March 2022 – Page 24

Solar farms are often bad for biodiversity — but they don’t have to be

Posted on March 23, 2022 by bamdj

Every several years — sometimes just once a decade — when the rains come in just the right amounts and at just the right times, rare flowers speckle the Mojave Desert in California. Some, like the Barstow woolly sunflower, emerge from plants no larger than a thumbnail. They spring forth from seeds that have persisted in the dry soil for years, waiting for just such a sporadic event.

In these brief “super-blooms,” the desert floor looks “like a carpet of wildflowers unfurled across the landscape,” said Karen Tanner, a researcher at University of California, Santa Cruz. The quick flash of flora helps replenish the seeds for future generations.

At other times, large sections of this deceptively fragile ecosystem look “like the moon,” Tanner said. Which, under the punishing sun, makes it seem like an ideal place to build large solar installations. Swaths of the desert, which spans four states, have already been converted to solar facilities, and more are on the way — in the Mojave and across the US. More than 4,600 square miles of land is projected to be covered by solar installations by 2030.

A massive expansion of solar electricity is a crucial part of US plans to reach 80 percent renewable energy by the beginning of the next decade. This is essential to cutting carbon emissions and slowing catastrophic climate change — which poses a dire threat to plants and animals the world over, humans included.

But the race to erect large-scale, maximally efficient solar operations could hurt local ecosystems if operators aren’t careful. Based on her research, Tanner suspects many of these solar projects as they are traditionally executed are causing more local harm than some realize. She has spent nearly a decade closely studying — often on hands and knees with a magnifying glass — experimental solar plots in the Mojave, all located within six miles of four large solar installations. Her most recent findings, published earlier this year, have noted that solar panels changed the immediate microhabitat and had a detrimental impact on rarer plants, such as the Barstow woolly sunflower.

One thing is clear to her: “It’s just not enough to do one survey in one year and be like, ‘Oh yeah, there’s nothing here. Go ahead and install the infrastructure,’” she said.

Solar doesn’t have to be a zero-sum game that prioritizes either clean energy or biodiversity, scientists told Vox. Many projects and studies are currently looking for ways that solar installations can better protect — and potentially even improve — local ecosystems, along with the bottom lines of operators and even nearby landholders like farmers. These solutions can be as simple as prioritizing native plants or picking a location that’s already been disturbed by humans.

The darker side of solar

Solar installations, on the scale needed to supply power grids, are massive by necessity, transforming the lands where they’re located into a new kind of built environment. They can alter everything from sun exposure to moisture to surface temperatures. This can have unintended and unexpected impacts on local plants, animals, and even the area’s microbiome.

Photovoltaic panels shade the land while blocking some areas from rainfall and dousing others with heavy runoff. This changes the growing conditions for plants, with implications for other connected species. The other prominent form of solar, concentrating solar — in which mirrors focus the sun’s rays — generates so much heat that it “can incinerate insects and burn the feathers of birds that fly through,” Jeffrey Lovich, a research ecologist with the US Geological Survey who studies the environmental impacts of these installations, wrote to Vox.

In areas like the US Southwest, solar installations appear to contribute to bird mortality. Scientists aren’t entirely sure why this is, but one prevailing idea, known as the “lake-effect” hypothesis, is that migrating waterfowl making their way through the arid landscape mistake the installations for bodies of water and crash into them.

Large solar facilities in particular can also fragment important wildlife habitat or migration corridors via fences and landscape alteration, and can restrict gene flow for animal as well as plant populations.

Operators of these installations are generally keen to cut the costs of construction and maintenance, so most solar facilities replace the existing land cover with graded packed dirt, gravel, or mowed grass, further harming local biodiversity. “‘Blade-and-grade’ site prep that removes all vegetation clearly has a negative effect on biodiversity,” Lovich said. He expects mowed grass would “stress plant communities and the animals that use them.”

Many of the impacts remain unknown. It’s often difficult for researchers to gain access to solar facilities and the environmental data they collect — “even though the majority of facilities are situated on publicly owned lands,” Lovich and colleagues noted in a 2017 paper.

But it’s possible to dial down the potential harms of big solar farms. The type of solar infrastructure — whether concentrated solar or photovoltaic, and whether panels are fixed or rotating, high, or low — affects the potential downsides of large-scale installations. So does the nature of the landscape itself.

How solar can help native plants and crucial pollinators

Some solar operators are reimagining their facilities as prime protected habitats for native plants, bringing back key local species and potentially improving lands that humans have already disturbed. “Solar can be a net benefit in terms of restoring a native habitat and improving ecosystem services, like storm water control and carbon storage and sequestration,” said Leroy Walston, a landscape ecologist with Argonne National Laboratory who studies the relationship between renewable energy and the environment.

One in-vogue mitigation measure is pollinator-friendly foliage. At one experimental solar installation in Minnesota, pollinator-friendly plants helped boost energy yields a tad (by making the microclimate a touch cooler) and slightly reduced long-term maintenance costs (due to less-frequent mowing), according to a 2019 analysis from the Center for Business and the Environment at Yale University. The report also noted bigger wins: The plants helped reduce erosion, increasing groundwater stores and bolstering crop yields.

Experts have brought up concerns that solar operators will use a few flowers to green the image, but not the substance, of their operations. To help prevent this, some 15 states now have pollinator-friendly solar scorecards that aim to measure the actual impact of solar projects on the crucial creatures that carry pollen from plant to plant.

“They are voluntary, but they do help solar facilities to attain an objective certification that they’re pollinator-friendly, that’s been helpful to encourage some use of pollinator habitat at solar facilities,” said Heidi Hartmann, a colleague of Walston who works as a program manager for land resources and energy policy at Argonne. For example, the California renewable electricity provider MCE is now asking its facilities on arable land to use “reasonable efforts” to hit a certain score on these pollinator tallies.

Walston calls for an even broader approach to solar — one that focuses not only on bees and butterflies, but on native habitat restoration overall. Native plants are keenly tuned to the local environment, thriving in specific climate conditions, improving soil retention, and often benefiting the widest range of other area species, in ways non-native, flashy pollinator species might not.

Hartmann and Walston have modeled the impact of switching from maintained grass to native plantings. They found that in the US Midwest, native plants would bring in three times the number of pollinators. They’d also boost the carbon storage potential of the soil by 65 percent and would be more effective, once established, at keeping weeds at bay, which could reduce the need for harmful herbicide use.

“The equation is complex,” said Alyssa Edwards, vice president of environmental affairs at solar producer Lightsource BP, about the company’s impact on local habitats. Lightsource advertises itself as protecting ecosystems and boosting biodiversity. “Pollinator habitat, considerations of seed availability, vegetation height, insurance requirements, fire risk, and cost all come into play. Not to mention that pollinator habitat may not be the right choice for all sites, as other initiatives may be more valuable contributions to sustainability.” The company, a joint venture with the oil and gas giant BP, says it’s working on various solar projects that incorporate pollinator habitat, conservation of short-grass prairie land, and even animal grazing.

Wildlife corridors are another way solar installations could help support biodiversity. But for large sites to become a part of corridors, they may require substantial adjustments to fencing and other built infrastructure (and even then, they’d probably pose barriers to some larger species).

As more sites incorporate biodiversity as a benchmark, the devil is in the details. Tanner and others have found that solar panels can actually increase the number of plant species that grow beneath them, especially in harsh environments like the desert. However, some of these additional species are invasive or threaten to outcompete the smaller, rarer native ones that could tolerate such extreme desert conditions.

These kinds of wrinkles make it all the more important that scientists and operators actually measure their impact on ecosystems — that they’re “pausing for a moment and considering what sort of species we are considering that are making up the diversity,” Tanner said.

Build solar on lands that humans have already messed with, one expert says

Solar operators tend to look for new sites based on sun and climate conditions, but also proximity to the existing power grid — and a utility company in the market for their energy. Scientists told Vox that firms should also look for places that humans have disturbed, because the local ecosystem may have less to lose.

Lovich suggests siting more solar farms on “brown fields, roof tops, abandoned agricultural fields, dry lakes, and even airports — where wildlife are unwanted.” They’re also well-suited for canals and human-made reservoirs, where they’re sometimes called “floatovoltaics,” not least because they can slow water loss by evaporation. These less-conventional arrangements may have higher up-front costs, but the eventual environmental costs will be lower.

Building on an ecologically sensitive site can also be costly. Take for example BrightSource Energy, which spent at least $56 million relocating threatened desert tortoises from its Ivanpah solar development site in the Mojave Desert. Although these efforts allowed the project to go through, scientists are still learning about the consequences. An early study found that the relocated tortoises needed more time and effort to settle into normal movement patterns, potentially exposing them to additional threats. But as Lovich pointed out, “since tortoises are long-lived, results for the long term are not yet available.”

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Such experiences have not deterred other desert sun-seeking operations. “Solar farms are operating or planned in excellent tortoise habitat affecting hundreds to thousands of tortoises,” Lovich said. Simply moving the tortoises — pricey as it may be — is not a sure cure. “Translocation has a checkered history of success,” he said.

