Moderna to Ask FDA for Emergency Authorization of Covid-19 Vaccine on Monday

Nurse Jessica Franz walks past a mobile morgue at Olathe Medical Center on Nov. 26, 2020, in Olathe, Kansas.

Nurse Jessica Franz walks past a mobile morgue at Olathe Medical Center on Nov. 26, 2020, in Olathe, Kansas.
Photo: Charlie Riedel (AP)

Biotech company Moderna will ask for an emergency use authorization from the Food and Drug Administration for its covid-19 vaccine on Monday, according to a new press release posted to the firm’s website. Moderna also released new information indicating its messenger RNA-based vaccine has a 94.1% efficacy rate in a study of 30,000 people—encouraging news for Americans still struggling with an uncontrolled pandemic. Moderna said it will also seek approval with the European Medicines Agency.

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“This positive primary analysis confirms the ability of our vaccine to prevent Covid-19 disease with 94.1% efficacy and importantly, the ability to prevent severe Covid-19 disease,” Moderna CEO Stéphane Bancel said in a statement. “We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death.”

Just 196 people in the latest Moderna trial contracted the coronavirus, with 185 of those cases occurring in the group who received a placebo rather than the actual experimental vaccine. None of the 11 people who received the vaccine but still contracted the virus showed signs of severe illness, whereas there were 30 cases of severe illness in the placebo group, including one person who died.

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Moderna’s vaccine requires two doses spaced about one month apart. Reported side effects included “injection site pain, fatigue, myalgia [muscle pain], arthralgia [joint pain], headache, and erythema/redness at the injection site,” according to the company.

There are two other high-profile vaccines being produced in the U.S. and Europe, including another mRNA vaccine from U.S.-based Pfizer developed with the German firm BioNTech. Pfizer, whose vaccine is reportedly 95% effective based on early data, is scheduled to give a presentation to the FDA on December 10, according to the Associated Press. Moderna will likely give its presentation the following week.

AstraZeneca has also developed a vaccine in the UK with Oxford University that’s not based on the newer mRNA technology used in the Pfizer and Moderna vaccines, and while AstraZeneca’s shot remains encouraging for its relative low cost and ease-of-storage, new concerns have been raised over transparency and the company’s clinical trials. It was only revealed late last week that some of the findings in AstraZeneca’s latest trial had been the result of errors in dosing rather than intentional scientific effort. Many experts were stunned when AstraZeneca found its vaccine worked better when study participants only received a half dose and then a full dose. This anomaly was encouraging but hard to explain, and it raised even more questions when it was later revealed on an investor phone call that the half dose had been given by mistake.

The U.S. recorded over 131,000 new cases of covid-19 and 790 new deaths on Sunday, numbers that are probably artificially low because of delays in data reporting due to the holiday weekend, according to the Covid Tracking Project. The number of Americans currently hospitalized with covid-19 reached a record high of 93,238 yesterday.

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If FDA quickly gives authorization to Moderna’s vaccine, there are still a lot of questions about who will get the vaccines first. Top priority will be medical professionals like doctors and nurses who are treating covid-19 patients, but the White House hasn’t publicly articulated a plan for which group will be second, an important question for everyday Americans.

Former FDA commissioner Scott Gottlieb, a regular on TV news shows, brought up this point of who may get the shot after health care workers on Sunday and said that it’s not clear whether priority will be given to the elderly or to so-called essential workers. If the goal is to limit the spread of the virus, it should go to essential workers, Gottlieb told CBS News host Margaret Brennan on “Face the Nation.” But if the goal is to save lives immediately, elderly Americans should be the first to receive the vaccine.

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“There’s only going to be 40 million doses available throughout the whole month of December if both companies get authorized on time,” Gottlieb said about the Moderna and Pfizer vaccines, noting that there won’t be enough vaccine for many people beyond health workers in that first batch.

“There’s about 85 million essential workers who might be eligible to be vaccinated if you— if you bifurcate it to that group. And there’s about 50 million people over the age of 65, 20 million over the age of 75,” Gottlieb continued. “And so that’s going to be some debate about which group gets prioritized first.”

It’s tough to decide who should get priority during a pandemic, but health care workers are already in the unenviable decision of doing precisely that as the number of cases and deaths continue to rise with each passing day. While hotspots of infection are slowing down, however modestly, in places like the Midwest, other parts of the country are seeing a disturbing rise in new cases and hospitalizations, including the West and the Northeast.

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In California, for example, the number of people hospitalized with covid-19 has doubled since November 12, going from roughly 4,000 to 8,000 patients, according to the Covid Tracking Project. The vaccine simply can’t get here fast enough.

Want to Know What the Covid-19 Vaccine Trials Are Like? There’s a TikTok for That

Illustration for article titled Want to Know What the Covid-19 Vaccine Trials Are Like? Theres a TikTok for That

Photo: Denis Charlet (Getty Images)

The viral short-form video app TikTok (which still isn’t banned, by the way) is becoming the unlikely new home for creators claiming to have first-hand experience with the covid-19 vaccine and giving expert testimonials about ongoing vaccine trials.

