Are vaccines the light at the end of the tunnel?

[chipmaster]

The belief or hope that high efficacy low risk vaccine will appear on 2020 is very low probability.  Track record for vaccines are spotty at best and the successful ones took years if not decades to identify and develop.

 

Yeah COVID19 is the number one health problem for humans so all the best are working, but that won't change the probability.  It'll take time.  Today we hear about a company making noise about successful trial, it'll get press, the company has no track record and the test was on what 45 people, wait till they test few thousand and we see the risk profile develop.

 

Then those who think if and when a vaccine appears they will go to their local place and get it, viola problem over.  

 

Do you remember toilet paper, vaccine demand will make toilet paper demand look like nothing at all, and supply and distribution will make toilet paper look like childs play. 

[Ken the cruiser]

21 minutes ago, chipmaster said:

The belief or hope that high efficacy low risk vaccine will appear on 2020 is very low probability.  Track record for vaccines are spotty at best and the successful ones took years if not decades to identify and develop.

 

Yeah COVID19 is the number one health problem for humans so all the best are working, but that won't change the probability.  It'll take time.  Today we hear about a company making noise about successful trial, it'll get press, the company has no track record and the test was on what 45 people, wait till they test few thousand and we see the risk profile develop.

 

Then those who think if and when a vaccine appears they will go to their local place and get it, viola problem over.  

 

Do you remember toilet paper, vaccine demand will make toilet paper demand look like nothing at all, and supply and distribution will make toilet paper look like childs play. 

So much negativity. But that's cool. You keep thinking that and we'll keep hoping for the best. 

[Fouremco]

16 minutes ago, Ken the cruiser said:

So much negativity. But that's cool. You keep thinking that and we'll keep hoping for the best. 

I think this is more a question of hoping for the best but planning for the worst.

[Shadow9612]

12 hours ago, TeeRick said:

I was able to get a COVID antibody test there for $10.  (It was negative).

@TeeRick I'd love to hear your thoughts on the efficacy of the antibody testing as well as recent news that antibody response is short lived...(eg levels decline or disappear within months)

[Ken the cruiser]

38 minutes ago, Fouremco said:

I think this is more a question of hoping for the best but planning for the worst.

That's cool. For us our plan is to get the vaccine as soon as one is made available in our area and follow whatever guidelines are published to make that adventure as easy as possible, whether it's made available at a nearby military base (as we are retired from the USAF) or a nearby pharmacy. I'm sure the process will be chaotic when it's first released, but I'm positive the distribution process will smooth out over time.

Edited July 15, 2020 by Ken the cruiser

[K.T.B.]

1 hour ago, npcl said:

No Corona vaccines largely for two reasons  1. SARS - the outbreak vanished before the vaccine candidates could be tested.  No outbreak no way to test for efficacy  2. The other corona virus have been pretty minor.  Not worth the effort. Considering that several of those and some rhino viruses all cause symptoms referred to as the common cold it would take a number of different vaccines to prevent the common cold.  I doubt people would want to get several vaccine shots each year to prevent the common cold

 

Neither situation applies to COVID-19

 

This is only the second Corona virus with serious enough symptoms to make a vaccine worthwhile.  The first, SARS, for which there were several vaccine candidates, died out before it could be tested for efficacy.

 

You beat me to the comment. 

 

You are mostly correct.  You missed MERS, which is in the same "family" as SARS and COVID.

 

And as of April there were some very promising results for a MERS vaccine.  No idea where it stands now, however, not with everything that's going on with COVID.

[npcl]

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

 

You beat me to the comment. 

 

You are mostly correct.  You missed MERS, which is in the same "family" as SARS and COVID.

 

And as of April there were some very promising results for a MERS vaccine.  No idea where it stands now, however, not with everything that's going on with COVID.

There is a vaccine candidate for MERS, but the incidence for MERS is so low that a clinical trial for efficacy would require and enrollment of around 100,000 members, of those that are most likely to get the illness (camel herders).  Not practical for a trial, so it will not move forward unless something changes.

 

 

Edited July 15, 2020 by npcl

[K.T.B.]

