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COVIDGATE (Part Two): Clinical Trials and Crusader Bias
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Participants in Pfizer and Moderna’s COVID-19 vaccine clinical trials can’t stop blabbing. The media is overflowing with testimonials explaining “Why I Volunteered” or “What It Was Like To Participate In The Clinical Trial For Moderna’s COVID-19 Vaccine.” Loudmouth liberal writer Molly Jong-Fast publicly begged for beatification:

Call Me the Joan of Arc of Coronavirus Vaccine Trials,” Jong-Fast’s ode to herself in The New York Times implored.

A striking number of advocacy journalists milked their status as clinical trial enrollees, including Washington Post staffer Walter Isaacson, CNN affiliate anchor Dawn Baker, USA Today writers Jackie Hajdenberg and Lindy Washburn, BBC science journalist Richard Fisher, Reuters writer Steve Stecklow and John Yang of the “PBS Newshour.” They describe their experiences in emotional terms — “empowering,” “making history” and “a miracle for genetic medicine.” Most did not bother to hide their pro-Big Pharma perspectives.

Given their breaches of journalistic neutrality, it’s hard to imagine they were able to contain themselves at the lab, either. They downplayed vaccine side effects and promoted universal immunization. Jong-Fast wrote that a doctor involved in her trial divulged to her that “people had so few symptoms that they thought they were in the placebo arm of the study.”

The flood of public comments from these zealous media cheerleaders and other clinical trial volunteers who’ve posted online raises alarming questions about the integrity of the clinical trial process. Pfizer and Moderna’s phase III clinical trials are randomized and placebo-controlled, meaning each person has an equal chance of receiving the vaccine or a placebo. The studies are also supposed to be “double-blind,” meaning that neither the volunteers nor the clinical trial investigators knew which group received which shots (although the administrators of the shots know who’s getting what).

Blinding prevents patients’ beliefs about the treatment from influencing the outcome of the study and also prevents investigators from inadvertently revealing clues about which treatment the subjects are receiving. But scores of comments on Twitter and Facebook from trial volunteers have exposed a phenomenon I call “crusader bias” that should trouble any adherent of good science. I will be submitting all of my findings to the FDA this week as public comments in advance of the Dec. 10 hearing on the Pfizer COVID vaccine.

Dozens of self-identified Moderna and Pfizer COVID-19 vaccine volunteers joined a private Facebook group originally dedicated to discussing Moderna investments this year to dish about their experiences. I obtained screenshots that showed volunteers discussing antibody test results they got on their own from commercial labs while the trials are still ongoing. They are trading information on how to get antibody tests, sharing their symptoms and plotting how to drop out of their trials and enroll in new ones if they suspect they didn’t get the vaccine.

Among the clinical trial volunteers’ gossipy disclosures, many of which threaten the integrity of the blinding procedure in the still-ongoing trials:

—One woman, K.C., told the Facebook group that her shot during the Pfizer vaccine trial “was covered in a bunch of tape, but the part I could see was dark.” A man, T.R., responded by posting a picture of his vial, partially covered in tape with a dark liquid visible. “They made me turn my head, but I got a peek,” K.C. told T.R.

—Another volunteer, J.D.T., said that “someone working at study site” told him “the placebo and the vaccine are different colors.”

 

—Two participants discussed being able to guess if they got the vaccine based on whether the administrator rushed into the room to inject volunteers. “The vaccine has to remain at a certain temp so once ready, it has to go. Pays to ask a lot of questions,” one advised the other.

 

—N.K.D., a woman identifying herself as a pathologist who works “at a private lab” told her fellow volunteers that she tested “negative right before the first dose” during a Moderna clinical trial and negative “two weeks after first dose.” She shared information on how to get antibody rapid testing done and offered to do them at her lab in Little Rock.

—When one volunteer expressed her concern that antibody testing was “kind of ‘cheating'” and “against the rules of the study,” another argued “My trial site said go for it. There is nothing in the legal documentation that says you cannot.”

—”Screw it,” said another volunteer who initially worried about jeopardizing his clinical trial’s scientific integrity. “I’m jumping on board and taking an antibody test.”

On Twitter, Icahn School of Medicine microbiology professor and clinical trial volunteer Benjamin tenOever boasted that he had “two adverse-free shots and ‘sky high’ antibody levels after four weeks.” He said he paid for the antibody test from a commercial lab facility, presumably not part of the still-ongoing clinical trial. He gloated: “The future is bright. Thank you @Pfizer.” Swedish infectious disease physician and European medicines regulator Rebecca Chandler responded bluntly:

“This is ethically concerning.”

Indeed. The science on COVID-19 testing and vaccine trials is not “settled.” It’s unsettling in the extreme.

***

Read COVIDGATE: the Corruption of Clinical Trials (Part One).

Michelle Malkin’s email address is [email protected] To find out more about Michelle Malkin and read features by other Creators Syndicate writers and cartoonists, visit the Creators Syndicate website at www.creators.com.

 
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  1. Thank you for all you do!

    • Agree: Achmed E. Newman
  2. So much fun that Trump was universally attacked for saying that, “We might have a vaccine by the end of this year.” Now we have no fewer than three of them in November and no one is saying that maybe they should not have attacked him.

