EYESAILOR

When offered the Vaccine, will you take it?

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The private sector has embarked on a major campaign to reassure the public that they will not release a vaccine until they are confident it is safe and effective. We can expect a joint statement from Pfizer J and J and Moderna in the next day or so. https://www.courant.com/coronavirus/ct-nw-nyt-vaccines-drug-companies-safety-statement-20200905-2hehhsrbgfgmdlax6dn3nrzmey-story.html

Yet various polls indicate that there is a possible reluctance to take the vaccine  https://www.vox.com/science-and-health/21364099/covid-19-vaccine-hesitancy-research-herd-immunity.

  What is your personal stance? and why?

I will start the ball rolling and give my personal reasons why I will be enrolling for the vaccine as soon as possible.

I am an MD, Harvard fellow and on staff in a reasonably per-eminent hospital system in the North East. My specialty is not infectious disease. These are my personal opinions and not the opinions of any medical organization or authority.

  • A successful preliminary phase 3 trial will either result in approval or Emergency use Authorization. I will accept a vaccination in either case.
  • I am not worried about safety. The current leading contenders have been in clinical trials on humans since April. If there are any material adverse effects they will have been indications by now. Phase 3 trials have included large sample sizes across most demographics.
  • There are over 100 vaccines in trials and I realize there may be more effective vaccines down the road. Medicine is a continually evolving science. I prescribe different drugs than I prescribed 5 years ago. There will always be something better. I will recommend patients go with the best that is available now. This applies to my attitude to the CV19 vaccines.
  • It is better to be safe now.  I have personally seen the side effects of CV19. I do not want to get sick. I want protection as soon as it is available.
  • I want to travel and work in safety. I want to visit restaurants and eat indoors in safety.  I want to go to concerts and parties again. I believe that mankind is a social animal and that social distancing, working fr0m home 7 days a week is damaging our psyche and moral.    
  • The economy is hurting and will never fully recover until society is immune from CV19. The longer it goes on, the more lasting the damage. I want to do my bit to build an immune population.         
  • We do not know the length of efficacy of the vaccines until they have been in 3 and even 7 year trials.  As long as it is effective now for a few months  a widely applied vaccine will largely and potentially completely eliminate CV19 .  
  • I want to lead by example. As an MD I will study the results of the phase 3 trials and if I find them credible, then I can tell my friends that I am vaccinated and feel good about the decision....and my judgement will likely be respected and more people will sign up.
  • The key to eliminate the disease from our daily lives is for as many people to be vaccinated as possible

  So stick that needle in my arm Baby, I am ready.

What about you?                                                                                                                                                      

Eye                                                                                                                                                                                                                                                                                                                                      

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From the article you cited:

Quote

In tweets and public comments, Trump has explicitly tied his reelection fortunes to a vaccine, an idea detailed last week at the Republican National Convention, where promotional videos featured the administration’s efforts to fund and develop one in its crash program called Operation Warp Speed.

Trump campaign advisers have privately called a preelection vaccine “the holy grail.”

Everyone wants to get back to normal.  Several of your points appeal to that universal desire but they are totally irrelevant to whether or not a vaccine is safe and effective.  Your last point ("The key to eliminate the disease from our daily lives is for as many people to be vaccinated as possible") simply isn't true.

Your professional reputation is on the line, don't blow it by letting your enthusiasm cloud your judgement.

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29 minutes ago, EYESAILOR said:

The private sector has embarked on a major campaign to reassure the public that they will not release a vaccine until they are confident it is safe and effective. We can expect a joint statement from Pfizer J and J and Moderna in the next day or so. https://www.courant.com/coronavirus/ct-nw-nyt-vaccines-drug-companies-safety-statement-20200905-2hehhsrbgfgmdlax6dn3nrzmey-story.html

Yet various polls indicate that there is a possible reluctance to take the vaccine  https://www.vox.com/science-and-health/21364099/covid-19-vaccine-hesitancy-research-herd-immunity.

  What is your personal stance? and why?

I will start the ball rolling and give my personal reasons why I will be enrolling for the vaccine as soon as possible.

I am an MD, Harvard fellow and on staff in a reasonably per-eminent hospital system in the North East. My specialty is not infectious disease. These are my personal opinions and not the opinions of any medical organization or authority.

  • A successful preliminary phase 3 trial will either result in approval or Emergency use Authorization. I will accept a vaccination in either case.
  • I am not worried about safety. The current leading contenders have been in clinical trials on humans since April. If there are any material adverse effects they will have been indications by now. Phase 3 trials have included large sample sizes across most demographics.
  • There are over 100 vaccines in trials and I realize there may be more effective vaccines down the road. Medicine is a continually evolving science. I prescribe different drugs than I prescribed 5 years ago. There will always be something better. I will recommend patients go with the best that is available now. This applies to my attitude to the CV19 vaccines.
  • It is better to be safe now.  I have personally seen the side effects of CV19. I do not want to get sick. I want protection as soon as it is available.
  • I want to travel and work in safety. I want to visit restaurants and eat indoors in safety.  I want to go to concerts and parties again. I believe that mankind is a social animal and that social distancing, working fr0m home 7 days a week is damaging our psyche and moral.    
  • The economy is hurting and will never fully recover until society is immune from CV19. The longer it goes on, the more lasting the damage. I want to do my bit to build an immune population.         
  • We do not know the length of efficacy of the vaccines until they have been in 3 and even 7 year trials.  As long as it is effective now for a few months  a widely applied vaccine will largely and potentially completely eliminate CV19 .  
  • I want to lead by example. As an MD I will study the results of the phase 3 trials and if I find them credible, then I can tell my friends that I am vaccinated and feel good about the decision....and my judgement will likely be respected and more people will sign up.
  • The key to eliminate the disease from our daily lives is for as many people to be vaccinated as possible

  So stick that needle in my arm Baby, I am ready.

What about you?                                                                                                                                                      

Eye                                                                                                                                                                                                                                                                                                                                      

I am a PhD Bioengineer, a serial entrepreneur, and affiliate faculty at a large public university. I dearly want there to be a safe and effective vaccine as soon as possible. I also believe that the CDC and FDA are under the leadership of corrupt political appointees. I further see evidence of corruption in the insider trading patterns of the Moderna executives and, for biological reasons, I'm skeptical of the persistence of immunity generated by RNA vaccines as a class. Given the above, I will:

1. strongly favor a live attenuated or modified live virus vaccine over an RNA vaccine

2. strongly favor a vaccine from a major pharma over a Moderna or other biotech without experience in manufacturing and distributing a vaccine at scale

3. favor a European pharma vaccine over a US pharma vaccine

4. demand to inspect the published Phase III trial result data before accepting any vaccine (no publication, no jab)

5. wait for several million people and several weeks to pass to validate the Phase III results in a larger and more diverse population

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common sense tells me that the haste is prone to errors .

I will not be in the first batch .

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My partner is a MD PhD clinician in a major academic medicine hospital. 
 

I will accept a vaccine provided that the trial results are public and verifiable by impartial expertise. 

My personal risk isn’t high but 1) I have older friends I don’t want to infect and 2) I would like to get on without being in a virtual silo with my partner because of her line of work. 

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I would like to accept a vaccine, but I wonder what level of effectiveness is really useful for me? 

If I am able to comfortably but wistfully carry on as I have been, never socializing or going anywhere, for another 6 months or year, should I wait to see what is the most effective vaccine?

I am high risk due to age and conditions as is Mr Clew. We doubt a 50% or 70% effective vaccine would let me get my nails done, let alone travel long distances by air, safely and happily. Am I wrong? 

Given vaccine refusals cannot count on others around being vaccinated. Only half or so get flu vaccine iirc.

If we got a first vaccine, is there a medical reason we could not get a different, better one later? That's a worry. Part of the consent statement for one phase 3 trial said "may affect your ability to get another vaccine."

 

 

 

 

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12 minutes ago, NeedAClew said:

I would like to accept a vaccine, but I wonder what level of effectiveness is really useful for me? 

If I am able to comfortably but wistfully carry on as I have been, never socializing or going anywhere, for another 6 months or year, should I wait to see what is the most effective vaccine?

I am high risk due to age and conditions as is Mr Clew. We doubt a 50% or 70% effective vaccine would let me get my nails done, let alone travel long distances by air, safely and happily. Am I wrong? 

Given vaccine refusals cannot count on others around being vaccinated. Only half or so get flu vaccine iirc.

If we got a first vaccine, is there a medical reason we could not get a different, better one later? That's a worry. Part of the consent statement for one phase 3 trial said "may affect your ability to get another vaccine."

 

 

 

 

In the case of covid, a vaccine’s “effectiveness” may also have to consider whether the your immune system, being taught to produce antibodies targeting covid19 - can help you have a mild case of it if you come into contact with covid19 in the wild. 
 

We don’t know yet - but “effectiveness” isn’t just about no observable illness. 

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Yeah but if the young and vigorous in the trial end up showing one is 50% effective not getting symptomatic disease that's not much for me. I can't flip a coin and travel. My goal is not to get sick on a liveaboard.

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6 hours ago, EYESAILOR said:

If there are any material adverse effects they will have been indications by now.

There may have been indications by now, but there is nothing telling us that such indications would be ethically reported.

Your statement shows a high level of naivete and trust in some sketchy companies with sketchy executives with oversight by sketchy political appointees.  

