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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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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