Category: Covid-19 Vaccine

Opening up yet another front in the war against COVID-19, the disease caused by the fast-spreadingSARS-CoV-2 coronavirus, GlaxoSmithKline (NYSE:GSK) announced it is contributing to another vaccine research effort.

The UK-based pharmaceutical giant wrote, in an update on its work combating the coronavirus and the disease, that it is collaborating with Xiamen Innovax Biotech. The China-based company is attempting to develop a COVID-19 vaccine.

Image source: Getty Images.

That candidate, known as COVID-19 XWG-03, is being developed by Innovax in conjunction with researchers from Xiamen University. GlaxoSmithKline says its role in the project will be to provide access to an adjuvant for use in the vaccine. Adjuvants, a specialty of GlaxoSmithKline, are additives used in certain vaccines to boost the body's immune response to the relevant threat.

This is not the first collaboration between the two companies. In 2019 they teamed up to develop a vaccine for human papillomavirus (HPV), a virus that can cause cancer. This work was to feed into GlaxoSmithKline's efforts to devise a successor to its HPV treatment, Cervarix.

Although GlaxoSmithKline is one of the top vaccine makers among the world's pharmaceutical companies, it has elected to take a largely secondary role in the development of COVID-19 vaccines. Innovax is only its most recently announced partner in these efforts -- it is also providing adjuvant technology for several other research organizations and companies; among the latter is China-basedClover Biopharmaceuticals.

On Friday, GlaxoSmithKline's share price dipped by 1.5%, more or less in line with the broader stock market indexes on that day.

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GlaxoSmithKline Re-Teams With Chinese Biotech For COVID-19 Vaccine - The Motley Fool

Fighting a pandemic involves many moving parts. That much has become clear to many of us in ways we've never before experienced or understood, as the lives of almost every American has slowed to a standstill. As much as 90 percent of the country is under some form of stay-at-homeorder requiring millions of people to suddenly figure out how to work from home.

Of all of those parts, one of the most important is the development of a vaccine that can prevent the continued spread of the virus.Bill Gates has some experience in this area, with his foundation already working on infectious disease research and funding vaccines. I wrote last year about how the Bill and Melinda Gates Foundation's work had all but eradicated polio from Nigeria, one of its last remaining holdouts.

In addition to that experience, Gates also happens to have another important resource necessary to help stop a pandemic--the cash tomake it happen. And Gates has already been working to slow the coronavirus outbreak, putting money towards testing kits that can increase the capacity for determining who might be infected.

And on Friday, Gates told Trevor Noah, the host of The Daily Show, that the foundation is funding the construction of factories for the seven most promising vaccine candidates, even though they know only one will end up getting picked.

There is something incredible aboutunderstanding that most of those efforts will fail. Most of the vaccines that the foundation will build facilities to produce won't ever make it that far. Those facilities will require millions--if not billions--to build, though most will never be used for those purposes.

In Gates's words, it'll cost money but save time. Right now, time is against us.

Before anyone talks about how that money could be put to better use, consider that the amount of money the Gates Foundation is spending is far less than the cost of delaying a vaccine further into next year. Gates even pointed out that a few billion now can prevent a few trillion in economic disaster later due to a prolonged outbreak. That's a roughly 1,000 times return on the investment. I'm not a math guy, but even I know that's worth it.

It's also probably worth mentioning here that this is exactly the same mentality that would benefit every business right now. Everything is up in the air. No one knows how long this will last. Millions of people have lost their jobs and hundreds of thousands of small businesses have closed their doors.

Right now, what we all need are people willing to invest in what will make the biggest difference. That doesn't just mean billionaires with their own private foundations, by the way. It also means every entrepreneur and small-business owner. The challenge is to invest now in what will make the biggest difference for your business, your team, your customers, and yourcommunity.

A bunch of theideas will fail,but that's how we get to the ones that will--quite literally--change the world.Thatkind of thinkingalways has a positive return.

Published on: Apr 6, 2020

The opinions expressed here by Inc.com columnists are their own, not those of Inc.com.

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Bill Gates to Spend Billions on a Covid-19 Vaccine - Inc.

The unprecedented response to the COVID-19 pandemic has prioritized keeping people apart to slow the spread of the virus. While measures such as business closures and travel restrictions are effective at fighting a pandemic, they also have a dramatic impact on the economy.

To help right the ship, the Coronavirus Aid, Relief, and Economic Security Act also known as the CARES Act was passed by U.S. lawmakers last week with little fanfare. The act became the largest economic stimulus bill in modern history, more than doubling the stimulus act passed in 2009 during the Financial Crisis.

Todays Sankey diagram is a visual representation of where the $2 trillion will be spent. Broadly speaking, there are five components to the COVID-19 stimulus bill:

Although the COVID-19 stimulus bill is incredibly complex, here are some of the most important parts to be aware of.

Amount: $603.7 billion 30% of total CARES Act

In order to stimulate the sputtering economy quickly, the U.S. government will deploy helicopter money direct cash payments to individuals and families.

The centerpiece of this plan is a $1,200 direct payment for those earning up to $75,000 per year. For higher earners, payment amounts will phase out, ending altogether at the $99,000 income level. Families will also receive $500 per child.

There are three other key things to know about this portion of the stimulus funds:

Amount: $500.0 billion 25% of total CARES Act

This component of the package is aimed at stabilizing big businesses in hard-hit sectors.

The most obvious industry to receive support will be the airlines. About $58 billion has been earmarked for commercial and cargo airlines, as well as airline contractors. Perhaps in response to recent criticism of the industry, companies receiving stimulus money will be barred from engaging in stock buybacks for the term of the loan plus one year.

