Are vaccines the light at the end of the tunnel?

[K.T.B.]

11 minutes ago, Threedrones said:

650,000 people die from the common flu every year worldwide. You are not required to show a flu shot before cruising.

 

This is NOTHING at all like the flu. And I wish people would stop comparing it to the flu. This year 39,000,000 – 56,000,000 people caught the flu resulting in 24,000 – 62,000 deaths (figures taken directly from CDC's site).  Whereas there has been approximately 5.1 million people who have caught Covid in the US with 164,000+ dying.

 

Comparing Covid-19 with the flu is dangerous and ignorant.  By the way, global deaths from influenza for 2019 were approximated at 389,000 (uncertainty range 294 000-518 000).  In 2017 the upper range was your figure, with the lower range being 290,000, but again it was an approximate.  Worldwide cases usually hit about the 1 billion mark for the flu.  Current Covid cases are about 19.6 million.  A freakin' HUGE difference.

 

So, please, just stop.

[ch175]

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

 

Why not?  This is a pandemic.  Keeping people healthy and safe and alive is what matters. 725,000 dead worldwide is no joke.

That is a big number for sure. But you need to put it in perspective.

 

7 million people worldwide die of tobacco-related causes every year. Those deaths are 100% preventable. Where is the outrage over that?

 

As of July, the CDC reported that the median age of people who died from COVID was 78. Current life expectancy in the US? 78.54.

 

Of course I don’t want people to get this and die. Or get this and go through the misery of dealing with it for a few weeks. But I look at the numbers, and I value being able to work, be with family, and live life as being a huge factor as far as being healthy and safe. I just take some precautions that I didn’t a year ago. 

[K.T.B.]

14 minutes ago, ch175 said:

That is a big number for sure. But you need to put it in perspective.

 

7 million people worldwide die of tobacco-related causes every year. Those deaths are 100% preventable. Where is the outrage over that?

 

As of July, the CDC reported that the median age of people who died from COVID was 78. Current life expectancy in the US? 78.54.

 

Of course I don’t want people to get this and die. Or get this and go through the misery of dealing with it for a few weeks. But I look at the numbers, and I value being able to work, be with family, and live life as being a huge factor as far as being healthy and safe. I just take some precautions that I didn’t a year ago. 

 

Smoking is a choice, catching Covid is not.  1.35 million people are killed on roadways worldwide.  800,000 people die from suicide every year.  I could go on and on and on, but so what?  Smoking, driving, committing suicide.... you cannot "catch" those by being breathed on by someone.  You cannot spread those unknowingly to someone else.  Trying to use the deaths of something else does NOT lessen the danger of Covid-19.  So people really need to just stop by saying, "Yeah, but..."

 

By the way, IQR is 67–87 years.  My wife is 73 and I'm 57.  So, yeah, I take this stuff seriously.

[npcl]

7 hours ago, Mark_T said:

 

The Oxford vaccine is already in phase III testing, the discussion about challenge testing is not a replacement for large scale testing in this case but it is a way of dealing with the problems that occur when the prevalence of the virus in the wild drops to a point where you can't reasonably assume that enough individuals are getting exposed...

 

Challenge testing has also been suggest for other vaccine candidates to help determine if they are effective enough to take to large scale phase III testing, that is more contentious I would say.

 

Keep in mind that anyone involved in a challenge trial is fully informed and knows what they are getting into and still wants to proceed with the trial, nobody is going to find themselves on such a trial without that disclosure.

Yes it is in phase 3 testing in a very early stage, but the only reason that anyone would want to do a challenge trial is because they do not want to wait for the stage 3 trials to complete.  After all if you are waiting for the phase 3 data than no need for the challenge trial. The only reason for doing the challenge trial is to use that to say it works to rush it into use. That means not waiting for the information in the phase 3 population.  Information on safety, immune response in different populations, and potential impacts like ADE or ERD. Especially for a technology that has not been used before. Same with Moderna's approach.

 

Coronavirus vaccine developers wary of errant antibodies

https://www.nature.com/articles/d41587-020-00016-w

 

You simply do not bypass sound procedures, the time they take, the information they gather, with a challenge trial, which in a disease of this kind tend to be counter to medical ethics.

 

This sounds more like a researcher who thinks their solution is wonderful and is  focused on being first (based upon this comment as well as some other unprofessional comments made concerning their competition in the vaccine race) than sound practice.

 

Then you have the issue of do you keep challenging the test group each month until they finally get the illness to see how long the immunity lasts.  After all a single challenge does not tell you much. Duration of immunity is one of the sets of data that comes from the phase 3 trial.

