Covid Vaccine

[Sarge]

You think 10-20-30% of nurses, some % of doctors willing to walk away from their professions is based on conspiracy theories??

Is it 10, 20 or 30 percent Tim? And what percent of doctors? I have heard of zero doctors walking off the job over this. Nurses? Sure. My brother in law is a doctor, and he recommends getting it.

 

[oneforthebus]

Sarge,
Can anyone answer "what happened to the pre-clinical, phase 1 and phase 2 studies" for any of the approved Covid vaccines?

Moderna, phase 1

Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis of SARS-CoV-2 Infection (COVID-19) - Full Text View - ClinicalTrials.gov

Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis of SARS-CoV-2 Infection (COVID-19) - Full Text View.

clinicaltrials.gov

Moderna, phase 2

A preliminary report of a randomized controlled phase 2 trial of the safety and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine

www.ncbi.nlm.nih.gov

I mean I can keep googling them for you or you can google them all yourself.

 

[Confluence]

Hell, I don't know. I'm not privy to that data. You'd have to ask the folks doing the study.

lol. Or a medical professional. Or the FDA.

They just skipped those parts.......the parts that speak to efficacy and safety.....they didn't use the FDA's long established paradigm, necessary for any drug approval, for these drugs -- scratch that -- vaccines. Drugs are not vaccines, because drugs attach liability for negative effects, and possibly for those who wrongly prescribe them. Vaccines magically have zero liability attached.

Here is what happened with Vioxx: https://www.npr.org/2007/11/10/5470430/timeline-the-rise-and-fall-of-vioxx
Note the data manipulation and mischaracterization of negative effects, timing, and other factors.

 

[Confluence]

Moderna, phase 1

Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis of SARS-CoV-2 Infection (COVID-19) - Full Text View - ClinicalTrials.gov

Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis of SARS-CoV-2 Infection (COVID-19) - Full Text View.

clinicaltrials.gov

Moderna, phase 2

A preliminary report of a randomized controlled phase 2 trial of the safety and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine

www.ncbi.nlm.nih.gov

I mean I can keep googling them for you or you can google them all yourself.

Thanks OFTB.

Can you tell me what this line means, please :

Estimated Primary Completion Date :

November 22, 2022

 

[oneforthebus]

Thanks OFTB.

Can you tell me what this line means, please :

Estimated Primary Completion Date :

November 22, 2022

Yes.

Primary completion date
The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "estimated" primary completion date is the date that the researchers think will be the primary completion date for the study.

 

[oneforthebus]

So and again I'm not an expert on this, just a reader but my reading of this is that the estimated primary completion date refers to an estimate of when data from the very last single participant has been collected and finalized. Certainly conclusions about safety and efficacy can be reached before this date based on the vast majority of study participants, and it is after all, an estimate. In no way does this date indicate that phase 1 or 2 data doesn't exist.

Anyone who wants to look at clinical trial data and try to find something that looks like some kind of lie or conspiracy can do that. Science is complicated. But there is usually a reasonable explanation for everything.

 

[madinsomniac]

It's not political for me, I'm not putting mRNA into my body. I'm crossing my fingers that Novavax gets their vaccine rollout going, and I'll take it.

"Unlike Pfizer or Moderna that made use of mRNA technology to develop their COVID-19 vaccines, Novavax took a well-established and older approach in making theirs. As a protein subunit vaccine, the Novavax vaccine injects a specific, isolated protein of the pathogen to trigger an immune response in the body. Some available vaccines for hepatitis B and pertussis currently use this technology."

Yes there are at least three simular vaccines all that have higher protection rates vs variants and the base virus all that have lessened uncertainty and all that are done with expedited testing…

just release them to the public… there is absolutely no reason to not do so unless it’s politically or financially motivated….

 

[Confluence]

Yes.

Primary completion date
The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "estimated" primary completion date is the date that the researchers think will be the primary completion date for the study.

