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Coronavirus vaccine: when will it be ready? – The Guardian

Even at their most effective and draconian containment strategies have only slowed the spread of the respiratory disease Covid-19. With the World Health Organization finally declaring a pandemic, all eyes have turned to the prospect of a vaccine, because only a vaccine can prevent people from getting sick.

About 35 companies and academic institutions are racing to create such a vaccine, at least four of which already have candidates they have been testing in animals. The first of these produced by Boston-based biotech firm Moderna will enter human trials imminently.

This unprecedented speed is thanks in large part to early Chinese efforts to sequence the genetic material of Sars-CoV-2, the virus that causes Covid-19. China shared 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.

But there is another reason for the head start. 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, says Richard Hatchett, CEO of the Oslo-based nonprofit the Coalition for Epidemic Preparedness Innovations (Cepi), which is leading efforts to finance and coordinate Covid-19 vaccine development.

Coronaviruses have caused two other recent epidemics severe acute respiratory syndrome (Sars) in China in 2002-04, and Middle East respiratory syndrome (Mers), which started in Saudi Arabia in 2012. In both cases, work began on vaccines that were later shelved when the outbreaks were contained. One company, Maryland-based Novavax, has now repurposed those vaccines for Sars-CoV-2, and says it has several candidates ready to enter human trials this spring. Moderna, meanwhile, built on earlier work on the Mers virus conducted at the US National Institute of Allergy and Infectious Diseases in Bethesda, Maryland.

Sars-CoV-2 shares between 80% and 90% of its genetic material with the virus that caused Sars hence its name. Both consist of a strip of ribonucleic acid (RNA) inside a spherical protein capsule that is covered in spikes. The spikes lock on to receptors on the surface of cells lining the human lung the same type of receptor in both cases allowing the virus to break into the cell. Once inside, it hijacks the cells reproductive machinery to produce more copies of itself, before breaking out of the cell again and killing it in the process.

All vaccines work according to the same basic principle. They present part or all of the pathogen to the human immune system, usually in the form of an injection and at a low dose, to prompt the system to produce antibodies to the pathogen. Antibodies are a kind of immune memory which, having been elicited once, can be quickly mobilised again if the person is exposed to the virus in its natural form.

Traditionally, immunisation has been achieved using live, weakened forms of the virus, or part or whole of the virus once it has been inactivated by heat or chemicals. These methods have drawbacks. The live form can continue to evolve in the host, for example, potentially recapturing some of its virulence and making the recipient sick, while higher or repeat doses of the inactivated virus are required to achieve the necessary degree of protection. Some of the Covid-19 vaccine projects are using these tried-and-tested approaches, but others are using newer technology. One more recent strategy the one that Novavax is using, for example constructs a recombinant vaccine. This involves extracting the genetic code for the protein spike on the surface of Sars-CoV-2, which is the part of the virus most likely to provoke an immune reaction in humans, and pasting it into the genome of a bacterium or yeast forcing these microorganisms to churn out large quantities of the protein. Other approaches, even newer, bypass the protein and build vaccines from the genetic instruction itself. This is the case for Moderna and another Boston company, CureVac, both of which are building Covid-19 vaccines out of messenger RNA.

Cepis original portfolio of four funded Covid-19 vaccine projects was heavily skewed towards these more innovative technologies, and last week it announced $4.4m (3.4m) of partnership funding with Novavax and with a University of Oxford vectored vaccine project. Our experience with vaccine development is that you cant anticipate where youre going to stumble, says Hatchett, meaning that diversity is key. And the stage where any approach is most likely to stumble is clinical or human trials, which, for some of the candidates, are about to get under way.

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, says Bruce Gellin, who runs the global immunisation programme for the Washington DC-based nonprofit, the Sabin Vaccine Institute.

There are good reasons for that. Either the candidates are unsafe, or theyre ineffective, or both. Screening out duds is essential, which is why clinical trials cant be skipped or hurried. Approval can be accelerated if regulators have approved similar products before. The annual flu vaccine, for example, is the product of a well-honed assembly line in which only one or a few modules have to be updated each year. In contrast, Sars-CoV-2 is a novel pathogen in humans, and many of the technologies being used to build vaccines are relatively untested too. No vaccine made from genetic material RNA or DNA has been approved to date, for example. So the Covid-19 vaccine candidates have to be treated as brand new vaccines, and as Gellin says: While there is a push to do things as fast as possible, its really important not to take shortcuts.

