Why Use Two Doses of COVID-19 Vaccines When One Works Almost as Well?

ModernaPfizerTamarDunduaDreamstime

With the Pfizer/BioNTech vaccine already cleared and the Moderna vaccine soon to be approved by the Food and Drug Administration (FDA), COVID-19 relief finally seems to be on the way. There remains the issue of distribution, and as it stands, rollout will not be completed until summer. But Duke data scientist Zeynep Tufekci and Harvard epidemiologist Michael Mina point out in a recent New York Times op-ed that changing the vaccines from a two-dose to a one-shot regimen would double the number of Americans who could be vaccinated soon, all without losing a significant amount of protection against COVID-19 infection.

Tufekci and Mina note that infections dropped off steeply after two weeks among the participants in clinical trials who were inoculated with the first dose of the vaccines. Preliminary data from the Pfizer/BioNTech trial suggested that the vaccine efficacy for the prevention of COVID-19 was 82 percent after the first dose. Efficacy against severe COVID-19 occurring after the first dose was 88.9 percent. In comparison, the two-dose regimen is 95 percent effective against infection.

The Moderna vaccine, according to preliminary clinical trial data, provides substantial protection after the first dose as well. Tufekci and Mina note, “Moderna reported the initial dose to be 92.1 percent efficacious in preventing Covid-19 starting two weeks after the initial shot, when the immune system effects from the vaccine kick in, before the second injection on the 28th day.” The Moderna vaccine is 94.5 percent effective after the second dose.

Back in June, the FDA issued guidance outlining the agency’s expectation that a COVID-19 vaccine would prevent disease or decrease its severity in at least 50 percent of people who are vaccinated. According to preliminary data, one dose of either the Pfizer/BioNTech or Moderna vaccines clears this low hurdle.

Tufekci and Mina note that important questions remain, namely how long immune protection may last. But even if immunity were to wane over, say, a year, that would still provide enough time for people to get a booster shot later this year while the initial one-dose inoculation protects people immediately. Tufekci and Mina suggest that clinical trials evaluating one-dose efficacy could be rolled out quickly among low-risk healthy younger health care and essential workers.

I appreciate their caution, but given the much lower 50 percent vaccine efficacy threshold set by the FDA in June, the benefits of adopting a one-dose strategy using these vaccines outweigh the current real risks of the rising pandemic.

In any case, they are not wrong when they assert, “The possibility of adding hundreds of millions to those who can be vaccinated immediately in the coming year is not something to be dismissed.”

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Why Use Two Doses of COVID-19 Vaccines When One Works Almost as Well?

ModernaPfizerTamarDunduaDreamstime

With the Pfizer/BioNTech vaccine already cleared and the Moderna vaccine soon to be approved by the Food and Drug Administration (FDA), COVID-19 relief finally seems to be on the way. There remains the issue of distribution, and as it stands, rollout will not be completed until summer. But Duke data scientist Zeynep Tufekci and Harvard epidemiologist Michael Mina point out in a recent New York Times op-ed that changing the vaccines from a two-dose to a one-shot regimen would double the number of Americans who could be vaccinated soon, all without losing a significant amount of protection against COVID-19 infection.

Tufekci and Mina note that infections dropped off steeply after two weeks among the participants in clinical trials who were inoculated with the first dose of the vaccines. Preliminary data from the Pfizer/BioNTech trial suggested that the vaccine efficacy for the prevention of COVID-19 was 82 percent after the first dose. Efficacy against severe COVID-19 occurring after the first dose was 88.9 percent. In comparison, the two-dose regimen is 95 percent effective against infection.

The Moderna vaccine, according to preliminary clinical trial data, provides substantial protection after the first dose as well. Tufekci and Mina note, “Moderna reported the initial dose to be 92.1 percent efficacious in preventing Covid-19 starting two weeks after the initial shot, when the immune system effects from the vaccine kick in, before the second injection on the 28th day.” The Moderna vaccine is 94.5 percent effective after the second dose.

Back in June, the FDA issued guidance outlining the agency’s expectation that a COVID-19 vaccine would prevent disease or decrease its severity in at least 50 percent of people who are vaccinated. According to preliminary data, one dose of either the Pfizer/BioNTech or Moderna vaccines clears this low hurdle.

Tufekci and Mina note that important questions remain, namely how long immune protection may last. But even if immunity were to wane over, say, a year, that would still provide enough time for people to get a booster shot later this year while the initial one-dose inoculation protects people immediately. Tufekci and Mina suggest that clinical trials evaluating one-dose efficacy could be rolled out quickly among low-risk healthy younger health care and essential workers.

