Moderna Stock Crash Intensifies: Losses Top $130 Billion After Scientists Find Covid Boosters Aren’t Halting Omicron Infections

Battered by a steep broad-market selloff this week, Moderna shares fell for a sixth straight day Friday as experts questioned whether Covid-19 vaccine sales alone will help justify the firm’s meteoric valuation, intensifying a crash that’s wiped out more than 60% of the value in one of last year’s top stocks and turned it into this year’s worst performer.

Moderna stock fell 4.4% Friday to an eight-month low of $160, pushing shares down more than 20% over the past week amid growing research suggesting Moderna’s Covid-19 booster, while very effective against previous strains, has been less effective against the rapidly spreading omicron variant.

Though the number of Covid infections has spiked amid the omicron-spurred wave of the pandemic, the Centers for Disease Control and Prevention said Friday that Moderna and Pfizer boosters were 90% effective at preventing people infected with the new variant from being hospitalized.

Speaking to Yahoo Finance on Thursday, Jefferies analyst Michael Yee said the “overly high expectations” set last year, as Moderna’s Covid-19 vaccine became widely available to the public, will “lead to challenges . . . as people digest” what’s next for the firm beyond Covid vaccines.

Yee said the recent stock drawback has helped put Moderna’s valuation in line with other biotechnology competitors, but he warned analysts increasingly expect Covid vaccine sales—currently Moderna’s sole revenue source from a commercialized product—will fall over the next few years as the pandemic becomes endemic and competition heats up among treatment and prevention options.

Moderna’s stock plunge has pulled prices down so much that Bank of America analyst Geoff Meacham told investors in a Friday note that its valuation is now “back to earth” after its meteoric rise during the pandemic.

Meacham said he’s now focused on the company’s pipeline beyond Covid (Moderna is also developing a flu vaccine), pointing to the firm’s massive $17 billion in cash as a source of “strategic” opportunity.

In a Friday note, UBS analyst Eliana Merle was more optimistic about Moderna’s prospects, calling its mRNA technology a disruptive force in the $35 billion annual vaccine market and saying its success with Covid-19 suggests a high likelihood of success for other vaccine targets.

Shares of Moderna have plunged 67% from an all-time closing high of $484 on August 9, wiping out about $133 billion from the firm’s market capitalization, which now stands at roughly $65 billion.

Though it skyrocketed 143% to land the S&P 500’s third-best gain in 2021, Moderna stock has plummeted 35% this year—even worse than Netflix, which is down 32% after a steep 20% plunge Friday following a disappointing earnings report. To compare, Devon Energy and Marathon Oil, last year’s top- and second-best-performing stocks in the S&P, have climbed 7% and 11% this year, respectively.

$5.3 billion. That’s how much Moderna CEO Stéphane Bancel, who joined the firm in 2011, is worth Friday, according to Forbes. The French native owns a roughly 8% stake in Moderna and was at one point worth more than $12 billion.

Founded in 2010, Cambridge, Massachusetts-based Moderna spent nearly a decade developing the technology for its messenger RNA vaccines, which tell the body to produce part of a pathogen to trigger an immune response—unlike traditional vaccines that instead use a piece of the pathogen.

Once the pandemic hit, the company doubled down on the efforts and filed for an emergency use authorization for its Covid-19 vaccine in November 2020. The shots have proven to be a massive boon for businesses heading up their development, but Moderna shares have struggled in recent months as critics increasingly question whether or not sales of Covid-19 vaccines alone will prove a viable revenue stream in years to come.

In November, the company reported third-quarter sales and earnings that failed to meet analysts’ expectations, with revenue falling short of $5 billion, despite average analyst projections calling for $6.2 billion. In addition to lower sales projections, supply chain constraints and the development of antiviral Covid-19 treatments have also dented investor sentiment—and triggered Moderna stock selloffs.

Moderna is expected to report fourth-quarter earnings by the end of February.

Shares of Moderna plunged 17% shortly after the market opened Thursday, wiping out more than $24 billion in market value and pushing prices to a three-month low of $287.

Triggering the morning crash, Moderna on Thursday reported third-quarter sales and earnings that failed to meet analysts’ expectations, with revenue falling short of $5 billion despite average analyst projections calling for $6.2 billion.

In a conference call, Moderna CEO Stéphane Bancel blamed a “more complex” supply-chain environment for the disappointing performance, adding that longer delivery times for international shipments may shift some deliveries to early 2022, instead of 2021’s fourth quarter.

Moderna said it now expects to deliver between 700 million and 800 million Covid-19 vaccine doses this year, down from previous projections calling for between 800 million and 1 billion doses; sales should now fall between $15 billion and $18 billion, instead of the $20 billion originally projected, the company said.