1 hour ago, chipmaster said:

The belief or hope that high efficacy low risk vaccine will appear on 2020 is very low probability.  Track record for vaccines are spotty at best and the successful ones took years if not decades to identify and develop.

 

Yeah COVID19 is the number one health problem for humans so all the best are working, but that won't change the probability.  It'll take time.  Today we hear about a company making noise about successful trial, it'll get press, the company has no track record and the test was on what 45 people, wait till they test few thousand and we see the risk profile develop.

 

Then those who think if and when a vaccine appears they will go to their local place and get it, viola problem over.  

 

Do you remember toilet paper, vaccine demand will make toilet paper demand look like nothing at all, and supply and distribution will make toilet paper look like childs play. 

 

AstraZeneca is on its way to having nearly 2 billion doses ready to go once they get approval (assuming mid-October, which is what it looks like right now).  400,000 million are earmarked for the US and UK.  The US & UK combined do not have 400 million citizens.  As of 2019. the total was 395 million.  Even though I'm sure the number has increased, those people who caused it to increased are all under a year old.....

 

I think we'll be good.  No need to play "Debbie Downer".  

[npcl]

1 minute ago, K.T.B. said:

 

AstraZeneca is on its way to having nearly 2 billion doses ready to go once they get approval (assuming mid-October, which is what it looks like right now).  400,000 million are earmarked for the US and UK.  The US & UK combined do not have 400 million citizens.  As of 2019. the total was 395 million.  Even though I'm sure the number has increased, those people who caused it to increased are all under a year old.....

 

I think we'll be good.  No need to play "Debbie Downer".  

The data on phase 1 for mRNA-1273 (the moderna vaccine) has been published.

 

An mRNA Vaccine against SARS-CoV-2 — Preliminary Report

https://www.nejm.org/doi/full/10.1056/NEJMoa2022483

 

 

It does look promising.  Though the side effect profile, while minor reminds me of a vaccine I got once back in my Air Force days back in the mid 70's (typhoid I think, back before the oral version).  The old pain at injection site, muscle aches, fever, etc.  You did not get the illness but it certainly felt like you did for a day or two.

 

 

[K.T.B.]

16 minutes ago, npcl said:

The data on phase 1 for mRNA-1273 (the moderna vaccine) has been published.

 

An mRNA Vaccine against SARS-CoV-2 — Preliminary Report

https://www.nejm.org/doi/full/10.1056/NEJMoa2022483

 

 

It does look promising.  Though the side effect profile, while minor reminds me of a vaccine I got once back in my Air Force days back in the mid 70's (typhoid I think, back before the oral version).  The old pain at injection site, muscle aches, fever, etc.  You did not get the illness but it certainly felt like you did for a day or two.

 

 

 

I can definitely handle that for a day or 2.  

[cscurlock]

1 hour ago, K.T.B. said:

 

AstraZeneca is on its way to having nearly 2 billion doses ready to go once they get approval (assuming mid-October, which is what it looks like right now).  400,000 million are earmarked for the US and UK.  The US & UK combined do not have 400 million citizens.  As of 2019. the total was 395 million.  Even though I'm sure the number has increased, those people who caused it to increased are all under a year old.....

 

I think we'll be good.  No need to play "Debbie Downer".  

The last trials will probably be into 2021.   The vaccine might only make you immune for a short period of time if its based on antibodies.   So will take multiple doses over a period of time.

[excitedofharpenden]

A friend of mine’s father in law is MD and Chief Medical Officer at Johnson and Johnson and is heavily involved in the work they are doing on a vaccine.  He is very hopeful and is working closely together with other senior management from the industry. The challenge is for all companies to put aside the financial politics and work together. I’m very encouraged by what I’ve heard.  🤞

 

Phil

[ipeeinthepool]

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

 

AstraZeneca is on its way to having nearly 2 billion doses ready to go once they get approval (assuming mid-October, which is what it looks like right now).  400,000 million are earmarked for the US and UK.  The US & UK combined do not have 400 million citizens.  As of 2019. the total was 395 million.  Even though I'm sure the number has increased, those people who caused it to increased are all under a year old.....