Lovich is currently studying the impact of the Gemini Solar Project in Nevada, which would cover 11 square miles of publicly owned tortoise habitat and is home to hundreds of these long-lived, vanishing animals. For this project, the plan is to capture the animals, place them in a holding center for up to two years during construction, and then release them into the facility grounds “to see how they fare,” Lovich said.

“All energy sources will come with a cost to some wildlife,” Lovich and his colleagues noted in a 2020 paper. “The best mitigation strategy is to avoid developing sensitive and pristine areas.”

Other landscapes would not only tolerate solar farms, but could benefit from them. For example, a pollinator-friendly solar installation could add yield for farmers whose soy, citrus, almonds, cotton, or alfalfa needs some pollination help. More than 500 solar facilities already exist within easy buzzing-distance — less than a mile — from these crops in California, Massachusetts, and North Carolina, respectively, according to a 2018 study by Walston, Hartmann, and their colleagues. Nationally, more than 1,350 square miles of cropland would benefit if existing solar installations added pollinator-friendly plants, they concluded.

As solar has moved into lands that could otherwise be farmed, it has caused some tension with local residents. But solar farms and actual farms don’t necessarily need to be in opposition. It’s possible to co-locate solar and crops into “agrivoltaic systems,” which can feature grazing grass, corn grown for biogas, and even lettuce and tomatoes that may flourish under solar panels. Other crops could even be grown under semi-transparent solar panels.

Solar can protect plants and animals while it helps the planet

Redesigning solar developments — and steering them to the places where they won’t cause harm — isn’t easy. Maximizing energy output means finding locations with the right combinations of sun, temperature, wind, and humidity (one study pegged the best spots as croplands, grasslands, and wetlands) and packing solar-harvesting devices as densely as possible. All of these often work at cross-purposes with supporting a diverse range of plant and animal species.

Additionally, permits for these facilities are typically done at a very local level. (President Barack Obama had instructed these sorts of projects on federal lands to have a mitigation strategy — an order that President Donald Trump struck down his second month in office.) So it’s a patchwork of different levels of regulations and approval processes, some of which are more in tune with thoughtful evaluation of sites and long-term impacts. There is “more education that can be done at local government levels,” Hartmann said.

Without more thorough before-and-after research, we may remain in the dark about how these large facilities are changing the landscapes they cover. If site evaluations are performed over a relatively brief period of time — such as a single season in the run-up to the construction of a solar farm — operators could easily miss key aspects of biodiversity, like the Barstow woolly sunflower, which waits for just the right pattern of rare desert rain to emerge.

“We’re just starting to scratch the surface and determine how different organisms are likely to respond” to solar, said Tanner, the UC Santa Cruz researcher. For now, it behooves us to mess with their environment as little as possible, she noted, and to preserve as much as we can. “Especially in a context of climate change, we don’t know what species are going to be able to pass through that aperture in the future.”

As the world barrels toward climate catastrophe, scaling up carbon-neutral energy production as quickly as possible couldn’t be more urgent. “We need all the help we can get, and we need to move quickly,” Tanner said. On a planetary scale, clean electricity can help safeguard all species, and could arguably be worth the trade-off if it harms a few local species in the process.

But maybe there doesn’t need to be a trade-off, Tanner suggested. “I’m not sure it’s an either-or question,” she said.

Astronomers were skeptical about dark matter — until Vera Rubin came along

Posted on March 23, 2022 by bamdj

Vera Rubin didn’t “discover” dark matter, but she put it on the map.

Dark matter is a wild concept. It’s the idea that some mind-boggling percentage of all the matter in the universe may be invisible, and wholly unlike the matter that makes up Earth. Rubin is celebrated because she forced much of the astronomy community to take it seriously.

That reckoning moment came in 1985, when she stood in front of the International Astronomical Union and walked the audience through some of the data she had collected.

Her data showed that stars at the edges of multiple galaxies were moving in ways that didn’t make sense, according to the rules of physics. One possible explanation for this strange phenomenon, Rubin suggested, was the existence of a mysterious “dark matter” at the edges of the galaxy. In the decades since that talk, research into dark matter has exploded, revolutionizing astronomy.

In Bright Galaxies, Dark Matter, and Beyond, a new biography of Rubin, science journalist Ashley Yeager explains how Rubin, who died in 2016, grew from a young researcher whose bold ideas were initially ignored into the kind of scientist who could change an entire field. In 2020, we interviewed Yeager for an episode of the Unexplainable podcast about dark matter. A transcript of our conversation, lightly edited for length and clarity, follows.

Noam Hassenfeld

When did Vera Rubin first get interested in astronomy? What’s her origin story?

Ashley Yeager

About the age of 11 is when she started to look at the stars. Vera and her sister, Ruth, shared a bedroom in their Washington, DC, townhouse. And Ruth remembers Vera constantly crawling over her at night to be able to open the windows and look out at the night sky and start to track the stars. So clearly, Vera was captivated by the night sky. And that stuck with her.

She then went to Vassar, where she studied astronomy. [While at Vassar, she met a mathematician named Robert Rubin.] They ended up getting married. And that drove one of the biggest decisions in Vera’s life, because she wanted to go to graduate school for astronomy.

She’d gotten into Harvard, but Robert Rubin was at Cornell. He was well into his graduate studies. They had to make a choice, and Vera said, “Let’s stay together. I’ll come to Cornell with you and I’ll do my master’s in astronomy while you finish your PhD in physics.”

Noam Hassenfeld

Isn’t that kind of a wild choice? To choose Cornell based on a husband?

Ashley Yeager

It’s the late 1940s. And Vera, in some ways, was very traditional, even though she was nontraditional in other ways. She felt that she was expected to get married by the end of her four years at Vassar. That was still something that was societally kind of expected.

And I actually think it set her up to be more successful than maybe she would have been, had she gone to Harvard or Princeton or somewhere else, just because of the exposure that she got. There was intellectual freedom she had at Cornell, to be able to probe into different questions in astronomy that she probably would have been pushed away from, had she been in a more structured graduate program.

Noam Hassenfeld

So she’s at Cornell. She’s probing into questions. She’s got a lot of intellectual freedom. What are the big questions that are occupying her mind?

Ashley Yeager

The biggest one, which becomes her master’s thesis, is really the idea of “Does the universe rotate?”

Noam Hassenfeld

Wait, does the universe rotate?

Ashley Yeager

So, probably no. This was a question posed by a very eccentric astronomer named George Gamow. Vera’s husband actually showed Vera this paper that George Gamow had written about this idea. And she thought, “Well, why would we not try to answer that question?”

Noam Hassenfeld

The kind of question that, if she were at another university, maybe she wouldn’t have had the freedom to dive into?

Ashley Yeager

I think so. I get the sense, reading through the literature and looking through the history, that she probably would have been guided to a more traditional question.

And as she started to look through the data, the numbers started to suggest that there was this odd, sideways motion that perhaps could be interpreted as a universal rotation. She presented her idea to her master’s thesis adviser, William Shaw.

He says, “Your conclusion is really good. I want to present it under my name at this upcoming astronomy conference.”

And Vera is like, “No! I might not be a member of this society yet. But you’re not presenting my data for me. I’m going to present it under my own name, come hell or high water.”

Noam Hassenfeld

So does she?

Ashley Yeager

Yes. She goes to this meeting. Apparently, the drive from New York to Pennsylvania, where the meeting was, was harrowing. It was the winter, snowy. They had a newborn in the car. Her dad was actually driving because he was the only one with a car at the time.

But she gives the presentation, and the reaction is less than great. There are some heavy critics in the room. A lot of scoffing. She does have one person, Martin Schwarzschild, who encourages her. He says, “This is really interesting. But we need more data to be able to make this conclusion.”

And that’s a criticism that really sticks with her throughout her career. Later on, she really tries to have or collect as much data as possible to support her conclusions, just because of that experience.

Noam Hassenfeld

What happens next?

Ashley Yeager

She takes a little bit of a break, because she really has this strong sense of wanting to set up a home and start a family. There’s this moment in the early 1950s, when she’s at the playground with her son. She had been reading astrophysical journals to stay connected with what was going on in astronomy.

So her son’s playing in the sandbox and she’s reading the journal, and she just breaks into tears because she misses doing research so much. She misses that curiosity of asking questions and searching for data, and really trying to figure out the answers to how the universe works.

It’s at that point that her husband says, “You need to go back to school. It’s time. We’ll figure out child care. We’ll figure out how to get dinners made. But let’s do it.”

Noam Hassenfeld

So she goes back into astronomy. And eventually she starts doing research at Kitt Peak National Observatory, right? What’s that like?

Ashley Yeager

We’re talking late 1960s. This is a 84-inch telescope, very large. Vera is at the telescope with Kent Ford, her collaborator. They’re looking at this galaxy called Andromeda, which is our nearest neighbor. They’re looking at these really young, hot stars on the edge of the galaxy, and they’re trying to get the speeds of these stars — how fast are these stars going around Andromeda?