Actually, as you can tell here, the 120 people now enrolled in the study started in March 2021, after the vaccine got EUA:

History of Changes for Study: NCT04283461

clinicaltrials.gov

The study takes 394 days, so I guess that is where they got to Nov 22, 2022 for the Phase 1 that started after Phase 3 was done....somehow.

 

[Confluence]

So and again I'm not an expert on this, just a reader but my reading of this is that the estimated primary completion date refers to an estimate of when data from the very last single participant has been collected and finalized. Certainly conclusions about safety and efficacy can be reached before this date based on the vast majority of study participants, and it is after all, an estimate. In no way does this date indicate that phase 1 or 2 data doesn't exist.

Anyone who wants to look at clinical trial data and try to find something that looks like some kind of lie or conspiracy can do that. Science is complicated. But there is usually a reasonable explanation for everything.

For clarity, on the study you posted, Phase 1 studies began after the vaccine was approved and in widespread use. You can look it up.

This is quite maddening.

 

[oneforthebus]

Yes there are at least three simular vaccines all that have higher protection rates vs variants and the base virus all that have lessened uncertainty and all that are done with expedited testing…

just release them to the public… there is absolutely no reason to not do so unless it’s politically or financially motivated….

See this is where you guys lose me.

Do you really think Joe Biden or someone else has the magic vaccine that could cure all this and is just hiding it from everyone? Cause making Pfizer rich is more important to them than anything else?

The person and/or company and/or government agency that stops this pandemic will have accolades and power beyond their wildest dreams. But you guys think they'd just really rather keep it going. For what? They get their jollies from seeing us wear masks? They want to tank the travel and tourism and restaurant industries because it helps them how?

Or what?

I don't get it.

 

[oneforthebus]

Actually, as you can tell here, the 120 people now enrolled in the study started in March 2021, after the vaccine got EUA:

History of Changes for Study: NCT04283461

clinicaltrials.gov

The study takes 394 days, so I guess that is where they got to Nov 22, 2022 for the Phase 1 that started after Phase 3 was done....somehow.

Actually that link says the study started March 2020.

Record Verification: February 9, 2021
Overall Status: Active, not recruiting
Study Start: March 16, 2020
Primary Completion: November 22, 2022 [Anticipated]
Study Completion: November 22, 2022 [Anticipated]

I'm not seeing where you're getting March 2021

 

[Stainless]

With all the stuff happening in Afghanistan, Joe is probably ready for everyone to be put on a ventilator.

 

[Confluence]

Actually that link says the study started March 2020.

Record Verification: February 9, 2021
Overall Status: Active, not recruiting
Study Start: March 16, 2020
Primary Completion: November 22, 2022 [Anticipated]
Study Completion: November 22, 2022 [Anticipated]

I'm not seeing where you're getting March 2021

My mistake. Recruitment was completed in July 2020. That would mean 394 days later is probably November 22, 2022, when the Phase 1 would be completed, then vetted and accepted prior to commencing Phase 2. Which needs completion before Phase 3, and then labelling agreement with FDA, etc. all prior to commercial release.

The simpler point is that they simply skipped any semblance of normal drug development, passing over the Phase 1 safety and Phase 2 efficacy studies. Otherwise, many other drugs would get fast tracked like this. The takeaway is that they cannot actually comment on safety in any historical context or legal framework, because it isn't done yet, and they cannot comment on efficacy for the same reason.

I get "pandemic" and all that. What I do not get is how the authorities can fastrack this and not say, in LARGE CAPS, that they are unsure of results over time. And that is the point. Pfizer's legal would not have let the drug be marketed unless it was called a vaccine so there was no liability, because the company simply had no safety data, or efficacy data to rely on. That means they guestimated, just like they do with the flu "vaccine".

 

[oneforthebus]

My mistake. Recruitment was completed in July 2020. That would mean 394 days later is probably November 22, 2022, when the Phase 1 would be completed, then vetted and accepted prior to commencing Phase 2. Which needs completion before Phase 3, and then labelling agreement with FDA, etc. all prior to commercial release.

