Category: Corona Virus Vaccine

Disclaimer: This post is from GomerBlog, a satirical site about healthcare.

CDC officials announced Tuesday that they believe the new vaccine currently under development aimed at controlling the rapidly spreading SARS-CoV-2 virus -- responsible for causing COVID-19 -- will be approved and ready to be utterly rejected by those in the anti-vaccination (anti-vax) movement by next year.

"This is an exciting development," said Eric Polsky, director of the CDC's Novel Vaccination Program, "and we will work tirelessly to ensure all anti-vaxxers have the opportunity to decline, refuse, and reject this potentially life-saving vaccine as early as possible."

The announcement has many in the anti-vaccination movement excited, including a local woman present at the press conference, who noted, "I just get such a thrill from ignoring mountains of scientific evidence at the danger of threatening the world around me, and the chance to do that by yet again opting out of a critical vaccine is just delightful."

At press time, officials noted conspiracy theories about the not-yet-developed vaccine containing mercury were spreading on Twitter.

Last Updated March 31, 2020

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CDC: Coronavirus Vaccine Will Be Ready for Refusal By Anti-Vaxxers By 2021 - MedPage Today

The past few weeks have revealed the worst and the best in human responses to the coronavirus crisis from the supermarket hoarders clearing the shelves to the neighbourhood groups organising help for elderly and vulnerable people.

When it comes to the pharmaceutical companies, how should we judge their response? They, after all, hold the key to ending the pandemic. Yet in one vital respect their behaviour has more in common with the supermarket hoarders than the neighbourhood groups.

Our exit strategy from the global lockdown depends on the development of an effective vaccine, as is well-known. A huge effort is under way to find such a vaccine, but we cannot afford to wait the 18 months it might take.

In the meantime, as the death toll increases, doctors are desperate for treatments that would lessen the impact of the virus, by shortening the infection, reducing its severity and in that way saving lives. There is now a global hunt for a coronavirus drug. But it is a fight against time. The focus is therefore on existing treatments already proved to be safe for other diseases which will need less testing and be easier and quicker to manufacture in quantity.

Scores of trials are under way around the world. The World Health Organization has identified four of the most promising therapies including an HIV combination treatment, an anti-malarial and a drug developed but never used against Ebola - for testing in a global trial launched last month. But we cannot pause the search while waiting for the results. The need for new effective agents is too great.

The best way to identify candidate drugs is to use artificial intelligence (AI) to crunch huge quantities of data to find the ones that might work. Major AI companies are putting their immense computing power at the service of scientists engaged in this hunt.

But they are being hampered: because some pharmaceutical companies are failing to share all of the data on potential candidate treatments that they hold. Like toilet roll profiteers, they are keeping it stashed in their digital attics and cellars where others cannot get at it, on the grounds that it is commercially confidential.

It was the open sharing of data around the world that allowed scientists to map the genome of the SARS-CoV-2 virus at unprecedented speed, working across institutional, commercial and international boundaries in a unique collective effort against a common global enemy. We now urgently need all pharmaceutical companies to set aside their individual commercial ambitions and join a similar collective effort to identify, test, develop and manufacture treatments to curb the disease.

There is a precedent. Last June, 10 of the worlds largest pharmaceutical companies including Johnson & Johnson, AstraZeneca and GlaxoSmithKline announced they would pool data for an AI-based search for new antibiotics, which are urgently needed as antibiotic-resistant bacteria have proliferated across the world, threatening the growth of untreatable disease.

That historic agreement was made possible by the development of a secure, blockchain-based system that allows an algorithm to search rival companies data with full traceability but without revealing commercial secrets to competitors. The advantage of using blockchain is that companies can trust the code rather than their partners.

AI researchers at the Massachusetts Institute of Technologys J-Clinic, who trained a neural network to predict which molecules will have antibiotic properties, announced in February that they had found a new compound which works against 35 different types of bacteria. They named it halicin, after the AI system in 2001: A Space Odyssey.

AI is now being harnessed across the globe in the hunt for a coronavirus treatment, from Hong Kong to Israel to the UK and US. Last month the worlds fastest supercomputer, the IBM Summit, identified 77 compounds as potential candidates. Last week an AI platform run by Gero, based in Singapore, identified six drugs already approved for human use in other conditions which could help combat Covid-19. Meanwhile, Thomas Siebel, the billionaire head of C3.ai, a Californian artificial intelligence company, announced a public-private consortium including Princeton, Carnegie Mellon University, MIT, the Universities of California, Illinois and Chicago, as well as C3.ai and Microsoft, which will provide scientists with funding and access to some of the worlds most advanced supercomputers in the search for solutions to the pandemic.

However, no matter how great the computing power or how advanced the software design, results from these initiatives will depend ultimately on the data fed into them. Without full access to comprehensive data, the scientists will be fighting with one hand tied behind their backs.