I appreciate their caution, but given the much lower 50 percent vaccine efficacy threshold set by the FDA in June, the benefits of adopting a one-dose strategy using these vaccines outweigh the current real risks of the rising pandemic.

In any case, they are not wrong when they assert, “The possibility of adding hundreds of millions to those who can be vaccinated immediately in the coming year is not something to be dismissed.”

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“‘New York Times’ Retracts Core Of Hit Podcast Series ‘Caliphate’ On ISIS”

An interesting NPR (David Folkenflik) story, prompted by the Times’ official retraction:

The New York Times has retracted the core of its hit 2018 podcast series Caliphate after an internal review found the paper failed to heed red flags indicating that the man it relied upon for its narrative about the allure of terrorism could not be trusted to tell the truth.

The newspaper has reassigned its star terrorism reporter, Rukmini Callimachi, who hosted the series.

Caliphate relayed the tale about the radicalization of a young Canadian who went to Syria, joined the Islamic State and became an executioner for the extremist group before escaping its hold.

Canadian authorities this fall accused the man, Shehroze Chaudhry, of lying about those activities. He currently faces criminal charges in a federal court in Ontario of perpetrating a terrorism hoax.

“We fell in love with the fact that we had gotten a member of ISIS who would describe his life in the caliphate and would describe his crimes,” New York Times executive editor Dean Baquet tells NPR in an interview on Thursday. “I think we were so in love with it that when when we saw evidence that maybe he was a fabulist, when we saw evidence that he was making some of it up, we didn’t listen hard enough.”

See also the Times’ own A Riveting ISIS Story, Told in a Times Podcast, Falls Apart (Mark Mazzetti, Ian Austen, Graham Bowley & Malachy Browne). (The controversy itself, of course, isn’t new.) It’s a sad reminder that, unfortunately, readers and listeners need to be skeptical about everything, including material published by leading media outlets, and by authors and editors who have a lot to lose in the event of error.

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Fair Use to Republish, in Annotated Form, Drone-Taken Photograph Used in a Political Argument

Prof. Eric Goldman (Technology & Marketing Law Blog) reports on Castle v. Kingsport Publishing, decided Monday by Judge Clifton L Corker (E.D. Tenn.):

Yes, this is another defense-favorable fair use ruling produced by a Richard Liebowitz lawsuit.

The case relates to a construction site for a proposed new school, which may have sinkholes. This concern sparked substantial community debate. The plaintiff flew his drone over the construction site and took photos purportedly showing the sinkholes. At a Board of Education meeting, the plaintiff gave a board member a 2 foot x 5 foot blowup of the photo to use as a visual aid. Soon after the meeting, the defendant published a news story about the controversy, including the photo displayed at the board meeting. You can see the photo in the linked story and in the opinion (I’m sure I could republish it here under fair use, but I don’t have the energy to deal with the potential drama).

The plaintiff agreed that the defendant republished the photo in connection with its “news reporting.” Nevertheless, the plaintiff claims, apparently without much credible evidence, that he would have charged $4,000-$5,000 to license the photo. Meanwhile, the defendant received “about” $15.20 in ad revenues from the news story….

Nature of the Use. The defendant used the photo to illustrate the public controversy over the construction site. The article reports on an expert’s disagreement with the narrative that the photographer and education board member had articulated in the board meeting. The court tries to position this critical commentary as a transformative use of the photo. It might have been cleaner to characterize the photo as a key piece of evidence from a government meeting that helps readers visualize the controversy and the criticism. That’s why the statute lists “news reporting” as a paradigmatic example of fair use.

The defendant also made a commercial editorial use, but the fact it made only $15 makes it feel not very commercial. This suggests a meta-commentary about the economics of journalism, especially when adding in the cost of dubious copyright litigation, but the court doesn’t engage with it….

For more details on the analysis, see Prof. Goldman’s post; I think the court’s approach is quite correct, and would apply to non-drone photographs as well.

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“‘New York Times’ Retracts Core Of Hit Podcast Series ‘Caliphate’ On ISIS”

An interesting NPR (David Folkenflik) story, prompted by the Times’ official retraction:

The New York Times has retracted the core of its hit 2018 podcast series Caliphate after an internal review found the paper failed to heed red flags indicating that the man it relied upon for its narrative about the allure of terrorism could not be trusted to tell the truth.

The newspaper has reassigned its star terrorism reporter, Rukmini Callimachi, who hosted the series.

Caliphate relayed the tale about the radicalization of a young Canadian who went to Syria, joined the Islamic State and became an executioner for the extremist group before escaping its hold.

