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The FDA just authorized the first pills for treating COVID-19

This post has been updated.

On Wednesday morning, the FDA issued the first emergency use authorization for a COVID treatment pill. In a phase III trial, Pfizer’s Pavloxvid was 89 percent effective at stopping high-risk COVID patients from becoming severely ill.

The treatment could keep people out of the hospital during the Omicron wave, reducing strain on a crumbling healthcare system. But shortages, both of Paxlovid itself and of COVID tests, could limit its impact during crucial weeks.

Molnupiravir, a COVID pill developed by Merck and partner Ridgeback Pharmaceuticals, was also issued an emergency use authorization (EUA) on Thursday. However, its progress was recently paused over concerns about the drug’s effects on developing fetuses (since it works by forcing the SARS-CoV-2 virus to mutate) as well as worse-than-anticipated final results.

Unlike Molnupiravir, Paxlovid works by inhibiting a crucial protein on SARS-CoV-2 particles. One of the ingredients can interact with other drugs, and it isn’t recommended for people with severe kidney or liver problems, but it doesn’t carry the same poorly-understood risks.

Both Paxlovid and Molnupiravir are given as a five-day series of various pills, and must be started within five days of symptom onset. In the phase III trial, which was conducted on people with conditions that put them at high risk for severe COVID, only .8 percent of those who received Paxlovid were hospitalized or died—versus six percent of those who took a placebo. In the Molnupiravir trial, 6.8 percent of the treated patients were hospitalized or died within a 29 day time period compared to 9.7 percent who received a placebo.

Who will get the COVID pill?

For the moment, Paxlovid will only be available by prescription to people over the age of 12 with a high risk of developing severe COVID. Molnupiravir will be available by prescription to adults 18 and older with COVID-19 risk factors. Those qualifying existing conditions are described by the CDC, and include immunocompromising diseases, smoking, and heart disease, among others.

People who have a BMI above 25 also fit those criteria, though the connection between BMI and COVID severity is ambiguous. Still, that makes about 73 percent of American adults eligible to receive Paxlovid should they catch COVID-19.

For now, the FDA has not specified whether vaccinated individuals who meet the criteria above will be eligible, which means physicians will likely make their own calls.

How big of a deal is the COVID pill?

When Paxlovid was first developed, it was promising largely because a pill is much easier to deliver than existing COVID treatments, like monoclonal antibodies, which are given intravenously in a hospital. But Omicron has made several of those antibody treatments less effective, leaving providers with an incoming rush of cases and less certainty about how to address them.

Paxlovid and Molnupiravir can be prescribed for use at home, but the catch is that they must be taken within a few days of symptom onset. With hours-long lines for PCR testing in many Omicron hotspots and a shortage of at-home rapid tests, getting diagnosed in time for the treatments to make a difference could prove challenging.

But even if you’re eligible and manage to get a quick diagnosis, you still might not have a course of COVID pills in your future. Pfizer representatives recently told the Washington Post that the company expects to manufacture enough of the drug to treat 180,000 patients by the end of 2021. The Biden administration is expected to buy 3 million courses of Merck’s drug by the end of January.

Last January, the US peaked at about 250,000 new COVID cases per day. US health officials expect Omicron, which appears to be much more transmissible than other variants, to beat that record. Many of those cases will be mild. But with so many unknowns about the risk of long-haul symptoms, the CDC may need to develop firmer guidelines to determine who receives these treatments.

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It’s too early to dismiss Omicron as a mild COVID variant

Over the last week, headlines across the internet suggested that Omicron might cause a milder form of illness compared to previous COVID variants. Many of the stories stemmed from a recent report from Discovery Health, a large healthcare and insurance system in South Africa. The report found that based on a 200,000-person study, adults were 29 percent less likely to be hospitalized now than they were during the first wave of the pandemic.

But COVID researchers continue to say that findings like these don’t necessarily mean that Omicron is intrinsically milder. In fact, they might suggest that vaccines combined with prior infection might simply be preventing deadly outcomes, as they were intended to do. The Discovery researchers themselves note that, given a 35 percent adult vaccination rate and a population that has already recovered from other COVID variants, it’s hard to estimate Omicron’s “true severity.”