All pharmaceutical companies must unlock their chemical libraries so candidate drugs can be identified, and trials to test the most promising treatments begin as soon as humanly possible. We cannot wait. Lives depend on it.

Prof Ara Darzi is a surgeon and director of the Institute of Global Health Innovation at Imperial College London. He is a former Labour health minister

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The race to find a coronavirus treatment has one major obstacle: big pharma - The Guardian

Jennifer Haller receives the first administration of an mRNA vaccine, made by the biotech firm Moderna, against the pandemic coronavirus.

By Jon CohenMar. 31, 2020 , 5:15 PM

Sciences COVID-19 reporting is supported by the Pulitzer Center.

The coronavirus that for weeks had been crippling hospitals in her hometown of Seattle changed Jennifer Hallers life on 16 Marchbut not because she caught it. Haller, an operations manager at a tech company in the city, became the first person outside of China to receive an experimental vaccine against the pandemic virus, and in the days since, she has been flooded by an outpouring of gratitude. Theres been overwhelming positivity, love, and prayers coming at me from strangers around the world, Haller says. We all just feel so helpless, right? This was one of the few things happening that people could latch on to and say, OK, weve got a vaccine coming. Disregard that its going to take at least 18 months, but its just one bright light in some really devastating news across the world.

The vaccine Haller volunteered to test is made by Moderna, a well-financed biotech thathas yet to bring a product to market. Moderna and Chinas CanSino Biologics are the first to launch small clinical trials of vaccines against coronavirus disease 2019 (COVID-19) to see whether they are safe and can trigger immune responses. (The CanSino vaccine trial also began on 16 March, according to researchers from the Chinese militarys Institute of Biotechnology, which is collaborating on it.) An ever-growing table put together by the World Health Organization now lists 52 other vaccine candidates that could soon follow. This is a wonderful response from the biomedical community to an epidemic, says Lawrence Corey, a virologist at the Fred Hutchinson Cancer Research Center who has run vaccine trials against a dozen diseases but is not involved with a COVID-19 effort. Its both gratifying and problematic in the sense of how do you winnow all this down?

Broadly speaking, these vaccines group into eight different platformsamong them old standbys such as inactivated or weakened whole viruses, genetically engineered proteins, and the newer messenger RNA (mRNA) technology that is the backbone of the Moderna vaccineand their makers include biotechs, academia, military researchers, and a few major pharmaceutical companies. On 30 March, Johnson & Johnson (J&J) announced what it said could bea $1 billion COVID-19 vaccine project, with about half the money coming from the U.S. Biomedical Advanced Research and Development Authority if milestones are met.

Many viruses, including HIV and hepatitis C, have thwarted vaccine developers. But the new coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), doesnt appear to be a particularly formidable target. It changes slowly, which means its not very good at dodging the immune system, and vaccines against the related coronaviruses that cause SARS and Middle East respiratory syndrome (MERS) have worked in animal models. Corey heads the United Statess HIV Vaccine Trials Network, which has seen one candidate vaccine after another crash and burn,is optimistic about a SARS-CoV-2 vaccine. I dont think this is going to be that tough.

One concern is whether people develop durable immunity to SARS-CoV-2, which is crucial given that vaccines try to mimic a natural infection. Infections with the four human coronaviruses that typically cause minor colds dont trigger long-lasting immunity. Then again, researchers have found long-lasting immune responses to the viruses causing SARS and MERS, and genetically they are far more like SARS-CoV-2. And unlike cold-causing viruses, which stay in the nose and throat, the new coronavirus targets the lower respiratory tract, where the immune response to a pathogen can be stronger, says Mark Slifka, an immunologist who studies vaccines at the Oregon National Primate Research Center. When you get an infection in the lungs, you actually get high levels of antibodies and other immune cells from your bloodstream into that space.

Even with this all-out effort, Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases (NIAID), predicts getting a vaccine to the public is going to take a year, a year and a half, at least. And Fauci adds at least because side effects, dosing issues, and manufacturing problems can all cause delays. Already some are calling for an ethically fraught shortcut to speed up clinical trials: giving people candidate vaccines and then intentionally attempting to infect them to see whether theyre protected.

A new vaccine might also be made available to health care workers and others at high risk even before phase III efficacy trials are completed. And Stanley Perlman, a veteran coronavirus researcher at the University of Iowa, suggests a vaccine that only offers limited protection and durability could be good enoughat first. In this kind of epidemic setting, as long as you have something that tides us along and prevents a lot of deaths, that may be adequate, he says.

On 13 January, 3 days after Chinese researchers first made public the full RNA sequence of SARS-CoV-2, NIAID immunologist Barney Graham at sent Moderna an optimized version of a gene that would become the backbone of its vaccine. Sixty-three days later, the first dose of the vaccine went into Haller and other volunteers participating in the small trial at the Kaiser Permanente Washington Health Research Institute. In 2016, Graham had made a Zika virus vaccine that went from lab bench to the first volunteer in what he then thought was a lightning-fast 190 days. We beat that record by nearly 130 days, he says.

