Category: Covid-19 Vaccine

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UW announces new COVID-19 vaccine research, $1.5 million in grants – The Badger Herald

April 3, 2020

The University of Wisconsin announced the development of a COVID-19 vaccine Thursday, and are offering $1.5 million in grants for COVID-19 research and community aid through the Wisconsin Partnership Program.

An international group of virologists at UW, in collaboration with the vaccine companies FluGen and Bharat Biotech, have begun to develop and test an original vaccine against COVID-19 called CoroFlu.

CEO of Wisconsin Alumni Research Foundation Erik Iverson spoke about the project in the news release.

The partners in this endeavor University of Wisconsin researchers, a biotech startup, and an international vaccine developer are moving forward with a sense of urgency and integrity incumbent upon us as scientists and world citizens, Iverson said.

UW predicts $100 million loss due to COVID-19 pandemicThe University of Wisconsin is expecting a $100 million loss due to the ongoing COVID-19 crisis, according to the Wisconsin Read

M2SR is a flu vaccine that activates an immune response against the flu. Based on this invention by UW virologists and FluGen co-founders Yoshihiro Kawaoka and Gabriele Neumann, M2SR will serve as the foundation for the COVID-19 vaccine, according to the news release.

Explained by the news release, Kawaokas lab will work to insert gene sequences from SARS-CoV-2, the coronavirus that causes the disease COVID-19, into M2SR in hopes the new vaccine will also prompt immunity against the coronavirus.

CoroFlu will also express the influenza virus hemagglutinin protein, which is the major influenza virus antigen, so we should get immune responses to both coronavirus and influenza, Neumann said the news release.

According to the news release, refinement of the vaccine and its testing at UW is expected to take three to six months. Bharat Biotech in Hyderabad, India will then produce the vaccine for clinical trials. Bharat Biotech has commercialized 16 vaccines and has the ability to produce almost 300 million doses of CoroFlu per year.

As a result of the expediency of the research, trials and production, CoroFlu could be tested in human clinical trials by fall 2020, according to the news release.

Also in response to the pandemic, a new Wisconsin Partnership Program funding opportunity hopes to aid researchers and community organizations to combat the present challenges facing Wisconsin from the COVID-19 pandemic, according to a news release from UW School of Medicine and Public Health.

Wisconsin Partnership Program University Relations Specialist Anne Pankratz discussed the expeditious turnaround time and communal relief focus of the COVID-19 Grant Program in an email.

COVID-19 Daily Updates: At least 31 confirmed deaths in Wisconsin, 228 confirmed cases in Dane CountyThe Badger Herald will update this article daily as more COVID-19 information comes out. Thursday, April 2. There are now Read

The grant program was developed to help researchers and community organizations address immediate needs and challenges that the pandemic is creating, Pankratz said. It was designed with a brief turn-around time in mind to help address immediate needs, rather than long-term challenges.

COVID-19 Response Grant Program serves as a rapid response mechanism to lessen the impact of the COVID-19 pandemic through scientific, medical or public health approaches, the grant program page said.

According to the Wisconsin Partnership Program, this funding opportunity supports community projects working to improve and protect the health of the people of Wisconsin, with an emphasis on high-risk populations.

We expect that researchers across the UW campus may apply for funding for projects that have the potential to lessen the impact of COVID-19, by focusing on medical and scientific advances as well as public health initiatives, Pankratz said.

According to the Wisconsin Partnership Program, the grant opportunity will fund up to $1.5 million in total awards. $750,000 will go to support community-led projects and the other $750,000 to support projects led by UW researchers. The grant opportunitys award amounts will range from $25,000 and $150,000, for up to 12 months.

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UW announces new COVID-19 vaccine research, $1.5 million in grants - The Badger Herald

Fighting COVID-19 Is Like ‘Whack-A-Mole,’ Says Writer Who Warned Of A Pandemic – NPR

April 3, 2020

A worker cleans an area along the Las Vegas Strip that's now devoid of the usual crowds, with casinos and many other business shuttered. John Locher/AP hide caption

A worker cleans an area along the Las Vegas Strip that's now devoid of the usual crowds, with casinos and many other business shuttered.

Two years ago, science writer Ed Yong wrote an article for The Atlantic in which he warned that a new global pandemic was inevitable and that the world would be unprepared for it when it arrived. Now, with the outbreak of COVID-19, much of what Yong warned about in his reporting has come true.

Yong says scientists are still working to understand how the novel coronavirus travels through air. His latest article for The Atlantic concerns whether or not people beyond health care workers and other front-line personnel should be wearing some sort of mask to help prevent spread of the coronavirus.

Yong notes that there are two ways in which respiratory viruses typically travel through air: as droplets of fluid and as evaporated specks of fluid called "aerosols."

Yong describes aerosols as "far-drifting" and "long-lasting" viral specks. "There is some growing evidence that aerosol transmission what people would traditionally describe as being 'airborne' does apply, to some extent, to the new coronavirus," he says.

He adds that it's not yet clear whether live infectious viral particles remain in the air where infected people have been: "That's the crucial thing to know," he says. "And then really, crucially, are there enough of those viral particles to actually start an infection? We don't know the answer to that yet."

Yong says the experts he has consulted have not come to a consensus regarding whether or not the general population should wear some sort of mask, when in public places. "There is a lot of movement towards recommending widespread mask usage from different countries," he says. "The CDC appears to be considering it. Health experts I've spoken to who were once dismissive about mask use are now edging towards recommending it."

But Yong adds that the short supply of N-95 respirator masks, and even professionally made surgical masks complicates matters.

"We're currently in a situation where masks are already running out in hospital settings and for health care workers, who are the people who need them the most. So any masks any protective equipment should go to health care workers as a matter of priority. And only then should we think about whether the general population should be considering wearing masks."