 

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32 minutes ago, NeedAClew said:

if the young and vigorous in the trial end up showing one is 50% effective not getting symptomatic disease

Its pretty much 100% effective for symptoms in this group before they get the jab, its antibodies they want to see so people supposedly won't pass it on if exposed.

A treatment that is effective at reducing the severity of symptoms would be just as good, but that's not as lucrative.

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 Not really just as good for me. I want them not to get infected so they don't spead it. 

And I want ME not to get infected in a herd of young barhopping hookeruppers and older loser TrumpCovidians at the airport, on the planes, in my doctor's office, at the spa. So I want something better than the seasonal flu vaccine. And sincecI am old with lots of discretionary income, I will pay lots.

 

 

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A good discussion so far. I think we just don't know enough now to make a definitive judgment. The experts will come at the appropriate time and tell us what is what. I would not be in the first cohort eligible for vaccination but would be in the second. I will get it if the general feeling is positive.

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1 hour ago, MR.CLEAN said:

There may have been indications by now, but there is nothing telling us that such indications would be ethically reported.

Your statement shows a high level of naivete and trust in some sketchy companies with sketchy executives with oversight by sketchy political appointees.  

 

If you sincerely believe the FDA phase 1-2 process has been compromised, then the game is up and we might as well start heil trump before the purge lists start getting published. 

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Yes. Abso-fucking-lutely. That question shouldn't even be needed. But only when it's been given the big red rubber stamp of approval. 

 

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7 hours ago, IStream said:

 

5. wait for several million people and several weeks to pass to validate the Phase III results in a larger and more diverse population

^^^^This. I don't know what the Russians are doing, but they seem to be playing with fire. With your background could you enlighten us on Sputnik-V? I have (a bit) of a physics background so all this shit about biology/medicine might as well be black magic for me. I just know they save millions of lives and myself included if I take the jabs properly and on time. 

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 I'll be taking it.

Depending on who develops the available vaccine, I don't think I'd trust anything coming out of the USA or Russia.

Other countries are well on the way through phase 3 trials. 

I work in a high risk area.

But apart from that, some have to step forward and take the "risk" so we can start to let the younger ones out to continue to work, pay their mortgages, get  the economy going etc and my age cohort is on the lower edge of those most at risk and also mostly reasonably healthy. (early 60's)

Time for us Boomers to step up to the plate IMHO.

The lockdowns and restrictions were largely for our benefit. Time to give something back. We can be the first Vac guinea pigs.

 

 

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Nice sentiment. Our younger ones are already living their lives now, roads are busy, shopping center parking lots full. White collar office buildings are empty because they work remotely and have been paid all along. Who has lost are personal service businesses and restaurants and a lot of those won't come back. But others will start. So there are permanent distributional effects.

But sorry, not going to be a guinea pig so the asshats having a house party across the street today can benefit. Or the ones with 50 kids in a bouncy house around the corner. 

They already decided not to benefit me so f em. I will wait for the good stuff.

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And yeah it's harsh and selfish of me but remember here in maskdivided America, half those youngsters yearning for "open up your legs and gyms" aren't getting vaccinated or getting their kids vaccinated. Autism, hair loss, sore arm, because liberty, it's a sign of weakness, or whatevers.

 

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certainly NOT a chinese vaccine...

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1 hour ago, Shortforbob said:

 I'll be taking it.

Depending on who develops the available vaccine, I don't think I'd trust anything coming out of the USA or Russia.

Other countries are well on the way through phase 3 trials. 

I work in a high risk area.

But apart from that, some have to step forward and take the "risk" so we can start to let the younger ones out to continue to work, pay their mortgages, get  the economy going etc and my age cohort is on the lower edge of those most at risk and also mostly reasonably healthy. (early 60's)

Time for us Boomers to step up to the plate IMHO.

The lockdowns and restrictions were largely for our benefit. Time to give something back. We can be the first Vac guinea pigs.

 

 

 

56 minutes ago, NeedAClew said:

Nice sentiment. Our younger ones are already living their lives now, roads are busy, shopping center parking lots full. White collar office buildings are empty because they work remotely and have been paid all along. Who has lost are personal service businesses and restaurants and a lot of those won't come back. But others will start. So there are permanent distributional effects.

But sorry, not going to be a guinea pig so the asshats having a house party across the street today can benefit. Or the ones with 50 kids in a bouncy house around the corner. 

They already decided not to benefit me so f em. I will wait for the good stuff.

read the bolded bits.

I certainly won't be taking anything that has been developed in the USA.

There will be "good stuff" coming out from elsewhere not far behind.

Besides, I think the worst thing about the first vaccines will be that they simply don't work terribly well.

So, you have another one later.

I've got two twenty somethings.. They are doing the right thing here in hard lock down Melbourne..as are all of their friends.

They've lost jobs, can't find work, can't have a normal "twenty something" life that WE all enjoyed UNTIL there is trust in a Vaccine.

We boomers need to lead. We are not significant at risk of the usual worries, we've had our kids, we are not going to be bearing children with tiny little batwings :D

I'd like to show them that us boomers are not the selfish generation they often think we are.

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6 hours ago, MR.CLEAN said:

There may have been indications by now, but there is nothing telling us that such indications would be ethically reported.

Your statement shows a high level of naivete and trust in some sketchy companies with sketchy executives with oversight by sketchy political appointees.  

 

Clean,

With the utmost respect....I have been a contributor to these forums for well over a decade. You know as well as anyone that I have never been known for naivete.

In this case your cynicism does sit with the Clean that I know so well.  There are times and places for  cynicism and discord. This honestly is not one of them. 

Pfizer is not a sketchy company.

Moderna is not a sketchy company or sketchy science. I have many former colleagues , good people, working there, working incredibly long hard hours for us....for you, for Mer, for your kids. They want to solve this . They may or may not produce the ultimately successful vaccine  but mRNA is real science with the prospect of real breakthroughs in vaccine development.  Moderna is an epicenter of mRNA research and it represents something that is great about American innovation and the funding of innovation. Yes, Stefan can come across as someone who over-promises but dont confuse his optimism and drive for "sketchy"....he is one of the most passionate and driven people that you wll meet - You would like him.....lets get him into sailing....he never does anything by half measures.

Astra Zeneca is not a sketchy company, nor is Regeneron , nor is Gilead.

Also ...a shout out to the folks at Roche Diagnostics USA  .....for their incredible (and underappreciated) 14 days of 23 hour days (literally getting 1 or 2 hours sleep) in the early stages of CV 19 getting us tests in the tri-state area when CDC let us down.

I digress.  Pfizer is shooting for preliminary phase 3 update in October. They are shooting for such a demanding schedule not due to any political deadline but because they think it can be done and they (like many of us) feel a sense of urgency .

When do we put our partisan cynicism aside and say "thank you" .   Its easy to dismiss the faceless companies but there are real people doing the work and they are not enjoying a long Labor Day weekend. Will we ever show our appreciation? or will we just bitch and moan and politicize everything? 

And the last paragraph was not aimed at clean but some of you know who you are.

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13 hours ago, IStream said:

I am a PhD Bioengineer, a serial entrepreneur, and affiliate faculty at a large public university. I dearly want there to be a safe and effective vaccine as soon as possible. I also believe that the CDC and FDA are under the leadership of corrupt political appointees. I further see evidence of corruption in the insider trading patterns of the Moderna executives and, for biological reasons, I'm skeptical of the persistence of immunity generated by RNA vaccines as a class. Given the above, I will:

1. strongly favor a live attenuated or modified live virus vaccine over an RNA vaccine In a phase 3 trial I would rather be a mRNA candidate than a modified virus candidate......but once the trials are complete I will go for least adverse events and reasonable immunity

2. strongly favor a vaccine from a major pharma over a Moderna or other biotech without experience in manufacturing and distributing a vaccine at scale

Lonza is doing manufacture for the moderna vaccine.

3. favor a European pharma vaccine over a US pharma vaccine

Do you consider the Pfizer vaccine to be US or European? 

4. demand to inspect the published Phase III trial result data before accepting any vaccine (no publication, no jab)

In the US the trial data must be published    Not sure about European process.

5. wait for several million people and several weeks to pass to validate the Phase III results in a larger and more diverse population

That was point of my question.  If everyone waits for someone else then we only have ourselves to blame. 

I think there needs to be an incentive process to motivate vaccination. At the very least allow increase insurance premiums and higher deductibles  for non-vaccinated,  but it could also be a requirement for interstate travel, college attendance etc  

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29 minutes ago, EYESAILOR said:

Clean,

With the utmost respect....I have been a contributor to these forums for well over a decade. You know as well as anyone that I have never been known for naivete.

In this case your cynicism does sit with the Clean that I know so well.  There are times and places for  cynicism and discord. This honestly is not one of them. 

Pfizer is not a sketchy company.

Moderna is not a sketchy company or sketchy science. I have many former colleagues , good people, working there, working incredibly long hard hours for us....for you, for Mer, for your kids. They want to solve this . They may or may not produce the ultimately successful vaccine  but mRNA is real science with the prospect of real breakthroughs in vaccine development.  Moderna is an epicenter of mRNA research and it represents something that is great about American innovation and the funding of innovation. Yes, Stefan can come across as someone who over-promises but dont confuse his optimism and drive for "sketchy"....he is one of the most passionate and driven people that you wll meet - You would like him.....lets get him into sailing....he never does anything by half measures.