The effort benefited from lessons Graham learned from his past vaccine efforts, including his work on respiratory syncytial virus (RSV). The search for an RSV vaccine has a checkered past: in 1966, a trial of a candidate vaccine was linked to the death of two children. Later studies identified the problem as vaccine-triggered antibodies that bound to the surface protein of the virus but did not neutralize its ability to infect cells. This antibody-viral complex, in turn, sometimes led to haywire immune responses.

The World Health Organization has tallied dozens of vaccine candidates, based on a variety of technologies. Two have started human safety trials (*).

Studying the 3D structures of the RSV surface protein, Graham discovered that the dynamic molecule had different orientations before and after fusing with the cell. Only the pre-fusion state, it turned out, triggered high levels of neutralizing antibodies, so in 2013 he engineered a stable form of the molecule in that configuration. It was so clear at that point that if you didnt have structure, you didnt really know what you were doing, Graham says. An RSV vaccine that built on this concept hasworked wellinearly trials.

The experience came in handy in 2015, when a member of Grahams lab made a pilgrimage to Mecca, Saudi Arabia, and came back ill. Worried that it might be MERS, which is endemic in Saudi Arabian camels and repeatedly jumps into humans there, Grahams team checked for the virus and instead pulled out a common cold coronavirus. It was relatively easy to determine the structure of its spike, which then allowed the team to make stable forms of the spikes for the SARS and MERS viruses, and, in January, for SARS-CoV-2s. Thats the basis of the Moderna COVID-19 vaccine, which contains m RNA that directs a persons cells to produce this optimized spike protein.

Still a new strategy, no mRNA vaccine has yet reached a phase III clinical trial, let alone been approved for use. But producing huge numbers of vaccine doses may be easier for mRNA vaccines than for traditional ones, says Mariola Fotin-Mleczek of the German company CureVac, which is also working on mRNA vaccine for the new coronavirus. CureVacs experimental rabies vaccine showed a strong immune response with a single microgram of mRNA. That means 1 gram could be used to vaccinate 1 million people. Ideally, what you have to do is produce maybe hundreds of grams. And that would be enough, Fotin-Mleczek says.

Many companies are relying on time-tested techniques. Sinovac Biotech is making a SARS-CoV-2 vaccine byinactivating whole virus particles with formaldehyde and adding an immune booster called alum. Sinovac used the same strategy for a SARS vaccine it developed and tested in a phase I clinical trial 16 years ago, says Meng Weining, a vice president at Sinovac. We immediately just restarted the approach we already know. The companys SARS vaccine worked in monkeys and although there were concerns that an inactivated coronavirus vaccine might trigger the sort of antibody enhancement disease that occurred with the RSV vaccine, Meng stresses that no such problems surfaced in their animal studies.

Florian Krammer, a virologist at the Icahn School of Medicine at Mount Sinai, says inactivated virus vaccines have the advantage of being a tried-and-true technology that can be scaled up in many countries. Those manufacturing plants are out there, and they can be used, says Krammer, who co-authored a status report about COVID-19 vaccines that appears online inImmunity.

CanSino is now testing another approach. Its vaccine uses a nonreplicating version of adenovirus-5 (Ad5), which also causes the common cold, as a vector to carry in the gene for the coronavirus spike protein. Other vaccine researchers worry that because many people have immunity to Ad5, they could mount an immune response against the vector, preventing it from delivering the spike protein gene into human cellsor it might even cause harm, as seemed to happen in a trial of an Ad5-basedHIV vaccine made by Merck that was stopped early in 2007. But the same Chinese collaboration produced an Ebola vaccine, which Chinese regulators approved in 2017, and a company press release claimed its new candidate generated strong immune responses in animal models and has a good safety profile. I think pre-existing Ad5 immunity and HIV vaccine risk are not a problem, Hou Lihua, a scientist working on the project at the Institute of Biotechnology, wrote in an email to Science, noting that the Ebola vaccine trial results adds to their confidence that these will not be issues.

Disregard that [a vaccine is] going to take at least 18 months, but its just one bright light in some really devastating news across the world.

Other COVID-19 vaccine platforms include a laboratory-weakened version of SARS-CoV-2, a replicating but harmless measles vaccine virus that serves as the vector for the spike gene, genetically engineered protein subunits of the virus, a loop of DNA known as a plasmid that carries a gene from the virus, and SARS-CoV-2 proteins that self-assemble into viruslike particles. J&J is using another adenovirus, Ad26, which does not commonly infect humans, as its vector. These different approaches can stimulate different arms of the immune system, and researchers are already challenging vaccinated animals with SARS-CoV-2 to see which responses best correlate with protection.