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A search for the hashtag #CovidVaccine, which has nearly 40 million views, brings up several videos of scientists and doctors debunking misinformation campaigns about the virus in addition to participants in covid-19 vaccine trials sharing their experiences, per a weekend NBC News report.

Ashley Locke, a 29-year-old who says her trial for AstraZeneca’s covid-19 vaccine started on Nov. 16 in Nashville, Tennessee, has garnered millions of views for her videos documenting the process. A post of her receiving her first injection as part of the study has roughly 2.8 million views alone, though you might want to skip it if needles make you queasy (I definitely felt my stomach flip watching it). She won’t find out if that injection was the real vaccine or a placebo until the end of the study, but she told NBC that she’s been busy responding to the flood of questions and comments about the trial that she’s received in the meantime.

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“I’ve seen people post TikToks about different journeys they’re having, like weight-loss journeys or moving to a new school and things like that, so I was, like, this vaccine trial is an interesting thing. I’ll post about that,” Locke said in an interview with the outlet. “Maybe some people will find that interesting.”

AstraZeneca, a pharmaceutical company that I can’t read the name of without hearing their “AstraZeneca may be able to help…” commercial catchline in my head, is co-developing the vaccine along with researchers at the University of Oxford. Their vaccine has reportedly shown to be 70% effective at protecting against the virus, though a recently revealed manufacturer error in phase III trials has raised concerns about the reliability of those results.

It’s one of three experimental vaccines that have reportedly shown promising results in recent weeks along with those developed by the biotech firms Moderna and BioNTech, the latter of which is working with drug manufacturer Pfizer.

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As NBC notes, other TikTok users have also posted videos claiming to share their own covid-19 vaccine trial experiences. Experts have begun weighing in too, with doctors and scientists posting videos that debunk common misinformation about vaccines and compare the differences among some of the vaccine trials.

Dr. Kate Bredbenner, a biomedical sciences specialist with a focus in biophysics, posted a video on Nov. 11 that’s already gained 3.6 million views where she walks through how Pfizer’s experimental vaccine would affect the novel coronavirus. She told NBC that while some anti-vaxxers have been cropping up here and there to leave nasty comments, for the most part, her comment section is mostly filled with curious users just trying to learn more.

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“It makes me feel so good. People are genuinely having real conversations, and people are asking questions, and I think that’s kind of magic,” Bredbenner said in an interview with the outlet.

In Locke’s video of her first injection, she said she’ll have regular check-ins and blood testing for the next two years to monitor any side effects. She told NBC that she plans to record a Q&A with doctors about the trial the next time she comes back.

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“I talked to the communications director [of Clinical Research Associates]. Next time I go in, I’m going to be able to ask some of the questions I’m not able to answer. I’m going to be able to ask my doctors and hopefully have them on my videos to be a little more informative and answer some more of those scientific things that I don’t know, but still in a clear way that’s easy for our audiences,” Locke said.

TikTok did not immediately respond to Gizmodo’s request for comment.

The coronavirus pandemic has raged on for far longer than most people anticipated, especially in the U.S. where basic science and health precautions have become political issues, so it’s no surprise that people are itching to learn how we can beat this thing. To date, there have been more than 62 million coronavirus cases and 1.4 million deaths worldwide, including more than 266,000 in the U.S. alone, per researchers at Johns Hopkins.

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When you’ll actually be able to get a vaccine is another question. On Tuesday, the U.S. Health and Human Services Secretary Alex Azar said that a covid-19 vaccine could be distributed “soon” after it’s approved for emergency authorization by the Food and Drug Administration, which could come as soon as Dec. 10. Pfizer announced last week that it would be seeking emergency approval for its vaccine, which appears to be 95% effective at preventing the illness according to the company’s testing. So a vaccine in time for Christmas is not entirely out of the question, but given the year 2020 has been so far, I’d take that timeline with a colossal size grain of salt.

[NBC News]

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Yes, Virtual Santa Claus Meet and Greets Are Happening on Zoom

Illustration for article titled Yes, Virtual Santa Claus Meet and Greets Are Happening on Zoom

Photo: Finnbarr Webster (Getty Images)

The pandemic has put Santa performers in a tough situation. As USA Today reports, many Santas count on their end-of-year gigs to make extra cash, and in some cases, a big chunk of their annual income. Mitch Allen, founder of HireSanta.com, which manages a network of about 2,000 performers, told the outlet that a mall Santa with “a real beard, real belly, real laugh” can make between $5,000 and $10,000 working in November and December.

Michael Howe, who is a retired public school teacher and has portrayed Santa on and off for 27 years, said the privilege of playing Santa is more important this year because of the unrest in the country, as well as because of the economic and social challenges. For him, the income is “very needed” because he’s not on social security yet, according to USA Today. Yet, it’s still a tough call.

“I want to do personal visits,’’ Howe told the outlet, “but I also want to make sure that I’m safe.’’

Dosing Mix-up Raises Questions About Promising Covid-19 Vaccine

Vials used by pharmacists to prepare syringes for an experimental vaccine.