    • Replies: @Dieter Kief
    @Bill H

    Never apologize! - First law of the Internat'n'l Internet Survival Guide. Seems to apply here too.

  3. This is irresponsible–it certainly isn’t journalism.

    You have people who claim to have been in a trial. No proof.

    A few of them (out of more than 10,000 volunteers) got antibody tests. At that point, knowing which arm they MAY have been in is immaterial–they either get symptoms of CoVid or they don’t. Unless they lie to the clinicians who follow them and deny symptoms when they have them, their knowledge of which they received is not material.

    Studies often unblind themselves because of differences in side-effects. And many studies are done unblinded. The FDA still accepts applications with both types of studies.

    Further, I doubt that anyone who was enrolled in one trial could enroll in another. There are screening questions, you know, before a volunteer can enroll.

    I don’t understand this anti-vaccine screed.

    • Replies: @Corvinus
    @LadyTheo

    She is carrying water for the anti-vaxxers. At least iSteve is more honest on this topic.

    https://www.unz.com/isteve/pfizer-releases-final-vaccine-stats-162-170th-effective/

    , @Biff
    @LadyTheo


    I don’t understand this anti-vaccine screed.

     

    You also don’t understand how money and power works either.

    Replies: @LadyTheo

    , @MarkU
    @LadyTheo


    I don’t understand this anti-vaccine screed.
     
    It isn't as simple as being pro or anti vaccination as such. There are older, tried and tested vaccines using well established methods and there are newer and totally experimental vaccines working on new and experimental principles. There are also slowly mutating diseases for which vaccines work well (and potentially permanently) Vs quickly mutating diseases for which vaccines are only temporary, if they work at all, flu is a good example.

    If you want to take a new, highly experimental vaccine that will probably work but equally probably will only be a temporary fix even if it does, then it is up to you. Bear in mind though that hastily contrived vaccines that are rushed into production have a dodgy record and can have very severe effects, including neurological damage or even death. Take whatever risks you want but at least do so with your eyes open. Consider the havoc being wreaked in Africa by Bill Gates's polio vaccine, we have had polio vaccines for decades and still people are being damaged, does that inspire confidence?

    I hope that clears up any confusion you might have had.

    Replies: @That Would Be Telling

  4. OT: I don’t know if you read these comments Michelle, but if you do, I just wanted to say how unfortunate it is that Hot Air went so far off the rails, in my opinion.

    I registered to comment there on the first day that it published, although I rarely commented.

    What the heck happened to allahpundit that he got tds so bad?

    Is he being blackmailed or something?

    He has become so petty and mean and small.

    It is just sad.

  5. The (((Left))) has an agenda that can only be derailed by MASSIVE… I mean MASSIVE doses of Truth.

  6. @LadyTheo
    This is irresponsible--it certainly isn't journalism.

    You have people who claim to have been in a trial. No proof.

    A few of them (out of more than 10,000 volunteers) got antibody tests. At that point, knowing which arm they MAY have been in is immaterial--they either get symptoms of CoVid or they don't. Unless they lie to the clinicians who follow them and deny symptoms when they have them, their knowledge of which they received is not material.

    Studies often unblind themselves because of differences in side-effects. And many studies are done unblinded. The FDA still accepts applications with both types of studies.

    Further, I doubt that anyone who was enrolled in one trial could enroll in another. There are screening questions, you know, before a volunteer can enroll.

    I don't understand this anti-vaccine screed.

    Replies: @Corvinus, @Biff, @MarkU

    She is carrying water for the anti-vaxxers. At least iSteve is more honest on this topic.

    https://www.unz.com/isteve/pfizer-releases-final-vaccine-stats-162-170th-effective/

  7. Often the placebo is just something like a flu shot which gives you arm pain and maybe chills and a headache for a day or two—you cant tell which shot you were given from the side effects.

  8. The phenomenon of proactive belief in the efficacy of an untested vaccine causing selective unblinding in the form of antibody testing by trial subjects may be entirely new. Never before have cheap antibody tests been widely available during vaccine testing. Interest in the phenomenon (e.g., by stories such as this) is not inherently anti or pro vaccine.

    What the story does not attempt to do is theorize how much, if at all, this form of pro-vaccine bias influences trial results, or a mechanism for such influence. One such mechanism may be leakage of antibody test results from test subjects to the scientists running the trial. If such leakage occurs, the scientists could use the information to influence trial results. For example, a scientist might reach a different conclusion regarding whether a reported illness is due to Covid19 or some other cause, based on whether a subject who received the trial vaccine produced antibodies detected by testing.

    Natural bias by funders of the double-blind studies for positive results is obvious, which is why studies are double-blinded in the first place. So anything that erodes the blinding barriers should be of interest and concern, even if discernible effects are minimal.

    • Agree: macilrae
  9. @LadyTheo
    This is irresponsible--it certainly isn't journalism.

    You have people who claim to have been in a trial. No proof.

    A few of them (out of more than 10,000 volunteers) got antibody tests. At that point, knowing which arm they MAY have been in is immaterial--they either get symptoms of CoVid or they don't. Unless they lie to the clinicians who follow them and deny symptoms when they have them, their knowledge of which they received is not material.

    Studies often unblind themselves because of differences in side-effects. And many studies are done unblinded. The FDA still accepts applications with both types of studies.

