Are vaccines the light at the end of the tunnel?

[Ken the cruiser]

Go Oxford University and AstraZeneca as their report published in the Lancet Medical Journal today offers good news on their Phase I/II trials!! To see some of this good news, do an Internet search on "Lancet AstraZeneca".

Edited July 20, 2020 by Ken the cruiser

[lucymorgan]

1 hour ago, TeeRick said:

I have recently read about this.  But it seems that about 40% of the population in the US is VitD deficient.  It helps a bit in summer in the sun to improve these numbers.  Or taking Vitamin D3 daily.  But it is very hard to say if VitD normal levels are helpful against coronavirus unless you could just reason that getting normal levels of VitD will give you a more healthy immune system.  It is quite often that "studies" correlate one effect with something else.  Pretty easy to do.  You are a statistician so I think you know more than I do about correlations.  You can make a case for almost any correlation if you want to do so.  But these things are rarely proven and are mostly impossible to prove one way or another.

Thanks for the response.  I agree - nothing is proven and it is easy to see false correlations.

 

If people are deficient in VitD, it perhaps cannot harm.   I take VitD because I have very fair skin, take the infamous hydroxychloroquine for arthritis not for covid19, which has a warning not to get too much sun while taking it, because it is winter here (although still sunny) and because Australia has a very large incidence of skin cancer - so taking VitD supplements are viewed by many as being safer than spending more time in the sun.  I have personally had a few skin cancers cut/burnt off.    

 

On cruises, I have always been amazed by the people who lie around on the pool deck getting tans - although I understand that some people are less susceptible to skin cancer as my partner has the type of skin that tans not burns.

Edited July 20, 2020 by lucymorgan

[fragilek]

On 7/18/2020 at 1:53 PM, TeeRick said:

We will need a combination of B-Cells (Antbodies) and T-Cells.  Let's forget about natural herd immunity for the time being.  Let's concentrate on acquired immunity (vaccine) and hopefully herd immunity from that vaccine if widely used.  What one might generate for vaccine-acquired immunity might be protective, albeit different than from natural infection.  There is confusion here.  Just because an antibody response wanes from natural infection does not mean that a vaccine will be ineffective.  Remember that all T-Cells are not created equal.  Most refer to CTL's or Killer T-Cells but the response of Helper T-Cells and cytokines greatly aid the antibody response.  So everything needs to be measured in the clinical trials.  We do not yet know the required immunity formula yet for a vaccine.

 Hi it looks like your knowledge of this stuff is much more advanced than mine  I only ever worked on the target drug substances and then latterly the drug product formulation.  The mode of action of the drugs was always beyond me! lol.  However, with my lack of Lymphocytes ( well near zero ) I have a personal interest in finding out how that impacts the function of this type of vaccine.  Can you shed any light on this for me and for any other hopeful future cruisers  in the same boat (no pun intend) as me?

[phoenix_dream]

1 hour ago, lucymorgan said:

Thanks for the response.  I agree - nothing is proven and it is easy to see false correlations.

 

If people are deficient in VitD, it perhaps cannot harm.   I take VitD because I have very fair skin, take the infamous hydroxychloroquine for arthritis not for covid19, which has a warning not to get too much sun while taking it, because it is winter here (although still sunny) and because Australia has a very large incidence of skin cancer - so taking VitD supplements are viewed by many as being safer than spending more time in the sun.  I have personally had a few skin cancers cut/burnt off.    

 

On cruises, I have always been amazed by the people who lie around on the pool deck getting tans - although I understand that some people are less susceptible to skin cancer as my partner has the type of skin that tans not burns.

Just as a footnote here, having a skin that tans and not burns definitely does not prevent skin cancer.  People with naturally dark skin get cancer less frequently, but even they are susceptible.  Tanning instead of burning means little.  Every time your skin changes color from the sun you are causing skin damage, period - be it tan or burn (granted, burning causes worse damage).  I also cringe at all the folks laying out in the sun so they can look better (per their own definition) or show off their tan to their friends or people at work because they were on a vacation and the others weren't.    (I am speaking of the burned and dark brown tanned ones, not those who just enjoy sun and take care to wear appropriate sunscreen and avoid staying out until they tan or burn)  As someone who saw someone suffer through a horrendous several years of melanoma before dying in his early 50's, I sincerely wish for their sake they would stop doing that.  He suffered horribly and his family was (and is) devastated.  What a foolish thing to do to (supposedly) look better.  Their life; their decision, but it depresses me every time I see it.  (ps - his work was mostly outside, which is how he got sick).  If someone wants to risk it, obviously it is not my place to tell them otherwise, but I don't have to like it.  End of rant.

