Tag: antibody

Pfizer Sues Employee, Alleging She Stole Covid-19 Vaccine Documents

Pfizer is suing one of its employees after she allegedly stole thousands of the company’s files with the intent to take a job with one of its competitors, with some of the files including information about the Covid-19 vaccine.

Key Facts

In a complaint filed Tuesday in San Diego federal court, Pfizer alleged one of its associate directors of statistics, Chun Xiao Li, uploaded over 12,000 files to her personal devices from a company issued laptop without permission.

Pfizer said it believes Li was offered a job at one of its competitors—Xencor Inc., a biopharmaceutical company. Pfizer claims Li is still in possession of a laptop containing documents “potentially related to numerous Pfizer vaccines, drugs, and other innovations,” with the complaint specifically focusing on information she allegedly has pertaining to the Covid-19 vaccine and monoclonal antibodies.

The drug company claimed Li tried to mislead it by providing a “decoy” laptop when they confronted her about the issue.

A U.S. district judge ordered a temporary block on Tuesday, halting Li from using any of Pfizer’s trade secrets, according to Reuters. Li did not respond to Reuters’ request for comment.

Crucial Quote

“Had Ms. Li left Pfizer honorably, she would not be named in this Complaint. But she made a different choice,” Pfizer wrote.

Key Background

Pfizer noted in the complaint that competitors have been trying “relentlessly” to recruvaccineit its employees, particularly in 2021.

Tangent

On Monday, the company announced its Covid-19 vaccine demonstrated 100% efficacy in adolescents ages 12-15. It plans to submit the vaccine for full regulatory approval in the age group in the U.S. and internationally.

Mason Bissada

Mason Bissada

I’m a Los Angeles-based news desk reporter for Forbes. Please feel free to contact me via email (mbissada [@] forbes.com) or Twitter (@masonbissada).

Source: Pfizer Sues Employee, Alleging She Stole Covid-19 Vaccine Documents

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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.

 

By : Dhruv Khullar

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

More on the Coronavirus

The COVID Vaccine For Kids Is Almost Here. Let’s Not Forget The Children Who Made This Possible

This week Pfizer and BioNTech said that their COVID-19 vaccine was safe for children aged 5 to 11. If approved by the FDA for emergency use, it could be ready for children as early as late October. Since the emergence of the delta variant, children have accounted for more than one in five new cases, and more children are hospitalized now, as a result of the coronavirus, than at any other time in the pandemic.

The concern and frustration surrounding relatively slow approval of treatment for kids under 12 years old is nothing new. For decades, kids with cancer have had to wait for trials to improve drug options and improve patient outcomes.

The call to do more, faster, has gone unanswered by drug companies who don’t invest in trials for a small number of unprofitable kids and by the National Cancer Institute (NCI), which allocates only 4% of its annual $6.56 billion budget to pediatric cancer and other rare diseases.

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Trials are a key component to curing cancer and achieving vaccine safety, yet come with a caveat that most parents aren’t willing to risk. It feels good to help mankind, but not at the expense of their child’s growing body.

In 2010, my husband and I agreed to send my 4-year-old daughter to trial to treat her stage IV high-risk neuroblastoma. Emily’s oncologist was desperate to enroll kids in the trial and we were desperate to get rid of the cancer. It was the most difficult decision we’ve ever made.

Emily received two back-to-back stem cell transplants. The theory was that two transplants — as opposed to one that was the protocol of care — would be better at killing the tricky neuroblastoma cells that often lurked and caused a relapse.

It would seem a no-brainer to want two opportunities to kill the cancer cells, but it wasn’t. Kids died during the transplants. The amount of chemo they got in one transplant would kill an adult instantly, but kids metabolized it quicker, so they lived, but just barely. Three weeks after being discharged from the first transplant, a kid in the trial would be admitted into the hospital for the second one. If the neuroblastoma didn’t kill them, the trial protocol might.

We wanted to do everything possible to prevent Emily from dying, so we agreed to the trial. We weren’t about to wait around for her cancer.

We watched her claw her way through line infections, thick mucus in her lungs and ICU visits. We doubted whether we made the right decision with every obstacle, especially when she needed surgery to drain seven ounces of liquid from her heart during her second transplant.

We wanted to do everything possible to prevent Emily from dying, so we agreed to the trial. We weren’t about to wait around for her cancer.

Emily almost got kicked out of the trial in the last few months when her damaged kidneys were failing and dipped below the trial parameters. After her tandem stem cell transplants, 21 rounds of radiation, and months of an experimental antibody therapy, she was so close to finishing. Yet somehow, with the help of smart doctors and more medicine, she finished the trial.

After 18 months, the trial was successful in eliminating Emily’s body of neuroblastoma cells, but it stole parts of her she’d never get back.

Emily, who’s now 16, has chronic kidney disease, estrogen levels of a post-menopausal woman, stunted growth, frail hair and a 65% bi-lateral hearing loss from the toxic drugs used during the trial protocol. It’s been the catch-22 of a lifetime: Agreeing to have her participate in a trial that saved her life, but also compromised the quality of it.