Many researchers assume protection will largely come from neutralizing antibodies, which primarily prevent viruses from entering cells. Yet Joseph Kim, CEO of Inovio Pharmaceuticals, which is making a DNA COVID-19 vaccine, says a response by T cellswhich clear infected cellsproved a better correlate of immunity in monkey studies of the companys MERS vaccine, which is now in phase II trials. I think having a balance of antibody and T cell responses probably is the best approach.

Kim and others applaud the variety of strategies. At this early stage, I think it makes sense to try anything plausible, he says. As Stephan Bancel, CEO of Moderna, says, Nobody knows which vaccines are going to work.

Spurring many of the efforts in the nascent COVID-19 field has been the Coalition for Epidemic Preparedness Innovations (CEPI), a nonprofit set up to coordinate R&D for vaccines against emerging infectious diseases. So far, CEPI has invested nearly $30 million in vaccine development at Moderna, Inovio, and six other groups. We have gone through a selective process to pick the ones that we think have the greatest likelihood of meeting our goalswhich we think ought to be the worlds goalsof speed, scale, and access, says CEPI CEO Richard Hatchett.But he is rooting for other candidates as well. We dont want to be in a situation where we have [one] successful vaccine and we have a contamination event [during manufacturing] and suddenly we dont have any vaccine supply.

CEPI invests in manufacturing facilities at the same time it puts money into staging clinical trials. By doing things in parallel rather than in serial fashion, we hope to compress the overall timelines, Hatchett says. After reviewing phase I data and animal model data, CEPI plans to move six of the eight products into larger safety studies to arrive at three that are worthy of full-scale efficacy trials that enroll perhaps 5000 participants.

CEPI has less than $300 million in its coffers for the effort, and Hatchett estimates the price tag at $2 billion. He says CEPI hopes to raise this money from governments, private philanthropies, industry, and the United Nations Foundation.

Seth Berkley, who heads Gavi, the Vaccine Alliance, arguedin an editorial in the 27 March issue ofSciencethat the world needs to come together even more to streamline the search for a COVID-19 vaccine. If ever there was a case for a coordinated global vaccine development effort using a big science approach, it is now, Berkley wrote, stressing that there must be extraordinary sharing of data, coordination of clinical trials, and funding. You cant move 100 vaccines forward, he says.

Moderna and J&J both say that if everything goes perfectly, they could launch an efficacy trial with about 5000 people by late November and determine by January 2021 or so whether the vaccine works. Meng says that, depending on approval from Chinese regulatory agencies, Sinovac could move its vaccine through small phase I and II tests by June. But, because of Chinas success at controlling its epidemic, the company may have to find another country that has high transmission of SARS-CoV-2 to stage an efficacy trial quickly.

Haller has had no serious side effects from the mRNA injected into her arm but realizes that the phase I study will not determine whether the vaccine is effective. The chances of the one that I got being really anything? I dont know, Haller says. This is just the first of many, many vaccines, and its just stupid luck that I was the first one.

With reporting by Kai Kupferschmidt.

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With record-setting speed, vaccinemakers take their first shots at the new coronavirus - Science Magazine

The devastation that coronavirus is causing around the globe will come to an end, but the questions on everyones lips is 'how' and 'when'. Despite strategies deployed to contain and limit the spread of the disease, the answer to the first part of the question is with the introduction of a vaccine. The second part regarding a timescale is at best an estimation.

Numerous companies across the globe are attempting to find a workable vaccine, and progress has been aided by the sharing of early information on the virus by China. The analysis that has followed in laboratories has advanced at pace, with studies into just how Sars-CoV-2 infects human cells. It is believed that there are already at least four organisations with potential vaccines, which are being tested on animals to see the effects. One, by American company Moderna, is expected to enter human trials very soon.

It may not feel like it to the average person who is suffering through the current situation, but scientists have had a head start on finding a solution to Covid-19. We have, in recent memory, experienced other coronavirus epidemics - with Sars in China (2002-04) and Mers from Saudi Arabia (2012) - and the work being done on a vaccine now builds on the back of that done then and put to one side.

Picture shows containers for the samples taken to drivers at a drive-through testing point for the COVID-19 disease at the University Hospital in Burgos.CESAR MANSO(AFP)

Human clinical trials take time. First the vaccine must be checked for safety, then for effectiveness to a group of a few hundred, and finally in a much larger group. Jumping ahead of this process - which can be tempting given the large number of people dying on a daily basis - is not prudent and this is why having a decent batch of candidates is important. Many of them will fail at one of the stages, and the hope is that one of them passes through to final approval.

Despite the blindly optimistic claims from US President, Donald Trump in early March, vaccines have sometimes taken decades to reach that approval stage. The general advice from the experts in this field suggest that around 18 months will be required. That takes us to the summer of 2021, quite some distance away, but a relatively speedy delivery in the world of vaccinologists.