So they’re looking at the data, and they’re going, “Oh my gosh, this is not what we expected.” The assumption was that the stars closer in would fly around the sun fast, and the stars farther out would go super slow. But these stars were moving faster than they expected.

The only way for those stars far out in the galaxy to move that fast is [that] there’s got to be something happening out there that we don’t understand.

Noam Hassenfeld

What does she think is going on?

Ashley Yeager

Well, she’s not really sure. And again, she doesn’t like to make assumptions or speak without data. So she and Kent Ford, and a couple other people, they really start to do a systematic study of galaxies.

She does 20 galaxies, and then 40, and then 60. And they all show this bizarre behavior of stars, these stars out far in the galaxy, moving way, way too fast. So at that point, you know, the astronomy community is like, “Okay, we have to deal with this.”

In 1985, Vera Rubin gives this talk at the IAU. She says, “Nature has played a trick on us. That we have been studying matter that makes up only a small fraction of the universe. The rest of the universe is stuff that we don’t understand, and we can’t see it.”

And I think because she did this in so many galaxies — we’re talking 60 galaxies — there was really no denying it. It was really her work that pushed the community over the edge, to say we have to accept the idea that dark matter exists.

Noam Hassenfeld

It sounds like if you really want to upend our entire conception of the universe, you have to come with some data.

Ashley Yeager

Yeah, absolutely. Because she held onto that criticism of her master’s and PhD work — she would just go after the data, and really make sure that the story she told from that data rang true.

One of the things that made her a remarkable scientist is her perseverance. She did face a lot of roadblocks, especially because she was a woman in science in the 1940s, 1950s, 1960s. She had to really persevere. Unfortunately, she will never get to see or know what dark matter is. But I don’t know that she had a problem with that. She would take pride in the fact that she opened a whole new realm of astronomy and physics.

She basically created more questions than answers, and I think that’s the mark of a remarkable scientist: when you open up these questions that no one ever thought of before. When you create a whole new generation of scientists who can go and answer them.

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What we actually know about the vaccines and the delta variant

Posted on March 23, 2022 by bamdj

The Covid-19 pandemic has changed, and with it, so has the effectiveness of the vaccines.

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The bottom line remains the same: The mRNA vaccines from Pfizer/BioNTech and Moderna that are most prevalent in the US are still quite effective in preventing any illness from the novel coronavirus, and extremely effective in preventing the kind of severe illness that leads to hospitalization and death. On Wednesday, the Centers for Disease Control and Prevention confirmed those basic facts with its most robust data yet.

But the statistics that were widely publicized when those vaccines were first approved in December — the ones that showed vaccines were 95 percent effective in preventing all illness and 100 percent effective in stopping hospitalization or death — are now thoroughly out of date. The risk that a vaccinated person would experience symptoms if they contract Covid-19 is higher than it was back then, even if it is still significantly lower than if the person were unvaccinated. The now-dominant delta variant is likely to blame.

So exactly how effective are the vaccines against this new, more dangerous iteration of the virus? And how long does immunity provided by the vaccines actually last?

We are finally starting to get some concrete answers to these questions. The vaccines did appear to lose some of their effectiveness in preventing any kind of illness as the delta variant became dominant, especially for people who are at highest risk from Covid-19. But the protection against severe illness held steady, according to the three CDC studies published this week.

The number of breakthrough infections is “increasing as the delta wave proceeds,” Eric Topol, director of the Scripps Research Translational Institute, told me. “But still, protection versus hospitalizations and deaths is very solid.”

With this new evidence of waning vaccine efficacy, the Biden administration announced plans this week to immediately make immunocompromised patients eligible for a booster shot and recommended that all vaccinated people get a third shot eight months after their second dose.

The new data and new guidance reflect this new chapter in the pandemic. Vaccinated people should still feel confident that they are protected against the worst outcomes from Covid-19. But the large number of unvaccinated Americans, and the delta variant’s potency, has contributed to surges in infections.

Some caution — continuing to wear masks and avoiding large indoor gatherings, for example — can help protect against the high level of spread currently in the US, experts said. Even with the powerful protection of vaccines, it’s possible to get sick after a coronavirus exposure.

We now know more than ever about Covid-19 vaccines and the delta variant

The Covid-19 vaccines were initially tested against the original version of the coronavirus, and they performed incredibly well. But delta has proven somewhat more capable of evading the vaccines and may cause more severe illness than its predecessors, based on early research out of the United Kingdom, one of the first places where delta took hold. The new CDC data is a big step forward because it brings our understanding of the vaccines closer to the present.

One of this week’s CDC studies tracked new cases and hospitalizations from early May to late July in New York. The study period covers the transition from the “alpha” variant to delta, which became dominant by the start of July, but only includes part of the recent surge in reported cases.

The vaccines grew less effective in preventing all illness as the delta variant took over, CDC researchers found. In May, vaccines had an estimated 90 percent effectiveness at preventing new cases. By mid-July, the estimated effectiveness had dropped to just under 80 percent. By that point, vaccinated people were more likely to get infected and actually feel sick. Breakthrough infections became more common.

But the vaccines have remained resilient against severe symptoms, with the estimated effectiveness against hospitalization holding steady around 95 percent from the start to the end of the study period.

“There was a reduction in vaccine effectiveness against SARS-CoV-2 infection, but not against hospitalization,” Celine Gounder, clinical assistant professor of medicine and infectious diseases at the NYU School of Medicine, told me. “The vaccines remain highly protective against hospitalization in all age groups.”

It’s important to remember that “severe” illness is a clinical term that might not align with the common parlance. A vaccinated person who becomes ill with Covid-19 might still feel very sick.

“Severe disease isn’t that you feel sick like a dog and are laid up in bed,” Gounder said. “Severe disease means your lungs are failing, your oxygen levels are dropping, and you need to be in the hospital.”

In other words, the vaccines have gotten less effective at stopping Covid-19 in its tracks but are still extremely good at protecting people from the kind of severe cases that need hospital beds or ventilators. Many patients with breakthrough infections can recover at home.

How the vaccines affect long Covid remains an open question. Preliminary evidence seems to suggest that they help alleviate (but not always eliminate) those long-term symptoms.

Why are vaccines somewhat less effective against infection than before?

The CDC researchers were careful to say the reasons for diminishing vaccine effectiveness are uncertain, but there are some things they’re confident about. The delta variant causes a substantially higher viral load than its predecessors — there is more of the virus when a person gets infected — and the sheer amount of the virus a person contracts may play a role. At the same time, people are now taking fewer precautions against Covid-19 than they were last fall and winter, the researchers said, making it more likely that they’ll be exposed to a high viral load.

Or to think of it another way: The rapid spread of delta in the unvaccinated population means vaccinated people are getting exposed to the virus more often, and being exposed to more of it than they were before.

Data from other countries shows a wide range of vaccine effectiveness against infection with the delta variant, but studies have generally found the protection is less robust than it was against the alpha variant. Still, in all cases, the vaccines available in the US continue to impress in their ability to prevent the worst outcomes.

A second CDC study examined national data to determine whether the vaccines are becoming less effective at stopping severe illness over time. Like the New York study, it found that vaccines are extremely effective — about 90 percent at preventing hospitalization due to Covid-19.

Reassuringly, there was not a meaningful difference in the vaccine’s ability to stop hospitalization as time wore on. The researchers estimated the vaccine’s effectiveness against hospitalization in two time periods: two to 12 weeks after patients received a second dose, and 13 to 24 weeks after that second dose.

They did not find a meaningful decline almost six months after patients received a second dose of the vaccine — which is very good news.

“There was no reduction in vaccine effectiveness over time,” Gounder said, “which demonstrates that protection against hospitalization did not drop over time or after the emergence of the delta variant.”

The best protection for the most vulnerable is everybody getting vaccinated

While the vaccines have generally held up well against the delta variant, some of the people most vulnerable to Covid-19 do not receive the same level of protection.

For people with compromised immune systems, the CDC researchers found that the vaccines were less effective at preventing hospitalization. That finding supported the Biden administration’s plan to make those people immediately eligible for a third shot, experts said.

For immunocompromised individuals, it’s also possible that immunity may wane more over time — but that didn’t happen, according to this research. Their level of protection appeared to be constant during the six-month period covered by the study.

The third CDC study evaluated vaccine effectiveness for nursing home residents, a population particularly vulnerable to Covid-19 and one of the first groups to get vaccinated at the beginning of this year. That study did find declining effectiveness over time against any illness for those Americans, from 75 percent pre-delta to about 50 percent post-delta.

That drop-off may partly reflect the nature of this population. Older people’s immune systems are not as strong as younger people’s; older adults already experienced a lower baseline vaccine effectiveness rate than the general population before delta took over (75 percent versus 90 percent). The decline also probably reflects the basic fact that the delta variant is better at evading the vaccines than the alpha variant was.

“It makes sense to give an extra dose of vaccine to vaccinated nursing home residents,” Gounder said. “But what will have an even bigger impact on protecting those nursing home residents is to vaccinate their caregivers.”