    Further, I doubt that anyone who was enrolled in one trial could enroll in another. There are screening questions, you know, before a volunteer can enroll.

    I don't understand this anti-vaccine screed.

    Replies: @Corvinus, @Biff, @MarkU

    I don’t understand this anti-vaccine screed.

    You also don’t understand how money and power works either.

    • Replies: @LadyTheo
    @Biff

    You are assuming facts not in evidence.

    I do understand clinical trials. Which most people don't. Like Malkin. She knows a little and assumes a lot. And working from an agenda, she speculates and rants. Tiresome. I guess she needs the clicks; she really has fallen off the national stage lately.

    Full disclosure: I work for Pfizer. I know a tiny bit more than Malkin or Sailer about how pharmaceutical trials work. And I know quite a bit more about the integrity of our medical people.

    Really. You non-scientists are tedious.

  10. Interesting and, of course, if a competing vaccine is promoted at a very low price the ‘industry’ can be depended upon to do everything possible to discredit it. Take this article for example: https://www.wired.com/story/the-astrazeneca-covid-vaccine-data-isnt-up-to-snuff/

    And don’t even begin to talk about the Sputnik V vaccine – which has been confirmed to be blended with a dash of novichok and a hint of polonium 210.

    • Replies: @That Would Be Telling
    @macilrae

    The problem is that AZ/Oxford hasn't even come close to doing an FDA level Phase 3 trial, with that article detailing even more problems with their work so far than I'd know. I mean, it's expensive, there's lots of details since you're dealing with a minimum of 30,000 people, but Pfizer/BioNTech and Moderna have had no great problems doing satisfactory versions of this FDA requirement, at least to point of being able to make an application for an Emergency Use Authorization (almost, Moderna still needs a little time to generate the required safety data, half the vaccine arm participants for two months after the second dose).

    Read the details with an open mind and it's clear AZ/Oxford, especially the latter with their unforgivable dosing accident, is a clown show. This can be remedied, and AZ is running a real FDA level Phase 3 trial in the US, but it'll take a lot of time, they were shut down for a month due to a participant somewhere else having a bad event, which I believe has been judged to not be related to taking the vaccine (large numbers mean stuff happens, one death so far in testing Western vaccines, a Brazilian who turned out to have gotten a placebo).

    Since their efficacy data shows two full strength doses is almost a dud at 62% (the FDA has said they'll approve anything that hits 50%, but when you've got two vaccines at 95%...), the US trial is going to be changed midstream to take advantage of the accident to get the possible 90% range efficacy (weasel words because too few people of too narrow a population set have tried that as of yet, only 1,800 or 2,700 depending on the source). AZ also won no favors from anyone with a clue by using a blended number to claiming an efficacy.

    Sputnik V isn't even open to question, it was approved by Russia one month before its Phase 3 trial started. If you don't understand what that means, you're too short for this ride. That said, it's got a better theory than AZ/Oxford, one explanation for the possibly much greater effectiveness of the "half-dose" followed by a full dose is that antibodies don't develop so much against the chimp adenovirus vector which is delivering the DNA for the spike protein. Sputnik V uses different human adenovirus vectors for the two doses But until we have Phase 3 results, they started recruiting participants September 10th so it'll be some time, Sputnik V is still a promising but untested theory.

    And do you hear anyone putting down Janssen (Johnson & Johnson)/BIDMC? Their vaccine is also an adenovirus vector one, i.e. existing vaccine technology like AZ/Oxford and Sputnik V that can be mass produced much more cheaply than the brand new mRNA ones. We'll just have to wait until they get enough data from their 60,000 (!) person Phase 3 trial. (Everyone else who's very far along is using non-invasive technologies, like proteins like the flu vaccines, or killed virus like the first for polio.)

    Replies: @macilrae

  11. @macilrae
    Interesting and, of course, if a competing vaccine is promoted at a very low price the 'industry' can be depended upon to do everything possible to discredit it. Take this article for example: https://www.wired.com/story/the-astrazeneca-covid-vaccine-data-isnt-up-to-snuff/

    And don't even begin to talk about the Sputnik V vaccine - which has been confirmed to be blended with a dash of novichok and a hint of polonium 210.

    Replies: @That Would Be Telling

    The problem is that AZ/Oxford hasn’t even come close to doing an FDA level Phase 3 trial, with that article detailing even more problems with their work so far than I’d know. I mean, it’s expensive, there’s lots of details since you’re dealing with a minimum of 30,000 people, but Pfizer/BioNTech and Moderna have had no great problems doing satisfactory versions of this FDA requirement, at least to point of being able to make an application for an Emergency Use Authorization (almost, Moderna still needs a little time to generate the required safety data, half the vaccine arm participants for two months after the second dose).

    Read the details with an open mind and it’s clear AZ/Oxford, especially the latter with their unforgivable dosing accident, is a clown show. This can be remedied, and AZ is running a real FDA level Phase 3 trial in the US, but it’ll take a lot of time, they were shut down for a month due to a participant somewhere else having a bad event, which I believe has been judged to not be related to taking the vaccine (large numbers mean stuff happens, one death so far in testing Western vaccines, a Brazilian who turned out to have gotten a placebo).