Vials used by pharmacists to prepare syringes for an experimental vaccine.
Image: Associated Press (AP)

A manufacturing error is raising concerns about a promising covid-19 vaccine being developed by pharmaceutical company AstraZeneca and the University of Oxford.

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Less than a week after we learned about the promising new vaccine, the developers have admitted to a manufacturing error that resulted in two different doses being administered during the recently concluded phase III trial, as the Associated Press reports. This promising covid-19 vaccine, developed by AstraZeneca and the University of Oxford, was described as being 70% effective at protecting against the coronavirus, but that number now seems a bit misleading—and not necessarily in a bad way.

The two separate doses used during the trial had a direct bearing on the results, in which participants who were given a lower dose of the vaccine appeared to be better protected (90% efficacy) than those who were given full doses (62% efficacy). That a lower dose group was included in the trial was the result of a manufacturing error, as the developers admitted yesterday. And because different age groups were included in the two versions of trial—one in the United Kingdom and one in Brazil—the results of this trial are clouded even further.

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According to Bloomberg, AstraZenica will now likely conduct an additional global trial to evaluate the efficacy of its covid-19 vaccine.

“Now that we’ve found what looks like a better efficacy we have to validate this, so we need to do an additional study,” said AstraZenica CEO Pascal Soriot, as quoted by Bloomberg. The pending trial will probably be another “international study, but this one could be faster because we know the efficacy is high so we need a smaller number of patients.”

This vaccine, known as AZD1222, uses a virus taken from a chimpanzee. The virus, technically an adenovirus, is harmless and incapable of self-replication, but it’s still capable of infecting a cell. And because it’s equipped with genetic instructions for churning out coronavirus surface proteins, it prompts the desired immune response to fight covid-19.

In the wake of the encouraging test results, AstraZeneca said it could produce 3.75 billion doses in 2021. Vaccine AZD1222 is particularly promising in that it’s relatively inexpensive to produce, and it can be stored in a regular refrigerator (unlike two other promising vaccine candidates, one from Moderna and one from Pfizer, that will require extreme cold storage).

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When the AZD1222 phase III trial first began, both the U.K. and Brazil groups were supposed to get a full initial dose, called the prime dose, followed by a booster dose around 30 days later. As the U.K. version of the study unfolded, however, the researchers noticed that the vials were only half full, the result of an unexplained manufacturing error.

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This meant that people participating in the U.K. trial had been receiving half of the required dose for the prime shot. Instead of calling it quits or excluding these half-dose people from the trial, the team decided to alter the study protocols, which they did after consulting with regulators. The updated protocol involved a half prime dose and full booster dose for participants in the U.K., and a full prime and full booster for participants in Brazil. In total, 2,741 participants were in the low dose group, and 8,895 were in the full dose group.

Unexpectedly, the vaccine worked better in the low dose group, at 90% efficacy, while the full dose group exhibited 62% efficacy. For some strange reason, however, the developers declared 70% efficacy, which doesn’t make any sense, as that figure now seems completely spurious.

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“You’ve taken two studies for which different doses were used and come up with a composite that doesn’t represent either of the doses,” David Salisbury, an associate fellow at the Chatham House think tank, told the Associated Press.

To further complicate the matter, no one in the low dose group was over the age of 55, which wasn’t the case for the full dose group. This convolutes the results even more, as younger people tend to mount stronger immune responses to covid-19.

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There are a bunch of takeaways here, but that’s not to say this vaccine won’t be a major contributor in our fight against the pandemic. It probably will.

We’re all rooting for this vaccine to succeed, but this latest episode reminds us of the challenges involved when trying to develop medicines on accelerated timelines. Relatedly, and as this incident also shows, it’s really tough to get the dosages right. When it comes to facilitating an optimal immune response, more isn’t necessarily better, as this trial has so splendidly revealed, even if it wasn’t deliberate.

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Finally, this news, which comes several days after the initial announcement of the test results, comes to us via a press release. As it stands, the AstraZeneca and University of Oxford scientists have yet to publish their results in formal scientific paper for all to see. Until that finally happens, we’re all left guessing about their phase III trial and this apparently promising covid-19 vaccine.

Virus-Killing UV Lamps Are Burning People’s Eyes, Doctors Warn

An employee of the Chilean-Brazilian airline LATAM monitors the operation of an autonomous robot that uses type C ultraviolet light (UV-C) to clean the interior of the aircraft.

An employee of the Chilean-Brazilian airline LATAM monitors the operation of an autonomous robot that uses type C ultraviolet light (UV-C) to clean the interior of the aircraft.
Photo: NELSON ALMEIDA/AFP (Getty Images)

Ultraviolet lamps meant to kill viruses and bacteria seem to be causing unfortunate eye damage in some people. In a new paper this month, doctors report several cases where people developed inflamed corneas due to UV radiation exposure from “germicidal lamps” put in place during the covid-19 pandemic. Some of the patients weren’t even aware the lamps had been installed.

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UV lighting has gotten plenty of attention as of late, since the radiation can degrade the stability of many unwanted germs. Specialized lamps have been used in the past to control outbreaks of other potentially airborne diseases, including tuberculosis. Now many businesses and hospitals are using UV light to disinfect rooms and equipment.