The simpler point is that they simply skipped any semblance of normal drug development, passing over the Phase 1 safety and Phase 2 efficacy studies. Otherwise, many other drugs would get fast tracked like this. The takeaway is that they cannot actually comment on safety in any historical context or legal framework, because it isn't done yet, and they cannot comment on efficacy for the same reason.

I get "pandemic" and all that. What I do not get is how the authorities can fastrack this and not say, in LARGE CAPS, that they are unsure of results over time. And that is the point. Pfizer's legal would not have let the drug be marketed unless it was called a vaccine so there was no liability, because the company simply had no safety data, or efficacy data to rely on. That means they guestimated, just like they do with the flu "vaccine".

I wouldn't say they skipped any semblance. I would say they realized early on the benefits of keeping a lot of people from dying would outweigh the risks which seemed to be (and still seem to be) minimal.

 

[oneforthebus]

"the company simply had no safety data, or efficacy data to rely on"

Again to say they had no safety or efficacy data is untrue. And you are only talking about phase 1 and 2. There were phase 3 trials involving tens of thousands of people before the EUA.

 

[Confluence]

"the company simply had no safety data, or efficacy data to rely on"

Again to say they had no safety or efficacy data is untrue. And you are only talking about phase 1 and 2. There were phase 3 trials involving tens of thousands of people before the EUA.

Then the vaccine companies and government could simply say : " there may be some unknown negative effects from these vaccines, and in those cases, we will provide quick financial and medical support for those adverse effects".

From the same multi Billion dollar bag of cash paying for vaccines, government and industry could easily fund the correction of the apparently small number of serious adverse effects.

Confidence in these drugs would increase dramatically.

 

[Tim Steelersfan]

We'll see how many actually do when push comes to shove.

Push has come to shove. Mandates are in full effect.

 

[Tim Steelersfan]

Is it 10, 20 or 30 percent Tim? And what percent of doctors? I have heard of zero doctors walking off the job over this. Nurses? Sure. My brother in law is a doctor, and he recommends getting it.

I don't know what the % is. But the stories are out there daily. I have posted links, like the healthcare workers protesting in Charlotte. Seemed to be over a thousand of them. A hundred lost their jobs in Houston refusing to adhere to the mandates.

The stories are now common. Health centers are understaffed due to losing healthcare workers who simply refuse to comply.

The fact that healthcare workers are willing to lose their career by the thousands seems to be newsworthy to me.

 

[Tim Steelersfan]

It was my choice to take it. I didn't have to.

As it should be.

Rapidly, it is no longer becoming a choice. My one son is now being forced - literally - to take the vax or forego his education at his school.

We are at the point that it is a mandate for more than for fewer.

 

[Tim Steelersfan]

But you guys think they'd just really rather keep it going. For what? They get their jollies from seeing us wear masks? They want to tank the travel and tourism and restaurant industries because it helps them how?

Or what?

I don't get it.

I don't get it either. For the past 18 months, there seems to be a habit of repeating the same failed approaches, would you not agree? Despite studies showing those approaches failed....

Masking did not work.
Lockdowns did not work.

Those actions cost us all dearly however.

Now, we are seeing the vaccines' efficacies fading. We are currently going through a rapid rise in cases. The vaccines aren't preventing spread despite the majority of Americans being vaccinated.

So what is the response? More masking. More lockdowns. More vaccine mandates.

What's the old saying? "The definition of insanity is doing the same thing over and over again and expecting a different result."

18 months in, the same tried and unproven approaches are being used...AGAIN...yet we appear nowhere closer to stopping this rise in cases using these methodologies.

For SOME reason, "they" keep repeating the same practices. You answer...why?

 

[Ron Burgundy]

But you guys think they'd just really rather keep it going. For what? They get their jollies from seeing us wear masks?

