Old 10-16-2021, 10:22   #1891
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Phase I, II and III are always conducted in humans. The difference in the case of vaccines is the size (#of test subjects) and complexity (# and type of cohorts, and #of test locations).

This is why I, as a small, private drug developer, would never, never embark down the path of vaccine development. The economics, risk/reward just don't work for a small company!

Oh, and to your question about the speed of development re: the mumps vaccine. The shortened development timeline was due entirely to the development of the antigen by using the newly developed mRNA technology rather than using killed virus or developing an inactivated variant. None of the safety/efficacy studies were abbreviated or altered in any way to shorten the Covid vaccine approval.

I apologize. I do not know anything about how the testing is done. I have always presumed that all measures were taken to make sure a vaccine does not endanger the subject it is given to.
If as you say none of the safety/efficacy studies were abbreviated or altered, then how is that there have been, as of October 8th, 16,766 deaths reported from the Covid vaccines?
The below graph depicts all deaths associated since 1990 when the Vaccine Adverse Events Reporting System (VAERS) was started. I'm seeing something wrong if none of the safety/efficacy studies were abbreviated or altered, when compared to all the previous developed vaccines.


vaccine deaths by year.jpg


Data from VAERS can be found at www.openvaers.com or vaers.hhs.gov
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Old 10-16-2021, 11:03   #1892
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Purely speculative on my part but, I do believe the bad data coming out “not in favor of” the Covid vaccine is the number of extreme elderly and those with preexisting medical co-morbidities that were given the vaccine as a prophylaxis but were going to die regardless.

I think there is too much hullabaloo about the vaccines and it’s not helpful in either direction.

Politics should have stayed out of the process but that is what this disease is about from the beginning!
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Old 10-16-2021, 11:15   #1893
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I apologize. I do not know anything about how the testing is done. I have always presumed that all measures were taken to make sure a vaccine does not endanger the subject it is given to.
If as you say none of the safety/efficacy studies were abbreviated or altered, then how is that there have been, as of October 8th, 16,766 deaths reported from the Covid vaccines?
The below graph depicts all deaths associated since 1990 when the Vaccine Adverse Events Reporting System (VAERS) was started. I'm seeing something wrong if none of the safety/efficacy studies were abbreviated or altered, when compared to all the previous developed vaccines.


Attachment 37538


Data from VAERS can be found at www.openvaers.com or vaers.hhs.gov
That graph is misleading. There have been no new vaccines developed since 1990. So of course all of the vaccine adverse events that are reported will be associated with the one new vaccine developed. I would need to get into the details for each event to comment further. But my point was that none of the requirements for safety evaluations were altered or abbreviated to bring this vaccine to market! I have already presented the factors that enabled the extraordinary rapid Covid vaccine development.

The larger question imho is, should we have focused on development of a vaccine against an endemic viral type, i.e corona virus instead of focusing on disease therapy?

My view is that vaccine against a corona virus is a fool's errand that may actually induce variants of virus! Development of low cost safe and effective therapeutics is a far better public health strategy imho. In this case the population would be able to easily survive disease and would ultimately develop natural immunity. But what do I know??
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Old 10-16-2021, 11:23   #1894
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Originally Posted by Trapper John View Post

The larger question imho is, should we have focused on development of a vaccine against an endemic viral type, i.e corona virus instead of focusing on disease therapy?

My view is that vaccine against a corona virus is a fool's errand that may actually induce variants of virus! Development of low cost safe and effective therapeutics is a far better public health strategy imho. In this case the population would be able to easily survive disease and would ultimately develop natural immunity. But what do I know??
Therapy and treatment!

Exactly why this isn’t and shouldn’t be called a “vaccine” but a prophylaxis like a Flu shot. A “vaccine” is something that prevents for life or most of our life an incurable disease like Polio, Yellow Fever, MMR and others that we had “eradicated” through vaccination programs. A Flu shot is something you get every year because that’s all the good each one is - if you are lucky.