One interesting pathway highlighted by todays Sankey diagram is the $17 billion allocated to maintaining national security. While this provision doesnt mention any specific company by name, the primary recipient is believed to be Boeing.

The bill also indicates that an inspector general will oversee the recovery process, along with a special committee.

Amount: $377.0 billion 19% of total CARES Act

To ease the strain on businesses around the country, the Small Business Administration (SBA) will be given $350 billion to provide loans of up to $10 million to qualifying organizations. These funds can be used for mission critical activities, such as paying rent or keeping employees on the payroll during COVID-19 closures.

As well, the bill sets aside $10 billion in grants for small businesses that need help covering short-term operating costs.

Amount: $340.0 billion 17% of total CARES Act

The biggest portion of funds going to local and state governments is the $274 billion allocated towards direct COVID-19 response. The rest of the funds in this component will go to schools and child care services.

Amount: $179.5 billion 9% of total CARES Act

The biggest slice of this pie goes to healthcare providers, who will receive $100 billion in grants to help fight COVID-19. This was a major ask from groups representing the healthcare industry, as they look to make up the lost revenue caused by focusing on the outbreak as opposed to performing elective surgeries and other procedures. There will also be a 20% increase in Medicare payments for treating patients with the virus.

Money is also set aside for initiatives such as increasing the availability of ventilators and masks for the Strategic National Stockpile, as well as providing additional funding for the Center for Disease Control and expanding the reach of virtual doctors.

Finally, beyond the healthcare-related funding, the CARES Act also addresses food security programs and a long list of educational and arts initiatives.

Hat tip to Reddit user SevenandForty for inspiring this graphic.

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Every Vaccine and Treatment in Development for COVID-19, So Far - Visual Capitalist

(Image via Getty)

I ask my outside law firms the obvious question: Will we win at trial?

I always hear the same responses: We havent yet finished discovery. We dont know. Or: Juries are always unpredictable. Or: Ill get back to you five minutes after the jury renders a verdict.

Its exactly the way one should hedge ones bets, but its not what the questioner is looking for.

So, too, with COVID-19. Will hydroxychloroquine treat this problem? We havent yet finished the clinical trials. And, like Sergeant Schultz, we know nothing until five minutes after we see the results of the clinical trials.

Thats crap. You know something. Youre just hedging your bets, and youre afraid to speak.

So I asked a couple of physicians to go out on a limb for me anonymously, of course and tell me whats really going to happen, even though we of course dont know anything until the results come in. Heres what I heard.

COVID-19 causes serious trouble breathing physicians call it acute respiratory distress syndrome, but Im leaving the fancy words to people with medical degrees. Serious trouble breathing has been causing people to be admitted into intensive care units ever since they invented intensive care units. As you would expect, because this has been a problem for decades, physicians have been studying it for decades. But they havent yet found a cure. Theres no decent medication for the problem. Many, many drugs dont work. In the words of one recent study: We found insufficient evidence to determine with certainty whether corticosteroids, surfactants, Nacetylcysteine, statins, or betaagonists were effective at reducing mortality in people with acute respiratory distress syndrome. I dont even know what all those words mean, but you can tell it aint good.

Theres some evidence that if you turn up the ventilator a little higher, that helps patients. But, for the most part, physicians have spent decades trying to cure acute respiratory distress, and no one has come up with anything that works.

President Donald Trump says that hydroxychloroquine might work. President Trump tells us that hes a smart guy, and he feels good about hydroxychloroquine. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, then says that hed be more cautious; hed wait for the results of the clinical trials to come in.

Translation: This is way too optimistic. I have to correct the president in a way that wont get me fired. Weve been working on the problem of breathing difficulties for decades, and no one has yet solved it. What are the odds that a drug that has been on the market for 50 years and is not aimed specifically at this virus is going to be the cure for COVID-19? Its conceivable, of course, but the odds are overwhelmingly against it.

Not only that: About half of the patients with COVID-19 who are put on ventilators die. Suppose a drug works. Perhaps it reduces the mortality rate from 50 percent to 40 percent of those put on ventilators, which would be a great treatment. Even with a 40 percent mortality rate, we still have a heck of a problem on our hands. Scientists hit singles and doubles more often than they hit home runs; its very unlikely that were going to unearth a miracle.

How about the other ideas for treating COVID-19? Theyre interesting, but theyre all crapshoots. Dont count on em.

How about a vaccine? Thats far more likely. As Fauci said, proving that a vaccine is safe and effective will take a year to 18 months. A year to 18 months is a long time to wait.

After the vaccine is developed, it will not be 100 percent effective. Perhaps it will be 70 or 80 percent effective.

So how will this all play out?

COVID-19 will not disappear. It exists, and it will exist for a long, long time.

But COVID-19 appears to be seasonal. The virus appears to spread far less in warm weather.

Thus: We now have flu season every year. Flu season arrives in the winter. Some people choose to get a vaccine, which is not 100 percent effective. Some people choose not to get a vaccine. Every year, the flu kills tens of thousands of people.

Starting two years from now, we will have COVID-19 season every year. It will arrive in the winter. Some people will choose to get a vaccine, which will not be 100 percent effective. Some people will choose not to get a vaccine. If enough people take the vaccine to create herd immunity, then relatively few people will die from COVID-19. Otherwise, every year, COVID-19 will kill tens of thousands of people.

And well live with it, just as we live with the flu, and people dying in car accidents and plane crashes, and the many other deaths that regularly occur in the background noise of society.

But dont expect a miracle cure in the next month or two.

The jury wont come back by then.