Edited July 20, 2020 by phoenix_dream

[lucymorgan]

18 minutes ago, phoenix_dream said:

Just as a footnote here, having a skin that tans and not burns definitely does not prevent skin cancer.  People with naturally dark skin get cancer less frequently, but even they are susceptible.  Tanning instead of burning means little.  Every time your skin changes color from the sun you are causing skin damage, period - be it tan or burn (granted, burning causes worse damage).  I also cringe at all the folks laying out in the sun so they can look better (per their own definition) or show off their tan to their friends or people at work because they were on a vacation and the others weren't.    (I am speaking of the burned and dark brown tanned ones, not those who just enjoy sun and take care to wear appropriate sunscreen and avoid staying out until they tan or burn)  As someone who saw someone suffer through a horrendous several years of melanoma before dying in his early 50's, I sincerely wish for their sake they would stop doing that.  He suffered horribly and his family was (and is) devastated.  What a foolish thing to do to (supposedly) look better.  Their life; their decision, but it depresses me every time I see it.  (ps - his work was mostly outside, which is how he got sick).  If someone wants to risk it, obviously it is not my place to tell them otherwise, but I don't have to like it.  End of rant.

Sorry to hear about your friend.  I agree with you.   🧡  

Edited July 20, 2020 by lucymorgan

[K.T.B.]

Some VERY good news:  https://www.ox.ac.uk/news/2020-07-20-new-study-reveals-oxford-coronavirus-vaccine-produces-strong-immune-response

[markeb]

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

Some VERY good news:  https://www.ox.ac.uk/news/2020-07-20-new-study-reveals-oxford-coronavirus-vaccine-produces-strong-immune-response

 

I mostly expected this and probably would have been surprised if it weren't true. Although I'm more than a little curious what they're seeing as a T-cell response and may have to dig up the actual Lancet article to see what they say. There are T-cell responses that would be integral to the antibody response, and there are T-cell responses that could offer a secondary immune pathway. Those nuances are probably beyond a press release.

 

There were interviews with the Oxford team on the news tonight. They're happy, and probably holding their breath a bit at the same time. Phase III is always scary!

[K.T.B.]

2 hours ago, markeb said:

 

I mostly expected this and probably would have been surprised if it weren't true. Although I'm more than a little curious what they're seeing as a T-cell response and may have to dig up the actual Lancet article to see what they say. There are T-cell responses that would be integral to the antibody response, and there are T-cell responses that could offer a secondary immune pathway. Those nuances are probably beyond a press release.

 

There were interviews with the Oxford team on the news tonight. They're happy, and probably holding their breath a bit at the same time. Phase III is always scary!

 

Here's another article that's a very interesting read:

 

https://www.bloomberg.com/news/features/2020-07-15/oxford-s-covid-19-vaccine-is-the-coronavirus-front-runner

[Ken the cruiser]

41 minutes ago, K.T.B. said:

 

Here's another article that's a very interesting read:

 

https://www.bloomberg.com/news/features/2020-07-15/oxford-s-covid-19-vaccine-is-the-coronavirus-front-runner

Great article. Thank you for posting it!

[lucymorgan]

Hope and very glad to see this in the article🙏

 

AstraZeneca has agreed to sell the vaccine on a not-for-profit basis during the crisis if it proves effective and has lined up deals with multiple manufacturers to produce more than 2 billion doses.

[TeeRick]

21 hours ago, fragilek said:

 Hi it looks like your knowledge of this stuff is much more advanced than mine  I only ever worked on the target drug substances and then latterly the drug product formulation.  The mode of action of the drugs was always beyond me! lol.  However, with my lack of Lymphocytes ( well near zero ) I have a personal interest in finding out how that impacts the function of this type of vaccine.  Can you shed any light on this for me and for any other hopeful future cruisers  in the same boat (no pun intend) as me?

fragilek- I am not qualified to make any comment on your specific medical condition.  Sorry.  Perhaps after there is an approved vaccine with all of its characteristics known, then an educated discussion with your doctor is the best step forward.  Best of health to you!

Edited July 21, 2020 by TeeRick

[TeeRick]

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

 

Here's another article that's a very interesting read:

 

https://www.bloomberg.com/news/features/2020-07-15/oxford-s-covid-19-vaccine-is-the-coronavirus-front-runner

Thanks!  Good article!  I am optimistic about this vaccine.  But there will be major safety concerns of injecting millions of people with a recombinant adenovirus vector.  I don't see this being used initially in children.  And not sure about immuno-compromised adults.  But it is a new world we live in. 