 

Then you have the question of informed consent. Take a group of predisposed individuals, give them a consent form with the risks (most of which would not be understood to someone that is not a medical professional) other than at a level you could catch the disease and die. But in an environment of the disease is low risk, and if they were not sure it was safe they would not be doing this.  In those cases is it really informed consent.  You can get some people to volunteer for almost anything. It is also one of the reasons that you do not do challenge trials like this.

 

There have been issues with vaccines in viruses studied far longer and far better understood than COVID-19. Do a search for Dengue Fever vaccine deaths.  They were pretty positive about their vaccine as well.

 

There is a lot we do not know about COVID-19, especially with a lot of the damage being cause by the response of the immune system itself. There is also the inflammation syndrome in children that sometimes appears a few weeks after a minor infection.

 

No the last thing we want to do is to bypass the time needed for a well run phase 3 clinical trial.

Edited August 8, 2020 by npcl

[npcl]

3 hours ago, ch175 said:

That is a big number for sure. But you need to put it in perspective.

 

7 million people worldwide die of tobacco-related causes every year. Those deaths are 100% preventable. Where is the outrage over that?

 

As of July, the CDC reported that the median age of people who died from COVID was 78. Current life expectancy in the US? 78.54.

 

Of course I don’t want people to get this and die. Or get this and go through the misery of dealing with it for a few weeks. But I look at the numbers, and I value being able to work, be with family, and live life as being a huge factor as far as being healthy and safe. I just take some precautions that I didn’t a year ago. 

As far as smoking there seem to be a lot of outrage, and a lot of laws passed to reduce the death toll and in many places make it quite annoying, as well as expensive, on the smokers to continue smoking.  Yet they still do making many of the same claims about their choice as are many made about wearing masks and doing social distancing  to prevent infection. In spite of the best efforts to save lives some still go out of their way to help kill themselves slowly.

 

As far as putting into perspective if COVID-19 is not controlled and everyone were to get infected then based upon current numbers between 1.7 and 3.4 million in the US would die.  Getting pretty close to your world wide smoking number.  Fortunately as of yet only a small percentage of the US population has been infected and many are working to keep that so.

 

The number might even be higher because with controls we have kept the hospitals from getting overwhelmed. Drop the controls and that is not likely to be the situtation.

 

The reality is that as a society we have worked to prevent unnecessary death, spending large amounts of effort and money to do so.  We have put laws in place (smoking, seatbelts, helmets, etc) to prevent as many as possible.  For that matter 50% of the medicare budget in the US is spent on last year of life care.  We spend millions in ICU to keep the failing elderly alive a few days longer.

[cl.klink]

Why the seatbelt metaphor may not be best: https://www.deseret.com/opinion/2020/7/17/21327346/guest-opinion-covid-19-seat-belt-analogy-wear-mask-mandate-public-health-pandemic-liberty-safety

 

- Joel

[Fouremco]

1 hour ago, cl.klink said:

Why the seatbelt metaphor may not be best: https://www.deseret.com/opinion/2020/7/17/21327346/guest-opinion-covid-19-seat-belt-analogy-wear-mask-mandate-public-health-pandemic-liberty-safety

 

- Joel

In support of his argument, the author states that "the seat belt analogy is perhaps less illuminating than the analogy of drunken or impaired driving. If I were to choose to drink to the point of intoxication and then get behind the wheel, I have chosen to cede my agency to an external force — the alcohol — which then works through me and may inflict harm upon others." He's forgotten that there is in fact an external force that one chooses to cede one's agency to when foregoing the use of seatbelts: inertia. 

[phoenix_dream]

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

 

This is NOTHING at all like the flu. And I wish people would stop comparing it to the flu. This year 39,000,000 – 56,000,000 people caught the flu resulting in 24,000 – 62,000 deaths (figures taken directly from CDC's site).  Whereas there has been approximately 5.1 million people who have caught Covid in the US with 164,000+ dying.

 

Comparing Covid-19 with the flu is dangerous and ignorant.  By the way, global deaths from influenza for 2019 were approximated at 389,000 (uncertainty range 294 000-518 000).  In 2017 the upper range was your figure, with the lower range being 290,000, but again it was an approximate.  Worldwide cases usually hit about the 1 billion mark for the flu.  Current Covid cases are about 19.6 million.  A freakin' HUGE difference.

 

So, please, just stop.