Looking ahead, Yong says that even if masks, frequent hand-washing and social isolation strategies are effective in slowing the virus' spread, the end to the pandemic is still a long way off: "We are in for this long, protracted game of whack-a-mole with the virus where different places will stamp it out at different times. It will surge back. It will need to be controlled again."

On what we know about how the virus travels through the air and how we're susceptible to inhaling it

There was one study that just shot virus-laden fluids into a rotating cylinder to create a cloud of aerosols. And they found that within that cloud, the virus remained stable for several hours, which suggests that it can at least survive in the air around us. Now, that's a pretty artificial setup. That's probably closer to a medically invasive procedure like intubation, rather than someone just breathing when they're walking down the street or sitting in a room. So it's hard to know what to make of that outside the health care setting.

But there are other studies that suggest that the coronavirus can be released into the air in less dramatic ways. For example, a new [study] released by the University of Nebraska Medical Center looked for traces of the virus' genetic material in the rooms of several patients who had COVID-19 many of whom only had mild symptoms. So they found traces of that genetic material on lots of different surfaces, including hard to reach spots like ventilation grates and the floors beneath beds. That's consistent with the idea that the virus is moving through the air over distances longer than a droplet might land.

What we don't know is whether there are actually live infectious viral particles in the air. The presence of genetic material doesn't indicate that. It's like finding a fingerprint in a crime scene. It means that the culprit was once there, but they might have long gone. So that's the crucial thing to know. ... And, [in each case], are there enough of those viral particles to actually start an infection? We don't know the answer to that yet. And that's a really crucial piece of the puzzle.

On how thinking about masks for the general population might be changing

Confusion is completely understandable, because even among the experts who I've spoken to including people who've studied airborne transmission and its possibility opinion is divided on the role of masks and how much protection they can provide. There's just a mess of data on whether masks worn by the general population will provide protection against respiratory illnesses in general; whether masks prevent you, if you are infected, from infecting other people. I think that's a little clearer, both from the evidence and just through common sense. And that might matter a lot for a disease like COVID-19.

We know that the virus behind it can spread from one person to another before they show symptoms, and that is perhaps the strongest argument for widespread usage of masks. Even if you aren't currently coughing or sneezing or breaking into a fever, you might not know that you have a virus, and wearing a mask might stop you from spreading that virus to someone else.

On why touching your mask negates its protection

One of the reasons why some people are still on the fence about recommending widespread mask usage is this idea that people who wear masks and aren't used to them kind of futz around with them. They fidget with the masks, they touch their faces. There's not a huge amount of data on this ... but almost everyone I've spoken to who has experience of actually using the masks properly, whenever they've seen people use them in more casual ways, people almost always get it wrong. They pull the mask over their chin, wipe their faces. They touch the masks constantly. They're always adjusting it. And that carries a risk, and maybe the risk is that you do lure yourself into a false sense of security, thinking you're safe, but in a situation when you're actually increasing the likelihood of infection.

On how American hubris and exceptionalism have contributed to the slow response

[A virus] has no interest in people's terror, only their cells. It just wants hosts to infect and doesn't care whether you're feeling brave or not. And I think that some aspects of America's national character do seem to have made it harder for people to take the necessary measures to slow the spread of the pandemic. And not just this sense of resilience, of being brave in the face of fearful threats, but also the sense of individualism and exceptionalism. This idea that "I have the freedom to do what I want to do," which stops people from just staying indoors and heeding advice about isolating yourselves when it's necessary. And I think that the country's famed exceptionalism the idea that this is the greatest country in the world that, I think, contributed to a delay in the nation's response.

The [U.S.] could have sprung into action ready for this, for the virus to eventually reach it. But if anything, America more or less sat idle. It was sluggish. And I do wonder if that propensity to think of itself as being truly exceptional, that slight hubris, left it more unprepared than it needed to be.

Ed Yong

COVID-19 was taking off in China for at least a month before it first reached U.S. shores. And during that month, not much actually happened [in the U.S.]. A lot of preparedness measures could have been launched. The country could have sprung into action, ready for this, for the virus to eventually reach it. But if anything, America more or less sat idle. It was sluggish. And I do wonder if that propensity to think of itself as being truly exceptional, that slight hubris, left it more unprepared than it needed to be. And I think that even though many people had warned about this for a long time, the underwhelming nature of America's response to this threat has really surprised even people who had been warning, who had been issuing alarms.

There is a thing called the Global Health Security Index, which ranks different countries according to their levels of preparedness for pandemics, according to 140 different criteria, based on regulations from the World Health Organization. And out of all the countries that were assessed, the United States has the highest score 83.5, a solid B. But if you look at how the country has actually reacted to the pandemic, I think we probably get something like an F. This nation that was meant to be the most prepared of all has really flubbed its response, and I think, to a degree, that has shocked even the most alarmed or pessimistic people who I'd spoken to before, in my earlier reporting.

On what happened to the medical supply chain for masks and swabs

The medical system runs on a just-in-time economy, much like the rest of the world, and products are made to order and they depend on these very long international supply chains, many of which have fractured in this pandemic. So, for example, Hubei Province, where the pandemic first took off in China, is also one of the world's leading centers for manufacturing medical masks. So the fact that the pandemic hit that region first and hardest really exacerbated the shortage of medical supplies. There's also now a shortage of the swabs that people used to collect viral samples as the very first step of testing. And one of the companies that leads the manufacture of those swabs is based in northern Italy, which is one of the centers of the pandemic in Europe. ...