Sin tituloA researcher works on the development of a vaccine against the new coronavirus COVID-19, in Belo Horizonte, state of Minas Gerais, Brazil.DOUGLAS MAGNO(AFP)

And having a vaccine approved is sadly not the end of the process. Political and economic challenges can make it a complicated to get the vaccine out to the many millions who require it. Often countries prioritise their key workers, like those in healthcare, as well as the defined at risk groups of the population. Richer countries tend to use their financial muscle too, meaning others can lose out relatively.

Providing people with an accurate date therefore of when a vaccine for Covid-19 will be ready for them to be administered is impossible. The belief is that we will come out of the worst of this, and possibly go through another spell at least, before one is ready for the general population. Clearly, there is an abundance of work being done to have it available as soon as it can be. Until then, the general advice of isolation, distancing, hygiene, etc, as well as the introduction of mass testing, must be followed to keep the spread in check.

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Coronavirus: when will the vaccine be ready? - AS South Africa

The biopharmaceutical industry will be able to make a Covid-19 vaccine probably a few of themusing various existing vaccine technologies. But many people worry that Covid-19 will mutate and evade our vaccines, as the flu virus does each season. Covid-19 is fundamentally different from flu viruses, though, in ways that will allow our first-generation vaccines to hold up well. To the extent that Covid does mutate, its likely to do so much more slowly than the flu virus does, buying us time to create new and improved vaccines.

Every virus has a genome composed of genetic material (either RNA or DNA) that encodes instructions for replicating the virus. When a virus infects a cell, it accesses machinery for making copies of its genomic instructions and follows those instructions to make viral proteins that assemble, with copies of the instructions, to form more viruses (which then pop out of the cell to infect new cells, either in the same host or in someone new).

There is a critical difference between coronaviruses and flu. The novel coronavirus genome is made of one long strand of genetic code. This makes it an unsegmented viruslike a set of instructions that fit on a single page. The flu virus has eight genomic segments, so its code fits on eight pages. Thats not common for viruses, and it gives the flu a special ability. Because the major parts of the flu virus are described on separate pages (segments) of its genome, when two different flu viruses infect the same cell, they can swap pages.

Imagine two people with eight-page reports fighting over a copy machine. In the tussle, some copies might turn out to have a mix of pages from two different reports. This page-swapping process, where viruses exchange parts of their genome, is called reassortment. The flu can change rapidly when multiple strains pass through the same host. But coronavirus, as a one-page report, tends to stay together, and while coronaviruses can swap sectionsin a process known as recombinationit is difficult to achieve and thus rare. (Imagine two pages ripping in the same way and swapping pieces that get glued together again.)

Coronavirus does mutate. All viruses mutate, in a way that can be likened to typos introduced by the copying process. Instead of a copy machine, imagine that a page of text is read by a scanner that then attempts to transcribe the words into a text file. The scanner may transcribe a page of text imperfectly, introducing a I for a l, and when thats printed out and then scanned again, the scanner makes more transcription mistakes on top of the old ones. After many cycles, the accumulating mutations in the code cause features of the virus to change gradually, a process called drift. When flu virus swaps entire pages with a different flu virus in a reassortment, we call that shift. Drift through typos tends to cause small changes. Shift through reassortment causes bigger ones.

A vaccine is like a description of a wanted criminal: it tells your immune cells whom to look out for. So long as the suspects appearance doesnt change too much, then the vaccine works. To the extent that the flu virus we see one year is only slightly different than the ones weve seen in recent years, our immune systems are at least partially prepared, and so we are partly protected. Even if we do get infected, it might be a milder illness because our immune system can react more quickly to fight it off.

Laboratories around the world are constantly surveilling todays flu strains and giving flu-vaccine manufacturers a heads-up as to what the viruses look like. So if we see a new strain of flu in Asia, its probably a good idea to start making a vaccine against it for the U.S. before that strain comes to our shores. Because large-scale manufacturing of current flu vaccines takes about six months from the time when we spot a new flu strain, the vaccines are six months out of date by the time we get them. Some years, the flu swaps out a genomic page with a less familiar strainmaybe one we havent seen for a decade or soand we get the vaccine wrong. When that happens, we suffer through a bad flu season, since our immune systems are less ready to fight it off.

In the worst case, the flu can suddenly pick up a page from a bird- or pig-flu strain to which most humans have had zero exposure. This can be far more deadly, because the new virus can evade our herd immunity entirely, cutting through the population unopposed. Thats a flu pandemic.

Todays novel coronavirus was brewing within bats for a long time, mutating into its current form through various typos and, to a lesser extent, rare recombination events among coronaviruses. Now that its here, its as new to us as a shifted flu strain that weve never seen before, and its causing a pandemic. But once weve developed a vaccine for this strainand once weve all taken itwell have herd immunity to it.

