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The Readout Damian Garde & Meghana Keshavan

A Johnson & Johnson Covid-19 trial is on pause

Another Covid-19 vaccine trial is on pause — potentially for safety reasons, STAT’s Matthew Herper reports. The online system used to recruit volunteers for Johnson & Johnson’s 60,000-patient clinical trial has been closed, and the study’s independent data safety monitoring board is convening. 

Further details aren’t yet available. But clinical trials tend to be paused due to safety concerns, or because interim data suggest a vaccine is either effective, or is not. It’s unlikely that enough data has been collected to determine whether the vaccine works, since the trial only began on Sept. 23 — so it’s a fair assumption that an adverse event triggered the pause. 

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Moderna’s CMO gets $1 million richer each week

All eyes are on Moderna’s Covid-19 vaccine. And with each passing week, the company’s chief medical officer, Tal Zaks, has been selling off his stock through pre-scheduled trades, earning him more than $50 million since the pandemic began, STAT’s Damian Garde and Adam Feuerstein write

Zaks isn’t the only Moderna exec to profit from the company’s Covid-19 work, and these selloffs are legal. But Zaks’ insider sales are being viewed by watchdogs as uniquely alarming, given their scale and frequency. 

“It’s atrocious,” one corporate governance expert told STAT. “It is indefensible, and it shows why many investors are concerned about options.” 

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The confusion around who would get aducanumab for Alzheimer’s

Biogen’s Alzheimer’s drug, aducanumab, could be approved by regulators next month — or not. But if it is approved, it's worth noting the drug has only been tested for efficacy in people experiencing the earliest stages of the neurodegenerative disease — and may only be approved for those patients. So what does that mean for people with moderate or advanced Alzheimer’s? 

For some families, it could be worth taking a gamble on the medication — provided physicians are willing to prescribe it off-label, STAT’s Ed Silverman writes. But this stirs up a new set of confounding questions, largely dependent on how Biogen chooses to price the drug — since it’s unclear whether payers will subsidize a drug with unproven efficacy in moderate and severe Alzheimer’s. 

“To put it mildly, this could be a major social dilemma,” one health policy expert told STAT. 

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The placebo effect could confuse Covid-19 trials

There’s an invisible threat in every Covid-19 trial that’s underway: the omnipresent placebo effect. This psychological reaction could contribute to trial failures, and delay getting medications and vaccines that might help curb the global pandemic, opine Erica Smith and Dominique Demolle, who lead a company focused on de-risking clinical drug development.  

For instance, participants in Covid-19 vaccine trials are tasked with self-reporting symptoms like body aches, cough, shortness of breath, and burden on everyday life. But these endpoints are variable, subjective, and vague. In the placebo arm of a Pfizer vaccine trial, volunteers are still showing increases in fatigue and headaches — which could ultimately confuse the overall safety profile of the vaccine. 

“Awareness of the phenomenon in the context of many ongoing Phase 3 clinical trials for Covid-19 therapies and vaccines will be crucial to understanding their true benefits,” the authors write. 

Read more.

More reads

  • Two Black university leaders urged their campuses to join a Covid-19 vaccine trial. The backlash was swift. (STAT)
  • From a small town North Carolina to big-city hospitals, how software infuses racism into U.S. health care. (STAT)
  • Meet Kernal Bio, the startup working on mRNA 2.0. (FierceBiotech)

Thanks for reading! More tomorrow,


Tuesday, October 13, 2020


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