Dr. Fauci just criticized Moderna for touting preliminary data on its Coronavirus vaccine, but said the results look 'very promising'

Last month, when Moderna released preliminary data on a phase 1 trial of its coronavirus vaccine, the early signs of success made headlines and sent the company's stock price soaring.

But Dr. Anthony Fauci of the National Institute of Allergy and Infectious Diseases said that though the initial data from the company looks "very promising from the neutralizing antibody standpoint," he disapproved of how the company jumped to share the news before it had more data.

"I didn't like that," Fauci told STAT News' Helen Branswell in an interview published Monday. "What we would have preferred to do, quite frankly, is to wait until we had the data from the entire Phase 1 — which I hear is quite similar to the data that they showed — and publish it in a reputable journal and show all the data."

The company, Fauci said, instead got excited when they saw the positive data and put out a press release without waiting for more information.

Moderna, which is partnering with the National Institutes of Health to develop its mRNA vaccine, said on May 18 that it had measured antibodies in eight of its vaccine study participants.

The results, Fauci said, were enough to warrant cautious optimism. That's because they showed not just binding antibody, or antibodies that would bind to the virus particle but wouldn't necessarily affect the virus's ability to infect the body, but "antibody that was neutralizing live virus, at levels that you would predict would be protective — if in fact neutralizing antibody, which is a reasonable assumption, is going to be a correlate of immunity."

Moderna is now moving onto the second phase of its clinical trials. Fauci said that other companies moving along quickly are likely to also show promising results.

Yeah, he said the same thing about Remdesevir right before it was found to have potentially serious side effects in humans.

The only thing he's not optimistic about is the one thing that's been on the market for 50 years, is super cheap, has been dispensed to millions without major side effects and the few that occur do so only after prolonged use, and is readily available. That one needs to be studied for a few years before we can consider it.

It's almost like he has an agenda...

If we are going to find vaccines and antivirals at Warp Speed (aka Trump Time) we need to speed up the trials and peer reviews. There is a new kind of adaptive or Bayesian trial being used. I’d call it more information theory based as opposed to Statistics 101.

Textbook: https://www.amazon.com/Bayesian-Adaptive-Methods-Clinical-Biostatistics/dp/1439825483/ref=sr_1_1?dchild=1&keywords=Bayesian+Adaptive+Methods+for+Clinical+Trials&qid=1591044889&sr=8-1
(You can probably find the pdf somewhere such as scribd)

The FDA recognises its advantages and recommends it. It is being used at MD Anderson, etc. https://www.fda.gov/media/78495/download

One “aha!” insight that comes out of this paradigm shift is that you realise you dont know how many samples you need to have a given confidence of a positive effect in advance. It depends on the strength of the correlation, which is what you are trying to measure, but will become apparent as the data rolls in.

Moderna reported eight out of the first eight subjects whose antibodies have been assayed and tested so far had not just some antibodies, but neutralizing antibodies. That makes a fair estimate of the probability of the desired effect 256:1. Certainly > 128:1 or 99%

People like Fauci don’t get it. They still think you need to see all the enrolled subjects to learn anything no matter what results roll in., What a dinosaur.

And another thing, Warp speed requires speeding up peer review. Dinosaurs don’t want anything to happen unless they have been seen to study it at length, criticise it, and maybe deign to bless it.

Some of you saw the Plandemic video. It may not all be true but the part about Fauci stalling the research of a competing team so his crony (Gallo?) published first and the right people got credit rang true to me.

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