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When offered the Vaccine, will you take it?


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Just now, Wess said:

Those in the military do not have the option of finding a new job - they have a commitment to fulfill. And they can and are forced to take certain treatments or vaccines that you would have the option not to.

Not true. They can refuse. This will lead to being discharged,  but they can still refuse. 

Nobody will be forced. You are just promoting victimhood. 

Interestingly enough, the government can force somebody with active TB to be treated. Lock them up and everything. What do you think of that? 

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2 hours ago, Wess said:

Those in the military ... snip

And there is your answer: "Yes, Sir!" ... you should be used to it, yes?

Got any complaints, even in advance, as there is no approved vaccine as of now, take them to the Surgeon General.

Good grief, man!

 

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1 hour ago, Wess said:

Those in the military do not have the option of finding a new job - they have a commitment to fulfill. And they can and are forced to take certain treatments or vaccines that you would have the option not to.

There are requirements that go with certain professions Wes.

Currently I am required to be tested frequently because I perform surgery.  I am also required to scrub, sterilize etc.  I dont know if we will be required to be vaccinated. I have received a notice from our public health department that a vaccine might be available in November- December time frame. If approved by OVRR etc, I will take it for all the reasons above but also because I owe a duty of care to patients.  If your parents were being operated on, you might find it reassuring that the doctor and nurses were either vaccinated or tested.  Many patients have deferred surgery because they are afraid. Vaccinated staff (with a test to ensure immunity was successful) might reassure them .

The military cannot always socially distance to execute the mission , so if a safe vaccine is available I could see how it would be part of the job because being in the military is usually being part of a team.

  

 

 

 

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10 minutes ago, EYESAILOR said:

There are requirements that go with certain professions Wes.

Currently I am required to be tested frequently because I perform surgery.  I am also required to scrub, sterilize etc.  I dont know if we will be required to be vaccinated. I have received a notice from our public health department that a vaccine might be available in November- December time frame. If approved by OVRR etc, I will take it for all the reasons above but also because I owe a duty of care to patients.  If your parents were being operated on, you might find it reassuring that the doctor and nurses were either vaccinated or tested.  Many patients have deferred surgery because they are afraid. Vaccinated staff (with a test to ensure immunity was successful) might reassure them .

The military cannot always socially distance to execute the mission , so if a safe vaccine is available I could see how it would be part of the job because being in the military is usually being part of a team.

  

 

 

 

I suspect that when a vaccine is available,  a substantial allotment will go to US military personal plus the   thousands of critical local employees at US military bases both local and overseas 

vaccinations  for low risk folks are far into the future 

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Ah you folks are so cute when you are condescending. No; I have no clue about the military at all. :rolleyes:  The victim comment was especially funny. The only victim would be anyone in the way when they get granted leave or liberty.

And what you continue to ignore is that there are many (especially young adults) who do not see the virus as a much of a risk at all and are tired of having their lives wrecked for scared fat aging boomers. It amazes me that you can’t see there are many people who disagree with your approach. For you they simply don’t matter. But yet you want them to care about you. Why should they when you don’t recognize or care about them and their views? 

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1 hour ago, Wess said:

Why should they when you don’t recognize or care about them and their views? 

Anti-vaxxers like you are on the same level as flat-earthers.  Only other wackos in your wacko peer group care about your fringe views. 

Up next, you'll be whing about how nobody cares about the view of folks that think lizard people run the world. 

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2 hours ago, Wess said:

 

And what you continue to ignore is that there are many (especially young adults) who do not see [substitute something that they aren't  bothered about, try "Hitler"] as a much of a risk at all and are tired of having their lives wrecked for [people they can't relate to and who probably are somewhat biologically at fault in their plight,  try "Europeans and Jews."]

we sure aren't the Greatest Generation, are we?

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4 minutes ago, NeedAClew said:

we sure aren't the Greatest Generation, are we?

Godwin's lawhttps://en.wikipedia.org/wiki/Godwin's_law

Quote

Godwin's law (or Godwin's rule of Hitler analogies) is an Internet adage asserting that "as an online discussion grows longer, the probability of a comparison involving Nazis or Hitler approaches 1". That is, if an online discussion (regardless of topic or scope) goes on long enough, sooner or later someone will compare someone or something to Adolf Hitler or his deeds, the point at which effectively the discussion or thread often ends.

 

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4 hours ago, Wess said:

 

And what you continue to ignore is that there are many (especially young adults) who do not see the virus as a much of a risk at all I dont ignore them but nor would I give them a lot of credibility when shaping policy. 

and are tired of having their lives wrecked for scared fat aging boomers.The virus has factually ruined many millions of lives , I dont think many lives have been ruined by fat boomers.  Every reasonably sized economy in the world has been negatively impacted by the virus. Trillions of dollars of debt have been created and millions remain unemployed. Businesses have been destroyed. A million people have died. Honestly its hard to blame a few fat people for the outlook for young adults.

It amazes me that you can’t see there are many people who disagree with your approach. For you they simply don’t matter. Of Course they matter. I care about the health and welfare of people who disagree with me as well as the people who agree with me.  I care about people whether they are low risk or high risk, who ever they voted for and whatever their political persuasion In the end there will have to be an approach. A decision or a plan that I dont fully agree with is better than no plan at all. Any approach chosen will not meet the approval of everyone. The reality is that when and if a safe and effective vaccine is available , it will likely be adopted by many countries in some form of policy. People who oppose vaccines still matter....their pov will be listened to .....but people may decide to go with vaccination.

But yet you want them to care about you. Why should they when you don’t recognize or care about them and their views? I would like them to care about themselves and their community. 

 

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What I love about you folks is you bring into focus the insanity of your arguments and in the end turn folks to the other side.  This is a tangent to the thread but this is an election blue should easily win by a landslide but are so extreme (and untruthful) in the views presented people in the center get turned off and turned away.  I am an anti vaxxer she says.  LOL, is she stupid, a liar, or incapable of reading?  I clearly wrote I would urge my parent to take it, would take it myself if necessary (though it would be pointless presently given my medical status) to prove to them its safe enough, made clear I think Clean is nuts with his FDA conspiracy theories (and factually incorrect if he bothered to dig a bit).  But because I also support the views of those younger folks who say thanks no I am somehow an anti vaxxer.  OK, but that statement says way more about you and your intelligence than it does about me.  BTW, what is the IFR these days, the original 10% or the revised 2% or the revised 0.6 % or the next revision of...?  Is the virus spread on surfaces or through the air; whoops that story changed?  Masks help or they don't?  That story changed too.  Is a healthy 20yo at greater risk of covid mortality or getting struck by lightning?  Two weeks to flatten a curve, or two months or two years?

What you folks have is a fanciful story that keep changing, facts that never are, and a never ending desire to silence or ban or condemn anyone who disagrees with you.  You remind me of Hilter to make light of the above.  :P

But I bet you this.  Covid ain't going away.  It will be here with us the rest of this year and next at least.  Nothing is going to stop it and metaphorically it will be waiting for you every time you step out of your house.  So if you are a great risk you best buckle up and hunker down and get vaccinated.  Says the so called anti vaxxer.  But I also say that those that want to live their live their way should be free to do so and the many restrictions declared unconstitutional.  There are many - so many - who simply disagree your view.  Go somewhere where there are no restrictions and see what people actually do.  Are they all nuts and only you smart?  Did they make a decision to consider relative risk and live in a way that best suits them and the people they care about? 

Oh and for gash sake have a living will because the only thing more greedy and dangerous than a lawyer, is a doctor.  :D  Or maybe its a health care bureaucrat or politician... its so hard to keep all the fools lined up these days.  :lol:

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3 hours ago, Wess said:

people in the center get turned off and turned away

People "in the center" at this point who could go either way just aren't paying attention or responding rationally to the facts anyway. They are gullible to "alternative facts" and emotional appeals about "us vs. them" and MAGA.

3 hours ago, Wess said:

its so hard to keep all the fools lined up these days

It's easier than ever when they proudly drive around with Trump flags on their cars and pickups.