As of late July, about 60 percent of nursing home workers had been vaccinated, substantially lower than the 80 percent rate among residents. The Biden administration announced on Wednesday that it would require nursing homes to mandate all their workers be vaccinated if the facilities want to receive federal health care funding.

Over the long run, so long as a substantial portion of the US population remains unvaccinated, there will be risks to everybody. Currently, 72 percent of the 18-and-over population and 60 percent of the entire US population are vaccinated, according to the New York Times tracker. That leaves millions of people without protection against the virus. Some of them are children not yet eligible for the vaccine, but millions of people who are currently eligible and could receive the vaccine for free still haven’t done so.

“Your risk depends on your vaccination status and what’s happening in your community,” Gounder told me. “Vaccines aren’t an immunity on/off switch for individuals. Vaccines work additively and synergistically across populations.”

Gounder deployed some hypothetical math to explain how risk works under different vaccination scenarios. If a country has a baseline of 1 million “units” of risk for each person, because the virus is very widespread, a 95 percent effective vaccine would reduce that risk to 50,000.

But if the baseline risk is 100, because the country contains the virus through vaccinations and mitigation measures, the vaccinated person faces just 5 units of risk. That huge difference in risk depends on how rampantly the virus is spreading in the overall population.

“This isn’t about individualism, individual rights, individual responsibility, and individual protection,” Gounder said. “This is about community immunity.”

How a cheap antidepressant emerged as a promising Covid-19 treatment

Posted on March 23, 2022 by bamdj

Since Covid-19 patients started showing up at clinics and hospitals a year and a half ago, doctors and researchers have been hard at work trying to figure out how to treat them. Most drugs and treatments haven’t panned out, producing either no results or small ones in large-scale clinical trials. Many of the few that work are expensive and difficult to administer.

Hydroxychloroquine, enthusiastically endorsed by President Trump last year, has been shown to have no measurable benefits. New drugs like monoclonal antibodies — proteins meant to imitate the immune system’s response to the disease — have been approved by regulators but must be administered by a doctor through an IV or series of injections.

But scientists haven’t stopped searching, and the results of a new massive clinical trial suggest they’re getting somewhere. In a large, randomized clinical trial conducted with thousands of patients over the past six months, researchers at McMaster University tested eight different Covid-19 treatments against a control group to figure out what works.

One drug stood out: fluvoxamine, an antidepressant that the Food and Drug Administration has already found to be safe and that’s cheap to produce as a generic drug.

These new results follow some promising findings in small-scale trials last year. In those smaller studies, researchers found that fluvoxamine was strikingly good at reducing hospitalization for Covid-19 patients — but small-scale trials can sometimes turn up spurious good results, so those findings were obviously tempered by a lot of caveats.

This study, called the TOGETHER study, is a lot bigger — more than 3,000 patients across the whole study, with 800 in the fluvoxamine group — and supports the promising results from those previous studies. The authors released it this week as a preprint, meaning that it is still under peer review.

Patients given fluvoxamine within a few days after testing positive for Covid-19 were 31 percent less likely to end up hospitalized and similarly less likely to end up on a ventilator. (Death from Covid-19 is rare enough that the study has wide error bars when it comes to how much fluvoxamine reduces death, meaning it’s much harder to draw conclusions.) It’s a much larger effect than any that has been found for an outpatient Covid-19 treatment so far.

“This is a huge finding,” study co-author Ed Mills, a professor of health sciences at McMaster University, told me. “The game changers are things we already had in the cupboards.”

What makes this result potentially such a big deal is that fluvoxamine is inexpensive and has already been FDA approved for obsessive-compulsive disorder (OCD), so any doctor can prescribe it for Covid-19 using their clinical judgment (what’s called “off-label” prescribing). It’s a pill, which means it doesn’t need to be administered in a hospital or by a medical professional.

To be clear, these results have just been released, and clinicians around the world will want to take a close look at them as they decide whether or not to prescribe fluvoxamine. Future research could also moderate this exciting result.

Here’s what we know: This is a large and well-designed study that affirms previous studies that pointed in the same direction. More research is needed, but the results from this trial might already start changing how we treat Covid-19. And the way researchers stumbled upon the drug as a potential treatment is a worthwhile story in itself about the scientific process and the unseen and often unheralded work that’s helping humanity fight the pandemic.

The shifting landscape of Covid-19 treatment

Covid-19 treatments fall into two categories: treatment for severe illness, generally administered in the hospital to reduce the risk of death; and treatment for the onset of illness, which hopefully reduces the odds that a patient will need to be hospitalized at all.

The FDA has granted emergency authorization to a variety of Covid-19 treatments, but the evidence base for many is limited and the effect sizes have tended to be small. Hopes were high for repurposed antiviral drugs, for instance. Many of them are routinely administered and at least one was shown to reduce the length of hospital stays, but some studies have found no effect on mortality.

The same is true of convalescent plasma, transfusions of blood proteins from people who recovered from Covid-19. After more than a year of research, it mostly looks like these treatments aren’t effective, though there’s still lots we don’t know.

The FDA has issued emergency use authorization for monoclonal antibody treatments — proteins that mimic the ones the immune system would produce to fight off the virus — for those at severe risk from Covid-19. Monoclonal antibodies are also infused intravenously or as a series of four injections. They cost $2,100 a dose, which in the US is paid by the federal government so they are free to patients. They seem to work best when given early, pre-hospitalization, and while under those conditions they appear to be highly effective. However, getting people who recently tested positive for Covid-19 and still have mild symptoms to a medical setting for an intravenous infusion or four injections is a logistical challenge — and the cost and the difficulty of delivery mean monoclonal antibodies will never be an option in much of the world.

Corticosteroids, which are powerful anti-inflammatory medicines, have a solid track record. Studies have found that administering the cheap steroid dexamethasone, which can be given as a pill or an infusion, to patients hospitalized with Covid-19 reduces their risk of death. But because it can constrain the immune system, it isn’t recommended early in the course of the disease, when the main concern is the direct damage from the virus.

That leaves a glaring hole: Where are cheap, outpatient treatments that can reduce the risk of hospitalization in the first place and don’t require a medical professional to administer in a medical setting? Fluvoxamine could hopefully fill that gap.

Fluvoxamine’s journey, explained

Fluvoxamine is an antidepressant, and in the US, it’s mostly prescribed for treating OCD. It is what is known as an SSRI, short for selective serotonin reuptake inhibitor — the same class of drugs as popular antidepressants like Zoloft, Prozac, and Lexapro.

Through an unusual journey, it ended up on scientists’ radars as a potential Covid-19 treatment — and subsequent research seems to bear that out.

Years ago, before the novel coronavirus had infected its first patient, Angela Reiersen, a psychiatrist at Washington University in St. Louis, was studying patients with a rare genetic disorder called Wolfram syndrome, which affects cellular stress responses. She noticed that they seemed to tolerate some SSRIs well and others poorly and dove into the differences in SSRI chemistry to figure out why.

It turned out that one of the SSRIs that worked well, fluvoxamine, binds to a receptor in cells that regulates cellular stress response and the production of cytokines, proteins that tell the body something is wrong and cause inflammation. Researchers at the University of Virginia found that fluvoxamine reduced inflammation in animals. Reiersen wondered if that was why it worked well for her patients.

Then the pandemic hit. One leading theory of what happens when patients suffer through Covid-19 is that cells damaged by the disease release tons of cytokines, which then causes inflammation in the lungs that can make it hard to breathe and cause lasting tissue damage. Early in the pandemic, Reiersen went to her colleagues at the Washington University School of Medicine in St. Louis with a wild idea: Fluvoxamine might help Covid-19 patients.

Eric Lenze, a leading clinical researcher, agreed they should test it with a randomized controlled trial. “I emailed him on March 25, 2020. We got the trial started by April 10,” Reiersen told me.

They spent the spring and summer recruiting and treating Covid-19 patients. By the fall, they had results: Of the 152 participants, half in the placebo group (receiving a sugar pill rather than active medication) and half in the fluvoxamine group, six patients in the placebo group had met their study’s threshold for respiratory difficulties. None in the fluvoxamine group had.

The results were published in the Journal of the American Medical Association. “What I think is the most supported mechanism is an anti-inflammatory effect,” Reiersen told me. “Fluvoxamine can reduce the level of these chemicals called cytokines, which are involved in inflammation, so you’d get less damage in the lungs.”

The results were promising, but 152 patients isn’t that many. Reiersen and Lenze started recruiting for a larger-scale trial, looking for more evidence that fluvoxamine could be a first-line Covid-19 treatment.

In the meantime, evidence was coming in from other angles, too. After a mass outbreak in California, researchers gave affected people the option to take fluvoxamine; 65 people opted to take it and 48 declined. None of those who took it required hospitalization, while six did among those who declined it.