Covid-19 vaccines, which are Moderna’s only commercialized product, have proven to be highly effective in preventing serious illness and the market’s best defense against the virus—making them a massive boon to a slew of businesses heading up their development.However, Moderna shares have struggled in recent months as critics increasingly question whether or not sales of Covid-19 vaccines will prove a viable revenue stream in years to come.

In August, Bank of America sparked one of the biggest selloffs in Moderna’s history after saying future sales expectations don’t justify the company’s current valuation. The analysts warned that lower-than-expected vaccine sales and more intense competition as Covid-19 research advances marked the biggest risks to Moderna stock prices.

Despite its recent weakness, Moderna is still the S&P’s best-performing component this year, with shares skyrocketing about 200% thanks to the company’s Covid-19 vaccine becoming widely available across the world. Still, shares have crashed nearly 40% from an all-time closing high of $484 on August 9.

$9.5 billion. That’s how much Bancel, who joined Moderna in 2011, is worth as of 10:00 a.m. EDT Thursday, according to Forbes. The French native, who owns a roughly 8% stake in Moderna, has seen his fortune plunge by about $1.6 billion as a result of the stock’s rout on Thursday.

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I’m a senior reporter at Forbes focusing on markets and finance. I graduated from the University of North Carolina at Chapel Hill, where I double-majored

Source: Moderna Stock Crash Intensifies: Losses Top $130 Billion After Scientists Find Covid Boosters Aren’t Halting Omicron Infections

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How To Move With Migraines

Migraines are the most common form of headache that can cause severe throbbing pain – usually on one side of the head – and severely affect quality of life. A migraine attack can last hours or days and often comes with nausea, vomiting and extreme sensitivity to light and sound.

According to a 2018 Deloitte Access Economics Report, almost 5 million people in Australia live with migraine, with 7.6% of them – around 400,000 people – experiencing chronic migraine, which means more than 15 migraine days per month.

Migraines are much more common in women than men and more prevalent in working-age people.

“During a flare, all people want to do is lie in a cold dark room and not do anything,” says Adnan Asger Ali, a physiotherapist and the deputy national chair at Musculoskeletal Physiotherapy Australia. But research shows regular exercise may have a preventive effect in reducing the number and intensity of migraines. One of the main reasons physical activity may help relieve migraines, says Ali, is that the body releases endorphins (natural painkillers) during exercise.

“Physical therapy can complement the pharmacological management of migraines,” he says. “It might mean that they take two Panadol instead of two codeine, and that’s still going to be a win because they’re not taking the hard stuff.”

A proper physical assessment is necessary to tailor a treatment plan to the individual, and individuals should consult with a health professional before embarking on a new exercise regime, but here are some suggestions on physical exercise that might help manage migraine.

The class: yoga and tai chi

Ali says slow movements, meditation and relaxation have significant beneficial effects on people who suffer from migraines. That includes activities such as yoga and tai chi.

In a recent randomized clinical trial that involved 114 patients aged 18 to 50 years with a diagnosis of episodic migraine, researchers found that people who practised yoga as an add-on therapy had less frequent and less intense migraines than those who received medical treatment alone.

Tai chi can also serve as a preventive measure for migraines. In a 2018 randomised controlled trial of 82 Chinese women with episodic migraines, researchers found that after 12 weeks of tai chi training, the women experienced significantly fewer migraine attacks.

The move: chin tuck

Neck stiffness and postural issues can be a driver for migraines, says Ali. He suggests the chin tuck, or cervical retraction, exercise to strengthen neck muscles and improve mobility.

The chin tuck exercise can be performed standing or sitting. Begin by sitting upright and looking straight ahead, keeping your neck and shoulders relaxed. Place a finger on your chin and gently glide your chin down – tuck your chin to your neck. Don’t hold your breath, move your head up or down or bend your neck forward.

You might feel a gentle pull at the base of the head and top of the neck. Hold the position for about five seconds and repeat the exercise 10 times – as long as it doesn’t cause any pain.

The activity: walking, jogging, running and cycling

Aerobic exercises such as walking, jogging, running and cycling might help mitigate migraine.

A systematic review of studies on exercise and migraine published in The Journal of Headache and Pain in 2019 found that moderate-intensity exercise – physical activities that elevate your heart rate and cause you to breathe harder but still allow you to carry on a conversation – can decrease the number of migraine days.

“Any activity that people will do consistently and that they enjoy will be good for them,” says Ali.

The hard pass: high-intensity interval training

Ali warns against HIIT workouts, which alternate short bursts of intense cardio exercise with rest or lower-intensity exercise. “Very high-intensity exercise is discouraged if it triggers your migraine,” he says.

In some people, high-intensity exercise can trigger a migraine attack. But research has shown that regular HIIT workouts might be more beneficial than moderate exercise for others, highlighting the importance of a personalized exercise plan.

By: Manuela Callari

Source: How to move: with migraines | Life and style | The Guardian

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Definition:

The main symptom of a migraine is usually an intense headache on 1 side of the head. The pain is usually a moderate or severe throbbing sensation that gets worse when you move and prevents you carrying out normal activities. In some cases, the pain can occur on both sides of your head and may affect your face or neck.