 

I think we'll be good.  No need to play "Debbie Downer".  

 

Remember that the AZ vaccine requires two doses 28 days apart, so that reduces the total number vaccinated to 1 billion and 200,000 million people in the US and UK.  It's still a lot of people and highlights the need for multiple sources of vaccines.

[K.T.B.]

6 hours ago, cscurlock said:

The last trials will probably be into 2021.   The vaccine might only make you immune for a short period of time if its based on antibodies.   So will take multiple doses over a period of time.

 

They're in the phase 2/3 right now.  Anticipation is that trails will be completed by September.  They're still on target for a mid-October release, assuming the FDA approves.  Though other countries probably won't need to wait as long as the US.

[bouhunter]

10 hours ago, Ken the cruiser said:

So much negativity. But that's cool. You keep thinking that and we'll keep hoping for the best. 

It's not being negative, but realistic...

[TeeRick]

10 hours ago, Shadow9612 said:

@TeeRick I'd love to hear your thoughts on the efficacy of the antibody testing as well as recent news that antibody response is short lived...(eg levels decline or disappear within months)

 

Ok some thoughts only for what they are worth (but if too much for this board just feel free to go to the links or just move to the next post.   I will try to put this in context of this current thread on vaccines for cruising.

 

I would refer you to the US CDC site for more complete information on AB testing that was recently updated June 30.

https://www.cdc.gov/coronavirus/2019-ncov/testing/serology-overview.html

 

1) Validity of AB Test Results: Early on there were a lot of AB tests rushed into production and to the states and providers out of necessity.  Then the FDA stepped in and created tough validation procedures and required all manufacturers to submit data.  A number of tests were pulled from the market.  Some, like the ones from the Abbot high throughput analyzer, were deemed very reliable.  This has become widely used and I know Labcorp uses this.  So that's why I personally chose Labcorp for my test.  If getting an AB test then check what instrument and labs are doing the tests.  See this from the US FDA for the best info:

https://www.fda.gov/medical-devices/letters-health-care-providers/certain-covid-19-serologyantibody-tests-should-not-be-used-letter-clinical-laboratory-staff-and

 

2) Antibody type:  After SARS-CoV-2 infection, in symptomatic people anyway (not clear about asymptomatic), people get an immediate IgM response but then within two weeks the antibodies are converted in a normal process to longer lasting IgG antibodies. That is what the AB tests are measuring these days.  But they might not be detectable until two weeks post initial infection.  That is why the nasal swab PCR test (viral RNA) is mostly used to diagnose early symptoms in most places.

 

3) Longevity of IgG antibodies:  Studies are all over the place on this and a lot more data is needed for conclusions.  Perhaps two weeks to 4 months?  Perhaps longer?  I thought I had the virus back in mid-January on Celebrity Eclipse by the symptoms I exhibited.  But I tested negative mid-June for antibodies.  Either I did not have the virus or my IgG antibodies were gone already. 

 

4) Neutralizing Antibodies:  Post infection,  you might or might not develop neutralizing antibodies which protect against future infections.  A lot a data needs to be assessed for this in the coming months.

 

5) Vaccine Response:  If neutralizing antibodies are important for viral protection, then an effective vaccine should produce these at a significant level - most likely higher than seen in COVID-19 infected patients.  It is entirely possible that at least two vaccine doses (or more) over a period of time might be required for this.  Problematic for early return to cruising.

 

6) Other Immune Responses:  Even if you have been infected (or vaccinated) your circulating IgG antibodies will wane over time.  But the good news is that a healthy immune system is primed to respond quickly if it sees the antigen (virus) again.  It will start making specific antibodies and various types of T-cells pretty rapidly.   This is what a vaccine (acquired immunity) is all about!  But that is also why you might need booster doses.  

 

7) Other:  Viruses replicate inside of cells so a T-cell response is also generated along with components called cytokines.  This might control your virus even if you become infected or infected again.  A very effective vaccine will likely produce both antibodies and T-Cell responses.  These are all being measured in current vaccine clinical trials.  Note that there is some evidence of a "cytokine storm"  in some very severe COVID patients which is quite serious so a lot of this needs to be looked at in detail for a safe vaccine approach.