It's really bad luck that both of those regions were particularly hit, but you could envisage the same problems for all sorts of other areas. I think this is what happens when you rely on a medical system that depends on these large international chains and that really don't have a lot of capacity to flex and surge in the event of a crisis. And that's especially bad now, because the pandemic has spread so quickly that the entire world is facing down the same problem at the same time and is after the same supplies at the same time which really has stretched many of these supply chains to a breaking point. Everyone is after the same supplies and there aren't enough of those supplies to go around. Everyone is competing with each other instead of cooperating, because the crisis has spread so quickly.

On rolling out a COVID-19 vaccine

The first steps so far have actually been encouragingly quick. A vaccine candidate has already entered early safety trials after a record-breakingly short time from actually identifying and sequencing the genome of this new virus. But the journey from these first trials to actually having a product that you can shoot into people's arms is very long and hard to shortcut. You need to know whether the vaccine is safe, whether it triggers an immune reaction. Then you need to know whether it's actually effective at preventing infections. You need to know what dose to use, how many doses to use, whether it also works in elderly people who are more at risk. All of these steps take time, and if you don't go through them, you might run the risk of creating a product that has really severe side effects or that is rolled out widely but just doesn't work.

So the experts I've spoken to feel that it will probably take between 12 and 18 months to even develop a working vaccine, let alone then to create the manufacturing capacity to create enough doses and then to distribute those doses and to actually inject them into people. This is not going to be a fast process. And until that process is complete, COVID-19 is going to be a part of our lives.

On the different methods being used to develop a vaccine for COVID-19

Most existing vaccines [against other viruses] use a dead or weakened virus or a fragment of that virus. So the idea is, you show that to the immune system, [and] the immune system can prepare defenses ahead of time. [One new vaccine candidate in development against the coronavirus] works in a slightly different way. It uses a piece of the virus' genetic material, its RNA. You inject that up into a person in the hope that that person then can build their own fragments of the virus using the instructions in that genetic material and that those sorts of homegrown fragments can then train the immune system. These RNA vaccines are a new technology. They have the potential to be really important and to be much faster. But the caveat is that no such vaccines have ever been taken to the market before. So we're breaking new ground and there aren't facilities already available that can manufacture such vaccines in the quantities that are needed.

By contrast, other teams are using more traditional approaches. For example, there's one group in France that is trying to repurpose the existing measles vaccine to instead target the new coronavirus. That might take a longer time at the front end. But on the plus side, if that actually works, then the world knows how to make measles vaccines in large quantities. So it's unclear which of ... these solutions will end up being quickest. But it's certainly reassuring that a lot of different options are being tried not just these two, but but many others. And we'll just have to wait and see which gets to the finish line soonest.

On the idea that the spread of the coronavirus might slow down in the summer

So, traditionally, coronaviruses and a lot of other respiratory viruses, like flu, do go away in the summer, and there are many possible reasons for that. Certainly, humidity and heat makes it easier for the cells of our airways to clear out a virus, and some of the immune response to these respiratory viruses appear to be stronger under those climatic conditions.

Now, is this new coronavirus going to behave in the same way? Possibly. Is that going to make a difference with the pandemic? I'm not sure. And the reason for that is that the virus is circulating through a global population that is completely immunologically naive to it. Our immune systems are not ready to deal with something like this. And so the virus has a large proportion of hosts among whom it can easily spread. To hope that the summer is going to downplay those dynamics far enough to contain the pandemic is, I think, wishful thinking. ... We're seeing transmission in places like Australia, which is just coming out of its summer, or Singapore, which is hot and humid in the tropics. And what that tells us is that it's probably wishful thinking to hope for heat and humidity to be the things that contain this virus. They may help, but only if we can slow its spread in other ways, such as through social distancing.

On being prepared for COVID-19 to come back

I think that's very likely. I think most experts would expect some kind of resurgence once current social distancing measures are released. That's sort of in the nature of these viruses. It's definitely likely because the pandemic is now so widespread that unless the entire world simultaneously brings the virus to heel, there are always going to be pockets where outbreaks are still ongoing, and that can seed [and] can reignite sparks of infection in places where outbreaks had already been extinguished. ...

And so we're likely looking at multiple rounds of social distancing, multiple bouts of social upheaval. Now, it's possible if we get our act together and if we do well in this first wave, that those subsequent bouts will be less dramatic and less uprooting than this current period of time has been, and that may well just be because of that uneven spread. So currently the virus is everywhere. It's hitting everywhere ... at more or less the same time. If different places can get it under control, there might be less potential for that sort of explosive worldwide spread. And then, over time, one would hope that surveillance measures would be better. We become better at testing for the virus and working out who's immune to it, at building up the necessary supplies to protect health care workers. All of those measures might mean that we can get a little bit more sophisticated in where social distancing is being rolled out, in the nature of those measures. But I think it's very clear that that is going to be a long game.

Pandemics often expose existing fault lines in societies, and they reveal whom a society cares about and whom it often ignores.

Ed Yong

On how the pandemic has hit society's most vulnerable

Clearly, the economic implications of this are going to be profound. I think, as with many disasters, it's going to hit people in different ways that are magnified by existing inequalities; people from low income groups, people from marginalized groups are going to feel the effects of this far more.

Pandemics often expose existing fault lines in societies, and they reveal whom a society cares about and whom it often ignores. The people who are still having to serve on the front lines of society while everyone else is sheltering indoors, people like grocery store workers, janitors, they are currently risking their lives because many of them don't have a choice. The elderly who have often been marginalized in the fringes of society are now [being asked to] isolate themselves even more, deepening the loneliness that many of them have already felt. People with mental health disorders, people with anxiety and obsessive compulsive disorder who have long been grappling with worries about infection and cleanliness, are now seeing some of their worst nightmares playing out around them and are struggling in a context where they don't have access to their usual support networks or therapists.