An illustration of that is a vaccine that was produced in the 1960s against respiratory syncytial virus, a common virus that causes cold-like symptoms in children. In clinical trials, this vaccine was found to aggravate those symptoms in infants who went on to catch the virus. A similar effect was observed in animals given an early experimental Sars vaccine. It was later modified to eliminate that problem but, now that it has been repurposed for Sars-CoV-2, it will need to be put through especially stringent safety testing to rule out the risk of enhanced disease.

Its for these reasons that taking a vaccine candidate all the way to regulatory approval typically takes a decade or more, and why President Trump sowed confusion when, at a meeting at the White House on 2 March, he pressed for a vaccine to be ready by the US elections in November an impossible deadline. Like most vaccinologists, I dont think this vaccine will be ready before 18 months, says Annelies Wilder-Smith, professor of emerging infectious diseases at the London School of Hygiene and Tropical Medicine. Thats already extremely fast, and it assumes there will be no hitches.

In the meantime, there is another potential problem. As soon as a vaccine is approved, its going to be needed in vast quantities and many of the organisations in the Covid-19 vaccine race simply dont have the necessary production capacity. Vaccine development is already a risky affair, in business terms, because so few candidates get anywhere near the clinic. Production facilities tend to be tailored to specific vaccines, and scaling these up when you dont yet know if your product will succeed is not commercially feasible. Cepi and similar organisations exist to shoulder some of the risk, keeping companies incentivised to develop much-needed vaccines. Cepi plans to invest in developing a Covid-19 vaccine and boosting manufacturing capacity in parallel, and earlier this month it put out a call for $2bn to allow it to do so.

Once a Covid-19 vaccine has been approved, a further set of challenges will present itself. Getting a vaccine thats proven to be safe and effective in humans takes one at best about a third of the way to whats needed for a global immunisation programme, says global health expert Jonathan Quick of Duke University in North Carolina, author of The End of Epidemics (2018). Virus biology and vaccines technology could be the limiting factors, but politics and economics are far more likely to be the barrier to immunisation.

The problem is making sure the vaccine gets to all those who need it. This is a challenge even within countries, and some have worked out guidelines. In the scenario of a flu pandemic, for example, the UK would prioritise vaccinating healthcare and social care workers, along with those considered at highest medical risk including children and pregnant women with the overall goal of keeping sickness and death ra tes as low as possible. But in a pandemic, countries also have to compete with each other for medicines.

Because pandemics tend to hit hardest those countries that have the most fragile and underfunded healthcare systems, there is an inherent imbalance between need and purchasing power when it comes to vaccines. During the 2009 H1N1 flu pandemic, for example, vaccine supplies were snapped up by nations that could afford them, leaving poorer ones short. But you could also imagine a scenario where, say, India a major supplier of vaccines to the developing world not unreasonably decides to use its vaccine production to protect its own 1.3 billion-strong population first, before exporting any.

Outside of pandemics, the WHO brings governments, charitable foundations and vaccine-makers together to agree an equitable global distribution strategy, and organisations like Gavi, the vaccine alliance, have come up with innovative funding mechanisms to raise money on the markets for ensuring supply to poorer countries. But each pandemic is different, and no country is bound by any arrangement the WHO proposes leaving many unknowns. As Seth Berkley, CEO of Gavi, points out: The question is, what will happen in a situation where youve got national emergencies going on?

This is being debated, but it will be a while before we see how it plays out. The pandemic, says Wilder-Smith, will probably have peaked and declined before a vaccine is available. A vaccine could still save many lives, especially if the virus becomes endemic or perennially circulating like flu and there are further, possibly seasonal, outbreaks. But until then, our best hope is to contain the disease as far as possible. To repeat the sage advice: wash your hands.

This article was amended on 19 March 2020. An earlier version incorrectly stated that the Sabin Vaccine Institute was collaborating with the Coalition for Epidemic Preparedness Innovations (Cepi) on a Covid-19 vaccine.

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The curious case of the cat with corona – The Brussels Times

Among the headlines from yesterdays meetings of the newly-empowered government and the national security council, one that caught the eye was the announcement of a cat diagnosed with coronavirus caught from its owner.