Additional symptoms

Other symptoms commonly associated with a migraine include:

  • feeling sick
  • being sick
  • increased sensitivity to light and sound, which is why many people with a migraine want to rest in a quiet, dark room

Some people also occasionally experience other symptoms, including:

Not everyone with a migraine experiences these additional symptoms and some people may experience them without having a headache. The symptoms of a migraine usually last between 4 hours and 3 days, although you may feel very tired for up to a week afterwards.

Symptoms of aura

About 1 in 3 people with migraines have temporary warning symptoms, known as aura, before a migraine.

These include:

  • visual problems – such as seeing flashing lights, zig-zag patterns or blind spots
  • numbness or a tingling sensation like pins and needles – which usually starts in 1 hand and moves up your arm before affecting your face, lips and tongue
  • feeling dizzy or off balance
  • difficulty speaking
  • loss of consciousness – although this is unusual

Aura symptoms typically develop over the course of about 5 minutes and last for up to an hour. Some people may experience aura followed by only a mild headache or no headache at all.

When to get medical advice

You should see a GP if you have frequent or severe migraine symptoms that cannot be managed with occasional use of over-the-counter painkillers, such as paracetamol. Try not to use the maximum dosage of painkillers on a regular or frequent basis as this could make it harder to treat headaches over time.

You should also make an appointment to see a GP if you have frequent migraines (on more than 5 days a month), even if they can be controlled with medicine, as you may benefit from preventative treatment. You should call 999 for an ambulance immediately if you or someone you’re with experiences:

References:

  • Paralysis or weakness in 1 or both arms or 1 side of the face
  • stroke or meningitis, and should be assessed by a doctor as soon as possible.

 

At-Home Covid Tests Are Getting Better

As many of us rush around trying to find the perfect Thanksgiving turkey and holiday gifts, there’s another thing experts recommend we stock up on: at-home tests for Covid-19.

“At-home testing will be essential over the next few months,” said Leana Wen, an emergency physician and professor of health policy at George Washington University.

The most common form of at-home testing is the rapid antigen test — think BinaxNOW, QuickVue, or Ellume — where you swab your own nostrils and get results back in around 15 minutes. These can be found at your local pharmacy, though supply has been erratic (more on this below). Antigen tests are typically contrasted with molecular tests — think lab-based PCR — which are better at picking up the virus, though you have to get swabbed by a professional and then wait, sometimes several days, until results come back.

Now, however, companies like Cue Health and Detect are selling a new class of tests: molecular tests that can be performed entirely at home. They promise PCR-quality results in under an hour — all without ever having to get up off your couch.

If you can find and afford at-home tests — whether they’re the relatively cheap antigen tests or their more expensive molecular cousins — experts say it will be particularly useful for you to have them on hand this fall and winter, for a few reasons.

For Americans who got their first two doses this spring, immunity may well be waning. Data so far shows the vaccines’ effectiveness against infection tapers off around the six-month mark. And so far, only 18 percent of Americans have gotten a booster shot (though that may well rise now that all adults are eligible). That, together with the fact that infection rates are climbing in the US, means breakthrough cases are likely to rise here, as they’ve already begun to do in Europe. And with the weather getting colder and the holidays coming, we’re all going to be spending more time indoors with others.

To be clear, if you’re fully vaccinated, the data shows you’re still well protected from severe disease or death from Covid-19, and reported infections in the US are so far still mainly among unvaccinated people. But should you get a breakthrough infection, you could infect others who are unvaccinated, have waning immunity, or are elderly and thus more at risk for severe illness even if they are vaccinated. That’s what testing can prevent.

“We need to shift from thinking about at-home testing as just a diagnostic tool to thinking about it as a preventative tool,” said Wen, who recommends taking a test before an indoor social gathering even if you’re not feeling symptoms.

Neil Sehgal, a health policy professor at the University of Maryland School of Public Health, told me he’s about to fly from Washington, DC, to California to spend Thanksgiving with relatives there. Everyone in his family plans to take a rapid test before the holiday meal, he said, to help ensure they don’t pose a risk to others.

“The challenge right now is that even if you are vaccinated, your breakthrough infection is a link in a chain that may end up infecting somebody for whom consequences may be more serious than for you,” Sehgal told me. “We all have to make a decision about whether or not we want to participate in those chains of transmission.”

Likewise, Wen said she’s planning to use rapid tests for holiday get-togethers. She also finds them useful for birthday parties and dinner parties; now that it’s getting too cold for outdoor meals, her family and her invited guests test before gathering in her home.

Both experts noted that there’s an additional reason why it’s useful to keep a few tests in your house in the coming months: Antiviral pills for Covid-19, produced by Merck and Pfizer, will probably soon be available in the US under an emergency use authorization. But these treatments are most effective if you take them soon after you’ve become infected. That means it’s in your interest to catch the virus early on — and having a test close to hand can help you do that.