So a lot of societal dynamics which were already being overlooked and which were already fraying are going to fray even more. I think it's important to be wary of [that unraveling] and to look out for the people who are most going to need help. A pandemic causes a wave of physical suffering, but following that, there is also economic suffering, mental suffering, emotional suffering. We will need to be wary of all of those things when society rebuilds in the wake of this crisis.

On the potential of the pandemic to inspire positive change

I think that this is the time to be imagining what a better world might look like and to start actively working towards it. These periods of great social upheaval carry with them great risk and tragedy, but also great potential. So on a very simple level, after HIV spread throughout the world and the '80s, it led to better awareness of sexual health that led to mainstreaming of condom use, of testing [for sexually transmitted infections]. And perhaps the COVID-19 pandemic will lead to a normalization of health behaviors that have been quite difficult to get people to take up, like regular hand-washing for 20 seconds sometimes a rarity even in hospital settings, let alone in homes. And now all of us well, many of us, hopefully [are] washing our hands on a regular basis every day. Hopefully that will become a normal part of our culture in the future.

I also really hope that a lot of the ethic of cooperation that we're starting to see, of people in communities looking out for each other, coming together at a moment of crisis, will continue through the rest of this long-haul pandemic and beyond. I think we're going to need that if we're going to be better-prepared for what's to come. We need that sense of cooperation between neighbors in a community, between states, in a country and between countries an international community.

Amy Salit and Seth Kelley produced and edited the audio of this interview. Bridget Bentz, Molly Seavy-Nesper and Deborah Franklin adapted it for the Web.

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Fighting COVID-19 Is Like 'Whack-A-Mole,' Says Writer Who Warned Of A Pandemic - NPR

COVID 19: U.S. says that Ultimate Game Changer Vaccine is on the Way – Yahoo Finance

April 3, 2020

By Gina Lee

Investing.com-Australia announced a $973 million package for its childcare sector.

Japans government debated an economic packageincluding ECMO machines.

The United States is on target to develop aCOVID-19 vaccine with biotech company Modernawithin 12 to 18 months.

As ofApril 1,thenumber of confirmed cases globally stood at827,419with40,777deaths, according to the World Health Organisation.

Australia

Prime Minister Scott Morrison announced an A$1.6 billion ($973 million) package for the countrys13,000-strongchildcare sector over the next three months.

The services will be rendered free of charge as theywill be paid from taxpayer subsidies.

Japan

The government is mulling the increased production of extracorporealmembranousoxygenation (ECMO) machinesas part of an economic package to combat COVID-19.

The machines will replace a persons breathing to supply oxygen and remove carbon dioxide.

United States

White Househealthadvisor Anthony Fauci announcedovernightthat the first human trialto test a potential COVID-19 vaccine is on target and will be an ultimate game changer.

Biotech company Moderna is working with Fauci and other healthofficialsto develop the vaccine. Human trials started on March 16.

The vaccine is estimated to bedistributedwithin 12 to 18 months, with phase two trials expected to begin in a few months.

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COVID 19: U.S. says that Ultimate Game Changer Vaccine is on the Way - Yahoo Finance

The race to develop Covid-19 drugs and vaccines is on here’s what’s happening in the UK – Endpoints News

April 3, 2020

Weeks away from the results of ongoing US and China trials testing its experimental antiviral remdesivir, Gilead is going to trial the failed Ebola drug in a small group of coronavirus patients in England and Scotland. The United Kingdom is also home to a range of other therapeutic efforts, as the pandemic rages on across the globe.

On Tuesday, Southampton, UK-based startup Synairgen kicked off a mid-stage placebo-controlled study testing its experimental drug, SNG001 an inhaled formulation of interferon-beta-1a that has previously shown to be safe and effective in improving lung function in asthma patients with a respiratory viral infection in a pair of Phase II trials.

Interferons, a family of naturally occurring proteins secreted by the immune system, typically boost the bodys immune response to uninvited guests such as viruses, bacteria and cancer.

When weve collected cells from patients with COPD and asthma and older peoplewe find that their lung cells dont respond very well to viruses, CEO Richard Marsden said in an interview. We have also along the way always recognized that with an emerging virus, the drug could be used.

As Covid-19 started to gather steam in China, Synairgen tried to get things started, but to no avail. Italy was the next plan. We had some really good interaction there, said Marsden. But they went from, you know, just busy to very busy to extremely busy to unable-to-communicate busy.

Eventually, they decided their home ground the UK, where they have an ongoing COPD trial would be the best place to kick off a Covid-19 study. Initially, the pilot phase of the trial will have 100 patients (50 will get a placebo, and 50 will get SNG001). If all goes well, a pivotal study will be conducted.

This approach is one of many, as companies race to design and develop diagnostics, drugs and vaccines to stem the tide of the pandemic. (W)e need high quality clinical research to work out what is working, what isnt working; we believe placebo-controlled trials are the way to do that, Marsden said.

Last week, the UK government issued a statement confirming that the two decades-old malaria drugs: chloroquine and hydroxychloroquine, which have been touted as potential treatments for patients infected with the coronavirus, have not been sanctioned for use against the virus in the UK.

Although clinical trials are ongoing, no conclusions have been reached on the safety and effectiveness of these medicines, noted the Medicines and Healthcare products Regulatory Agency. In stark contrast, in the United States, the FDA on Sunday issued emergency authorization for the pair of drugs that President Donald Trump has repeatedly backed, on the basis of anecdotal reports.

In the UK, scientists at Oxford University are also looking at repurposing other drugs for use against Covid-19. Last week, researchers announced they would be testing lopinavir-ritonavir, approved used to treat HIV, and the steroid dexamethasone, in consenting adults that have tested positive for Covid-19 in NHS hospitals. The project, in which patients will either get one of the two drugs, or placebo in addition to standard-of-care treatment, has won 10.5 million in government funding.