The cat was reported to have caught the virus from close contact with its owner, who had recently returned from Italy. When the cat became ill, its stool was examined and traces of the virus discovered.

The experts were quick to reassure pet owners that the case was exceptional, that animals were not considered a vector for the disease, and that there was no reason to be afraid either for their pets or for themselves.

But one animal virologist has raised questions about the whole story.

Hans Nauwynck is a professor at the faculty of veterinary medicine at the University of Ghent, and a specialist in virology. The news of the corona cat took him by surprise.

Before sending this news out into the world, I would have had some other tests carried out, he told Het Laatste Nieuws. When you hear about this right now, I wouldnt wish to be a cat tomorrow.

The discovery was made by the vet faculty at Liege university, who concluded the infection passed from human to cat and not the other way around.

Look, I have no criticism of my colleagues at Liege university, he stressed. The diagnosis has been made, Ive no doubt about the result, but were dealing here with a PCR test, a way of identifying genetic material of the virus.

The polymerase chain reaction (PCR) test allows scientists to multiply a very small sample of genetic material to produce a quantity large enough to study.

Im simply questioning the interpretation of the results. The test is positive for corona, fine, but how was the test carried out? How was the sample taken, and can that result be trusted? I would advise people to slow down. There may somehow have been genetic material from the owner in the sample, and so the sample is contaminated.

To be absolutely certain, he said, more tests should have been done to confirm the initial result, and certainly before making an announcement to the world.

I think its too bad they didnt look further, he said. There should also have been research carried out to see if the cat had produced antibodies. Im worried that people will be scared by this news and animals will be the ones to suffer, and thats not right. As scientists we ought to put out clear and full information, and I dont think that has happened.

In the latest update, the cat is doing well. Its owner is also recovering, albeit more slowly.

Alan HopeThe Brussels Times

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Novartis new analysis further showed durable and potent LDL-C reduction with inclisiran, an investigational first-in-class siRNA cholesterol-lowering…

EAST HANOVER, N.J., March 28, 2020 /PRNewswire/ --Novartis today announced results from a prespecified analysis of pooled data from three Phase III studies evaluating the safety and efficacy of inclisiran, its first-in-class investigational treatment for hyperlipidemia in adults. The data was presented during a Late Breaker session at the American College of Cardiology's Annual Scientific Session Together with World Congress of Cardiology (ACC.20/WCC Virtual). The pooled analysis of the ORION-9, -10 and -11 Phase III trials showed a durable and potent reduction in LDL-C of 51% when used in addition to other lipid-lowering therapies (LLT) over 17 months of treatment1. The prespecified analysis of pooled data is consistent with the efficacy and safety findings of the individual Phase III trial results recently published in The New England Journal of Medicine.

Additionally, a prespecified exploratory analysis using the safety reporting from all three trials indicated fewer MACE with inclisiran compared to placebo (7.1%, 9.4% respectively)1. The overall safety and tolerability profile was generally similar between the inclisiran and placebo groups. While these preliminary observations are based on a low number of events, they are consistent with the general concept that however LDL-C is lowered, it is thought to result in reduced risk of future cardiovascular events2. This further supports the research currently underway in the Phase III ORION-4 trial. The ORION-4 trial aims to recruit 15,000 participants from 150 sites in the United States and the United Kingdom with pre-existing atherosclerotic cardiovascular disease (ASCVD) and who are unable to achieve LDL-C goal. Expected to finish in 2024, this trial will bring additional information on inclisiran's effects on cardiovascular outcomes.

"There remains a compelling need for new and novel LDL-C-lowering therapies given the residual risk faced by many patients with atherosclerotic cardiovascular disease and the inability of oral lipid-lowering therapy alone to achieve important LDL targets," said ORION-10 principal investigator R. Scott Wright, M.D., Professor of Medicine, Consultant in Cardiology, Mayo Clinic in Rochester, Minnesota. "Inclisiran harnesses the body's natural mechanisms for RNA silencing and lowers LDL-C. This analysis confirmed that twice-yearly dosing of inclisiran achieved durable and potent reductions in LDL-C in the phase III studies."