 

[Ken the cruiser]

22 minutes ago, TeeRick said:

Ok some thoughts only for what they are worth (but if too much for this board just feel free to go to the links or just move to the next post.   I will try to put this in context of this current thread on vaccines for cruising.

Thank you TeeRick for this as well as all of the other insightful thoughts you have provided on this thread! The value of your thoughts with regards to vaccines has been very helpful when trying to understand some of what is going on behind the scenes. 

[K.T.B.]

4 hours ago, ipeeinthepool said:

 

Remember that the AZ vaccine requires two doses 28 days apart, so that reduces the total number vaccinated to 1 billion and 200,000 million people in the US and UK.  It's still a lot of people and highlights the need for multiple sources of vaccines.

 

I've seen nothing about that, and I've been following this "religiously" because my wife and I are in the "at risk" group.  But they do suspect that it will probably require a yearly booster.

[TeeRick]

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

 

I've seen nothing about that, and I've been following this "religiously" because my wife and I are in the "at risk" group.  But they do suspect that it will probably require a yearly booster.

They are testing multiple types of dosing protocols and booster times in the clinical trials.  Nothing has been really decided.  Far too early.

[TeeRick]

35 minutes ago, Ken the cruiser said:

Thank you TeeRick for this as well as all of the other insightful thoughts you have provided on this thread! The value of your thoughts with regards to vaccines has been very helpful when trying to understand some of what is going on behind the scenes. 

Thanks for the kind words.  Over the last 30 years if I have not been cruising then I have spent a lot of time in R&D on a number of different vaccines.

[cangelmd]

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

 

AstraZeneca is on its way to having nearly 2 billion doses ready to go once they get approval (assuming mid-October, which is what it looks like right now).  400,000 million are earmarked for the US and UK.  The US & UK combined do not have 400 million citizens.  As of 2019. the total was 395 million.  Even though I'm sure the number has increased, those people who caused it to increased are all under a year old.....

 

I think we'll be good.  No need to play "Debbie Downer".  

 

8 minutes ago, TeeRick said:

They are testing multiple types of dosing protocols and booster times in the clinical trials.  Nothing has been really decided.  Far too early.

To answer another question that is floating around this thread, there is a group, probably an off-shoot or sub-committee of Drs Fauci and Birx’s team, that is working hard on the priorities for distributing the vaccine. I read that on a credible source, either major news outlet or Medscape, which is a “major news outlet” for physicians. I don’t remember the exact makeup of this group, but it was what you would expect- not just physicians, but also bioethicists, disaster planners, govt rep, etc, a mix of background. The questions they were reportedly debating were interesting too - beyond the obvious groups, like health care workers including paramedics, EMTs and nursing home employees, what about teachers? Food and power industries, especially where social distancing is problematic? Should race be considered and if so, how? Age? What is the contingency if the vaccine isn’t effective in elderly or children?

At least someone is systematically working through these questions.

 

 I know from reading these threads and talking to friends and family, there is a LOT of feeling that the US has just given up, and I’m not trying to say mistakes weren’t made, but some of those mistakes weren’t incompetence, just plain bad luck, exacerbated by our political climate and the US way of doing things and mindset (pure individualism without strong personal responsibility is not helpful in this situation). What you don’t know is that there is lots of work going on in the background by the govt, that won’t get reported in the mainstream press. Distribution of drug, and now I think we are going to get some testing kits and instruments, distribution of PPE, etc, after initial hiccups, are more equitable and sensible. I don’t think people in other countries, not even our good neighbors in Canada, truly understand how much harder it is to get things to happen in such a decentralized and profit based system as ours.

The next big scandal you are going to hear about will be over Remdesivir, distribution has been hard enough because once it gets to the hospital, by pharmacy laws and rules, I don’t think it is easy to pack it up and send to another hospital, and once the hospital starts having to pay, it will be a mess for awhile until it gets sorted out.