100% agree.  The differences are many.  This virus is significantly more contagious.  This virus can be easily spread by asymptomatic people for days, which is not the case with the flu (someone coming down with the flu may spread for a day or two before it fully breaks out, but not weeks).   If you get the flu, you know you have it.  With this virus you may never show any symptoms, or you may have very mild symptoms which you attribute to something else.  In the meantime you are exposing untold numbers of others.  This virus is significantly more deadly.  They are also learning that this virus can cause serious health issues for people weeks, months, and possibly permanently.  That is generally not the case with the flu.

 

Please, please, people gather all the available data before you make judgments.  Or for that matter, perhaps you might want to consider the opinions of scientists and medical specialists who have been trained for years to make a better evaluation than you can by reading articles on Facebook or Google searches.  This is not one person or one political party making claims.  This is hundreds of knowledgeable scientists and doctors around the world.  

[Threedrones]

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

 

This is NOTHING at all like the flu. And I wish people would stop comparing it to the flu. This year 39,000,000 – 56,000,000 people caught the flu resulting in 24,000 – 62,000 deaths (figures taken directly from CDC's site).  Whereas there has been approximately 5.1 million people who have caught Covid in the US with 164,000+ dying.

 

Comparing Covid-19 with the flu is dangerous and ignorant.  By the way, global deaths from influenza for 2019 were approximated at 389,000 (uncertainty range 294 000-518 000).  In 2017 the upper range was your figure, with the lower range being 290,000, but again it was an approximate.  Worldwide cases usually hit about the 1 billion mark for the flu.  Current Covid cases are about 19.6 million.  A freakin' HUGE difference.

 

So, please, just stop.

 

[Threedrones]

I’m sorry you did not comprehend what I posted. I was not comparing Covid to the flu. I was pointing out facts from W.H.O. and the Lancet medical journal about the number of people who die from the flu on a worldwide basis, and the fact that a flu shot is not required to cruise. I NEVER mentioned Covid. YOU DID!  The upper range you cite was actually adjusted recently to 646,000. That is addressed in the previously mentioned sources. Covid 19 is also a new virus. If you want to compare numbers, which apparently you do though I did not, maybe you should wait until established treatments are perfected. Numbers for ANY infectious disease will be highest when it first appears on the scene. YOU are the person who made the comparison. So, please, just stop.

[cangelmd]

On 8/6/2020 at 9:06 PM, Fouremco said:

Absolutely! Vaccination, with proof, is an absolute necessity to get me back aboard.

Lord I hope we don’t have to prove all vaccinations! I was raised so far out in the sticks that I didn’t get a lot of the vaccines - yes to polio and smallpox (remember how that worked?). - no to the other childhood ones. I still don’t know if I ever had the mumps lol!

[cangelmd]

4 hours ago, npcl said:

Yes it is in phase 3 testing in a very early stage, but the only reason that anyone would want to do a challenge trial is because they do not want to wait for the stage 3 trials to complete.  After all if you are waiting for the phase 3 data than no need for the challenge trial. The only reason for doing the challenge trial is to use that to say it works to rush it into use. That means not waiting for the information in the phase 3 population.  Information on safety, immune response in different populations, and potential impacts like ADE or ERD. Especially for a technology that has not been used before. Same with Moderna's approach.

 

Coronavirus vaccine developers wary of errant antibodies

https://www.nature.com/articles/d41587-020-00016-w

 

You simply do not bypass sound procedures, the time they take, the information they gather, with a challenge trial, which in a disease of this kind tend to be counter to medical ethics.

 

 

Then you have the issue of do you keep challenging the test group each month until they finally get the illness to see how long the immunity lasts.  After all a single challenge does not tell you much. Duration of immunity is one of the sets of data that comes from the phase 3 trial.

 

Then you have the question of informed consent. Take a group of predisposed individuals, give them a consent form with the risks (most of which would not be understood to someone that is not a medical professional) other than at a level you could catch the disease and die. But in an environment of the disease is low risk, and if they were not sure it was safe they would not be doing this.  In those cases is it really informed consent.  You can get some people to volunteer for almost anything. It is also one of the reasons that you do not do challenge trials like this.

 

There have been issues with vaccines in viruses studied far longer and far better understood than COVID-19. Do a search for Dengue Fever vaccine deaths.  They were pretty positive about their vaccine as well.

 

 

No the last thing we want to do is to bypass the time needed for a well run phase 3 clinical trial.

Would a challenge trial be ethically acceptable for a vaccine developed with standard technology?