"After decades of declining cardiovascular disease mortality, it is on the rise again, renewing the urgency behind our longstanding commitment to and extensive experience in this space," said David Platt, M.D., Vice President, US Clinical Development and Medical Affairs, Cardiovascular, Renal & Metabolism Medical Unit, Novartis Pharmaceuticals. "We are excited by the results we have seen to date with inclisiran, and we look forward to the potential opportunity to make the first and only LDL-C-lowering treatment in the small interfering RNA (siRNA) class available to patients with ASCVD and familial hypercholesterolemia."

Inclisiran is currently under review by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for use in adults with ASCVD or heterozygous familial hypercholesterolemia (HeFH) who have elevated LDL-C while being on a maximum tolerated dose of a LLT. Inclisiran was administered subcutaneously with an initial dose, again at 3 months and then every 6 months, offering a unique dosing regimen. If approved, inclisiran will be the first and only LDL-C-lowering treatment in the siRNA class.

Hyperlipidemia refers to the high level of lipids (fats, cholesterol, triglycerides), such as LDL-C, found in the blood that are either acquired or from genetic disorders3. LDL-C is the most readily modifiable risk factor for ASCVD4-9. Despite the widespread use of therapies to reduce LDL-C, the majority of patients do not reach guideline-recommended treatment goals, leaving them at continued risk of a life-threatening condition10.

About the pooled analysisThe pooled analysis includes data from inclisiran's ORION-9, -10 and -11 trials, which are multicenter, double-blind, randomized, placebo-controlled,18-month studies evaluating inclisiran in patients with heterozygous familial hypercholesterolemia (ORION-9), ASCVD (ORION-10) and ASCVD or ASCVD risk equivalents (ORION-11). The primary endpoints for these studies were percentage change in LDL-C from baseline to 17 months and time-adjusted percentage change in LDL-C from baseline between 3 months and up to 18 months. The primary endpoints were achieved in all three studies. The prespecified analysis of pooled data assessed inclisiran's efficacy for lowering of LDL-C and other lipids/lipoproteins, as well as safety and tolerability, across these studies1.

In the prespecified analysis of pooled data, inclisiranresulted in placebo-adjusted LDL-C reduction at 17 months of 51% and a time-adjusted placebo-adjusted percentage reduction in LDL-C between 3 and 18 months of 51%. In a prespecified exploratory safety analysis, MACE were significantly lower with inclisiran versus placebo (7.1%, 9.4% respectively); measures included non-fatal myocardial infarction (5.2%, 7.8%), stroke (0.9%, 1.0%), cardiovascular death (0.9%, 0.8%) and resuscitated cardiac arrest (0.2%, 0.1%). The overall safety and tolerability profile was generally similar between inclisiran and placebo groups. No differences in adverse outcomes were observed between groups1.

About inclisiranInclisiran, an investigational cholesterol-lowering treatment, was added to the pipeline from the Novartis acquisition of The Medicines Company. Inclisiran will potentially be the first and only LDL-C lowering siRNA treatment. It is intended to be administered by a healthcare professional by subcutaneous injection with an initial dose, again at 3 months and then every 6 months thereafter. Its twice-yearly dosing by subcutaneous injection may integrate seamlessly into a patient's healthcare routine. As a siRNA, inclisiran is thought to harness the body's natural process of clearing LDL-C from the bloodstream. Inclisiran is a double-stranded siRNA, conjugated on the sense strand with triantennary N-acetylgalactosamine (GalNAc) to facilitate uptake by hepatocytes. In hepatocytes, inclisiran increases LDL-C receptor recycling and expression on the hepatocyte cell surface, thereby increasing LDL-C uptake by hepatocytes and lowering LDL-C levels in the circulation. Data from each of the Phase III studies was recently published online, ahead of print, in The New England Journal of Medicine11,12. A cardiovascular outcomes trial, ORION-4, is ongoing.

In the Phase III studies, inclisiran was reported to be well-tolerated with a safety profile similar to placebo. The most common adverse reactions reported (3% of patients treated with inclisiran and occurring more frequently than placebo) were, diabetes mellitus, hypertension, nasopharyngitis, arthralgia, back pain, dyspnea, bronchitis and upper respiratory tract infection. Adverse events at the injection site were more frequent with inclisiran than placebo and were generally mild and none were severe or persistent11,12.

Novartis has obtained global rights to develop, manufacture and commercialize inclisiran under a license and collaboration agreement with Alnylam Pharmaceuticals.