In France, Nicolas Hoertel, a psychiatry researcher at the University of Paris who is not affiliated with the TOGETHER study, had conducted and published an observational study finding that patients on certain antidepressants were less likely to have severe Covid-19. “This effect is not just fluvoxamine, but it’s not all antidepressants,” he told me.

Observational studies don’t assign patients a specific treatment but just record what treatment they receive and how well they do. They don’t involve randomization, so they can be misleading if, say, people on antidepressants are systemically different from people not on antidepressants or if people who agree to try an experimental medication are healthier than people who refuse. So the results from these studies couldn’t be taken as definitive — but it was additional data.

The limited, promising literature around fluvoxamine prompted its inclusion in the large-scale study of treatments for Covid-19 run by Ed Mills at McMaster University and primarily conducted in Brazil. Dubbed the TOGETHER study after other prominent mega-clinical trials like RECOVERY and SOLIDARITY by other organizations, it randomized patients across eight prospective treatments, including metformin (a diabetes medication), hydroxychloroquine (an antimalarial), and ivermectin (an antiparasite).

The team announced their results at an August 6 symposium that was sponsored by the National Institutes of Health. Most of the treatments failed: Their study couldn’t detect an effect. “A lot of drugs against Covid just don’t work very well,” Mills told me. Two other treatments were still in progress, and it was too early to rule out the chance that they’ll work.

But fluvoxamine was a different story. In the trial, it improved patient outcomes substantially — and while it’s not the first drug to do that, ease of delivery and price give it the potential to have an outsized impact on patient care, especially outside the rich world.

Do we know enough to recommend fluvoxamine to Covid-19 patients?

In the research conducted so far, fluvoxamine was prescribed to patients who started experiencing Covid-19 symptoms.

In the TOGETHER study, they typically visited a doctor to enroll in the trial — and start taking medication or a placebo — three days after their symptoms began.

The results of the study are strong enough that researchers are suggesting changing clinical practice to recommend fluvoxamine to people with symptomatic Covid-19.

“We have now growing evidence from different kinds of research — technical, clinical — indicating that [treatment with certain antidepressants] is very likely to be effective in Covid,” Hoertel said. “The likelihood of benefits is very high.”

Critical to changing clinical recommendations is having enough information about the risks and benefits of a treatment. Since fluvoxamine is decades old, its risks are already well understood.

“We know a great deal about the safety and tolerability of fluvoxamine,” Lenze told me. “It can cause in about one-quarter of people some nausea, which is usually mild. It’s not fatal even in overdose, it’s been around for over a quarter of a century so there’s not going to be any unpleasant surprises about safety issues, and it’s really easy to use — it’s just a pill. I don’t see anything that should stop people from taking it.”

There are still things scientists want to know about fluvoxamine, including exactly how it works within the body. And pinning down precisely how much the drug reduces hospitalization and death will definitely take more evidence — though from the 31 percent reduction in hospitalizations in the McMaster study, the researchers who spoke to Vox think it’s likely that the effect is real and sizable.

The TOGETHER trial hasn’t yet been peer-reviewed, though I spoke with numerous unaffiliated researchers who’d seen the results and found them convincing.

“Bottom line, in my opinion at least, Ed [Mills]’s finding proves that the drug works,” Lenze told me.

“We’ve all been burned by promising studies of these repurposed drugs, and it’s quite reasonable to reserve final judgment until we see the complete data, and even other studies. … But this already feels different from hydroxychloroquine and company given the high quality of the research,” Paul Sax argued in NEJM Journal Watch Infectious Diseases. “We might finally be onto something.”

Another possibility to account for when looking at clinical trial data is publication bias — studies that find results get published, while those that find null results often don’t. Lenze is attempting a large-scale replication of his small-scale fluvoxamine study from last year, and so far hasn’t been able to validate the huge reduction in hospitalizations he found the first time around — mainly because recruiting for Covid-19 clinical trials in the US has gotten increasingly difficult as most high-risk people are vaccinated and not at risk of hospitalization, and unvaccinated people are less likely to enroll in clinical trials or adhere to a recommended course of medication. (The TOGETHER study got around this problem by recruiting in Brazil.)

Another worry is that variants will make our understanding of Covid-19 treatments obsolete as soon as we develop one. The TOGETHER study was mostly conducted before the delta variant predominated in Brazil. There’s no strong reason to think fluvoxamine wouldn’t work against delta, but we’ll need additional research to see if the effect size remains the same.

But crucially, we don’t have to answer every unanswered question for doctors to prescribe fluvoxamine to patients. Researchers do have answers to the questions of “Is the drug safe?” and “Does the balance of evidence suggest significant improvement in patient outcomes?” The evidence on those two points looks convincing, so even though there’s lots more to learn, the researchers and clinicians studying fluvoxamine feel ready to say that the drug is a good idea.

One question lots of doctors and patients have about a Covid-19 treatment, of course, is: “Is it FDA-approved?” Fluvoxamine is FDA-approved — but for OCD, not for Covid-19. In fact, Lenze told me, ”I don’t think the FDA ever will approve it for Covid. The reason the FDA will never approve it for Covid is exactly the reason it’s so useful for Covid, namely it’s cheap and it’s widely available. No one can make any money off it, so no one is going to spend the money to appeal to the FDA to approve it.”

Doctors can prescribe drugs the FDA has approved as a treatment for one condition to treat another condition off-label, using their clinical judgment. Doctors may vary in how comfortable they feel with it, but it is common and fully permitted by US regulations.

How Covid-19 is changing the process of clinical trials

One other thing about the emergence of fluvoxamine worth discussing is the process by which it happened: a new approach to clinical trials that is changing how we find new treatments.

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Conducting clinical trials takes a long time. Most people will not be eligible to join a given trial. Finding the eligible ones and recruiting and enrolling them is time- and labor-intensive.

In order to find moderate-effect sizes and be confident in the results, a clinical trial needs to enlist thousands of patients, but that also means it will take much longer to recruit for and conduct — and with Covid-19, delays have costs in human lives. Clinical trials on this scale are expensive, too. TOGETHER is funded by private philanthropists, including Fast Grants, an initiative by Silicon Valley billionaire Patrick Collison and economist Tyler Cowen to speed pandemic response by getting grant money out rapidly.

For the past year, Mills has been using a new approach to clinical trials in order to test potential Covid-19 treatments faster. The key thing was to conduct them in parallel using what’s called an adaptive platform trial. “They’re multi-armed, so you’re testing lots of substances at a time, which allows you to only have one control group,” Mills told me. “What all of the useful trials in Covid have in common is that they’re an adaptive platform trial.”

Running, say, eight clinical trials, with eight control groups, requires many thousands of patients to get an informative sample, which can take a long time. Having eight experimental groups sharing a single control group cuts the number of patients required nearly in half.

This study model reallocates patients among treatment groups once a given treatment has been demonstrated not to work. That leads them to have larger, more convincing sample sizes for the most promising treatments. “You make decisions based on the data that emerges early,” Mills said. “After you have randomized 200 patients to the drug, if you can’t tell that it’s working, it’s probably not a very good drug. Every drug that’s not showing effects is a waste of patients.”

Fluvoxamine was one of eight treatments Mills and colleagues tested. Over time, as other treatments showed no effect, more patients got randomized to the fluvoxamine arm of the trial — letting the researchers learn more about the drug that seemed the most promising.

Mills says that played a huge role in their ability to quickly figure out what worked and what didn’t. “Prior to Covid, it was really just MD Anderson [the cancer hospital in Houston] doing this design. I think it’s going to be how almost all clinical trials happen going forward.”

Vaccines are great — but treatments are as badly needed as ever

Now that there are Covid-19 vaccines, the race for a treatment might seem less urgent than it was last year. But researchers say that mindset would be a mistake.

Vaccine uptake has stalled in most rich countries around 60 to 70 percent, and the delta variant means that the virus is still spreading. Effective treatments could mean dramatically fewer people hospitalized in places where hospitals are overwhelmed.

In poor countries, the situation is starker. Vaccines are not yet widely available, and the prospects for mass vaccinations are grim. And many existing treatments for Covid-19 are unaffordable for the global poor. That’s where fluvoxamine’s promise really comes in.

“It’s $2,000 for a dose for a monoclonal antibody,” Mills told me. “Our drug costs $4.” The supply chain, too, is simpler. Fluvoxamine doesn’t need to be kept in a freezer, doesn’t expire quickly, and can be mass-manufactured cheaply. If it continues to show health benefits for Covid-19 patients, making it widely available in poor countries could help them weather delta.

The fight to discover new treatments isn’t over, either. When I talked with Mills, he was excited about research in the UK finding that steroid inhalers — another cheap, widely available medication — reduced Covid-19 hospitalizations. Mills is also in the process of enrolling patients for a study of both steroids and fluvoxamine, to see whether the benefits are greater when patients take both drugs. “We go from having no drugs for early treatment that are cheap and widely available to having two,” he told me. “What does it look like if we use them together?”

The world is still months of research away from an answer to that question. But even the partial answers available today might make all the difference for some patients.