The streamlined design of this clinical trial allows consenting patients to be enrolled in large numbers easily and without compromising patient safety or adding significantly to the workload of busy hospitals and their staff, said the trials deputy chief investigator Martin Landray, who also serves as a professor of medicine and epidemiology University of Oxford, in a statement.

Oxford researchers also have a vaccine candidate in place.

On January 10 long before the coronavirus infection was named Covid-19 or assumed pandemic proportions a team of Oxford researchers led by Professors Sarah Gilbert, Andrew Pollard, Adrian Hill and Dr. Sandy Douglas had begun their search for a vaccine. On March 18, they honed in on a candidate: a chimpanzee adenovirus vaccine vector (ChAdOx1).

Chimpanzee adenoviral vectors are well studied, having been used in vaccines targeting over 10 different diseases. The Oxford vaccine contains the genetic sequence of the surface spike protein found on SARS-CoV-2 the virus behind Covid-19 inside the ChAdOx1 construct. If the project is successful, vaccination with this product will produce the surface spike protein of the coronavirus, priming the immune system to attack the coronavirus if it later infects the body.

The researchers who have previously developed a vaccine for MERS that showed promise in early clinical trial said last week they would start screening people for a clinical trial, although the vaccine is still weeks away from being ready for human testing. The enrollment goal is to hit 510 volunteers, and work is being done to scale up manufacturing in haste.

About a two-hour drive away, researchers at the University of Cambridge also have a Covid-19 vaccine in the works.

Professor Jonathan Heeney, head of the laboratory of viral zoonotics and chief of spinoff company DIOSynVax, has spearheaded research, aided by computer modeling of the virus structure.

By putting the genetics of the virus under a microscope, the company has identified a key part of the genetic code that the virus uses to produce the essential part of its coat: the spikes, which is what the vaccine is engineered to target.

A vaccine strategy needs to be laser specific, targeting those domains of the virus structure that are absolutely critical for docking with a cell, while avoiding the parts that could make things worse, he said in a statement. Our technology does just that.

Preclinical trials are yet to be conducted, but he expects the vaccine candidate could be ready for human trials by June. Funding, however, is required.

We need a Big Pharma partner to help us scale up our activities, he said.

For a look at all Endpoints News coronavirus stories, check out our special news channel.

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The race to develop Covid-19 drugs and vaccines is on here's what's happening in the UK - Endpoints News

Over 35 Companies in Race to Develop Vaccine for COVID-19 – All On Georgia

April 1, 2020

The race is on as a number of companies around the globe are fighting for the chance to be first to develop a COVID-19 vaccine.

The World Health Organization has announced that while the search for treatments of COVID-19 continues, even some of the more draconian containment initiatives have only slowed the spread of the virus. Thats why companies are working around the clock to create a vaccine before, as some worry, the virus mutates again.

Financialnewsmedia.com reports:

According to The Guardian, about 35 companies and academic institutions are racing to create such a vaccine, and Human trials will begin imminently but even if they go well and a cure is found, there are many barriers before global immunization is feasible. This unprecedented speed is thanks in large part to early Chinese efforts to sequence the genetic material of the virus.Chinashared that sequence in early January, allowing research groups around the world to grow the live virus and study how it invades human cells and makes people sick.

Active healthcare stocks in news today include: BioSig Technologies, Inc.(NASDAQ:BSGM),Gilead Sciences, Inc. (NASDAQ:GILD), CytoDyn Inc.(OTCQB:CYDY), Novavax, Inc. (NASDAQ:NVAX),Roche Holding AG(OTCQX:RHHBY).

Clinical trials, an essential precursor to regulatory approval, usually take place in three phases. The first, involving a few dozen healthy volunteers, tests the vaccine for safety, monitoring for adverse effects. The second, involving several hundred people, usually in a part of the world affected by the disease, looks at how effective the vaccine is, and the third does the same in several thousand people. But theres a high level of attrition as experimental vaccines pass through these phases. Not all horses that leave the starting gate will finish the race, saysBruce Gellin, who runs the global immunization program for theWashington DC-based nonprofit, theSabin Vaccine Institute.

The Guardian also reported:

Though nobody could have predicted that the next infectious disease to threaten the globe would be caused by a coronavirus flu is generally considered to pose the greatest pandemic risk vaccinologists had hedged their bets by working on prototype pathogens. The speed with which we have [produced these candidates] builds very much on the investment in understanding how to develop vaccines for other coronaviruses, saysRichard Hatchett, CEO of theOslo-based nonprofit theCoalition for Epidemic Preparedness Innovations(Cepi), which is leading efforts to finance and coordinate Covid-19 vaccine development.

According to a news release, CytoDyn Inc.recently announced that an additional three critically ill COVID-19 patients have been treated with leronlimab. These additional patients increase the total to 10 patients receiving leronlimab treatment under an Emergency Investigational New Drug (EIND) granted by the U.S. Food and Drug Administration (FDA).

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Over 35 Companies in Race to Develop Vaccine for COVID-19 - All On Georgia

A Creator of the Ebola Vaccine Has Hope for Slowing Covid-19 – WIRED

April 1, 2020

When the late Bob Simon interviewed Gary Kobinger for 60 Minutes in 2015, Kobinger was working principally in a space suit in a special clean room behind bulletproof glass. At the time, he was a top virologist at Canadas National Microbiology Lab, where he became a critical player in the development of the early Ebola vaccine ZMapp. Now hes the director of the Infectious Disease Research Center at the Universit Laval in Quebec City, his hometown. His lab helped with the early development of Inovio Pharmaceuticals Zika vaccine in 2017.

Today, Kobinger is among hundreds of scientists worldwide working on potential Covid-19 vaccines; he is working with Inovio and Medicago, another drug company. WIRED talked with Kobinger by phone last week. The conversation has been condensed and edited.