Astra Zeneca is not a sketchy company, nor is Regeneron , nor is Gilead.

Also ...a shout out to the folks at Roche Diagnostics USA  .....for their incredible (and underappreciated) 14 days of 23 hour days (literally getting 1 or 2 hours sleep) in the early stages of CV 19 getting us tests in the tri-state area when CDC let us down.

I digress.  Pfizer is shooting for preliminary phase 3 update in October. They are shooting for such a demanding schedule not due to any political deadline but because they think it can be done and they (like many of us) feel a sense of urgency .

When do we put our partisan cynicism aside and say "thank you" .   Its easy to dismiss the faceless companies but there are real people doing the work and they are not enjoying a long Labor Day weekend. Will we ever show our appreciation? or will we just bitch and moan and politicize everything? 

And the last paragraph was not aimed at clean but some of you know who you are.

We (both Harvard U. Graduates) own 6 copies of different Saint-Saens Symphony #3’s, and one is superior to the rest, by far...so what do you expect?  Art and Science are equals here, something a Harvard Fellow should appreciate.  I understand and appreciate the model you are expressing, but it’s hard to believe in the numbers, given the vagueness of your assumptions.  Does this make any sense? 

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18 minutes ago, EYESAILOR said:

I think there needs to be an incentive process to motivate vaccination. At the very least allow increase insurance premiums and higher deductibles  for non-vaccinated,  but it could also be a requirement for interstate travel, college attendance etc  

The insurance industry does this easily. 
 

Free vaccine. Lower deductible. Don’t get vaccinated and catch covid? Congrats your coverage is shit. You’re headed to bankruptcy. 

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6 hours ago, EYESAILOR said:

When do we put our partisan cynicism aside and say "thank you" .   Its easy to dismiss the faceless companies but there are real people doing the work and they are not enjoying a long Labor Day weekend. Will we ever show our appreciation? or will we just bitch and moan and politicize everything? 

In the face of widespread professional skepticism about meeting an election day deadline and enormous political and financial pressure to produce results before then, your optimism aligns perfectly with Trump's corrupt agenda.  Either you are politically naive or have made a conscious choice to shill for him.

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49 minutes ago, ProaSailor said:

In the face of widespread professional skepticism about meeting an election day deadline and enormous political and financial pressure to produce results before then, your optimism aligns perfectly with Trump's corrupt agenda.  Either you are politically naive or have made a conscious choice to shill for him.

Don't be so fucking rude.

ES is perfectly entitled to ask for some non political goodwill for people working on this.

"When do we put our partisan cynicism aside and say "thank you" .   Its easy to dismiss the faceless companies but there are real people doing the work and they are not enjoying a long Labor Day weekend. Will we ever show our appreciation? or will we just bitch and moan and politicize everything? "

 

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1 hour ago, Shortforbob said:

Don't be so fucking rude.

ES is perfectly entitled to ask for some non political goodwill for people working on this.

 

 

Thank you Bob. Much appreciated.

I fully understand the political motivations behind announcement from the Administration and the pressure that some of the federal agency heads are under.

However, I think some people misunderstand the process of a clinical trial and to have some kind of conspiracy theory that the scientists and clinicians conducting the trials and writing up the results and making the submission are somehow politically motivated is not only unfair on those scientists but it is also dangerous to the rest of us. The conspiracy theories may make people scared to take the vaccine.

Pfizer and Moderna have both publicly stated that they are aiming to provide early results from phase 3 trials in October.     This is a tough deadline and much will have depended on how quickly they signed up their cohorts, the actual results of vaccinated vs placebo and how quickly the data can be written up and analyzed ...its a lot of data!   But if they hit that deadline, it will be due to hard work not political manipulation .

The submission will be one of three outcomes

1. We do not yet have conclusive data

2. We have data that suggests that the vaccine is not providing statistically significant immunity

3. We have conclusive data that suggests the vaccine is providing significant immunity.

If the outcome is #3, the companies will be asking the FDA for approval to start vaccinations.  The FDA will review the data to check it. 

I would be shocked if the FDA discover improper data, so provided that they agree with the submissions, the FDA will either approve the vaccine or not.  I have no idea if that approval will come before or after the election, but it will not impact manufacturing or distribution because that is already underway.

If the submissions concluded that the vaccine provides immunity and has not material adverse effects and the FDA approves that submission I will be getting a vaccine. I do not believe there is a conspiracy between scientists and political operatives. 

I dont think a vaccine will be available to me before Q1 2021.  

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9 hours ago, Amati said:

We (both Harvard U. Graduates) own 6 copies of different Saint-Saens Symphony #3’s, and one is superior to the rest, by far...so what do you expect?  

A college student goes to the supermarket for groceries. By the end of his trip he's gotten fifteen items.

He goes up to the lane labeled "Express Checkout: 10 Items Or Less" and starts putting his purchases on the belt.

The cashier says, "Why, you must go to college at Harvard or MIT!"

"Why, yes I am a college student, but how could you know I went to Harvard or MIT?"

"Because Harvard students can't count, and MIT students can't read."

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15 hours ago, Miffy said:

If you sincerely believe the FDA phase 1-2 process has been compromised, then the game is up and we might as well start heil trump before the purge lists start getting published. 

The FDA is controlled by political appointees from a party that is expressly anti-science.  Those appointees control every aspect of the FDA process now.    

I choose not to ignore that very clear reality.  You do so at your own peril.

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You are welcome, and it's Meli.

But I wouldn't trust any company that Trump's admin  have had their fingers in as far as I could throw them.

No disrespect to the ordinary techies and people that are working their arses off for these companies ..they are but dedicated people doing what they do with dedication and being as professional as they know how to be. They'll probably get stiffed too.

anyway..it's moot because other countries will get their first..safely. :P

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10 hours ago, EYESAILOR said:

Clean,

With the utmost respect....I have been a contributor to these forums for well over a decade. You know as well as anyone that I have never been known for naivete.

In this case your cynicism does sit with the Clean that I know so well.  There are times and places for  cynicism and discord. This honestly is not one of them. 

Pfizer is not a sketchy company.

Moderna is not a sketchy company or sketchy science. I have many former colleagues , good people, working there, working incredibly long hard hours for us....for you, for Mer, for your kids. They want to solve this . They may or may not produce the ultimately successful vaccine  but mRNA is real science with the prospect of real breakthroughs in vaccine development.  Moderna is an epicenter of mRNA research and it represents something that is great about American innovation and the funding of innovation. Yes, Stefan can come across as someone who over-promises but dont confuse his optimism and drive for "sketchy"....he is one of the most passionate and driven people that you wll meet - You would like him.....lets get him into sailing....he never does anything by half measures.

Astra Zeneca is not a sketchy company, nor is Regeneron , nor is Gilead.

Also ...a shout out to the folks at Roche Diagnostics USA  .....for their incredible (and underappreciated) 14 days of 23 hour days (literally getting 1 or 2 hours sleep) in the early stages of CV 19 getting us tests in the tri-state area when CDC let us down.

I digress.  Pfizer is shooting for preliminary phase 3 update in October. They are shooting for such a demanding schedule not due to any political deadline but because they think it can be done and they (like many of us) feel a sense of urgency .

When do we put our partisan cynicism aside and say "thank you" .   Its easy to dismiss the faceless companies but there are real people doing the work and they are not enjoying a long Labor Day weekend. Will we ever show our appreciation? or will we just bitch and moan and politicize everything? 

And the last paragraph was not aimed at clean but some of you know who you are.

I know that scientists are working hard to solve this problem. But I work for the C-suite of large companies and some of them are always sketchy, especially when they are competing to get a piece of a trillion dollar pie.  I have seen firsthand how much agency processes and policies and internal corporate actions that depend on them have been corrupted by Trumpy appointees and corp executives emboldened by lack of oversight and competition for political rewards; if your assumptions about the quality of the approval process are based on your knowledge of said process from a year ago or more, I believe your information is out of date.  

Regarding your praise for these nonsketchy companies, do some searching and you'll find they are all always as close to the edge of sketchy as they can get.  

https://violationtracker.goodjobsfirst.org/parent/roche

https://violationtracker.goodjobsfirst.org/prog.php?parent=&major_industry_sum=&offense_group_sum=&primary_offense_sum=&agency_sum=&agency_sum_st=&hq_id_sum=&company_op=starts&company=astrazeneca&major_industry[]=&case_category=&offense_group=&all_offense[]=&penalty_op=>&penalty=&govt_level=&agency_code[]=&agency_code_st[]=&pen_year[]=&pres_term=&free_text=&case_type=&ownership[]=&hq_id=&naics[]=&state=&city=

and so on....

 

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"

Pfizer is shooting for preliminary phase 3 update in October. They are shooting for such a demanding schedule not due to any political deadline but because they think it can be done and they (like many of us) feel a sense of urgency ."

Again, I believe that you are being incredibly naive here.  The people who allocate the budgets and choose the research teams and set the schedules know exactly what they stand to earn should they be first to market.  They also know what they stand to earn through political favors and winning government bids over the next four years should their discovery help Trump win the election. 

The researchers are every bit as dedicated as you say they are, but they are not the ones calling the shots.

 

 

 

 

 

 

 

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39 minutes ago, EYESAILOR said:

 

However, I think some people misunderstand the process of a clinical trial and to have some kind of conspiracy theory that the scientists and clinicians conducting the trials and writing up the results and making the submission are somehow politically motivated is not only unfair on those scientists but it is also dangerous to the rest of us. 