MarkHerrmannspent 17 years as a partner at a leading international law firm and is now deputy general counsel at a large international company. He is the author ofThe Curmudgeons Guide to Practicing LawandDrug and Device Product Liability Litigation Strategy(affiliate links). You can reach him by email atinhouse@abovethelaw.com.

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COVID-19: How Long To Treatment? How Long To Vaccine? - Above the Law

Researchers work around the clock developing COVID-19 vaccine at Mayo Clinic  ActionNewsJax.com

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Researchers work around the clock developing COVID-19 vaccine at Mayo Clinic - ActionNewsJax.com

The coronavirus pandemic is a serious health risk, which is why countries around the world are racing to find vaccines and treatments. Nearly 1,000,000 cases of COVID-19 have been confirmed globally, and by the time you read this, the death toll will have surpassed 50,000.

Some potential treatments listed here were previously in clinical testing for other diseases, such as cancer, allowing the trials for COVID-19 to be fast-tracked. Many arent aimed at the coronavirus itself but instead will hopefully reduce some of the severe side effects the disease causes, like hyperinflammation and respiratory distress.

Notably, many of the proposed treatments have gone through U.S. Food and Drug Administration (FDA) approval for other uses or are currently going through that process, meaning the route to getting approved for a clinical trial to study their effects on COVID-19 patients is shorter and faster than it would be for a new drug. Some of these are being utilized under compassionate use rules, meaning they arent part of clinical trials but are being administered to COVID-19 patients in life-threatening situations.

The path from trial to treatment is long and complex. As new treatments and vaccines make their way to new phases, well update this list. For now, weve excluded those in preclinical phases.

Note: These drugs are all in the early stages of testing for efficacy against COVID-19 and taking them without supervision can have tragic consequences. An Arizona man died after reportedly taking a form of chloroquine used to clean fish tanks. Youll see a long list of potential treatments below, but many of them wont progress to wider testing or use, because theyll prove either unsafe or ineffective.

A vaccine would prevent people from getting sick, instead of treatments to alleviate the system or kill the disease once it has already infected you. Often, vaccines either use an inactive (dead) or live attenuated (less potent) version of the pathogen to build up the bodys defenses. By introducing these weakened forms to the immune system, it can start making antibodies without having to battle the virus itself. Once the body has made antibodies once, it has been trained to recognize the pathogen and can start making them again if the actual virus finds its way inside. Immunity from an inactive vaccine may not last as long, while live-attenuated types have implications for immunocompromised people. In addition, such vaccines havent proven effective for some viruses, like HIV.

Currently, there is no approved vaccine for COVID-19. Coronaviruses caused SARS in the early 2000s and MERS in 2012. The two epidemics were contained before vaccines were created, but some work was started for both. Some companies are building on that research to find a vaccine for COVID-19, which is caused by a novel coronavirus. The Coalition for Epidemic Preparedness Innovations, or CEPI, is an organization helping to accelerate vaccine development. About 35 companies and academic institutions are searching for a COVID-19 vaccine; two in phase-1 clinical trials, and over 40 in preclinical development. A few have begun testing in animals, while biotech firm Modernas attempt has started human trials.

Despite how quickly the research is being developed, there are some aspects of the process that cant be sped up, like widespread testing for side-effects and dosing. Even then, there are logistical hurdles to scaling production and distributing vaccines to affected countries. Experts are predicting it will take 18 months for a vaccine to be widely available.

Non-replicating viral vector; Adenovirus Type 5 vector (Ad5-nCoV): Adenoviruses are common viruses that can lead to bronchitis or pneumonia. Theyve been heavily studied as potential vectors for vaccines, to deliver the antigens that stimulate the production of protective antibodies. These viral vectors can also bolster the immune response in ways traditional vaccines do not.

CanSino Biologics is testing a vaccine candidate in healthy adults, the first phase of clinical testing. In 2017, the company, collaborating with the Chinese Academy of Military Medical Sciences Bioengineering Institute, developed an ebola vaccine. The potential COVID-19 vaccine, AD5-nCoV, is based on the same technology. Its a non-replicating viral vector, so it can infect cells but has been rendered incapable of multiplying. Johnson & Johnson is working on a similar type of vaccine, which will be ready for phase one trials in September.

RNA; LNP-encapsulated mRNA (mRNA 1273): The National Institute of Allergy and Infectious Diseases (NIAID) and Modernas potential vaccine builds on research into the MERS virus. Its a messenger RNA or mRNA vaccine, where a bit of the viruss genetic material gets injected into your muscle. The role of mRNA is to carry genetic information from DNA needed to make proteins. The RNA is packaged in lipid nanoparticles (LNPs), to help effectively deliver it. The mRNA would deliver instructions to cells on how to make proteins to fight the virus. No RNA vaccines have even been approved for human use, but this effort is one of several backed by CEPI.

Coronavirus Testing Labs

Monoclonal antibodies (mAb) are used in treatments for cancer and ebola. Made in a laboratory, these molecules work as substitute antibodies, according to the Mayo Clinic, boosting or mimicking the bodys immune system to attack the virus. They can do so in a variety of ways, including flagging cells for destruction and binding to different types of cells. The majority of those being researched for COVID-19 are in the pre-clinical phase, but several are in clinical trials right now.

Actemra (tocilizumab): Small proteins known as cytokines are part of the bodys immune response, released when theres an infection. Inflammation is a side effect, as blood and other fluids flow to the source of infection. A cytokine storm is when an abundance of the proteins cause hyperinflammation, which can lead to serious complications and death. It has been reported in SARS and MERS patients and could be causing some of the more severe symptoms in some people with COVID-19. Interleukins are one group of cytokines. Actemra is a rheumatoid arthritis drug that blocks interleukin-6 (IL-6) to keep it from attacking healthy tissue when the immune system overreacts. It helped several critical COVID-19 patients recover, but a controlled clinical study needs to be performed, according to The Wall Street Journal.