That immunity may fade as our immune system forgets the picture that the vaccine showed it, but we can solve that by getting booster shots of the same Covid-19 vaccine periodically. What we dont have to worry about is the virus rapidly mutating away from our vaccines as fast as flu can, because owing to its simplicity, it cant pull off the flus face-swapping tricks.

We hear reports that the novel coronavirus is already mutating into new strains, but these mutations are minor, and theyre unlikely to add up to anything significant. Even identical human twins have many genetic differences between them, but we still think of them as identical. In the case of Covid-19, very few of the changes weve seen so far would affect a vaccine. But if such changes do accumulate over time, our vaccine programs will be able to keep up.

Think of it this way: if flu evolves with the speed of a growing vine, then coronavirus is like a cactus. If you look very closely, a cactus can appear to be changing from day to day, but its nothing like a vine.

Were now inventing new vaccines from scratch and could plausibly go from nothing to a marketed vaccine in about a year. If laboratories around the world detect that this coronavirus is changing gradually, well most likely have time to match new strains before they change enough to cause a new outbreak. Rest assured: a vaccine is coming, it will work, and it will continue to work for as long as humanity must contend with Covid-19. Until then, we must maintain our social distancing so that our strained health-care system can keep up with the infections that we cant seem to prevent.

Peter Kolchinsky, a biotechnology investor and scientist, is Managing Partner of RA Capital Management, L.P., and author of The Great American Drug Deal.

Photo: Meyer & Meyer/iStock

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A Coronavirus Vaccine Is Coming, And It Will Work - City Journal

While many scientists are working on developing a coronavirus vaccine, others are busy testing antiviral drugs.

Vaccines are generally only effective when administered prior to infection, but antiviral agents are important because they can treat people who already have COVID-19.

Heres an overview of antiviral drugs scientists are investigating for coronavirus.

Read more: How does coronavirus kill?

How do antiviral drugs work? First, its important to understand the genome of animals and plants is composed of deoxyribonucleic acid (DNA), but viral genomes can also be comprised of ribonucleic acid (RNA). This is the case for SARS-CoV-2 coronavirus the virus that causes COVID-19.

In order to replicate, an RNA virus needs to make more copies of its RNA genome. This means antiviral drugs which block the copying of RNA genomes can potentially help treat COVID-19 patients. These drugs are known as RNA-polymerase inhibitors.

Read more: Here's why the WHO says a coronavirus vaccine is 18 months away

These types of drugs have successfully cured people of chronic hepatitis C another RNA virus infection.

But not all viral RNA polymerases are the same, so the drugs that work for hepatitis C virus will not necessarily work for human coronaviruses.

Favilavir is an RNA polymerase inhibitor drug scientists are currently trialling against coronavirus.

Another successful antiviral drug strategy is to use non-functional analogues, or inauthentic copies of the basic building blocks of the viral RNA genome. The presence of these analogues in the viral genome blocks the viral polymerase, meaning the virus cannot make another copy of its RNA. Acyclovir, ribavirin and azidothymidine (AZT) are examples of these drugs.

Unfortunately, this coronavirus is a bit tricky, because it proofreads the authenticity of its RNA genome. As such, it identifies the analogues as being inauthentic and removes them. This stops certain antiviral drugs like ribavirin from being effective.

Fortunately, the coronavirus proofreading powers dont block a similar drug, remdesivir. So remdesivir potently halts coronavirus replication and represents a promising drug option for COVID-19 patients.

Remdesivir is also effective against other RNA viruses including Ebola virus and the coronaviruses SARS and Middle Eastern respiratory syndrome (MERS).

Scientists are currently assessing remdesivir in clinical trials in the United States and China. Time will tell if remdesivir is effective for COVID-19 patients. But doctors are already considering how the drug is best administered for optimal results and whether it should be used in combination with other drugs or as a single agent.

Read more: COVID-19 treatment might already exist in old drugs we're using pieces of the coronavirus itself to find them

Many RNA viruses produce a single multi-protein thats later broken down into individual proteins via enzymes called proteases. Any molecules that inhibit these proteases have potential as antiviral drugs. Viral protease inhibitor drugs have been highly effective in treating the human immunodeficiency virus (HIV) and hepatitis C virus.

Lopinavir and ritonavir are a combination protease-inhibitor drug (Kaletra) that can inhibit coronaviruses in human cells. Kaletra has already been used to treat a patient with COVID-19 in South Korea, but a larger trial found its effects were unconvincing. The reasons for these discrepancies are currently unclear and more research is obviously needed.

With any antiviral drug, the sooner its administered once a patient is infected, the better the outcome. This is because viruses replicate quickly, producing tens to hundreds of new infectious viruses.

In respiratory infections caused by influenza or SARS-CoV-2 viruses, clinically serious infection involves whats called a cytokine storm. Here, a strong immune response results in the production of high levels of inflammatory mediators: cytokines and chemokines.