About Novartis in Cardiovascular-Renal-MetabolismBending the curve of life requires addressing some of society's biggest public health concerns. Novartis has an established and expanding presence in diseases covering the heart, kidney and metabolic system. In addition to essential treatment Entresto (sacubitril/valsartan), Novartis has a growing pipeline of potentially first-in-class molecules addressing cardiovascular, metabolic and renal diseases.

DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "seek," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About NovartisLocated in East Hanover, NJ Novartis Pharmaceuticals Corporation an affiliate of Novartis is reimagining medicine to improve and extend people's lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. Novartis employs about 15,000 people in the United States. For more information, please visit http://www.novartis.us.

Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartisnews For Novartis multimedia content, please visit http://www.novartis.com/news/media-libraryFor questions about the site or required registration, please contact media.relations@novartis.com

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Face mask shortages have sparked creative solutions. Will they work? – Science News

As COVID-19 sweeps across the United States, hospitals are runningout of masks, gowns and eye protection. New supplies arent being made fastenough to keep up with demand, and stockpiles seem insufficient.

There is no bailout, says David Witt, an infectiousdisease specialist and epidemiologist at Kaiser Permanente Oakland MedicalCenter in California. There is no military supply. There is no nationalstockpile that will suffice. Its not coming from another country in aid.

Mask-making company 3M is rampingup production, and other companies, including Ford,are pitching in. But these efforts will take time. Meanwhile, carpenters,clothing companies and local sewing circles are stepping up to help.Crowdsourcing efforts such as #getmePPE and the 100 Million Mask Challengeare seeking to fill supply gaps in face masks, goggles and other personalprotective equipment, or PPE.

An editorial published March 20 in JAMA requested creative ideas.Proposals have flooded in with predominant themes emerging on how to reuse the facemasks called N95s, thick, tight-fitting masks that can block tiny virusparticles, and how to make alternatives to commercial ones. The innovation ondisplay convinced surgeon Ed Livingston, a coauthor of the editorial and aneditor at JAMA, that this is thebiomedical engineering communitys Apollo 13 moment.

In this fast-moving emergency, its unclear which homespunefforts will help the most. Heres what we know, and dont know, about how tobest conserve the PPE that we have and how to make more.

Scientists and journalists share a core belief in questioning, observing and verifying to reach the truth. Science News reports on crucial research and discovery across science disciplines. We need your financial support to make it happen every contribution makes a difference.

Hospitals are asking for donations from anyone who might have PPE on hand, including construction workers, dentists and spa workers. Wearing a single mask for multiple patients is something that we would normally never do, Witt says.

Though that practice is not ideal, it might not be terrible.Masks dont necessarily pick up a lot of contamination, a small study finds. Researchersin Singapore swabbed N95 face masks, goggles and shoes of 30 health careworkers as they exited rooms of 15 patients with COVID-19. Noviral genetic material was detected, the researchers report March 26 in Infection Control & HospitalEpidemiology, suggesting that extended use of masks and goggles might work,in certain conditions. The study might have missed some virus on masks due tothe limited way researchers tested the masks. And the patients were inisolation rooms with 12 air exchanges per hour. Conditions differ at otherhealth care facilities.

Assuming reused masks are bound to get some level of contamination,others have been exploring how to best disinfect masks. Time is a powerfuldisinfectant; infectivity of SARS-CoV-2, the virus responsible for the COVID-19illness, plummetsafter two to three days on hard surfaces. The virus lasts evenless time on other surfaces (SN:3/4/20). Some researchers have recommended rotating through a series ofmasks, so that worn masks can rest and passively become virus-free again.

Other suggestions include heat, chemical disinfectants andultraviolet light. At the University of Nebraska Medical Center, health careworkers hangup strings of used masks in a room with two UV light towers. After atreatment of about five minutes, the masks are ready to be used again. Theapproach is experimental, and its not clear whether multiple rounds of UV lightdamages the masks.

The U.S. Centers for Disease Control and Preventions new crisisguidelines to health care workers says that where no face masks are available,homemade masks, made of bandannas or scarves, for instance, canbe used as a last resort.Thatshow desperate they are, that they said that, Livingston says.

Cloth masks arent ideal. A 2015 study of over 1,000healthcare workers in Hanoi, Vietnam, found that those who were assigned towear cloth masks were morelikely to get a respiratory virus than those who wore medical masks, madeof thick fibers that catch a range of particles. That study appeared in BMJ Open.