What full FDA approval for Covid-19 vaccines really means

Posted on March 23, 2022 by bamdj

Nearly nine months after the first Americans received their shots, the Covid-19 vaccine from Pfizer/BioNTech received full approval from the Food and Drug Administration for people 16 and older on Monday. This could help increase the number of people willing to get vaccines and make it easier to compel those who are less willing — if health officials can cut through the mounting confusion around their efficacy, booster shots, and the threat of the delta variant.

Covid-19 vaccines from Johnson & Johnson, Pfizer/BioNTech, and Moderna have thus far been distributed across the US under emergency use authorizations. This form of limited approval allows the FDA to fast-track the distribution of drugs, vaccines, and medical devices during a public health emergency, like a pandemic.

Getting an emergency use authorization requires data from clinical trials showing that an intervention is safe and effective, but the bar for full approval is higher. Now, with 200 million people at least partially vaccinated, the FDA has effectively removed the asterisks from Pfizer/BioNTech’s mRNA vaccine.

“While millions of people have already safely received Covid-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” said Janet Woodcock, acting commissioner of the FDA, in a statement on Monday.

Full approval grants the vaccine manufacturers permission to advertise their products and allow them to continue selling them after the public health emergency around Covid-19 ends. For doctors, full approval also allows them to use vaccines off-label, potentially as booster shots.

But perhaps the most significant change would be a potential boost in public confidence in the vaccines, amid a rising tide of confounding information. Full approval could serve as a valuable messaging tool and help close some of the lingering gaps in immunization across the country.

A significant share of unvaccinated people — millions of people, according to polling — say that full approval will increase the likelihood that they’ll get a Covid-19 vaccine. These individuals may be hesitating “because they know there will be much more data available at the time of an approval … three times as much data on safety and three times as much data on effectiveness,” said Sidney Wolfe, founder and senior adviser at the health research group at Public Citizen.

More employers may also be willing to require vaccines among their workers (some have already begun to do so). And full approval from the FDA could bolster support for these vaccines in other countries that look to the US agency for its rigor. However, to get the maximum public health value out of a full approval, messengers from the president on down to local doctors have to be ready to explain what it all means.

Full approval requires long-term evidence that Covid-19 vaccines are safe and effective

For vaccines, the FDA grants emergency use authorizations after it reviews at least two months of follow-up results for clinical trial participants who received the actual injection. For full approval, known in FDA-speak as a “biologics license application,” the agency wants to see six months of data to ensure there are no widespread problems or to detect adverse reactions. Both reviews examine safety and efficacy while also studying what the optimal distribution strategy might be.

In May, Pfizer and BioNTech submitted their license application. Moderna began its application in June, and Johnson & Johnson said it will begin the process later this year.

With vaccines in general, almost all complications that occur tend to happen shortly after the vaccine is administered, often within a day or two. Most side effects of the Covid-19 vaccines in the US tend to be mild or moderate, ranging from pain at the injection site to fatigue to fever. A very small number of recipients reported severe allergic reactions shortly after their shots, which is why most vaccine clinics have a waiting period where they can monitor patients for 15 to 30 minutes.

But in clinical trials, some extremely rare complications can be hard to detect even among tens of thousands of people after following them for two months. In April, the CDC and FDA paused the distribution of the Johnson & Johnson Covid-19 vaccine after 15 people reported a rare blood-clotting disorder out of the 8 million people who had received a dose at that point. After investigating, regulators concluded the benefits of the vaccine far outweigh the risks and allowed distribution to resume.

Monitoring clinical trial participants over six months also yields more information about how long protection from the vaccine lasts and whether any subsets of the population are more vulnerable. And it presents an opportunity to see how well the vaccines hold up against variants that were not widely circulating earlier in the pandemic.

This additional information — not just from clinical trials but from wide-scale distribution — helps the FDA identify any risks and better tailor its recommendations for use of the vaccine. Full approval also requires inspections of vaccine production facilities, looking at how the shots are made and how they’re packaged to ensure that production is consistent.

“That’s a much larger package of data, and that in itself means it takes much longer” to review, Wolfe said.

The licensing process for vaccines usually takes about a year. By granting full approval to the Pfizer/BioNTech vaccine just four months after the companies applied, Covid-19 vaccines have broken yet another speed record.

One caveat is that the full vaccine license only applies to the specific age groups included in a given clinical trial. The original trials mainly included adults, and Covid-19 vaccine testing in younger children has only recently begun, so the FDA has fully approved the Pfizer/BioNTech vaccine for use in adults 16 and older. Children 12 to 15 can continue to receive the shot under the emergency use authorization that was already in place.

Full FDA approval for a Covid-19 vaccine may help convince the hesitant

At this point, the majority of adults in the US have received at least one dose of a Covid-19 vaccine under an emergency use authorization. The spread of the delta variant has increased the rate of new vaccinations, which reached more than a million doses in a day on August 19, but the rate is still far below the April peak of more than 4.4 million doses per day. There remain pockets of the country where fewer than half of all eligible people have been vaccinated, and these regions are driving the rise in new Covid-19 cases, hospitalizations, and deaths.

There are several factors that divide the vaccinated from the unvaccinated, including political affiliation, race, income, and age. The reasons these people cite vary, such as a lack of access, a belief that Covid-19 isn’t that serious, and concerns that the vaccines have not been fully vetted.

According to polling from the Kaiser Family Foundation, almost one-third of unvaccinated people said they would be more inclined to get a shot if it graduates from an emergency use authorization to a full license. Full FDA approval could mean a lot for this last group of people.

But convincing people to get shots is not the job of the FDA; that falls to other public health messengers, and they have to be prepared to seize the opportunity. “It can have a modest effect or be a game changer, depending on how it’s handled,” said Drew Altman, president and CEO of the Kaiser Family Foundation. “It’s a question then of what the president does, what state and local public health leaders do, what the experts on television do.”

It’s not clear that people who cite the lack of FDA approval as a reason for not getting vaccinated are genuinely concerned with regulatory procedure or whether that’s just a proxy for general hesitancy. There’s also widespread confusion about the approval process: Kaiser’s polling also showed that at least two-thirds of US adults believed that Covid-19 vaccines already had full approval or weren’t sure about their regulatory status.

As for vaccine mandates, it’s already legal for private and public institutions to require their employees and customers to get shots. Companies like Google, Disney, and Walmart have begun to require many workers to get Covid-19 vaccines. But full approval could tip more employers, airlines, event venues, and other institutions that are on the fence to impose vaccinate mandates.

“I would look for significant movement on the part of more employers after full approval comes down from the FDA,” Altman said.

Now that the Pfizer/BioNTech vaccine is fully approved for people 16 and older, that doesn’t mean Moderna and Johnson & Johnson will stop distributing their vaccines under emergency use authorizations. While one of the conditions for granting an emergency use authorization is that there is no FDA-approved alternative available, emergencies like Covid-19 affect the calculus, the agency told Vox.

“For example, if the approved vaccine is only available in limited quantities, that vaccine may not be considered adequate to address the public health emergency,” said an FDA spokesperson in an email. “Another example would be if the vaccine is approved for use only in a limited population, then that vaccine may not be considered adequate to address the public health emergency for other populations.”

All the while, the dynamics of the pandemic are still changing, particularly with the surging delta variant of the coronavirus. While vaccines remain highly protective against severe Covid-19, delta seems to have increased the likelihood of breakthrough infections. Recent CDC data suggests that the shots aren’t as protective for vulnerable people like older adults who were vaccinated many months ago.

To counter this, the FDA is now on the verge of approving booster doses for many Covid-19 vaccine recipients. Meanwhile, the Centers for Disease Control and Prevention has gone back to recommending face masks in some circumstances for vaccinated people.

For health officials, it’s a fine line to walk: reassuring people vaccines are safe and effective while also noting that precautions are still needed. Regulators like the FDA also have to balance the needs of an urgent public health crisis with taking the time to go through the proper procedures.

And there are tough challenges that will remain even after a vaccine gets the bright green light from the FDA. There are still parts of the US where vaccination rates remain stubbornly low, and many unvaccinated people are not just hesitant but outright refusing to get immunized. Convincing these holdouts is difficult, but necessary, because as long as they remain unprotected, the virus will have ample opportunity to wreak havoc.

Update, August 23, 10 am ET: This article has been updated with the FDA’s full approval of the Pfizer/BioNTech vaccine.

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The lab leak hypothesis — true or not — should teach us a lesson

Posted on March 23, 2022 by bamdj

The origins of the novel coronavirus that caused the Covid-19 pandemic remain a mystery. US intelligence agencies have now completed a 90-day probe into the origins of SARS-CoV-2, but their classified findings, according to the New York Times, were inconclusive as to whether the virus escaped from a laboratory in Wuhan, China, or made a natural jump from an animal into a human.

Yet to prevent the next pandemic, scientists don’t need a definitive answer about the genesis of Covid-19. Regardless of how the coronavirus outbreak started, researchers say the world urgently needs to do more to prevent both lab leaks and so-called “spillover” infections from animals. Tracing the route of the virus is an important scientific question, but countries can and should take steps to reduce these risks now, even without a final answer.