Avastin (bevacizumab): In healthy adults, vascular endothelial growth factor (VEGF) promotes the formation of new blood vessels and is important for healing wounds. Some COVID-19 patients have been shown to have elevated levels of VEGF, possibly due to hypoxia (low blood oxygen) and inflammation. Avastin is a VEGF blocker and has been used to treat several types of cancer for over 15 years. A clinical trial at the Qilu Hospital of Shandong University in Jinan, China will assess its effectiveness at treating shortness of breath.

Gimsilumab: Gimsilumab is a monoclonal antibody that targets a pro-inflammatory cytokine known as a granulocyte-macrophage colony-stimulating factor (GM-CSF). Its presence can elevate the expression of pro-inflammatory cytokines, causing a kind of feedback loop that increases inflammation. GM-CSF has been found in elevated levels of COVID-19 patients admitted to the ICU, according to pharmaceutical company Roivant. It wants to test Gimsilumab as a treatment for acute respiratory distress syndrome (ARDS). The condition is caused by fluid build-up in the lungs air sacs and the breakdown of surfactant, so that lungs cant fully inflate. Targeting GM-CSF represents a promising strategy for curbing lung damage while allowing time for the virus to clear, Dr. Elizabeth Volkmann, founder and co-director of the UCLA Connective Tissue Disease-Related Interstitial Lung Disease Program, said in Roviants press release.

Kevzara (sarilumab): Like Actemra, Kevzara is a rheumatoid arthritis drug that blocks IL-6. Dr. Naimish Patel told The Wall Street Journal why blocking that cytokine could help COVID-19 patients recover: Even though the virus is diminishing, its sending signals to the immune system to keep attacking. Hes head of global development for immunology and inflammation for Sanofi, which makes Kevzara, along with Regeneron.

Leronlimab (PRO 140): CCR5 is a protein on the surface of white blood cells that plays an important role in the way HIV develops in the human body. Leronlimab is a monoclonal antibody being studied as a potential treatment for HIV. It binds to the CCR5 receptor, which inhibits the release of inflammatory cytokines. Biotechnology company CytoDyn modified its clinical trial to evaluate Leronlimabs effect on severe cases of COVID-19.

PD-1 blocking antibody: There are two types of tolerance in your immune system. Central tolerance is the main way it distinguishes your own cells from outside threats, while peripheral tolerance keeps the body from over-reacting when it encounters allergens or microbes. Usually, the protein programmed cell death-1 (PD-1) helps limit T cell activity during infection to reduce inflammation. But if PD-1 binds to another protein, PD-L1, it prevents T cells from attacking cancerous cells. Monoclonal antibodies that block PD-1 are known as immune checkpoints inhibitors (ICIs). Theyve shown success in treating various types of tumors by preventing PD-1 from binding with PD-L1, freeing T cells to target the tumor. Thymosin, meanwhile, targets PD-L1. A clinical trial at Southeast University in China will study the efficacy of PD-1 and thymosin in COVID-19 patients with severe pneumonia caused by lymphocytopenia (low levels of lymphocytes, including T cells).

Sylvant (siltuximab): Another monoclonal antibody that blocks the action of IL-6, siltuximab is approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to treat multicentric Castleman disease (MCD). This rare lymph node disease acts similarly to lymphoma, causing an overgrowth of cells. Doctors at Papa Giovanni XXIII Hospital in Italy will observe its effects on patients with COVID-19, in the hopes it will reduce inflammation in those with severe respiratory disorders.

TJM2 (TJ003234): TJM2, like Gimsilumab, is a monoclonal antibody that targets pro-inflammatory cytokine GM-CSF. In November 2019, the FDA approved it for clinical trials to treat rheumatoid arthritis. I-Mab Biopharma, which makes TJM2, is a U.S.- and China-based biopharmaceutical company. It will now explore the mAbs effectiveness in fighting cytokine storming in patients with serious reactions to COVID-19.

There are a variety of antiviral drugs for diseases like hepatitis, the flu, and herpes many of which could potentially be repurposed to fight coronavirus. They work in different ways to stop the replication of viruses. For example, some flu antivirals are neuraminidase inhibitors. Neuraminidases are enzymes that cut acids and proteins on the surface of virus envelopes, releasing the replicated virus to infect new cells. Neuraminidase inhibitors can help reduce the amount of new viruses that are released inside the human body. The hope is that some of these antivirals will also stop the replication of COVID-19 once a patient has contracted it, lessening the duration or severity of the disease.

Arbidol (umifenovir): This broad-spectrum antiviral blocks virus entry into healthy cells by inhibiting membrane fusion. Its not currently approved by either the EMA or FDA, though it is available in Russia and China. A study at the Guangzhou 8th Peoples Hospital in China will observe its effect on patients with COVID-19. Though people are selling Arbidol on eBay in the U.K., the Medicines and Healthcare Regulatory Agency told The New Statesman, Not only are they breaking the law, they are acting with total disregard of your health.

ASC09: HIV requires protease enzymes to reproduce. Protease inhibitors prevent newly replicated viruses from maturing and invading healthy white blood cells. To see if the same disruption works on COVID-19, China-based biotechnology company Ascletis Pharma will test ASC09 in clinical trials.

Azvudine: Azvudine is a nucleoside reverse transcriptase inhibitor (NRTI). HIV uses the enzyme reverse transcriptase in reverse transcription, converting RNA into DNA. Inhibitors block the enzyme, preventing the virus from replicating. The clinical trial for Azvudines efficacy against COVID-19 will take place at the Peoples Hospital in Guangshan County, China.