 

Please answer this question: Who has final approval of a submission?

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3 minutes ago, MR.CLEAN said:

I know that scientists are working hard to solve this problem. But I work for the C-suite of large companies and some of them are always sketchy, especially when they are competing to get a piece of a trillion dollar pie.  I have seen firsthand how much agency processes and policies and internal corporate actions that depend on them have been corrupted by Trumpy appointees and corp executives emboldened by lack of oversight and competition for political rewards; if your assumptions about the quality of the approval process are based on your knowledge of said process from a year ago or more, I believe your information is out of date.  

Regarding your praise for these nonsketchy companies, do some searching and you'll find they are all always as close to the edge of sketchy as they can get.  

https://violationtracker.goodjobsfirst.org/parent/roche

https://violationtracker.goodjobsfirst.org/prog.php?parent=&major_industry_sum=&offense_group_sum=&primary_offense_sum=&agency_sum=&agency_sum_st=&hq_id_sum=&company_op=starts&company=astrazeneca&major_industry[]=&case_category=&offense_group=&all_offense[]=&penalty_op=>&penalty=&govt_level=&agency_code[]=&agency_code_st[]=&pen_year[]=&pres_term=&free_text=&case_type=&ownership[]=&hq_id=&naics[]=&state=&city=

and so on....

 

Clean,

When you said "sketchy", I thought you might be referring to the science and scientific credentials of the leading vaccine companies and their employees.

If you mean that capitalism without oversight can lead to unfavorable results, then yes, all sectors, not just pharma needs oversight. That is why we have regulators.  Roche's dominance in diagnostics  may have led to come anti-competitive behaviour .  Apple, Google, Honeywell, and even Sailing Anarchy occasionally step over the line. We live in society where commerce is subject to the law of the land,....which is a good thing compared to some parts of the world .  In November you get to elect a Chief Executive to supervise the implementation of  regulation and laws of the land.....you also get to choose legislators to design those laws. You are blessed. Use that vote to pick who you think will do the best job. You can even argue and persuade others to vote alongside you on Political Anarchy.

I just dont think it is right to try and dissuade people to take vaccines for political reasons or to suggest that the folks working on those vaccines of having political agendas. I think our discussion on this tthread can hot up in October but hopefully we will be discussing the scientific merits of the vaccines .

 

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27 minutes ago, EYESAILOR said:

Clean,

When you said "sketchy", I thought you might be referring to the science and scientific credentials of the leading vaccine companies and their employees.

If you mean that capitalism without oversight can lead to unfavorable results, then yes, all sectors, not just pharma needs oversight. That is why we have regulators.  Roche's dominance in diagnostics  may have led to come anti-competitive behaviour .  Apple, Google, Honeywell, and even Sailing Anarchy occasionally step over the line. We live in society where commerce is subject to the law of the land,....which is a good thing compared to some parts of the world .  In November you get to elect a Chief Executive to supervise the implementation of  regulation and laws of the land.....you also get to choose legislators to design those laws. You are blessed. Use that vote to pick who you think will do the best job. You can even argue and persuade others to vote alongside you on Political Anarchy.

I just dont think it is right to try and dissuade people to take vaccines for political reasons or to suggest that the folks working on those vaccines of having political agendas. I think our discussion on this tthread can hot up in October but hopefully we will be discussing the scientific merits of the vaccines .

 

I know there are thousands of great people working on this stuff. 

And over the years you and I have agreed on almost everything.

I think we would still agree if you had more information on what has happened to federal regulatory agencies since Trump lost congress and realized the agencies and court appointments were his only avenue to implementing the authoritarian policies he and the new GOP are so enamored with.  I believe you are operating under outdated assumptions.

 

 

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13 minutes ago, MR.CLEAN said:

Please answer this question: Who has final approval of a submission?

Sure I will try:

At Moderna , the preparation of the submission is a major team effort.  The final decision to approve the submission will  likely rest on Tal Zaks but he will really be spear heading a team.  Stefan as CEO will of course have the final say of anything this important going out from the company but Tal will be making the go/no go call.

Once their submission goes to the FDA, the FDA will be checking the data.  I suspect the review and approval of the submission will be driven by Marion Gruber, and Konstantin Chumakov, with a lot of heavy lifting from Karen Farizo , Jerry Weir and Zhiping Ye.

Marion Gruber will ultimately make the recommendation to the head of the FDA.  We are in good hands with Marion.

Marion will not be influenced by political considerations and by the way she was appointed deputy head of OVRR  during George "shrub" Bush presidency and head of OVRR during Obama's presidency. Not that it should matter , other than it was meritocratic.

To substantiate conspiracy theories you have to persuade me that Marion is unethical.  That will be tough to persuade me.

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7 minutes ago, EYESAILOR said:

 

To substantiate conspiracy theories you have to persuade me that Marion is unethical.  That will be tough to persuade me.

Thank you for the response.  If the submission is amended by those above Marian Gruber in unethical ways, would she resign and go public with such information?

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1 minute ago, MR.CLEAN said:

I know there are thousands of great people working on this stuff. There really are.  Doubtless the money is a motivating factor as well. The winning companies will make money but I think there is a sense of mission as well.  It wont move the needle on Pfizers financials. It is being priced at a low margin by Moderna, but what it really does for moderna is establish the credibility of mRNA vaccine process and open the doors for other vaccines they have in pipeline like HPVAC etc.  But hoenstly I think there is a real sense of mission in the teams. They will be able to look back and say they were a part of the team that saved the world from CV 19. It must be incredible to be part of those teams right now.

And over the years you and I have agreed on almost everything. Oh come now....we have had our fair share of disagreements as well. Its been fun.

I think we would still agree if you had more information on what has happened to federal regulatory agencies since Trump lost congress and realized the agencies and court appointments were his only avenue to implementing the authoritarian policies he and the new GOP are so enamored with.  I believe you are operating under outdated assumptions. I am aware of some of the sh1t that has gone down at the EPA etc and doubtless immigration but you are right I dont know as much about those organizations as I do about the FDA. 

Now, treading carefully because of my respect for the good people at the FDA, the FDA did need a bit of a kick in the pants . The regulatory approval process for drugs has gotten unwieldy. But this does not apply here. Everyone at the FDA understands the importance of this and are geared up to give it their full ongoing attention. By the way , I think the FDA has willingly adopted this new emphasis on parallel process and they are simultaneously reviewing the data alongside the trials alongside the companies and agencies conducting the trials.  There are new processes and protocols that CV19 has catalyzed.  It may be a good thing going forward.Again....honestly...political agendas have had no place here. In fact I doubt Trump even knows about or understands some of the regimes and protocols the FDA is working with.  

Im sure Trump would have approved the vaccine after the mice trials if he had his way but he hasnt.

 

 

 

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1 hour ago, EYESAILOR said:

If you mean that capitalism without oversight can lead to unfavorable results, then yes, all sectors, not just pharma needs oversight. That is why we have regulators.

Trump has replaced five inspectors general since April (in a span of six weeks!)

Trump has pushed out 5 inspectors general since April. Here’s who they are
https://www.politifact.com/article/2020/may/19/trump-has-pushed-out-5-inspectors-general-april-he/

Quote

Since early April, Trump has taken steps to remove or replace five inspectors general from their respective offices in the intelligence community and the departments of defense, health and human services, state and transportation. Four of the changes came on Friday nights.
[...]
But there’s no precedent for Trump’s rapid removals, experts told us. President Barack Obama fired one inspector general, according to the Washington Post. Trump, meanwhile, said he’s suggested for years that his agencies fire any Obama-appointed investigators. 

"We are seeing right now, in real time, a true crisis in terms of the ability for there to be independent oversight and accountability within the executive branch," said Liz Hempowicz, director of public policy at the nonprofit Project On Government Oversight.
[...]
"A lot of people have asked me to put this in historical perspective," added Donald Sherman, deputy director of the nonprofit Citizens for Responsibility and Ethics in Washington. "The challenge is that in the 42 years since the passage of the Inspector General Act, there hasn’t been a president that has reacted with this level of hostility to the inspector general community."

One wrinkle that's troubling, experts said, is the replacement of acting inspectors general at the departments of transportation and defense with new acting inspectors general — a move that, unlike for permanent nominations, doesn’t require Senate confirmation.
[...]
Christi Grimm, acting inspector general of the Health and Human Services Department

Grimm, the Health and Human Services Department’s top deputy inspector general since January, had been serving as the department’s acting inspector general until early May, when Trump announced he was nominating an assistant U.S. attorney to fill the post. 

Her replacement came shortly after she drew Trump’s ire for an April 3 report that said hospitals were experiencing shortages of tests, personal protective equipment and medical staff at a time when Trump was celebrating his administration’s response to the coronavirus.

 

Replacing inspectors general is a bad habit with Republicans.  From Wikipedia: https://en.wikipedia.org/wiki/2020_dismissal_of_inspectors_general

Quote

The president may dismiss an inspector general, but is supposed to give Congress 30 days' notice and an explanation of the reason for removing them. The 30 days' notice requirement was added to the 1978 law in 2008; its purpose was to re-emphasize the role of the IG as an independent watchdog and to dissuade presidents from retaliatory firings.