Still, homemade cloth masks are better than nothing. Is itas good as [masks from] medical grade, quality-controlled, assured storage,temperature-controlled warehouse? Probably not, Witt says. Is it good enough?Absolutely. A 2008 study of homemade cloth masks worn by members of thegeneral public, published in PLOS ONE,backs that up, finding that though imperfect, homemade masks can offersome protection against viral particles.

The mask needs to strike a balance between filteringcapabilities and breathability. Some materials, such as vacuum bags, are betterat filtering than others, a 2013 study in DisasterMedicine and Public Health Preparednesssuggests. But vacuum bags are hard to breathe through. Cotton T-shirtsoffer a breathable fabric that filtered microorganisms roughlyhalf as well as a surgical masks in those experiments.

Other work-arounds focus on 3-D printing, which can churnout hard, clear face shields that protect health care workers eyes and possiblyextend the life of face masks. Thats what the Qualcomm Institute at theUniversity of California, San Diego is attempting to do. Improvised visorswith some 3D-printed parts seem the most feasible, say engineer Ramesh Rao,the institutes director.

In response to the JAMAeditorials call for ideas, several health care workers suggested scuba masks.Theyre durable enough to be sterilized, they protect the eyes, nose and mouth,and best of all, they channel air through a small tube that a filter can beplaced in. Why not? Livingston says. It makes sense.

Livingston and colleagues are digging through the ideas, talking with experts and hoping to update people with guidance soon. But for now, I dont think anyone can say whats right or wrong, he says. People need to do their best.

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You can’t kill the coronavirus. That’s OK. – Mashable SE Asia

Some viruses look like moon landers.

Called phages, they hijack bacteria by landing on the hapless cells and injecting them with a ream of genetic material. Then, the phages use the commandeered cells to multiply.

Similar to the new coronavirus, these phages are excellent parasites. They can be aggressive, dogged, and seem to act with purpose. Yet, many microbiologists who know viruses best say it's a stretch to call any virus truly alive. And so, they can't be killed only disarmed, like pulling the plug on an appliance.

But today, with a rapidly spreading viral pandemic that's stirring serious unease in American emergency rooms, it doesn't really matter if a virus meets biologists' definitions of dead or alive. Whatever these entities are, they're powerful.

"It's more of a philosophical question," said Ryan Relich, a medical microbiologist at Indiana University's School of Medicine, of whether viruses are alive or not.

"What's more important is that they're winning," he said.

Today, the coronavirus isn't just winning. It's dominating us. It's closed our arenas. Shut down our bars. Emptied California beaches. The increasingly austere governor of New York is now demanding ventilators from the federal government. Our best, and most critical, defense until a vaccine is developed in a year at the earliest is social distancing: We're avoiding infected persons and hiding from the microbes themselves, which are basically genes surrounded by a shell.

Viruses, like coronavirus, have become globally dominant because they evolved to become master replicators. But they can't multiply alone, so they take over other cells and exploit this cellular machinery to multiply. It's exquisite parasitism. A single coronavirus-infected cell can manufacture millions of coronaviruses.

"Parasitism is an old, venerated way of making a living," said Siobain Duffy, who researches the evolution of viruses at Rutgers University.

6/

Now, lets get it out of the way: viruses are not alive. They do not possess all the characteristics of a living organisms so, no, you cannot kill them. You can, however, inactivate them, denature them, neutralize them, etc. pic.twitter.com/ODGVoa5q1J

Efra Rivera-Serrano, PhD (@NakedCapsid) March 17, 2020

A colorized image of a cell (brown) from a patient infected with coronavirus (pink).

Yet, unlike parasites such as intestinal worms, viruses are almost completely dependent upon the cells they hijack. "Viruses don't actually do anything on their own," explained Relich.

They don't breathe. They don't eat. They don't make energy. They appear mindless, floating around with the possibility of landing on a cell. "They don't get up and go to work every day," said Relich. "I dont consider them to be living. But hey, maybe you want to consider them to be alive so that its easier to personify them or rationalize things in a more palatable way."

So, microbiologists can make a good argument that viruses don't have the same hallmarks of living as do amoebas, elephants, and emus.

