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.

[Related: Your up-to-date guide on international travel during the pandemic]

“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.

[Related: The Delta variant is on the rise in the US]

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.

Philip Kiefer

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Automotive Journalist Dick DeLoach Succumbs to COVID-19

Dick DeLoach

Dick DeLoach, a 44-year automotive industry journalist, who was instrumental at Lowrider magazine and many other automotive enthusiast publications, died on November 9, 2020, following complications from COVID-19. He had been admitted to Kaiser Permanente Hospital in Ontario on October 25th.

Dick DeLoach

DeLoach, 76, of Chino, California, spent his career in the industry as an editor, writer, and photographer. A veteran journalist who specialized in technology, product guides, how-to articles, celebrity profiles, and business features, DeLoach could often be found covering industry and enthusiast events.

Among the publications he worked for were Truckin’ magazine, Lowrider magazine, DUB magazine, LFTD X LVLDParts & People, and Aftermarket Matters Weekly. In addition to his broad career, DeLoach made friendships in and out of the industry and served as a trustee on the ASC Educational Foundation.

I first met Dick when he was on the staff of Truckin’, then owned by McMullen Publishing, and I was a contributor to Custom Rodder, another McMullen title. DeLoach was affable, easygoing, and intelligent. He and I were reunited for a short time at Lowrider, which was not a good fit for me but was for Dick, judging by the number of years he was with the magazine.

Dick DeLoach

Lowrider was an icon of Chicano culture that existed for decades, offering a mix of cultural and political content alongside cars and trucks of that genre. As a staff member who covered the growing popularity of the lowrider movement, Dick played an essential part in chronicling it.

Lowrider played a critical role in forming the culture and image of the lowriding lifestyle and its aesthetics. Popular among Mexican-Americans, the magazine was as much a statement about Chicano identity and pride as it was about ground-hugging vintage cars. By the fall of 1988, Lowrider hit 60,000 in monthly newsstand sales, and by 2000, it was among the bestselling newsstand automotive periodicals in the country, with an average monthly circulation of about 210,000 copies.

DeLoach’s humor could be found in his biography, in which he said he wrote some 30,000 articles. I would tell him whenever we saw each other at a show or event that I was getting close to his total, if only he would stop and take a break for a while.

[Images: Courtesy of Tate DeLoach]