In South Africa, cases in the Omicron wave have already begun peaking after three weeks, but deaths haven’t climbed as quickly as in previous waves. “We believe it might not necessarily just be that Omicron is less virulent, but coverage of vaccination [and] natural immunity … also adding to the protection,” Joe Phaahla, the country’s health minister, told Britain’s the Times.

South Africa recently recovered from a national Delta surge, epidemiologists at Massachusetts General Hospital and Harvard’s School of Public Health noted in a working paper this week. “Thus, Omicron enters a South African population with considerably more immunity than any prior SARS-CoV-2 variant has encountered,” the researchers wrote, “enriched among those who would have been at greatest risk for severe outcomes.”

The result, they wrote, suggest “the true risk of severe infection will be systematically underestimated.”

Darryl Falzarano, a vaccine researcher at the University of Saskatchewan, says that estimating severity becomes harder as time goes on. “How many infections did we miss that are asymptomatic, or never ended up getting diagnosed?” he says. “If those people now get infected with Omicron, you would expect severity to be lower… Pulling that apart and knowing if it’s truly a naive Omicron infection”—in someone who’s never been infected or vaccinated—makes assessing severity difficult.”

The recent report in Discovery Health is complicated by the fact that children under 18 were 20 percent more likely to be admitted to the hospital with Omicron than in the first wave, though much less likely than adults. “In the fourth wave, [South African hospitals] are seeing a similar increase in admissions [to Delta] for children under five years of age,” wrote Shirley Collie, Discovery’s top health actuary, in the report. The highest rates of admission were among children under 5.

That could be because children are more representative of a naive population. South Africa approved vaccines for 12 to 17 year olds in October, and children have been less likely to catch and spread the coronavirus. That would suggest that Omicron is more severe, at least in children. But that’s not necessarily what’s happening. “It’s children who have become the most unvaccinated of our population, and as expected, cases are going to concentrate in those age groups,” says Sallie Permar, pediatrics chair at Weill Cornell Medicine. “It’s very common to test [hospitalized kids] now,” but was less common early in the pandemic. Some of those kids test positive, even if it’s not clear that they were hospitalized for COVID in the first place.”You find them much more frequently at a time that there’s a surge,” says Permar. The Discovery Health report notes that those ‘incidental’ cases could be contributing to the apparent risk as well.

It could turn out that Omicron tends to cause milder disease, even in people with no prior immunity.

“I think that there is more data beginning to suggest that this reduced virulence may in fact hold true across more global regions BUT we’re waiting for data to substantiate that,” says Jason Kindrachuk, a virologist at the University of Manitoba who has written on COVID’s pathogenicity, in an email to Popular Science. “And the crux of all of this is that the transmissibility and movement of Omicron through global populations is outpacing our ability to acquire enough data to answer this question.”

At a briefing on December 10, University of the Witwatersrand infectious disease researcher Anna von Gottberg presented a similar finding. The data relied on the fact that Omicron gives a telltale reading on some PCR tests, allowing researchers to estimate its presence even without sequencing cases. During the November spike in Omicron cases, but before it pushed out other variants, von Gottberg said that Omicron-suspected cases were less likely to lead to hospitalization. There are “some hints that maybe the disease is less severe, but we need to wait several weeks,” she said. It could be that Omicron was simply infecting a lot of people who were resistant to other variants, and have some immunity.

Why exactly fewer people are getting very sick from Omicron doesn’t matter so much for understanding its impacts. A mild variant, whether via immunity or intrinsic qualities, still poses profound challenges.

“I would say that everything so far has been reassuring to say this is not a virus that is scarier than the first, in terms of how sick it makes people,” says Permar. “Whereas two years ago we were overwhelmed with sick people needing ventilators… now it’s going to be complicating our staffing.” COVID positive healthcare providers can’t work. Meanwhile, hospitalizations in the United States are rising because of Delta. There are national nursing shortages, driven by burnout and pay issues after two years of managing a crisis.

Staffing shortages are “a nice outcome” relative to ventilator shortages, says Permar. But it’s an outcome that raises deep questions about the capacity of the American healthcare system.