Favilavir/Favipiravir/T-705/Avigan: Favipiravir is a broad-spectrum antiviral thats been utilized in Japan to treat influenza. Inside cells, it mimics the organic compound purine and eventually becomes included in the viruss RNA strand as it grows. Exactly how Favipiravir inhibits viral RNA synthesis once its incorporated is unclear, but there is some indication it could be used in COVID-19 patients as well. In clinical trials in China, patients who received the medication tested negative for the virus after a median of four days; those who didnt receive it took 11 days to test negative, according to The Guardian.

Ganovo (danoprevir): Ascletis Pharma developed Ganovo as a direct-acting antiviral agent (DAA) to treat hepatitis C. The efficacy of DAAs in general has been called a monumental advance over previous hepatitis C therapies. Ganovo inhibits the viruss protease, which is necessary for its replication. The effectiveness of Ganovo, in combination with another protease inhibitor (ritonavir), will be tested at Chinas Ninth Hospital of Nanchang.

Kaletra/Aluvia (lopinavir/ritonavir): Kaletra is a combination of protease inhibitors ritonavir and lopinavir, used to treat HIV. Earlier this year, The New England Journal of Medicine published the results of a study of 199 patients with severe COVID-19 patients at Jin YinTan Hospital in China. Those that received the lopinavir-ritonavir treatment saw no difference in the mortality rate. Future trials in patients with severe illness may help to confirm or exclude the possibility of a treatment benefit, according to the authors of the study.

Prezcobix (darunavir): Like ASC09, Prezcobix is a protease inhibitor, used to treat HIV, in conjunction with a pharmacokinetic enhancer. Cobicistat is one such drug, which slows the breakdown of Prezcobix, allowing it to stay in the body for longer and at a higher concentration. Johnson & Johnson sent Prezcobix to Chinese health authorities in January to gauge its effectiveness in treating COVID-19. The companys chief scientific officer, Paul Stoffels, told The Wall Street Journal that studying the drugs effects in ill patients could help researchers find a treatment that works.

Remdesivir: This drug has gotten more press than many of the other potential treatments. Its a broad-spectrum antiviral, and has been studied as a treatment for Middle East respiratory syndrome (MERS), a respiratory illness that is caused by the same family of viruses as COVID-19. Gilead, the company that makes Remdesivir, hoped the drug would work against Ebola, but it wasnt nearly as effective as two other drugs at preventing death from the disease. Some experts are hopeful that it will have more luck with COVID-19, and there are several clinical trials underway.

Truvada (emtricitabine and tenofovir): You may have seen commercials for this drug for whats known as PrEP (pre-exposure prophylaxis). When taken properly, it can reduce the risk of HIV infection. Truvada is a combination of two antiretroviral medications: emtricitabine and tenofovir. Both prevent HIV from replicating, and while they work in different ways, each blocks the reverse transcriptase enzyme needed for reproduction. The Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital are conducting the clinical trial for Truvada against COVID-19.

Xofluza (baloxavir marboxil): Endonuclease is an enzyme that initiates flu virus replication. Polymerase acidic endonuclease inhibitors, like Xofluza, interfere with that replication. Xofluza received FDA approval in 2018 to treat the flu, and now the First Hospital Affiliated of Zhejiang Universitys Medical School wants to research the drug as a treatment option for COVID-19 patients with pneumonia.

Catalog DNA Data Storage

Cellular therapy replaces or repairs damaged cells or tissues and is used in a range of diseases. Many types of cells have been studied for this purpose, including stem, progenitor, and primary cells. Cell therapy is being used and researched for everything from inflammatory bowel disease to cancer. CAR T-cell, for example, is a therapy in which doctors modify a patients T cells to identify and go after cancer cells.

Mesenchymal stem cells: Stem cells can self-renew through cell division and can also differentiate into different types of cells, like bone cells or liver cells. Mesenchymal stem cells (MSCs) are adult stem cells and can be taken from either humans or animals. Pneumonitis, or the inflammation of the walls in the air sacs of the lungs, is one potential side-effect of COVID-19. There has been some research on using MSCs to treat lung damage caused by radiation for cancer treatment. Chinas Institute of Basic Medicine is conducting clinical trials to see the cell therapys effect on COVID-19 patients with pneumonitis.

MultiStem: Biotech company Athersys created MultiStem, a stem cell product made from multipotent adult progenitor cells (MAPCs) derived from bone marrow. MPACs can self-renew and differentiate into several cell types. Acute respiratory distress syndrome (ARDS) is similar to pneumonia; it makes it difficult for the lungs to fully inflate and can lead to serious complications and death. MultiStem already underwent an early-stage clinical trial for treating ARDS, and the results showed the patients had lower mortality rates and were off ventilators more quickly than those who didnt receive the treatment. The company is working with the FDA to fast-track a clinical trial testing for COVID-19, according to WKSU.

RNA therapies are a fairly recent development and are being studied to treat several diseases, including macular degeneration and Zika. The therapies work in a few different ways, either by targeting nucleic acids (DNA or RNA), targeting proteins, or encoding proteins. A therapy might prevent messenger RNA from being translated into protein or it might encode a normal version of a protein instead of a mutated one. Right now, the potential RNA therapies for COVID-19 are all in preclinical phases.

There are a number of other treatments scientists are researching to see if they can help alleviate some of the severe symptoms of COVID-19. They dont necessarily fit into the categories above.