About a year after Emily finished treatment, when she was 5, the trial she’d been enrolled in was stopped early. The data showed that the kids who had received two transplants were relapsing less and had a significantly better chance of survival than the kids who had received one transplant. It worked.

As a result, 300 to 400 kids a year who are diagnosed with stage IV neuroblastoma receive the protocol of care that Emily helped pioneer 10 years ago.

Despite the dark days of treatment and unpredictable secondary effects from chemo, I would make the same decision again, and send her into the trial. Emily would agree, though she longs for the hair that didn’t grow back well after treatment. We know how much worse the alternative could have been. She might not be alive, picking out a homecoming dress and watching Tik Tok videos for hours a day. She might be a statistic.

[The COVID vaccine trials] serve as a gatekeeper to kids’ health from a nation that doesn’t like to wait.

And now a nation of parents looks toward science to approve a COVID-19 vaccine to keep their kids from being statistics, too. The American Academy of Pediatrics reported 225,978 child COVID-19 cases last week, nearly 26% of the weekly reported cases. It’s the second-highest total of new diagnoses among children over the course of the pandemic.

As desperate as we are for our children to get their COVID-19 vaccines, the trial pharmaceutical companies are running — and the in-depth data analysis the FDA undertakes — exists to protect millions of kids from adverse effects that can’t be predicted. It serves as a gatekeeper to kids’ health from a nation that doesn’t like to wait.

When the FDA approves a vaccine for kids — and they will — let’s acknowledge the kids who, like Emily, answered the call. They’re the unsung heroes in getting a nation back to health.

Follow Cognoscenti on Facebook and Twitter.

By: Amy McHugh

Cognoscenti contributor
Amy McHugh is a high school teacher on Cape Cod where she lives with her husband, two teenage daughters, and two goldendoodles. She’s helped raise over $750,000 for neuroblastoma research at Dana-Farber’s Jimmy Fund Clinic.

Source: The COVID Vaccine For Kids Is Almost Here. Let’s Not Forget The Children Who Made This Possible | Cognoscenti

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Related Contents:

Five Things You Need to Know to Start Your Day

Delta fears are growing, central banks face challenges and the shape of the U.K. and Europe post-Brexit continues to form. Here’s what’s moving markets.

Delta Fears

Concern about the more contagious Delta coronavirus variant is growing and those fears helped fuel a rise in Moderna shares to a record high after the drugmaker said its vaccine produces protective antibodies against the strain. The medicine was approved for restricted emergency use in India, where little more than 4% of the population is so far fully vaccinated. The variant is rippling through emerging markets, with more curbs in Indonesia and warnings of a potentially “catastrophic” wave in Kenya. A widening gap in vaccination rates in the U.S. also shows the risks faces to certain regions.

Policy Challenges

The major challenge for central banks is going to be how to wean the global economy off the unprecedented support they have deployed to deal with the disruption Covid-19 has caused. U.S. and European confidence data is soaring, underlining the rebound the economy is experiencing, while China’s central bank has also struck a more positive tone. Some more data points will arrive for policymakers to mull over on Wednesday, led by U.K. GDP and European inflation numbers.

Brexit Shifts

Paris is JPMorgan’s new trading center in the European Union post-Brexit as the U.S. banking giant inaugurated a new headquarters in the French capital. It is a victory for France in the ongoing race with other European countries to lure business from London after the referendum to leave the EU. It comes as the U.K. government unveiled a system of overseeing subsidies to companies, promising “more agile” decisions. And the U.K. is expecting to reach a truce in the so-called “sausage wars’’ with the EU over post-Brexit trading rules in Northern Ireland.

OPEC+ Delay

OPEC and its allies have delayed preliminary talks for a day to create more time to find a compromise on oil-output increases. It comes with crude oil prices on track for the best half of a year since 2009. Surging commodity prices are creating all sorts of headaches for policy makers, from rising inflation expectations that could move the hand of central bankers to a higher cost in shifting to more sustainable energy sources. This has initially led to a surge in profit for commodity trading houses but will end up hitting consumers down the road through higher prices.

Asian stocks mostly rose following a record close in the U.S. on signs that vaccines can protect against the delta variant of the coronavirus. European and U.S. stock futures are steady. The earnings calendar is relatively thin but watch for the reaction to two long-running takeover sagas moving toward a conclusion.

EssilorLuxottica, the eyewear giant, decided to go ahead with the acquisition of smaller peer GrandVision and the board of France’s Suez has backed its takeover by rival Veolia. And the Organization for Economic Cooperation and Development meets in Paris to finalize plans to overhaul the global minimum corporate tax.

What We’ve Been Reading

This is what’s caught our eye over the past 24 hours. 

And finally, here’s what Cormac Mullen is interested in this morning

With just one more day of trading in the first half of 2021 to go, global stocks are on track for their second-best performance since 1998. If the MSCI AC World Index’s gain of about 12% through June 29 holds, it would be beaten only by a 15% rise in 2019. The global stock benchmark closed at a record on June 28, and has risen almost 90% since its pandemic low in March 2020.