    Since their efficacy data shows two full strength doses is almost a dud at 62% (the FDA has said they’ll approve anything that hits 50%, but when you’ve got two vaccines at 95%…), the US trial is going to be changed midstream to take advantage of the accident to get the possible 90% range efficacy (weasel words because too few people of too narrow a population set have tried that as of yet, only 1,800 or 2,700 depending on the source). AZ also won no favors from anyone with a clue by using a blended number to claiming an efficacy.

    Sputnik V isn’t even open to question, it was approved by Russia one month before its Phase 3 trial started. If you don’t understand what that means, you’re too short for this ride. That said, it’s got a better theory than AZ/Oxford, one explanation for the possibly much greater effectiveness of the “half-dose” followed by a full dose is that antibodies don’t develop so much against the chimp adenovirus vector which is delivering the DNA for the spike protein. Sputnik V uses different human adenovirus vectors for the two doses But until we have Phase 3 results, they started recruiting participants September 10th so it’ll be some time, Sputnik V is still a promising but untested theory.

    And do you hear anyone putting down Janssen (Johnson & Johnson)/BIDMC? Their vaccine is also an adenovirus vector one, i.e. existing vaccine technology like AZ/Oxford and Sputnik V that can be mass produced much more cheaply than the brand new mRNA ones. We’ll just have to wait until they get enough data from their 60,000 (!) person Phase 3 trial. (Everyone else who’s very far along is using non-invasive technologies, like proteins like the flu vaccines, or killed virus like the first for polio.)

    • Replies: @macilrae
    @That Would Be Telling

    Perhaps I allowed my cynicism to get the better of me in my use of the referenced article as an example of Industry kick-back against an impudent upstart; fielding a product at an insulting price.

    Nevertheless, we need to be alert to the fact that the dominant pharmaceutical companies will use such means to preserve their position in the most lucrative markets and retain our cynicism when reviewing both positive and negative articles on this topic. There is deception and dishonesty everywhere we look.

    As for the Russian vaccine, even if it proved itself conclusively in phase III trials, and then in a country like Brazil, do you really think there is the least chance it could ever be adopted in the Western markets served by J&J and Pfizer? It is sufficient just to mention that this vaccine has been approved of by Vladimir Putin himself.

    Replies: @That Would Be Telling, @LadyTheo

  12. @LadyTheo
    This is irresponsible--it certainly isn't journalism.

    You have people who claim to have been in a trial. No proof.

    A few of them (out of more than 10,000 volunteers) got antibody tests. At that point, knowing which arm they MAY have been in is immaterial--they either get symptoms of CoVid or they don't. Unless they lie to the clinicians who follow them and deny symptoms when they have them, their knowledge of which they received is not material.

    Studies often unblind themselves because of differences in side-effects. And many studies are done unblinded. The FDA still accepts applications with both types of studies.

    Further, I doubt that anyone who was enrolled in one trial could enroll in another. There are screening questions, you know, before a volunteer can enroll.

    I don't understand this anti-vaccine screed.

    Replies: @Corvinus, @Biff, @MarkU

    I don’t understand this anti-vaccine screed.

    It isn’t as simple as being pro or anti vaccination as such. There are older, tried and tested vaccines using well established methods and there are newer and totally experimental vaccines working on new and experimental principles. There are also slowly mutating diseases for which vaccines work well (and potentially permanently) Vs quickly mutating diseases for which vaccines are only temporary, if they work at all, flu is a good example.

    If you want to take a new, highly experimental vaccine that will probably work but equally probably will only be a temporary fix even if it does, then it is up to you. Bear in mind though that hastily contrived vaccines that are rushed into production have a dodgy record and can have very severe effects, including neurological damage or even death. Take whatever risks you want but at least do so with your eyes open. Consider the havoc being wreaked in Africa by Bill Gates’s polio vaccine, we have had polio vaccines for decades and still people are being damaged, does that inspire confidence?

    I hope that clears up any confusion you might have had.

    • Replies: @That Would Be Telling
    @MarkU


    If you want to take a new, highly experimental vaccine that will probably work but equally probably will only be a temporary fix even if it does, then it is up to you.
     
    Nope, we have every expectation based on theory and serological testing of those who've already taken them that mRNA vaccines provide a long lasting immune system response, because they mimic exactly what the wild type virus does. Except for doing this with only one protein, wild type immune responses also include the nucleocapsid protein. The only question here is how well conserved the parts of it our adaptive immune system's antibodies latch onto.

    And that's where you're wrong about mutations and vaccines. Flu vaccines are not "eternal" because we just don't make antibodies against sufficiently conserved parts of it. Vaccines against RNA viruses that don't have the coronaviruses' unique proofreading mechanisms and thus mutate at much higher rates can be "eternal" because the immune system targets conserved parts of it. As the name implies, these parts can't significantly change or "the virus won't virus."

    Bear in mind though that hastily contrived vaccines that are rushed into production have a dodgy record and can have very severe effects, including neurological damage or even death.
     
    That's already in the cards, we know any vaccine will maim and kill some people who take it if the numbers are high enough, and here we're talking billions. But you ought to cite examples of "hastily contrived vaccines that are rushed into production" vaccines, any recent ones? Any chance we've learned anything since say 1976, four and a half decades ago?