These molecules recruit inflammatory cells to the site of the virus infection, for example, the lungs of patients with COVID-19. These cytokines and cells then fight the virus infection, but their presence also partly obstructs the air sacs where oxygen exchange occurs.

Researchers are now considering add-on therapies that partly limit the inflammatory response by blocking the effects of certain cytokines and chemokines. These add-on therapies include antibody-based drugs, such as tocilizumab that blocks the interleukin-6 cytokine receptor or leronlimab that blocks the chemokine receptor CCR5. When cytokine receptors and chemokine receptors are blocked then it matters less that there are high levels of cytokines or chemokines, because their effects are significantly minimised.

The good news is antibody-based drugs have minimal side effects, and have proved effective for many human chronic inflammatory diseases. Expanding these drugs for use in COVID-19 patients is therefore an attractive possibility. Although this would require caution for careful dosing, and these drugs would need to be co-administered together with an antiviral drug.

Chloroquine, a well-known anti-malarial drug, has also gained attention. One study tested it together with a broad-spectrum antibiotic azithromycin. While some COVID-19 patients in this small study recovered, other patients died (despite chloroquine treatment), and some patients ceased treatment for a variety of reasons including the severity of their symptoms.

Nevertheless, people are interested in how chloroquine and azithromycin might work for coronavirus. Chloroquine exhibits antiviral activity and is currently used to treat autoimmune diseases because it also has anti-inflammatory properties. Azithromycin is an antibiotic used to treat bacterial infections, but it, too, exhibits antiviral activity, including against rhinovirus that causes the common cold. Chloroquine might need to be given early after infection to be most effective against coronavirus.

Read more: Could chloroquine treat coronavirus? 5 questions answered about a promising, problematic and unproven use for an antimalarial drug

The World Health Organisation has announced a global clinical trial program testing possible COVID-19 treatments, including remdesivir, lopinavir/ritonavir, chloroquine, and certain antiviral cytokines.

The escalating number of coronavirus patients worldwide means alongside vaccine development, the focus must remain squarely on finding effective antiviral drugs that can treat those already seriously ill from SARS-CoV-2 infection.

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In the fight against coronavirus, antivirals are as important as a vaccine. Here's where the science is up to - The Conversation AU

Johnson & Johnson says it could have a COVID-19 vaccine available by early 2021 with the capability to produce as many as a billion doses. In a press release, the company says its planning to start clinical trials in September and has begun investing in a rapid production capability to make the vaccine at scale should it prove safe and effective. Johnson & Johnson began work on a possible vaccine in January and has now selected a lead candidate vaccine and two backups which will enter early production phases to prepare for the expected overwhelming demand. If early trials validate the companys vaccine, the company would need an emergency use authorization from the FDA to begin providing the vaccine.

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Johnson & Johnson Says It Could Have Coronavirus Vaccine Ready by Early 2021 - The Daily Beast

The race to stop the fast-spreading coronavirus is on. Its going to be a long road to safe and effective treatment, but pharmaceutical companies and research facilities are exploring a variety of therapeutics to find a way to combat the virus.

Pharmaceutical companies are studying drugs already approved by the Food and Drug Administration to see if any might work in fighting COVID-19, the disease caused by the novel coronavirus. Simultaneously, companies are in the process of developing vaccines for the virus that can be deployed to protect the uninfected population.

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Repurposed drugs could be a faster route to an effective treatment, but they would still need to go through clinical testing to ensure their effectiveness. Malaria drug hydroxychloroquine and Ebola antiviral remdesivir are being tested in small batches of infected patients. Even with promising results, its unclear at this time whether any of these treatments will be successful in the larger population.

A vaccine tailored to combat the virus is the long-term solution. But according to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, the earliest a coronavirus vaccine would be deployable would be a year to 18 months from now. Any vaccine would have to go through three phases of clinical trials and then apply for approval by the FDA.

Johnson & Johnson in a partnership with Janssen Pharmaceuticals identified a lead vaccine candidate. They expect to initiate human clinical trials by September and the first batches could be available for emergency use in 2021.

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NBC News compiled a list of some of the potential treatments and where they stand in development. This work is ongoing and will be updated as time goes on and more pharmaceutical companies jump in to do their part to find a way to combat the virus.

Emily Siegel is an associate producer with the NBC News Investigative Unit.

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Tracking the development of coronavirus treatments - NBC News

As the worldwide spread of the COVID-19 virus continues, with countries facing lockdowns and hospitals dealing with unprecedented demand, a research team at the USC Viterbi School of Engineering is working around the clock on a new vaccine, the school announced Saturday.

The team is also looking at isolating the human antibodies that can successfully fight the viral infection in order to create working therapeutic treatments to improve recovery times for COVID-19 patients, according to researchers.