Canadian authorities this fall accused the man, Shehroze Chaudhry, of lying about those activities. He currently faces criminal charges in a federal court in Ontario of perpetrating a terrorism hoax.

“We fell in love with the fact that we had gotten a member of ISIS who would describe his life in the caliphate and would describe his crimes,” New York Times executive editor Dean Baquet tells NPR in an interview on Thursday. “I think we were so in love with it that when when we saw evidence that maybe he was a fabulist, when we saw evidence that he was making some of it up, we didn’t listen hard enough.”

See also the Times’ own A Riveting ISIS Story, Told in a Times Podcast, Falls Apart (Mark Mazzetti, Ian Austen, Graham Bowley & Malachy Browne). (The controversy itself, of course, isn’t new.) It’s a sad reminder that, unfortunately, readers and listeners need to be skeptical about everything, including material published by leading media outlets, and by authors and editors who have a lot to lose in the event of error.

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Fair Use to Republish, in Annotated Form, Drone-Taken Photograph Used in a Political Argument

Prof. Eric Goldman (Technology & Marketing Law Blog) reports on Castle v. Kingsport Publishing, decided Monday by Judge Clifton L Corker (E.D. Tenn.):

Yes, this is another defense-favorable fair use ruling produced by a Richard Liebowitz lawsuit.

The case relates to a construction site for a proposed new school, which may have sinkholes. This concern sparked substantial community debate. The plaintiff flew his drone over the construction site and took photos purportedly showing the sinkholes. At a Board of Education meeting, the plaintiff gave a board member a 2 foot x 5 foot blowup of the photo to use as a visual aid. Soon after the meeting, the defendant published a news story about the controversy, including the photo displayed at the board meeting. You can see the photo in the linked story and in the opinion (I’m sure I could republish it here under fair use, but I don’t have the energy to deal with the potential drama).

The plaintiff agreed that the defendant republished the photo in connection with its “news reporting.” Nevertheless, the plaintiff claims, apparently without much credible evidence, that he would have charged $4,000-$5,000 to license the photo. Meanwhile, the defendant received “about” $15.20 in ad revenues from the news story….

Nature of the Use. The defendant used the photo to illustrate the public controversy over the construction site. The article reports on an expert’s disagreement with the narrative that the photographer and education board member had articulated in the board meeting. The court tries to position this critical commentary as a transformative use of the photo. It might have been cleaner to characterize the photo as a key piece of evidence from a government meeting that helps readers visualize the controversy and the criticism. That’s why the statute lists “news reporting” as a paradigmatic example of fair use.

The defendant also made a commercial editorial use, but the fact it made only $15 makes it feel not very commercial. This suggests a meta-commentary about the economics of journalism, especially when adding in the cost of dubious copyright litigation, but the court doesn’t engage with it….

For more details on the analysis, see Prof. Goldman’s post; I think the court’s approach is quite correct, and would apply to non-drone photographs as well.

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Sound of Metal Creates an Entire World Out of Sound

soundofmetal-lguse

What, exactly, does metal sound like? Sound of Metal, writer-director Darius Marder’s gentle story of loss, addiction, and recovery, offers a series of answers. 

At first, it’s musical, the enveloping cacophony of brutal noise rock heard from the throne of a drum kit. The drummer in this story is Ruben Stone (Riz Ahmed), a four-years-clean drug addict who has devoted his life to playing brash, pulverizing music with his partner, Lou (Olivia Cooke). The movie puts you in the middle of the sound as Ruben crashes cymbals and slams out impossible blast-beats. If you’ve ever played in a rock ‘n’ roll band before, you’ll recognize the sensation—the intimacy and connection with the crowd, the overwhelming swell of the music as it drowns out all else. If you haven’t played in a band before, this is about as close to the live-show experience as you’ll get. Sound of Metal doesn’t just show you what it’s like to play music. It shows you what it’s like to live it. 

Which makes it that much more painful when Ruben discovers that he’s rapidly losing his ability to hear. Suddenly, the movie’s soundtrack shifts; dialogue becomes warbled and muddy, odd ringing noises interject themselves where they shouldn’t. The whole world suddenly feels out of whack. Once again, the sonic simulation of hearing disorientation is strikingly vivid and realistic. It’s more than an irritating ringing noise; it’s a fundamental and deeply frightening shift in how you interact with the world.  