APN01: Scientists have found that during infection, COVID-19s viral trimeric spike protein binds to human receptor angiotensin-converting enzyme 2 (ACE2). One study showed that deactivating ACE2 caused severe lung injury in mice infected with a strain of avian influenza while administering recombinant human ACE2 was effective at lessening the damage. APN01 is a recombinant human angiotensin-converting enzyme 2 (rhACE2) created by Aperion Biologics to treat acute lung injury (ALI), acute respiratory distress syndrome (ARDS), and pulmonary arterial hypertension (PAH). The company began a clinical trial with APN01 on COVID-19 patients in February. A similar trial is underway at the First Affiliated Hospital of Guangzhou Medical University.

Chloroquine/Hydroxychloroquine: These two antimalarial drugs have been getting a lot of attention, though their efficacy as a treatment for COVID-19 is still unknown. Malaria is caused by a parasite, while COVID-19 is caused by a virus. The reason some researchers are looking at these drugs as potential coronavirus treatments is that chloroquine and other drugs were able to block coronaviruses from infecting cells in laboratory testing. These drugs were researched as possible treatments for MERS during the 2012 outbreak. The mechanism by which these malarial drugs would work against COVID-19 is uncertain, but one hypothesis is they change cells surface acidity, so the virus cant infect them. Or chloroquines might activate the immune system. Chloroquine and hydroxychloroquine have not been appropriately evaluated in controlled studies, not to mention that they have numerous and, in some cases, very deadly side effects, Katherine Seley-Radtke, professor of chemistry and biochemistry at the University of Maryland, wrote at The Conversation. There are a few clinical trials underway looking into their efficacy.

Gilenya (fingolimod): Multiple sclerosis causes the bodys own immune system to attacknerves insulating layer, or myelin. The presence of pro-inflammatory white blood cells in the central nervous system can also damage the myelin sheath. A sphingosine 1-phosphate receptor modulator is believed to keep certain white blood cells (lymphocytes) from leaving the lymph nodes and crossing the blood-brain barrier, where they would further damage nerve cells. Pneumonia is an acute inflammatory response that develops in some people with COVID-19, and the First Affiliated Hospital of Fujian Medical University wants to test this MS drugs effectiveness on reducing its severity.

Jakafi/Jakavi (ruxolitinib): Myelofibrosis is a somewhat rare blood cancer in which fibrous scar tissue replaces spongy bone marrow. Many patients with this and a couple of other types of blood cancer have an acquired mutation in the Janus Kinase 2 gene. It causes bone marrow to produce too many abnormal blood cells. Janus kinase inhibitors, or JAK inhibitors, block the function of these enzymes. Because of their role in cytokine production, JAK inhibitors are also used to treat inflammatory diseases, including rheumatoid arthritis. (Cytokines are a normal part of the bodys response to infection, but an overabundance can lead to hyperinflammation.) Patients with severe reactions to COVID-19 could have an excess of cytokines causing lung inflammation. A clinical trial at Tongji Medical College of Huazhong University of Science and Technology will study the effect of Jakafi and mesenchymal stem cells on COVID-19 patients with pneumonia.

Losartan: Angiotensin is a peptide hormone that constricts blood vessels and raises blood pressure. Angiotensin II receptor antagonists or blockers are prescribed for hypertension because they block the hormone. Losartan is one such drug, and the University of Minnesota is conducting clinical trials to see its effect on lung inflammation in COVID-19 patients.

Methylprednisolone/corticosteroids: Methylprednisolone is a synthetic corticosteroid, which mimics how the bodys hormones work to reduce inflammation. Corticosteroids are used to treat a plethora of conditions, from asthma to lupus to arthritis. Though they were used during severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) outbreaks, the World Health Organization doesnt currently advise the use of corticosteroids for COVID-19, according to a February article from The Lancet. Clinical trials for glucocorticoid therapy are going forward at Peking Union Medical College Hospital and Tongji Hospital.

Novaferon: Interferons are cytokine mediators that alert the immune system when theres a viral infection. Lab-made interferons are used to treat several diseases, including hepatitis B. Exactly how interferons affect the virus is unclear, but its thought to interfere with its life cycle, while also boosting cell-mediated immunity. Novaferon is one man-made interferon used to treat hepatitis B, and the First Affiliated Hospital of Zhejiang University Medical School will study whether its effective against COVID-19.

Rebif (interferon beta-1a): Interferon beta-1a is an interferon used to treat multiple sclerosis. Exactly how Rebif, an interferon made by Merck KGaA, works in MS patients isnt known, but it does lessen inflammation and reduce the bodys immune response that damages the myelin sheath. The French Institut National de la Sant et de la Recherche Mdicale (INSERM) will use Rebif in a clinical trial, to see if it similarly reduces inflammation in COVID-19 patients.

Washed microbiota transplantation: Some people who take antibiotics end up wiping out their colon of the healthy bacteria that help stave off clostridium difficile (C. difficile), which can lead to a serious infection. Fecal microbiota transplantation (FMT) reintroduces healthy bacteria via a donors stool, transferred by colonoscopy or another procedure. The washed microbiota process is a way of purifying the sample beforehand. A clinical trial at the Second Affiliated Hospital of Nanjing Medical University is doing a clinical trial on the procedure to examine its effect on COVID-19 patients with antibiotic-associated diarrhea.

For the latest updates on the novel coronavirus outbreak, visit the World Health Organizations COVID-19 page .

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All the COVID-19 vaccines and treatments currently in clinical trials - Yahoo Tech

"Know thy enemy," Sun Tzu advised in The Art of War. That axiom rings true not just for military strategists, but also for your immune system: Your body might "know" the flu, either from a prior infection or a vaccine.

