https://t.co/w3LClAhU9h
a little thread of stuff that has inspired my thinking this year. 1/
https://t.co/w3LClAhU9h
https://t.co/TXkepMesrF
https://t.co/ahsq7YWpoW
https://t.co/QlJhyVfeWg
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https://t.co/YspH80QEbA
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This is a limited point about availability of efficacy data for vaccines under development in the context of the approval for CovidShield and Covaxin in India.
There have been many so-called experts on the idiotbox opining about apparent availability of P III data which 1/n
2/n apparently the SEC had access to based on which it "supposedly" approved Covaxin. Another argument that is prevalent is other regulators (US FDA and MHRA) also approved vaccines based on P II data alone. Let me give you a few facts so that you can make your own decision.
3/n The protocols for both mRNA vaccines are publicly available. You can check. Both protocols *define* when the interim analysis will be done. This is not subjective. They clearly define how many infections need to be documented before the Data Safety Monitoring Board meets.
4/n Find the protocols for the bridging study for CovidShield and Covaxin and look for a similar milestone.
Here is one set of efficacy data post the interim analysis of a mRNA vaccine.
Source: https://t.co/BAPnP3PxEb
5/n This data was analyzed post the interim analysis where the blind was broken by the DSMB. Now ask yourself this question:
How does the SEC, or the sponsor of these studies, or the experts who are offering their opinion liberally on the idiotbox know what the efficacy is
There have been many so-called experts on the idiotbox opining about apparent availability of P III data which 1/n
2/n apparently the SEC had access to based on which it "supposedly" approved Covaxin. Another argument that is prevalent is other regulators (US FDA and MHRA) also approved vaccines based on P II data alone. Let me give you a few facts so that you can make your own decision.
3/n The protocols for both mRNA vaccines are publicly available. You can check. Both protocols *define* when the interim analysis will be done. This is not subjective. They clearly define how many infections need to be documented before the Data Safety Monitoring Board meets.
4/n Find the protocols for the bridging study for CovidShield and Covaxin and look for a similar milestone.
Here is one set of efficacy data post the interim analysis of a mRNA vaccine.
Source: https://t.co/BAPnP3PxEb
5/n This data was analyzed post the interim analysis where the blind was broken by the DSMB. Now ask yourself this question:
How does the SEC, or the sponsor of these studies, or the experts who are offering their opinion liberally on the idiotbox know what the efficacy is
I think @SamAdlerBell in his quest to be the contrarian on Fauci gets several things wrong here. 1/
First, the failure last year actually was driven by the White House, the #Trump inner circle. Watch what's happening now, the US' scientific and public health infrastructure is creaking back to life. 2/
I think Sam underestimates the decimation of many of our health agencies over the past four years and the establishment of ideological control over them during the pandemic. 3/
I also am puzzled why Tony gets the blame for not speaking up, etc. Robert Redfield, Brett Giroir, Deb Birx, Jerome Adams, Alex Azar all could have done the same. 4/
Several of these people Bob Redfield, Brett Giroir, Alex Azar were led by craven ambition, Jerome Adams by cowardice, but I do think Deb Birx and Tony tried as institutionalists, insiders to make a difference. 5/
— Matthew Yglesias (@mattyglesias) January 30, 2021
First, the failure last year actually was driven by the White House, the #Trump inner circle. Watch what's happening now, the US' scientific and public health infrastructure is creaking back to life. 2/
I think Sam underestimates the decimation of many of our health agencies over the past four years and the establishment of ideological control over them during the pandemic. 3/
I also am puzzled why Tony gets the blame for not speaking up, etc. Robert Redfield, Brett Giroir, Deb Birx, Jerome Adams, Alex Azar all could have done the same. 4/
Several of these people Bob Redfield, Brett Giroir, Alex Azar were led by craven ambition, Jerome Adams by cowardice, but I do think Deb Birx and Tony tried as institutionalists, insiders to make a difference. 5/
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@EricTopol @NBA @StephenKissler @yhgrad B.1.1.7 reveals clearly that SARS-CoV-2 is reverting to its original pre-outbreak condition, i.e. adapted to transgenic hACE2 mice (either Baric's BALB/c ones or others used at WIV labs during chimeric bat coronavirus experiments aimed at developing a pan betacoronavirus vaccine)
@NBA @StephenKissler @yhgrad 1. From Day 1, SARS-COV-2 was very well adapted to humans .....and transgenic hACE2 Mice
@NBA @StephenKissler @yhgrad 2. High Probability of serial passaging in Transgenic Mice expressing hACE2 in genesis of SARS-COV-2
@NBA @StephenKissler @yhgrad B.1.1.7 has an unusually large number of genetic changes, ... found to date in mouse-adapted SARS-CoV2 and is also seen in ferret infections.
https://t.co/9Z4oJmkcKj
@NBA @StephenKissler @yhgrad We adapted a clinical isolate of SARS-CoV-2 by serial passaging in the ... Thus, this mouse-adapted strain and associated challenge model should be ... (B) SARS-CoV-2 genomic RNA loads in mouse lung homogenates at P0 to P6.
https://t.co/I90OOCJg7o
@NBA @StephenKissler @yhgrad 1. From Day 1, SARS-COV-2 was very well adapted to humans .....and transgenic hACE2 Mice
1. From Day 1, SARS-COV-2 was very well adapted to humans .....and transgenic hACE2 Mice
— Billy Bostickson \U0001f3f4\U0001f441&\U0001f441 \U0001f193 (@BillyBostickson) January 30, 2021
"we generated a mouse model expressing hACE2 by using CRISPR/Cas9 knockin technology. In comparison with wild-type C57BL/6 mice, both young & aged hACE2 mice sustained high viral loads... pic.twitter.com/j94XtSkscj
@NBA @StephenKissler @yhgrad 2. High Probability of serial passaging in Transgenic Mice expressing hACE2 in genesis of SARS-COV-2
1. High Probability of serial passaging in Transgenic Mice expressing hACE2 in genesis of SARS-COV-2!
— Billy Bostickson \U0001f3f4\U0001f441&\U0001f441 \U0001f193 (@BillyBostickson) January 2, 2021
2 papers:
Human\u2013viral molecular mimicryhttps://t.co/irfH0Zgrve
Molecular Mimicryhttps://t.co/yLQoUtfS6s https://t.co/lsCv2iMEQz
@NBA @StephenKissler @yhgrad B.1.1.7 has an unusually large number of genetic changes, ... found to date in mouse-adapted SARS-CoV2 and is also seen in ferret infections.
https://t.co/9Z4oJmkcKj
@NBA @StephenKissler @yhgrad We adapted a clinical isolate of SARS-CoV-2 by serial passaging in the ... Thus, this mouse-adapted strain and associated challenge model should be ... (B) SARS-CoV-2 genomic RNA loads in mouse lung homogenates at P0 to P6.
https://t.co/I90OOCJg7o