It shouldn’t be so hard to get at-home tests. Here’s what went wrong.

One issue clouds these expert recommendations: The availability of at-home test kits has been spotty at best.

An American, looking at how easy it is to snag a rapid test across the pond in the UK or Germany, could be forgiven for feeling a pang of envy — and a hefty dose of frustration. More than a year and a half into the pandemic, over-the-counter antigen tests are often sold out at stores like CVS or Walgreens.

Despite the Biden administration’s decision to invest $1 billion in rapid tests, the market remains constrained, in part because of regulatory hurdles. Early on, the US decided to categorize these tests as medical devices, which means they needed to pass a stringent FDA approval process, Sehgal explained. As a result, only a few companies’ tests squeezed through to market in 2021.

“We’ve been slow to adopt and approve them in the US because they’re not as sensitive as PCR tests,” Sehgal said. But even though antigen tests are not foolproof at detecting the virus, “they are sensitive enough to give you a pretty realistic sense of whether you pose a risk to the people you’re gathering with” — that is, of whether you’re actively contagious.

“I do think a more public-health-minded mental model would have led to quicker approval of more rapid antigen testing options,” Sehgal continued. In other words, the US should have conceived of the tests as a harm reduction measure: We know they’re not perfect, but if we deploy them at scale, they’ll reduce harm overall.

“The FDA would still have to approve them under an emergency use authorization to make it to market, but the urgency with which the FDA has acted with vaccines could have been similarly applied to testing. If so, I think we’d have seen earlier approvals for more domestic manufacturers of rapid tests,” he added.

Another reason for the low stock is simply that bigger purchasers snapped up a lot of the tests early on. Companies, sports teams, and school systems placed bulk orders in the spring and ate up a lot of the stock before the general public could get to it. “They made contracts because they knew that to resume in-person activity, this would be a good strategy,” Sehgal said.

The upshot is that when regular individuals walk into their drugstores to try and buy a couple boxes, there’s not much left on the shelf.

Under the Trump administration, officials at times appeared to discourage testing, for fear that it would reveal more positive cases. Instead, the US focused on developing vaccines at warp speed, thinking of them as the silver bullet that would destroy the pandemic.

But this fall, the Biden administration decided to make testing a more integral part of its pandemic strategy. White House coronavirus response coordinator Jeff Zients said in October that the $1 billion investment “puts us on track to quadruple the amount of at-home, rapid tests available for Americans by December. So that means we’ll have available supply of 200 million rapid, at-home tests per month starting in December.”

Many experts hailed it as a welcome, if overdue, commitment.

“What rapid tests do is they allow us to live more peacefully with this virus — to actually be able to not have it be so disruptive to society,” Michael Mina, an epidemiologist who’s been one of the most vocal proponents of rapid tests, told the Washington Post. These tests can make quarantines unnecessary, allowing us “to keep students in school, to keep businesses running and to stop the need for shutdowns, even amid outbreaks.”

The next generation of at-home tests

Up till now, at-home testing has been pretty much synonymous with antigen tests, such as BinaxNOW or QuickVue. Overall, these tests’ sensitivity tends to be in the range of 85 percent, meaning they miss about 15 percent of people who are infected. That said, they’re very good at detecting an infection when people have high viral loads, which is when they’re likeliest to infect others.

Molecular tests are considered the gold standard in Covid-19 testing. They take your sample and amplify the genetic material in it many times over, so if there’s even a tiny shred of virus in it, they will almost certainly detect it. Traditionally, the downside has been that you need a professional to swab you and a lab to process your results.

At-home molecular testing is starting to change that. This month, the health tech company Cue Health began selling directly to consumers a molecular test that can be performed entirely at home. You can buy it online, no prescription needed, and get lab-quality results without leaving home, according to the company. The Cue test shows results in line with lab PCR results 97.8 percent of the time, as verified in an independent study conducted by the Mayo Clinic.

And it’s quick, offering results in 20 minutes, similar to the wait time for antigen tests. There’s a catch, though: It’s not cheap. A three-pack of single-use tests will run you $225, and that’s not counting the reusable reader, which costs $250. At that price point, it’s far from ripe for equitable access. (For comparison, antigen tests are priced from about $10 to $40 per test.)

“We’re not priced like an antigen test, but we don’t perform like an antigen test,” said Clint Sever, Cue’s co-founder and chief product officer, adding that the test is used by the likes of Google, NASA, and the NBA. “It’s a breakthrough technology.”

Detect is another health tech company offering an at-home molecular test (the product will be available soon). This one will also come with a reusable hub and single-use individual tests. With the hub priced at $39 and each test at $49, Detect’s system will be more affordable than Cue’s, though still pricier than an antigen test. The Detect test is 97.3 percent accurate, similar to a PCR lab test, according to Axios. It returns results in one hour.