That familiarity makes the flu easier to vanquish than the novel coronavirus sparking the current pandemic.

Beyond a lack of immunity, testing mishaps and unproven treatments make the novel coronavirus pandemic a new and distinct challenge from influenza outbreaks, which researchers have been working to control for decades.

During flu season even a severe one much of the population is already immune. Your immune system might recognise the viral enemy from a previous infection and pump out antibodies to clear the contagion. Or you might have received a flu shot, a dose of dead influenza viruses that trains your body to fend off a live attack.

People with immunity, whether by infection or injection, help keep the greater public relatively safe from the flu, according to Abigail Carlson, an infectious disease specialist at Washington University in St. Louis.

"When the virus infects them, it reaches a dead end," Carlson told Business Insider. "They don't get sick, they don't pass it on. And they stop the virus in its tracks."

This protective process is called herd immunity. While not perfect tens of thousands of Americans die of flu every year herd immunity generally keeps the flu at levels that hospitals can manage. That's not the case for the new coronavirus.

"There's very little to no herd immunity" with SARS-CoV-2, the virus that causes COVID-19, Carlson said. "Even though the virus might not be extremely deadly, there's a larger number of people who can get infected."

Without herd immunity, humans are ideal hosts for the coronavirus, which has raced across the globe in mere months and encountered few dead ends.

"We're at a point now where the health system is under enormous strain," Carlson said. "Masks are limited, ventilators are limited, beds are limited."

As of Thursday afternoon, the US had recorded more than 236,000 COVID-19 cases and at least 5,600 deaths, according to Johns Hopkins University.

A novel coronavirus vaccine to seed herd immunity is likely more than a year away, and developing it is a tall order compared to configuring the annual flu shot, according to Otto Yang, an infectious disease researcher at UCLA.

First, there's no precursor vaccine to work from: Of the seven coronavirus types that infect humans including four that cause the common cold none has a proven vaccine. Researchers are still seeking how best to craft a vaccine against the new coronavirus, whether by using active virus particles, inactivated ones, or synthetic compounds.

Last month marked the first of many clinical trials another reason Yang believes a COVID-19 vaccine will prove more elusive than the flu shot. The FDA doesn't require clinical trials to approve the annual flu vaccine. Although the exact strains the shot targets vary from year to year, the basic biochemistry stays the same and has proven safe.

So while researchers can fast-track the flu shot each year, they must carefully test any new coronavirus vaccine before offering it to the public. And that's likely to be a lengthy process.

A botched rollout of testing for COVID-19 has also left the US less prepared for the disease than for a flu pandemic, Yang said. To find out if a patient has a viral disease like flu or COVID-19, researchers search for the virus' genes in a swab sample from the patient's nose or mouth.

For the flu, that testing process is reliable. Though the virus mutates, most changes affect proteins on its outer surface, which bind to your cells to initiate an infection. Flu tests target more stable genes that encode for proteins inside the virus' shell.

When it comes to flu, "we have PCR tests that test all the strains," Yang said, adding that the same flu testing procedures are used every year. "All that infrastructure for testing was already in place."

In contrast, figuring out which genes to target in a test for the coronavirus "had to be worked out from scratch," Yang said.

The World Health Organisation developed an effective protocol in January but the US decided to develop its own, and then was slow to produce and distribute it. The lack of testing has hindered researchers' understanding of how widely the disease is spreading.

The US has "failed pretty miserably" when it comes to COVID-19 testing, Yang said. Testing rates in countries like South Korea and Italy are more than double those of the US.

(Ruobing Su/Business Insider)

Patients who do test positive for the novel coronavirus have little choice but to ride out the illness. Antiviral medications that help fight the flu appear to be less effective for COVID-19 patients, Yang said.

"There's no proven treatment at this point for SARS-CoV-2." Some doctors are administering anti-malarial drugs to try and combat the coronavirus, but the efficacy of such treatments is still unclear.

The new coronavirus pandemic poses numerous distinct obstacles compared to the flu. Still, Yang and Carlson see room for optimism as we await a vaccine, because so many people though not everyone are taking social distancing seriously.

"You're really seeing people doing their best to stay at home, stay away from others, and bring that curve down in the US," Carlson said. "Those interventions are working if we just give them a chance Things will get better and this pandemic will indeed pass."

This article was originally published by Business Insider.

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Experts Explain The Important Reasons Why COVID-19 Differs From a Flu Pandemic - ScienceAlert

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Social distancing can slow the spread of Covid-19, and new therapeutics could blunt its death toll, but a true return to normalcy is unlikely without a widely-available vaccine.

There are currently at least 47 vaccine programs under way, according to a list kept by the Milken Institute. Below are details on nine of the most notable. Probabilities of success are impossible to gauge, and it will only take one truly successful vaccine to effectively save the world. Here are some to keep an eye on.

Status: Human trials ongoing. First patient dosed on March 16

This is perhaps the most well-known of the Covid-19 vaccine programs. Moderna, a clinical-stage biotech that develops messenger RNA-based vaccines and therapeutics, has already begun dosing patients with its experimental mRNA-based Covid-19 vaccine. Heres an overview of the mRNA-based Covid-19 vaccine programs.

Status: Human trials to begin in April

The German biotech BioNTech is designing another mRNA-based Covid-19 vaccine. It plans to begin clinical trials of the vaccine in April. Outside of China, BioNTech is collaborating on the development of the vaccine with Pfizer. Inside China, the company is working with Fosun Pharma, a Chinese pharmaceutical company.

Status: Human trials to begin in April

Inovios Covid-19 vaccine program drew enormous attention early this year. The company is developing a DNA plasmid vaccine. Inovio says that it plans to start a clinical trial in 30 healthy volunteers in the U.S. next month.