    [...] Consider the havoc being wreaked in Africa by Bill Gates’s polio vaccine, we have had polio vaccines for decades and still people are being damaged, does that inspire confidence?
     
    It's not "Bill Gate's" polio vaccine, it's Sabin's or rather derived from his original attenuated one. And the trade offs of using it vs. a Salk type killed virus vaccine have been known for decades (details on request, but Wikipedia covers this well, here's a good place to start).
  13. @Biff
    @LadyTheo


    I don’t understand this anti-vaccine screed.

     

    You also don’t understand how money and power works either.

    Replies: @LadyTheo

    You are assuming facts not in evidence.

    I do understand clinical trials. Which most people don’t. Like Malkin. She knows a little and assumes a lot. And working from an agenda, she speculates and rants. Tiresome. I guess she needs the clicks; she really has fallen off the national stage lately.

    Full disclosure: I work for Pfizer. I know a tiny bit more than Malkin or Sailer about how pharmaceutical trials work. And I know quite a bit more about the integrity of our medical people.

    Really. You non-scientists are tedious.

  14. @MarkU
    @LadyTheo


    I don’t understand this anti-vaccine screed.
     
    It isn't as simple as being pro or anti vaccination as such. There are older, tried and tested vaccines using well established methods and there are newer and totally experimental vaccines working on new and experimental principles. There are also slowly mutating diseases for which vaccines work well (and potentially permanently) Vs quickly mutating diseases for which vaccines are only temporary, if they work at all, flu is a good example.

    If you want to take a new, highly experimental vaccine that will probably work but equally probably will only be a temporary fix even if it does, then it is up to you. Bear in mind though that hastily contrived vaccines that are rushed into production have a dodgy record and can have very severe effects, including neurological damage or even death. Take whatever risks you want but at least do so with your eyes open. Consider the havoc being wreaked in Africa by Bill Gates's polio vaccine, we have had polio vaccines for decades and still people are being damaged, does that inspire confidence?

    I hope that clears up any confusion you might have had.

    Replies: @That Would Be Telling

    If you want to take a new, highly experimental vaccine that will probably work but equally probably will only be a temporary fix even if it does, then it is up to you.

    Nope, we have every expectation based on theory and serological testing of those who’ve already taken them that mRNA vaccines provide a long lasting immune system response, because they mimic exactly what the wild type virus does. Except for doing this with only one protein, wild type immune responses also include the nucleocapsid protein. The only question here is how well conserved the parts of it our adaptive immune system’s antibodies latch onto.

    And that’s where you’re wrong about mutations and vaccines. Flu vaccines are not “eternal” because we just don’t make antibodies against sufficiently conserved parts of it. Vaccines against RNA viruses that don’t have the coronaviruses’ unique proofreading mechanisms and thus mutate at much higher rates can be “eternal” because the immune system targets conserved parts of it. As the name implies, these parts can’t significantly change or “the virus won’t virus.”

    Bear in mind though that hastily contrived vaccines that are rushed into production have a dodgy record and can have very severe effects, including neurological damage or even death.

    That’s already in the cards, we know any vaccine will maim and kill some people who take it if the numbers are high enough, and here we’re talking billions. But you ought to cite examples of “hastily contrived vaccines that are rushed into production” vaccines, any recent ones? Any chance we’ve learned anything since say 1976, four and a half decades ago?

    […] Consider the havoc being wreaked in Africa by Bill Gates’s polio vaccine, we have had polio vaccines for decades and still people are being damaged, does that inspire confidence?

    It’s not “Bill Gate’s” polio vaccine, it’s Sabin’s or rather derived from his original attenuated one. And the trade offs of using it vs. a Salk type killed virus vaccine have been known for decades (details on request, but Wikipedia covers this well, here’s a good place to start).

  15. @That Would Be Telling
    @macilrae

    The problem is that AZ/Oxford hasn't even come close to doing an FDA level Phase 3 trial, with that article detailing even more problems with their work so far than I'd know. I mean, it's expensive, there's lots of details since you're dealing with a minimum of 30,000 people, but Pfizer/BioNTech and Moderna have had no great problems doing satisfactory versions of this FDA requirement, at least to point of being able to make an application for an Emergency Use Authorization (almost, Moderna still needs a little time to generate the required safety data, half the vaccine arm participants for two months after the second dose).

    Read the details with an open mind and it's clear AZ/Oxford, especially the latter with their unforgivable dosing accident, is a clown show. This can be remedied, and AZ is running a real FDA level Phase 3 trial in the US, but it'll take a lot of time, they were shut down for a month due to a participant somewhere else having a bad event, which I believe has been judged to not be related to taking the vaccine (large numbers mean stuff happens, one death so far in testing Western vaccines, a Brazilian who turned out to have gotten a placebo).

    Since their efficacy data shows two full strength doses is almost a dud at 62% (the FDA has said they'll approve anything that hits 50%, but when you've got two vaccines at 95%...), the US trial is going to be changed midstream to take advantage of the accident to get the possible 90% range efficacy (weasel words because too few people of too narrow a population set have tried that as of yet, only 1,800 or 2,700 depending on the source). AZ also won no favors from anyone with a clue by using a blended number to claiming an efficacy.