 

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3 hours ago, Wess said:

What I love about you folks is you bring into focus the insanity of your arguments and in the end turn folks to the other side.  This is a tangent to the thread but this is an election blue should easily win by a landslide but are so extreme (and untruthful) in the views presented people in the center get turned off and turned away.  I am an anti vaxxer she says.  LOL, is she stupid, a liar, or incapable of reading?  I clearly wrote I would urge my parent to take it, would take it myself if necessary (though it would be pointless presently given my medical status) to prove to them its safe enough, made clear I think Clean is nuts with his FDA conspiracy theories (and factually incorrect if he bothered to dig a bit).  But because I also support the views of those younger folks who say thanks no I am somehow an anti vaxxer.  OK, but that statement says way more about you and your intelligence than it does about me.  BTW, what is the IFR these days, the original 10% or the revised 2% or the revised 0.6 % or the next revision of...?  Is the virus spread on surfaces or through the air; whoops that story changed?  Masks help or they don't?  That story changed too.  Is a healthy 20yo at greater risk of covid mortality or getting struck by lightning?  Two weeks to flatten a curve, or two months or two years?

What you folks have is a fanciful story that keep changing, facts that never are, and a never ending desire to silence or ban or condemn anyone who disagrees with you.  You remind me of Hilter to make light of the above.  :P

But I bet you this.  Covid ain't going away.  It will be here with us the rest of this year and next at least.  Nothing is going to stop it and metaphorically it will be waiting for you every time you step out of your house.  So if you are a great risk you best buckle up and hunker down and get vaccinated.  Says the so called anti vaxxer.  But I also say that those that want to live their live their way should be free to do so and the many restrictions declared unconstitutional.  There are many - so many - who simply disagree your view.  Go somewhere where there are no restrictions and see what people actually do.  Are they all nuts and only you smart?  Did they make a decision to consider relative risk and live in a way that best suits them and the people they care about? 

Oh and for gash sake have a living will because the only thing more greedy and dangerous than a lawyer, is a doctor.  :D  Or maybe its a health care bureaucrat or politician... its so hard to keep all the fools lined up these days.  :lol:

So Wes, Please hold your comments to your knowledge base and not your wild imagination.  I don't know where you are, but in my 5 mi circle, most are compliant, no militaristic shit is going on and the mask requirements are not mandatory...We just had a regatta(Social distanced) and  99% of businesses are compliant and my police force has been protected from lawsuits apparently..  so, to summarize, your view does not equal my view...  

With your centrist views you are clouding your judgement.  People will comply if enough people comply..  And that is a good thing...  Get it...??  

 

Oh, 

Eye is a Dude....  

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1 hour ago, shaggy said:

 

Eye is a Dude....  

 

More interesting facts from the "informed" I see but uh you might want to consider below...

On 9/21/2020 at 7:53 AM, EYESAILOR said:

I am a woman

 

 

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Just now, Wess said:

More interesting facts from the "informed" I see but uh you might want to consider below...

 

LOL I was 60/40 on that one.  I was leaning toward the better looking gender at the beginning of the pandemic, now, well I guess I got the answer.  THX!!

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Nations who have recovered fastest quarantined the fastest. The ruling elites won't allow that here by BOB HENNELLY, SEPTEMBER 21, 2020
Both parties are to blame for the economic rot precipitated by corporations and the super-rich

https://www.salon.com/2020/09/21/nations-who-have-recovered-fasted-quarantined-the-fastest-the-ruling-elites-wont-allow-that-here/

Quote

For Trump's base, the Make America Great Again cult, our nation achieved its zenith in the post–World War II era, when a white family could be supported by a single breadwinner. For them, Donald Trump was just on the verge of a restoration of those halcyon days when the Chinese unleashed the coronavirus and wrecked what he called the "greatest economy in history." 

And now, as the pandemic body count passes 200,000, many MAGA voters believe the virus is "a hoax" and public health measures that aim to stop its spread are part of a deep state conspiracy to deprive Americans of their fundamental civil liberties while kneecapping Donald Trump, who was in the process of delivering that so-called greatest economy. 

So deeply held is this conviction these folks believe that letting their fellow Americans succumb to the virus is a reasonable trade off, because the more people that die and the faster the virus spreads, the quicker herd immunity will be conferred on a grateful nation who can resume in basking in Trump's restoration of white male greatness.

The prevalence of this worldview, blue state or red, is most apparent when we see just what a high percentage of local police officers refuse to wear a mask, even though so many of their colleagues have died from the virus. Yet the large number of Americans who believe the coronavirus, or its concomitant public health restrictions, constitute some kind of conspiracy play right into the hands of a ruling elite that is funneling money from these very same Americans and — with their masks firmly fitted on their faces — are laughing all the way to the bank.
[...]
As Nick Hanauer and David M. Rolf wrote recently in Time:

"The United States went into the COVID-19 pandemic wracked by preexisting conditions. A fraying public health infrastructure, inadequate medical supplies, an employer-based health insurance system perversely unsuited to the moment—these and other afflictions are surely contributing to the death toll. But in addressing the causes and consequences of this pandemic—and its cruelly uneven impact—the elephant in the room is extreme income inequality.

How big is this elephant? A staggering $50 trillion. That is how much the upward redistribution of income has cost American workers over the past several decades.

This is not some back-of-the-napkin approximation. According to a groundbreaking new working paper by Carter C. Price and Kathryn Edwards of the RAND Corporation, had the more equitable income distributions of the three decades following World War II (1945 through 1974) merely held steady, the aggregate annual income of Americans earning below the 90th percentile would have been $2.5 trillion higher in the year 2018 alone. That is an amount equal to nearly 12 percent of GDP—enough to more than double median income—enough to pay every single working American in the bottom nine deciles an additional $1,144 a month. Every month. Every single year."

 

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5 hours ago, Wess said:

Is the virus spread on surfaces or through the air; whoops that story changed?  Masks help or they don't?  That story changed too.  Is a healthy 20yo at greater risk of covid mortality or getting struck by lightning?  Two weeks to flatten a curve, or two months or two years?

What you folks have is a fanciful story that keep changing, facts that never are, and a never ending desire to silence or ban or condemn anyone who disagrees with you.  You remind me of Hilter to make light of the above. 

 But I also say that those that want to live their live their way should be free to do so and the many restrictions declared unconstitutional.  There are many - so many - who simply disagree your view.  Go somewhere where there are no restrictions and see what people actually do.  Are they all nuts and only you smart?  Did they make a decision to consider relative risk and live in a way that best suits them and the people they care about? 

 

If an air siren sounds the alarm that London will be bombed, does it specify which building? No, but people are expected to run for cover. On a balance of probabilities, the govt is protecting the most citizens it can by executive measures taken.

Back to my 9/11 analogy, the carnage of which is being repeated every 3 or 4 days from COVID in the US. Was ensuring the safety of US citizens a moving target like it is under covid? You bet. Recall the sliding scale of airline boarding requirements mandated by the TSA. Belts and shoes removed, at one point toothpaste and shampoo was scrutinized, no pen knives, but hey ‘couldn’t this duty free bottle of liquor be turned into a weapon?’. I recall one violinist having to check their Stradivarius.

The upgraded screening requirements by the TSA were all measures that mildly infringed on the comfort of passengers but not their rights. Like a myriad of measures, public safety, or even more accurately the attempt by the government to ensure and provide public safety can supersede individual rights. As far as vaccination in this context, you can go all the way back to 1905.

As far as mask mandates, unless one has a disability, the states’ or federal government’s responsibility to ensure public safety would again supersede perceived individual rights under a pandemic.

https://www.google.ca/amp/s/theconversation.com/amp/the-constitution-doesnt-have-a-problem-with-mask-mandates-142335

Now, while many in the US are confusing mandated safety measures under a pandemic with their constitutional rights, a stance that seems to co mingle with an introduced scepticism of the effectiveness of those very measures, most ‘free’ western democratic citizens seem willing to go along with the ‘balance of probabilities’ measures taken by their government. Masks? Check. Quarantine? Check. Limit Crowds? Check. Social Distancing? Check.

Do these measures affect commerce? Check. By following  all of them as closely as possible will we return to more commerce faster? Check.

The problem as I see it, is the lack of a visible, concrete enemy to galvanize the citizenship, and instead a mysterious unseen enemy that is ideal fodder for a brand of hucksterism not seen since the late 30s in Germany. 

As for this,

“Go somewhere where there are no restrictions and see what people actually do.”

Again, the laws on the books protecting people  from themselves and each other, even during peacetime, are too numerous to mention. Introduce war or a pandemic, and those constitutional laws should be brought into sharper focus, not more obfuscation.