You know a lot more than Saint Fauci so don’t sell yourself short Doc! (Finest Kind!)
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Old 10-16-2021, 14:50   #1895
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Originally Posted by Trapper John View Post
The larger question imho is, should we have focused on development of a vaccine against an endemic viral type, i.e corona virus instead of focusing on disease therapy?

My view is that vaccine against a corona virus is a fool's errand that may actually induce variants of virus! Development of low cost safe and effective therapeutics is a far better public health strategy imho. In this case the population would be able to easily survive disease and would ultimately develop natural immunity. But what do I know??
HERETIC!

I have a question to pose. It seems that, no matter the sample size - dozens, many hundreds, from this or that proponent of a therapeutic regimen - has anyone privately or nationally considered tracking those who have embarked on those regimens and assess them for antibodies? "In general" it sure seems easy for someone in East Ottertail, MN to get a Covid test. On the other hand, it doesn't seem, to me, that it's much advertised to get an antibody test. It almost makes me wonder why, at a national response level, they wouldn't want to know the state of that particular factor. Proving a negatiive... shucks.


But there would be no way to assess an assumption of validity without corraling people who've been, for example, on the FLCCC IVM preventive regimen, who have been outwardly without disease, and testing them.
I may have fumbled that a bit, but hope you can get my drift & the question.
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Old 10-16-2021, 15:02   #1896
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Operation Warp Speed

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There are a couple of questions embedded in that response so my apology in advance for a lengthy reply:
3. "Operation Warp Speed" accelerated manufacturing by removing the financial risk associated with scale-up of manufacturing processes and therefore the time required for the vaccine being ready for distribution. I am getting outside of my wheelhouse at this stage. SurfnTurf can probably more adequately respond here.
Operation Warp Speed

A preface…I believe that the Covid 19 was presented to the NCA as a potential worldwide pandemic, with potential high mortality. That would explain the sometimes outrageous response we are experiencing.

First, let me take a shot at explaining “Warp Speed” accelerated manufacturing, as I understand it.

1. The Federal government pre-purchased several BILLION dollars of vaccine and multi BILLION dose orders for “discovery or early- clinical testing ”medicines from the Pharma industry (many companies, not just Moderna, J&J, Janssen, or Pfizer). This allowed the companies to laser focus on common clinicals, Manufacturing and distribution, and to not worry about marketing, selling, or profits for their effort. They were guaranteed sales, profit and liability protection from the Federal Government. This process also allowed many different types and variants of vaccine to be tested and manufactured. (Salk / Sabin polio vaccine comes to mind, (though years apart).

This was a radical change to the business model, and to my knowledge had never been attempted before. There are now several HUNDRED companies that have Covid treatments in development / phased testing for a Covid remedy.

2. To shorten the time-to-market, “Warp speed” allowed IND, Phase 1, 2 and 3 clinical trials, “quantifiable” manufacturing, and distribution to all happen in parallel. (i.e.)The companies did not have to wait on Phase 3 approval before beginning production (Labs, equipment, staffing), Manufacturing (Plant, scheduling, procurement) and distribution to warehouses. Because of this compression several vaccines were “available” within WEEKS of the “Experiential Use Authorization” approval.

NOTE: by way of comparison, it normally takes 3 to 10 years to bring a new vaccine to market / distribution.

3. OPINION..This new method of responding to what was called a PANDEMIC may be useful in the future if we are “hit” with a real superbug, with high mortality. The major problems with the current vaccines are:

a. We don’t have reliable data on the true outcomes of the various vaccines (mortality, heart problems, neurological disorders, etc.) .

b. We don’t have any history of a vaccine that was just released, and is still labeled as experimental. (ed. This probably requires a trust between Government and the citizens that has not happened)


c. The threatening compulsory mandates for an injection of an experimental Covid-19 vaccine and the coercion with potential punishments, including loss of employment (Take the jab or lose your job) suspension, not honoring religious objection, discharge from the Armed Forces, and other major threats. Threatening the entire populating is not a good way to build confidence in the Covid treatments and the “science” behind it.