The research is led by Prof. Pin Wang, Zohrab A. Kaprielian Fellow in Engineering and Professor of Chemical Engineering and Materials Science and Biomedical Engineering. Wang's lab specializes in the emerging field of immunobioengineering, which uses engineering tools to better understand the immune system and develop novel molecular and cellular immunotherapies.

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To create the vaccine, Wang and his team have engineered a hybrid virus, the core of which is based on that of the vesicular stomatitis virus; a family of viruses which includes rabies among others. The surface of the hybrid virus is then covered with spike proteins derived from the COVID-19 virus.

"The reason that this hybrid virus can be a good vaccine format is that by having the COVID-19 surface protein, this can hopefully trick our immune system into recognizing it," Wang said. "That way we can induce the neutralizing antibody to stop the virus from infecting us in future."

Wang said the team is "hoping we'll have a very potent product compared to other vaccine platforms."

This type of vaccine is known as a vectored vaccine and does not contain the harmful components of original viruses, and thus has safety benefits as opposed to vaccine forms using live-attenuated viruses, he said.

Wang said the vaccine research was also looking into ways in which cells' immune response works to combat the virus so that this process can be replicated in the development of therapeutics to manage COVID-19.

"If we can immunize animals like mice, then we can isolate the B cells that can generate antibodies; antibodies that can neutralize the virus," Wang said.

Excerpt from:

USC Working on Coronavirus Vaccine, Researchers Announce - NBC Southern California

For biotechnology companies, responding to a sudden public health crisis, like the coronavirus, can be risky business. It can take more than a year to develop a vaccine or treatment. By that time, the threat may be gone, leaving little or no demand for a drug.

The current coronavirus pandemic appears to be different.

The race to beat the pathogen is on, with many biotechs now expecting a large market for coronavirus therapies in 2021 or beyond.But the starting gun didn't fire right away when the virus began spreading late last year.

"There were a lot of companies that kind of felt once bitten, twice shy," saidJose Trevejo, chief executive of SmartPharm Therapeutics in Kendall Square.

Companies were shy because drug makers have been bitten in the past when they've hustled to confront an outbreak, only to see the danger subside and their efforts go to waste. That's what happened during a previous coronavirus scare the SARS outbreak of 2003, which ended before any vaccine maker could earn a buck.

"There was also Ebola, and then a lot of people forget about the swine flu the H1N1," Trevejo said. "So, I think a lot of big pharma were a bit hesitant to plunge fully into coronavirus."

In recent weeks, the industry's view has changed. At LabCentral, the shared workspace where Trevejo's gene therapy startup operates, more than a dozen companies have turned their attention to the coronavirus, including SmartPharm.

And that's just one lab in Cambridge.

The number of companies pursuing coronavirus drugs is constantly growing, according to Yasmeen Rahimi, co-head of biotechnology research at Roth Capital Partners, an investment banking firm in Newport Beach, Calif.

"I track COVID-19 on a daily basis," she said. "Almost every day we get 10 or 12 companies that are coming."

Rahimi said the most notable may be Moderna, another Cambridge biotech. It's the first company to begin testing a potential coronavirus vaccine on humans in the U.S.

Moderna didn't respond to an interview request. But in a public document this week, the company said that "a commercially-available vaccine is not likely to be available for at least 12-18 months."

Moderna doesn't think the virus will peter out by then. Instead, it is "scaling up manufacturing capacity toward the production of millions of doses per month."

That may not be enough, according to Dr. Lee Wetzler, an infectious disease specialist at Boston Medical Center.

"Just like the flu vaccine, you're talking not just millions of doses," said Wetzler, who is also a professor at Boston University School of Medicine. "Tens tens of millions of doses and even more."

Then again, Wetzler added, it's hard to predict what this previously unknown virus will look like a year from now. It's possible that the pandemic will be under control, which would be good for the world but maybe not so good for companies, like Moderna and others, investing in drugs to stop it.

There's a cautionary tale in theonce-hot biotech Vical, which received federal money to chase vaccines for anthrax, SARS and Ebola. The fear and the funding always faded before Vical could cross the finish line, said John Carroll, editor of Endpoints News, a biotech publication.

"What Vical did was just flame out," he said. "They weren't able to come up with a vaccine and, after repeated failures, they just couldn't make it anymore."

The risk of failure is well understood by James Sietstra, chief business officer of Totient, one of the startups at LabCentral that have shifted to the coronavirus. But he maintains that working on the coronavirus won't be futile, even if the disease runs its course before Totient can bring a drug to market.

"As a business case for us, this is a great proof point for the power of our platform," he said.

Sietstra said the same method Totient will use to attack the coronavirus could also be used against other diseases including the company's original target, cancer.

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Vaccine Development Is Risky Business. Biotechs Are Tackling The Coronavirus, Anyway - WBUR