Note: I’m not arguing for one, I’m not sure in the modern understanding of biomedical ethics, if there is a scenario where a challenge trial for a vaccine would be acceptable... maybe if the masking, distancing and hand washing clearly wasn’t slowing viral transmission...

[Fouremco]

51 minutes ago, cangelmd said:

Lord I hope we don’t have to prove all vaccinations! I was raised so far out in the sticks that I didn’t get a lot of the vaccines - yes to polio and smallpox (remember how that worked?). - no to the other childhood ones. I still don’t know if I ever had the mumps lol!

To solve the problem of proof, I modestly propose that we start injecting vaccine recipients with a subcutaneous RFID chip contain containing the related information. It could be updated when additional vaccinations are received, and once the trend is established, we could add medical records and other biodata. Everything from your driver's licence to your passport could be added too.  Cruise lines could piggyback on the idea by adding the necessary data to your chip when you check in, eliminating the need for a SeaPass. 😷

[Mark_T]

6 hours ago, npcl said:

Yes it is in phase 3 testing in a very early stage, but the only reason that anyone would want to do a challenge trial is because they do not want to wait for the stage 3 trials to complete. 

 

It is not the only reason though, the other consideration is the prevalence of the virus in the wild.

 

If the current measures being taken are successful in reducing transmission and/or if there is a mutation to a less contagious form as has happened with some other viruses, it may prove impossible to conduct a meaningful stage 3 trial and effectively stall any progress towards approval.

 

From what I've read so far I don't think the team are aggressively seeking to run a challenge trial but I'm not convinced that such a trial is inherently a bad idea, we already routinely perform such a trial on non-consenting primates, it doesn't seem unreasonable to at least consider doing it with informed and willing humans...  

Edited August 8, 2020 by Mark_T

[K.T.B.]

5 hours ago, Threedrones said:

I’m sorry you did not comprehend what I posted. I was not comparing Covid to the flu. I was pointing out facts from W.H.O. and the Lancet medical journal about the number of people who die from the flu on a worldwide basis, and the fact that a flu shot is not required to cruise. I NEVER mentioned Covid. YOU DID!  The upper range you cite was actually adjusted recently to 646,000. That is addressed in the previously mentioned sources. Covid 19 is also a new virus. If you want to compare numbers, which apparently you do though I did not, maybe you should wait until established treatments are perfected. Numbers for ANY infectious disease will be highest when it first appears on the scene. YOU are the person who made the comparison. So, please, just stop.

 

You most certainly were comparing, otherwise why even mention then flu?  Especially in a thread where the discussion is about a vaccine for Covid-19.

[npcl]

4 hours ago, cangelmd said:

Would a challenge trial be ethically acceptable for a vaccine developed with standard technology?

Note: I’m not arguing for one, I’m not sure in the modern understanding of biomedical ethics, if there is a scenario where a challenge trial for a vaccine would be acceptable... maybe if the masking, distancing and hand washing clearly wasn’t slowing viral transmission...

Usually it is not a matter of the technology as it is more the nature of the disease.  I have seen challenge trails done as part of research on the common cold.  The FDA guidance document describes one that  was approved in 1998 for Cholera for a vaccine for travelers passing though a potential problem area (not an easy trial to conduct)  That trial was applied for in 1993 and finally approved in 1998. After 2 different medical advisory boards met on the subject. 

 

That is for fairly well known illness with a pretty good knowledge of  therapies where risk is minimal even if someone develops the disease in a medical setting.. Though I do not know for sure if a challenge trial was ever conducted.  I will have to look into it.

 

The biggest problem is this case is you are dealing with a potentially fatal illness, caused by a new virus, of which very little is known, and for which no effective treatment exists.

 

From the FDA guidance document

https://www.fda.gov/files/vaccines, blood & biologics/published/Guidance-for-Industry--General-Principles-for-the-Development-of-Vaccines-to-Protect-Against-Global-Infectious-Diseases.pdf

In some situations, it may be possible to conduct challenge studies in human subjects during early development or in lieu of clinical trials in an endemic area. Such studies may be conducted to demonstrate “proof of concept” of the vaccine antigen early inclinical development (e.g., Plasmodium falciparum sporozoite challenge of malaria-naïve U.S. volunteers previously administered a candidate malaria vaccine).

 

Of note, use of challenge studies to demonstrate efficacy does not preclude the requirement for adequate safety data. As human challenge studies may present unique considerations, we recommend that the sponsor discuss its development plan with CBER prior to initiation of such studies for either proof of concept or vaccine efficacy.