https://media.defense.gov/2020/Aug/1...E-TIMELINE.PDF

SnT
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Last edited by Surf n Turf; 10-16-2021 at 15:05. Reason: spelling correction
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Old 10-16-2021, 19:30   #1897
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Paternity Leave:

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I'm sure Transportation Secretary Pete Buttigieg is on it.
Sect. Pete Butt has been on Paternity Leave since August... Even the Transportation Crisis at the Ports is terrible, he is not coming off leave...This Communist Democrat (POS) is helping to ruin this country...REMEMBER ALL Politics are Local... You might not be able to do anything about Buttige, or Biden, but there is the local democrat that supported them... Show the local democrat supporters that you oppose their policies.
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Old 10-16-2021, 20:42   #1898
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I realized this morning that I am mentally and emotionally exhausted by all things COVID.

The CCP fucked us.
The CCP fucked everybody.
They fucked everyone and yet there is still an endless stream of pimps and whores parading as "elected officials" that are profiting by doing business with a country that has fucked us all.
Pimps and whores parading as "elected officials" that push an eat-the-rich narrative while they are depositing their millions into tax-sheltered offshore bank accounts.

I've decided not to post in any more COVID-related threads - instead, I'm going to start doing something positive that will stimulate the mind instead of beating down people's emotional states.

I'm going to start posting word scrambles to get people's minds working again.
Here we go.........


elstograbnod


Welcome back to sanity my friends.
Stay healthy


Bonus Word Scramble:

petisneiddtnliklmihlsef
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Last edited by Box; 10-16-2021 at 20:46.
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Old 10-16-2021, 23:05   #1899
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That graph is misleading. There have been no new vaccines developed since 1990. So of course all of the vaccine adverse events that are reported will be associated with the one new vaccine developed. I would need to get into the details for each event to comment further. But my point was that none of the requirements for safety evaluations were altered or abbreviated to bring this vaccine to market! I have already presented the factors that enabled the extraordinary rapid Covid vaccine development.

The larger question imho is, should we have focused on development of a vaccine against an endemic viral type, i.e corona virus instead of focusing on disease therapy?

My view is that vaccine against a corona virus is a fool's errand that may actually induce variants of virus! Development of low cost safe and effective therapeutics is a far better public health strategy imho. In this case the population would be able to easily survive disease and would ultimately develop natural immunity. But what do I know??

Okay Trapper, I'm not picking a fight. I respect your medical education and experience as it is definitely not my field. I completely agree that focus should be put on therapeutics that from reports are working exceptionally well.
But, in interest of trying not to make myself look like I'm really stupid I posit the following:

1990 – First vaccine for Hantavirus hemorrhagic fever with renal syndrome
1991 – First vaccine for hepatitis A[13]
1998 – First vaccine for Lyme disease
1998 – First vaccine for rotavirus[14]
21st century
2003 – First nasal influenza vaccine approved in U.S. (FluMist)
2003 – First vaccine for Argentine hemorrhagic fever.[15]
2006 – First vaccine for human papillomavirus (which is a cause of cervical cancer)
2012 – First vaccine for hepatitis E[16]
2012 – First quadrivalent (4-strain) influenza vaccine
2013 – First vaccine for enterovirus 71, one cause of hand foot mouth disease[17]
2015 – First vaccine for malaria[18]
2015 – First vaccine for dengue fever[19]
2019 – First vaccine for Ebola approved[20]
2020 – First vaccine for COVID-19.


source: https://en.wikipedia.org/wiki/Timeli...human_vaccines



I'm not a huge fan of the source but that was just a quick search. Again, all respect, just defending my position how I don't think the vaccine has been proven safe; from the viewpoint of an uneducated Bravo.

