Category: Covid-19 Vaccine

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Virologist says it’s "optimistic" to think a COVID-19 vaccine will be ready in a year – WTSP.com

April 8, 2020

ST. PETERSBURG, Fla Information about COVID-19 has been rapidly changing, from added symptoms, to whether or not you should cover your face. So, 10News reporter Liz Burch caught up with an expert to ask him some of your questions.

Doctor Michael Teng is an associate professor at USFs Morsani College of Medicine. He's spent decades studying vaccines, so we asked what he thought the biggest piece of coronavirus news was this week.

"The first thing is that I think our models have gotten better, the new modeling is showing a decrease in mortality and morbidity, which is great," Dr. Teng said.

He stressed that the models are "just well-educated guesses."

He also mentioned that work has started on a vaccine and shared when he believes the public can realistically expect one.

"When I hear a year, a year and a half for a vaccine, thats an aggressive estimate, optimistic opinion, about when it could be done. This is if everything goes right," he said.

So it could be a little longer, but Teng says the good news is, a lot of resources are going into developing that vaccine right now.

On Twitter, a user named Donald asked: If youre asymptomatic carrying the virus, how long does it last in you?"

"Thats a really good question that we dont have a great answer for. If youre asymptomatic you dont know a start and stop to when you got infected, what we know from people who have symptoms, if that they are infectious before and after they have symptoms," Teng responded.

And on Instagram, a user named Jay asks: "Once a vaccine is developed, will it be needed yearly?"

"If we do have a vaccine, it will be a vaccine that will protect you for a while, but, what we dont know is how long that vaccine will last," Teng said.

Dr. Teng says he believes we have started to flatten the curve because of what he calls significant social distancing.

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Virologist says it's "optimistic" to think a COVID-19 vaccine will be ready in a year - WTSP.com

GSK allies with Innovax for COVID-19 vaccine R&D project – FierceBiotech

April 8, 2020

GlaxoSmithKline has teamed up with Xiamen Innovax Biotech to evaluate a vaccine against the novel coronavirus behind the COVID-19 pandemic. The agreement gives Innovax access to a GSK adjuvant to enhance the immune response triggered by its recombinant protein-based vaccine.

GSK teamed up with Innovax last year to develop a human papillomavirus vaccine, tapping into the work of the Chinese biotech to drive its search for a successor to Cervarix. The latest deal moves the partnership into COVID-19 and, in doing so, continues GSKs effort to support the response to the pandemic SARS-CoV-2 virus through the provision of its AS03 adjuvant.

While GSK developed its own vaccine against the 2009 H1N1 pandemic, the Big Pharma has opted to play a supporting role in the industrys response to COVID-19, primarily by providing its AS03 adjuvant to Clover Biopharmaceuticals and the Coalition for Epidemic Preparedness Innovations.

Virtual Clinical Trials Online

This virtual event will bring together industry experts to discuss the increasing pace of pharmaceutical innovation, the need to maintain data quality and integrity as new technologies are implemented and understand regulatory challenges to ensure compliance.

Innovax will apply the adjuvant to a vaccine it is developing with Xiamen University. The vaccine, like others in development, is based on the coronavirus spike protein. Innovax is screening a series of truncated spike proteins to gather immunogenicity data to inform the selection of a lead candidate. Adding AS03 to the mix may reduce the level of protein needed to protect patients.

GSK has early evidence to suggest AS03 can deliver those benefits to COVID-19 vaccines, noting that one of its collaborators has reported encouraging preclinical data. The Big Pharma expects partners to publish more data over the next three months, setting them up to plot out clinical strategies. GSK is also evaluating further collaboration opportunities with several other companies and institutions.

The vaccine work is advancing in parallel to efforts to develop COVID-19 medicines. In a statement about its activities related to the pandemic, GSK said it is evaluating whether drugs in its portfolio of experimental and approved medicines can play a role in the response to COVID-19, either as a direct antiviral or in the management of secondary complications.

As previously disclosed, GSK is part of a group of companies that have made libraries of compounds available for screening by the COVID-19 Therapeutics Accelerator, an initiative involving the Bill & Melinda Gates Foundation. The accelerator is screening compounds shared by Big Pharma companies for efficacy against SARS-CoV-2.

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GSK allies with Innovax for COVID-19 vaccine R&D project - FierceBiotech

Beaufort Man and his Atlanta Based company inching closer to COVID-19 vaccine – WSAV-TV

April 8, 2020

SAVANNAH, Ga. (WSAV)- Beaufort Native, David Dodd and his company GeoVax are inching closer to a vaccine for the coronavirus. Scientists have narrowed down three possible vaccines.