But as long as you mention it...

“Go somewhere where there are no restrictions and see what people actually do.”

...Sturgis? Or how bout a full stadium for a Gators game w 110 000 students just before they go home to Thanksgiving?

 

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I think the debate with Wess is just a waste of time.

Further upthread he claimed medical knowledge, later legal knowledge, now the military and somewhere inbetween he was even smarter than Bill Gates. Clean called his bluffs and of course Wess was not and is not any of those. Not a doctor, not a lawyer, not an officer and certainly not Bill Gates.

At best he is some semi educated guy trying to pull some legs on an internet forum ... belay that, there is no "at best" here, because of the topic and the possible consequences he is one of those bullshitters, even with his happy-go-lightly attitude, that will get less informed people hurt or worse.

And as other shills of his kind he uses more and more words to make no point at all. Pointless. Waste of time.

Fuck him.

 

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45 minutes ago, Wess said:

Well hey at least I can tell the difference between a guy and a woman.  Your side hasn't figured that out yet.  :P

As I said: Fuck him ... or her.

Whatever.

 

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10 hours ago, Wess said:

 I am an anti vaxxer she says. I said that?????  I dont think so. You said I didnt care about those whose views differed from mine. I said that I did.  

 LOL, is she stupid, a liar, or incapable of reading? None of the above, I am smart, well read, truthful as I can be and stunningly good looking to boot .

I clearly wrote I would urge my parent to take it, would take it myself if necessary (though it would be pointless presently given my medical status) to prove to them its safe enough, That would be a worthy gesture. Of course I would prefer you take it for yourself and your wider community of friends and family....but hey any reason is good

  Is the virus spread on surfaces or through the air; whoops that story changed?  It is and always has been a respiratory infection.  It can get into your respiratory system  in various ways.  If you touch an infected surface and then wipe your face you can catch covid 19.  Most likely infection is breathing  Masks help or they don't?  They help SIGNIFICANTLY

That story changed too.  Is a healthy 20yo at greater risk of covid mortality or getting struck by lightning? Greater risk is covid mortality.

 

What you folks have is a fanciful story that keep changing, facts that never are, and a never ending desire to silence or ban or condemn anyone who disagrees with you.  No desire to silence you. Answer your question as best and factually as I can.

But I bet you this.  Covid ain't going away.  It will be here with us the rest of this year and next at least.  Medically I agree with you. Of course a vaccine starting some time early next year will dramatically reduce risk

  But I also say that those that want to live their live their way should be free to do so and the many restrictions declared unconstitutional.  There are many - so many - who simply disagree your view.  Go somewhere where there are no restrictions and see what people actually do.  Are they all nuts and only you smart?  Did they make a decision to consider relative risk and live in a way that best suits them and the people they care about?  We agree to disagree.  When we live in a democratic society we agree to certain common rules that are voted in by those elected in a  democracy. Where one persons behaviour risks the other , we accept these rules. Speed limits on the highway are irksome to my husband but he complies with them.  I realize theer are those who disagree.

Oh and for gash sake have a living will because the only thing more greedy and dangerous than a lawyer, is a doctor.  :D  Or maybe its a health care bureaucrat or politician... its so hard to keep all the fools lined up these days.  :lol:  Im sorry you feel that way.

 

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Trump’s Vaccine Czar Refuses to Give Up Stock in Drug Company Involved in His Government Role, Sept. 23, 2020
https://www.propublica.org/article/trumps-vaccine-czar-refuses-to-give-up-stock-in-drug-company-involved-in-his-government-role

Quote

The former pharmaceutical executive tapped by President Donald Trump to lead the administration’s race to a COVID-19 vaccine is refusing to give up investments that stand to benefit from his work — at least during his lifetime.

The executive, Moncef Slaoui, is the top scientist on Operation Warp Speed, the administration’s effort to develop a coronavirus vaccine in record time. Federal law requires government officials to disclose their personal finances and divest any holdings relating to their work, but Slaoui said he wouldn’t take the job under those conditions. So the administration said it’s treating him as a contractor. Contractors aren’t bound by the same ethics rules but also aren’t supposed to wield as much authority as full employees.

Slaoui agreed to sell stock worth $12 million and resign from the board of Moderna, the developer of a leading potential vaccine. But Slaoui insisted on keeping his roughly $10 million stake in his former company, GlaxoSmithKline, another contender in the Operation Warp Speed vaccine race. “I won’t leave those shares because that’s my retirement,” he has said. GlaxoSmithKline, working with Sanofi, has started human trials for a coronavirus vaccine using similar technology to Sanofi’s flu shot. It is supported by up to $2.1 billion from the U.S. government.
[...]
But in addition to Slaoui’s retained GlaxoSmithKline shares, the records obtained by the House Democrats revealed he has a holding in another biotechnology company, Lonza Group, that wasn’t previously disclosed. The company has a contract with Moderna to manufacture its coronavirus vaccine.

 

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On 9/22/2020 at 10:29 PM, Grog said:

As I said: Fuck him ... or her.

Whatever.

Quoting myself because I am afraid this could be misunderstood.

That message was for and about Wess, and Wess alone.

 

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So the latest development in possible political interference in approving a vaccine is that POTUS Trump stated yesterday that the White House may or may not approve the guidelines for approving Emergency Use Authorization.

Let us rule out a couple of things. The White House does not get to privately approve a vaccine that has not been recommended for approval by OVRR. If OVRR determines that a vaccine is unproven , or worse unsafe.....the vaccine is rejected . It doesnt make it to Peter Marks or the FDA commissioner. Its done .

However the twist here is that the FDA and OVRR will not be granting full overall approval to any vaccine, they will initially designate it as EUA  as a matter of procedure. This procedure ensures that the phase 3 trials continue and that the vaccine companies monitor all the ongoing results of the vaccine and report it to the FDA on an ongoing basis. I think we all agree that is something we want. Above all we want to monitor how long the vaccine remains effective and whether booster shots are required and which of the various shots works the best.  No worries there, its the right thing to do and is not unusual with new drugs that have proven initial effectiveness but the FDA wants the trials to be ongoing..  However it creates a slight gray area because as a matter of fairness, the vaccine companies are entitled to receive some guidelines that the OVRR and FDA will set for the EUA.   That way, the vaccine companies will seek to obtain the data such that OVRR can review under those guidelines.

The way these guidelines are established is that the FDA produces guidelines and gets feedback from the drug company as to feasibility etc.   It is clear from the vaccine protocols that the FDA and Vaccine companies have already agreed on most bench marks which are included in the trials.

It is virtually unheard of for the White House to interfere with those guidelines, and this is not something I have considered.

I can contemplate how the White House could toughen the guidelines . They could send back an approved drug and ask for more proof. But its hard for them to affect a vaccine that hasnt reached them.  They are not going to push back on effectiveness because the bar is suitably low on that and all the vaccines have passed those hurdles with flying colors. They are not going to lower the bar on SAE because those hurdles have already been set and none of the vaccine companies have indicated any discomfort with those measures.

The only guideline that I can think of which would compromise the trials is the length of time of the trials or reduce the number of participants. The protocols agreed by OVRR and vaccine companies specify a specific period post the shot when the candidate is studied for advers side effects.   Could POTUS shorten the study period to speed up an approval for political reasons?  Honestly I dont have a technical answer for that....I simply do not know if the white house could review the trial protocol and send back a revision specifying a shorter trial period. or revise the number of completed tests to determine statistical  significance.

It has certainly never been done.......but @clean I realize there have been a lot of firsts in this administration.

Here are some things to look out for.

1. We (and hopefully the press) would be able to see this because we have the protocols published and we will also have the trial results.  If the time has been shortened it will be blatantly obvious to any decent healthcare journalist.

2.  The review team at the OVRR know the hurdles they want met and just because the bar is lowered in a guidline doesnt mean their approval cannot wait for longer. You cannot approve a drug which falls below the standard of a guideline but I know for a fact that can wait for more data or even decline  adrug that meets the guideline but the team feels more proof is needed. The responsibility of the oVRR is defined in broad as well as specific terms to determine if a vaccine is both safe and sufficiently effective.

This is all just speculation because an offhand comment at a press conference does not mean very much.