[TeeRick]

18 minutes ago, cangelmd said:

 

To answer another question that is floating around this thread, there is a group, probably an off-shoot or sub-committee of Drs Fauci and Birx’s team, that is working hard on the priorities for distributing the vaccine. I read that on a credible source, either major news outlet or Medscape, which is a “major news outlet” for physicians. I don’t remember the exact makeup of this group, but it was what you would expect- not just physicians, but also bioethicists, disaster planners, govt rep, etc, a mix of background. The questions they were reportedly debating were interesting too - beyond the obvious groups, like health care workers including paramedics, EMTs and nursing home employees, what about teachers? Food and power industries, especially where social distancing is problematic? Should race be considered and if so, how? Age? What is the contingency if the vaccine isn’t effective in elderly or children?

At least someone is systematically working through these questions.

 

 I know from reading these threads and talking to friends and family, there is a LOT of feeling that the US has just given up, and I’m not trying to say mistakes weren’t made, but some of those mistakes weren’t incompetence, just plain bad luck, exacerbated by our political climate and the US way of doing things and mindset (pure individualism without strong personal responsibility is not helpful in this situation). What you don’t know is that there is lots of work going on in the background by the govt, that won’t get reported in the mainstream press. Distribution of drug, and now I think we are going to get some testing kits and instruments, distribution of PPE, etc, after initial hiccups, are more equitable and sensible. I don’t think people in other countries, not even our good neighbors in Canada, truly understand how much harder it is to get things to happen in such a decentralized and profit based system as ours.

The next big scandal you are going to hear about will be over Remdesivir, distribution has been hard enough because once it gets to the hospital, by pharmacy laws and rules, I don’t think it is easy to pack it up and send to another hospital, and once the hospital starts having to pay, it will be a mess for awhile until it gets sorted out.

I am encouraged that such a group has been assembled and they are actively debating the various vaccine success scenarios.    I would expect nothing less from Dr Fauci and Dr Birx who I respect and admire.  A lot will depend on the type of vaccine, if easily distributed or not (does it require refrigeration as an example?), the required doses and frequency, and what age groups is it initially approved to treat?  All adults over 18?  All adults over 60?  Kids or no kids?  I would not expect initial vaccine trials to include infants and  kids under 18 from a safety perspective.  I think that will come later.  Fortunately this virus does not appear too serious in most healthy kids.  Maybe just test initially immunocompromised kids in separate focused safety trials for antibody responses?  It is all very complicated.  This type of effort usually takes years for very good reasons.

[lucymorgan]

1 hour ago, cangelmd said:

 

To answer another question that is floating around this thread, there is a group, probably an off-shoot or sub-committee of Drs Fauci and Birx’s team, that is working hard on the priorities for distributing the vaccine. I read that on a credible source, either major news outlet or Medscape, which is a “major news outlet” for physicians. I don’t remember the exact makeup of this group, but it was what you would expect- not just physicians, but also bioethicists, disaster planners, govt rep, etc, a mix of background. The questions they were reportedly debating were interesting too - beyond the obvious groups, like health care workers including paramedics, EMTs and nursing home employees, what about teachers? Food and power industries, especially where social distancing is problematic? Should race be considered and if so, how? Age? What is the contingency if the vaccine isn’t effective in elderly or children?

At least someone is systematically working through these questions.

 

 I know from reading these threads and talking to friends and family, there is a LOT of feeling that the US has just given up, and I’m not trying to say mistakes weren’t made, but some of those mistakes weren’t incompetence, just plain bad luck, exacerbated by our political climate and the US way of doing things and mindset (pure individualism without strong personal responsibility is not helpful in this situation). What you don’t know is that there is lots of work going on in the background by the govt, that won’t get reported in the mainstream press. Distribution of drug, and now I think we are going to get some testing kits and instruments, distribution of PPE, etc, after initial hiccups, are more equitable and sensible. I don’t think people in other countries, not even our good neighbors in Canada, truly understand how much harder it is to get things to happen in such a decentralized and profit based system as ours.