[dgraham]

This may have been mentioned already, but since vaccines will probably be very difficult to obtain at first even when they are released, perhaps the cruise companies could offer them to anyone taking a cruise with a company, in fact insist on having a vaccine to board (while offering the option dockside). That way everyone on board would be. vaccinated and hopefully not a carrier.

[markeb]

Just now, dgraham said:

This may have been mentioned already, but since vaccines will probably be very difficult to obtain at first even when they are released, perhaps the cruise companies could offer them to anyone taking a cruise with a company, in fact insist on having a vaccine to board (while offering the option dockside). That way everyone on board would be. vaccinated and hopefully not a carrier.

 

That is almost certainly NOT how distribution will work, nor should it.

 

Depending on the data and label: Healthcare workers, first responders, high risk individuals within the age group of the initial label (subject to any limitations on their response), other essential workers, very likely members of the Armed Forces, extended label for high risk pediatrics and other individuals outside the age group of initial label (avoiding the word geriatric on this board) ... Leisure Travelers (Last).

 

2 billion doses is at most 1 billion people based on what AZ and Oxford are seeing. It could easily go to more like 700 million (it wouldn't surprise me to see a six month dose tested if the titres decline too soon after the 28 day dose).

[Ken the cruiser]

13 minutes ago, markeb said:

 

That is almost certainly NOT how distribution will work, nor should it.

 

Depending on the data and label: Healthcare workers, first responders, high risk individuals within the age group of the initial label (subject to any limitations on their response),

I keep hearing folks mention "high risk individuals" when it comes to administering an eventual vaccine. What exactly does this mean? My DW is 66 and I'm 68. Are we considered to be part of that group?

Edited July 21, 2020 by Ken the cruiser

[markeb]

1 minute ago, Ken the cruiser said:

I keep hearing folks mention "high risk individuals" when it comes to administering an eventual vaccine. What exactly does that mean? My DW is 66 and I'm 68. Are we considered to be part of that group. 

 

I'm throwing that around as well, probably without definition. The initial clinical trials are 18-55 from what I've read, so the three of us are all at least in that extended group.High risk 18-55 is probably Type II diabetes, history of cancer,  possibly current chemotherapy patients (depends on data), etc. Without a known underlying condition, age increases your risk, but age plus a risk factor really increases risk (going back a few months now as things change rapidly).

 

I'm pretty sure AZ is enrolling people outside the 18-55 age range in their clinical trials. They may have trouble getting enough statistical power to prove effectiveness in those groups. Assuming safety holds, they'd likely file to extend their label with the data they have and commit to post-marketing surveillance to develop further data.

 

That's a little sausage making, in all honesty. And an educated guess. 

[Ken the cruiser]

4 minutes ago, markeb said:

 

I'm throwing that around as well, probably without definition. The initial clinical trials are 18-55 from what I've read, so the three of us are all at least in that extended group.High risk 18-55 is probably Type II diabetes, history of cancer,  possibly current chemotherapy patients (depends on data), etc. Without a known underlying condition, age increases your risk, but age plus a risk factor really increases risk (going back a few months now as things change rapidly).

 

I'm pretty sure AZ is enrolling people outside the 18-55 age range in their clinical trials. They may have trouble getting enough statistical power to prove effectiveness in those groups. Assuming safety holds, they'd likely file to extend their label with the data they have and commit to post-marketing surveillance to develop further data.

 

That's a little sausage making, in all honesty. And an educated guess. 

No problem. I was just wondering, but you're probably right. Folks with an underlying condition, regardless of age, should be placed at the head of the pack, That is, of course, if they are willing and able to take the vaccine. I'm sure once the vaccines start flowing, we'll all be able to get ours soon enough.

[markeb]

4 minutes ago, Ken the cruiser said:

No problem. I was just wondering, but you're probably right. Folks with an underlying condition, regardless of age, should be placed at the head of the pack, That is, of course, if they are willing and able to take the vaccine. I'm sure once the vaccines start flowing, we'll all be able to get ours soon enough.

 

I generally agree, I'm just not sure when that will be. And I don't want to sound like a pessimist suggesting a 6 month dose. That's actually a reasonable strategy to extend immunity if the titres do drop, but that means you need a 6-month titre after two doses (the vaccine response was not surprisingly much better in the small group that received a 28-day dose and I would expect a 2-dose arm in the Phase III) to see if another dose adds to the response.

 

BTW, none of this would be going on in public like this for pretty much any other vaccine. I really wouldn't want to be Oxford or AZ trying to figure out the best way to manufacture and use this vaccine with essentially the entire world watching! There are time frames that make sense immunologically and from experience in vaccine development, but there's both an art and a science to dose optimization and scheduling, and I just don't know they've got the freedom to try a 90 day dose, for instance, when the world has been thinking, with no real basis, one and done...