 

 

 

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2 hours ago, EYESAILOR said:

So the latest development in possible political interference in approving a vaccine is that POTUS Trump stated yesterday that the White House may or may not approve the guidelines for approving Emergency Use Authorization.
[...]
It is virtually unheard of for the White House to interfere with those guidelines, and this is not something I have considered.
[...]
It has certainly never been done.......but @clean I realize there have been a lot of firsts in this administration.

TLTR but glad to see you finally acknowledge the potential for meddling by Trump.

This guy states openly that he isn't willing to wait for votes to be counted and will do everything possible to cast doubt and confusion on the process, even delaying it beyond the 35 day period when states are required to certify their votes.  That enables GOP state legislatures to ignore their states' vote totals and appoint Trump stooges to the Electoral College.  There are no limits to what Trump will do to retain power.  Vaccine meddling is only one small part of a much bigger picture.

The Deadline That Could Hand Trump the Election, SEPTEMBER 9, 2020
A 133-year-old law creates perverse incentives for the Trump administration—and could make a chaotic postelection period even more tumultuous.

https://www.theatlantic.com/politics/archive/2020/09/trump-biden-electoral-count-act-1887/615994/

 

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12 hours ago, ProaSailor said:

TLTR but glad to see you finally acknowledge the potential for meddling by Trump.

 

 

I am seeking to be objective and understand any and all risks involved with all of us taking an approved vaccine.

In the absence of meddling, I anticipate that Pfizer is still on track to announce phase 3 trial results in late October and followed by Moderna. An EUA process will start immediately .  We should be able to spot if there is any meddling in that process because we have the existing protocol and can see if the bar is lowered.

This will not affect anyone on this thread because EUA will prioritize healthcare workers and emergency responders. But it is possible I will be offered a vaccine. Personally I like the sound of the J and J vaccine but I will take the Pfizer one if I am satisfied with trial and approval process and if it is offered early.  I see so many patients each day and despite the lower infection rate, I believe that law of averages I will be exposed to  CV19 again.....and I just do not want to catch this thing.

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11 minutes ago, EYESAILOR said:

Personally I like the sound of the J and J vaccine but I will take the Pfizer one if I am satisfied with trial and approval process and if it is offered early.  

At the start of this thread, you were willing to accept the FDA's approval without question based on your confidence in the scientists and approval process. Now you're saying that you need to be satisfied with the trial and approval process, at least for the Pfizer vaccine. What changed?

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In the UK they're going full economy smash down...


Wankcock chooses to ignore the false positive working reality - 30% is a given, with labs pushed to the limit on due process could be way higher false pos rate in fact.

Mix in the technocratik marvel which is this weeks NHS contact/trace app... This leads to hundreds/neigh thousands being needlessly locked out of life and the economy, over the coming months, as it bluetooth chews through the plague ridden 'carriers'....

Thankfully the coming GSK vaccine for Brits will save them and the NHS for sure, and no clash of conflict at all for the UK's chief health science officer...


https://www.thelondoneconomic.com/politics/uks-chief-scientific-adviser-has-600k-shareholding-in-firm-contracted-to-develop-vaccines/24/09/

Yes... the comedy just keeps rollin'....

The true sad reality being that those thousands of UK jobs destroyed by false positives will be gone for good, never coming back.

 

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On 9/25/2020 at 8:18 AM, IStream said:

At the start of this thread, you were willing to accept the FDA's approval without question based on your confidence in the scientists and approval process. Now you're saying that you need to be satisfied with the trial and approval process, at least for the Pfizer vaccine. What changed?

Hi Istream.   I was really more focused on the choice between 2 different vaccines. If I have a choice I will look at the trial and approval data to choose. What I meant is that if my choice is between getting the Pfizer vaccine now and waiting for the JandJ vaccine, I will probably go for the Pfizer vaccine now but I would review the data before making the final call.

If by the time a vaccine is made available to me, there is a choice....then currently I like the "one shot" feature of the J and J version.

I do have a high degree of confidence in the work of the OVRR within the FDA. If they approve a vaccine without qualification for EUA, I will trust that the work has been done. If they qualify the approval, then I will see if I am affected by the risks described in the qualification. 

I will try and ignore the political layers on top.  The election will be over by the time the vaccine is actually available to me or you.

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On 9/25/2020 at 8:19 AM, ProaSailor said:

Doctor, you are politically blind and incredibly obstinate about it.

I am not blind to the political impact on our country .  I really do feel a sense of despair and huge uncertainty about the future of our country and economy .

But I am politically blind when it comes to my work.  I treat patients the same whatever their political persuasion. I examine vaccine approvals the same way.  Yes I generally trust the scientists in medical research.

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12 minutes ago, EYESAILOR said:

I am not blind to the political impact on our country

Yet despite the consensus of experts that having a vaccine before election day isn't likely, you consistently proclaim the Trump line that it will happen.  Like a partisan.

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2 hours ago, EYESAILOR said:

Hi Istream.   I was really more focused on the choice between 2 different vaccines. If I have a choice I will look at the trial and approval data to choose. What I meant is that if my choice is between getting the Pfizer vaccine now and waiting for the JandJ vaccine, I will probably go for the Pfizer vaccine now but I would review the data before making the final call.

If by the time a vaccine is made available to me, there is a choice....then currently I like the "one shot" feature of the J and J version.

I do have a high degree of confidence in the work of the OVRR within the FDA. If they approve a vaccine without qualification for EUA, I will trust that the work has been done. If they qualify the approval, then I will see if I am affected by the risks described in the qualification. 

I will try and ignore the political layers on top.  The election will be over by the time the vaccine is actually available to me or you.

Thank you for your answer. I would characterize your take on the second scenario (Pfizer now, waiting for J&J) as converging on mine: evaluate the data before deciding. I will go further and wait for a few million people to get vaccinated before me and a few weeks for any serious reactions to surface but I don't share your risk profile. 

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https://worldnewsera.com/news/business-news/china-gives-unproven-covid-19-vaccines-to-thousands-with-risks-unknown/

"First, workers at state-owned companies got dosed. Then government officials and vaccine company staff. Up next: teachers, supermarket employees and people traveling to risky areas abroad.

The world still lacks a proven coronavirus vaccine, but that has not stopped Chinese officials from trying to inoculate tens of thousands, if not hundreds of thousands, of people anyway. Three vaccine candidates are being injected into workers whom the government considers essential, along with many others, including employees of the pharmaceutical firms themselves.

Officials are laying out plans to give shots to even more people, amounting to a big wager that the vaccines will eventually prove to be safe and effective.

China’s rush has bewildered global experts. Many of the injections appear to be taking place outside the typical drug approval process. The vaccine candidates are in Phase 3 trials, or the late stages of testing, which are mostly being conducted outside China. The people in those trials are closely tracked and monitored. It is not clear that China is taking those steps for everyone who is getting the shots within the country.

 

The unproven vaccines could have harmful side effects. Ineffective vaccines could lead to a false sense of security and encourage behavior that could lead to even more infections.

The wide use of vaccines also raises issues of consent, especially for employees of Chinese vaccine makers and state-owned companies who might feel pressure to roll up their sleeves. The companies have asked people taking the vaccines to sign a nondisclosure agreement preventing them from talking about it to the news media."

 

I will wait, however long it takes.

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4 hours ago, IStream said:

Thank you for your answer. I would characterize your take on the second scenario (Pfizer now, waiting for J&J) as converging on mine: evaluate the data before deciding. I will go further and wait for a few million people to get vaccinated before me and a few weeks for any serious reactions to surface but I don't share your risk profile. 

I agree we are aligned in many ways

There is one difference. Although factually I am unlikely to get the opportunity to be one of the first million to be vaccinated (and I doubt you will be either), I take the view that we should be ready to take the vaccine when it is our turn (subject to quality approval etc.) . I want to avoid the impression that other people must go first. If everyone waits until a few million people are vaccinated , then of course  nobody will go first.  Its a kind of prisoners dilemma. So I take the view that if a vaccine has been submitted by a reputable pharma company where their scientists are convinced it is safe and effective, then that vaccine and its trials are carefully reviewed in a transparent manner by the OVRR and submitted with a request for approval for EUA to the FDA and then approved by the FDA.....then I will be ready to make myself and my family safe + play my part in generating herd immunity by getting vaccinated. I am certainly not trying to persuade you to adopt this view and I respect the difference, just sharing my view.

