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The Readout Damian Garde & Meghana Keshavan

How to get real vaccines to the placebo arm

Pfizer and its partner BioNTech are working on the logistics behind getting Covid-19 vaccines to trial participants who were initially placed in the placebo arm. The question they’re grappling with now, according to a memo to researchers obtained by STAT, is when to dole out live vaccines to placebo recipients. It won’t happen until after the FDA has granted some form of approval for the vaccine, STAT’s Matthew Herper writes.

This would require Pfizer to unblind the study, a common practice in clinical trials when a drug or vaccine proves successful. But the timing here is complex, since regulators want the trials blinded for as long as possible. Premature unblinding might diminish the reliability safety and efficacy results — which is why Johnson & Johnson, for example, was clear that it might not offer a vaccine to its placebo arm for two years.

Read more.

How well does Pfizer's Covid-19 vaccine work? 

What's the difference between efficacy and effectiveness? And should the FDA approve Biogen's Alzheimer's drug? 

We discuss all that and more on this week's episode of “The Readout LOUD,” STAT's biotech podcast. First, biostatistician Natalie Dean joins us to break down Pfizer's promising recent data on its vaccine for Covid-19. Then, following last week's stinging setback for Biogen's Alzheimer's drug aducanumab, we interview two people at the center of the story. Caleb Alexander, a Johns Hopkins epidemiologist, explains why he recommended against FDA approval for the drug, and Jeff Borghoff, who has early-onset Alzheimer's and has received aducanumab, discusses why he believes it works.

Listen here.

An SSRI may help stabilize Covid-19

An antidepressant called fluvoxamine might have the potential to prevent Covid-19 from worsening in non-hospitalized people, according to a small study published in JAMA. The drug, which used to treat anxiety and obsessive-compulsive disorder, has anti-inflammatory properties and may help modulate the immune system.

The study gave fluvoxamine to 80 volunteers, and 72 patients were placed on placebo. After 15 days, none of the patients on the drug deteriorated, but six of the patients on placebo did. 

Although the data fall short of demonstrating efficacy, the idea is tantalizing enough to merit further study in more patients, STAT’s Liz Cooney and Matthew Herper write.

Read more.

Cancer trial recruitment taxed by Covid-19

Cancer patients are far more reticent to enroll in clinical trials in the wake of Covid-19. Recruitment has been paused at some institutions to help slow the virus’s spread. Will patients be willing to participate in the future, even if the virus is still circulating? A new JAMA Oncology paper surveyed 933 cancer patients on this topic — and found that nearly 1 in 5 were hesitant to participate, largely because they were afraid of being exposed to Covid-19, STAT’s Priyanka Runwal writes

“There are so many barriers already that adding another in the form of the pandemic is really challenging,” the study’s co-author told STAT. 

Read more.

More reads

  • Medtronic launches connected smart insulin pen gained in Companion Medical deal. (FierceBiotech)
  • China’s health care listings break records. (Wall Street Journal)
  • These Researchers Tested Positive. But the Virus Wasn’t the Cause. (New York Times)

Thanks for reading! More next week,

Damian

Friday, November 13, 2020

STAT

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