Both Cue’s and Detect’s tests have earned an emergency use authorization from the FDA, and both companies have their sights set on much more than just Covid-19 testing. With a bit of tweaking, their platforms should be able to test for other health issues, too.

Detect’s plan “is that you’ll be able to get a flu test or a Covid test or whatever you need, at home,” Owen Kaye-Kauderer, the company’s chief business officer, told Axios.

Cue envisions a future where its reader will be able to test you for everything from the flu and strep throat to chlamydia and gonorrhea. “Covid has basically accelerated the transition to virtual care services and connected diagnostics,” Sever told me.

The fundamental innovation here — giving your humble home the diagnostic capabilities of a professional lab — will likely become popular in many areas of health care over the next few years. That helps explain why companies like Cue and Detect are eager to get into the game, even though many experts say that as we approach springtime, Covid-19 will likely be entering the endemic phase: It’ll keep circulating in parts of the population, but its prevalence and impact will come down to relatively manageable levels, so it becomes more like the flu than a world-stopping disease.

“When we get to the point where transmission has slowed and we enter the endemic phase,” Sehgal said, “at-home testing becomes much less important.”

In the meantime, Wen recommends that each family keep a few at-home tests in the house. Don’t fret too much about whether they’re antigen or molecular; get what you can find and afford.

“This is a case of ‘don’t let the perfect be the enemy of the good,’” she said. “These tests can allow us to go from Covid-19 as a threat that feels almost existential to just another risk among all the risks we take into account every day. They can let us get back the normalcy we’re craving.”

Sigal Samuel

Source: At-home Covid tests are getting better. Stock up for winter holidays. – Vox

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How Will the COVID Pills Change the Pandemic?

In March, 2020, researchers at Emory University published a paper about a molecule called NHC/EIDD-2801. At the time, there were no treatments available for the coronavirus. But NHC/EIDD-2801, the researchers wrote, possessed “potency against multiple coronaviruses,” and could become “an effective antiviral against SARS-CoV-2.” A few days later, Emory licensed the molecule to Ridgeback Biotherapeutics, a Miami-based biotechnology company which had previously developed a monoclonal antibody for Ebola.

Ridgeback partnered with the pharmaceutical giant Merck to accelerate its development.The Emory researchers named their drug molnupiravir, after Mjölnir—the hammer of Thor. It turns out that this was not hyperbole. Last month, Merck and Ridgeback announced that molnupiravir could reduce by half the chances that a person infected by the coronavirus would need to be hospitalized. The drug was so overwhelmingly effective that an independent committee asked the researchers to stop their Phase III trial early—it would have been unethical to continue giving participants placebos.

None of the nearly four hundred patients who received molnupiravir in the trial went on to die, and the drug had no major side effects. On November 4th, the U.K. became the first country to approve molnupiravir; many observers expect that an emergency-use authorization will come from the U.S. Food and Drug Administration in December.

Oral antivirals like molnupiravir could transform the treatment of COVID-19, and of the pandemic more generally. Currently, treatments aimed at fighting COVID—mainly monoclonal antibodies and antiviral drugs like remdesivir—are given through infusion or injection, usually in clinics or hospitals. By the time people manage to arrange a visit, they are often too sick to receive much benefit. Molnupiravir, however, is a little orange pill.

A person might wake up, feel unwell, get a rapid COVID test, and head to the pharmacy around the corner to pick up a pack. A full course, which needs to start within five days of the appearance of symptoms, consists of forty pills—four capsules taken twice a day, for five days. Merck is now testing whether molnupiravir can prevent not just hospitalization after infection but also infection after exposure.

If that’s the case, then the drug might be taken prophylactically—you could get a prescription when someone in your household tests positive, even if you haven’t.Molnupiravir is—and is likely to remain—effective against all the major coronavirus variants. In fact, at least in the lab, it works against any number of RNA viruses besides SARS-CoV-2, including Ebola, hepatitis C, R.S.V., and norovirus. Instead of targeting the coronavirus’s spike protein, as vaccine-generated antibodies do, molnupiravir attacks the virus’s basic replication machinery. The spike protein mutates over time, but the replication machinery is mostly set in stone, and compromising that would make it hard for the virus to evolve resistance.

Once it’s inside the body, molnupiravir breaks down into a molecule called NHC. As my colleague Matthew Hutson explained, in a piece about antiviral drugs published last year, NHC is similar to cytosine, one of the four “bases” from which viral RNA is constructed; when the coronavirus’s RNA begins to copy itself, it slips into cytosine’s spot, in a kind of “Freaky Friday” swap. The molecule evades the virus’s genetic proofreading mechanisms and wreaks havoc, pairing with other bases, introducing a bevy of errors, and ultimately crashing the system.