But maybe viruses are alive just in another sense of alive. After all, life has been evolving on Earth for some 3.8 billion years, noted Duffy. There are all kinds of curious things out there that might blur the boundary between alive and not alive. For example, there are viruses with longer genomes than bacteria (which we all agree are alive), and viruses that make some bacteria better at things, like photosynthesis. Our human DNA is embedded with some viral genetic material, too, noted Relich.

"Life continues to astound us."

"People want a clear dividing line between life and non-life," said Duffy. But that line might be blurrier than we think, she added.

The quandary of whether a virus can ever be killed, then, is a bottomless philosophical hole that may never have a certain answer. But it's safe to say, at least, that there are effective ways "to inactivate viruses or otherwise render them kaput," said Relich.

Chemicals like bleach and rubbing alcohols can massively damage the exterior wrappings of viruses, which for some include a fatty membrane envelope, making viruses useless. Thorough hand washing destroys these viral shells, too. Though there are no proven antiviral medications for coronavirus (and there may not be for many months), these types of drugs are designed to disrupt a virus' activity. For instance, the HIV drug Enfuvirtide blocks the virus from even attaching to human cells. Other drugs stop viruses from replicating, once they've already slipped inside a cell.

There's another very certain thing about viruses. Humanity has a ton to learn about them. There are countless species, and they're everywhere. "There are more viruses in this world than there are cells," said Duffy. But only 6,828 virus species have been formally named by scientists. Meanwhile, there could be millions more species out there. Finding and understanding theses microscopic entities could reveal much more about their nature, and "lives."

"We need more research, we need more researchers, we need more funding for research," said Relich.

Only in 1977 did humanity discover the third domain of life, a massive, ancient group of organisms called archaea (the other two domains are bacteria and eukaryotes which include humans.) What might the great diversity of viruses in this domain, still being discovered, tell us?

"Life continues to astound us," said Duffy. Indeed.

For now, we're focused on the minority of viruses that can threaten our ability to breathe, like the new coronavirus which can result in the serious respiratory disease COVID-19. And for good reason.

"It's to our own advantage to know our enemies as well as possible," said Relich.

Even if they can't be killed.

"Whether or not theyre alive, viruses influence life," said Duffy.

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You can't kill the coronavirus. That's OK. - Mashable SE Asia

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HaloVax Announces Agreement with Hoth Therapeutics – Citybizlist Real Estate

HaloVax, LLC a biopharmaceutical company and special purpose subsidiary of Voltron Therapeutics, Inc., announced they have reached an agreement with Hoth Therapeutics, Inc (NASDAQ: HOTH) (previously released) to advance an application of VaxCelerate, a self-assembling vaccine (SAV) platform licensed from the Vaccine and Immunotherapy Center (VIC) at Massachusetts General Hospital (MGH), to develop a vaccine designed to protect patients at risk of Coronavirus (COVID-19) infection. Voltron Therapeutics, Inc. has acquired an exclusive license to this technology.

HaloVax and Hoth, with the support of MGH, will work jointly on bringing this SAV to patients at risk of being infected with COVID-19. The VaxCelerate platform was developed to improve patient outcomes by engaging the immune system to identify and remove infectious agents. The technology initially demonstrated proof of concept in Lassa Fever, an emerging infectious disease, with the support of the Department of Defense (DoD). [REF] These same principles are being applied to developing a vaccine against the COVID-19 pandemic.

VaxCelerate offers two unique elements to combat the Coronavirus - one fixed immune adjuvant and one variable immune targeting. VaxCelerate offers several potential advantages over other compounds in combination therapy. In infectious applications, it allows rapid development against viruses and other pathogens. The vaccine focuses on both DNA and internal / external mutated proteins providing the immune system with more potential targets to attack.

Pat Gallagher, Voltron's CEO commented, "Voltron has been fortunate to work the team at the VIC and the Partners Organization for the past two years advancing our Self Assembling Vaccine (SAV) platform (developed at the VIC and licensed by Voltron). During this time, we have demonstrated the ability to both modulate and stimulate the immune system in a number of disease states. Data in four animal models in both infectious disease and oncology suggest the SAV's unique flexibility may have a clinically relevant impact in a number of settings. We believe that this platform can potentially help eradicate new pathogens as they emerge in a timely fashion. Our novel structural/manufacturing approach to vaccines could reduce development timelines and improve the patient experience. We are excited to be partnering with Hoth as we believe that that they have a strong SAB which can help Voltron's subsidiary, HaloVax, accelerate it's clinical work at some of the country's top hospitals. We are delighted to partner with Hoth to advance our COVID-19 vaccine."