WIRED: You've been watching and helping with epidemics your entire career. How does Covid-19 compare to, say, the Ebola epidemic?

GARY KOBINGER: Well, it's on a global scale of course, so its more widespread than Ebola. But its also important to remember that this virus has a less than 5 percent fatality rate, versus 80 percent for Ebola before vaccines. [There were 28,652 Ebola cases during the 2014-2016 outbreak in West Africa and 11,310 deaths, according to the Centers for Disease Control and Prevention. There are more than 775,000 Covid-19 cases, according to Johns Hopkins University. It has killed more than 37,000 people.]

But pandemics are so similar in the way societies respond. I went to many different countries in Africa because of Ebola outbreaks. And often we were accused of being the ones bringing in the virus and infecting the population. We have the same thing today, where countries are saying its the Army or a secret Defense Department plan or whatever to export the virus.

Read all of our coronavirus coverage here.

We also see the same delays. Theres this natural optimism of societies, where you think the virus isnt going to come here, and you end up facing exactly the same last-minute urgent needs for things like PPEs [personal protective equipment like masks and gowns]. China had problems with PPEs in mid-January. So you could argue that we should have planned for that. Instead we are scrambling as if we never saw it coming.

The difference this time is, because Covid-19 is affecting so many countries, you see a lot more sense of urgency to develop countermeasuresvaccines, treatments, better supportive care like ventilators. Compare that to being in the middle of the tropical forest in Africa, like we were with Ebola. We would have liked to have had all that fancy equipment. But people were not that interested in what we were doing. With Covid-19, Ive had all levels of the Canadian government coming to me, saying, Gary, if you need anything, please let us know. We are here to help. I've never had that kind of support in my career.

There are dozens of labs worldwide working on a Covid-19 vaccine, including yours. Is that a good thing, or should we be coordinating and focusing that effort more to maybe get a vaccine faster?

Its a good thing. Its actually important to test a lot of vaccines. We dont want to put all our eggs into one basket, only to have that one vaccine fall short in clinical trials. If we could have five vaccines that are safe and work and are potent, that would be much better. It also reduces the chances for manufacturing bottlenecks. With five vaccines, maybe we could manufacture enough for everybody on the planet. But with only one manufacturer, I dont think it will be possible.

But it needs to be done the right way. If you develop a vaccine thats not powerful enough to counter the virus, it can actually make the infection harder to treat. What you could see are people becoming more susceptible to acquiring the infection and maybe more susceptible to severe disease. That's something to really watch out for.

"Its actually important to test a lot of vaccines."

Gary Kobinger, virus researcher

Whats clear is that the development is going to be expensive. If we had done this work ahead of time, we could have done it for $500 million to $800 million. Now we're spending billions of dollars because we're rushing, in an emergency. When the virus was first emerging in China, I said this has the potential to show our level of preparedness. We will probably realize we are not very ready for this kind of event.

Is there any way to speed the development, which is expected to take at least 18 months? Thats a long time.

Yes. With some government and regulatory coordination, we can be faster than 12 months rolling out a vaccinenot for the planet, but maybe for target populations like health care workers. You could also target vulnerable populations like the elderly or those with co-morbidities by doing risk analysis for each of those populations. The track we are on nowwith a vaccine that needs to work for everybody with no side effectsis slower. We'll see. With Ebola in West Africa, we saw things happenpeople working together, work that got donethat were unprecedented. I hope we are in another of those moments.

What about therapies? If we made Covid-19 less lethal, that could do almost as much as a vaccine and provide relief much faster.

You need bothdevelop therapies and vaccines. Therapies are important, but you have to be reasonable with your expectations. You have to be very careful about creating false hope with therapies. On one hand, if you dont have a randomized trial, its hard to make any claim about their effectiveness. At the same time, its important to listen to health care workers who are using those drugs on the front lines. They have a very good sense of what may be worth pursuing and not pursuing in trials, even if they are not using it in a randomized trial. So with drugs like chloroquine and azithromycin that are already approved, lets put them in the clinic as soon as possible, and at same time design the best clinical study you can.

"It will get worse before it gets better, but a lot of the control measures are working."

Gary Kobinger, virus researcher

But the ultimate goal is to find a vaccine that keeps people from getting the virus at all. Sometimes patients who get it are left with lung damage that's not repairable. And even if the virus recedes, it could come back worse later. In 1918 the Spanish flu in the spring was a very mild wave, and then it came back with a vengeance in the fall.

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A Creator of the Ebola Vaccine Has Hope for Slowing Covid-19 - WIRED

COVID-19 Vaccine Development Gets Boost From HHS : Coronavirus Live Updates – NPR

April 1, 2020

A scientist works in a lab at Moderna in Cambridge, Mass., in February. Moderna has developed an experimental coronavirus medicine, but an approved treatment could be more than a year away. David L. Ryan/Boston Globe via Getty Images hide caption

A scientist works in a lab at Moderna in Cambridge, Mass., in February. Moderna has developed an experimental coronavirus medicine, but an approved treatment could be more than a year away.

The Department of Health and Human Services outlined how it will support Moderna and Johnson & Johnson as they develop vaccines against the novel coronavirus that's sickened more than 800,000 people worldwide as of Tuesday afternoon.

HHS's Biomedical Advanced Research and Development Authority, BARDA, said Monday that it will help speed up clinical trials for both companies' experimental vaccines, and support Janssen Pharmaceuticals, a unit of Johnson & Johnson, in making up to 300 million doses annually in the U.S.

"Vaccines are essential to saving lives," BARDA director Rick Bright said in a statement. "Delivering a safe and effective vaccine for a rapidly spreading disease like COVID-19 requires accelerated action with parallel development streams. The rapid progress we are making with industry partners clearly demonstrates a commitment to protecting people at home and abroad."