Previously in 1981, Ronald Reagan fired 16 inspector generals when he became president, with his administration explaining that Reagan intended to hire his own people. After Congress objected, Reagan rehired 5 of the fired inspector generals. In 1989, George H. W. Bush also attempted to dismiss all the inspector generals upon becoming president, but after the inspector generals and Congress objected, Bush relented. In 2009, President Barack Obama dismissed Corporation for National and Community Service inspector general Gerald Walpin citing a lack of confidence in him. After Congress objected to the lack of explanation, the Obama administration cited that Walpin had shown "troubling and inappropriate conduct", and pointed to an incident that year where Walpin was "disoriented" during a board meeting of the Corporation, which led to the board asking for Walpin's dismissal. Walpin sued for a reinstatement, but the courts ruled against Walpin.

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11 minutes ago, MR.CLEAN said:

 

Thank you for the response.  If the submission is amended by those above Marian Gruber in unethical ways, would she resign and go public with such information?

Marion not Marian....she is originally from Germany.

Marion's line of report would be Peter Marks at CBER and of course the head of the FDA. 

If the head of the FDA rejected the recommendations from the OVRR and the CBER then that will become public knowledge.

 

FWIW, here is what Peter Marks said when asked about the change of administration from Obama to Trump:

Does a change in administration affect your work at the FDA?

Some priorities may change with a new presidential administration, but our priority at the FDA remains the same: protecting and promoting public health. When there’s an administration change we must brief a whole new group of people, but we’ve been fortunate that people on both sides of the aisle have recognized the importance of our work. Administration changes can affect different people in different ways; my way of dealing with it – and I think that many of my colleagues have the same approach – is to stay focused on our public health mission.

Both sides of the aisle?  You really think that the administration could override the OVRR?  At the end of the day this is still the USA with some semblance of checks and balances. Dont become too cynical about America. For all the faults of American system of democracy is better than the alternative.

And returning to the subject at hand, I also think the American system of checks and balances within our drug approval process will provide us with a safe vaccine. A company with spurious data will not have a vaccine approved . A vaccine with effective results will not be withheld.   Neither Republican operatives nor Democrat operatives will be able to move public health dates to suit their agenda. I say the same to Republicans who believe there is a "deep state" within the FDA trying to hold up the vaccine.  

I will be taking the vaccine. I hope that Clean and Mer will also. 

Personally I think it would be great if a number of the scientists including Marion are allowed to take the podium if approval was allowed ...although sthey are unliikely to be  Fauci when it comes to public speaking.

 

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11 hours ago, EYESAILOR said:

I think there needs to be an incentive process to motivate vaccination. At the very least allow increase insurance premiums and higher deductibles  for non-vaccinated,  but it could also be a requirement for interstate travel, college attendance etc  

There's plenty of incentive for the majority of the population. Millions of people will have faith in the integrity of the science and trust in the regulators who blessed it and will line up to get the vaccine at their first opportunity so their lives can get back to normal as soon as possible. This cohort will easily constitute a third of the population.

Others will be skeptical about the process and will take a wait and see attitude about vaccination before getting it themselves. This is not a big problem for the overall vaccination effort, as supply and distribution constraints wouldn't allow you to vaccinate these people any faster even if you could coerce them. I could easily see this cohort being another third of the population.

The last third will be the toughest. These are the anti-vaxxers, the anti-government radicals, the "I'll let everyone else get it and benefit from herd immunity" types. You'll need external incentives to get these folks to take the vaccine.

FWIW, I could easily see myself in the first 1/3rd mentioned above. I don't need a data set of 100 million people to be vaccinated before I feel comfortable getting it but I will not blindly accept the assurances of our current federal government either and will not get vaccinated in the first tranche even if I have the opportunity, which I won't.

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That first cohort could be in trouble if the vaccine is not very effective for them, or for some of them anyway and they "get back to life" mingling.

I probably could get it among the first tranches but although I have no fear it will harm me, I don't trust it enough, absent large scale placebo vs vaccine efficacy trials, to think  it would let me safely make any changes in my life. So why bother? 

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That's why we need serum testing for everyone in the weeks after they get the vaccine, assuming it's not close to 100% effective. Of course, that's not going to happen because we don't do surveillance testing of any kind here in Murca.

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1 hour ago, EYESAILOR said:

Marion not Marian....she is originally from Germany.

Marion's line of report would be Peter Marks at CBER and of course the head of the FDA. 

If the head of the FDA rejected the recommendations from the OVRR and the CBER then that will become public knowledge.

 

FWIW, here is what Peter Marks said when asked about the change of administration from Obama to Trump:

Does a change in administration affect your work at the FDA?

Some priorities may change with a new presidential administration, but our priority at the FDA remains the same: protecting and promoting public health. When there’s an administration change we must brief a whole new group of people, but we’ve been fortunate that people on both sides of the aisle have recognized the importance of our work. Administration changes can affect different people in different ways; my way of dealing with it – and I think that many of my colleagues have the same approach – is to stay focused on our public health mission.

Both sides of the aisle?  You really think that the administration could override the OVRR?  At the end of the day this is still the USA with some semblance of checks and balances. Dont become too cynical about America. For all the faults of American system of democracy is better than the alternative.

And returning to the subject at hand, I also think the American system of checks and balances within our drug approval process will provide us with a safe vaccine. A company with spurious data will not have a vaccine approved . A vaccine with effective results will not be withheld.   Neither Republican operatives nor Democrat operatives will be able to move public health dates to suit their agenda. I say the same to Republicans who believe there is a "deep state" within the FDA trying to hold up the vaccine.  

I will be taking the vaccine. I hope that Clean and Mer will also. 

Personally I think it would be great if a number of the scientists including Marion are allowed to take the podium if approval was allowed ...although sthey are unliikely to be  Fauci when it comes to public speaking.

 

Re: Marks' comments - They are completely irrelevant unless they were made within the last year.  

Re: OVRR - Unless it is not a US agency, of course it can be overridden with a single phone call.  Can it be hidden?  YES, for a few weeks at least.  C'mon, you know this.

Re: Democracy: You are falling into a trap of unwarranted optimism.  "This is still the USA" is not data, it's aspiration.  

I believe 100% that the FDA will approve a vaccine in the next 50 days, and they will give Trump a shot on live TV before the election, and of course it will be saline.  That's how his people work.

 

 

 

 

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2 hours ago, EYESAILOR said:

 

If the head of the FDA rejected the recommendations from the OVRR and the CBER then that will become public knowledge.

 

 

"That will become" is not a mechanism.  What reporting mechanism will ensure that it becomes public knowledge, and will it have to wait for a FOIA lawsuit as has become the norm under Trump?

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Some light reading on the FDA, big Pharma, the federal government and the medical community re the opioid crisis https://www.google.ca/amp/s/www.newyorker.com/magazine/2017/10/30/the-family-that-built-an-empire-of-pain/amp

And here is a more detailed timeline. Initially the FDA figured ‘controlled release’ of OxyContin would prevent addiction. Along the way, and some 25 years later, they realized they got that wrong. 

https://www.fda.gov/media/85029/download

Why am I posting these? Because recent history undermines the credibility of Big Pharma, maybe the FDA, and the federal government(regardless of party affiliation) in the eyes of a portion of the general public.

To probably a wider spectrum of the general public, the perception of ‘rushing to market’ furthers this scepticism about an initial vaccine for a mysterious virus that they hear confounds much of the medical community. People that would be comfortable taking(or their kids taking)a vaccine for older diseases(typhoid, cholera, measles etc) apparently want to wait on the sidelines for a bit.

From Forbes article:

An opinion survey on vaccine development, approval and administration in the United States.

ROBERTPEARLMD.COM

https://www.google.ca/amp/s/www.forbes.com/sites/robertpearl/2020/08/10/coronavirus-vaccine-gone-wrong/amp/

The article also mentions:

‘Major drug companies like Pfizer, Moderna and others vying to create a Covid-19 cure are relying on a method that has not produced a safe or effective mRNA vaccine against any viral infection in more than two decades of research.‘

 

This next article underscores the basic safety of modern vaccines with the caveat of not rushing. https://www.aamc.org/news-insights/here-s-why-we-can-t-rush-covid-19-vaccine

“...Dengue fever: The Philippines halted a school-based vaccination program in 2017 after reports of complications and several deathslinked to the product, Dengvaxia. The French manufacturer, Sanofi Pasteur, later said the vaccine posed a risk to people without prior infection from one of the disease’s four stereotypes, actually increasing the risk that the child would contract a more severe form of the disease. The U.S. Food and Drug Administration (FDA) approved the vaccine last year for limited use: for children of certain ages, living in endemic areas, and previously infected with a form of the virus. 

Despite those and other reports of harmful effects, the CDC estimates that since 2011, vaccines have averted 23.3 million deaths from disease worldwide. “Smallpox is gone,” Jones notes. Polio, once blamed for paralyzing an average of 35,000 people a year in the United States, was declared eradicated in the country in 1979. 

Now as researchers dream of doing the same to COVID-19, the testing and revising phases apply the brakes.

Reducing risks

Vaccine testing proceeds slowly because the human body responds slowly: It takes weeks to produce the antibodies that provide immunity, and it can take longer to show harmful side effects. 

“The regulatory pathway is meant to be slow, deliberate, reflective,” Poland says. “Data-rich, data-informed, and peer reviewed. Where you shortcut that, you can run into problems.”...”