A drug that’s so good at messing with viral RNA has led some to ask whether it messes with human DNA, too. (Merck’s trial excluded pregnant and breast-feeding women, and women of childbearing age had to be on contraceptives.) This is a long-standing concern about antiviral drugs that introduce genomic errors. A recent study suggests that molnupiravir, taken at high doses and for extended periods, can, in fact, introduce mutations into DNA. But, as the biochemist Derek Lowe noted, in a blog post for Science, these findings probably don’t apply directly to the real-world use of molnupiravir in COVID patients. The study was conducted in cells, not live animals or humans.

The cells were exposed to the drug for more than a month; even at the highest doses, it caused fewer mutations than were created by a brief exposure to ultraviolet light. Meanwhile, Merck has run a battery of tests—both in the lab and in animal models—and found no evidence that molnupiravir causes problematic mutations at the dose and duration at which it will be prescribed.With winter approaching, America is entering another precarious moment in the pandemic. Coronavirus cases have spiked in many European countries—including some with higher vaccination rates than the U.S.—and some American hospitals are already starting to buckle under the weight of a new wave. Nearly fifty thousand Americans are currently hospitalized with COVID-19.

It seems like molnupiravir is arriving just when we need it.It isn’t the only antiviral COVID pill, either. A day after the U.K. authorized Merck’s drug, Pfizer announced that its antiviral, Paxlovid, was also staggeringly effective at preventing the progression of COVID-19 in high-risk patients. The drug, when taken within three days of the onset of symptoms, reduced the risk of hospitalization by nearly ninety per cent. Only three of the nearly four hundred people who took Paxlovid were hospitalized, and no one died; in the placebo group, there were twenty-seven hospitalizations and seven deaths. Paxlovid is administered along with another antiviral medication called ritonavir, which slows the rate at which the former drug is broken down by the body.

Like Merck, Pfizer is now examining whether Paxlovid can also be used to prevent infections after an exposure. Results are expected early in 2022. (It’s not yet known how much of a difference the drugs will make for vaccinated individuals suffering from breakthrough infections; Merck’s and Pfizer’s trials included only unvaccinated people with risk factors for severe disease, such as obesity, diabetes, or older age. Vaccinated individuals are already much less likely to be hospitalized or die of COVID-19.)

Living in an Age of ExtinctionPaxlovid interrupts the virus’s replication not by messing with its genetic code but by disrupting the way its proteins are constructed. When a virus gets into our cells, its RNA is translated into proteins, which do the virus’s dirty work. But the proteins are first built as long strings called polypeptides; an enzyme called protease then slices them into the fragments from which proteins are assembled.
If you can’t cut the plywood, you can’t build the table, and Paxlovid blunts the blade. Because they employ separate mechanisms to defeat the virus, Paxlovid and molnupiravir could, in theory, be taken together. Some viruses that lead to chronic infections, including H.I.V. and hepatitis C, are treated with drug cocktails to prevent them from evolving resistance against a single line of attack. This approach is less common with respiratory viruses, which don’t generally persist in the body for long periods.
But combination antiviral therapy against the coronavirus could be a subject of study in the coming months, especially among immunocompromised patients, in whom the virus often lingers, allowing it the time and opportunity to generate mutations.

Merck will be producing a lot of molnupiravir. John McGrath, the company’s senior vice-president of manufacturing, told me that Merck began bolstering its manufacturing capacity long before the Phase III trial confirmed how well the drug worked. Normally, a company assesses demand for a product, then brings plants online slowly. For molnupiravir, Merck has already set up seventeen plants in eight countries across three continents. It now has the capacity to produce ten million courses of treatment by the end of this year, and at least another twenty million next year.

It expects molnupiravir to generate five to seven billion dollars in revenue by the end of 2022.How much will all these pills soften the looming winter surge? As has been true throughout the pandemic, the answer depends on many factors beyond their effectiveness. The F.D.A. could authorize molnupiravir within weeks, and Paxlovid soon afterward. But medications only work if they make their way into the body. Timing is critical. The drugs should be taken immediately after symptoms start—ideally, within three to five days. Whether people can benefit from them depends partly on the public-health infrastructure where they live. In Europe, rapid at-home COVID tests are widely available.

Twenty months into the pandemic, this is not the case in much of the U.S., and many Americans also lack ready access to affordable testing labs that can process PCR results quickly.Consider one likely scenario. On Monday, a man feels tired but thinks little of it. On Tuesday, he wakes up with a headache and, in the afternoon, develops a fever. He schedules a COVID test for the following morning. Two days later, he receives an e-mail informing him that he has tested positive. By now, it’s Friday afternoon. He calls his doctor’s office; someone picks up and asks the on-call physician to write a prescription. The man rushes to the pharmacy to get the drug within the five-day symptom-to-pill window.