The trouble is that UV radiation can harm humans, too, as anyone who’s ever gotten a sunburn well knows. Exposure to UV rays can damage both our skin and our corneas, the transparent and protective outer layer of our eye. When this happens, it causes a painful inflammation called photokeratitis.

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In this new paper, published in the journal Ocular Immunology and Inflammation, the authors describe seven cases in which people developed photokeratitis several hours after exposure to UV lamps. All the cases were seen by doctors at the Bascom Palmer Eye Institute at the University of Miami Miller School of Medicine.

Slit-lamp photography of both eyes of one patient who developed inflamed corneas after exposure to a UV lamp.

Slit-lamp photography of both eyes of one patient who developed inflamed corneas after exposure to a UV lamp.
Image: Sengillo, et al/Ocular Immunology and Inflammation

In addition to irritation and redness, some patients experienced mild symptoms such as feeling like there was something stuck in their eyes. Others experienced severe, painful burning and a sensitivity to light. In three cases, the lamps had been installed at home, while three of the patients had been exposed at work. In all these cases, the patients reported making direct contact with the lighting without eye protection (a seventh case involved someone exposed to UV lighting at a dentist’s office).

Thankfully, people’s symptoms were short-lasting following treatment—usually a combination of lubricating eye drops, antibiotics, and steroids—and most recovered completely within two or three days. But these injuries aren’t the first of their kind to be seen during the pandemic. Earlier in April, the authors noted, doctors in Hong Kong reported three similar cases in a single household.

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It’s not clear whether UV lighting has really been all that helpful during this pandemic. Enough UV radiation should be able to kill coronavirus lingering in the air or on surfaces and objects, like the protective masks used by health care workers. But the exact type of UV radiation that’s most effective at killing viruses (UV-C) is also very dangerous to people, limiting how useful this disinfection strategy can be in the real world. The World Health Organization now explicitly warns people to not disinfect themselves using UV lamps for that very reason.

“Installation of UV-C air disinfection in medical facilities requires well-trained technicians to avoid direct exposure of occupants,” the doctors wrote. “The authors caution all persons to avoid direct exposure to UV-C germicidal lamps and follow manufacturer recommendations closely.”

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While this current study isn’t intended to weigh in on the effectiveness of UV lamps for covid-19 prevention, it does reinforce why people should be careful around them at all times.

Ivanka Boldly Highlights Trump Administration’s Big Pandemic Success

Just having fun with it!

Just having fun with it!
Photo: Joe Raedle (Getty Images)

Finally, we are getting some FACTS out of the White House. Noted environmentalist and nepotistic grifter Ivanka Trump dropped some KNOWLEDGE on Twitter on Tuesday.

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The daughter of the president let it be known that greenhouse gas emissions have dropped 9.2% this year, mentioning the Environmental Protection Agency to give it some extra authority. That, folks, is a truth bomb we could all learn from, straight from the bird app to our brains. The incoming Biden administration should take notes from the plucky adviser to the current president that [checks notes] failing to address a once-in-a-generation pandemic and killing more than 250,000 Americans is a surefire way to address climate change.

The Trump administration has spent the past four years dismantling climate rules, propping up the fossil fuel industry, and otherwise terrorizing the natural world. Over the past eight months, it’s also largely neglected addressing the pandemic, propping up conspiracy theorists rather than actual scientists. So while it’s particularly rich for Ivanka to suddenly tweet about some perceived climate gain, it’s definitely on-brand with how the administration has treated the pandemic.

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It’s also on-brand to treat this as some smashing success, ignoring the huge toll of the virus on American life. Let’s talk about some more FACTS. More than a quarter million Americans have died due to a mismanaged pandemic that White House has treated as a PR problem and not a public health one, and it’s getting more dire by the day. For comparison, that’s the entire population of Reno, dead. The pandemic is projected to be a $16 trillion hit to the economy. A quarter of the people in Rhode Island can’t feed themselves right now, underscoring a national crisis; one in six Americans are facing hunger due to the pandemic. Yet talks to provide people with relief have evaporated due to Senate Republicans and no political will from Ivanka’s dad, who spent the weekend golfing rather than attend the G20 session focused specifically on the pandemic.

Of course, Ivanka is right that emissions dropped—because millions of people have no money and nowhere to go and most of those that do are afraid of getting sick with a disease that could cause long-term consequences despite the Trump administration pretending everything is fine. Transportation is the biggest source of U.S. greenhouse gas emissions, and empty roads have meant cleaner air and lower carbon pollution levels. Energy use hit its lowest level since 1989 this spring. The oil industry—another massive source of pollution—has also been in free fall because there’s no demand for its product. So sure, emissions dropped.

But the Trump administration has funded a dirty recovery that could make the “gains” in emissions cuts temporary. Globally, the dip is likely to be a “blip” of a drop, according to researchers. Touting that drop as some kind of accomplishment hearkens back to the early pandemic days and the woefully misguided the “humans are the virus” meme. Why Ivanka is re-upping it now is beyond me. Maybe she just wasn’t online much back then, which, honestly, good for her.