So to answer the OPs question, what is my personal stance? I’m with the poll cited in Forbes where only 54% of healthcare professionals would take it immediately on FDA approval. That is, a coin flip consensus isn’t quite good enough for me, I’ll stay on the sidelines and practice social distancing until more rigorous and lengthy testing occurs.

As of this writing, the general public willing to take an initial vaccine is down to 21% as reported by CNN. It all comes down to perceived credibility and it’s gonna be a tough sell initially, so in the meantime, better to double down on every measure that is CURRENTLY available to us.

 

 

 

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the average medical professional is going to have an unrealistic opinion of the quality of federal licensure and approval, because they are heavily invested in the public's trust of such a system. 

Many of them do not have the time to keep up with current events.

 

 

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2 hours ago, MR.CLEAN said:

Re: Marks' comments - They are completely irrelevant unless they were made within the last year.  

Re: OVRR - Unless it is not a US agency, of course it can be overridden with a single phone call.  Can it be hidden?  YES, for a few weeks at least.  C'mon, you know this.

Re: Democracy: You are falling into a trap of unwarranted optimism.  "This is still the USA" is not data, it's aspiration.  

I believe 100% that the FDA will approve a vaccine in the next 50 days, and they will give Trump a shot on live TV before the election, and of course it will be saline.  That's how his people work.

 

 

 

 

43 minutes ago, MR.CLEAN said:

the average medical professional is going to have an unrealistic opinion of the quality of federal licensure and approval, because they are heavily invested in the public's trust of such a system. 

Many of them do not have the time to keep up with current events.

 

 

 

Clean,

Sigh!

OVRR has to recommend approval before the FDA can approve a vaccine. So a conspiracy theory rests on one of two occurrences.

1. The conspiracy theorist has to believe that Marion Gruber is a person capable of fraud who will submit a falsified approval, putting millions of human beings at risk,  Does anyone have the slightest bit of evidence to support this claim?  Marion has spent 30+ years of her life dedicated to public health in vaccine research and approval , never once tempted by the higher salaries in the private sector.  Do you really think she is capable of changing a recommendation because she gets a single phone call?  Do you think she is a crook?  I hope and trust you do not.

2. OVRR recommends a vaccine is not approved but the head of the FDA (Stephen Hahn) breaks the law, overrides that recommendation and tells the world that the FDA and OVRR has approved the vaccine.  Stephen Hahn was appointed by the administration and in his case confirmed 72-18 by the senate.  But if he is the puppet that you say he is, over 50 people people, including Peter Marks and all of Marion's staff would know he has broken the law, but in your view he does this bad thing jeopardizing his life career and freedom because......(Conspiracy theorists to fill in blanks) .

Your extensive experience of current events gives you this insight?  

In this conspiracy theory, who are "his people" at the FDA?

I only push back because the conspiracy theory is as dangerous in my mind to public health as Trump's theory about hydroxychloroquine and ultraviolet light.  If people start to believe the rantings of the conspiracy theorists then they will be scared away from vaccines.

Conspiracy theory is a uniquely American pastime ranging .   Frankly Im shocked the Clean has taken the bait on this one. Plenty of information available about how the FDA really approves vaccines.

 

The convalescent plasma episode which lasted all of a day and a half should reassure most observers that it is pretty much impossible for either the Presdient or the head of the FDA to attribute a false finding to the FDA without the FDA staff correcting the misstatement.

 

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Sigh.

I am not disputing any of what you say regarding FDA approval process.  I am disputing that it still works that way.  If nothing else, we have now seen that knowledge by many people of a crime means precisely nothing if the perpetrator of such crime is Trump or an appointee. 

How many people saw Trump's initial tweet last week soliciting people to commit a felony by voting twice?  Do you need the other 500 examples to acknowledge that the norms we have been operating under since 1974 regarding criminal and unethical activities by the executive branch are no longer in effect?  Do you want a list of the pardons?

I challenge you to find me supporting a single conspiracy theory in my 18 years on this site other than (1) the Trump admin being responsible for releasing COVID and (2) this vaccine shit.  The reason is very simple:  It wasn't until last year that my legal work brought me into close contact with government agencies and I learned how fucking insane the stuff going on inside them actually is.  You would not believe it.

I have no information that any of that is going on inside the FDA, but I am a firm believer that a person's conduct tends to be consistent from one arena to the next.

I will be the first to admit I was wrong if a Trump doesn't get a shot in the arm on camera within a week or two before the election.

 

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2 hours ago, IStream said:

That's why we need serum testing for everyone in the weeks after they get the vaccine, assuming it's not close to 100% effective. Of course, that's not going to happen because we don't do surveillance testing of any kind here in Murca.

They are testing everyone on the trial with the vaccine.

 

2 hours ago, NeedAClew said:

, I don't trust it enough, absent large scale placebo vs vaccine efficacy trials, to think  it would let me safely make any changes in my life. So why bother? 

Phase 3 is 30,000 people. Mathematically that is a very large sample.   IMO, the FDA could do one of three things if the results are satisfactory.

1. Increase size of Trial

2. Emergency Use Approval. Priority to healthcare workers and first responders.

3. Approve for general use.

 

Net effect is the same. The limited number of tests available at end of year would be distributed and results monitored. The so-called phase one. It is not however ossible to monitor a cohort of 1 million people so I favor #2 or #3.  

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^But Phase 3 for Moderna is 25 months long.  Started late August.  I know, I was in the group but not selected because I could not on my honor promise to be exposed more with a 50-50 chance of placebo. Placebo and 2 shots.  What evidence of efficacy is expected a few  of months into the trial?

 

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2 minutes ago, MR.CLEAN said:

Sigh.

I am not disputing any of what you say regarding FDA approval process.  I am disputing that it still works that way.  If nothing else, we have now seen that knowledge by many people of a crime means precisely nothing if the perpetrator of such crime is Trump or an appointee. 

How many people saw Trump's initial tweet last week soliciting people to commit a felony by voting twice?  Do you need the other 500 examples to acknowledge that the norms we have been operating under since 1974 regarding criminal and unethical activities by the executive branch are no longer in effect?

 

 

The approval process for a vaccine is still the same. 

If you see a vaccine approved by the EPA and distributed by Colony Financial ....then yes, you might want to wait.

But if it is manufactured by Pfizer and approved by OVRR and FDA , then I am rolling up my sleeve.

 

 

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11 minutes ago, NeedAClew said:

What evidence of efficacy is expected a few  of months into the trial?

 

"What the hell have you got to lose?"

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19 hours ago, Shortforbob said:

 

read the bolded bits.

I certainly won't be taking anything that has been developed in the USA.

There will be "good stuff" coming out from elsewhere not far behind.

Besides, I think the worst thing about the first vaccines will be that they simply don't work terribly well.

So, you have another one later.

I've got two twenty somethings.. They are doing the right thing here in hard lock down Melbourne..as are all of their friends.

They've lost jobs, can't find work, can't have a normal "twenty something" life that WE all enjoyed UNTIL there is trust in a Vaccine.

We boomers need to lead. We are not significant at risk of the usual worries, we've had our kids, we are not going to be bearing children with tiny little batwings :D

I'd like to show them that us boomers are not the selfish generation they often think we are.

Just talked to 20 something.  After 2 weeks at school, well it sucks.  None of the social stuff is happening obviously, but the freshmen have been doing the covid Boogie for the last 2 weeks.  He is a senior so not missing much and he can concentrate on graduating...  But, He was alittle down and said he should have taken a gap year...  I pointed out that if he took a gap year he would be in our basement, living with us, grandma and 3 dogs while searching for a nonexistent job or driving for uber.  Better to be up there, with his roommates able to at least be semi social...  sucks. but it's the new reality...   Perked him up alittle...  :)

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25 minutes ago, EYESAILOR said:

The approval process for a vaccine is still the same. 

If you see a vaccine approved by the EPA and distributed by Colony Financial ....then yes, you might want to wait.

But if it is manufactured by Pfizer and approved by OVRR and FDA , then I am rolling up my sleeve.

 

 

Not to mention they’re all looking to make profits abroad internationally. The locked in gov risk investment only secures US domestic production and they don’t make any more or less money getting US approval or not. 
 

they need international approval to make additional revenues. 

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Since Eyesailor asks: I will listen to the "This Week in Virology" podcast (TWIV) and make a decision based on what I learn there. 

The all-science, no-politics TWIV podcast can be found at: https://www.microbe.tv/twiv/.

With respect to those who doubt that vaccines for coronaviruses (coronavirii?) can be found, I learned listening to TWIV that an effective SARS vaccine was indeed found long ago, but that it was never commercialized because of lack of demand as the SARS crisis faded without its being needed.  But COVID is nastier, it looks like we need vaccines this time.

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7 minutes ago, bacq2bacq said:

But COVID is nastier, it looks like we need vaccines this time.

Minor point. SARs was so awful it died out because those who got sick got really sick and we were walking thru thermal imagery detectors in all public spaces for a good two years. 
 

The problem with COVID-19 is it is so relatively mild for so many there’s a diffusion of responsibility and opportunity to intervene is harder to create. 

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26 minutes ago, EYESAILOR said:

They are testing everyone on the trial with the vaccine.

 

Phase 3 is 30,000 people. Mathematically that is a very large sample.   IMO, the FDA could do one of three things if the results are satisfactory.