He says each vaccine is considered a candidate because all three will go through animal testing before they are narrowed down to one.

The company has dedicated their efforts to the COVID-19 outbreak since early January. They have also teamed up with another vaccine developer, BravoVax who are located in Wuhan, China.

Weve been identified as one of the 30 or so companies worldwide that are working on a COVID-19 vaccine and have requisite experience and doing such, said David Dodd, CEO of GeoVax.

All three vaccine candidates are in what is called the purification process.

In looking at the genetic structure and the virology and what we learned from SARS in the past weve actually constructed four vaccines of which weve put into testing, said Dodd. Three of which we are going to move forward into animal testing and all.

Once the vaccine moves through animal testing it will go into the human testing phase. Dodd said that could happen by the end of the year.

We need a vaccine to be able to halt this from infecting additional people, said Dodd. Especially if there should be additonal outbreaks in the future and all.

Using their signature MVA-VLP platform scientists are able to move faster.

The bases of their vaccine has already been tested on thousands of people in six clinical trials for HIV.

We have shown our platform is really safe and we can make single dose vaccines you know against the most terrible diseases like Ebola, Zika and so on, said Dr. Farshad Guirakoo, GeoVaxs Chief Scientific Officer. But, as a small company it is really difficult until they realize how good the platform is.

For a company like GeoVax, funding is paramount.

Dodd is in talks with the Biomedical Advanced Research and Development Authority (BARDA) about grant money.

BARDA is an agency within the U.S. Dept. of Health and Human Services that oversees the manufacturing, production, and purchasing of COVID-19 vaccines and treatments.

We made an application in February to BARDA based upon our plans, timelines, budgets, and what we were going to develop, said Dodd.

Dr. Guirakoo tells WSAV News 3 that funding is absolutely critical at this point in the vaccine development process.

The safety needs to be studied carefully in large number of people before you can deploy the vaccine, he said. Before the effects can be seen in millions and billions of people.

Dodd hopes all the planning leads to a vaccine that will one day save lives.

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Beaufort Man and his Atlanta Based company inching closer to COVID-19 vaccine - WSAV-TV

A second potential COVID-19 vaccine, backed by Bill and Melinda Gates, is entering human testing – TechCrunch

April 6, 2020

A new COVID-19 vaccine candidate is entering Phase 1 clinical human testing today, after the U.S. Food and Drug Administration (FDA) accepted an application from Inovio Pharmaceuticals under the regulators Investigational New Drug program. Inovio plans to inject its first volunteer test subject with the INO-4800 DNA vaccine candidate it has developed, following promising results from preclinical studies performed on animals that did indicate increased immune response.

The Inovio DNA vaccine candidate works by injecting a specifically engineered plasmid (a small, independent genetic structure) into a patient so that their cells can produce a desired, targeted antibody to fight off a specific infection. DNA vaccines, while available and approved for a variety of animal infections in veterinary medicine, have not yet been approved for human use.

That said, Inovios work isnt starting from scratch: The company previously completed a Phase 1 study for a DNA vaccine candidate for Middle East Respiratory Syndrome (MERS), where it showed promising results and a high level of antibodies produced in subjects that persisted for an extended period of time.

Inovio has been able to scale up quickly, developing and producing thousands of doses of INO-4800 in just a few short weeks in order to support its Phase 1 and Phase 2 trials. The company has done so in part thanks to backing from the Bill and Melinda Gates Foundation, as well as funding from other non-profits and organizations. If clinical trials are succeeding, Inovio says that it will be able to have up to one million doses of the vaccine ready by end of year, for use both in additional trials and for potential emergency use pending authorization.

This is the second vaccine to undertake Phase 1 clinical testing on human subjects: Moderna began its trial in mid-March. Inovios trial will be made up of 40 volunteers, all health adults selected via screening conducted at either Philadelphias Perelman School of Medicine at the University of Pennsylvania, and the Center for Pharmaceutical Research in Kansas City. Itll span the next several weeks, and the company expects data around the immune responses from test subjects as well as info pertaining to the safety of the treatment for humans, to be available by late this summer.

Any broad clearance or approval for use is still likely at least a year to 18 months away, but the pace with which human trials are beginning is already still exceptional, so hopefully we wont have to wait too much longer than that.

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A second potential COVID-19 vaccine, backed by Bill and Melinda Gates, is entering human testing - TechCrunch

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

April 6, 2020

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

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

April 6, 2020

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.

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

April 6, 2020

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

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

April 6, 2020

(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

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

April 3, 2020

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 .

Originally posted here:

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

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