Envision how the week might have unfolded for someone who’s uninsured, elderly, isolated, homeless, or food insecure, or who doesn’t speak English. Taking full advantage of the new drugs will require vigilance, energy, and access.Antivirals could be especially valuable in places like Africa, where only six per cent of the population is fully vaccinated. As they did with the vaccines, wealthy countries, including the U.S. and the U.K., have already locked in huge contracts for the pills; still, Merck has taken steps to expand access to the developing world.

It recently granted royalty-free licenses to the Medicines Patent Pool, a U.N.-backed nonprofit, which will allow manufacturers to produce generic versions of the drug for more than a hundred low- and middle-income countries. (Pfizer has reached a similar agreement with the Patent Pool; the company also announced that it will forgo royalties for Paxlovid in low-income countries, both during and after the pandemic.) As a result, a full course of molnupiravir could cost as little as twenty dollars in developing countries, compared with around seven hundred in the U.S. “Our goal was to bring this product to high-, middle-, and low-income countries at fundamentally the same time,” Paul Schaper, Merck’s executive director of global pharmaceutical policy, told me.

More than fifty companies around the world have already contacted the Patent Pool to obtain a sublicense to produce the drug, and the Gates Foundation has pledged a hundred and twenty million dollars to support generic-drug makers. Charles Gore, the Patent Pool’s executive director, recently said that, “for large parts of the world that have not got good vaccine coverage, this is really a godsend.” Of course, the same challenges of testing and distribution will apply everywhere.

Last spring, as a doctor caring for COVID patients, I was often dismayed by how little we had to offer. We tried hydroxychloroquine, blood thinners, and various oxygen-delivery devices and ventilator maneuvers; mostly, we watched as patients got better or got worse on their own. In the evenings, as I walked the city’s deserted streets, I often asked myself what kinds of treatment I wished we had. The best thing, I thought, would be a pill that people could take at home, shortly after infection, to halt the cascade of biological processes that sends them to the hospital, the I.C.U., or worse.

We will soon have not one but two such treatments. Outside of the vaccines, the new antiviral drugs are the most important pharmacologic advance of the pandemic. As the coronavirus becomes endemic, we’ll need additional tools to treat the inevitable infections that will continue to strike both vaccinated and unvaccinated people. These drugs will do that, reducing the damage that the coronavirus can inflict and, possibly, cordoning off avenues through which it can spread. Still, insuring that they are meaningfully and equitably used will require strength in the areas in which the U.S. has struggled: early and accessible testing; communication and coördination across health-care providers; fighting misinformation and building trust in rapid scientific advances. Just as vaccines don’t help without shots in arms, antivirals can’t work without pills in people.

 

Source: https://www.newyorker.com/

More on the Coronavirus

How Connected Life Sciences Devices Lead To Continuous Care

With connected medical devices, apps and data, life sciences organizations can bridge long-standing gaps in healthcare and deliver a more continuous care experience, says Brian Williams, Cognizant’s Chief Digital Officer for Life Sciences.

Global health systems have traditionally delivered services episodically, by focusing on acute, critical care rather than individual health and well-being. It should come as no surprise, then, that life sciences companies often deliver their solutions following that same model of care.

Sadly, this leads to gaps in data and service alignment, not to mention significant disconnects with the broader healthcare ecosystem. Consumer devices and wellness apps, for example, often exist within their own individual siloes — causing organizations to miss out on valuable data that could inform patient diagnosis, management and treatment.

This lack of orchestration produces sub-optimal outcomes at significant expense to providers, payers and patients alike. It is also at direct odds with patients’ increasing digital expectations when using medical devices and when taking drugs and therapies. Whether they are participating in a clinical trial, living with a chronic condition or recovering from a procedure, patients expect to be informed and cared for with seamless digital experiences on par with what they receive when shopping or banking online.

However, the emergence of integrated, connected devices, apps and data has opened new possibilities for treatments and clinical trials. This new level of connectivity helps bridge a longstanding gap in wellness: the disconnect between an individual’s everyday health behavior and their episodic healthcare. These experiences generate valuable data insights, creating new commercial opportunities and the promise of better patient outcomes.

The impact of life sciences connectivity

Drawing from our recent series on healthcare IoT, here are three stakeholder groups within the healthcare and life sciences ecosystem that stand to benefit greatly from this new level of connectivity and the more continuous, predictive and preventive care it enables.