    Sputnik V isn't even open to question, it was approved by Russia one month before its Phase 3 trial started. If you don't understand what that means, you're too short for this ride. That said, it's got a better theory than AZ/Oxford, one explanation for the possibly much greater effectiveness of the "half-dose" followed by a full dose is that antibodies don't develop so much against the chimp adenovirus vector which is delivering the DNA for the spike protein. Sputnik V uses different human adenovirus vectors for the two doses But until we have Phase 3 results, they started recruiting participants September 10th so it'll be some time, Sputnik V is still a promising but untested theory.

    And do you hear anyone putting down Janssen (Johnson & Johnson)/BIDMC? Their vaccine is also an adenovirus vector one, i.e. existing vaccine technology like AZ/Oxford and Sputnik V that can be mass produced much more cheaply than the brand new mRNA ones. We'll just have to wait until they get enough data from their 60,000 (!) person Phase 3 trial. (Everyone else who's very far along is using non-invasive technologies, like proteins like the flu vaccines, or killed virus like the first for polio.)

    Replies: @macilrae

    Perhaps I allowed my cynicism to get the better of me in my use of the referenced article as an example of Industry kick-back against an impudent upstart; fielding a product at an insulting price.

    Nevertheless, we need to be alert to the fact that the dominant pharmaceutical companies will use such means to preserve their position in the most lucrative markets and retain our cynicism when reviewing both positive and negative articles on this topic. There is deception and dishonesty everywhere we look.

    As for the Russian vaccine, even if it proved itself conclusively in phase III trials, and then in a country like Brazil, do you really think there is the least chance it could ever be adopted in the Western markets served by J&J and Pfizer? It is sufficient just to mention that this vaccine has been approved of by Vladimir Putin himself.

    • Replies: @That Would Be Telling
    @macilrae


    Perhaps I allowed my cynicism to get the better of me
     
    Cynicism is tired and boring, the big problem with your post is that it's either self-refuting---did you not realize AstraZeneca is a $24 billion 2019 FY annual revenue pharma giant with 70,000 employees?---or a lie, Sputnik V will remain a political stunt until it gets some serious use outside of the censorship abilities of Russia.

    Nevertheless, we need to be alert to the fact that the dominant pharmaceutical companies....
     
    Which include AstraZeneca and even bigger giant Johnson and Johnson with $85 billion in 2018 FY annual revenues and 132,000 employees, the leading companies with inherently cheap vaccines. Moderna by comparison is a flea that has never been able to take a prior drug or vaccine candidate beyond Phase 1.

    will use such means to preserve their position in the most lucrative markets
     
    Vaccines are very much not lucrative markets, and include political dangers that can be company ending. Vaccines in the context of a pandemic, with even greater monopsony purchasing patterns?? Please. As it is, all three of these most leading companies or combinations have received huge multi-deci- or centi-million subsidies to merely develop these vaccines (although I'm going by memory for AZ/especially Oxford, Wikipedia couldn't confirm that).

    and retain our cynicism when reviewing both positive and negative articles on this topic.
     
    Cynicism is tired, boring, and makes you stupid, as your last posting showed.

    As for the Russian vaccine, even if it proved itself conclusively in phase III trials, and then in a country like Brazil, do you really think there is the least chance it could ever be adopted in the Western markets served by J&J and Pfizer? It is sufficient just to mention that this vaccine has been approved of by Vladimir Putin himself.
     
    No, it's sufficient to mention that it was approved by Russia one month prior to even starting its first Phase 3 trial. Do you think there's the slightest chance it will officially fail that trial after Russia/Putin has made such a big deal in falsely boasting it was the first (pretty sure even by Russia's standards the PRC gets that prize)? Where's your vaunted cynicism in judging a science free political stunt?
    , @LadyTheo
    @macilrae

    The fact that Pfizer was prepared to turn over its manufacturing facilities to produce another company's vaccine in the event that Pfizer's efforts failed argues against your assertions that pharma is only in it for the money.

    Further, given the political nature of this vaccine, Pfizer/Moderna/ AZ (maybe) will be in no position to profit wildly off of it. Billions of doses are going to have to be provided for poor countries with no ability to pay. And the terrible PR from the optics of "fleecing" the American public would far outweigh any material benefit Pfizer would gain.

    No, what Pfizer/Modern/AZ stand to gain from a successful effort here is massive goodwill, something sorely lacking on the part of the public for the past two decades or more. Not to mention that at least on the part of Pfizer, they can put their people back to work in meat-space--with the improved financial results that will come from that. Of all the pharma companies of which I am aware (many, given that I have been in pharma for over 20 years), Pfizer has taken one of the most cautious approaches to any return to normality that I have seen. I joke that I may be ready to retire before Pfizer ever lets me get on a plane again.

  16. @macilrae
    @That Would Be Telling

    Perhaps I allowed my cynicism to get the better of me in my use of the referenced article as an example of Industry kick-back against an impudent upstart; fielding a product at an insulting price.

    Nevertheless, we need to be alert to the fact that the dominant pharmaceutical companies will use such means to preserve their position in the most lucrative markets and retain our cynicism when reviewing both positive and negative articles on this topic. There is deception and dishonesty everywhere we look.