The Janssen vaccine clinical trials are expected to begin "no later than" this fall, according to the HHS announcement, which also said the goal is to get a COVID-19 vaccine ready for emergency use in the U.S. in early 2021.

Meanwhile, the company will begin preparation for large-scale vaccine production Wednesday, Janssen spokeswoman Katie Buckley wrote in an email. The company would be able to make 600 million vaccine doses by the end of 2020, with 300 million manufactured in the U.S., she wrote. "We are however investing in new production facilities to increase that number."

If Janssen's vaccine is proven safe and effective, the company will also make it available "in China and other parts of the world," said a statement by Paul Stoffels, chief scientific officer at Johnson & Johnson.

Moderna's early vaccine trials are already underway with help from the National Institutes of Health. BARDA will support phase 2 and 3 clinical trials, which typically involve hundreds or thousands of patients.

"Given the pandemic, Moderna has already started to prepare for the rapid acceleration of its manufacturing capabilities that could allow for the future manufacture of millions of doses should mRNA-1273 prove to be safe and of expected benefit," the company said in a statement. "Moderna is engaged in discussions for outside funding, including with BARDA, of such activities and will continue to work with government, industry and other third parties to responsibly and rapidly move forward."

HHS declined to share specific dollar figures with NPR, but Johnson & Johnson said that the company and BARDA would together contribute $1 billion toward its COVID-19 vaccine efforts.

A Moderna spokesperson didn't respond in time for publication to a question about how much money BARDA was committing toward the company's vaccine development.

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COVID-19 Vaccine Development Gets Boost From HHS : Coronavirus Live Updates - NPR

COVID-19 vaccine candidates: 6 front-runners – ABC News

April 1, 2020

As the novel coronavirus continues to spread across the country, those who are not infected can protect themselves by avoiding close contact with others and aggressively washing their hands. But beyond this, many are desperately hoping for another form of protection: a vaccine.

Vaccines work by exposing our bodies to something that resembles a certain pathogen, training our immune systems to recognize, attack and kill the invader. When presented with the real pathogen itself, our immune armies are ready to fight.

While not a treatment or cure, vaccines can help eradicate a disease by starving the virus of people to infect and transmit the disease.

Vaccines are especially needed by health care workers on the front lines and other vulnerable members of the population who have a higher risk of contracting the infection.

While the race to develop a COVID-19 vaccine is well underway with over 40 hopeful candidates, only three have entered Phase I of clinical trials, the first of three stages of human testing before drug approval.

Phase I testing is only a test to see if the vaccine is safe. Researchers won't know if it's effective until Phase II is studied. Below is a brief overview of these three candidates, plus three promising ones that are still in earlier stages of development.

mRNA-1273: The front-runner in the U.S., which is backed by the NIAID and developed by Moderna Therapeutics, is based upon a specific type of genetic material, mRNA. This vaccine, mRNA-1273, codes for a specific protein on the novel coronavirus -- the spike protein the key into a human cell. An mRNA-based virus has never been approved for use in humans, but animal studies have been promising. This particular vaccine, however, was rushed to human trials before it was even tested in animals -- skipping a step in traditional vaccine development.

A Phase I trial testing the vaccines safety in 45 healthy adult volunteers began earlier this month at Kaiser Permanente Washington Health Research Institute in Seattle. The participants will receive two injections of low, medium or high doses of the vaccine and be monitored for any adverse events or immune response. The company is hopeful that it may have a vaccine as early as fall 2020 for some particularly vulnerable groups, such as health care workers. The Phase I safety study should be completed by June 2021.

Donna Schaferkotter, medical laboratory scientist at UMMC, analyzes samples during COVID-19 testing in Jackson, Miss., March 25, 2020, The Medical Center started in-house testing for the novel coronavirus using a commercially available kit and is developing additional ways to test for COVID-19.

Ad5-nCoV: The front-runner across the globe, Ad5-nCoV, was developed by the Beijing Institute of Biotech and CanSino Biologics, a Chinese biopharmaceutical company. This vaccine uses a viral vector, a virus that has been engineered to not contain its infectious properties and instead delivers genetic material to the recipient. Phase I testing of this vaccine is underway at Hubei Provincial Center for Disease Control and Prevention, where 108 healthy adult volunteers will receive one of three doses of the vaccine to assess for safety. Ad5-nCoV is perhaps the most promising because CanSino has already produced a nearly identical vaccine, Ad5-EBOV, to protect against Ebola. The Ebola vaccine has already entered Phase II testing, meaning its even further along. Still, the official anticipated completion date for Ad5-nCOV safety testing is December 2020, with all testing completed by 2022.

ChAdOx1: The University of Oxford is one of the most recent groups to bring its vaccine candidate into human studies -- a major milestone. The vaccine is simultaneously being tested for both safety (Phase I) and efficacy (Phase II) by injecting 510 healthy participants with either vaccine or placebo. This vaccine uses an inactivated (non-infectious) virus that contains genetic material for the key protein on the novel coronavirus, similar to Ad5-nCoV in China. This viral vector, however, was derived from chimpanzees which, the researchers argue, creates an even more robust response than other viruses to which humans may have already been exposed. This vaccine is being funded by the United Kingdom government and is moving quickly. Still, its anticipated completion date of this phase isnt until May 2021.

BNT162: Biopharmaceutical giant Pfizer, along with partner company BioNTech, is working on an mRNA-based vaccine that is similar to Modernas model. The duo was already working on an influenza vaccine using this scientific strategy so their vaccine candidate, BNT162, is moving particularly fast. Clinical trials are anticipated to begin in April in both the U.S. and Germany.