As we begin the second half, investor focus will soon switch to the upcoming earnings season. The second quarter could well mark peak earnings growth so comments on the outlook will be key for stock performance as will the impact of rising costs on margins. Outside of that, the same themes that dominated the first half will monopolize the second, and whether we get an equally strong next six months will likely depend on the path of other asset classes most notably bonds.

By: and

Source: Stock Markets Today: Delta Variant, Central Banks, Brexit Changes, OPEC+ – Bloomberg

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Critics:

A financial crisis is any of a broad variety of situations in which some financial assets suddenly lose a large part of their nominal value. In the 19th and early 20th centuries, many financial crises were associated with banking panics, and many recessions coincided with these panics. Other situations that are often called financial crises include stock market crashes and the bursting of other financial bubbles, currency crises, and sovereign defaults. Financial crises directly result in a loss of paper wealth but do not necessarily result in significant changes in the real economy (e.g. the crisis resulting from the famous tulip mania bubble in the 17th century).

Many economists have offered theories about how financial crises develop and how they could be prevented. There is no consensus, however, and financial crises continue to occur from time to time. Negative GDP growth lasting two or more quarters is called a recession. An especially prolonged or severe recession may be called a depression, while a long period of slow but not necessarily negative growth is sometimes called economic stagnation.

Some economists argue that many recessions have been caused in large part by financial crises. One important example is the Great Depression, which was preceded in many countries by bank runs and stock market crashes. The subprime mortgage crisis and the bursting of other real estate bubbles around the world also led to recession in the U.S. and a number of other countries in late 2008 and 2009.

Some economists argue that financial crises are caused by recessions instead of the other way around, and that even where a financial crisis is the initial shock that sets off a recession, other factors may be more important in prolonging the recession. In particular, Milton Friedman and Anna Schwartz argued that the initial economic decline associated with the crash of 1929 and the bank panics of the 1930s would not have turned into a prolonged depression if it had not been reinforced by monetary policy mistakes on the part of the Federal Reserve,a position supported by Ben Bernanke.

See also

Specific:

 

 

Regeneron Says Antibody Therapy Prevents COVID-19 Infections

Regeneron Pharmaceuticals is planning to ask the Food and Drug Administration (FDA) to allow its antibody cocktail to be used as a preventive treatment for COVID-19, the company said Monday.

New results from a clinical trial conducted with the National Institute of Allergy and Infectious Diseases found the drug reduced the risk of symptomatic infection by 81 percent in people who were not infected at the start of the trial, Regeneron said.

The company has already received emergency use authorization from the FDA to use its antibody drugs to treat adults with mild to moderate COVID-19 and pediatric patients at least 12 years old who have tested positive for the virus and are at high risk of severe disease but are not yet hospitalized.

The trial enrolled 1,505 people who were not infected with the virus but lived in the same household as someone who recently tested positive. The patients were randomized to receive either one dose of the antibody therapy or a placebo administered as injections.

After 29 days, 11 people out of the 753 who received a single 1,200 mg dose of the treatment developed symptomatic COVID-19; 59 people who received a placebo out of 752 participants developed symptomatic COVID-19.

The drug provided 72 percent protection against symptomatic infections in the first week and 93 percent protection in subsequent weeks, Regeneron said. The data has not yet been peer reviewed or published.

Regeneron also said the trial found individuals treated with the therapy who experienced a symptomatic infection resolved their symptoms in one week, compared to three weeks with placebo. Infected individuals also cleared the virus faster with the therapy, the company said.

Adverse events occurred in 20 percent of patients who received the antibody drug and 29 percent of those who received a placebo, Regeneron said, but nobody withdrew from the trial because of them.

None of the participants who received the therapy were hospitalized or went to the ER because of COVID-19 over the course of 29 days; four in the placebo group did so. There were four deaths in the trial — two in the therapy group and two in the placebo group — but none were reported due to COVID-19 or the drug.

“With more than 60,000 Americans continuing to be diagnosed with COVID-19 every day, the REGEN-COV antibody cocktail may help provide immediate protection to unvaccinated people who are exposed to the virus, and we are also working to understand its potential to provide ongoing protection for immunocompromised patients who may not respond well to vaccines,” George Yancopoulos, president and chief scientific officer at Regeneron, said in a statement.

The trial tested the antibody treatment for use as a “passive vaccine,” which involves directly injecting antibodies into the body. Traditional vaccines rely on a person’s immune system to activate and develop its own antibodies.

That means the treatment may provide immediate benefits, in contrast to active vaccines, which take weeks to provide protection. In addition, using injections rather than an infusion could make administering it more convenient than the currently authorized use for antibody drugs.

While much of the attention has been focused on vaccines, experts say therapeutic treatments are just as important to ending the pandemic, which has killed more than 562,000 Americans.

By Nathaniel Weixel

Source: Regeneron says antibody therapy prevents COVID-19 infections | TheHill

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