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Or maybe this is it, the great Ivanka climate awakening we’ve been waiting for. From the get-go of her father’s administration, anonymous sources that are totally not her have painted her as someone who really cares about climate despite her never appearing to have taken an interest publicly. A 2016 puff piece in Politico titled “Ivanka Trump, Climate Czar?” kicked it off, but the trail of nebulous, vague stories about Ivanka caring about the climate continued even into last year.

Sure, Tuesday’s tweet is the first time she has ever tweeted anything that could remotely be eschewed as her understanding the causes of climate change, let alone caring about them. And yes, it’s extremely terrible to pretend the drop in emissions due to a pandemic that has left the country in shambles while Republicans fail to put a relief package together is a good thing. But maybe she’s still working through how this caring about people and the environment thing works. Or maybe she’s just really invested in ecofascism, which seems like a logical endpoint for Republican climate policy. Luckily, she’ll have plenty of time to do just that after Jan. 20, 2021.

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Personal Responsibility Alone Is Doom

An inmate (center) works loading bodies wrapped in plastic into a refrigerated temporary morgue trailer in a parking lot of the El Paso County Medical Examiner’s office on Nov. 17, 2020 in El Paso, Texas.

An inmate (center) works loading bodies wrapped in plastic into a refrigerated temporary morgue trailer in a parking lot of the El Paso County Medical Examiner’s office on Nov. 17, 2020 in El Paso, Texas.
Photo: Mario Tama (Getty Images)

Here are three crucial numbers from the past week: 2 million, 1.2 million, and 83,782.

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They represent, respectively, the number of people screened by TSA on Friday and Saturday, the number of new covid-19 cases last week, and the number of people currently in a hospital bed for the disease across the U.S. They all represent high water marks since the pandemic began and illustrate the wild failure of the federal government, foisting the lion’s share of the pandemic response onto individuals’ actions and choices rather than taking a system-wide approach. But it’s not just responsibility that individuals are being forced to bear; individuals are left to bear the suffering. The government’s approach to a once-in-a-generation pandemic has been to largely sleepwalk through it, and more quarter of a million Americans have died. Personal responsibility alone has failed.

There are so many lessons to take away from this episode of American history, but it’s never been clearer that we need a bury the American approach to crises, succinctly summed up by journalist Amy Westervelt: “You’re supposed to bear the brunt of the problem, take the blame for causing it, and also solve it all on your own.” The acute spike of suffering we see now due to the coronavirus and the systemic failure mirrors what could be a similar but more drawn form of suffering tied to the climate crisis, if we don’t change course.

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Consider the state of the U.S. at this very moment. The entire response to the pandemic largely rests on people making “smart choices.” Americans have been tasked with making personal choices about a public health problem. The language of personal responsibility during a pandemic works as long as we can all agree to do our part for the greater public good. I choose to wear a mask to protect those around me. Yet, instead of using that premise to set up a unified national response, Republicans, led by President Donald Trump and the Fox News propaganda machine, have turned that concept on its head, telling people to do what feels best for them. Wearing masks has been at the center of that war, despite the fact that if more of us wore masks for an extended period, we could put this pandemic behind us. Thanksgiving dinner has now being coopted the same way. The CDC has told Americans to stay home, but Fox News and Republican leaders have instead turned it into more culture war fuel while preaching “personal responsibility.”

At the same time that we are all being tasked with making “smart choices,” the federal government has essentially done the opposite, abdicating all responsibility. The best way to social distance is to stay home. Yet outside the CARES Act’s one-time infusion of cash and a loans program for businesses that kept people on payroll but has now expired, there’s been next to no efforts to incentivize people to do just that. Instead, leaders pushed to fully open the economy after patchwork lockdowns that never quite beating back the virus. Republicans in the Senate have refused to consider another relief bill to match the scope of the crisis. As a result, Americans are being left to suffer alone; businesses are going under, widespread unemployment continues to persist, people are lining up for food banks in miles-long queues or even worse, dying alone in hospitals.

While Republicans are certainly the biggest perpetrators of bullshit, they’re far from the only ones. “Outdoor” dining regulations are so lacking in New York that new enclosed structures are springing up across the city as cold weather sets in for the winter. I get it, how do you keep your restaurant in business and generate income for your employees otherwise. It’s an impossible situation absent the federal government making the money machine go brrrrr to help businesses survive through the economic hardship rather than undertaking risky practices. Meanwhile, the richest people in the U.S. have made nearly $1 trillion during the pandemic, indicating that wealth has also been privatized and consolidated into just a few greedy hands.

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“The message might be that we’re still in a crisis, but the actions say we’re not, and that our roles as economic contributors eclipse our identity as human beings,” Paul Blest wrote in Discourse Blog.

This along with record-high levels of covid-19 cases and hospitalizations are the result of laissez-faire approach to the pandemic, but pale to what’s likely next. With so many traveling for Thanksgiving, we’re staring down a cross-country superspreader event that makes the Sturgis Motorcycle Rally look like small bump in the covid-19 case graph. It’s already led to the macabre line that a Zoom Thanksgiving is better than a Christmas funeral. We’re likely going to see a lot of the latter as hospitals are overwhelmed.

