approve these vaccines prior to the US FDA.  Particularly since it is an unfortunate political situation as you say.  We shall see.  

 

I think the cases of re-infection seem to be rare and not widespread.  We would have seen this trend by now if it was a common occurrence.   They are not well understood.  Possible that they never really cleared the original infection.  We will all know more in the coming months for sure.

 

Well any approval is a move forward so that is good news.  I would think early approval elsewhere would provide more data for the US to comfortably move forward as well.

 

The re-infections seem to be a slightly different strain (sequenced). The previous infection didn't seem to provide a lesser infection which is what would be expected.  More good new is that it doesn't seem a problem in vaccine groups, especially since it is something they have been alerted to in a previous experimental vaccine (Dengue, as previously posted).

 

I also just heard right now on the news that Pfizer is hoping to apply for EAU next month!

 

M

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I’m enrolled in the Novavax phase 3 trial here in Scotland. First appointment on Tuesday next week.

A bit like an earlier poster, however small it may be, I feel as though I’m helping.

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23 hours ago, TeeRick said:

So in the UK drugs and vaccines are controlled and approved by the MHRA (like the US FDA).

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

 

In most instances the MHRA has worked closely with the EMEA (European Union FDA equivalent).  Not sure about the level of collaboration since Brexit.  https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines

 

The Pfizer vaccine and now the Moderna vaccine (as of this week) are submitting data now to the EMEA in what is called a rolling submission process - they do not need to wait until the end to submit everything at once.  Moderna is also submitting early data to Canada.  https://www.pharmaceutical-technology.com/news/moderna-rolling-submission/

 

It is possible that these countries and regions could approve these vaccines prior to the US FDA.  Particularly since it is an unfortunate political situation as you say.  We shall see.  

 

I think the cases of re-infection seem to be rare and not widespread.  We would have seen this trend by now if it was a common occurrence.   They are not well understood.  Possible that they never really cleared the original infection.  We will all know more in the coming months for sure.

 

 

keep in mind that most of the infections have occured in the last 6 months and that in most countries less than 10% of the population has been infected. So if there is any natural immunity at all (with other Corona viruses 6 to 12 months is not unusual), someone would have to be very unlucky or practice very poor practices to be infected twice. So while it is rare, at this stage of the outbreak one would expect it to be very rare.

 

Let's see 12 months from now.

 

In the documented cases they mapped the virus and found differences between fist and second infection Pretty much rules out failure to clear original infection.

 

Good news is some cases milder some more severe so no trend of AED as of yet

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6 hours ago, zanderblue said:

I’m enrolled in the Novavax phase 3 trial here in Scotland. First appointment on Tuesday next week.

A bit like an earlier poster, however small it may be, I feel as though I’m helping.

Good to hear and good luck.  The Novavax vaccine is a more traditional protein subunit vaccine and it should be a safe approach which has been used for other licensed vaccines.  

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31 minutes ago, nocl said:

keep in mind that most of the infections have occured in the last 6 months and that in most countries less than 10% of the population has been infected. So if there is any natural immunity at all (with other Corona viruses 6 to 12 months is not unusual), someone would have to be very unlucky or practice very poor practices to be infected twice. So while it is rare, at this stage of the outbreak one would expect it to be very rare.

 

Let's see 12 months from now.

 

In the documented cases they mapped the virus and found differences between fist and second infection Pretty much rules out failure to clear original infection.

 

Good news is some cases milder some more severe so no trend of AED as of yet

 

Here is the Lancet publication (Oct 12)  on one of these rare re-infections and here is a quote in the conclusion section.

 

 "If our patient is a case of reinfection, it is crucial to note that the frequency of such an occurrence is not defined by one case study: this event could be rare."

https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30764-7/fulltext

 

I still think that reinfections seem to be quite rare.  But of course they will happen at some as yet undefined frequency.  Not unheard of with other viruses.  

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What I find interesting is that in Alabama most of us normal folks can't even call to get an appointment to get a COVID test unless we have some of the related symptoms. But yet some folks are saying up to 40% of the those that test positive are asymptomatic. Could there be a lot more folks that have had COVID, but didn't get tested because they didn't have any symptoms? Just curious how so many folks think they need to get tested if they aren't displaying any symptoms?

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

What I find interesting is that in Alabama most of us normal folks can't even call to get an appointment to get a COVID test unless we have some of the related symptoms. But yet some folks are saying up to 40% of the those that test positive are asymptomatic. Could there be a lot more folks that have had COVID, but didn't get tested because they didn't have any symptoms? Just curious how so many folks think they need to get tested if they aren't displaying any symptoms?