“We don’t have to wait for all these results to start acting,” said Andrew Weber, senior fellow at the Council on Strategic Risks and a former assistant secretary of defense for nuclear, chemical, and biological defense programs under President Barack Obama. “There’s some big policy decisions that we can make now.”

Right now, the Covid-19 pandemic is continuing to rage around the world; dozens of countries are fighting the spread of the highly contagious delta variant, and many are struggling to get enough vaccines to protect themselves. Figuring out just where the virus came from would do little to mitigate the current crisis.

It may be years before the world gets a satisfying answer, and one may never emerge. But in the meantime, from regulating wildlife markets to transparency around biological research, there are many measures that can reduce the risk of future outbreaks.

Both spillovers and laboratory leaks of pathogens have happened before

There were warnings that humanity was at risk of a pandemic even before Covid-19, and at several points the world has come scarily close.

Several dangerous pathogens have escaped laboratories in the past and gone on to infect people. In 1977, an outbreak of H1N1 influenza erupted on the border between China and the Soviet Union. Based on a genetic analysis of the strain, many researchers concluded the virus escaped from a lab. Smallpox, meanwhile, was eradicated from the wild in 1977; the following year, Janet Parker, a photographer at Birmingham Medical School in the UK, became infected and later died. The building she worked in housed a research laboratory where scientists were studying smallpox.

In 2004, at least two unnamed researchers contracted the SARS virus at the Chinese National Institute of Virology in Beijing. One of the researchers went on to infect her mother, who later died, as well as a nurse at the hospital where her mother was treated. The outbreak led to 1,000 people being quarantined or placed under medical supervision. At the time, the World Health Organization (WHO) reported there may have been similar outbreaks of SARS in Taiwan and Singapore that also may have originated in labs.

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There have been even more alarming close calls where scientists were exposed to dangerous pathogens due to equipment failure or lax adherence to containment protocols.

However, every known lab leak to date has involved a pathogen that was previously identified. There has never been a confirmed case of a never-before-seen virus escaping a research facility.

At the other end of the spectrum of possibilities, virologists point out that the vast majority of pathogens that infect humans originate in nature, and almost all come from interactions with animals. Over the past century, about two new viruses per year have been discovered in humans, most of which spilled over from animals, according to a 2012 paper in Philosophical Transactions of the Royal Society B.

“All these spillovers, wherever they are, it’s because human activity is encroaching upon animal activity,” Vincent Racaniello, a virologist at Columbia University, told Vox in June.

Influenza, for example, is found in birds, poultry, pigs, and seals. HIV likely originated in chimpanzees. Measles has an ancestor in cattle.

In fact, another coronavirus, the 2003 SARS virus, was found to have jumped from bats to civet cats before making the leap to humans. And scientists have warned for years that another bat coronavirus could trigger an outbreak in people.

The debate over Covid-19’s origins may never be resolved to everyone’s satisfaction

Many researchers in the early days of the Covid-19 pandemic were quick to attribute the emergence of the SARS-CoV-2 virus to a natural occurrence, likely a human contact with a bat coronavirus via an intermediary. Two recent papers, one in the journal Science and one in the journal Cell, emphasized this conclusion, citing genetic evidence tracing both the lineage of the virus and the circumstances in China in late 2019 that increased the likelihood of humans coming into contact with wild animals that could harbor the pathogen.

Still, some scientists have argued for closer scrutiny of the possibility that the novel coronavirus escaped from a lab. The most basic hypothesis is that a worker at the Wuhan Institute of Virology was infected by a naturally occurring virus under study there. There is no direct evidence for this, nor any indication that SARS-CoV-2 or a progenitor was being studied at the lab, let alone that someone who worked there was infected. Wuhan is about 1,000 miles away from where the bats that harbor a similar virus are found, raising the question of how SARS-CoV-2 crossed that distance. The laboratory was also known to handle its viral samples at a lower safety level than most scientists recommend for such a pathogen. In addition, no one has found an animal that clearly hosted the virus or a precursor just before it leaped into humans.

More fringe ideas are also circulating, like the notion that the virus was deliberately engineered to be more dangerous or deliberately released as a bioweapon. There’s no evidence for these claims.

With the passage of time, however, it’s becoming more difficult for scientists to study the origins of Covid-19. In a recent article in the journal Nature, WHO researchers warned that time is running out: “The window of opportunity for conducting this crucial inquiry is closing fast: any delay will render some of the studies biologically impossible.”

Another complication is that the question of where the virus came from has become a political issue domestically and internationally. Within the US, some politicians have been eager to blame a lab for the pandemic and shift the blame to China.

That, in turn, has become a major source of friction between the United States and China. Chinese officials stopped cooperating with a WHO investigation into the origins of the coronavirus earlier this year and responded with their own allegations that the virus originated in a US lab (for which there is no evidence).

And without cooperation from Chinese authorities, it’s unlikely that a definitive answer — one way or the other — will emerge anytime soon.

Scientists already know how to stop lab leaks

There are many ways to improve safety in laboratories and install safeguards to prevent dangerous diseases from escaping and wreaking havoc. Even scientists who think the emergence of SARS-CoV-2 was a natural event say that preventing lab leaks should be a high priority.

Gigi Gronvall, senior scholar at the Johns Hopkins Center for Health Security, said it’s important to think about two key concepts: “Biosafety” is about protecting people who work with pathogens from the things they are studying, usually through accidents. “Biosecurity” is preventing misuse of pathogens via deliberate actions.

Both are essential to prevent leaks of biological agents, but they’re often afterthoughts when it comes to conducting research on pathogens. “It’s hard to make this exciting,” Gronvall said. “That is why very often the money goes to research, and biosafety is less emphasized.”

One way to enhance biosafety is to deploy several different methods of containment in a laboratory. For instance, biosafety level 3 precautions for handling pathogens that can spread through the air include only handling samples in “biological safety cabinets” that filter air, controlling lab access with two sets of self-locking doors, and wearing respirators, eye protection, and lab coats. It also includes routine medical screening of lab workers.

“Ideally, if there is any kind of accident, there are still multiple layers before it becomes an issue for anyone outside a laboratory,” Gronvall said.

Biosafety also hinges on the type of studies being conducted. Of particular concern is gain-of-function research, in which pathogens are deliberately modified to become more dangerous to humans. The goal is to map out potential changes that could emerge in the wild and develop ways to counter them before they become major threats. It’s a controversial form of research, and some have alleged that the Wuhan Institute of Virology was conducting such experiments — though, again, there is no evidence this occurred. US officials have also been adamant that they have not funded any gain-of-function research, either in the US or abroad.

Some scientists say this kind of research should not be conducted at all because the risk of an escape is too great, but others say gain-of-function studies can be conducted safely with appropriate precautions.

“Lab incidents will still occur. A robust biosafety and biosecurity system, along with appropriate institutional response, helps to ensure that these incidents are inconsequential,” biosafety experts David Gillum (Arizona State University) and Rebecca Moritz (Colorado State University) wrote for the Conversation. “The challenge is to make sure that any research conducted — gain-of-function or otherwise — doesn’t pose unreasonable risks to researchers, the public and the environment.”

Building a robust biosecurity system requires cooperation from institutions ranging from laboratories to regulators to governments. It demands rigorous oversight to enforce safety standards. Transparency among institutions about the kinds of biological research they’re conducting, as well as potential mishaps and accidents, is also critical. But there’s a pervasive fear among laboratories and the individuals who work there that disclosing problems will hurt their reputations.

“If there is a biosafety incident, it is very hard to get that addressed in a way that doesn’t cause problems for an institution,” Gronvall said. “They have a lot of incentives to keep it under wraps.”

That’s also why it’s been hard to know whether China is stonewalling investigators because of a potential lapse in laboratory protocol or out of general distrust of other countries and institutions like the WHO. “A bat could’ve walked out of a cave wearing a name tag and China would behave the same way,” Gronvall said.

Fixing this requires a change in the culture surrounding biological research to create an environment where mistakes and problems are discussed openly and addressed immediately. Inspections, monitoring, and documentation would also make it harder to sweep any problems under the rug.

What’s tougher is enforcing these principles around the world. There is an international agreement restricting research on biological weapons, the Biological Weapons Convention, but there’s no similar agreement for general biological research. Many countries have their own research programs for pathogens, and it’s the Wild West when it comes to what standards are used and what studies are done.

“There’s really no international body that has the authority to oversee biological security or biological safety,” said Weber, from the Council on Strategic Risks. “We should work with [the] international community to adopt real standards for biosecurity and for high-risk research.”

Some pathogen laboratories, like the US Army’s Fort Detrick in Maryland, already have exchange programs with researchers around the world. More exchanges and international inspections of biological research labs could help ensure that every facility adopts best practices and upholds the highest safety and security standards. But setting up such a regime requires trust and cooperation, and that’s in short supply.