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All this is deeply horrifying to watch and know it doesn’t have to be this way. Seriously, look at this image from a weekend rugby match in Australia with thousands of maskless people in the stands or this indoor Yo Yo Ma concert in Taiwan attended by 4,000 people. Robust government responses work. Those countries relied on a mix of mask mandates, lockdowns, and multiple rounds of economic stimulus to help people and now are enjoying activities with relatively low risk of transmission most Americans could only dream of. In the U.S., instead of images of thousands enjoying sporting events without masks, we’re more likely to see ones of rolling morgues like those in the top image from El Paso will be needed as the virus spins further out of control.

Now consider this in the context of the climate crisis and what’s to come if we continue down this path. The American approach of individualism above all else has provided cover for those responsible for leaving us on the precipice of the worst crisis humanity faces to continue to skate. Big Oil knew about the risks of its products and lied. Fossil fuel companies also poured money into a political system so that they wouldn’t experience any threats to their hegemony as drivers of the global economy. Even as the climate crisis worsens, they’re continuing to trot out the personal responsibility playbook, asking what people are willing to do about our individual carbon footprints.

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A few people driving Priuses alone isn’t going to stop the climate crisis. Driving oil companies out of business is. But doing so also requires policies to help workers in the fossil fuel industry have a soft landing rather than just being collateral damage, similar to what should be in place now for essential workers. No amount of GoFundMe campaigns can take the place of robust federal support.

Similar support will be needed for those on the frontlines of the impacts. Nobody makes a choice to have their house burned over by a wildfire. While there are things individuals can do to reduce their risks, ultimately the climate crisis is a bigger, badder entity than any single person can fend off. Leaving those in the danger zone to fend for themselves or chalking up their loss to personal responsibility is needlessly cruel and also ignores the fact this is a crisis of systemic failures.

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The pandemic has proven beyond a shadow of a doubt that the American approach to disaster is actually a crisis multiplier, locking in more suffering. But that’s what makes it all the more important for us to learn from this. Because if we don’t, the climate crisis will eventually come for us all, exacting trillions of dollars of damage and mass, private suffering if we don’t act together and demand more from our government and the corporations most responsible.

Another Experimental Covid-19 Vaccine Seems Effective, Doesn’t Need Extreme Cold Storage

Illustration for article titled Another Experimental Covid-19 Vaccine Seems Effective, Doesnt Need Extreme Cold Storage

Image: Justin Tallis/AFP (Getty Images)

On Monday, researchers in the UK became the latest to announce promising results from their experimental vaccine candidate against covid-19. In the data seen so far, the vaccine appeared to be at least 70% effective at preventing infection from the coronavirus, though it may be up to 90% effective with a certain dosage. Its developers, which include pharmaceutical company AstraZeneca, will now submit the vaccine for review by regulatory authorities in the UK and other countries.

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The vaccine was developed through a collaboration between the University of Oxford and AstraZeneca. It works by packing genetic instructions on proteins from the coronavirus inside another, neutered virus—in this case, an adenovirus. Once introduced into the body, the dummy virus infects cells and compels them to produce these proteins (the virus is altered to be incapable of replicating itself like normal, rendering it harmless). These proteins will then hopefully provoke a strong-enough response that trains the immune system on how to fend off a real infection from the coronavirus. The vaccine is provided through two doses, taken one month apart.

The data presented on Monday is said to be from over 11,000 people given the vaccine, who were compared to a similar-size group given a control vaccine and placebo (the control vaccine protects against bacterial meningitis). The results are from two separate trials in the UK and Brazil.

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Out of these participants, 131 had developed covid-19 when the analysis was completed. Across the UK and Brazil trials, 101 people in the control group caught the infection, compared to 30 in the vaccine group. That translates to a vaccine with roughly 70% effectiveness. There were also no reports of serious illness from covid-19 in the vaccinated group, as well as no serious safety concerns confirmed to be related to the vaccine. Earlier this year, a panel of outside experts determined that there wasn’t enough evidence to conclusively link two reports of neurological illness among trial participants to the vaccine.

“Today marks an important milestone in our fight against the pandemic. This vaccine’s efficacy and safety confirm that it will be highly effective against COVID-19 and will have an immediate impact on this public health emergency,” Pascal Soriot, the CEO of AstraZeneca, said in a statement.

As with the results previewed by companies Pfizer and Moderna on their respective vaccine candidates, the data here has to be yet studied in full by the scientific community, so the news should be taken with some caution. And there are a few added quirks that will make understanding the potential for this vaccine more difficult for the time being.

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For one, people in the UK received a different dosing regimen than people in Brazil. They received half the dosage of the vaccine in the first shot, then a full strength shot the second dose. In these volunteers, the vaccine’s effectiveness was 90%, compared to 62% effectiveness in the Brazil trial.