Istream, in reality you are NOT going to be in the first 2 million vaccinated, so perhaps this is all academic , but you will be offered a chance to get vaccinated before phase 3 trials are over because phase 3 will take 2-3 years to complete.  We will not know the length of immunity when we get vaccinated but we will know if it is effective in its first 6 months and we will know if it is safe.

My main push back has been against the conspiracy / social media campaigns suggesting that the team at the OVRR can be corrupted/threatened to approve a vaccine that has not met their guidelines .  I know some of the people at Moderna. I know by reputation some of the people at the OVRR. I trust them. As part of your due diligence before getting vaccinated, look at the trial results by all means but also go online to the OVRR site and look at the names of the people who will be reviewing this vaccine (I posted them upthread). Look at their linked-in profiles and their experience and dedication . Then form your own independent opinion as to whether you will trust the work they do. You have to ignore the social media from both sides of the spectrum and form your own view on 2 things #1 The most important - Do I trust the people conducting and reviewing the trials and #2 Am I impressed/comfortable with the results (and you can only trust the results if you say yes to #1).   Do not get distracted by who is head of the FDA, EPA, FBI , etc. The team doing the work and publishing the results is all you should care about. 

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6 minutes ago, EYESAILOR said:

we will know if it is effective in its first 6 months and we will know if it is safe.

If the immunogenicity is 50% or 70% or even 90%, you won't know for sure if it's effective for you.  And you won't truly know if it's safe either.

9 minutes ago, EYESAILOR said:

I know some of the people at Moderna. I know by reputation some of the people at the OVRR. I trust them. As part of your due diligence before getting vaccinated, look at the trial results by all means but also go online to the OVRR site and look at the names of the people who will be reviewing this vaccine (I posted them upthread). Look at their linked-in profiles and their experience and dedication .

Sorry but this is complete rubbish.  The more you repeat it, the more desperate and deluded your sales pitch sounds.

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6 hours ago, ProaSailor said:

Yet despite the consensus of experts that having a vaccine before election day isn't likely, you consistently proclaim the Trump line that it will happen.  Like a partisan.

Just to be wholly accurate.

1. I have not proclaimed any Trump lines

2. I have said that there is a reasonable likelihood of one phase 3 trial having preliminary results in October (probably 2nd half October)  I also think we will have 3 x phase 3 trial preliminary results by the end of December. 

3. I have also made it clear that once the result are submitted, there are 2 additional steps. Approval (and lets not repeat the debate on whether to trust the OVRR or not....I think we have agreed to differ) and then distribution.  

4. I have no doubt there will be lots of opportunities for political spin at the time of submission but I shall be objective.

If "having a vaccine" means a vaccine is available and approved for the wider general public, I strongly doubt we will be "having" a vaccine before election date.

If "having a vaccine" means a submission of a successful phase 3 preliminary trial with a request for EUA, I think there is a 30+% probability of that by election day . I think there is an 80% probability of that before January 30.   Unfortunately the way science works is we discover failures first, so brace yourself for an earlier announcement that a trial is being suspended .  I think there is an 75% chance of a trial result one way or another before election day. Overall, I think that CV19 has shown itself susceptible and enough candidates are underway that we will over time we will have a vaccine. But.....nothing is certain in vaccines until we cross the finish line.

I have not seen this consensus of experts that disagree with Pfizer, but feel free to link me. Everything I read suggests they are still on tracks. A_Z is the one that got derailed for a bit. They were in the lead for a while.

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6 minutes ago, ProaSailor said:

If the immunogenicity is 50% or 70% or even 90%, you won't know for sure if it's effective for you.  And you won't truly know if it's safe either.

 

1.  If the level of immunity generated is 50% or greater, it will succeed in stopping the disease if everyone gets vaccinated . A level of 70% would be highly effective.  The math is compelling as the transmission rate halves or even falls by 70% from its current levels well above 1. Im sure you are familiar with how that works. 

That said, I agree that 50% effectiveness is not an easy sell nor would it make much of a dent .  Not everyone is going to understand the epidemiology

2. . From phase 1 trials I think a successful candidate will emerge with  over 90% immunity...but again, that is speculation. Lets wait for results.

 

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1 hour ago, Imogi said:

So how do flu vaccines work went they are less than 50% effective?

Not that great when the strains picked don't match the circulating viruses that year. I have had flu a few times in my decades of shots. Mr. Clew, never. 

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3 hours ago, EYESAILOR said:

I take the view that we should be ready to take the vaccine when it is our turn (subject to quality approval etc.)

Hedging your bets a bit there, makes the rest of your argument less than credible, are you worried you will be offered an unsafe vaccine?

Go ask your buddies why its taking so long for treatments with results submitted for approval to take so long to be assessed. Then ask them why the treatments that have been approved are so ineffective and were approved near instantly.

More money to made if you need a vaccine, don't need a vaccine if the treatments work. Open your other eye.

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On 9/21/2020 at 3:02 PM, Wess said:

And what you continue to ignore is that there are many (especially young adults) who do not see the virus as a much of a risk at all and are tired of having their lives wrecked for scared fat aging boomers. It amazes me that you can’t see there are many people who disagree with your approach. For you they simply don’t matter. But yet you want them to care about you. Why should they when you don’t recognize or care about them and their views? 

Oh we're all well aware that there are many people out there that are such ignorant, selfish, narcissistic, cunts that nobody gives a shit about them either, so they don't care if they kill their parents, or grandparents, or aunts, or uncles, etc. etc. etc, what's your point?

 

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"But five experts interviewed by ABC News all agreed with Redfield, saying that masks are, in fact, our strongest weapons against the pandemic.

During his Senate testimony, Redfield explained that a vaccine might not be 100% effective at producing an immune response strong enough to stave off infection. Masks, however, provide an evidence-backed protective barrier."

So why are we still waiting for a vaccine and having lockdowns?

Maybe the marketing budgets of the big pharmas are a lot bigger and more effective than that of thousands of little mask manufacturers.

Or like here in NZ (or maybe OZ), too busy on the election vote coming up to look at the evidence, take some advice and change the course.

So what is it eye, politics? money? stop pretending they have nothing to do with it, vaccines being the only answer just doesn't stand scrutiny.

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4 hours ago, EYESAILOR said:

I agree we are aligned in many ways

There is one difference. Although factually I am unlikely to get the opportunity to be one of the first million to be vaccinated (and I doubt you will be either), I take the view that we should be ready to take the vaccine when it is our turn (subject to quality approval etc.) . I want to avoid the impression that other people must go first. If everyone waits until a few million people are vaccinated , then of course  nobody will go first.  Its a kind of prisoners dilemma. So I take the view that if a vaccine has been submitted by a reputable pharma company where their scientists are convinced it is safe and effective, then that vaccine and its trials are carefully reviewed in a transparent manner by the OVRR and submitted with a request for approval for EUA to the FDA and then approved by the FDA.....then I will be ready to make myself and my family safe + play my part in generating herd immunity by getting vaccinated. I am certainly not trying to persuade you to adopt this view and I respect the difference, just sharing my view.

Istream, in reality you are NOT going to be in the first 2 million vaccinated, so perhaps this is all academic , but you will be offered a chance to get vaccinated before phase 3 trials are over because phase 3 will take 2-3 years to complete.  We will not know the length of immunity when we get vaccinated but we will know if it is effective in its first 6 months and we will know if it is safe.

My main push back has been against the conspiracy / social media campaigns suggesting that the team at the OVRR can be corrupted/threatened to approve a vaccine that has not met their guidelines .  I know some of the people at Moderna. I know by reputation some of the people at the OVRR. I trust them. As part of your due diligence before getting vaccinated, look at the trial results by all means but also go online to the OVRR site and look at the names of the people who will be reviewing this vaccine (I posted them upthread). Look at their linked-in profiles and their experience and dedication . Then form your own independent opinion as to whether you will trust the work they do. You have to ignore the social media from both sides of the spectrum and form your own view on 2 things #1 The most important - Do I trust the people conducting and reviewing the trials and #2 Am I impressed/comfortable with the results (and you can only trust the results if you say yes to #1).   Do not get distracted by who is head of the FDA, EPA, FBI , etc. The team doing the work and publishing the results is all you should care about. 

I agree, my wanting to wait is moot because I won't have the opportunity to be early in line. I also think there are many, many people willing to go before me because they have a higher risk profile than I do. If I shared their risk profile, I would be less likely to wait as well. 