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The Delta variant is forcing parts of Australia back into lockdown

Most of Australia is under fresh COVID-19 restrictions as case numbers rise and the Delta variant threatens to overwhelm the country’s contact tracing apparatus. Sydney, the country’s largest city, went into a lockdown on Saturday evening, as did much of the surrounding region. The lockdown is expected to last until July 9.

Right now, the federal government estimates that there are 271 active cases, and reports 58 hospitalizations.

The scale of the outbreak is smaller than those in the United States, but Australia has also controlled the pandemic successfully for most of the past year and a half, lifting initial lockdowns last summer. However, it’s kept tight restrictions on foreign travel—most people can’t fly anywhere besides New Zealand, and incoming travellers are required to quarantine. So far, the entire country has reported 910 total deaths over the course of the pandemic, which is fewer than in North Dakota alone.

“Covid zero [sic] became the de facto strategic goal of Australian public health policy,” wrote Bill Bowtell, a health policy expert who helped craft Australia’s HIV response, in a Guardian op-ed. “It delivered the precious gift of time to regroup, free from the pressure of rising caseloads, unnecessary social and economic disruption, and death.”

But, he argued, Australia has failed to capitalize on that success with a fast vaccine rollout, leaving itself vulnerable to outbreaks.

The bulk of the new cases are in the southeastern state of New South Wales, where Sydney is located. According to the Guardian, 120 cases in this most recent outbreak have been linked to a Sydney suburb called Bondi. Yesterday, the state reported 23 new cases, three of which were picked up overseas.

That prompted concern and travel restrictions in New Zealand as well, after one Australian tourist reportedly tested positive after returning home from Wellington, the neighboring nation’s capital.

In response, the New South Wales government has imposed a two-week stay-at-home order for the metro area, although it includes broad carvouts, including travel to childcare, weddings, and funerals. The state also resumed a mask requirement.

The Australian government is trying to head off a national outbreak, and people who have travelled to the region since June 21 are also being asked to stay at home.

But other cases appear to be slipping through Australia’s net. In Australia’s Northern Territory, a gold miner became infected at a quarantine hotel, then took a charter flight back to the mine. Now, health officials are tracking down about 900 miners who might have carried the virus across the country. The Northern Territory went into lockdown as of Sunday.

This outbreak has triggered extra alarms because many of the cases are suspected to be the highly contagious Delta variant.

That variant, first detected in India, is not only more contagious than the original strain of COVID, but is also more contagious than the Alpha variant, first detected in the UK. It appears to be more deadly as well. And unlike Alpha, it’s adept at reinfecting people who have already recovered from COVID.

Delta kicked off a round of lockdowns in the UK when it arrived, and sent authorities scrambling to deliver second doses of the vaccine—fully vaccinated people are strongly protected, but half vaccinated people still appear to be vulnerable.

Low vaccination rates are also driving the urgency in Australia. Although around 30 percent of the country has received one dose, only about five percent of Australians are fully vaccinated. (Australia hasn’t administered any Johnson & Johnson, which requires only a single shot.) In New South Wales, just 4.3 percent of people have completed the series. In three other states, fewer than one percent of people have.

That’s in part because Australia relies heavily on the AstraZeneca vaccine, some of which is manufactured in the country. But this spring, the AstraZeneca vaccine came under intense scrutiny after European regulators determined that it was possibly linked to extremely rare, but deadly, blood clots, especially in young people. In April, Australia stopped giving AstraZeneca to almost anyone under 50, and turned to its much more limited supply of Pfizer instead.

As this outbreak has taken off, the government has lifted that restriction, and allowed anyone over the age of 40 to request the AstraZeneca vaccine. Currently, anyone over 40 is eligible to be vaccinated, as are those older than 16 who do frontline work or have a high-risk health condition.

And Monday’s news that a “mix-and-match” course of AstraZeneca and Pfizer provides powerful protection could give the country more flexibility in its vaccination program.

Still, in an interview last week, when asked if Australians could expect to fly by Christmas of 2022, Prime Minister Scott Morrison said, “That’s too far away to… I mean, I would certainly hope so.”