Yes, absolutely. It's a sign of control and obedience to the government. Sort of the American burka. YouTube took the video down but early on in a presser with Dr. Deborah Birx the first words out of her mouth were, "Look at the control we have!" Note that our betters at Pelosi's fundraiser and Bomma's birthday party no one is wearing a mask.

They want to tank the travel and tourism and restaurant industries because it helps them how?

Or what?

I don't get it.

They want to destroy the middle class, yes. A large and strong middle class does not need what the Democrats are selling. People who become dependent on the government do. For example, the Dems hate private property (except their private property). So we have bans on evictions for not paying rent due to the pandemic but no bans on banks foreclosing on the landlords' rental properties when the landlords can't pay their mortgages because they're not collecting rent. Presto, the government will gladly take those off the banks' hands and turn them into public housing that the government controls. Canadian PM Trudeau recently said "By 2030 you will have no property and be happy."

 

[Troglodyte]

You go with that. All you do is repeat bullshit and guess anyway.

Here is Oregon’s State Health Official Dr. Dean Sidelinger confirming that the OVERWHELMING MAJORITY of the hospitalized are UNVACCINATED. Enjoy another **** sandwich brought on by your willful ignorance, Tim.

Oregon reports 30 new coronavirus deaths as hospitalizations reach a pandemic high

Oregon health officials reported 30 new fatalities related to coronavirus on Tuesday just as hospitalizations across the state have reached a pandemic high. “Today, OHA is reporting 1,000 COVID-19 hospitalizations, a pandemic high and yet another grim milestone in Oregon’s ongoing struggle with...

katu.com

 

[Troglodyte]

And there we go. Floggy discounting medical professionals that disagree with "The Religion." She knows a **** ton more about this situation than you, yet you dismiss her.

You're a feeble sheep.

There are far more medical professionals that vehemently disagree with her including over 96% of Medical DOCTORS who have a “**** ton” more education and training than she has.

AMA survey shows over 96% of doctors fully vaccinated against COVID-19

New data point toward high COVID-19 vaccine confidence among practicing physicians.

www.ama-assn.org

 

[Troglodyte]

Yes, absolutely. It's a sign of control and obedience to the government. Sort of the American burka. YouTube took the video down but early on in a presser with Dr. Deborah Birx the first words out of her mouth were, "Look at the control we have!" Note that our betters at Pelosi's fundraiser and Bomma's birthday party no one is wearing a mask.


They want to destroy the middle class, yes. A large and strong middle class does not need what the Democrats are selling. People who become dependent on the government do. For example, the Dems hate private property (except their private property). So we have bans on evictions for not paying rent due to the pandemic but no bans on banks foreclosing on the landlords' rental properties when the landlords can't pay their mortgages because they're not collecting rent. Presto, the government will gladly take those off the banks' hands and turn them into public housing that the government controls. Canadian PM Trudeau recently said "By 2030 you will have no property and be happy."

Holy Way Off the Deep End, Batman!

Interested to know why the CDC loosened mask guidelines not long ago? Why did they relinquish control?

 

[Confluence]

18 months ago, the point of "flatten the curve" was to provide the healthcare system with the time necessary to handle more virus cases: more capacity, better treatment. No one expected that the virus wouldn't be viral, like every other cold/flu that has afflicted the globe.

Trillions of dollars have been spent, vaccines developed, treatments vastly improved.

Unless hospital and treatment capacity has not been adjusted upwards meaningfully (where did the money go?), why are we not just letting this virus run its course? What is the capacity increase in hospital beds and ICU by city, state?

Have those vulnerable been protected with the best of medical preventative preparation? If not, why not?

We worry about a bunch of at risk folks here at home, advocating for a booster even, but do not seem to give a **** about the 5 billion other folks that would be far more at risk (poorer, worse healthcare, more susceptible to disease). So if future nasty variants are the real worry, why are we not worried about the massive potential in these poorer foriegn lands? Why wouldn't the same governments spending trillions of taxpayer dollars want those really poor folks given a vaccine or two to prevent further mutations?

Follow the money