INO-4800: An entirely different technology is being developed by Inovio Pharmaceuticals, a company that uses a proprietary platform for activation immunotherapy. This vaccine delivers DNA, another genetic material, into a hosts cells by utilizing a hand-held smart device CELLECTRA. The DNA is translated into proteins that activate an individuals immune system to generate a targeted immune response. While that may sound like science fiction, the company has used the same technology to rapidly advance vaccines against MERS, a closely related coronavirus, and HPV-related cervical precancer, among others. None of these, however, have completed their trial phase and entered the market. Trials for the COVID-19 specific vaccine, INO-4800, are anticipated to begin in April.

Sanofi recombinant DNA vaccine (unnamed): Last month, Sanofi Pasteur announced that it was partnering with the U.S. Department of Health and Human Services to create a DNA-based vaccine. Their vaccine, which is yet to be named, relies on recombinant (engineered) DNA that encodes for proteins found on COVID-19 surface -- the same basic principle of many of the other candidates. The company had been previously working on a vaccine for SARS, a close relative of the novel coronavirus, which showed promise in animal models. More importantly, however, Sanofi has proved immensely successful in the vaccine market: they have influenza vaccines, including Flublok and Fluzone, that are widely in use today. They claim that their technique -- and their experience with mass production of their products -- would allow a COVID-19 vaccine to be introduced much more quickly than traditional production methods. Still, human trials are yet to begin but will likely start in April.

Chlo E. Nunneley, MD, is a pediatric resident physician at Boston Childrens Hospital & Boston Medical Center and a contributor to the ABC News Medical Unit.

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COVID-19 vaccine candidates: 6 front-runners - ABC News

COVID-19 Vaccine Updates: J&J Identifies Lead Candidate, IMV Eyes Clinical Testing In Summer, Altimmune Partners With University Of Alabama – Yahoo…

April 1, 2020

Two coronavirus vaccine candidates are in the clinics and 42 more are in preclinical studies, according to updated data provided by the World Health Organization onMarch 20.

Three biopharma companies issued updates Monday on their developmental efforts for vaccines to combat the deadly virus, which has so far killed more than 35,000 people and infected about 735,000 more, according to Johns Hopkins University.

IMV On Track For Summer Start

Canadian pharma Imv Inc (NASDAQ: IMV), which announced March 18 its intention to develop a DPX-based vaccine candidate for the new coronavirus, said it has initiated discussions with Health Canada to prepare for a clinical trial application.

Using the genomic and proteomic sequences of the novel coronavirus, the company said it identified several hundred epitopes and shortlisted 23based on their biological relevance to the virus and potential to generate neutralizing antibodies.

IMV said it has begun manufacturing peptide candidates targeting these epitopes, and said it is in talks with suppliers and contract manufacturers to prepare for the cGMP batch required to support a clinical study.

The company has finalized the design of aplanned Phase 1 study in 48 healthy subjects and identified clinical sites in Nova Scotia and Quebec, according to a press release.

IMV said it is scheduled to meet with regulators in the week of April 20, with a goal of beginning clinical testing in summer 2020. It also said it has submitted several grant applications in Canada to help support the program.

"We remain committed to serving the unmet needs of patients, both through our efforts to potentially develop a prophylactic vaccine to curb this novel coronavirus and across our ongoing clinical studies with DPX-Survivac in advanced-stage cancer patients," CEO Frederic Ors said in a statement.

See also: Novavax Shares Rally On Flu Vaccine Study Results: What You Need To Know

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Altimmune To Work With University of Alabama On Intranasal Vaccine

Altimmune Inc (NASDAQ: ALT) said it has launched a collaboration with the University of Alabama at Birmingham for developing a single-dose, intranasal COVID-19 vaccine, AdCOVID.

The company said it is preparing for immunogenicity studies and manufacturing of Phase 1 trial material. Altimmune said it will work with universityinvestigators on preclinical animal studies and characterization of vaccine immunogenicity. The company is planning a Phase 1 study in the third quarter.

J&J Plans Clinical Testing By September, Commits Over $1B In Funding

Johnson & Johnson (NYSE: JNJ) said it has selected a lead COVID-19 vaccine candidate from constructs it has been working on since January.

The company said that, through a new partnership with the BARDA, it has committed more than $1 billion to co-fund vaccine research, development and clinical testing.

Separately, the company and BARDA have provided additional funding to enable expansion of their ongoing work to identify potential treatments for the virus.

Additionally, J&J said it is expanding its global manufacturing capacity to assist in the rapid production of a vaccine and supply of more than 1 billion doses of a safe and effective vaccine globally.

J&Jsaid it is "committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use."

J&J expects to initiate human clinical studies at the latest by September 2020 and make available the first batch of a vaccine for emergency use authorization in early 2021.

At the time of publication Monday:

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COVID-19 Vaccine Updates: J&J Identifies Lead Candidate, IMV Eyes Clinical Testing In Summer, Altimmune Partners With University Of Alabama - Yahoo...

UAB researchers working on COVID-19 vaccine – WHNT News 19

April 1, 2020

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Researchers at the University of Alabama at Birmingham are working on a potential COVID-19 vaccine. What they're working on is a nasal spray vaccine, and right now, they tell our news partners at AL.com they're testing its effectiveness on mice.

It's a collaboration between UAB and Altimmune, a biopharmaceutical company based in Maryland. According to UAB, first, they will test the vaccine in mice to investigate the immune responses. This will happen at UAB. Later this year, Altimmune plans to start human trials.

According to UAB, the vaccine is called Adcovid and is a single-dose vaccine that is delivered by an intranasal spray. This vaccine is based off other nasal spray vaccines that Altimmune has developed, like the vaccine candidate for the flu.

Experts say that six labs at UAB will be used to work on this collaboration. Testing and collecting the data is their highest priority so that Altimune can move on to the next step in the trial.

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UAB researchers working on COVID-19 vaccine - WHNT News 19

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