According to the researchers, this disparity might be explained by a known limitation of these types of vaccines, which are called vector vaccines. Put simply, giving someone too high a first dose of the dummy virus could prime the immune system to defend itself too well against it, which then limits the effectiveness of a second dose given later (a similar problem is that a person’s preexisting immunity to other adenoviruses could limit an adenovirus-based vaccine’s potency). So it’s possible that the dosage used in the UK trial may be the more effective method to use going forward.

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That said, the UK data right now comes from a much smaller sample of volunteers than the data from the Brazil trial, though this gap might not be as big or exist at all by the time of a final analysis. There may also be other factors that explain the effectiveness variation, such as population-level differences between people in Brazil and the UK.

On the flip side, these results could be underselling themselves, compared to what we’ve seen from other vaccine trials. The AstraZeneca/Oxford trials were designed to look for both asymptomatic infections and symptomatic infections. This was done by asking volunteers to take weekly swab tests and also included people who felt sick enough to see a doctor and get confirmation that way. The Pfizer and Moderna trials, however, focused only on symptomatic cases where people were sick enough to want testing. It’s possible that AstraZeneca’s vaccine is overall more effective at preventing either type of infection—we just don’t have the data to know right now.

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Another unanswered question for all of these vaccines is how effective they are at preventing transmission of the virus. That’s important to find out, because someone who is vaccinated could possibly still carry enough of the virus once infected to spread it to other unvaccinated people for a brief time, even if the vaccine succeeds in keeping that person from becoming seriously ill. Given that it will take months if not years to vaccinate much of the world’s population, it’s a crucial potential risk we have to understand better. And of course, we don’t know how long any vaccine-provided immunity will last, though there are encouraging signs that natural immunity may stick around for possibly years for most people.

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Caution aside, this is yet another piece of good news for the long-term outlook of the pandemic. AstraZeneca/Oxford’s vaccine is the first of its kind to reach this stage of development, yet there are other candidates close behind. Unlike Pfizer’s mRNA vaccine, vector vaccines only need standard refrigeration, not extreme cold temperatures, to be kept viable. Moderna’s mRNA vaccine is said to have overcome this limitation, but AstraZeneca/Oxford’s vaccine is based on long-existing technology that’s expected to make mass production more affordable. The University of Oxford has said that it has plans to mass-produce the vaccine in 10 countries the moment it’s approved for use, and it has reached an agreement with AstraZeneca to provide the vaccine on a not-for-profit basis to low- and middle-income countries for as long as needed.

Early reports suggest the UK may dole out an emergency approval for the vaccine as early as next week, with India following close behind. In the U.S., meanwhile, the Food and Drug Administration has now scheduled December 10 to have an advisory committee look over the data from Pfizer and possibly Moderna’s candidate and recommend whether they should get emergency approval. If all of this goes well, the first batch of covid-19 vaccines could start to reach high-risk members of the public, such as health care workers, by year’s end.

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Food Delivery Worker Dies in Australia, Becoming Fifth Gig Economy Death Since September

File photo of a food delivery rider driving past a Chanel store on October 26, 2020 in Melbourne, Australia.

File photo of a food delivery rider driving past a Chanel store on October 26, 2020 in Melbourne, Australia.
Photo: Asanka Ratnayake (Getty Images)

Another Uber Eats delivery worker in Sydney died on Monday evening, local time, after his bike was hit by a truck, according to the Sydney Morning Herald. The unnamed man is the fifth death of an app-based delivery worker in Australia over the past two months, prompting questions about the safety of gig economy workers and what’s owed to the families of people who die on the job.

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The man was reportedly hit by a truck in the Sydney suburb of Surry Hills and emergency workers arrived at the scene around 6:40 p.m. local time, 2:40 a.m. ET. The truck driver was taken to a local hospital for tests, which are standard in Australia after a serious incident on the road.

The news follows at least four other deaths of gig economy workers in Australia rover the past two months, all of whom were immigrants.

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  • Bijoy Paul, 27, died on November 21 near Sydney while delivering a McDonald’s order for Uber Eats. Paul, originally from Bangladesh, was in Australia working on a masters degree and was killed while riding a bicycle.
  • Chow Khai Shien, 36, died on October 24 while delivering food in Melbourne for the app DoorDash. Chow was driving a motorized scooter when he was struck and killed by a woman who was allegedly driving a stolen car, according to the Guardian. Chow, like many delivery drivers, had worked for multiple apps, including Uber Eats. Chow is originally from Malaysia and his family back home became suspicious after they didn’t hear from him in over a day. Chow’s sister has been in touch with DoorDash, according to a recent podcast episode of the Guardian’s AM, but haven’t come to terms about financial compensation.
  • Xiaojun Chen, 43, died on September 29 while delivering food in Sydney for the Chinese-based app Hungry Panda. Chen’s motorcycle collided with a bus and the bus driver has subsequently been charged according to the Sydney Morning Herald. Chen had a wife and two children, though they are ineligible for compensation because delivery apps classify their workers as independent contractors. A GoFundMe crowdfunding page was started for the family and has raised over $50,000.
  • Dede Fredy, 36, died on September 27, three days after he was hit while delivering an order for Uber Eats. Fredy, originally from Indonesia, was sending money to his family back home in what’s become a tragically common story for app-based delivery workers in Australia.