[Ken the cruiser]

25 minutes ago, markeb said:

I generally agree, I'm just not sure when that will be. And I don't want to sound like a pessimist suggesting a 6 month dose. That's actually a reasonable strategy to extend immunity if the titres do drop, but that means you need a 6-month titre after two doses (the vaccine response was not surprisingly much better in the small group that received a 28-day dose and I would expect a 2-dose arm in the Phase III) to see if another dose adds to the response.

On that note, I wonder if after the initial COVID vaccine dosage is released and administered to the masses, either in 1 or 2 doses, it might be subsequently included in the annual flu vaccine we get every year?

[markeb]

2 minutes ago, Ken the cruiser said:

On that note, I wonder if after the initial COVID vaccine dosage is released and administered to the masses, either in 1 or 2 doses, it might be subsequently included in the annual flu vaccine we get every year?

 

Probably stay separate. The influenza vaccine is just so well understood and documented and requires pretty much the minimum safety and efficacy every year. Adding an unrelated component to it would change all of that.

 

And they may not be compatible. I could see both as an annual recommendation, again depending on the data from the COVID19 trials, but I don't see mixing them in the same vial.

[Covepointcruiser]

The vaccine tested by the U of Penn in Philadelphia requested individuals over 50.   I would be surprised if the other vaccines were not also tested on more senior individuals.      Immune compromised individuals would not have a good response to a vaccine.   Our cancer patients are not getting the flu vaccine.

[WrittenOnYourHeart]

Town Hall call with the UFT this afternoon indicated that they are definitely pushing for teachers to be in the initial groups eligible as well - especially if we're going back to classroom learning.

[lucymorgan]

4 hours ago, Covepointcruiser said:

The vaccine tested by the U of Penn in Philadelphia requested individuals over 50.   I would be surprised if the other vaccines were not also tested on more senior individuals.      Immune compromised individuals would not have a good response to a vaccine.   Our cancer patients are not getting the flu vaccine.

Which is exactly why people who care about others should.  

 

My immune system tends to be over-reactive rather than under-reactive (autoimmune thyroid disease, arthritis, coeliac) and I get the flu shot every year.

 

I wonder if the hydroxychloroquine I have taken daily for the past year is one reason why my normally overactive immune system didn't fight off the virus (covid?) I caught on my January cruise, which developed into bacterial pneumonia.  

 

I hope that they find a vaccine for covid that is safe and works as quickly as possible.  

Edited July 22, 2020 by lucymorgan

[terrydtx]

The US Federal Government announced this morning that they are ordering 100 million doses of Pfizer Covid Vaccine for delivery by December once the phase 3 trials are finished and the drug is approved. They have an option to deliver another 500 million doses as well. The cost to US citizens will be zero to receive the vaccine. This is great news for all of us and only one of the several drug companies already in phase 3 trials. There is light at the end of the tunnel now.

 

https://www.sfgate.com/business/article/Feds-agree-to-buy-100-M-doses-of-potential-Pfizer-15425389.php

Edited July 22, 2020 by terrydtx

[TeeRick]

16 hours ago, markeb said:

 

I'm throwing that around as well, probably without definition. The initial clinical trials are 18-55 from what I've read, so the three of us are all at least in that extended group.High risk 18-55 is probably Type II diabetes, history of cancer,  possibly current chemotherapy patients (depends on data), etc. Without a known underlying condition, age increases your risk, but age plus a risk factor really increases risk (going back a few months now as things change rapidly).

 

I'm pretty sure AZ is enrolling people outside the 18-55 age range in their clinical trials. They may have trouble getting enough statistical power to prove effectiveness in those groups. Assuming safety holds, they'd likely file to extend their label with the data they have and commit to post-marketing surveillance to develop further data.

 

That's a little sausage making, in all honesty. And an educated guess. 

markeb- you have hit on a point I have been trying to make but your post explains it much better.  A vaccine will initially be approved in the population tested in the phase III trial.  In the case of AZ/Oxford, adults 18-55.  I'm not sure how many understand what this means as many of us cruising folk are over 55.  It is likely that additional large bridging trials will need to take place to expand the approval to other groups.  Maybe that will be straight-forward once the efficacy and dosing protocol are starting to be clear from the first phase III trial.  But I still do not see the Oxford vaccine, being a recombinant vector of adenovirus,  going into kids of any age for quite some time.  Just my opinion based upon my previous vaccine development and approval experience.