Again, the issue isn't that immunity will be short, While it would be a bummer to have to get the vaccine every year or even every 6 months for a time, that's not really a big deal to me. The issue is adverse effects.

There *will* be a judgement call to make about what constitutes acceptable morbidity and acceptable frequency before approval is granted. Given the enormous economic impact of the pandemic, there will be legitimate logical, ethical, and yes, financial arguments in favor of approving and accepting more serious and more frequent side effects (if they manifest) than would be made under normal circumstances. This is to be expected and is not indicative of some conspiracy. Nevertheless, what may be an acceptable tradeoff  when looking at approval for society as a whole may not be acceptable to me personally. If the safety profile of the first vaccine approved looks dodgy to me, I may wait for the second or third to see if they're better.

 

 

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5 hours ago, NeedAClew said:

Not that great when the strains picked don't match the circulating viruses that year. I have had flu a few times in my decades of shots. Mr. Clew, never. 

Correct. The flu vaccine is not one vaccine. It is usually a combination of 3,4 or 5 (I cant remember the exact number) of vaccines for viruses deemed most likely to be prevalent in that particular year.In the case of CV19, we know what we are shooting at.

Still, no guarantees until we get a vaccine that hits the target.

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Interesting article in the Washington Post  which suggests that the African American community most at risk due to fear and distrust of a vaccine approval process. 
 

The organization for Black medical practitioners is setting up an independent review board to review trial results. 
 

Something like only 30% ofAfrican American population will take a vaccine compared to 56% of white. 

 

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2 hours ago, IPLore said:

Interesting article in the Washington Post  which suggests that the African American community most at risk due to fear and distrust of a vaccine approval process. 
 

The organization for Black medical practitioners is setting up an independent review board to review trial results. 
 

Something like only 30% ofAfrican American population will take a vaccine compared to 56% of white. 

 

https://www.washingtonpost.com/nation/2020/09/26/black-vaccine-mistrust/

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I think this survey by Pew Research really illustrates the challenge

https://www.pewresearch.org/science/2020/09/17/u-s-public-now-divided-over-whether-to-get-covid-19-vaccine/

 

In May 72% of the population were prepared to take the vaccine. Note that in May the target date for completion of phase 3 was October/November.

By September that number had fallen precipitously and was down to 51%.  Even more worryingly the number definitely ready to take thevaccine  had halved to 21%. 

What has changed? The time line to phase 3 and the vaccine candidates remain the same .  The change has been political posturing. Such is the distrust for statements from POTUS that his statements on the vaccine have actually had a negative effect. His statements promising to have a vaccine by the election has created distrust. The Pew survey finds three-quarters of Americans (77%) think it’s very or somewhat likely a COVID-19 vaccine will be approved in the United States before its safety and effectiveness are fully understood.

Interestingly, Democrats trust the independence of the Drug review process more than Republicans. Only 44% of Republican voters will lkely take the vaccine vs 58% Democrats.....but still way down from 79% in May.

This was really the reason behind starting this thread.  Poor messaging and political posturing has created distrust and damaged the outlook for the vaccine. I am hoping that trust can be restored.


 

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In an alternative universe where I was president, perhaps the message might have been something more reassuring like:

  • We have 170 vaccine candidates being tested
  • Four are in massive phase 3 trials partially funded by the US government
  • We expect preliminary results from phase 3 trials starting in October and going through to November and December. I cannot promise a result before the election date ...but I can promise that the right people are working on this as fast as they can in a responsible manner.
  • The trials results will be reviewed by the OVRR who will determine whether to recommend approval by the FDA. The results and the approval will be publicly available and will also be reviewed by independent boards. 
  • If a vaccine is approved by the OVRR and the FDA, we will move swiftly to support production and distribution of the vaccine.
  • The government has pre-funded the manufacture of all four of these candidates ahead of time, so that if one of them is successful we can supply doses immediately to those most in need without waiting for the usual 6 month time lag to build a new factory. Not all of the vaccines will be successful but we have funded the construction of factories and production lines and have already manufactured vaccines in bulk in order to be ready to supply a vaccine earlier than otherwise have been the case.
  • The approval process and phase 3 trials have not been shortened . No corners will b e cut,  A safe vaccine is goal #1, 2 and 3!  The time line from approval to delivering the approved vaccine from a ready built plant has been shortened by at least 6 months. 

 

But that is wishful thinking.

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53 minutes ago, EYESAILOR said:

In May 72% of the population were prepared to take the vaccine. Note that in May the target date for completion of phase 3 was October/November.

That target date of October/November was politically motivated from Day 1.  You have consistently ignored that and tried to convince us that it's nothing more than coincidence.

53 minutes ago, EYESAILOR said:

This was really the reason behind starting this thread.  Poor messaging and political posturing has created distrust and damaged the outlook for the vaccine. I am hoping that trust can be restored.

What you have done instead is damaged your own credibility.  I trust you less now because your zealous crusade has been blind about the obvious connection between election day and "vaccine day".

 

Taxpayers Hit With $300 Million Tab For Ads Spreading Positive Spin On COVID: Report, 09/26/2020
https://www.huffpost.com/entry/defeat-dispair-happy-news-covid-hhs_n_5f6fdcb0c5b64deddeeec8fa

Quote

The Department of Health and Human Services is shelling out an astonishing $300 million for an ad campaign putting a positive spin on COVID-19, Politico reported. It’s reportedly the brainchild of a controversial HHS official who stepped aside last week after warning supporters of President Donald Trump to buy ammo before the election.

The “defeat despair” ad blitz reportedly plays down the dire consequences of the pandemic and touts Trump’s low-key efforts against COVID-19 even as the U.S. death toll rockets past 200,000, sources told Politico.

The “public awareness” campaign is conveniently set to begin airing before the November election and features HHS officials and Trump-supporting celebrities, such as actor Dennis Quaid and country singer Garth Brooks, Politico reported.

The ad blitz was largely organized by controversial former HHS Deputy Secretary and top spokesperson Michael Caputo, Politico reported. He said in a recent Facebook video that the ad campaign was “demanded of me by the president of the United States. Personally.”

 

‘It’s like every red flag’: Trump-ordered HHS ad blitz raises alarms, 09/25/2020
Staffed in part by associates of a longtime GOP operative, the ad campaign includes CeCe Winans, Dennis Quaid and others pushing an optimistic line about coronavirus.

https://www.politico.com/news/2020/09/25/trump-hhs-ads-coronavirus-421957

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1 hour ago, EYESAILOR said:

We expect preliminary results from phase 3 trials starting in October and going through to November and December. I cannot promise a result before the election date ...but I can promise that the right people are working on this as fast as they can in a responsible manner.

@EYESAILOR I sincerely hope you read the very detailed Politico article and realize how this $300 million dollar campaign has been publicly funded political advertising for Trump since its conception in May by Michael Caputo.  Your own messaging has been entirely consistent with his stated goals (ignoring his unstated primary goal of re-electing Trump).

‘It’s like every red flag’: Trump-ordered HHS ad blitz raises alarms, 09/25/2020
Staffed in part by associates of a longtime GOP operative, the ad campaign includes CeCe Winans, Dennis Quaid and others pushing an optimistic line about coronavirus.

https://www.politico.com/news/2020/09/25/trump-hhs-ads-coronavirus-421957

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14 hours ago, ProaSailor said:

That target date of October/November was politically motivated from Day 1.  You have consistently ignored that and tried to convince us that it's nothing more than coincidence.

 

We have to agree to disagree.  Back in early March when the vaccine companies were pulling apart the DNA of the virus molecule and had some immediate success, they modeled out the timeline to a vaccine and shared those timelines.   The results of each phase were published and scientific and not politically motivated.

We are both consistent.

You are right I have consistently said that the scientific vaccine development protocols are not politically motivated  .

Conversely ,you have consistently said the process and the timeline of the process is politically motivated.

If one of us is on a  zealous political crusade, it is not me. 

I agree that there will be lots of announcements motivated by political spin.  I will choose to ignore the spin and focus on the science.

If, in your mind, a successful phase 3 trial result helps one party over another then that suggests the somewhat morbid conclusion that you want the vaccine trials to fail or hit delaying road blocks or that you simply want the phase 3 results delayed until after the election for political reasons. . 

I do not want the phase 3 results to arrive either before or after the election, I simply want them to be thorough and hopefully successful.