And that means that Australia is yet another sign of what might be to come in under-vaccinated swaths of the United States. Last week, Anthony Fauci estimated that 20 percent of cases in the United States are caused by the Delta variant. Within a month or so, the variant will likely be the dominant strain, accelerating transmission in a country that already has far more SARS-CoV-2 circulating than Australia. As WNYC reported, the Delta variant is so transmissible that it might cause fast-moving outbreaks even in a population that is was 40 percent vaccinated. And with vaccination rates below 50 percent in the South, Midwest, and mountain West, future surges in individual pockets seem almost certain.

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Worsening droughts could increase arsenic exposure for some Americans

More than half of the continental US is currently experiencing some level of drought, and about a quarter is in severe drought or worse. In recent years, the western and southwestern US has been in a seemingly continual state of reduced rainfall and snowpack. Droughts have many well-known, potentially catastrophic consequences, from crop failures to water shortages to wildfires. Yet they can also have more direct human health impacts by not only affecting how much water there is, but also the quality of that water.

Recent research from the US Geological Survey (USGS) suggests that droughts, particularly the prolonged kind happening in parts of the US, could increase the risk of harmful arsenic exposure for people that rely on well water.

Hundreds of millions of years ago, the baseline quality of your drinking water may have been set in stone, literally. Arsenic is a common groundwater contaminant, largely because of local geology. In Maine, for instance, the formation of the Appalachian Mountains and volcanic activity came together to concentrate arsenic and other metals into cracks inside the bedrock, explains Sarah Hall, a geologist at College of the Atlantic in Bar Harbor. From those fissures, subtle shifts in acidity, temperature, or water flow rates can draw contaminants out of the rock and into underground aquifers.

And it’s not just Maine. In many parts of New England, the Midwest, and the Southwest arsenic levels above the 10 parts per billion (ppb) federal level are particularly common—posing an especially big problem for families that rely on well water, which can be contaminated without homeowners knowing it.

Arsenic exposure can cause a litany of health issues, including bladder and lung cancers, heart problems, lung infections, immune system depression, and cognitive decline in children, says Bruce Stanton, a molecular physiologist at the Geisel School of Medicine at Dartmouth in New Hampshire.

Municipal water supplies are routinely tested, monitored, and treated for contaminants including arsenic, says Taehyun Roh, an environmental health epidemiologist at Texas A&M University in College Station, Texas. “But in the case of private wells,” he says, “there is no regulation.” Cities, towns, and counties that provide public water are legally required by the Safe Drinking Water Act to make sure their supply meets federal standards. Although there are many documented cases of municipal governments failing in their duty to provide clean, safe water (Roh references Flint, Michigan), the more than 43 million people relying on private wells in the US aren’t protected by federal standards at all. Domestic well water testing and treatment is entirely the responsibility of the individual landowner.

Between 1.5 and 2.9 million people in the US are currently drinking from wells with arsenic concentrations above the federal limit of 10 parts per billion, according to one 2017 estimate from USGS. That number could rise to more than four million during periods of drought, according to a January 2021 USGS study.

The recent research, based on computer models, estimates that drought could increase arsenic levels in wells by an average of 10 percent. “Which doesn’t seem like a lot, but when you take that over the whole country, that impact is actually pretty large,” says Melissa Lombard, lead study author and USGS hydrologist based in Pembroke, New Hampshire. Though she also cautions that her study is the first of its kind and the model is “in its infancy,” says Joseph Ayotte, another USGS hydrologist and study coauthor.

The study offers a couple of explanations for why droughts might increase the risk of arsenic exposure through well water in some areas. During droughts, groundwater levels decrease. This change in volume can cause shifts in water chemistry, like increased acidity. Because metals leaching out of rock is a chemical reaction, changes in water chemistry can speed up the process. Less groundwater also means contaminants already present in the water become more concentrated. So, even if a drought doesn’t change the total amount of dissolved arsenic in a well, every glass of water from that well may contain more.

The USGS research also partially accounted for human responses to drought that might lead to increased exposure in certain regions. During periods of extended drought in California, for instance, surface water is limited and more water is pumped from underground to meet the state’s needs, says Rich Pauloo, a hydrologist studying the issue. Overpumping can cause the land itself to sink, in the process squeezing natural arsenic out of clays and into groundwater used for drinking, according to a 2018 study published in Nature Communications.