Eventually, Ruben enters a recovery home in the Midwest, a place where people with histories of addiction can learn to be deaf. He resists at first, but learns sign language as part of a class of deaf children, and begins to find a community with the other adults and teachers. And in the process, the movie offers a second answer to the question of what metal sounds like: This time, it’s the physical pulse of tapping on a slide. Although Ruben and the deaf children he’s surrounded with cannot hear music, they can feel it, so just as they helped teach him to speak in signs, he begins to teach them to play drums. Once again, the sound of metal is not just a particular sound he hears, but a way of perceiving and communicating with the rest of the world. 

That sound transforms one more time in the movie’s third act, after Ruben scrapes together money to surgically install a cochlear implant, giving him a new way to hear. The implant, which bypasses the cochlear nerve, is attached to a small array of microphones and digital signal processors that he wears on his head. He can hear again—but it’s a different kind of hearing. It’s digitized and glitchy, clear enough to make out dialogue, but distinctly unmusical in its character. It sounds metallic. And, yet again, that sound is his entire world, and the movie’s.  

Which also means that it becomes the viewer’s. Sound of Metal is a sensitive and empathetic film about losing your identity and finding a new one, and one of the ways it showcases Ruben’s loss of identity is by subsuming viewers in his sensory disorientation.

It’s also a movie about the life-shaping and live-saving influence of subcultures, from the metal-music world where Ruben begins to the deaf community where he ends up to the shaggy French villa he visits during the film’s final stretch. Marder gives each location a distinct sense of place, showing both the subtle and obvious ways in which the particular culture of each location inevitably changes one’s outlook and identity. 

But for a relatively small, naturalistic production about bodily frailty, Sound of Metal is also a remarkable technical achievement. The movie’s sound design isn’t as flashy as a new Star Wars or Transformers film, but its representation of Ruben’s hearing loss and subsequent transformation is as remarkable as anything I’ve heard from a movie. Writer-director Darius Marder and composer-sound designer Nicolas Becker have built an immersive, densely realized depiction of personal and sonic degradation that plays out in meticulously rendered surround sound. 

Sadly, the streaming release (it’s playing on Amazon Prime Video) means that although the film will be widely available, many home viewers won’t have the opportunity to hear the art and effort that went into the surround mix. If you don’t have a surround-sound system at home, this is a movie that’s worth watching on a good pair of over-ear headphones in order to experience the immersive aural depth and detail. Well-acted, warm, and endlessly humane, Sound of Metal is perhaps too understated at times, but it’s a worthwhile reminder of the importance of good sound in both movies and in life. 

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Sound of Metal Creates an Entire World Out of Sound

soundofmetal-lguse

What, exactly, does metal sound like? Sound of Metal, writer-director Darius Marder’s gentle story of loss, addiction, and recovery, offers a series of answers. 

At first, it’s musical, the enveloping cacophony of brutal noise rock heard from the throne of a drum kit. The drummer in this story is Ruben Stone (Riz Ahmed), a four-years-clean drug addict who has devoted his life to playing brash, pulverizing music with his partner, Lou (Olivia Cooke). The movie puts you in the middle of the sound as Ruben crashes cymbals and slams out impossible blast-beats. If you’ve ever played in a rock ‘n’ roll band before, you’ll recognize the sensation—the intimacy and connection with the crowd, the overwhelming swell of the music as it drowns out all else. If you haven’t played in a band before, this is about as close to the live-show experience as you’ll get. Sound of Metal doesn’t just show you what it’s like to play music. It shows you what it’s like to live it. 

Which makes it that much more painful when Ruben discovers that he’s rapidly losing his ability to hear. Suddenly, the movie’s soundtrack shifts; dialogue becomes warbled and muddy, odd ringing noises interject themselves where they shouldn’t. The whole world suddenly feels out of whack. Once again, the sonic simulation of hearing disorientation is strikingly vivid and realistic. It’s more than an irritating ringing noise; it’s a fundamental and deeply frightening shift in how you interact with the world.  

Eventually, Ruben enters a recovery home in the Midwest, a place where people with histories of addiction can learn to be deaf. He resists at first, but learns sign language as part of a class of deaf children, and begins to find a community with the other adults and teachers. And in the process, the movie offers a second answer to the question of what metal sounds like: This time, it’s the physical pulse of tapping on a slide. Although Ruben and the deaf children he’s surrounded with cannot hear music, they can feel it, so just as they helped teach him to speak in signs, he begins to teach them to play drums. Once again, the sound of metal is not just a particular sound he hears, but a way of perceiving and communicating with the rest of the world. 

That sound transforms one more time in the movie’s third act, after Ruben scrapes together money to surgically install a cochlear implant, giving him a new way to hear. The implant, which bypasses the cochlear nerve, is attached to a small array of microphones and digital signal processors that he wears on his head. He can hear again—but it’s a different kind of hearing. It’s digitized and glitchy, clear enough to make out dialogue, but distinctly unmusical in its character. It sounds metallic. And, yet again, that sound is his entire world, and the movie’s.  