  • Patients with chronic conditions. Chronic diseases are often accompanied by additional conditions, such as depression, that can impede effective treatment. Consequently, information about an individual’s behavioral health status has become increasingly important in treatment decisions, as has information about the individual’s relationships with the people around them.
  • Wearable IoT devices that monitor fitness and health conditions can pair with an ever-growing set of apps for health, wellness and nutrition monitoring. Over time, a baseline of physiological indicators such as an individual’s heart rate and blood pressure, as well as activity, diet and sleep patterns, will develop. When additional data from clinical encounters, including diagnostic imaging, lab tests, genomics, stress tests and physician notes, is integrated with that baseline, it increases the ability to predict how an individual may respond to any particular treatment.
  • Elderly patients. Quite often, the most effective tools for early detection of a developing condition in elderly patients are not implants or biometric monitors, but devices that monitor changes in activities of daily living (ADL).
  • For example, the onset of congestive heart failure can be detected through reduced use of the bed, as patients with trouble breathing when lying down switch to sleeping semi-upright in a recliner. Changes in toilet flushes, meanwhile, can detect a urinary tract infection or incipient dehydration. Moreover, while one in four Americans over 65 falls each year, only half tell their doctor.
  • Passive infrared motion detectors, pressure sensors in beds and chairs, sensors for CO2 concentration, sound (vibration) and video — anonymized as necessary for privacy — can all be used to first establish a baseline of normal variability, and then be applied to detect significant deviations from that baseline. This continuous and nearly invisible sensing can be surprisingly effective in assisting in care.
  • Hospital clinicians and support staff. Healthcare is increasingly a team enterprise — including not only physicians, nurses, allied health staff and technicians but also AI-enabled equipment. The point of care is also expanding, with shortened hospital stays and more care delivered in outpatient facilities and in-home settings.
  • Connected sensors enable every member of the team to access to real-time data relevant to their task. Smart hospitals with a real-time health system (RTHS) can leverage sensors to collect data widely, distill and analyze it — and then quickly distribute curated findings to users. When captured remotely, this eases the transition in care from the hospital to other settings, allowing a more continuous and participatory level of care that extends long past a patient’s physical stay in a healthcare facility.
  • An RTHS can improve operations, clinical tasks and patient experience. For example, providers that boost operational effectiveness typically rely on a wide range of IoT-enabled asset management solutions that locate mobile assets, monitor equipment operating conditions and track inventories of consumables, pharmaceuticals and medical devices. This optimizes equipment utilization, reduces waste, increases equipment uptime and ensures optimal inventories.
  • Once clinicians and support staff can view how long various steps take in their workflows, where delays occur and what patients experience as a result, they can then evolve solutions based on a combination of their intimate day-to-day knowledge and data on how that workflow interacts with or is used by other functions.

From episodic to continuous care

Too often, the life sciences industry has delivered a one-size-fits-all approach to clinical trials and patient care that may not represent real-life, individual situations — situations that require tailored engagement that wrap therapies and interventions in end-to-end, digital solutions.

This can and should change. Device connectivity and access to data are impacting every aspect of healthcare and life sciences, moving the industry away from acute, episodic care, to a system that is more participatory and predictive.

For example, a patient may be walking a mere 24 hours after a typical hip surgery and could be discharged from the hospital a day or two after the procedure. However, that episodic care experience belies a much longer recovery and rehabilitation period spanning weeks or months.While that care experience today takes place largely outside the purview of the orthopedic surgeon, better device connectivity can enable patient monitoring — and even patient services — to be extended well beyond the length of the initial hospital visit.

Rather than relying on spotty reporting from physical therapists or the patients themselves, an orthopedist can continuously and seamlessly track a patient’s progress, and then decide when and how to intervene if things aren’t going as expected. Zimmer’s mymobility application, which supports patient engagement and monitoring outside the hospital following surgery, is a good example of what this looks like in practice.

A fully orchestrated ecosystem

Sensors and instrumentation — and the hundreds of APIs that connect them — can provide accurate and timely data about many parameters of the human condition. When this is all properly orchestrated, we can better understand how diseases progress and how bodies respond to various interventions.

That’s the intent behind our alliance with Philips and its HealthSuite Digital Platform, which is built on AWS and designed to simplify and standardize device connectivity, data access, identity management, and structured and unstructured data management within a high-trust, HIPAA and GDPR-compliant environment.

We believe that life sciences companies can derive true value from this influx of new data. Not only can the resulting insights inform new services, drugs and therapies and inspire new models of continuous engagement; they can also improve adherence to treatment and patient health.

To learn more, visit the Life Sciences section of our website.

Brian is Cognizant’s Chief Digital Officer for Life Sciences and is responsible for designing digitally enabled solutions to facilitate care access and delivery. He is also the Global Life Sciences Consulting

Source: How Connected Life Sciences Devices Lead To Continuous Care

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Related Contents:

M. Birkholz; A. Mai; C. Wenger; C. Meliani; R. Scholz (2016). “Technology modules from micro- and nano-electronics for the life sciences”. WIREs Nanomed. Nanobiotech. 8 (3): 355–377. doi:10.1002/wnan.1367. PMID 26391194

“What is Biomonitoring?” (PDF). American Chemistry Council. Archived from the origin(2005-04-08). Natural Fibers, Biopolymers, and Biocomposites. CRC Press. ISBN 978-0-203-50820-6.

National Human Genome Research Institute (2010-11-08). “FAQ About Genetic and Genomic Science”

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