Now, on to Box's word challenge..........
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Old 10-16-2021, 23:09   #1900
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Word Challenge

...............lets go brandon


and Bonus:

epstein didnt kill himself
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Old 10-17-2021, 07:33   #1901
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Okay Trapper, I'm not picking a fight. I respect your medical education and experience as it is definitely not my field. I completely agree that focus should be put on therapeutics that from reports are working exceptionally well.
But, in interest of trying not to make myself look like I'm really stupid I posit the following:

1990 – First vaccine for Hantavirus hemorrhagic fever with renal syndrome
1991 – First vaccine for hepatitis A[13]
1998 – First vaccine for Lyme disease
1998 – First vaccine for rotavirus[14]
21st century
2003 – First nasal influenza vaccine approved in U.S. (FluMist)
2003 – First vaccine for Argentine hemorrhagic fever.[15]
2006 – First vaccine for human papillomavirus (which is a cause of cervical cancer)
2012 – First vaccine for hepatitis E[16]
2012 – First quadrivalent (4-strain) influenza vaccine
2013 – First vaccine for enterovirus 71, one cause of hand foot mouth disease[17]
2015 – First vaccine for malaria[18]
2015 – First vaccine for dengue fever[19]
2019 – First vaccine for Ebola approved[20]
2020 – First vaccine for COVID-19.


source: https://en.wikipedia.org/wiki/Timeli...human_vaccines



I'm not a huge fan of the source but that was just a quick search. Again, all respect, just defending my position how I don't think the vaccine has been proven safe; from the viewpoint of an uneducated Bravo.

Now, on to Box's word challenge..........
I stand corrected! I over-stated my case. I should have pointed out that (i) total adverse events not normalized to the test subject population is very misleading and (ii) not reporting co-morbidity in the test subject populations further skews the results.

When I see graphs like these, my first reaction is that the author has an agenda and is trying to be convincing to a lay audience. I suspect that is the case here. I should have done my research and dived into the weeds before posting. I appreciate you calling me out on this one!

Finest Kind Brother!

Good job on the word scramble too.

Note added for clarification: A meaningful comparison would be adverse events observed per capita over the same time (90 days for example) post vaccination for each vaccine, and of course gender and age matched.
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Old 10-17-2021, 09:47   #1902
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Quote:
Originally Posted by Box View Post
I realized this morning that I am mentally and emotionally exhausted by all things COVID.

The CCP fucked us.
The CCP fucked everybody.
They fucked everyone and yet there is still an endless stream of pimps and whores parading as "elected officials" that are profiting by doing business with a country that has fucked us all.
Pimps and whores parading as "elected officials" that push an eat-the-rich narrative while they are depositing their millions into tax-sheltered offshore bank accounts.

I've decided not to post in any more COVID-related threads - instead, I'm going to start doing something positive that will stimulate the mind instead of beating down people's emotional states.

I'm going to start posting word scrambles to get people's minds working again.
Here we go.........



elstograbnod


Welcome back to sanity my friends.
Stay healthy


Bonus Word Scramble:

petisneiddtnliklmihlsef

Thank you, I think I'd rather have my head scrambled then have to hear one more word about "Covid"....CCP is Asshole...
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Old 10-17-2021, 11:55   #1903
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Thank you, I think I'd rather have my head scrambled then have to hear one more word about "Covid"....CCP is Asshole...

Okay...
Than I'll post an extra bonus one - just for you - but if you dont get it - it's back to remedial word jumble school for you:

dsgreernlathsevcidoiospots
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Old 10-20-2021, 08:52   #1904
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4 out of 5 Doctors prefer Chesterfields. Remember those ads?

Never have I seen 'medicine' sell out so quickly since the days of 'big Tobacco'.
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Old 10-20-2021, 13:14   #1905
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4 out of 5 Doctors prefer Chesterfields. Remember those ads?

Never have I seen 'medicine' sell out so quickly since the days of 'big Tobacco'.
Don't forget - this is the SAME profession that kills as many as 400,000 people a year through malpractice - COVID (nearing her second birthday) has only killed about 350,000 per year.

When your profession kills more people per year than a dangerously uncontrollable and extremely deadly global pandemic, it only makes sense to help advertise the health benefits of unfiltered Chesterfields.
...especially when it brings with it the protection from malpractice lawsuits.



oonndbarelsgt
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