Which also means that it becomes the viewer’s. Sound of Metal is a sensitive and empathetic film about losing your identity and finding a new one, and one of the ways it showcases Ruben’s loss of identity is by subsuming viewers in his sensory disorientation.

It’s also a movie about the life-shaping and live-saving influence of subcultures, from the metal-music world where Ruben begins to the deaf community where he ends up to the shaggy French villa he visits during the film’s final stretch. Marder gives each location a distinct sense of place, showing both the subtle and obvious ways in which the particular culture of each location inevitably changes one’s outlook and identity. 

But for a relatively small, naturalistic production about bodily frailty, Sound of Metal is also a remarkable technical achievement. The movie’s sound design isn’t as flashy as a new Star Wars or Transformers film, but its representation of Ruben’s hearing loss and subsequent transformation is as remarkable as anything I’ve heard from a movie. Writer-director Darius Marder and composer-sound designer Nicolas Becker have built an immersive, densely realized depiction of personal and sonic degradation that plays out in meticulously rendered surround sound. 

Sadly, the streaming release (it’s playing on Amazon Prime Video) means that although the film will be widely available, many home viewers won’t have the opportunity to hear the art and effort that went into the surround mix. If you don’t have a surround-sound system at home, this is a movie that’s worth watching on a good pair of over-ear headphones in order to experience the immersive aural depth and detail. Well-acted, warm, and endlessly humane, Sound of Metal is perhaps too understated at times, but it’s a worthwhile reminder of the importance of good sound in both movies and in life. 

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Law and Equity: The Generator Analogy

Today I am working on materials for the remedies casebook that is edited by Emily Sherwin and me. (The book is Ames, Chafee, and Re on Remedies, third edition.) I included an analogy that readers of the blog might be interested in:

By the way, one of us illustrates the idea of law and equity as two systems like this. Imagine an entity that must have access to power, such as a hospital or a computer server facility. It won’t want to run to generators all the time—the cost would be extraordinary, and the pollution. So the hospital or server facility quite sensibly uses power from the electric grid. But what happens when there is a disruption in the transmission of power to the hospital or server site? Should it simply “go dark”? No, again sensibly, it uses a backup generator system. Now one could ask, “Why not just ensure there are no failures in the transmission of power from the electric grid?” But it is more efficient to get the power grid to 99.9% reliability, and have a backup generator for the .1% of cases, than it is to try to make the power grid so perfect that it is 100% reliable. For law and equity these aren’t the percentages, but the analogy is helpful in showing how two systems can work better than one, with one system providing the general rule and the other as a backup when there is a failure in system one.

If you want to explore further the idea of law and equity as distinct systems, good places to start are Henry E. Smith, “Fusing the Equitable Function in Private Law” in Private Law in the 21st Century 173 (Kit Barker, Karen Fairweather, and Ross Grantham eds., 2017); and Henry E. Smith, “Equity as Meta-Law,” Yale L. J. (forthcoming).

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Law and Equity: The Generator Analogy

Today I am working on materials for the remedies casebook that is edited by Emily Sherwin and me. (The book is Ames, Chafee, and Re on Remedies, third edition.) I included an analogy that readers of the blog might be interested in:

By the way, one of us illustrates the idea of law and equity as two systems like this. Imagine an entity that must have access to power, such as a hospital or a computer server facility. It won’t want to run to generators all the time—the cost would be extraordinary, and the pollution. So the hospital or server facility quite sensibly uses power from the electric grid. But what happens when there is a disruption in the transmission of power to the hospital or server site? Should it simply “go dark”? No, again sensibly, it uses a backup generator system. Now one could ask, “Why not just ensure there are no failures in the transmission of power from the electric grid?” But it is more efficient to get the power grid to 99.9% reliability, and have a backup generator for the .1% of cases, than it is to try to make the power grid so perfect that it is 100% reliable. For law and equity these aren’t the percentages, but the analogy is helpful in showing how two systems can work better than one, with one system providing the general rule and the other as a backup when there is a failure in system one.

If you want to explore further the idea of law and equity as distinct systems, good places to start are Henry E. Smith, “Fusing the Equitable Function in Private Law” in Private Law in the 21st Century 173 (Kit Barker, Karen Fairweather, and Ross Grantham eds., 2017); and Henry E. Smith, “Equity as Meta-Law,” Yale L. J. (forthcoming).

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