Lombard’s study model was based on previously observed drought conditions, but climate change is projected to continue to increase the number and intensity of droughts worldwide. “By the end of the 21st century, people living under extreme and exceptional drought could more than double,” says Yadu Pokhrel, an environmental engineer at Michigan State University. This means arsenic contamination could become even more rampant in a changing climate.

Further, adverse health effects from arsenic can pop up even at levels of exposure lower than the allowable 10 ppb federal limit, emphasize both Roh and Stanton. “Many scientists think it’s not enough,” Roh says. In one 2017 study in Iowa, he found a correlation between arsenic exposure levels as low as 2.07 ppb and increased prostate cancer risk.

On top of the health risks, arsenic is odorless, colorless, and tasteless, making it impossible to detect without a test until symptoms show up. “It’s not like if you ate a bad clam and that night, you know you ate the bad clam,” says Stanton.

All that undetected exposure adds up and can lead to later-in-life effects, like cancer, he says, even long after someone is no longer drinking contaminated water. Research he’s done in mice and fish also suggests arsenic exposure may have epigenetic effects, which can permanently alter how the genes encoded in our DNA are expressed.

As scary as the health issues might sound though, arsenic in well water is a largely solvable problem. In many cases, all it takes is awareness of the issue, testing, and the resources for remediation. States in high risk areas like Maine, Michigan, and New Mexico have county and state programs that help provide low-cost or free arsenic tests. Well owners can also pay for private well testing from accredited labs, although these tests can cost upwards of $100. Most states recommend re-testing every three to five years. If you live in a high-risk region and your well tests near the federal limit, though, Hall says you should consider arsenic testing twice per year, as levels can vary seasonally.

Depending on how high your levels are, says Stanton, a simple water filter pitcher could resolve the issue. In his house, “even the dog gets the filtered water.” Although, he adds, high arsenic concentrations—far above the 10 ppb federal limit—can exceed a faucet or pitcher filter’s capacity, and require expensive reverse osmosis systems that can cost thousands. According to Stanton, the preventative cost of reducing exposure is worth it. He references “horror stories of people who are in and out of the hospital multiple times” or become chronically ill and end up with hundreds of thousands of dollars in medical bills.

“You worry about people with low incomes who simply can’t afford it,” says Stanton. People living in rural areas reliant on well water are more likely to be living in poverty, with less disposable income, than those in denser areas on public water. “This has to do with environmental justice,” he adds.

In New England, scientists, community members, and advocacy groups have come together to try to tackle issues of well testing and remediation access. Jane Disney, director of the community environmental health laboratory at Mount Desert Island Biological Laboratory in Bar Harbor, Maine co-runs a community citizen science project with Stanton’s Dartmouth lab. The project, titled “All About Arsenic—Data to Action” enlists middle and high school students in testing their families’ wells for arsenic, covering the cost of testing, while simultaneously teaching the students data literacy skills and creating a platform for youth advocacy.

So far, the project has collected more than 3,000 water samples from around the state and worked with more than 20 schools. Students from the project have recently teamed up with Defend Our Health, an environmental health advocacy organization based in Portland, Maine. The group is campaigning to expand testing resources across multiple states, mandate landlords disclose well testing information, and strengthen Maine’s drinking water standards. In Texas, Roh is in the early stages of a similar community testing program, which adds urine and toenail sample collection along with tap water testing. These biological samples can show if participants actually have detectable arsenic levels in their bodies. In exchange for participating, Roh says, people will receive a water filter to put on their tap.

Hopefully, increased awareness, research, and testing leads to change and resilience in the face of current and future droughts—but it will take persistence. In her work studying arsenic in well water, Hall says she’s encountered some resistance to the idea of testing and treatment. “There’s this idyllic version of rural life where it’s like, ‘oh, we’re living off the land and drinking our water.’” People imagine that water to be as pure and natural as the bucolic landscape, but ultimately, Hall cautions, “there’s nothing [natural] about drilling 100 to 600 foot well into rock and sucking water out of it.”

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