    As for the Russian vaccine, even if it proved itself conclusively in phase III trials, and then in a country like Brazil, do you really think there is the least chance it could ever be adopted in the Western markets served by J&J and Pfizer? It is sufficient just to mention that this vaccine has been approved of by Vladimir Putin himself.

    Replies: @That Would Be Telling, @LadyTheo

    Perhaps I allowed my cynicism to get the better of me

    Cynicism is tired and boring, the big problem with your post is that it’s either self-refuting—did you not realize AstraZeneca is a $24 billion 2019 FY annual revenue pharma giant with 70,000 employees?—or a lie, Sputnik V will remain a political stunt until it gets some serious use outside of the censorship abilities of Russia.

    Nevertheless, we need to be alert to the fact that the dominant pharmaceutical companies….

    Which include AstraZeneca and even bigger giant Johnson and Johnson with $85 billion in 2018 FY annual revenues and 132,000 employees, the leading companies with inherently cheap vaccines. Moderna by comparison is a flea that has never been able to take a prior drug or vaccine candidate beyond Phase 1.

    will use such means to preserve their position in the most lucrative markets

    Vaccines are very much not lucrative markets, and include political dangers that can be company ending. Vaccines in the context of a pandemic, with even greater monopsony purchasing patterns?? Please. As it is, all three of these most leading companies or combinations have received huge multi-deci- or centi-million subsidies to merely develop these vaccines (although I’m going by memory for AZ/especially Oxford, Wikipedia couldn’t confirm that).

    and retain our cynicism when reviewing both positive and negative articles on this topic.

    Cynicism is tired, boring, and makes you stupid, as your last posting showed.

    As for the Russian vaccine, even if it proved itself conclusively in phase III trials, and then in a country like Brazil, do you really think there is the least chance it could ever be adopted in the Western markets served by J&J and Pfizer? It is sufficient just to mention that this vaccine has been approved of by Vladimir Putin himself.

    No, it’s sufficient to mention that it was approved by Russia one month prior to even starting its first Phase 3 trial. Do you think there’s the slightest chance it will officially fail that trial after Russia/Putin has made such a big deal in falsely boasting it was the first (pretty sure even by Russia’s standards the PRC gets that prize)? Where’s your vaunted cynicism in judging a science free political stunt?

  17. Nope, we have every expectation based on theory and serological testing of those who’ve already taken them that mRNA vaccines provide a long lasting immune system response,

    Expectations are not always borne out and who is ‘we’? do you work for a drug company?

    And that’s where you’re wrong about mutations and vaccines. Flu vaccines are not “eternal” because we just don’t make antibodies against sufficiently conserved parts of it.

    Which is telling me that I’m wrong by explaining why I am right. If the virus didn’t mutate so fast there would presumably be ‘sufficiently conserved parts’. You are just mincing words.

    Vaccines against RNA viruses that don’t have the coronaviruses’ unique proofreading mechanisms and thus mutate at much higher rates can be “eternal” because the immune system targets conserved parts of it.

    Are you sure that is what you meant to say? it makes no sense. Explain to me please about the coronaviruses ‘unique proofreading mechanisms’ and how vaccines for (by implication) every other existing RNA virus can be ‘eternal’ because they mutate at much higher rates. It seems counter-intuitive and seems to suggest that a permanent flu (an RNA virus) vaccine should be possible because flu doesn’t have the ‘unique proofreading mechanism’ (even if I assume a simple error and replace can with can’t it doesn’t work) Feel free to get moderately technical (I am a science graduate and know a little about these matters) but try to use plain, direct language where possible for the benefit of all.

    we know any vaccine will maim and kill some people who take it if the numbers are high enough

    Which is what I said, so why pretend to correct me? Given that young people have an extremely low risk of serious symptoms from Covid-19, I am far from convinced that the vaccination is worth the risk.

    Any chance we’ve learned anything since say 1976, four and a half decades ago?

    The recent polio vaccine debacle in Africa is evidence that there is still much to learn, unless you have another theory about how that happened?

    It’s not “Bill Gate’s” polio vaccine, it’s Sabin’s.

    Good grief, do you actually imagine I thought Bill Gates personally developed the vaccine? If someone writes ‘Hitler’s Germany’, Stalin’s Russia or ‘Thatcher’s Britain’ do you feel the need to write in to explain that the named person didn’t actually found the country in question? I doubt it. It matters not at all, polio is an old disease, we have had a vaccine for decades and it still isn’t safe.

    https://www.theguardian.com/global-development/2020/sep/02/vaccine-derived-polio-spreads-in-africa-after-defeat-of-wild-virus

    I’m sorry but you are coming across as a person with an agenda, a person with a ‘professional interest’ in the pharmaceutical industry. You seem to be using the standard attack dog strategy, disagree with or ‘correct’ everything however lame and pointless your criticism. I also not convinced that you fully understand everything you are writing (as noted earlier) I might be wrong.

    • Replies: @That Would Be Telling
    @MarkU

    You omission from quoting my reply of "As [conserved] implies, these parts can’t significantly change or “the virus won’t virus.”" which explains most of the points you claim to be confused about shows you're a dishonest debater, you'll get no more replies from me. If any others are confused, please jump in.

  18. @macilrae
    @That Would Be Telling

    Perhaps I allowed my cynicism to get the better of me in my use of the referenced article as an example of Industry kick-back against an impudent upstart; fielding a product at an insulting price.