“Natural” spillovers, which often have human causes, can be prevented, too

Pathogens found in the wild have infected people for millennia, but there are ways to tame this force of nature. “What we can do is reduce the rate of exposure of humans,” said Andrew Dobson, professor of ecology and evolutionary biology at Princeton University.

For example, a key route for new human diseases is contact with wildlife. Such interactions increase as cities sprawl into the wilderness and people venture further into remote areas in search of food, fuel, and raw materials. When humans destroy habitats, especially through deforestation, they force animals to flee to new areas and interact with people in cities and suburbs. In one paper published in the journal Science in 2020, Dobson reported that when more than 25 percent of original forest cover is lost, it’s much more likely for humans and their livestock to come into contact with wildlife that may carry diseases.

“That’s what’s exposing people to the hosts and the carriers of these viruses,” said Dobson. Drastically reducing deforestation and placing strict limits on how much people can encroach into forests, grasslands, and deserts can slow the emergence of dangerous new parasites, viruses, bacteria, and fungi.

Domesticated animals, particularly livestock, can also be a source of new diseases. The combination of changes in land use and factory farming of cattle, chicken, and hogs can increase the risk of a pathogen hopping between species.

Another way to reduce the chances of a spillover is to close unregulated markets that sell wildlife as food, ingredients for medicines, or materials for clothing. Phasing out legal wildlife markets and screening the health of animals that humans do come into contact with would also reduce the risks of new diseases jumping into people. “There needs to be [many] more international treaties around that to protect people,” said Dobson.

The hurdle is that the wildlife trade is quite lucrative. The legal wildlife market is worth about $300 billion, while estimates of the value of illegal wildlife trading can be as high as $23 billion. So reducing some of the highest-risk forms of wildlife trade also demands an economic solution for people whose livelihoods would be affected, such as helping them find new jobs.

Surveillance — actively looking for dangerous pathogens in the wild to stay ahead of outbreaks — is another important tactic, but there are some risks. Sending researchers into remote areas to collect samples and study them could expose them to dangerous diseases.

“We need to think more about the precautions people take and the security level in those labs,” Dobson said. “[But] the amount we’ll learn will significantly reduce the risk of future outbreaks.”

The history of narrowly averted pandemics is full of crucial lessons

Beyond probing the roots of the Covid-19 pandemic, it’s also worth investigating close calls of the past. Viruses like the original SARS virus in 2003, for example, had the potential to go global but didn’t. The virus itself had some traits that prevented it from spreading further, and while many of the countries most acutely affected by the outbreak, like China and Vietnam, learned critical public health lessons, much of the rest of the world remained complacent.

In a 2013 paper in the Journal of Management, researchers looking at problems with uncrewed NASA missions highlighted the important lessons that can be found in near-miss scenarios like this. “Disasters are rarely generated by large causes,” the authors noted. “Instead disasters are produced by combinations of small failures and errors across the entire organizational system.” So whether SARS-CoV-2 came from a lab or a natural event, a lot of other things also had to go wrong for it to become an international crisis.

When all these factors don’t align in a particular instance and fail to produce a disaster, it’s easy to take the wrong lesson — that humans were adequately prepared or that the status quo of science and public health is good enough already. But it’s dangerous to ignore close calls, whether it’s a near collision between satellites or a new pathogen that was narrowly contained.

“If near-misses masquerade as successes, then organizations and their members will only learn to continue taking the risks that produced the near-miss outcome until a tragedy occurs,” the researchers wrote.

That’s why it’s important to study the factors behind not just the Covid-19 pandemic but also other outbreaks like those of Ebola, SARS, and MERS, which raised alarms and revealed weaknesses in national and global public health systems.

We may not unravel the origins of SARS-CoV-2 anytime soon — if ever. But by treating both spillovers and lab leaks as urgent risks right now, scientists, health officials, and governments can protect us all from outbreaks of the future.

What’s causing California’s unprecedented wildfires

Posted on March 23, 2022 by bamdj

Another explosive wildfire season is underway in California, with more than a million acres already burned in 2021. While still short of the unprecedented 2020 fire season, the blazes this year are well above average and are still gaining ground.

The Caldor Fire burning near Lake Tahoe has forced thousands of people to evacuate as it has spread to more than 207,000 acres, an area larger than New York City. The blaze ignited August 14 and was 23 percent contained as of Thursday.

The Dixie Fire near Chico, California, that ignited on July 14 has scorched more than 847,000 acres. It was 52 percent contained as of Thursday.

Spread by winds reaching 40 mph and fueled by abundant dry vegetation, wildfires across the Golden State have whipped up enormous clouds of smoke and ash. Some have even spawned fire tornadoes.

Across the United States as a whole, more than 2.7 million acres have been charred in wildfires this year, according to the National Interagency Fire Center.

Researchers said that the current fires align with what they forecast earlier this year, noting that the region was parched by a massive drought, was facing severe heat, and had plenty of trees, brush, and grass ready to burn.

Even so, the blazes have proved surprising in other ways. The Caldor and Dixie fires are the first wildfires on record to cross the Sierra Nevada mountain range, posing new challenges for firefighters working to contain them. “These two big fires started in very steep canyons [that are] difficult to access, with very dry, overloaded forests that are burning intensely and so it’s very hard to get a handle on this,” said Craig Clements, director of the Wildfire Interdisciplinary Research Center at San Jose State University.

And as humans continue to drive up wildfire risks — from building in fire-prone regions to suppressing natural fires to changing the climate — scientists are having to rethink what’s possible.

Even by California standards, the current wildfires are surprising

There are several key ingredients needed for wildfires. They need favorable weather, namely dry and windy conditions. They need fuel. And they need an ignition source.

The California Department of Forestry and Fire Protection said that they are still investigating the origins of most of the blazes underway. But other factors this year stacked the deck in favor of massive conflagrations.

California and much of the western US are in the midst of a years-long drought. With limited moisture, plants dry out and turn into kindling. Ordinarily, vegetation at higher altitudes would still hang onto some moisture and act as a barrier to wildfires in places like the Sierra Nevada. However, the severity of the drought has caused even this greenery to turn yellow and gray.

“That’s the unique thing, that these fires have burned over the Sierra Nevada crest,” said Clements. “The fuel moistures are still at record lows across the state of California. That’s allowing these fires to burn at higher altitudes.”

Moisture in the soil and in vegetation can also act as a cooling mechanism as it evaporates. With the drought, this effect is diminished, allowing even more heat to accumulate and pushing temperatures up to the new record highs achieved this summer. The hot weather in turn drove even more drying across the landscape, reaching aridity levels not typically seen until October.

It’s likely that even more fires are in store for the rest of the year across the West. As the autumn Santa Ana and Diablo winds pick up, the risks remain high.

People make wildfires worse, but can take steps to mitigate them

Wildfires are a natural part of ecosystems across much of the western United States. They serve vital functions like clearing decaying vegetation, regulating forest density, restoring nutrients to soils, and helping plants germinate.

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But human activity has made wildfires worse at every step. Climate change caused by burning fossil fuels is increasing the aridity of western forests and increasing the frequency and severity of extreme heat events.

People are also building closer to wildland areas. That means that when fires do occur, they cause more damage to homes and businesses. That proximity also means that humans are more likely to spark new infernos. The vast majority of wildfires are ignited by people, up to 84 percent, whether through errant sparks, downed power lines, or arson.

And for hundreds of years, people have suppressed naturally occurring fires. European settlers also halted cultural burning practices from the Indigenous people of the region. Stopping these smaller fires has allowed forests, grasslands, and chaparral to grow much denser than they would otherwise. Paradoxically, that means more fuel is available to burn when fires do occur, causing blazes to spread farther and faster.

The combination of these factors leads wildfires to keep breaking records, forcing scientists to reevaluate what kinds of fires are possible. Decades ago, a 20,000-acre blaze would have been considered massive. Now, wildfires can gain that much ground overnight. “What we’re finding is that even forecasting the fires is so difficult for us because the domain size is huge,” Clements said. “These fires are massive and we keep having to expand the domain of our weather models.”

There are well established ways to reduce the risks of destructive wildfires. Directly attacking a fire once it’s ignited can only go so far, so much of the focus has to be on prevention. One key way is to reduce fuel load. That can take the form of forest thinning and prescribed burns. Towns and cities in fire-prone regions can build defensible perimeters, cutting fire breaks and clearings to reduce the chances of a fire encroaching.

Building codes that demand fire-resistant materials and avoiding construction in the highest-risk areas can reduce the impact of fires as well. Ignitions can be reduced by hardening or burying power lines.

Restoring Indigenous burning practices can also help mitigate wildfire risk — but that will require governments to address historical wrongs, restoring tribes’ access to and sovereignty over ancestral lands.

Over the long term, slowing climate change by drastically reducing greenhouse gas emissions can also stop fires from becoming even more destructive.

The factors that laid the foundation for massive wildfires took centuries to build and won’t be reversed overnight. But the process of reducing these risks can begin now.

Climate change worsens extreme weather. A revolution in attribution science proved it.

We have to accept some risk of Covid-19