1. Increase size of Trial

2. Emergency Use Approval. Priority to healthcare workers and first responders.

3. Approve for general use.

 

Net effect is the same. The limited number of tests available at end of year would be distributed and results monitored. The so-called phase one. It is not however ossible to monitor a cohort of 1 million people so I favor #2 or #3.  

I understand that they're testing everyone on the trial. They have to. Without that, it's impossible to establish efficacy and the durability of the immune response. Given the compressed timeline of the current trial and the fact that option 1 will never happen because it will take more time, durability will remain unknown until after the vaccine has been approved, whether on an emergency basis or for general use.

It is entirely possible to monitor a cohort of 1 million people and I would argue that's what needs to be done. While 30,000 people is a good sized Phase III trial, it's not large enough to get a representative sample of individuals of every gender, age, race, category of comorbidity, COVID exposure, and other factors to really understand how the vaccine is working and for how long. We're going to need large-scale longitudinal studies to know what's happening out there. We've been flying blind this whole pandemic because of Trump's fear of data and if we don't fix that it's very possible that it'll bite us in the ass again.

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2 hours ago, MR.CLEAN said:

"What the hell have you got to lose?"

If it turns out not to be very effective for my demographic and I go out and about, I could get covid and/or give it to Mr Clew. That's a lose in my book. 

No point getting a vaccine and continuing to stay home because there aren't enough data points yet. And I still do not know if I get one asap, can I get a different one later if it's more effective. 

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The more the rResident promotes it, the less likely I am to take it.  

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Vaccination (like masks) is as much about protecting others as it is about protecting me. So, although I am in a relatively low risk cohort, I will be accepting the vaccination, even if there is, potentially, some risk. I honestly am not virtue signalling when I say this is not all about me. I am relatively well educated. I am not a conspiracy theorist or an anti-vaxxer (and those nincompoops should be put in stocks and pelted with rotten fruit and vegetables). I mistrust the competency of teh gubmint in general, but I do trust the competence of the scientific and medical fraternity in general.

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49 minutes ago, Weyalan said:

Vaccination (like masks) is as much about protecting others as it is about protecting me. So, although I am in a relatively low risk cohort, I will be accepting the vaccination, even if there is, potentially, some risk. I honestly am not virtue signalling when I say this is not all about me. I am relatively well educated. I am not a conspiracy theorist or an anti-vaxxer (and those nincompoops should be put in stocks and pelted with rotten fruit and vegetables). I mistrust the competency of teh gubmint in general, but I do trust the competence of the scientific and medical fraternity in general.

Thank you.

Right on all counts.

One minor point, having been involved in a study of so-called survivors there is not really  a zero risk cohort. As sad as the 75 year old who dies, the 30 year old with a whole life in front of him/her afflicted with a long term vascular disability is almost as sad.

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Okay......2 cocktails sitting next to Mr. Eye...I feel a need to vent against the conspiracy theorists in America. Its a national affliction in the USA.

The Right wing conspiracy nuts are convinced there is a deep state within the FDA etc that is deliberately delaying remedial treatments and vaccines. The Left wing conspiracy nuts are convinced that the Administration has the power to threaten the folks at the OVRR and the FDA to  approve a vaccine that should not be approved.

They are both as dangerous as each other and base their claims  on no evidence other than what they read on face Book and following "current events" with absolutely no true understanding of how the FDA works or any actual experience.

There is no "deep state" and there is no conspiracy to release a vaccine that has not been reviewed and approved

It is incredible that this dumb virus with no brain but just an innate motivation to survive and spread is able to defeat human ingenuity. The virus has a life span of approximately 2 weeks !   Why? Because we are our own worst enemy. 

The conspiracy theorists told us that the virus was a hoax.  That helped the virus live to fight another day as vast numbers in America didnt wear masks. Now the conspiracy theorists are going to tell us that 6 months of vaccine trials and data have probably been "fixed" and the vaccine is dangerous.  Lucky virus,,,,it thrives on our prejudices and distrust.

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27 minutes ago, EYESAILOR said:

They are both as dangerous as each other and base their claims on no evidence...

The old "both sides do it" fallacy.  You are fabricating theories and motivations about "Left wing conspiracy nuts" that I haven't heard or said, here or anywhere else.  And ignoring the political benefits to one side only of false promises about how imminent and effective a vaccine will be.  Naive at best.

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Sure I will have it. A vaccine could hardly be a dangerous as half the shit I put in my body when I was young and reckless.

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1 hour ago, ProaSailor said:

The old "both sides do it" fallacy.  You are fabricating theories and motivations about "Left wing conspiracy nuts" that I haven't heard or said, here or anywhere else.  And ignoring the political benefits to one side only of false promises about how imminent and effective a vaccine will be.  Naive at best.

Hello Proa.......I certainly dont condone false promises or accusations of the deep state.

On the other hand , nor do I condone accusations that the people who work at OVRR and FDA will improperly approve a vaccine. 

The reason I am critical of those views is because they will encourage people to be scared of the vaccine and slow down or even prevent our opportunity to eliminate this disease. 

Perhaps I should not have accused them of conspiracy theory and political bias but merely fear, fear caused by the politics of the last 4 years and social media.  So surely our role is to reassure and allay those fears with facts and science.

Anyway, lets put aside politics and conspiracy, Here is to wearing masks and rolling up our sleeves for a vaccine. I have $5 that says we will have phase 3 results , either good or bad before last day of October but vaccines will not be widely available until well into 2021.

 

 

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1 hour ago, EYESAILOR said:

Okay......2 cocktails sitting next to Mr. Eye...I feel a need to vent against the conspiracy theorists in America. Its a national affliction in the USA.

The Right wing conspiracy nuts are convinced there is a deep state within the FDA etc that is deliberately delaying remedial treatments and vaccines. The Left wing conspiracy nuts are convinced that the Administration has the power to threaten the folks at the OVRR and the FDA to  approve a vaccine that should not be approved.

They are both as dangerous as each other and base their claims  on no evidence other than what they read on face Book and following "current events" with absolutely no true understanding of how the FDA works or any actual experience.

There is no "deep state" and there is no conspiracy to release a vaccine that has not been reviewed and approved

It is incredible that this dumb virus with no brain but just an innate motivation to survive and spread is able to defeat human ingenuity. The virus has a life span of approximately 2 weeks !   Why? Because we are our own worst enemy. 

The conspiracy theorists told us that the virus was a hoax.  That helped the virus live to fight another day as vast numbers in America didnt wear masks. Now the conspiracy theorists are going to tell us that 6 months of vaccine trials and data have probably been "fixed" and the vaccine is dangerous.  Lucky virus,,,,it thrives on our prejudices and distrust.

Think of the problem at hand like...traffic. If you've got too many cars on the road, you could just build more roads. That's the take two aspirins and call me in the morning approach.

The other approach is to look at it from a governance standpoint. Incentivizing car pooling, via tolls on single drivers, which would cut traffic in half, and reduce the need to build more roads with money left over. 

The governance approach says, 'yes we are confident in our ability to enforce social distancing and other measures and carry on and adapt', while the 'take two aspirins and call me in the morning' approach seems to instead look for a blanket panacea in the form of an undelivered vaccine and throw in the towel(and responsibility)  on significant behavioural change, even in the short term.

2 weeks. Damn. That's all it would take with the governance approach. Wow. To think that is unattainable is really disappointing.

This has nothing to do with conspiracy theorists. This has to do with a shell game sleight of hand which switches the narrative away from a failed social distancing initiative and towards a panacea, that will be arriving just on time. To a lot of people, this holds about as much weight as filling churches by Easter.

There are a lot of countries that are getting on with things in a modified fashion and not waiting around for a vaccine. This Nov. delivery schedule is homegrown.

 

 

 

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On 9/6/2020 at 6:23 PM, Shortforbob said:

Time for us Boomers to step up to the plate IMHO.

Highly educated people on this thread! I have an MBA in finance, a BA in political philosophy, and I passed ASA 101 & 103. So I don’t know shit!

I will take it. Most people make decisions like this using a framework of “enlightened self interest”. The problem in the 21st century is they are not very enlightened at all because (1) most of the information we get that should inform the decision comes from biased assholes, (2) the real information we actually need is highly technical and we aren’t equipped to understand it, (3) outcomes are probabilistic, and (4) half the people are stupid. The last point may seem cruel but I saw a Trump Boat Parade this weekend, and it’s true.

In the absence of real knowledge humans go with tribal knowledge, instinct, religion and total bullshit. Which sometimes works out but that is probabilistic as well.

So, what to do? (1) ignore the biased assholes, (2) listen to the scientists who actually do understand how to interpret the technical data, and (3) deploy an “ethics” framework instead of enlightened self interest. As soon as Dr Fauci and my doctors say I should take a vaccine from a reputable pharma I will take it because it’s the right thing to do for other people not just me. If the first vaccine is 48% effective or 52% effective is immaterial. And probabilistic.

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9 hours ago, fufkin said:

Think of the problem at hand like...traffic. If you've got too many cars on the road, you could just build more roads. That's the take two aspirins and call me in the morning approach.

The other approach is to look at it from a governance standpoint. Incentivizing car pooling, via tolls on single drivers, which would cut traffic in half, and reduce the need to build more roads with money left over. 