Status: Human trials to begin in late Spring

Novavax, another small biotech that was among the first to announce a Covid-19 vaccine program, is developing a type of recombinant vaccine to prevent Covid-19. In mid-March, it said it had received $4 million to develop the vaccine from the Coalition for Epidemic Preparedness Innovations, a coalition of governments and philanthropies. The company says it expects to begin testing the vaccine in humans in late spring.

Status: Human trials to begin in September

Johnson & Johnson, the worlds largest pharmaceutical company, was one of the first drug developers to announce a Covid-19 vaccine program. On Monday, the company said that the vaccine could be available for emergency use early next year, and that it will start manufacturing it immediately. The company is planning to begin testing the drug in humans by September. It said Monday it planned to make the vaccine available on a not-for-profit basis for emergency pandemic use.

Status: Expects to test in humans by end of 2020

Translate and Sanofi are collaborating on another mRNA-based Covid-19 vaccine, announced late last week. Ron Renaud, Translates CEO, said Friday he hoped to begin testing the vaccine by the end of this year, and hoped for the vaccine to be approved by the second half of next year.

Status: Expects to begin in vitro testing this summer

In addition to its collaboration with Translate, Sanofi is also working on another, previously announced Covid-19 vaccine effort, this one with funding from the Biomedical Advanced Research and Development Authority (BARDA). This program is seeking to develop a recombinant vaccine, as distinct from the mRNA vaccines, and will use Sanofis recombinant DNA platform, which has been used to develop a flu vaccine.

Status: Pre-clinical

Arcturus is working on a Covid-19 vaccine that uses a variation on the messenger RNA approach taken by companies like Moderna and Translate. It is collaborating with the Singapore-based Duke-NUS Medical School, and received a grant for the program from the Singapore Economic Development Board, a government agency.

Status: Pre-clinical

This private German company is also developing an mRNA-based Covid-19 vaccine. Drama has surrounded the company in recent weeks, including allegations that Trump administration officials tried to lure the company to move its research to the U.S., plus shuffles among its top leadership.

Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com

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Coronavirus Vaccine Update: When Will a Covid-19 Vaccine Be Ready? These Programs Are Making Progress. - Barron's

GAINESVILLE, Fla. (WCJB)-- Experts held a COVID-19 Data Science Zoomposium today featuring an employee from the University of Florida.

Biostatistic Assistant Professor Natalie Dean spoke on vaccines and therapeutics.

She says there are over 50 candidates testing their vaccines and predicts it will take around 12 to 18 months before a vaccine for COVID-19 can be used.

One of the challenges is we dont have a animal model, this is an animal that has similar symptoms to humans so we can test the vaccine actually reduces disease and then it goes into these early human trials and then gradually we get a bigger trials that tell whether the vaccine prevents infection to people being exposed, she said.

She says it is very likely the world will still need the vaccine come 2021.

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COVID-19 vaccine expected in over a year - WCJB

Convalescent plasma

Plasma from those who have recovered from COVID can be used to treat those who have yet to get disease or are early in their disease progression. The plasma contains neutralizing antibodies that can boost a persons immune system to fight the virus. A team of investigators including Ray Goodrich, CSUs executive director of the Infectious Disease Institute and Heather Pidcoke, CSUs chief medical research officer, are collaborating on a project to study the efficacy and potential methods to improve the safety of this repurposed plasma treatment as part of planning for potential clinical trials.

The antibodies in convalescent plasma are specifically made to find the virus and take it out. We are studying pathogen reduction methods that may lower the chance of accidentally giving someone COVID-19 or another infection without meaning to, Pidcoke said. Ultimately we want to protect healthcare workers and other high-risk people from getting sick if they are exposed to the virus that causes COVID-19.

The FDA has already approved a number of individual drugs to treat patients showing symptoms of COVID-19 but use of those drugs in new combinations requires additional approval. CSU researchers have established the use of vero cells to screen cocktails of approved drugs to accelerate the approval process.

CSU researchers have initiated projects with at least six industry partners details to be announced shortly to quickly move these combination drug products toward FDA approval.

A lot of industries are limited with how they can work with the virus, said Rushika Perera, an associate professor of virology who is leading the project to repurpose approved drugs for COVID treatment. They need to partner with CSU to do this research. We have the expertise, labs and physical space.

Vaccines can offer long term protection from COVID-19 and CSU has two vaccine candidates in development.

Solavax repurposes a commercial platform that is currently used to inactivate pathogens in blood transfusions. The strategy uses light and riboflavin to produce an inactivated virus which stimulates a persons immune system to fight the virus.

We are building off of nearly 20 years of experience of using this process to improve the safety of blood transfusion products. That prior knowledge and current experience helps to translate this rapidly into a way to manufacture vaccine products, said Goodrich.

Another vaccine project underway would use a genetically modified form of the common probiotic Lactobacillus acidophilus to avert infection by the novel coronavirus. The concept of this work, led by Gregg Dean, head of CSUs Department of Microbiology, Immunology and Pathology, starts with a microorganism that thrives in the mucous membrane exactly where the new coronavirus attacks the body. The vaccine would interrupt attachment of the virus to host cells at two key junctures, sites that amount to the Achilles heel of the virus, Dean said.

Were fortunate to have such a depth and breadth of expertise in infectious disease here at CSU, he said. Investigators are working on vaccines, on antiviral therapies, on diagnostic strategies, and on how we can inactivate the virus on surfaces. Were trying to tackle this problem from every angle we can.

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CSU researchers rapidly developing treatments, drugs and vaccines for COVID-19 - Source