 

 

 

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23 hours ago, EYESAILOR said:

In an alternative universe where I was president, perhaps the message might have been something more reassuring like:

  • We have 170 vaccine candidates being tested

We? This thread seems to be about the US only. The US government has allocated USD9 billion for 7 vaccines: Federal spending on COVID-19 vaccine candidates tops $9 billion, spread among 7 companies. Some important quotes from that article:

The vaccine candidates now receiving government funding are all based on new technologies, most of which have not been the basis of previously approved vaccines.

It is not known exactly what percentage of a population must be vaccinated to provide enough "herd immunity" to stop or prevent an outbreak, but researchers believe at least 50%-70% of the population will need protection.

The FDA has said it will approve any vaccine that is shown to be safe and to prevent infection or severe symptoms in at least half of those who are vaccinated. Several companies have said they are hoping to show their vaccine is effective at least 60% of the time.

So it's not really about "the" vaccine, but which one. If efficacy is only around 60%,  will people just not bother?

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Old news (3 days ago):

Trump, White House demand FDA justify tough standards for coronavirus vaccine, raising concerns of political interference, September 25, 2020
https://www.washingtonpost.com/politics/2020/09/25/coronavirus-vaccine-trump-interference/

Quote

On the same day President Trump blasted the Food and Drug Administration’s plan for tougher standards for a coronavirus vaccine as a “political move,” a top White House aide demanded detailed justifications from the agency in what some fear is an attempt to thwart or block the standards designed to boost public trust in a vaccine.
[...]
White House officials are especially interested in the agency’s recommendation that manufacturers provide safety data for their clinical trial participants for a median of two months after they get their second vaccination shot. The FDA’s data request would make it exceedingly difficult, though not entirely impossible, for a vaccine to be cleared by Election Day, experts say.

The recommendation is a way of ruling out some vaccine-related side effects, such as spinal cord inflammation called transverse myelitis or blood clotting issues, several experts said.

At a vaccine forum Thursday, Peter Marks, the top FDA career official who oversees vaccine reviews, said those types of side effects, though rare, tend to occur 42 to 60 days after the second dose of a vaccination, according to a research note from analyst Geoffrey Porges.

 

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On 9/27/2020 at 7:05 AM, EYESAILOR said:

In an alternative universe where I was president, perhaps the message might have been something more reassuring like:

  • We have 170 vaccine candidates being tested
  • Four are in massive phase 3 trials partially funded by the US government
  • We expect preliminary results from phase 3 trials starting in October and going through to November and December. I cannot promise a result before the election date ...but I can promise that the right people are working on this as fast as they can in a responsible manner.
  • The trials results will be reviewed by the OVRR who will determine whether to recommend approval by the FDA. The results and the approval will be publicly available and will also be reviewed by independent boards. 
  • If a vaccine is approved by the OVRR and the FDA, we will move swiftly to support production and distribution of the vaccine.
  • The government has pre-funded the manufacture of all four of these candidates ahead of time, so that if one of them is successful we can supply doses immediately to those most in need without waiting for the usual 6 month time lag to build a new factory. Not all of the vaccines will be successful but we have funded the construction of factories and production lines and have already manufactured vaccines in bulk in order to be ready to supply a vaccine earlier than otherwise have been the case.
  • The approval process and phase 3 trials have not been shortened . No corners will b e cut,  A safe vaccine is goal #1, 2 and 3!  The time line from approval to delivering the approved vaccine from a ready built plant has been shortened by at least 6 months. 

 

But that is wishful thinking.

If Only....

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1 hour ago, Marinatrix447 said:

“Biotech firms and drugmakers across the globe are pumping in millions of dollars to develop a vaccine to wipe out the deadly coronavirus, with many already ramping up production of their vaccine candidates if one gets an approval…”

A must read for any tech focused anarpist lurking here who’s mantra is follow the ‘science’

https://www.aier.org/article/a-primer-for-the-media-on-viruses-vaccines-and-covid-19/

 

(You’re welcome)
 

Care to explain why you thought this worth reading? This is merely an opinion piece, meandering all over the place including all sorts of anti-vaxxer BS, to make a point that "responsible journalism" has apparently died. And for that claim he cites one (!) headline from one article he found on Yahoo (!). WTF?!

And if you can be bothered: Why did you put the word science in quotes?

 

Other than that, I would like to have my 20 minutes back.

 

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Google Hendra Virus.

Had a vaccine rushed out based on an existing version.  Rolled it out and one of our horses went a bit mental.  Was dangerous for about a year, after two years it was almost back to normal.

The 'Racing Industry' refuses to use it and they have been allowed not to.  Odd seeing as the original outbreak was in race horses.  Some have died although the vets refuse to list it a cause of death.

They turned backyard horses into cash-cows at $300 a pop/year.  Not good when you have a few of them.

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1 hour ago, Marinatrix447 said:

“Biotech firms and drugmakers across the globe are pumping in millions of dollars to develop a vaccine to wipe out the deadly coronavirus, with many already ramping up production of their vaccine candidates if one gets an approval…”

A must read for any tech focused anarpist lurking here who’s mantra is follow the ‘science’

https://www.aier.org/article/a-primer-for-the-media-on-viruses-vaccines-and-covid-19/

 

(You’re welcome)
 

When we want pandemic information from Economists we will give you a call.  Till then, Why don't you just fuck off. 

The American Institute for Economic Research (AIER)[2] is a 501(c)(3) economic research institute located in Great Barrington, Massachusetts. The institute aims to promote individual sovereignty, limited government, and "a society based on property rights and open markets."[3] It was founded in 1933 by Edward C. Harwood, an economist and investment advisor, with the intention of protecting individual rights.[4]

EDIT: They are funded by the Koch Brothers.  Oh and did I say that this makes you officially a "Disinformation Agent"?  

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On 9/25/2020 at 6:56 AM, EYESAILOR said:

This is all just speculation because an offhand comment at a press conference does not mean very much.

 

 

Well why the fuck post bullshit?

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3 hours ago, Grog said:

Care to explain why you thought this worth reading? This is merely an opinion piece, meandering all over the place including all sorts of anti-vaxxer BS, to make a point that "responsible journalism" has apparently died. And for that claim he cites one (!) headline from one article he found on Yahoo (!). WTF?!

And if you can be bothered: Why did you put the word science in quotes?

 

Other than that, I would like to have my 20 minutes back.

 

quoting misinformation makes you a mark

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58 minutes ago, MR.CLEAN said:

quoting misinformation makes you a mark

Not my intention, sorry.

I can't edit the quoted BS anymore. Can you? If so, feel free to delete the quote and/or my post #361.

I see the original post from Marinatrix is already gone.

 

Oddly enough, I have had an exchange of PMs with one of SA's coders some years ago on how to maintain quoted text as an alias to the original message, so it could be ignored or deleted. As it is (and was) the quoted text loses it's database id and becomes just text, now associated to the quoter.

There ... it's not that I should have known better, I actually know better. Which makes it twice as stupid. Hmpf. <_<

 

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2 hours ago, IStream said:

Marinatrix is a kook. She's usually pushing some Zero Hedge article on the topic of the day. 

Thanks! (Had to look up ZH. Despicable.)

So I got played by a troll. Don't like it under normal circumstances and much less on this topic. There is more than enough BS floating around and I seriously don't want to spread it any further.

Strange creatures lurk in these waters. I shall not be caught off guard by one of those again.

 

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Regeneron just announced the results of a 270 cohort trial of their anti-body cocktail. Im listening to the results presentation live. There is a bit more information than in the press release.

Released a couple of hours before presidential debate.....have at it!

 

Please note.....this is NOT been subjected to regulatory review yet. This is just the results that Regeneron will be submitting.

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 You might want to contemplate that the vaccine tests have cohorts of 30.000-40,000 vs an antibody cocktail trial on 270 people.