    Nevertheless, we need to be alert to the fact that the dominant pharmaceutical companies will use such means to preserve their position in the most lucrative markets and retain our cynicism when reviewing both positive and negative articles on this topic. There is deception and dishonesty everywhere we look.

    As for the Russian vaccine, even if it proved itself conclusively in phase III trials, and then in a country like Brazil, do you really think there is the least chance it could ever be adopted in the Western markets served by J&J and Pfizer? It is sufficient just to mention that this vaccine has been approved of by Vladimir Putin himself.

    Replies: @That Would Be Telling, @LadyTheo

    The fact that Pfizer was prepared to turn over its manufacturing facilities to produce another company’s vaccine in the event that Pfizer’s efforts failed argues against your assertions that pharma is only in it for the money.

    Further, given the political nature of this vaccine, Pfizer/Moderna/ AZ (maybe) will be in no position to profit wildly off of it. Billions of doses are going to have to be provided for poor countries with no ability to pay. And the terrible PR from the optics of “fleecing” the American public would far outweigh any material benefit Pfizer would gain.

    No, what Pfizer/Modern/AZ stand to gain from a successful effort here is massive goodwill, something sorely lacking on the part of the public for the past two decades or more. Not to mention that at least on the part of Pfizer, they can put their people back to work in meat-space–with the improved financial results that will come from that. Of all the pharma companies of which I am aware (many, given that I have been in pharma for over 20 years), Pfizer has taken one of the most cautious approaches to any return to normality that I have seen. I joke that I may be ready to retire before Pfizer ever lets me get on a plane again.

  19. @MarkU

    Nope, we have every expectation based on theory and serological testing of those who’ve already taken them that mRNA vaccines provide a long lasting immune system response,
     
    Expectations are not always borne out and who is 'we'? do you work for a drug company?

    And that’s where you’re wrong about mutations and vaccines. Flu vaccines are not “eternal” because we just don’t make antibodies against sufficiently conserved parts of it.
     
    Which is telling me that I'm wrong by explaining why I am right. If the virus didn't mutate so fast there would presumably be 'sufficiently conserved parts'. You are just mincing words.

    Vaccines against RNA viruses that don’t have the coronaviruses’ unique proofreading mechanisms and thus mutate at much higher rates can be “eternal” because the immune system targets conserved parts of it.
     
    Are you sure that is what you meant to say? it makes no sense. Explain to me please about the coronaviruses 'unique proofreading mechanisms' and how vaccines for (by implication) every other existing RNA virus can be 'eternal' because they mutate at much higher rates. It seems counter-intuitive and seems to suggest that a permanent flu (an RNA virus) vaccine should be possible because flu doesn't have the 'unique proofreading mechanism' (even if I assume a simple error and replace can with can't it doesn't work) Feel free to get moderately technical (I am a science graduate and know a little about these matters) but try to use plain, direct language where possible for the benefit of all.

    we know any vaccine will maim and kill some people who take it if the numbers are high enough
     
    Which is what I said, so why pretend to correct me? Given that young people have an extremely low risk of serious symptoms from Covid-19, I am far from convinced that the vaccination is worth the risk.

    Any chance we’ve learned anything since say 1976, four and a half decades ago?
     
    The recent polio vaccine debacle in Africa is evidence that there is still much to learn, unless you have another theory about how that happened?

    It’s not “Bill Gate’s” polio vaccine, it’s Sabin’s.
     
    Good grief, do you actually imagine I thought Bill Gates personally developed the vaccine? If someone writes 'Hitler's Germany', Stalin's Russia or 'Thatcher's Britain' do you feel the need to write in to explain that the named person didn't actually found the country in question? I doubt it. It matters not at all, polio is an old disease, we have had a vaccine for decades and it still isn't safe.

    https://www.theguardian.com/global-development/2020/sep/02/vaccine-derived-polio-spreads-in-africa-after-defeat-of-wild-virus

    I'm sorry but you are coming across as a person with an agenda, a person with a 'professional interest' in the pharmaceutical industry. You seem to be using the standard attack dog strategy, disagree with or 'correct' everything however lame and pointless your criticism. I also not convinced that you fully understand everything you are writing (as noted earlier) I might be wrong.

    Replies: @That Would Be Telling

    You omission from quoting my reply of “As [conserved] implies, these parts can’t significantly change or “the virus won’t virus.”” which explains most of the points you claim to be confused about shows you’re a dishonest debater, you’ll get no more replies from me. If any others are confused, please jump in.

  20. WE need a permanent vaccine against liberalism … the severe and dangerous mental disease. It counts as an embarrassing STD too.

  21. Dr. Reiner Fuellmich, attorney, is cooperating with doctors, scientists, and other attorneys to bring suit against the perpetrators of this pandemic hoax as crimes against humanity. If his team succeeds, the resulting trials will make Nuremberg look like an opening act. See video below.


  22. @Bill H
    So much fun that Trump was universally attacked for saying that, "We might have a vaccine by the end of this year." Now we have no fewer than three of them in November and no one is saying that maybe they should not have attacked him.

    Replies: @Dieter Kief

    Never apologize! – First law of the Internat’n’l Internet Survival Guide. Seems to apply here too.

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