Local unions have called for app-based workers to receive more protections from Australian labor laws, and countless people have pointed to the disproportionate number of immigrants who are dying on the job. Students and other immigrants from overseas, like Bijoy Paul, have not been eligible for the Australian government’s financial assistance that’s been made available to citizens during the covid-19 pandemic. Financial strain has forced many to look for part time work in a struggling economy.

Uber did not immediately respond to a request for comment early Monday. We’ll update this post if we hear back.

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FDA Issues Emergency Use Authorization for Regeneron Monoclonal Antibody Cocktail

An attending physician listens to the breathing of a patient who is recovering after admission to an intensive care unit in the coronavirus patient nursing department of The HMC Westeinde Hospital in The Hague on April 4, 2020.

An attending physician listens to the breathing of a patient who is recovering after admission to an intensive care unit in the coronavirus patient nursing department of The HMC Westeinde Hospital in The Hague on April 4, 2020.
Photo: Remko de Waal/ANP/AFP (Getty Images)

The Food and Drug Administration on Saturday issued an emergency use authorization to Regeneron for its covid-19 monoclonal antibody cocktail, which is made up of the antibodies casirivimab and imdevimab, citing a reduction in hospitalizations and emergency room visits in patients in a clinical trial as well as a reduction in viral load.

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Monoclonal antibodies, which are used to treat other conditions such as cancer or autoimmune disorders, are antibodies created from a single cell and cloned in a lab. They are based on the antibodies naturally created by the body’s immune system, although they are often modified for efficacy and safety. In this case, the casirivimab and imdevimab cocktail is directed against the spike protein in SARS-CoV-2 and is designed to block the virus’ attachment and entry into human cells.

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In its authorization, the FDA stated that Regeneron’s treatment could be used to treat mild to moderate covid-19 in adults and kids aged 12 or older (with a weight of at least 88 pounds) who are at high-risk of developing a serious case of the disease. Casirivimab and imdevimab must be administered together via an IV infusion.

The FDA said it based its decision to issue the emergency authorization for the treatment on the data from a randomized, double-blind, placebo-controlled clinical trial of 799 patients. The patients were not hospitalized and had mild to moderate covid-19 symptoms. It’s worth noting that Regeneron’s most famous patient is President Donald Trump, who received the cocktail shortly after he was diagnosed with the disease after months of reckless behavior.

In the clinical trial, patients were divided into three groups. One group of 266 people was given 2,400 milligrams of the cocktail; another group of 267 received 8,000 mg of the cocktail; and a third group of 266 received a placebo. The treatment was administered within three days of receiving a positive covid-19 test. According to the FDA, viral load reduction in patients given the cocktail was larger than those given the placebo on day seven. The agency highlighted, however, that the most important evidence that suggests the cocktail could be effective was the resulting visits to the hospital and emergency room within 28 days after treatment.

On average, only 3% of patients at high-risk for severe illness that had received the cocktail went to the hospital or emergency room within that time frame, the FDA stated, compared to 9% of the patients treated with the placebo. The effects on viral load and reductions in hospitalizations and emergency room visits was similar for patients that received either dose.

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Dr. Stephen Hahn, the FDA commissioner, said in a statement announcing the authorization that monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on the country’s health care system. On Saturday, with at least 83,227 new covid-19 hospitalizations, the U.S. broke its record for hospitalized patients with covid-19 for the 12th straight day, per CNN.

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Other highlighted the fact that medical professionals had yet another tool to use against the virus.

“The emergency authorization of these monoclonal antibodies administered together offers health care providers another tool in combating the pandemic,” said Dr. Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research, in a statement. “We will continue to facilitate the development, evaluation and availability of covid-19 therapies.”

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The Regeneron antibody cocktail is the second monoclonal antibody treatment to receive authorization by the FDA this month. Nearly two weeks ago, the agency issued an emergency use authorization to Eli Lilly for bamlanivimab, which also targets SARS-CoV-2’s spike protein. In that authorization, it cited an interim analysis of a clinical trial in which patients receiving the treatment saw reduced hospitalizations and emergency room visits.

Nonetheless, the Regeneron antibody cocktail is not for everyone. It is not authorized for use in patients who are hospitalized; require oxygen therapy due to covid-19; or use chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to covid-19, the company affirmed in a press release.

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In fact, Regeneron found that hospitalized patients had not benefitted from its cocktail. It added that monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients on high flow oxygen or mechanical ventilation due to covid-19.

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Regeneron has received hundreds of millions of dollars from the U.S. government to development and manufacture its treatment. As part of the agreement, the company aims to provide the government with treatment for approximately 300,000 patients—which will be given at no cost to patients, although health care facilities may charge administrative fees—by the end of January.

There’s a big problem, though. According to the Centers for Disease Control and Prevention, the U.S. reported roughly 1.1 million new cases in the last seven days. Although having another tool to use in the pandemic is welcome news, it won’t be of much help if we continue to break records in cases and hospitalizations. As we marvel at the advances of science, let us also do our part to stop the spread.

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