VaxCelerate was created by Drs. Mark Poznansky, MD, PhD, and Jeffrey Gelfand, MD, who will continue to support its research and development, as COVID-19 has reached pandemic status. Dr. Poznansky is the Director of the Vaccine and Immunotherapy Center (VIC) and Physician at Massachusetts General Hospital and an Associate Professor of Medicine at Harvard Medical School. Dr. Poznansky will serve as both scientific founder and scientific advisory board member to help advise on the early clinical research and implementation of testing in the hospital setting as well as to help gather additional academic and clinical KOLs to serve on the SAB.

Dr. Gelfand is an infectious disease specialist in Boston, Massachusetts. He received his medical degree from Tufts University School of Medicine and has been in practice for more than 20 years. Dr. Gelfand specializes in infectious diseases. He is also a Clinical Professor of Medicine, where he has developed a novel approach for targeting (tumor) antigens whose sequence may not be known or structure even identified.

Dr. Mark Poznansky, Director, Vaccine and Immunotherapy Center, MGH stated, "The team at the Vaccine and Immunology Center at Massachusetts General Hospital is focused on developing a self-assembling vaccine (SAV) for COVID-19 through its existing VaxCelerate platform. The mobilization of T-cells in the eradication of viruses is well documented. Our experience in proof of concept studies supports the ability of SAV to evoke immune responses to viruses. Through our partnership with HaloVax, we look forward to collaborating with Hoth to bring this potentially lifesaving vaccine to the clinic and ultimately the population at large and especially individuals who are at risk for the most serious consequences of COVID-19 infection."

Dr. Michael Callahan, Chief of Translational Medicine, Vaccine and Immunotherapy Center, MGH said, "This SAV technology developed at the VIC, which has proof of concept data in infectious diseases and oncology in four animal models, has the potential to rapidly address the global COVID-19 pandemic. The customizable cellular immunity generated by the SAV may safely and effectively protect patients worldwide. Additionally, the SAV platform affords remarkable flexibility to alter or add targets if the Coronavirus begins to drift genetically. Having worked on many 'emergency' pandemics before, I believe that SAV could offer a number of advantages in treating patients and sparing healthcare workers."

The SAV program has intellectual property surrounding composition of matter. Incorporating HSP70 more broadly activates the immune system in contrast to prior vaccine efforts, which used classic adjuvants like alum, etc. The vaccine is >90% HSP70 and Aviden. Neoantigens are then incorporated to customize the vaccine.

About HaloVax, LLC

Halovax, LLC is a special purpose subsidiary of Voltron Therapeutics, Inc. The mission of HaloVax is to develop a novel, Self-Assembling Vaccine against COVID-19, utilizing technology licensed by Voltron Therapeutics, Inc. from the Vaccine and Immunotherapeutics Center at the Massachusetts General Hospital. The vaccine is being designed from a validated platform to provide customized cellular immunity against COVID-19, as well as be able to adapt rapidly to potential genetic drift of the virus. For more information, please visit http://www.HaloVax.com.

About Voltron Therapeutics, Inc

Voltron Therapeutics, Inc., a Delaware corporation, was founded in 2017 to lead and accelerate the development of the Vaccine and Immunotherapy Center (VIC), and the Massachusetts General Hospital's novel Self Assembling Vaccine technology in a variety of indications, including in Oncology and emerging Infectious Diseases. Voltron holds an exclusive worldwide license to this technology. With the work of our world class team of researchers and physicians, this technology has shown in certain pre-clinical studies initial proof of concept in two infectious diseases (Lassa Fever and Q Fever) as well as two oncology indications (Ovarian and HPV Related). For more information please visit http://www.voltrontx.com.

About Hoth Therapeutics, Inc.

Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing new generation therapies for dermatological disorders. Hoth's pipeline has the potential to improve the quality of life for patients suffering from indications including atopic dermatitis, chronic wounds, psoriasis, asthma and acne. To learn more, please visit http://www.hoththerapeutics.com.

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HaloVax Announces Agreement with Hoth Therapeutics - Citybizlist Real Estate

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