 

 

[npcl]

5 hours ago, cangelmd said:

Would a challenge trial be ethically acceptable for a vaccine developed with standard technology?

Note: I’m not arguing for one, I’m not sure in the modern understanding of biomedical ethics, if there is a scenario where a challenge trial for a vaccine would be acceptable... maybe if the masking, distancing and hand washing clearly wasn’t slowing viral transmission...

Here is something you might find interesting detailing considerations with the ethics of clinical trials

 

https://clinicalcenter.nih.gov/recruit/ethics.html

 

Some of the influential codes of ethics and regulations that guide ethical clinical research include:

• Nuremberg Code (1947)
• Declaration of Helsinki (2000)
• Belmont Report  (1979)
• CIOMS (2002)
• U.S. Common Rule (1991)

Using these sources of guidance and others, seven main principles have been described as guiding the conduct of ethical research:

• Social and clinical value
• Scientific validity
• Fair subject selection
• Favorable risk-benefit ratio
• Independent review
• Informed consent
• Respect for potential and enrolled subjects

 

[npcl]

3 hours ago, Mark_T said:

 

It is not the only reason though, the other consideration is the prevalence of the virus in the wild.

 

If the current measures being taken are successful in reducing transmission and/or if there is a mutation to a less contagious form as has happened with some other viruses, it may prove impossible to conduct a meaningful stage 3 trial and effectively stall any progress towards approval.

 

From what I've read so far I don't think the team are aggressively seeking to run a challenge trial but I'm not convinced that such a trial is inherently a bad idea, we already routinely perform such a trial on non-consenting primates, it doesn't seem unreasonable to at least consider doing it with informed and willing humans...  

You notice that no one has done challenge trials with the MERS vaccine candidates which is certainly rare in the wild so to speak.

 

You woud have to go a long way before you reached the point where you could not conduct a clinical trial on this outbreak. If it got so rare that you not conduct a clinical trial then like SARS the need has gone away as well.  In which case the vaccine candidate would stay on the shelf pending another outbreak, just as the one for SARS sits.

 

A lot of labs do not do primate testing anymore either.

[Mark_T]

5 hours ago, npcl said:

You notice that no one has done challenge trials with the MERS vaccine candidates which is certainly rare in the wild so to speak.

 

True, but that is precisely why it is being talked about now, the Oxford vaccine was based on a MERS candidate which is how it got started as quickly as it did but the low prevalence of MERS has prevented the original candidate progressing to approval.

 

We still know far too little about Covid-19 but AFAIK the possibility of challenge trials was raised originally in the context of a seasonal or at least periodic disappearance and strong reoccurrence pattern, but if that doesn't happen then the debate around challenge trials becomes moot as they should not be needed. 

[Threedrones]

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

 

You most certainly were comparing, otherwise why even mention then flu?  Especially in a thread where the discussion is about a vaccine for Covid-19.

Why mention the flu? Because the OP was talking about vaccines being necessary to cruise. 

[phoenix_dream]

18 hours ago, Fouremco said:

To solve the problem of proof, I modestly propose that we start injecting vaccine recipients with a subcutaneous RFID chip contain containing the related information. It could be updated when additional vaccinations are received, and once the trend is established, we could add medical records and other biodata. Everything from your driver's licence to your passport could be added too.  Cruise lines could piggyback on the idea by adding the necessary data to your chip when you check in, eliminating the need for a SeaPass. 😷

Please tell me you wrote this tongue in cheek.  Please.

[Fouremco]

1 minute ago, phoenix_dream said:

Please tell me you wrote this tongue in cheek.  Please.

LOL. I guess you missed the smile behind the mask! 

[markeb]

1 minute ago, phoenix_dream said:

Please tell me you wrote this tongue in cheek.  Please.

 

He did. And the chips don't have enough room to actually store that kind of data...

 

You should look up the rabies testing and microchip requirements to import a dog or cat into Hawaii...

[phoenix_dream]

1 minute ago, Fouremco said:

LOL. I guess you missed the smile behind the mask! 

Yep, my old eyes can't read emojis that small.  I assumed you were based on your other posts, but these days with some of the opinions floating around it gets scary.  There would probably be some who thought you had a great idea!

[Fouremco]

5 minutes ago, phoenix_dream said:

There would probably be some who thought you had a great idea!

There are thousands of Swedes who jumped on this concept some time ago. You'll find some interesting reading if you Google the subject, including this older article: https://www.npr.org/2018/10/22/658808705/thousands-of-swedes-are-inserting-microchips-under-their-skin