We got tested in our state (PA) because we wanted to travel for a vacation to another state (ME) that required a test within 72 hr of entry.  Most testing sites where we live require at least one symptom (cough? nasal congestion? headache? ) or underlying risk condition (obesity?) to get tested.  Many people in the population without any sign of active COVID could easily check off one of these boxes and get tested).  But we also have test sites which are working with companies that just want to generate any and all data on the virus and will just test anybody.  We went to a pharmacy chain doing this type of testing and got back our negative results within 48 hours.  So we were able to travel.

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1 hour ago, TeeRick said:

 

Here is the Lancet publication (Oct 12)  on one of these rare re-infections and here is a quote in the conclusion section.

 

 "If our patient is a case of reinfection, it is crucial to note that the frequency of such an occurrence is not defined by one case study: this event could be rare."

https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30764-7/fulltext

 

I still think that reinfections seem to be quite rare.  But of course they will happen at some as yet undefined frequency.  Not unheard of with other viruses.  

In one of the medical articles I read this week, that here are only 5 world wide confirmed cases of reinfection with Covid 19 if true is extremely rare. and should not be an issue to worry about.

 

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6 minutes ago, TeeRick said:

We got tested in our state (PA) because we wanted to travel for a vacation to another state (ME) that required a test within 72 hr of entry.  Most testing sites where we live require at least one symptom (cough? nasal congestion? headache? ) or underlying risk condition (obesity?) to get tested.  Many people in the population without any sign of active COVID could easily check off one of these boxes and get tested).  But we also have test sites which are working with companies that just want to generate any and all data on the virus and will just test anybody.  We went to a pharmacy chain doing this type of testing and got back our negative results within 48 hours.  So we were able to travel.

Here in San Antonio, Texas anyone can use one of the many testing sites without any symptoms to be tested. Our daughter is going through 6 months of Chemo for breast cancer and we get tested before we travel to Dallas to visit just to be cautious and protect her suppressed immune system.

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3 minutes ago, terrydtx said:

Here in San Antonio, Texas anyone can use one of the many testing sites without any symptoms to be tested. Our daughter is going through 6 months of Chemo for breast cancer and we get tested before we travel to Dallas to visit just to be cautious and protect her suppressed immune system.

I love visiting San Antonio!  Best of wishes for your daughter!

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13 minutes ago, Ken the cruiser said:

What I find interesting is that in Alabama most of us normal folks can't even call to get an appointment to get a COVID test unless we have some of the related symptoms. But yet some folks are saying up to 40% of the those that test positive are asymptomatic. Could there be a lot more folks that have had COVID, but didn't get tested because they didn't have any symptoms? Just curious how so many folks think they need to get tested if they aren't displaying any symptoms?

A couple of months ago, my DW was displaying possible symptoms. As we live together, there was no issue having me tested at the same time, even though I was asymptomatic. Today, however, things have tightened up considerably because of the huge demand, and I would only be tested if DW's results came back positive.

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1 hour ago, Ken the cruiser said:

What I find interesting is that in Alabama most of us normal folks can't even call to get an appointment to get a COVID test unless we have some of the related symptoms. But yet some folks are saying up to 40% of the those that test positive are asymptomatic. Could there be a lot more folks that have had COVID, but didn't get tested because they didn't have any symptoms? Just curious how so many folks think they need to get tested if they aren't displaying any symptoms?

 

I heard one of the docs on t.v. describing some of the people going in for tests as "the worried well".

I thought that was a great description why some might go get tested.

In my state they are having some random community testing just on specific days that anyone can go to with or without symptoms as they try and determine how widespread it is.

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4 hours ago, Ken the cruiser said:

What I find interesting is that in Alabama most of us normal folks can't even call to get an appointment to get a COVID test unless we have some of the related symptoms. But yet some folks are saying up to 40% of the those that test positive are asymptomatic. Could there be a lot more folks that have had COVID, but didn't get tested because they didn't have any symptoms? Just curious how so many folks think they need to get tested if they aren't displaying any symptoms?

Clearly not everyone that has the virus gets tested.  For many that are asymptomatic they have no reason to unless they are notified that they have had close contact with someone that has it.  For many with mild symptoms not worth the effort.  Then you also have categories such as undocumented immigrants that do not have insurance and are concerned that getting tested would cause problems for them.

 

The last estimate I saw for the US was that the actual numbers that have had the virus is as much as 5X the official tested numbers.  In the early days (April/May) it was estimated to be as high as 10X when testing was in short supply and there was a lot of confusion about the virus.

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4 hours ago, terrydtx said:

Here in San Antonio, Texas anyone can use one of the many testing sites without any symptoms to be tested. Our daughter is going through 6 months of Chemo for breast cancer and we get tested before we travel to Dallas to visit just to be cautious and protect her suppressed immune system.

If I might ask, did you have to pay a fee to be tested in your situation?

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