The governance approach says, 'yes we are confident in our ability to enforce social distancing and other measures and carry on and adapt', while the 'take two aspirins and call me in the morning' approach seems to instead look for a blanket panacea in the form of an undelivered vaccine and throw in the towel(and responsibility)  on significant behavioural change, even in the short term.

2 weeks. Damn. That's all it would take with the governance approach. Wow. To think that is unattainable is really disappointing.

This has nothing to do with conspiracy theorists. This has to do with a shell game sleight of hand which switches the narrative away from a failed social distancing initiative and towards a panacea, that will be arriving just on time. To a lot of people, this holds about as much weight as filling churches by Easter.

There are a lot of countries that are getting on with things in a modified fashion and not waiting around for a vaccine. This Nov. delivery schedule is homegrown.

I would offer that 2 weeks for the "governance approach" is wildly optimistic.  You would have to globally shut down and isolate every person with the virus simultaneously (no essential workers at all) and drive the R-naught to 0.0 immediately for it to die out in 2 weeks and that presumes that infected people all die or clear the virus in that 2 weeks.  

No doubt, between Trump and selfish morons, the US has shown how to screw it up, but the countries "getting on with it in a modified fashion" are now experiencing a second wave. France, the UK and Spain are showing sharp increases.  Even New Zealand has shown that all it takes is 1 infected person spreading the disease for it to come back.  Victoria just extended their latest shutdown by another 2 weeks to 7 weeks and demonstrations protesting the shutdown are taking place.    Shut downs and quarantines have always been about slowing the disease to prevent New York style disasters until treatments and vaccines could be developed.  

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19 hours ago, shaggy said:

Just talked to 20 something.  After 2 weeks at school, well it sucks.  None of the social stuff is happening obviously, but the freshmen have been doing the covid Boogie for the last 2 weeks.  He is a senior so not missing much and he can concentrate on graduating...  But, He was alittle down and said he should have taken a gap year...  I pointed out that if he took a gap year he would be in our basement, living with us, grandma and 3 dogs while searching for a nonexistent job or driving for uber.  Better to be up there, with his roommates able to at least be semi social...  sucks. but it's the new reality...   Perked him up alittle...  :)

Houseguests' freshmen nephew just sent home from Auburn with the covid, he is now living in the garage at immunocompromised parent house.

Dumb fucking SEC school ran out of student quarantine beds in 10 days and have now distributed covid-positive kids throughout the country.  Gyms were open on campus.    #MAGA

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1 hour ago, MR.CLEAN said:

Houseguests' freshmen nephew just sent home from Auburn with the covid, he is now living in the garage at immunocompromised parent house.

Dumb fucking SEC school ran out of student quarantine beds in 10 days and have now distributed covid-positive kids throughout the country.  Gyms were open on campus.    #MAGA

Its what happens when $$ is put in front of education.  30 kids might get into the draft and we will make mega bucks.  Let's have a season!!!!!!  Fuck it, haha, they want to play.. haha..  petri dish. Meet guinea pig..  MAGA

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15 hours ago, EYESAILOR said:

The Left wing conspiracy nuts are convinced that the Administration has the power to threaten the folks at the OVRR and the FDA to  approve a vaccine that should not be approved.

The administration has been threatening and firing literally hundreds of people at their agencies since the day they took power.  The administration has committed numerous crimes and is in the process of covering them up as we speak.  This is not 'conspiracy theory.'  It is conspiracy.  

Somehow you think it is not effecting the Agencies that you are familiar with because...science?  Know what else is supposed to be science? The EPA.  Know who has stopped enforcing dozens of clean water and clean air laws?  Know who has fought against every public records/FOIA request?  

Denying the multiple active and enthusiastic conspiracies and cover-ups going on today by the trump administration is sticking your head in the sand.  You have a lot of faith but you have not made a single assertion that justifies that faith. 

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13 hours ago, EYESAILOR said:

Hello Proa.......I certainly dont condone false promises or accusations of the deep state.

On the other hand , nor do I condone accusations that the people who work at OVRR and FDA will improperly approve a vaccine. 

 

you are straw manning.  No one here wrote that  'people who work at OVRR and FDA' will improperly approve a vaccine any more than someone said that Dr. Birx improperly approved Trump telling people they didn't need to wear a mask just because she stood next to him silently while he said it. 

It's not 'the people who work at OVRR'. It's their bosses.  Your passion and faith are making you blind.

 

 

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13 hours ago, EYESAILOR said:

So surely our role is to reassure and allay those fears with facts and science.

Facts and science do not allay fears of political appointees who supervise and oversee scientists doing illegal and/or unethical things.  If scientists were quicker to resign and speak out when they are used like stage props in the literal war against science, maybe we'd have more faith in the agencies.  Birx and Fauci's inability to grow a spine has helped cement the lack of faith in the spine of all those thousands of scientists working for the government.

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22 hours ago, EYESAILOR said:

 

I only push back because the conspiracy theory is as dangerous in my mind to public health as Trump's theory about hydroxychloroquine and ultraviolet light.  If people start to believe the rantings of the conspiracy theorists then they will be scared away from vaccines.

Conspiracy theory is a uniquely American pastime ranging .   Frankly Im shocked the Clean has taken the bait on this one. Plenty of information available about how the FDA really approves vaccines.

 

 

 

Here are the FDA approval guidelines for COVID vaccines drafted back in June. 

https://www.fda.gov/media/139638/download

Remember, this was same month this agency both approved and revoked emergency use status for hydroxychloroqine and chloroquine, a more easily expedited process as it was a drug already approved for other uses.

Now this same agency is being asked to fast track approval for a brand new vaccine for a novel virus. When the average traditional vaccine process can take years https://www.google.ca/amp/s/www.bloombergquint.com/amp/quicktakes/the-keys-to-speed-in-race-for-vaccine-and-its-perils-quicktake , when success rate can be as low as 6% across all research initiatives(see article), with a SARS type virus that has proven tricky for researchers thus far...all this with aggressive competitors grappling like barbarians at the gate, with an administration hell bent on shifting a failed policy narrative to a Hollywood ending in the form of an 11th hour panacea...

...well I guess you might excuse the average observer for seeing that the optics aren’t ideal. 

But hey, don’t confuse conspiracy theories for healthy scepticism. If anything the conspiracy theorist in chief who said poof it’ll be gone, who orchestrated an unmasked and un distanced  RNC bit of pageantry that was clearly a desperate grasp at normalcy that flew in the face of any advice of his top infectious disease experts, if you want to know why uptake numbers are 21% for an over promised yet to be delivered vaccine that is being rushed through reduced trials, look squarely at the Executive for sowing confusion.

 

 

 

 

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My wife, upon hearing the announcement by the drug companies concerning vaccine testing this am, said something :rolleyes:  to the effect that our government has really failed when we need to rely on corporations for our safety.  


 

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6 hours ago, loneshark64 said:

Highly educated people on this thread! I have an MBA in finance, a BA in political philosophy, and I passed ASA 101 & 103. So I don’t know shit!

I will take it. Most people make decisions like this using a framework of “enlightened self interest”. The problem in the 21st century is they are not very enlightened at all because (1) most of the information we get that should inform the decision comes from biased assholes, (2) the real information we actually need is highly technical and we aren’t equipped to understand it, (3) outcomes are probabilistic, and (4) half the people are stupid. The last point may seem cruel but I saw a Trump Boat Parade this weekend, and it’s true.

In the absence of real knowledge humans go with tribal knowledge, instinct, religion and total bullshit. Which sometimes works out but that is probabilistic as well.

So, what to do? (1) ignore the biased assholes, (2) listen to the scientists who actually do understand how to interpret the technical data, and (3) deploy an “ethics” framework instead of enlightened self interest. As soon as Dr Fauci and my doctors say I should take a vaccine from a reputable pharma I will take it because it’s the right thing to do for other people not just me. If the first vaccine is 48% effective or 52% effective is immaterial. And probabilistic.

And then how long do you keep up social distancing and masks?

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24 minutes ago, Amati said:

And then how long do you keep up social distancing and masks?

As for me I am planning to keep it up indefinitely or until it is essential under control like H1N1. I have flown on an airplane once this summer with all precautions, and worked, but not going out to dinner and movies etc. I think that’s the new reality.

In years past I went to China on business maybe 20 times and multiple times to Japan, Singapore, Hong Kong. I saw many people wearing masks there for years. I think it’s going to be like that.

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I have no professional medical background, just maybe some basic understandig.

I understand that vaccines have reined in or erased a lot of wide spread and potentially deadly diseases.

I understand that my youth and most of my life I didn't have to care about too many people in a too confined space because of vaccines.

So, I believe that a vaccine will help to be safe(ish) from this virus and, yes, I would take it.

But there's a very big BUT attached to that: I need to trust it. The scientists, the company, the testing protocols, the reviews and the approvement. And I have to admit, that I deeply distrust anything coming from or approved by any organisation that has anything to with Trump or the people he has appointed. So this might stretch the timeline a little.

However, I just stumbled over some news reporting a statement by 9 of the big players [businesswire.com] that reinstalls some trust.

 

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48 minutes ago, Amati said:

My wife, upon hearing the announcement by the drug companies concerning vaccine testing this am, said something :rolleyes:  to the effect that our government has really failed when we need to rely on corporations for our safety.  


 

The CEO of our government would have been fired if he were the CEO of any publicly held corporation. Probably why he never worked for one in any capacity. She’s right, the corporations are probably better run, sadly.

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