The next big scandal you are going to hear about will be over Remdesivir, distribution has been hard enough because once it gets to the hospital, by pharmacy laws and rules, I don’t think it is easy to pack it up and send to another hospital, and once the hospital starts having to pay, it will be a mess for awhile until it gets sorted out.

From Australia - I agree with you.  There is a "LOT of feeling that the US has just given up" and there is a lot of disappointment about this.   From visiting every year (and spending our dollars) my DH and I are sadly realising that it will be a very long time before we visit again and we are not feeling positive about supporting the US economy either.  There are reports that the US is trying to monopolize vaccinations which doesn't go down well here.  The anti vaxxers movement is also a factor.      

 

I take hydroxychloroquine and, as soon as I heard that it was being promoted as a cure in the US, I rushed out to refill my prescription so I have plenty (no you cannot have my address 😂).  When I got my flu shot the pharmacist told me that it was good I had filled my script because it was almost impossible to get.  Now the next 'great hope' touted by US commentators will take over and I will be able once again to fill my script.      

 

The whole situation is incredibly sad. 

 

Edited July 15, 2020 by lucymorgan

[UnorigionalName]

16 hours ago, Shadow9612 said:

@TeeRick I'd love to hear your thoughts on the efficacy of the antibody testing as well as recent news that antibody response is short lived...(eg levels decline or disappear within months)

 

I feel like people are being overly pessimistic about the vaccine.  I think people want it to fail so that the US won't look as stupid as it is.

 

The antibody response does potentially go away, but what does that mean?

 

- reinfection by COVID that causes a severe disease the second go around has not been yet described, and this far into the pandemic that is a very good sign

- It seems that those that get severe lung infections, get higher levels of titers that so far persist longer, possibly for years, so those people are probably somewhat safe

- We lose antibody titers for all other coronaviruses in a similar fashion to those with maybe weak covid infections

-  usually in other coronaviruses, there is limited data suggesting that future infections produce less severe symptoms, and higher antibody responses

-  probably after repeated responses, older people have more antibodies to other common-cold coronaviruses and you get less active infections as you get older

-  The titers produced so far by the current front runner vaccines are high and more similar in amount to those with deep lung infections, but unknown if it will persist

-  Unknown how effective the antibodies from the vaccine are compared with antibodies from a real deep lung infection

 

So you have to realize the number one goal is preventing mortality and permanent morbidity.  Maybe if you get the vaccine, and then lose the antibody titers, it turns out when you get covid, it turns into more of a normal common cold, with no mortality risk and no permanent damage to the body.  That would be a win, even if it means we can't monitor the antibodies.  Maybe it will turn out that with the correct dosing and the correct timing of multiple administrations, we can devise a vaccination strategy that will produce effective antibodies that least years.  And maybe that's all we need.  Maybe we can get rid of this thing for good if all countries try and like sars we won't have to worry about the same strain again.

 

or maybe the worst case scenario is you have to get the vaccine every few months for a few years till you get more durable antibodies.  I mean, that's not too horrible of a worst case scenario.

 

The real real worst case scenario of never being able to make a vaccine, like in HIV, does not seem like it is going to be true. Or the other real possible worst case scenario of vaccine worsening the disease (like some SARS models suggest) does not seem to be overly happening so far.

Edited July 15, 2020 by UnorigionalName

[npcl]

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

 

They're in the phase 2/3 right now.  Anticipation is that trails will be completed by September.  They're still on target for a mid-October release, assuming the FDA approves.  Though other countries probably won't need to wait as long as the US.

I think September my be a bit optimistic for trial completion.  If it is released by the end of the year I would expect it to be limited approval, such as for medical professionals, first responders, etc.

 

We still need to see what the efficacy is.  We also need to see how long the immunity remains. 

 

In additional we  should see what happens when someone gets infected, after they have had the vaccine, then have the immunity wear off. This is especially of concern if we see people tending to more severe symptoms the second time they are infected (as some cases have reported). Just to make sure we do not run into a situation like Sanofi did with their Dengue fever vaccine.  Now Dengue is pretty unique, but Corona viruses have some unique characteristics as well and so little is still known about COVID-19.

Edited July 15, 2020 by npcl