Interesting features:

  • All patients were CV19 positive. Half seropositive (already developed their own anti-bodies) Half seronegative (had not developed their own immune response - antibodies)
  • They discovered that the seropositive population already had a much lower viral load that the seronegative.  Eye notes, we all expected this but it good to have clear evidence supporting this.
  • Seronegative cohort had much more CV19 symptoms that the cohort that had developed their own immune response. The viral symptoms in terms of viral load (many million of viral molecules per millliter) and length of symptoms were worse in seronegative. Seropositive patients started with a lower viral load and cleared the viral load quicker. So even in absence of treatment, we know that the bodies own antibodies are effective on the disease. Not a surprise but paves the way for this treatment and also for vaccines.
  • The antibody cocktail had the biggest effect on seronegative population where (but note small sample), where there was significant reduction in viral load and corresponding less symptoms than the placebo

 

My guess on how this will affect protocols IF subsequent trials reinforce these conclusions:

1) Patient is tested for CV19

2) If patient is positive, patient will be tested with an assay to determine if (a) Sero-negative (no antibodies) or (b) High Viral load.

3)  Patients with high viral load  (or sero-negative) can be treated with antibody cocktail

I believe trial need to be expanded .  This was prophylactic (a patient pop of outpatients who were not hospitalized) so not sure if it can get EUA yet.  But they have similar trial is going  with hospitalized patients.   Thus far studies by others suggest that trying to reduce viral load  once patients are experiencing severe symptoms is not effective. The severe patients have typically not been dying due to viral load but because of response. However, severe patients have 10X the viral load  of non-severe patients which suggests that getting ahead of the viral load is important.

George is being aasked about EUA as I write this

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George says that results deserve to be discussed with the regulatory body and that this solution can help lives and deserves to be discussed. Refers frequently to "regulators and society" deciding if this should be approved.

It is clear that they are going to push for getting some kind of approval, but acknowledges will also be asking regulator what further information the regulator requires.

300,000 doses will be available by end of year. The substantial majority is already made. This is a contract with Department of Defense. DoD plans to provide it for free to general public where required.

Roche will help with 250,000 doses .....then can combined they an provide several million per year.

"Enormous benefit potential to stop high spreaders, asymptomatic high viral load cohort...we have potential to shut the down!"

(I dont know how George plans to find the asymptomatic patients)

George thinks diagnostic tools will be key "WE as a society are trying to fly the plane at the same time as we are building the plane. We as a sociaty have to decide how we use potentially powerful but scarce tool.....we are flying the plane while we are loading it with all kinds of different components and figuring out how to best fit them all together and get the most effective way to defeat the disease"

Question put to him

"What are the implications for vaccines?"

George  "Obviously we think this provides a very strong tool even when vaccines arrive, but there is also no doubt that this study gives significant cause for optimism for vaccines. Our antibody cocktail binds with the spike protein preventing the spike from connecting with the ace receptor in patients who already have CV19. The more advanced vaccine candidates in trials are stimulating the body to produce its own antibodies with exactly the same mechanism of responding to and neutralizing the spike. Our trial shows that this type of antibody is an effective way of suppressing the disease . Neutralizing the spike seems very effective.  So cause for optimism. "

" We were also pleased with the half life of the antibodies suggesting that the cocktail will provide coverage for a long time. We will know more about his oevr time"

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13 hours ago, ProaSailor said:

Who the fuck is George?  As if being on a first name basis with someone working at one of these companies gives them more credibility?  Too much drama, jargon and rah-rah.

Chief scientific officer at Regeneron.  

I dont know him and I cant spell his last name. I was merely quoting as I listened to the webcast as they announced the trial results.

 

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42 minutes ago, EYESAILOR said:

Chief scientific officer at Regeneron.  

I dont know him and I cant spell his last name. I was merely quoting as I listened to the webcast as they announced the trial results.

 

Thank you BTW,

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Feedback from some of my colleague today who actually understand p stats in trial results was that 

"Good news is that no adverse effects

The results themselves though were not particularly compelling. If I got CV19 and I had a low anti-body response, yeah I'd want to take it but we should be hoping for something better to come along. It will be interesting to see how the hospitalized cohort fares. Dont hold your breath.

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Moderna has stated that it will not have preliminary phase 3 results until late November.  While this puts rest to the political conspiracy theory , it also means pushing back timelines in general.

According to Moderna this will mean submitting for approval in January and general availability in April.

This seems to mean we are only about half way through this marathon. Masks and SD for a long time yet.

Some test candidates have been leaking to journalists that the jab is painful and can give chills etc.  This is very non-scientific because they dont know if they have placebo or vaccine.....but overall, its a bit worrisome.

 

 

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From Pfizer:

The head of Pfizer, one of the drugmakers  told employees he was disappointed that its work was politicized during this week’s presidential debate and tried to reassure U.S. staff that the company won’t bend to pressure to move more quickly.

Chief Executive Officer Albert Bourla told the employees Thursday that the company is “moving at the speed of science,” rather than under any political timing, according to a staff letter obtained by The Associated Press.

“The only pressure we feel — and it weighs heavy — are the billions of people, millions of businesses and hundreds of government officials that are depending on us,” Bourla wrote.

Pfizer has said that it expects to have data from its ongoing late-stage test by October that could show whether the vaccine is safe and effective. In his letter to employees, Bourla wrote that the company hopes to have “a hundred million doses delivered by the end of the year.”

 

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For somebody who claims to be a doc you seem amazingly ignorant about the drug development processes, it’s challenges and pitfalls, and realistic timelines, as well as how long most people will put up restrictions that lack a logical basis.  You also seem to like to hear yourself talk. A lot.

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11 minutes ago, EYESAILOR said:

Moderna has stated that it will not have preliminary phase 3 results until late November.  While this puts rest to the political conspiracy theory...

There's just no other way to put this - you are seriously full of shit.

Moderna Says Its Coronavirus Vaccine Will Not Be Ready Until Spring 2021 — 9/30/20, 9:22 p.m. ET
https://www.huffpost.com/entry/covid-19-live-updates-credibility-problem-cdc_n_5f71f436c5b6cdc24c1c769c#update20200930-2122

Quote

Moderna Therapeutics said Wednesday that the drug-making company’s coronavirus vaccine won’t be available for widespread distribution until at least next spring

CEO Stéphane Bancel told the Financial Times that Moderna would not apply for emergency use authorization from the Food and Drug Administration until at least Nov. 25. An emergency use authorization lets frontline medical workers and at-risk individuals use the vaccine during the pandemic.

Bancel also told the publication that his company will not seek FDA approval for vaccine use in the general population until late January, adding that such an approval will more likely come closer to late March or early April.

 

Coronavirus vaccine trial participants report day-long exhaustion, fever and headaches — but say it’s worth it, THU, OCT 1 2020
https://www.cnbc.com/2020/10/01/coronavirus-vaccine-trial-participants-exhaustion-fever-headaches.html

Quote

Luke Hutchison woke up in the middle of the night with chills and a fever after taking the Covid-19 booster shot in Moderna’s vaccine trial. Another coronavirus vaccine trial participant, testing Pfizer’s candidate, similarly woke up with chills, shaking so hard he cracked a tooth after taking the second dose.  

High fever, body aches, bad headaches and exhaustion are just some of the symptoms five participants in two of the leading coronavirus vaccine trials say they felt after receiving the shots.

In interviews, all five participants — three in Moderna’s study and two in Pfizer’s late-stage trials  — said they think the discomfort is worth it to protect themselves against the coronavirus. Four of them asked not to be identified, but CNBC reviewed documentation that verified their participation in the trials.

While the symptoms were uncomfortable, and at times intense, they often went away after a day, sometimes sooner, according to three participants in the Moderna trial and one in Pfizer’s as well as a person close to another participant in Moderna’s trial.

 

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1 hour ago, ProaSailor said:

There's just no other way to put this - you are seriously full of shit.

Moderna Says Its Coronavirus Vaccine Will Not Be Ready Until Spring 2021 — 9/30/20, 9:22 p.m. ET
https://www.huffpost.com/entry/covid-19-live-updates-credibility-problem-cdc_n_5f71f436c5b6cdc24c1c769c#update20200930-2122

 

 

You just posted an article that confirms what I just posted.

Moderna has moved back earliest date for Emergency Use Application until Nov 25 , They shooting for a goal of submitting an application for general approval January, with goal of recieving that approved in April.

FWIW, I question the January- April timeline. I think it can go faster than that.

 

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6 minutes ago, EYESAILOR said:

FWIW, I question the January- April timeline. I think it can go faster than that.

As I've said before, your go fast rah-rah is contrary to what expert opinions have said all along and fully inline with Trump's wild claims.  Every time you try to deny the obvious political pressure on the vaccine process you bury your head further in the sand.  Stop bringing politics into your statements when you are so clearly oblivious (or worse) on the subject.

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